prijzen hiv-medicatie nederlandse antillen

Challenges to getaccess toaffordable treatment

April 2009Dokters van de Wereld

ARV PRICESin the Netherlands Antilles

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Challenges to getaccess toaffordable treatment

A.M. DiazDokters van de Wereld / Médecins du MondeThe Netherlands

With the support of the Royal Tropical InstituteThe Netherlands

April 2009

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Correspondence to: [email protected]

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TABLE OF CONTENTS

ABSTRACT ----------------------------------------------------------------------------------- 6

1. INTRODUCTION ----------------------------------------------------------------------7

2. BACKGROUND -----------------------------------------------------------------------8

2.1 General Context --------------------------------------------------------------------- 8

2.2 Health Care System ---------------------------------------------------------------- 10

2.3 HIV/AIDS ---------------------------------------------------------------------------- 12

3. PROBLEM STATEMENT ----------------------------------------------------------- 16

4. OBJECTIVES AND RESEARCH QUESTIONS ---------------------------------- 17

5. METHODS --------------------------------------------------------------------------- 18

6. RESULTS ---------------------------------------------------------------------------- 20

6.1 ARV costs, price composition and affordability ---------------------------------- 216.1.1. How are ARV prices composed in the Netherlands Antilles? ---------- 216.1.2. What are the current costs of ARV drugs in the Netherlands Antilles? ------------------------------------------------------- 226.1.3. How are these costs compared to regional and international reference prices? --------------------------------------------------------- 266.1.4. How affordable are ARV drugs in the Netherlands Antilles? ----------- 32

6.2 Underlying causes of high ARV prices -------------------------------------------- 356.2.1. What are the underlying causes at local level? -------------------------- 356.2.2. What are the underlying causes at kingdom/ international level? ----- 36

6.3 Policy options to improve access to affordable ARVs ------------------------- 406.3.1 What has so far been done and achieved with regards to the issue? - 406.3.2. What ways to improve access to affordable ARV drugs do stakeholders suggest? ------------------------------------------------------ 43

7. DISCUSSION------------------------------------------------------------------------ 53

7.1 ARV costs, price composition and affordability-------------------------------- 537.2 Underlying causes of the high ARV prices -------------------------------------- 547.3 Policy options to improve access to affordable treatment -------------------- 54

7.3.1. Options that may effect the import price --------------------------------- 55

7.3.2. Options that may effect price components ------------------------------- 56

7.3.3. Options for further lobby and advocacy ---------------------------------- 57

8. CONCLUSIONS AND RECOMMENDATIONS ----------------------------------- 59

ACKNOWLEDGEMENT -----------------------------------------------------------------

LIST OF REFERENCES ------------------------------------------------------------------

ANNEXES ---------------------------------------------------------------------------------

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LIST OF ABBREVIATIONS

AAI Accelerated Access InitiativeAIDS AcquiredImmuneDeficiencySyndromeAIPPI International Association for the Protection of Intellectual PropertyANG Netherlands Antillean GuilderARV Anti RetroviralAWG Aruban GuilderAZV General Health InsuranceBNA Bank of the Netherlands AntillesBZV Bureau Ziektenkosten VoorzieningenCAREC Caribbean Epidemiology CentreCARICOM Caribbean CommunityCBS Central Bureau of StatisticsCHAI Clinton HIV/AIDS InitiativeCIF Cost, Insurance & FreightCOHSOD Council for Human and Social DevelopmentCUR CuraçaoDEZ Department of Economic AffairsEPC European Patent ConventionERNA Island Regulation Netherlands AntillesEU European UnionFDA French Departments of the AmericasFZOG Health insurance fund for retired government employeesGDP Gross Domestic ProductGGD Department of Medical and Public ServicesGNI Gross National IncomeGP General PractitionerGSK GlaxoSmithKlineGST Goods and Services TaxGVS Reference Pricing SystemHAI Health Action InternationalHAART High Active Anti Retroviral TherapyHDI Human Development IndexHIV HumanImmunodeficiencyVirusHMF HIV Monitoring FoundationIDA International Dispensary AssociationIOM International Organization for MigrationLDC Least Developed CountriesMDG Millenium Development GoalsMDM Médecins Du MondeMOH Ministry of HealthMOU Memorandum of UnderstandingMPR Mean Price RatioMSD Merck, Sharp & DomeMSF Médecins Sans FrontièresMSH Management Sciences for HealthMSP Manufacturer’s Selling Price NA Netherlands AntillesNASHKO Netherlands Antilles Foundation for Clinical Higher Education NGO Non Governmental OrganizationNSP National Strategic PlanOCT Overseas Territories of the Caribbean

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OECS Organization of Eastern Caribbean StatesPANCAP Pan Caribbean Partnership Against HIV/AIDSPAHO Pan American Health OrganizationPEPFAR U.S. President’s Emergency Plan for AIDS ReliefPLWHA People Living with HIV/AIDSPP Pro PauperRNA Ribonucleid AcidROW Rijks Octrooi WetSEHOS St Elisabeth HospitaalSF Strategic FundSFK Stichting Farmaceutische KengetallenSMMC St Maarten Medical CentreSTD Sexually Transmitted DiseaseSVB Social Security BankSXM St MaartenTRIPS Trade Related Aspects of Intellectual Property RightsUN United NationsUNAIDS Joint United Nations Programme on HIV/AIDSUNDP United Nations Development ProgrammeUNFPA United Nations Population FundUNGASS United Nations General Assembly Special Session on HIV/AIDSVAT Value Added TaxVCT Voluntary Counseling and TestingWHO World Health OrganisationWTO World Trade Organisation

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ABSTRACT

‘ARV prices in the Netherlands Antilles;Challenges to get access to affordable treatment’

KEY WORDS: Netherlands Antilles, anti retroviral therapy, drug prices, access to treatment

PROBLEM STATEMENT/ OBJECTIVES High prices for ARV drugs in the Netherlands Anti-llesconstituteafinancialburdenforthehealthcaresystem,andpresentabarriertopeoplein need of accessing antiretroviral treatment. This study aims to elucidate prices, price com-position and affordability of ARV drugs. Furthermore, it describes factors contributing to high ARV prices, and strategies that may result in effective price reductions.

METHODS ARV procurement prices were gathered at three different locations. Information on price composition was found through local health authorities. Prices per unit were com-pared to international/regional reference prices using WHO/HAI methodology. Affordability was determined by comparing it to the number of days wages paid for treatment by the low-est paid unskilled government worker. Through semi-structured interviews, factors contribut-ing to high ARV prices and suggestions for effective ways to tackle the ARV price issue were explored.Thesesuggestionswereverifiedbyconsultingexperts,andbyliteratureresearch.

FINDINGS Pricesaresignificantlyhigher than internationaland regional referenceprices,and comparable to those in Aruba and in the Netherlands. Treatment is unaffordable ac-cording to WHO/HAI criteria. Factors contributing to high ARV prices include a small-scale market, relatively high GNI per capita, high mark-ups, and limited political will. The constitu-tional status of the Netherlands Antilles is an important additional contributing factor. Options to effectively reduce ARV prices include pooled procurement, price negotiations, limiting maximum mark-ups, challenging patent laws, regional collaboration and increased political commitment, both at the local and Kingdom level.

DISCUSSION/ CONCLUSION There are various options to tackle the ARV price issue, and improve access to HIV treatment. Political commitment is crucial to establish effective meas-ures.

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1. INTRODUCTION

The price and affordability of medicines are major determinants of access to treatment. This is even more so for chronic diseases including HIV, where the continuous need for treatment, mayhavemajorimpactonfinancialresourcesoftheindividualorinstitutethatisresponsiblefor carrying the costs. Not only developing countries are struggling with high prices. Also countries known as high income countries, including the Netherlands Antilles, are facing dif-ficultiesinprovidingsustainableHIVcareandtreatment.

In line with the WHO/UNAIDS universal access goals, Dokters van de Wereld is exerting itself to improve access to HIV care and treatment as part of an effective response against the HIV epidemic. During the preparation phase of an integrated comprehensive Dokters van de Wereld HIV program in Curaçao, which included the introduction of voluntary counseling and testing(VCT)units,thepricesofHIVtreatmentwereidentifiedasanimportantobstacletosuccessful program implementation.

Alarmed by reports on limited access for the uninsured, and discontinuity of treatment be-cause of drug stock-outs, Dokters van de Wereld took up the initiative to investigate prices, price composition and affordability of ARV drugs in the Netherlands Antilles, and to explore what factors are contributing to elevated ARV prices. Moreover, it studied possible ways to increase access to affordable drugs.

Investigating drug prices in the Netherlands Antilles has proved to be a complicated matter. It touches commercially and politically sensitive issues. Data were not available in the public domainanditwasdifficulttogatherthecorrectinformation.However,thankstothesupportof individuals concerned about the high ARV drug prices, it was possible to complete the research activities and to write this report.

Through this, Dokters van de Wereld aims to provide a reference document about the issue of high ARV prices in the Netherlands Antilles for stakeholders and policy makers, which will facilitate further actions to reduce ARV prices and will consequently remove obstacles for the implementation of a comprehensive HIV care and treatment program of high quality.

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2. BACKGROUND

2.1 General Context

The Netherlands Antilles consists of five islands in the Caribbean archipelago: the sou-thern Leeward Islands of Bonaire and Curaçao just 60 km off the Venezuelan coast, and the northern Windward Islands of Saba, Sint Eustatius, and Sint Maarten (the latter being the southern portion of an island shared with France), located 900 km to the North East. The islands form an autonomous part of the Kingdom of the Netherlands. Curaçao, with an area of 444 km², is the largest of the islands, and its capital, Willemstad, is the seat of the Nether-lands Antilles’ central government.

DemographyAccording to the Central Bureau of Statistics (CBS), the total Netherlands Antilles population is 197.184. The distribution of the population per island: Bonaire 12.103, Curaçao 140.796, Saba 1.524, St Eustatius 2.754 and St Maarten 40.007 (CBS, 2007).

Positive population growth has occurred over the past few years. Migration, mostly from other Caribbean states, represents an important determinant of population growth. In the year 2007 8.530 people immigrated, while 6.089 people emigrated (CBS, 2007). However the total number of people entering the Netherlands Antilles is assumed to be much higher, withmanyenteringillegallyandthusnotbeingrepresentedinofficialdata.Accordingtoanimmigration lawyer (personal communication, Biegelaar, 2006), the Department of Immigra-tion estimates that the current number of unregistered migrants in Curaçao alone is between 20.000 and 40.000. Anecdotal reports suggest that St Maarten has an even higher percen-tage of unregistered inhabitants.

Socioeconomic SituationWhen compared with surrounding Caribbean islands, the Netherlands Antilles (NA) is rela-tively wealthy. In 2004, the NA Gross National Income (GNI) per capita was 31.105 Nether-lands Antillean Guilders (ANG) (= 17.377 US dollars)1 (CBS, 2004).

CBSdatafrom2006showasignificantincreaseinGNIcomparedtothepreviousyear(Cu-raçao1.5%Bonaire3.0%StMartin5.2%).Despitethesefigures,theNetherlandsAntillesfacessocioeconomicdifficulties.AccordingtotheCentralBankoftheNetherlandsAntilles(BNA) national debt at 31 December 2005 was 2.79 billion US dollars, which is approximately 85.6% of the Gross Domestic Product (GDP).

A poverty assessment survey conducted by the Central Bureau of Statistics in 2004–2005 (1) revealed that the percentage of households with a very low monthly income (equivalent to approximately US$ 280 adjusted for household size) ranged from 5.3% on Saba to 16.1% on Curaçao,withanoverallaverageof14.0%forthefiveNetherlandsAntillesislands.

1TheexchangeratefortheUSdollarisfixedatarateof1,79

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Table 2.1

Distribution of Households by Equivalent Income2 and Island

Gross monthly income in ANG

Bonaire Curaçao St Maarten St Eustatius Saba

%

<= 500 6.0 16.1 10.9 14.1 5.3

501 – 1000 15.5 19.1 24.5 28.2 14.5

1001 – 1500 23.1 20.2 19.8 13.4 22.9

1501 – 2000 19.6 15.5 14.9 14.1 16.8

2001 – 2500 10.8 7.5 10.1 10.7 16.0

2501 – 3000 9.5 6.7 8.7 7.4 7.6

3001 – 3500 7.6 3.7 4.1 5.4 8.4

3501 – 4000 2.5 4.1 1.1 3.4 5.3

4001 - 4500 2.8 1.9 2.7 0.7 1.5

4501 – 5000 0.6 1.3 0.8 0.7 1.5

5001 – 5500 0.3 0.4 0.5 0.7 -

> 5500 1.6 3.4 1.9 1.3 -

Source: 2004-2005 Budget Survey, CBS

Table 2.2 below shows the household distribution of wealth by island. In Bonaire and Saba, households with the lowest 20% (quintile) of household income receive approximately 6 times less than the highest 20% quintile. In St Maarten and St Eustatius it is approximately 9 and 12 times less than the highest group, respectively. Curaçao has the highest income inequality, with the lowest quintile receiving nearly 14 times less than the highest quintile. The Ginicoefficient2 in Curaçao was 0,465 (2006), showing a slight decrease in comparison to the0,487in2003(2),butnonethelessthisisamongstthehighercoefficientsworldwide(Ginicoefficient,Netherlands:0,31(3))

Table 2.2

Household Income distribution by quintile by Island

Bonaire Curaçao St Maarten St Eustatius Saba

1st (lowest) 20% group 6.4 3.3 4.6 3.7 6.2

2nd 20% group 12.5 10.0 11.0 9.9 13.0

3rd 20% group 17.4 15.9 16.1 16.5 19.3

4th 20% group 24.2 24.3 24.3 25.3 24.7

5th (highest) 20% group 39.4 46.5 44.0 44.6 36.8Ratio highest group – lowest group

6.2 14.1 9.6 12.1 5.9

Source: 2004-2005 Budget Survey, CBS

2Equivalentincomeisdefinedasthehouseholdincomeadjustedfordifferencesinhouseholdsize.3TheGinicoefficientisameasureoftheincomeinequalityinasociety.Itmeasuresthedegreetowhichtwofrequency(percentage)distributionscorrespond.TheGinicoefficientisanumberbetween0and1, where 0 means perfect equality (exact correspondence, e.g. everyone has the same income) and 1 meansperfectinequality(onepersonordefinedgrouphasalltheincomeandallothersearnnothing).

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In July 2008, CBS calculated the poverty line for the Netherlands Antilles. This was done at the request of the Ministry of Economic Affairs with technical support from the United Nati-ons Population Fund (UNFPA). The poverty line for a standard household (2 adults, 2 children) was determined at 2.195 ANG (US$ 1226 (monthly income after deduction of tax and social security charges). For a single person the poverty line was determined at 1.045 (US$ 584) (4). This means that for both Curaçao and St Maarten, roughly about 70% of the population live below the poverty line.

Political/Constitutional ContextThe Netherlands Antilles is an autonomous territory within the Kingdom of the Netherlands3. The system of government is that of a parliamentary democracy. The Netherlands Antilles is responsible for its own administration and political affairs, except for defence and foreign affairs (Kingdom Regulations; Article 3 paragraph 1 and Article 41 paragraph 1 (5)). There are two levels of government: the central government, with a parliament on Curaçao composed of representatives of all the islands, and the local government of each island, consisting of an island council and an assembly. The central government generally functions as a legislative and controlling body, while the local government is more an executive body. However, some responsibilities of the central government have been delegated to the islands, as stipulated in the Island Regulation Netherlands Antilles (ERNA)(6).

Between 2000 and 2005, referendums were held on each of the islands to determine their future status. This process has, in effect, initiated the dismantling of the Netherlands Antilles. Voting results on both Curaçao and St Maarten were eventually followed by the signing of an agreement on 2 November 2006 by the Netherlands and the Antillean government, granting these two islands autonomy. According to the current plan, the islands of Curaçao and St Maarten will govern themselves independently from the 1st of January 2010, except on mat-ters of defence and foreign policy, which will still be decided at The Hague. Bonaire, Saba, and St Eustatius, will become public entities within the Netherlands according to a signed agreement dated October 2006.

2.2 Health Care System

Organization of the Health Care SystemIn the Netherlands Antilles the central government is engaged in the preparation of legislation, supervision and inspection of all public health issues, while the islands, through implementa-tion of the Island Regulation Netherlands Antilles in 1952, maintain a great deal of autonomy in developing and executing their public health policy (ERNA, Article 2 paragraph E) (6).

Atthecentrallevel,theDirectorateofPublicHealthisresponsibleforfulfillingthehealthcaremandate. On the central government’s website the areas of responsibility under the Directo-rate are described (7). These include health care and public health; epidemiological surveil-lance; monitoring of health status, mortality data, and selected diseases; and research for policymaking. The tasks assigned to meet these responsibilities include formation of policy, legislation and regulations, conducting research and surveillance, promotion of regional and international collaboration, and development and implementation of cost-cutting measures. TheDirectorateneedstofittheirhealthpolicieswithpoliciesofotherministriesandwiththehealth authorities and executive bodies of each island. Furthermore they provide support to the islands at policy level, when support is needed.

4 The island of Aruba was part of the Netherlands Antilles until 1986. That year it was granted ‘status aparte’, becoming yet another part of the Kingdom of the Netherlands as a separate country within the

Kingdom.

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Control of the health care system is assigned to the Inspectorate of Public Health. The actual Inspectorate of Public Health consists of three departments: the Health Care Inspectorate, the Pharmaceutical Inspectorate and the Health Protection Inspectorate.

At the island level, each island has a Department of Medical and Public Services (GGD). These institutions are responsible for development, evaluation and adjustment of local health policies.Theymonitoraccess,availability,efficiencyandqualityofhealthcareservicespro-vided and the health care status of the local population. With this information they advise the local health authorities, as well as the Directorate of Health about required legislative adjust-ment for policy implementation. They also advise about budget and cost-cutting measures. Executive tasks of the GGD include infectious disease control and vaccinations (8).

Figure 2.1. Organization of the Health System

Health Care ServicesPrimary health care is provided by general practitioners (GPs). Secondary health care is pro-vided in hospitals. Each island has its own in-patient facility. St Elisabeth Hospital (SEHOS) in Curaçao is the largest of all the islands’ hospitals and functions as a referral centre for the more complex cases from the other islands.

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Health Insurance SystemThere are several insurance modalities (9, 10):

. The PP (‘pro-pauper’) card is intended for inhabitants who are unemployed, have a substandard level of income, or are retired and have no access to other health insurance modalities. The service is provided by ‘Bureau Ziektekosten Voorziening- en’ (BZV) and is entirely funded by the island revenue.

. The insurance modality for central and local government employees provides 100% coverage for lower income employees and 90% for employees with higher incomes. This services is also provided by BZV;

. The Social Insurance / Security Bank (SVB) is a government-sponsored modality. It provides health insurance coverage to non-governmental and private-sector employees earning below a certain income threshold. The SVB also has an insurance fund for retired employees (FZOG);

. Private health insurance is purchased by people earning an annual salary which exceeds the maximum salary enabling eligibility for SVB.

Despitetheabovementionedoptionsthereisasignificantnumberofuninsuredindividuals.According to the most recent health study conducted by the Epidemiology & Research Unit of the Medical and Public Health Services in Curaçao (1996) 9.2% of those questioned in Curaçao reported that they were uninsured (9). In St Maarten the proportion of uninsured was reportedly 30.9% (10). The high cost of private health insurance is an important contributing factor.Itissuspectedthatasignificantnumberofuninsuredindividualsarefromthe(undoc-umented) migrant population.

There has been ongoing political discussion on reforming the health insurance system. It has been decided to introduce a general health insurance (AZV), as implemented in Aruba since 2001. The AZV is intended to provide basic coverage to all legal inhabitants within the Netherlands Antilles. Old modalities will cease to exist or will merge within the new system. Lack of agreement on premiums and the content of the basic insurance package have so far obstructed further design and implementation of this reform. No progress is expected before dismantling of the Netherlands Antilles (personal communication, van Schendel, 2009).

2.3 HIV/AIDS

EpidemiologyBased on calculations by the GGD Epidemiology and Research Unit in 2005, the prevalence of HIV/AIDS was estimated to be between 0.85% and 1.41% for the general population in the Netherlands Antilles. These numbers were estimated to be between 1.39% and 2.32% within the population aged 15-49 years. For Curaçao the prevalence in this age group was estimated between 1.21% and 2.02%. For St Maarten this prevalence rate was estimated even higher at 2.20 - 3.67% (11).

An increase in the number of newly diagnosed cases has been observed, from approximately 84 new cases per year between 1996 and 2000, compared to a mean of 100 new cases per year between 2001 and 2006 (12). Underreporting might obscure a clear picture of the size of the problem.

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Table 2.3.

Estimated prevalence of HIV infection for the Netherlands Antilles, 2005

(Is)landAbsolute number PLWHA

Point preva-lence

Estimated prevalence range for entire popu-lation

Estimated prevalence range for age group 15-49

Curaçao 325 0.24 0.73 - 1.22 1.21 - 2.02

Bonaire 7 0.07 0.21 - 0.34 *

St Eustatius 6 0.24 0.72 - 1.20 *

Saba 8 0.70 2.09 - 3.49 *

St Maarten (NA) 165 0.50 1.49 - 2.49 2.20 - 3.67

St Martin (Fr) 331 1.06 3.17 - 5.28 *

St Maarten (Fr + NA) 469 0.77 2.31 - 3.85 *

Netherlands Antilles 511 0.28 0.85 - 1.41 1.39 - 2.32

* small or unkown numbers

Source: Epidemiology and Research Unit, Medical and Public Health Services of Curaçao

Table 2.4. Number of new HIV-diagnosis per year in the Netherlands Antilles, 1996-2006

Source: Epidemiology and Research Unit, Medical and Public Health Services of Curaçao

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Within the Netherlands Antilles (especially Curaçao and St Maarten), the prevalence and incidence of HIV/AIDS continues to increase, posing a greater public health problem. Many factors contribute to the spread of HIV/AIDS. According to a report of the International Or-ganization for Migration (IOM, 2004) (13), one factor is the relatively favourable economic situation in Curaçao that attracts labour migration from lesser-developed islands, including islands with a higher HIV prevalence.

In a 2003 Status and Trends report of the Caribbean Epidemiology Centre (CAREC) the multi-national feature is described as an important aspect of the HIV/AIDS epidemic in the Ne-therlands Antilles (14). More than half of the HIV-infected come from neighbouring islands and countries. They showed that during 2002, of the 87 AIDS patients being treated in St Maarten, 64% (56) were from 14 different countries including: Curaçao (2), Aruba (1), Haiti (21), the Dominican Republic (15), Guyana (3), Venezuela (1), Jamaica (3), Dominica (3), St Lucia (2), St Kitts (1), St Vincent and the Grenadines (1), Trinidad and Tobago (1), Suriname (1), and the USA (1).

HIV/AIDS PolicyCoordinated by the national HIV coordinator, and supported by the United Nations Joint Pro-gramme on HIV/AIDS (UNAIDS), national strategic plans were developed in 2002 by each of the islands of the Netherlands Antilles. No separate HIV/AIDS policy was developed for the Netherlands Antilles as a whole; HIV/AIDS policy was essentially delegated to each island. Initially, the national HIV coordinator was assigned the task of coordination and leadership. At the end of 2005, due to lack of human resources and different priorities, these tasks were removed fromherportfolio.However, unofficially thenationalHIVcoordinatormaintainedher role as representative of the islands, in regional networks and meetings. Though recent reports suggest that funds of the European Union (EU) have recently been released, lack of funding, coordination, and political commitment has severely limited effective implemen-tationof theNSP, inCuraçaoespecially.StMaartenmanagedtofindexternal fundingforimplementation of its NSP. Care and treatmentHIV care and treatment is only available on the two islands of Curaçao and St Maarten. In order to facilitate patient monitoring and control, HIV care and treatment in Curaçao is cen-tralized in St Elisabeth Hospital (SEHOS) 4. Here, a single internist is responsible for a case load of 268 patients (16). For St Maarten, responsibility for patient care is divided between an internist in the St Maarten Medical Centre (SMMC) and a general practitioner (GP). The last, voluntarilytookthetaskofprovidingcareandtreatmenttoasignificantnumberofpeopleliving with HIV/AIDS (PLWHA). PLWHA living in Bonaire, Saba or St Eustatius depend on the treatment facilities at the bigger islands.

In Curaçao distribution of anti-retroviral drugs is centralized; ARV drugs are only available through the SEHOS pharmacy. For St Maarten, ARV drugs are distributed through the private pharmacy connected to SMMC and through the private pharmacy neighbouring the clinic of the treating GP.

5 In addition to regular patient care, Curaçao has a non-governmental organisation (NGO), Consperanza, that provides ARV treatment to a small number of uninsured PLWHA during pregnancy, labour and postpartum at their maternity clinic. ARV drugs provided to these women and their offspring are mostly donated to Consperanza (personal communication, Schroen, 2006).

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At the end of 2005, the HIV Monitoring Foundation (HMF), in collaboration with SEHOS, started registration and data collection for HIV-infected patients living in Curaçao. The latest HMF report (2008) shows that 379 HIV patients are registered in Curaçao, 268 of whom are receiving ARV treatment (16). The GP in St Maarten reports that approximately 200 PLWHA are receiving care on the Dutch side of the island, 170 of whom are under his care and super-vision. Approximately 120 of these receive ARV treatment. A joint data collection system with the French side of the island is presently being implemented. First results of the data analysis are expected halfway 2009 (personal communication, van Osch, 2009).

The expenses for care and treatment are a heavy burden on the government’s health budget. Calculations in 2004 showed that the average cost of ARV treatment in Curaçao was approxi-mately 3000 ANG (US$ 1675.98) per patient per month for drugs alone, and 3 million ANG (US$ 1.675.978) per year for the total patient load. Additional expenses (incl. laboratory tests and hospital admissions) result in a total costs of care and treatment in Curaçao of 9 million ANG per year (15). Calculations based on a total health expenditure of 612.563.639 ANG (US$ 342.214.323) for the Netherlands Antilles in 2001 (17), show that total costs for HIV care and treatment account for approximately 1,5% of the national health budget.

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3. PROBLEM STATEMENT

During the preparation phase of an integrated comprehensive Dokters van de Wereld HIV program in Curaçao, including voluntary counseling and testing services, the prices of HIV careandtreatmentwereidentifiedasanimportantobstacleforsuccessfulprogramimple-mentation.

It was argued that large scale voluntary testing might present the health care services with anoverwhelmingnumberofnewlyidentifiedPLWHAneedingHIV/AIDScareandtreatment.Considering the high costs of ARV drugs, the health care system might eventually not be able to ensure access to treatment. At the present time care and treatment is available to all insured patients. The number of HIV-infected persons covered by private insurance is minimal, so the majority of costs is absorbed by the SVB and BZV. These institutions have already indicated that sooner or later they will not be able to carry these costs (13). A sudden increase in patient load, after suc-cessfulimplementationofVCTunits,mightcausefinancialproblemsforthehealthinsurancesystem.

Moreover,asdiscussedabove,asignificantnumberof inhabitantsoftheNetherlandsAn-tilles, especially in St Maarten, do not have health insurance. As reported in the Curaçao National Strategic Plan (NSP) HIV/AIDS/STD 2003-2008 it is currently not possible to of-fer complete and continuous ARV treatment for uninsured people. Only in case of medical emergency will the patient receive treatment, which is then paid by the hospital (15). The St MaartenHIV/AIDSStrategicPlan2007-2011describessimilardifficultiesinprovidingcareto this population. It states that medical care cannot be denied to any individual, insured or not,onStMaarten.Thefinancialconsequencethereforebecomestheresponsibilityofthehealth care providers (18). There are no funds available to serve the uninsured population.

One additional problem caused by the high cost of drugs is that of providing continuity of stock. Due to the high costs of treatment, stock-outs have occurred in the past years. Ac-cording to a testimony (2008) of a PLWHA living in Curaçao, who had been taking ARV drugs for 9 years, there have been three occurrences when one of the prescribed drugs was not ‘in stock’. At one occasion this drug was not available for 2 weeks, during which he was obliged to take an alternative drug (19).

In an HMF treatment monitoring report (2007), the limited number of therapy options in Cu-raçao is considered a major concern. Of the drugs that are available in Curaçao, some are rarely used in the Netherlands, because of their side effects, the likelihood of resistance, or because better alternatives are available. Not having access to the full range of drugs availa-ble on the international market leads to inferior suppression of HIV RNA levels, development of drug resistance, and a faster disease progression than is seen in patients in the Nether-lands (20). From St Maarten similar treatment monitoring reports are not yet available.

Thus,thehighARVpricesformamajorfinancialburdenforthehealthcaresystemandpre-sent a barrier to access to quality antiretroviral drugs for the uninsured, and at times even for the insured. They have an adverse effect on the quality of care and the prescribing of appropriate modern drug regimes. In turn they have a negative impact on interventions that aim to control the epidemic. As a consequence, the number of infectious individuals is likely to increase, forming a growing reservoir for further transmission of HIV to the uninfected population.

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4. OBJECTIVES AND RESEARCH QUESTIONS

The problem of high ARV prices, the consequent suboptimal access and quality of care, the hampered implementation of widespread VCT services as part of a comprehensive HIV program, and the resulting increased public health risk led to the development of a research proposal with the following objectives:

General objectiveTo provide a reference document about the issue of ARV prices in the Netherlands Antilles for stakeholders and policy makers, aiming to facilitate further actions to reduce ARV prices and, consequently, to improve access and quality of care and remove obstacles for the implemen-tation of a comprehensive HIV program.

Specific objectives 1. To describe costs, price composition and affordability of ARV drugs in the Nether- lands Antilles 2. To explore underlying causes of the high ARV prices 3. To explore possible ways to improve access to affordable treatment

Thesespecificobjectiveshavebeentranslatedintoanumberofresearchquestions:

Ad 1) To describe costs, price composition and affordability of ARV drugs in the Nether- lands Antilles

n How are ARV prices composed in the Netherlands Antilles? n What are the current costs of ARV drugs in the Netherlands Antilles? n How are these costs compared to regional and international reference prices? n How affordable are ARV drugs in the Netherlands Antilles?

Ad 2) To explore underlying causes of the high ARV prices

n What are the underlying causes at local level? n What are the underlying causes at kingdom/ international level?

Ad 3) To explore policy options to improve access to affordable treatment?

n What has so far been done and achieved with regards to the issue? n What methods do stakeholders suggest to improve access to affordable ARV drugs?

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5. METHODS

The methods for this research were developed over an extended period of time. It started off in September 2006 during a preparation phase prior to the implementation of a com-prehensive HIV program in Curaçao. The proposed program included the establishment of widespread VCT services. Through interviews with local stakeholders it became clear that thecostsofARVtreatmentwereasignificantobstaclefortheimplementationoftestingfaci-lities. It was considered unethical to perform widespread HIV testing, while not being able to provide access to affordable treatment when needed. Thus, before introducing VCT services, it would be indispensable to ensure access to treatment for all infected patients, including the uninsured.

Taking this into account, Dokters van de Wereld considered procuring ARV drugs for the uninsured population. In preparation of this procurement is was necessary to explore local legislation and patent limitations, which was done through interviews with the Inspectorate of Health, and other non-governmental organizations (NGOs), who were procuring drugs. Furthermore, there was contact with the Bureau of Intellectual Property, who referred to the NetherlandsPatentOfficeinRijswijk,whoagainreferredtoaDutchpatentattorney.Thisat-torney was asked to write a report on patent laws valid in the Netherlands Antilles. Unfortuna-tely, due to budget limitations the procurement of drugs was hindered, and it was necessary to take distance from this option.

At this time, contact was established with stakeholders in St Maarten, who were carrying out a strong lobby for access to affordable HIV/AIDS care. Much information about the ARV price issue; its underlying factors, its consequences, past activities and creative suggestions to tackle the issue, came from this source. However, it was apparent that the ARV price issue neededresearchwithamoresolidandscientificbasis.

StartingfromDecember2007,amorescientificresearchstrategywasimplemented.Collectionof data was done in several steps:

1. Data collection was obtained through semi-structured face-to-face interviews with key stakeholders. These include key persons from the Ministry of Health (MOH), health policy makers and health authorities at island level, insurance companies, NGOs, treating physicians, and pharmacists responsible for the procurement of ARV treatment.

The following questions were asked: a. What are the underlying factors of the high ARV prices? b. What has been done so far to obtain access to affordable care? c. Why did these activities not lead to adequate price reductions? d. What would be your advice to tackle the ARV price issue?

Interviews were done in Curaçao and in St Maarten. In total 23 stakeholders were interviewed. For St Maarten, one key stakeholder facilitated contact with a select group of relevant stakeholders to be interviewed.

Responses were recorded on paper by the interviewer and later assessed for common themes and terms.

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2. Based on information gained through the semi-structured interviews, additional data were collected through reading of key documents. These included documents on drug registration within the Netherlands Antilles, on local insurance company regulations,onhealthfinancing,drugpricecompositionandcontrol.Inaddition, reports on regional partnerships, and Kingdom relations / affairs were examined. Documents were available through the Inspectorate of Health, the SVB, the Directorate of Economic Affairs (central level), the Department of Economic Affairs (island level), and through internet.

3. Another step in data collection was through the design and distribution of a standardized drug pricing form, completed by the three pharmacies distributing ARV drugs within the Netherlands Antilles. Procurement prices were provided on a price per unit basis, as priced in 2007. Pharmacists and/or treating specialists were askedtoindicatethetreatmentregimensoffirstchoice.Procurementpricesand pricecomponents were used to calculate patient prices.

Based on methodology described in the WHO/HAI workbook5, regional/international price comparisons were made. Reference prices not included in the MSH Interna- tional Drug Price Indicator Guide6, were collected through contact with local representatives (for Aruba) or through an online source7 (for the Netherlands). In addition, affordability of treatment was derived from the number of days wages needed to pay for treatment by the lowest paid unskilled government worker. Cost for treatment exceeding one day’s wages is considered unaffordable.

4. Datawerefurtherverifiedthroughcontactwithexpertsinthefield.Theseexperts included a patent attorney, a public health specialist, legislation lawyer, human rights specialist and an intellectual property (IP) consultant, who is an expert in the fieldoflobbyandadvocacyforaccesstoaffordableARVdrugs.

6 WHO/HAI workbook provides methodology and tools for conducting reliable and standardized surveys on drug prices, availability and affordability, thereby facilitating national and international comparisons.7 The International Drug Price Indicator Guide contains a spectrum of prices from pharmaceutical sup-pliers, international development organizations, and government agencies. The Guide is published and yearly updated by Management Sciences for Health (MSH)8 The pharmaceutical Compass

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6. RESULTS

Usingtheabovementionedmethodology,eachspecificobjectivewasaddressed.Withthedatacollectedwethenaddressedthedefinedresearchquestions.

6.1 ARV costs, price composition and affordability

6.1.1. How are ARV prices composed in the Netherlands Antilles? Thefinalpricepaidforamedicinebyhealthservices,ahealthinsurerorthepatient,reflectsthe manufacturer’s selling price (MSP), plus all intervening price additions. As described in the workbook ‘Measuring medicine prices, availability, affordability and price components’ published by WHO / HAI (2008), these add-ons to the producer’s price are known as ‘price components’ and represent the cost of importation, distribution and dispensing. They con-sist of local costs that may differ substantially from one country to another, and also between medicines (21).

Price components typically include:

n Insurance and freight; the price paid to the manufacturer or wholesaler from whom the product is imported. It includes the costs of insuring and shipping the product to the destination country. n Import tax or duty; import tax or duty can be quite substantial. If there is an import tax, it may apply to some or all imported medicines.

n Port and inspection charges; to cover such costs as clearance, handling, storage in port and inspection. n Distribution margin/wholesale mark-up; a mark-up is a certain percentage added to theprocurementpricetocoverthecostsandprofitofthewholesaler.Itiscommon tofindthataceilingappliesandthegovernmentallowsamaximumpercentageto the wholesale mark-up. However, it may also be that pricing is unrestricted, allowing wholesalers to charge what they wish. n Retail mark-up; the retail mark-up is the percentage that retailers (pharmacies) add tocovertheircosts,includingprofit.Itiscommontofindthataceilingappliesand the government sets a maximum percentage mark-up. The government may also set a maximum sales price and leave it to the retailer to agree on their respective mark-ups. Some countries may have different maximum percent mark-ups for different price bands: this is called ‘regressive mark-up’ and means that a more expensive medicine will have a lower percent mark-up. n Value Added Tax (VAT)/Goods and Services Tax (GST); The size of a Value Added Tax on goods varies considerably from country to country, ranging from 2% up to 25% in some European countries. In many countries, however, medicines are exempted from VAT. VAT is normally charged at all levels. Retailers pay cost plus VAT and add VAT to their selling price. In some countries, a Goods and Services Tax (GST) or other sales tax is charged on medicines. n Dispensing fees; Pharmacies may be allowed to charge a dispensing fee; this is nor- mallyafixedfeeperprescribediteminsteadof,orinadditionto,apercentage mark-up.Thefeemoreaccuratelyreflectstheworkinvolvedinhandlingaprescrip- tion.

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The table below shows the price components applied for ARV drugs in the Netherlands Antil-les. Sources of information are the Department of Economic Affairs (Curaçao) (22), the In-spectorate of Health (23) and several stakeholders including pharmacists and wholesalers8.

Table 6.1. Price components for ARV drugs in the Netherlands Antilles

CURAÇAO ST MAARTEN

Amount of charges

Cummulative mark-up (max.)

Amount of chargesCummulative mark-up (max.)

CIF PRICE 100% 100%

Port and inspection charges

2% 102% N/A 100%

Import tax 5,5% 107,6% N/A 100%

VAT/GST 5% 113,0% 5% 105%

Wholesaler mark-up 37% 154,8% *34% 140,7%

Retail mark-up 40-50% 232,2% **30- 50% 211%

Dispensing fee N/A

***7-10 ANG

140,7% (plus 7-10 ANG)

* not regulated ** for patients with BZV (30-35-40%) or private insurance (50%) only*** for patient with SVB insurance

Pricecomponents,aredefinedthroughlegislation;Importduty,VATanddispensingfeeareestablished at central level (ERNA Article 2 paragraph A) (6), while wholesaler and retail mark-up are established at island level.

Arecentamendmentofthelaw(OfficialJournal2008,number29,Article7,paragraph18)has exempted all drugs, available on prescription only, from VAT. This amendment was in-troduced retroactively from 2000. The exemption of VAT is not implemented earlier-on in the drug supply chain; wholesalers still need to pay 5% VAT.

CuraçaoThrough a letter from the island council of Curaçao (1991), directed to the board of a phar-maceutical wholesaler’s collective, the agreement on a maximum mark-up of 37% was con-firmed.However, there isnoconcrete legislation that reflects thisagreement. Wholesalermark-up is therefore considered a ‘gentleman’s agreement’.

9 Information on price components, available through different sources, including written documents, presentconflictingdataonchargesapplied.

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Both Curaçao and St Maarten have a ‘regressive retail mark-up’ for patients with BZV insu-rance, which means that a drug with a higher procurement price will have a lower retail mark-up, and vice versa. For patients with private insurance the maximum retail mark-up is 50%. Since2006SVBhas introducedadispensingfee;afixedfeeof7guildersperprescribeditem in place of a percentage mark-up. The insurance fund for retired government employees (FZOG)recentlyfollowedwithafixedfeeof10guilders.BZVisalsoexpectedtointroduceadispensing fee of 9 guilders soon. A dispensing fee does not apply for the SEHOS pharmacy. It is reported that the hospital pharmacy may still impose a mark-up of 50% on ARV drugs with unit prices below 20 ANG. For ARV drugs with unit prices higher than 20 ANG this mark-up is 40%.

Research done by the Department of Economic Affairs (DEZ) in Curaçao between 2000 – 2001 has shown that the wholesaler mark-up is not always applied to the maximum. On average wholesalers impose a mark-up of 34%. The same is true for retailers. Earlier research done by DEZ (1997) showed that the average retail mark-up was approximately 39%.There are examples of restrictions on wholesaler and retail mark-ups, implemented for contraceptive and anti-diabetic drugs: For contraceptive drugs the maximum mark-ups are 20 and 30% respectively. For anti-diabetic drugs these are 10 and 25%. These maximum mark-ups have been established since contraceptive and anti-diabetic drugs are considered a primary need (22).

St MaartenSt Maarten is considerably different to Curaçao; the island of St Maarten is duty free, implying that there are no customs and no import taxes. VAT (called GST in St Maarten), is only applied early in the supply chain. Furthermore, the wholesaler pricing is free, which means that the government does not impose any restriction on the wholesaler mark-ups; though, according to the Netherlands Antilles’ Inspectorate of Public Health (personal communication, 2008), mark-upsinpracticedonotdiffersignificantlyfromthemark-upsappliedinCuraçao.

6.1.2. What are the current costs of ARV drugs in the Netherlands Antilles?

Procurement pricesThe pharmacy of the St Elisabeth hospital, connected to the SMMC, and providing for the patient population under supervision of the treating GP provided the requested procurement price data.

The data collected and reported in table 6.2. below are ARV procurement prices (i.e. not the price charged to the patient) in 2007. Unit prices (price per capsule, tablet or millilitre) were calculated by dividing the price per pack, ampoule or bottle by the number of capsules or tablets in a pack (pack size), or by the number of millilitres in an ampoule or bottle. For St Maarten, there was no notable price difference between the two pharmacies. Therefore, pri-ces from both these pharmacies are reported as one.

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Medicine Name Medicine Strength

Dosage Form (Unit)

Target Pack Size

Manu-facturer

CURAÇAO Unit Price (Local Cur-rency)

ST MAARTEN Unit Price (Local Cur-rency)

Abacavir 300 mg tab 60 GSK 14,94 10,89

Abacavir 20 mg/ml ml 240 GSK 1,25

Didanosine 400 mg cap 30 BMS 17,63 12,40

Emtricitabine 200 mg cap 30 Gilead 22,73

Lamivudine 150 mg tab 60 GSK 5,95 5,63

Lamivudine 10 mg/ml ml 240 GSK 0,75 0,53

Stavudine 40 mg cap 60 BMS 5,64 6,18

Tenofovir 300 mg tab 30 Gilead 1,72 43,93

Zidovudine 100 mg cap 100 Cipla 1,60

Zidovudine 10 mg/ml ml 200 GSK 0,46 0,36

Zidovudine iv. 10 mg/ml ml 20 GSK 2,17

Zidovudine 300 mg tab 60 GSK 3,59 5,07

Efavirenz 600 mg tab 30 MSD 29,03 4,38

Efavirenz 200 mg cap 90 MSD 9,86

Nevirapine 200 mg tab 60 BI 9,50 2,50

Nevirapine 10 mg/ml ml 240 BI 0,69

Atazanavir 150 mg cap 60 BMS 13,02

Indinavir 400 mg cap 180 MSD 1,24 2,5

Lopinavir/ritonavir 133/33 mg cap 180 Abott 4,44

Lopinavir/ritonavir 200/50 mg tab 120 Abott 7

Lopinavir/ritonavir 80/20 mg/ml ml 160 Abott 9,69

Ritonavir 100 mg cap 84 Abott 3,61 4,04

Nelfinavir 250 mg tab 270 Roche 5,21

Saquinavir 500 mg tab 120 Roche 4,75 4,28

FTC+TDF 200/300 mg tab 30 Gilead 2,66 66,53

ZDV+3TC 300/150 mg tab 60 GSK 8,49 6,98

ABC+3TC+ZDV300/150/300 mg

tab 60 GSK 39,33

10 Unit prices provided by the hospital pharmacy in Curaçao were summarized in 3 different tables. There wereremarkablediscrepanciesbetweenthetablesforseveralunitprices.Requestsforverificationofthesespecificdatadidnotresultinaresponse.Wherediscrepanciesweremildarandomchoicewasmade on which unit price to include in data analysis. For bigger discrepancies a choice was made for the ‘most likely’ unit price.

Table 6.2. ARV procurement prices (price per unit) in the Netherlands Antilles, 200710

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Using the WHO/HAI survey methodology (21) it is possible to compare the ARV drug prices of the Curaçao and St Maarten pharmacies. This comparison is based on the Median Price Ratio (MPR)10 of the drugs that are available in all pharmacies included is this study. Table 6.3. Difference Median Price Ratio Procurement Prices for Curaçao and St Maarten

Median MPR Procurement prices

Curaçao

Median MPR Procurement prices

St Maarten

# of drugs found in both locations

% Difference MPRProcurement

prices Curaçao - St Maarten

12,25 15,92 15 30,0%

Table 6.3. above shows the overall difference in procurement prices (expressed as MPR) for ARV drugs in Curaçao and St Maarten. As is shown in table 6.2. St Maarten generally has slightly better unit prices than Curaçao. However, when comparing overall prices, St Maar-ten’s prices are 30,0% higher. A factor contributing to this could be the distinct difference in unit prices for Tenofovir and Truvada. Pharmacies in St Maarten pay 25 times more than the hospital pharmacy in Curaçao for the same product11. Marked lower prices in St Maarten, are noted when comparing unit prices of Efavirenz 600 mg and Nevirapine 200 mg. Curaçao is paying respectively 6,6 and 3,8 times more than St Maarten for the same products.

Patient pricesPrices charged to the patient were calculated hypothetically for each of the pharmacies, by adding legally applied price components. For the pharmacy in Curaçao the maximum 50 % retail mark-up was added for unit prices below 20 ANG, while for unit prices above 20 ANG 40% was added. No other charges are applied. For St Maarten, no retail mark-ups are ap-plied (except for a minority of BZV or privately insured patient). Instead they apply a 7 guilder dispensing fee per prescription line per month (10 guilders for retired government working in-sured through FZOG). The table below summarizes the prices (per unit) charged to patients.

11 The Median Price Ratio (MPR) ic calculated by dividing the local price by an international reference price(converted to the local currency).12 During this assessment, St Maarten was informed about considerably better prices for Tenofovir and Truvada (Tenofovir + Emtricitabine) on other islands, including Aruba (see paragraph ). Aruba, as well as Curaçao, were included in a Gilead’s Global Access Program late 2007. Halfway 2008, St Maarten man-aged to negotiated similar price reductions as Curaçao and Aruba. From September 2008, procurement costs for Tenofovir and Truvada in St Maarten are respectively 1,66 and 2,58 ANG per unit (down from 43,93 and 66,53 ANG) (Landino, 2008).

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Table 6.4. Prices charged to patients (price per unit) in the Netherlands Antilles, 2007


Dosage Form (Unit)

Target Pack Size Manu-

facturer

CURAÇAO Unit Price

(Local Currency)

ST MAARTEN Unit Price

(Local Currency)

Abacavir 300 mg tab 60 GSK 22,41 11,01

Abacavir 20 mg/ml ml 240 GSK 1,28

Didanosine 400 mg cap 30 BMS 26,45 12,63

Emtricitabine 200 mg cap 30 Gilead 31,82

Lamivudine 150 mg tab 60 GSK 8,93 5,75

Lamivudine 10 mg/ml ml 240 GSK 1,12 0,56

Stavudine 40 mg cap 60 BMS 8,46 6,30

Tenofovir 300 mg tab 30 Gilead 2,58 44,16

Zidovudine 100 mg cap 100 Cipla 2,39

Zidovudine 10 mg/ml ml 200 GSK 0,70 0,40

Zidovudine iv. 10 mg/ml ml 20 GSK 3,26

Zidovudine 300 mg tab 60 GSK 5,39 5,19

Efavirenz 600 mg tab 30 MSD 40,64 4,61

Efavirenz 200 mg cap 90 MSD 14,79

Nevirapine 200 mg tab 60 BI 14,25 2,97

Nevirapine 10 mg/ml ml 240 BI 0,69

Atazanavir 150 mg cap 60 BMS 13,14

Indinavir 400 mg cap 180 MSD 1,86 2,54

Lopinavir/ritonavir 133/33 mg cap 180 Abott 4,48

Lopinavir/ritonavir 200/50 mg tab 120 Abott 10,50

Lopinavir/ritonavir 80/20 mg/ml ml 160 Abott 9,73

Ritonavir 100 mg cap 84 Abott 5,42 4,27

Nelfinavir 250 mg tab 270 Roche 5,23

Saquinavir 500 mg tab 120 Roche 7,13 5,21

FTC+TDF 200/300 mg tab 30 Gilead 3,99 66,76

ZDV+3TC 300/150 mg tab 60 GSK 12,74 7,10

ABC+3TC+ZDV 300/150/300 mg

tab 60 GSK55,06

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When comparing prices charged to patients in Curaçao and St Maarten, a shift in percen-tage difference is notable. Despite the fact that the pharmacy in Curaçao was able to have a better overall procurement price for ARV drugs, the overall patient price in St Maarten was 11,4% lower than in Curaçao as is shown in the table below. This overall difference in patient prices is due to the 40-50% retail mark-up applied in Curaçao.

Table 6.5. Difference Median Price Ratio Patient Prices for Curaçao and St Maarten

Median MPR Patient prices

Curaçao

Median MPR Patient prices

St Maarten

# of drugs in both locations

% Difference MPR Patient prices Curaçao - St Maarten

18,37 16,28 15 -11,4%

6.1.3. How are these costs compared to regional and international reference prices?

As previously mentioned, the WHO/HAI survey methodology presents prices as median price ratios (MPR). An MPR of 1 means the local price is equivalent to the reference price whereas an MPR of 2 means the local price is twice the reference price. As described in the methodo-logy section, the international reference prices used for this survey were either taken from the 2007 MSH International Drug Price Indicator Guide or were collected through contact with local representatives (Aruba).

Price comparison to overall international reference prices

The MSH International Drug Price Indicator Guide provides a spectrum of drug prices from pharmaceutical suppliers, international development organizations, and government agen-cies.These‘supplierprices’arepricesofbulkgenericmedicinessoldbynot-for-profitsup-pliers. Therefore, prices are relatively close to the price of production. From this spectrum of drug prices a median price per drug is calculated, which can be used a an international reference price. An estimated 15% is added to this reference price to account for insurance and transportation charges (24).

Table 6.6. below shows the median prices ratio for the 15 ARV drugs available in both Cura-çao and St Maarten. The median price ratio is 16,85 which means that the overall price for ARV drugs in the Netherlands Antilles is nearly 17 times the international reference price. The interquartile range indicates high unit prices in comparison to international reference prices, with 75% of the prices being more than 6.82 times the reference prices, and 25% of the prices even more than 21 times.

Table 6.6. Overall comparison to international reference prices

Number of drugs included 15

Median MPR 16,85

25 %ile MPR 6,82

75 %ile MPR 21,00

Minimum MPR 1,74

Maximum MPR 51,90

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As is shown in table 6.7. below, not all drugs are so high priced when comparing to the international reference price. In Curaçao, Tenofovir and Truvada are relatively lower priced, being priced respectively only 1,6 and 1,5 more expensive than the international reference price. In St Maarten, Lopinavir/Ritonavir capsules 133/33 mg are even better priced than the international reference price12. On the contrary, Lamivudine 150 mg and Nevirapine 200 mg (in Curaçao) are respectively about 53 times and 71 times more expensive than the interna-tional reference price.

Table 6.7. Unit Price comparison to international reference prices


Dosage Form (Unit)

Target Pack Size

MPR NA Unit Price 2007 (Local Currency)*

MPR CUR Unit Price 2007 (Local Currency)*

MPR SXM Unit Price 2007 (Local Currency)*

Abacavir 300 mg tab 60 10,59 12,25 8,93

Abacavir 20 mg/ml ml 240 8,19

Didanosine 400 mg cap 30 10,44 12,26 8,62

Emtricitabine** 200 mg cap 30

Lamivudine 150 mg tab 60 51,90 53,33 50,46

Lamivudine 10 mg/ml ml 240 21,28 24,93 17,63

Stavudine 40 mg cap 60 38,13 36,39 39,87

Tenofovir 300 mg tab 30 20,72 1,56 39,87

Zidovudine 100 mg cap 100 11,7

Zidovudine 10 mg/ml ml 200 1,74 1,96 1,52

Zidovudine iv. 10 mg/ml ml 20 7,85

Zidovudine 300 mg tab 60 13,60 11,27 15,92

Efavirenz 600 mg tab 30 16,85 29,28 4,42

Efavirenz 200 mg cap 90 23,17

Nevirapine 200 mg tab 60 44, 84 71,00 18,68

Nevirapine 10 mg/ml ml 240 25,78

Atazanavir** 150 mg cap 60

Indinavir 400 mg cap 180 3,21 2,13 4,29

Lopinavir/ritonavir 133/33 mg cap 180 0,43

Lopinavir/ritonavir 200/50 mg tab 120 9,73

Lopinavir/ritonavir 80/20 mg/ml ml 160 1,21

Ritonavir 100 mg cap 84 2,32 2,19 2,45

Nelfinavir 250 mg tab 270 8,48

Saquinavir 500 mg tab 120 3,16 3,32

2,99FTC+TDF 200/300 mg tab 30 18,83 1,45 36,21

ZDV+3TC 300/150 mg tab 60 20,50 22,50 18,50

* NA= Netherlands Antilles; CUR= Curaçao; SXM= St Maarten

** No international reference prices available

13 For Lopinavar/Ritonavir 133/33 mg the unit price of only one supplier is available in the MSH Drug Price Indicator Guide. This might make this comparison less representative.

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The pharmacy in Curaçao is the only one to has introduced generic ARV drugs, Zidovudine, which is already off-patent. Unfortunately, even this generic equivalent is still being procured at 11,7 times the international reference price.

SignificantpricereductionsgivenbyMSDforEfavirenzandIndinavirin2004,areonlypartlyvisible in the mean price ratio table. Indinavir is 3,2 times more expensive than the internati-onal reference price, which is rather acceptable. The same can be noticed for Efavirenz sup-plied to St Maarten. However, Efavirenz supplied to Curaçao is 30 times more expensive than the international reference prices. Price reductions are unlikely to have been applied13.

Price comparison to Barbados drug prices

Barbados reference prices were available through the MSH International Drug Price Indicator Guide. The Guide did not provide reference prices for the whole basket of drugs available in the Netherlands Antilles. Costs for freight and insurance are included in these reference prices.14

Table 6.8. below shows the median prices ratio for the 12 ARV drugs available both in the Netherlands Antilles and in Barbados. The median price ratio is 5,08 meaning that the overall price for ARV drugs in the Netherlands Antilles is about 5 times more than the prices available in Barbados. The interquartile range indicates high unit prices in comparison to those in Bar-bados, with 25% of the prices being procured at more than 11.74 times the Barbados prices. 25% of the unit prices in the Netherlands Antilles are less than twice the Barbados prices.

Table 6.8. Overall comparison to Barbados drug prices


Median MPR 5,08

25 %ile MPR 1,94

75 %ile MPR 11,74

Minimum MPR 0,95

Maximum MPR 221,11

14 Curaçao was asked for comments on the high, seemingly not reduced prices for Efavirenz. Unfortu-nately we have received no response. 15 Barbados reference prices are provided to the International Drug Price indicator Guide through the Barbados Drug Service.

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As is shown in table 6.9. below, the price differences between Barbados and the Netherlands Antilles range from equivalent pricing for Saquinavir 500 mg in Curaçao, to a unit price that is up to 35 times higher in Curaçao than in Barbados for Nevirapine 200 mg.



Dosage Form (Unit)

Target Pack Size

MPR NA Unit Price 2007 (Lo-cal Cur-rency)

MPR CUR Unit Price 2007 (Local Currency)

MPR SXM Unit Price 2007 (Local Currency)

Abacavir 300 mg tab 60 4,65 5,38 3,92

Abacavir 20 mg/ml ml 240 3,88


Emtricitabine** 200 mg cap 30



Stavudine 40 mg cap 60 27,98 26,70 29,26

Tenofovir** 300 mg tab 30

Zidovudine** 100 mg cap 100


Zidovudine iv.** 10 mg/ml ml 20

Zidovudine 300 mg tab 60 5,52 4,58 6,46

Efavirenz** 600 mg tab 30


Nevirapine 200 mg tab 60 22,11 35,01 92,13

Nevirapine 10 mg/ml ml 240 4,02

Atazanavir 150 mg cap 60 1,52

Indinavir 400 mg cap 180 1,73 1,15 2,31


Lopinavir/ritonavir** 200/50 mg tab 120


Ritonavir 100 mg cap 84 1,47 1,39 1,56


Saquinavir 500 mg tab 120

0,951,00

0,90

FTC+TDF** 200/300 mg tab 30

ZDV+3TC 300/150 mg tab 60 10,44 11,46 9,42


** No reference price available

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Price comparison to Aruba drug prices

Reference prices from Aruba were provided by the hospital pharmacy. Costs for freight and insurance are included in these reference prices. Only innovator brand drugs are available in Aruba15.

Table 6.10. below shows the median price ratio for the 11 ARV drugs available both in the Netherlands Antilles and in Aruba. The interquartile range indicates that 25% of the drugs are procured at more than 1,27 times the Aruba reference price. However, another 25% of these drugs are more than 20% cheaper than those in Aruba. Overall, the median price ratio is 0,95 which means that the overall prices for ARV drugs in the Netherlands Antilles is about equivalent to the ARV drug prices in Aruba.

Table 6.10. Overall comparison to Aruba drug prices


Median MPR 0,95

25 %ile MPR 0,80

75 %ile MPR 1,27

Minimum MPR 0,64

Maximum MPR 3,79

At the time of this study Aruba was just included in Gilead’s Global Access Program. Starting from January 2008 procurement costs for Tenofovir and Truvada were respectively 1,62 and 2,45 Aruban Florin16 per unit (van Drie, 2008).

As is shown in table 6.11 below the most remarkable comparison between ARV prices in Aruba and the Netherlands Antilles is again the high price paid by the pharmacy of Curaçao for Efavirenz. The price per unit for this drug is 6,6 times higher in Curaçao than it is in Aruba. Another remarkable price difference is the price St Maarten paid for Lopinavir/Ritonavir solu-tion. St Maarten paid more than 3,3 times more than Aruba per ml solution.

In 2008, both Aruba and St Maarten changed from using Lopinavir/ritonavir capsules 133/33 mgtousingthecheapertablet200/50mg.Arubabuysitat6,83Aflpertablet,andStMaar-ten at 6,66 ANG per tablet, both slightly better priced than in Curaçao, though still more than 9 times the international reference prices.

Price comparison to drug prices in the Netherlands

Reference prices from the Netherlands were available online17. Costs for freight and insu-rance are not included in these reference prices.

Table 6.12. below shows the median prices ratio for the 15 ARV drugs available both in the Netherlands Antilles and in the Netherlands. The median price ratio is 0,79 which means that the overall price for ARV drugs in the Netherlands Antilles is about 20% lower when com-pared to ARV drug prices in the Netherlands. The interquartile range indicates that 25% of the products available in the Netherlands Antilles are procured at prices 30% lower than the Dutch reference prices .

16 Only innovator brands are available in Aruba, despite the fact that there are no patents on ARV drugs that are valid in Aruba (in contrast to the Netherlands Antilles).17 An Aruban Florin (Afl) is equivalent to the Netherlands Antilles Guilder (ANG)18 The pharmaceutical Compass

16

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Dosage Form (Unit)

Target Pack Size

MPR NA Unit Price

2007 (Local Currency)

MPR CUR Unit Price


MPR SXM Unit Price


Abacavir 300 mg tab 60 0,94 1,09 0,79

Abacavir** 20 mg/ml ml 240


Emtricitabine 200 mg cap 30 1,23



Stavudine 40 mg cap 60 0,75 0,71 0,78

Tenofovir 300 mg tab 30 0,64 0,05 1,23



Zidovudine iv 10 mg/ml ml 20 0,96

Zidovudine** 300 mg tab 60

Efavirenz 600 mg tab 30 3,79 6,59 0,99

Efavirenz** 200 mg cap 90

Nevirapine** 200 mg tab 60

Nevirapine** 10 mg/ml ml 240


Indinavir 400 mg cap 180 1,74 1,15 2,33

Lopinavir/r 133/33 mg cap 180 0,90

Lopinavir/r** 200/50 mg tab 120

Lopinavir/r80/20 mg/ml

ml 160 3,26

Ritonavir** 100 mg cap 84


Saquinavir** 500 mg tab 120

FTC+TDF 200/300 mg tab 30 1,53 0,12 2,94

ZDV+3TC 300/150 mg tab 60 0,84 0,93 0,76



Table 6.12. Overall comparison to Dutch drug prices


Median MPR 0,79

25 %ile MPR 0,69

75 %ile MPR 1,09

Minimum MPR 0,46

Maximum MPR 1,41

32

Table 6.13. Unit Price comparison to prices in the Netherlands


Dosage Form (Unit)

Target Pack Size

MPR NA Unit Price


MPR CUR Unit Price


MPR SXM Unit Price


Abacavir 300 mg tab 60 1,09 1,26 0,92

Abacavir** 20 mg/ml ml 240

1,49Didanosine 400 mg cap 30 1,12 1,31 0,92

Emtricitabine 200 mg cap 30 1,45



Stavudine 40 mg cap 60 0,87 0,83 0,91

Tenofovir 300 mg tab 30 0,79 0,06 1,52



Zidovudine iv. 10 mg/ml ml 20 1,17

Zidovudine** 300 mg tab 60 0,47 0,39 0,55

Efavirenz 600 mg tab 30 0,76 1,32 0,20

Efavirenz** 200 mg cap 90 1,35

Nevirapine** 200 mg tab 60 0,63 1,00 0,26

Nevirapine** 10 mg/ml ml 240 1,10


Indinavir 400 mg cap 180 0,51 0,34 0,68


Lopinavir/ritonavir** 200/50 mg tab 120 0,74


Ritonavir** 100 mg cap 84 1,41 1,33 1,49


Saquinavir** 500 mg tab 120 0,85 0,90 0,81

FTC+TDF 200/300 mg tab 30 0,79 0,06 1,51

ZDV+3TC 300/150 mg tab 60 0,46 0,51 0,42



For several drugs, the Netherlands Antilles is paying more than the Netherlands. These in-cludeLamivudine,whichiscommonlyusedinfirstlinetreatment.

6.1.4. How affordable are ARV drugs in the Netherlands Antilles?To assess treatment affordability, the average price paid for a one-month supply of highly active antiretroviral treatment (HAART) is compared with the number of days wages needed to pay for this treatment by the lowest paid unskilled government worker. Treatment costs that exceed 1 day’s wages is considered unaffordable (25).

33

In 2007 the minimum gross monthly wage for an unskilled government worker in the Nether-lands Antilles was 1236 ANG (= 690,50 US$). After deduction of all compulsory charges and taxes the net monthly wage was 1106,81 ANG (= 618,33 US$) , which is a daily wage of 39,53 ANG (= 22, 08 US$)(26).

Graph6.1. PercentageonHAARTbyspecifictreatmentregimeovertime

As is shown in graph 2.1. above, the most frequently used initial ARV regimen in Curaçao is Lopinavir/Ritonavir (Lop/r) + Zidovudine (ZDV) + Lamivudine (3TC), used in 45% of these cases. Zidovudine and Lamivudine were frequently used as the backbone, either as separate drugs or as Combivir (ZDV + 3TC) (16, 20).

Procurement costs alone for one day treatment with Lopinavir/ritonavir + Zidovudine + Lami-vudine or Lopinavir/Ritonavir + Combivir are 49,5 and 45 ANG per day respectively, which is already considered unaffordable. Adding the maximum 50% retail mark-up, daily treatment costs reach 74,2 and 67,5 ANG, which is 1,9 and 1,7 times the day’s wages for the lowest paid unskilled government worker; it would take 56,3 and 51,2 days work respectively, to be able to pay for one-month treatment.

For both pharmacies in St Maarten the most common initial regimes were Lopinavir/Rito-navir + Combivir (40,6 ANG/day) and Efavirenz (EFV) + Lamivudine + Tenofovir (TDF) (van Osch/Landino, 2008). A dispensing fee, respectively adds 0,47 ANG and 0,70 ANG on the daily costs. Treatment with Lopinavir/Ritonavir and Combivir would just be affordable for the lowest paid government worker. However, treatment with Efavirenz + Lamivudine + Tenofo-vir, even without a retail mark-up, would be considered unaffordable by these criteria (table 6.14.)

19 AZT = ZDV = Zidovudine

19

34

Table6.14.AffordabilityoftreatmentoffirstchoiceinCuraçaoandStMaarten

CUR= Curaçao; SXM= St Maarten

With the recent price reduction of Tenofovir and Truvada (FTC + TDF). The treatment regimen Efavirenz + Lamivudine + Tenofovir or Efavirenz + Truvada has become much more afforda-ble. In St Maarten, the cost of one day treatment with Efavirenz + Lamivudine + Tenofovir or Efavirenz + Truvada will respectively drop to only 18 and 7,4 ANG (including dispensing fee), which is considered as affordable. In Curaçao, despite similar price reductions, these treat-ments still cost 64,3 and 48,4 ANG per day. The lowest paid unskilled government worker still has to work 49,2 days (for Efavirenz + Lamivudine + Tenofovir) and 36,7 days (for Efavirenz + Truvada) to be able to pay for this treatment. High retail mark-ups are thus causing these treatment to be unaffordable.

Medicine Name

Strength UnitDaily dose

Curaçao unit prices (in local currency)

St Maarten unit prices (in local currency)

Treatment CUR Lop/r+ZDV+3TC

Treatment CUR Lop/r+Combivir

Treatment SXM Lop/r+Combivir

Treatment SXM EFV+ 3TC + TDF

Lamivu-dine

150 mg tab 2 8,93 5,63 17,86 11,26

Tenofovir 300 mg tab 1 2,58 43,93 43,93

Zidovudine 100 mg cap 6 2,39 14,34

Zidovudine 300 mg tab 2 5,39 5,07

Efavirenz 600 mg tab 1 4,38 4,38


Lopinavir/r 133/33 mg cap 6 4,44 26,64

Lopinavir/r 200/50 mg tab 4 10,5 42 42

FTC+TDF 200/300 mg tab 1 3,99 66,53

ZDV+3TC 300/150 mg tab 2 12,74 6,98 25,48 13,96

Dispensing fee (only for St Maarten) 0 0 14 21

TOTAL COSTS ONE DAY TREAMENT 74,2 67,5 41,1 60,3

TOTAL COSTS ONE-MONTH TREAMENT 2226,0 2024,4 1232,0 1808,1

NUMBER OF DAYS WAGES FOR ONE DAY TREATMENT 1,9 1,7 1,0 1,5

NUMBER OF DAYS WAGES FOR ONE MONTH TREATMENT 56,3 51,2 31,2 45,7

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6.2 Underlying causes of high ARV prices

To explore underlying causes of the high ARV prices, 23 stakeholders in Curaçao and St Maar-ten were interviewed. These stakeholders were or still are directly or indirectly involved in the ARVpriceissue,whetheratgovernmental,policymaking,insuranceorfieldlevel.

Table 6.15.

POSITION AND NUMBER OF STAKEHOLDERS INTERVIEWED

Netherlands Antilles

Ministry of Health 4

Inspectorate of Health 3

Insurance company 1

Curaçao

Island authorities 2

GGD 0

Treatment/care 2

Pharmacy 1

Insurance company 1

St Maarten

Island authorities 1

GGD 5

Treatment/care 1

Pharmacy 2

TOTAL 23

Each stakeholder interviewed was asked about their thoughts on the underlying causes of high ARV prices. Unfortunately, stakeholders from the GGD Curaçao abstained from partici-pation18. To verify and further explore given answers, additional research was done. This ad-ditionalresearchincludedin-depthinterviewswithselectedexpertsinthefield,andastudyof relevant literature.

6.2.1. What are the underlying causes at local level?All 23 stakeholders mentioned the fact that the Netherlands Antilles is perceived as a wealthy country by pharmaceutical industries. GNI per capita is relatively high, and therefore the Netherlands Antilles cannot apply for reduced ARV prices, unlike other countries in the region with a lower GNI. In addition, stakeholders shared the idea that the Netherlands Antilles is a small market for ARVs, which greatly limits negotiating power. Lack of competition amongst wholesalers also allows for higher market prices.

Acommonthoughtwasthatthroughopen-endfinancing19, the NA government has to date been able to pay ARV drug costs. Some interviewed voiced concern that this would be per-ceived by pharmaceutical companies as having adequate funds and thus not needing special consideration for reduced drug prices.

AllstakeholderssharedtheassumptionthattherearesignificantcommercialprofitsinhighARV prices. Wholesaler and retail mark-ups favour procurement of expensive drugs, as there is no incentive for the procurement of low priced medication. Despite initiatives to limit wholesaler and retail mark-ups, this never succeeded. All stakeholders were convinced that conflictsof interestsareinvolved.Stakeholdersbelievedthatthereareimportantlinksbe-

20 They reported to have other priorities.21Open-endfinancingisfinancingwithoutsetlimitationtoexpenses;contrarytobudgetfinancing.

20

21

36

tween wholesalers/ retailers and individuals with political power. Some stakeholders reported that political campaigns are often sponsored by local wholesalers. Some reported that past attempts to bypass local wholesalers have resulted in protest, threats and even repercus-sions.

Afewstakeholdersdescribedaninefficientprocurementpolicy,wheredrugsaresometimesbought in the Netherlands and sometimes through local wholesalers. Though sometimes cheaper to procure through a wholesaler in the Netherlands, bills need to be paid directly. Procurement through local wholesalers is allowed on credit. Bills are often left unpaid for sev-eralmonths,increasingthefinancialrisksforwholesalers,whoarethusnotwillingtolowermark-up prices. Another stakeholder argued that the Netherlands Antilles strives to keep up with European (Dutch) care and treatment standards, using modern treatment regimes in HIV care, while looking at the socioeconomic circumstances, this might be too ambitious.

Amongstthestakeholders,criticismcomesfromalllevels.Manyaffirmedthereisalackofpolitical commitment to tackle the ARV price issue. Presently, there is no government priority for HIV/AIDS, and there is no country HIV/AIDS policy. Thus, no responsibility is taken by the central government. They have referred the issue to the separate islands. The islands con-sider the ARV price issue a priority, but lack initiative and/or the capacity to make a change. Somesay that responsibilities and tasksarenot clearlydefinedbetween thecentral andisland levels.

All stakeholders in St Maarten considered the present geopolitical situation (dependence on a central government at 900 km distance), and their position within the Netherlands Antilles a major drawback in developing their own strategy to tackle the issue. They have limited trust that the central government will come up with effective measures to reduce ARV prices in a reasonable amount of time.

6.2.2. What are the underlying causes at kingdom/ international level?The international patent agreements are discussed by a few stakeholders (especially those from St Maarten) as an important obstacle to accessing the cheaper generic equivalents of ARV drugs. Others thought that even without international patent agreements laws some will be hesitant to introduce generic ARV treatment out of fear for lower quality products. Most stakeholders assumed that patent laws in the Netherlands Antilles are identical to those in the Netherlands. Some stakeholders stated that being part of the Kingdom of the Netherlands is a reason for high ARV prices. The international community and pharmaceutical industries do not consi-der the Netherlands Antilles as a separate entity, despite the fact that public health is not a kingdomaffair,butthe(financial)responsibilityoftheNetherlandsAntillesitself.Duetotheirparticular constitutional status, they are often excluded from special agreements, in which in-dependent Caribbean states are included, as well as from donor funding for implementation of adequate HIV/AIDS programs.

Related to the above is the fact, as mentioned by stakeholders in St Maarten, that the Ne-therlands Antilles only has observer status within the Caribbean Community (CARICOM). As observantCARICOMmember,itisnotpossibletoprofitfromcertainregionallynegotiatedprice reductions as do associate or full member states.

37

Table 6.16.

UNDERLYING CAUSES FOR HIGH ARV PRICES AS MENTIONED BY STAKEHOLDERS

Local level

Central level

Lack of leadership

Lack of HIV/AIDS priority

Lack of will-power

Island level Lack of initiative and/or capacity

Field level

Insufficientlobby/advocacy

Inefficientprocurementpolicy

Bills not paid in time

European care and treatment standards

Other factors

Relatively high GNI per capita

Small market

Commercialprofits

Market monopoly of wholesalers

High wholesaler/retail mark-ups

No incentives for procurement of cheaper drugs

Openendfinancing(billsarepaid)

No price control system

Fear for low quality or counterfeit products

Conflictsofinterest

Dependence of the central government in Curaçao

Kingdom/international level

International patent laws

Being part of the Kingdom of the Netherlands

Observant, and not associate CARICOM membership

Additional researchNotalldiscussionpointscanbeverifiedandfurtherexploredthroughadditionalresearch.What can be further explored are the following points: 1. The relatively high GNI is an absolute obstacle for procurement of affordable ARV drugs 2. International patent laws are an obstruction to get access to affordable care 3. Associate CARICOM membership would provide access to regional price reductions

Ad 1. Is the relatively high GNI indeed an absolute obstacle for procurement of affordable ARV drugs?A report of Médecins Sans Frontières (MSF, 2007) aims to provide transparency and reliable information about pricing of pharmaceutical products on the international market. It descri-bes the differential pricing schemes of pharmaceutical industries, which are a considerable source of confusion for purchasers. When originator companies apply discounted prices on ARV drugs, each has different eligibility criteria. Most companies offer their most discounted prices(‘firstcategoryprices’)onlytoacertaingroupofcountries,usuallytotheleastdevelo-ped countries (LDCs) and countries in sub-Saharan Africa. Other companies do it differently: Merck,Sharp&Dome(MSD)extendsfirstcategorypricestocountriesrankedas‘low’and‘medium’ on the Human Development Index (HDI) with HIV prevalence rates greater than 1%; GlaxoSmithKline (GSK) offers differential prices for their products to all Global Fund grantees;

38

Gilead has established its own list of eligible countries using mixed criteria, including some middle-income countries. Certain manufacturers also offer second category prices for some middle-incomecountries.Thesearealmosttwiceashighasthefirstcategoryprices(27).

The table below is derived from the MSF report and summarizes the conditions for reduced prices, as quoted directly by the companies. Restrictions to the offer of reduced prices are largely, but not only, based on GNI per capita. Often HDI, and sometimes HIV prevalence, are taken into account. Some companies determine prices on a case-by-case basis. For the Ne-therlands Antilles differential pricing is not obvious; it is not separately ranked on the United Nations Development Program (UNDP) HDI list, as it is not a United Nations (UN) member state (3). Also the Netherlands Antilles is neither present on the UN list of LDC, nor on the IMF list for Developing Economies, while countries with a comparable socioeconomic situation (e.g.Barbados)areonthelatter(28).Inaddition,theWorldBankclassifiestheNetherlandsAntilles as a high-income country (29). For these reasons, the Netherlands Antilles needs tobehighlycreativetofindargumentsastowhytheyshouldalsohaveaccesstoreducedprices. Past experiences with MSD (paragraph 6.3.1) and recent experience with Gilead (pa-ragraph 6.1.2) show that this is not impossible.

Ad 2. Are International patent laws indeed an obstruction to get access to affordable care?Information from the Bureau of Intellectual Properties (BIP) did not provide a complete picture of implemented patent laws. Therefore, a patent attorney was involved to investigate the local patent situation. Her report (2007) describes the Kingdom Act on patents (Rijksoctrooi-wet, ROW) currently in force in the Netherlands Antilles. This Act applies to the entire king-dom,withtheexceptionthattheso-calledSupplementaryProtectionCertificates(grantedtoa patentee in compensation for the time lost in obtaining marketing approval) do not apply for the Netherlands Antilles (Article 113). Patent research showed that no Dutch national patents are in force for the ARV drugs presently used in the Netherlands Antilles (see ANNEX I).

Before April 2007, European patents were not valid in the Netherlands Antilles. However, in October 2006, a declaration from the Dutch government was sent to the European Patent OfficeforextensionoftheEuropeanPatentConvention(EPC)totheNetherlandsAntilles.Article168paragraph1oftheEPCdefinesthatEuropeanpatentsgrantedforthatContrac-ting State shall also have effect in the territory for which such a declaration has taken effect. Article168paragraph2oftheEPC,definesthattheConventionistobeextendedwithin6months after sending the declaration. From the day of extension, all European patents that have been granted (and validated) for the Netherlands will also be valid in the Netherlands Antilles.

The extension of the effect of European patents to the Netherlands Antilles came into effect by amendment of ROW 1995 Article 49, that entered into force on the 1st of April 2007. Arti-cle 49 (as amended) states that from the day of publication of their grant, European patents will have the same effect as Dutch national patents. The words ‘in the Netherlands’ have been deleted from this paragraph, with the purpose of extending their effect to the Nether-lands Antilles as well. No transition period was included20.

In summary, no national Dutch patent rights exist for the ARV drugs used in the Netherlands Antilles. With respect to European patents however, most of the ARV drugs have become patented by European patents as of the 1st of April 2007. Generic ARV drugs that could be legally imported prior to the 1st of April, now constitute an infringement (30, 31).

21 The extension of the effect of European patents does not apply for Aruba.

22

22

39

Ad 3. Would associate CARICOM membership indeed provide access to regional price re-ductions?The PAHO congress paper ‘An Open Competition Model for Regional Price Negotiations Yields Lowest ARV Prices in the Americas’ (2003) describes the achievements of price ne-gotiations between 2000 and 2003 by participation in the Accelerated Access Initiative (AAI). Initially only 5 countries in Latin America and the Caribbean (Barbados, Chile, Jamaica, Tri-nidad&Tobago,Haiti)participatedintheAAI,receivingsignificantpricereductions.Nextwas a sub-regional approach in which the CARICOM countries participated. They highlighted similarities within the region regarding the status of the HIV epidemic and the response of the countries, as well as the importance of population movement between countries. The Carib-bean countries, coordinated by the Pan American Partnership Against HIV/AIDS (PANCAP), developed a proposal for Accelerating Access to Care and Treatment in the Caribbean, that

DIFFERENTIAL PRICING; CONDITIONS OF OFFER BY COMPANY

COMPANY ELIGIBILITY

Abbott

Category1countries:AllAfricancountriesandallLDCs(asdefinedbyUN)outside of Africa

Category 2 countries: All low income countries plus all lower middle-income countries

Bristol-Myers Squibb (BMS)

Category 1 countries: Sub-Saharan Africa (except Southern African coun-tries)pluscountriesclassifiedaslow-incomebytheWorldBank(exceptKorea, Kyrgyzstan, Moldova and Uzbekistan)

Category 2 countries: Southern African Countries

For all other developing countries, prices are negotiated on a case-by-case basis

Boehringer- Ingelheim Category 1 countries: All LDCs, all low-income countries and all Africa

Category 2 countries: All middle income countries not covered under category 1

Gilead

98 countries including all African states and 44 additional countries classi-fiedaslow-incomebytheWorldBank

For all other developing countries, prices are negotiated on a case-by-case basis

GlaxoSmithKline (GSK)

LDCs plus Sub-Saharan Africa

AllCountryCoordinationMechanismsprojectsfullyfinancedbytheGlobalFund to Fight AIDS, TB and Malaria, as well as projects funded by PEPFAR

For other low and middle-income countries, public sector prices are negoti-ated on a case-by-case basis, either bilaterally or through GSK’s Accelerat-ing Access Initiative

Merck, Sharp & Dome (MSD)

Category 1 countries: Low HDI countries plus medium HDI countries with adult HIV prevalence of 1% or greater

Category 2 countries: Medium HDI countries with adult HIV prevalence less than 1%

Roche

Category 1 countries: All countries in Sub-Saharan Africa and all countries classifiedasLDCbytheUN

Category 2 countries: Low-income countries and lower middle-income countries,asclassifiedbytheWorldBank

Source: MSF, Untangling the web of price reductions, 2007

Table 6.17.

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would form the basis for sub-regional negotiations. During the 14th AIDS Conference in Bar-celona (July 2002) the Caribbean countries reached an agreement with the pharmaceutical companiesparticipatingintheAAI,resultinginsignificantpricereductionsforARVdrugsintheregion:areductioninthepriceofthefirst-linetripletherapyregimentothepriceofferedto Sub-Saharan Africa, approximately US$ 1,100 for a one-year treatment (32).

Despite successful negotiations, countries could still not access the ARV drugs at reduced prices. This gained the attention of former United States President Clinton and, as a result, the Clinton Foundation became a partner in PANCAP and a major player in helping member countries provide better access to treatment (33).

The Netherlands Antilles, even though being a member of the Pan American Partnership Against HIV/AIDS, was not included in the regional price negotiations and could thus not benefitfromtheagreedpricereductions;onlyCARICOMcountrieswereincluded.Onemightassume that to become an associate or full CARICOM member would lead to reduced ARV prices in the Netherlands Antilles; however, according to the Edward Greene, Assistant Se-cretaryGeneralofCARICOM,thespecificconstitutionalstatusoftheNetherlandsAntilles,being part of the Dutch kingdom, whether associate CARICOM member or not, will still be aseriousobstaclefortheNetherlandsAntillestobenefitfromregionalpricearrangements.Pharmaceutical companies, as well as donors, are likely to object to the Netherlands Antilles’ participation (personal communication, Greene 2008). The Netherlands Antilles has never been able to participate in regional HIV/AIDS programs; bilateral and multilateral donors do not allow their funds to be spent on the Netherlands Antilles, as it is (incorrectly) perceived as dependent territory.

6.3 Policy options to improve access to affordable ARVs

6.3.1 What has so far been done and achieved with regards to the issue?The 23 stakeholders interviewed, were asked what had yet been done and what had been achieved with regards to the high ARV prices. In contrast to the previous question about underlying causes for high ARV prices, stakeholder answers were more diverse, answering more from their own experience. Through additional background research (including reports, interviews with experts), efforts were made to verify and further explore the given answers.

Netherlands AntillesMany stakeholders refer to a series of activities coordinated by the central government between 2002 and 2005. After the Barcelona AIDS conference in 2002, at which ARV price agreements were made between pharmaceutical industries and several Caribbean countries, the Directorate of Health (through the appointed HIV coordinator) attempted to get access to similar price reductions as negotiated by neighbouring states through the Pan Caribbean Partnership Organization (PANCAP). However, the Netherlands Antilles, as other dependent states, were not included in the agreement. The central government argued strongly that the Netherlands Antilles has comparable public health problems as other Caribbean states, stating that due to high regional mobility and migration, HIV/AIDS is not just a local, but a regional problem. Negotiations with PANCAP ultimately ended without success, at the time of retirement of the involved PANCAP staff member. Further attempts to reduce ARV prices followed, including efforts to negotiate individual ARV price reductions with pharmaceutical industries, were met with limited success; in 2004 Merck, Sharp & Dome (MSD) granted a reduction of approximately 80% for the supply of Crixivan (Indinavir) and Stocrin (Efavirenz). Negotiations with other pharmaceutical companies in 2004 (Gilead, Abbott) were discontinu-ed due to lack of time and human resources. Options to get access to affordable ARV drugs through the Clinton Foundation were explored. Lack of time, human resources, and the com-plicated procedure were the main reasons that this exploration did not end in a commitment with the Clinton Foundation. Finally, the procurement of generic ARV drugs was investigated. The former Health Minister visited generic suppliers in several countries, including India, Co-

41

lombia and Chile. Due to a change of political power this option was never further explored.

The Ministry of Health (MOH) initiated all the above mentioned activities, and tried to mobilize stakeholders at island level. Due to lack of staff and other priorities the central government had to reduce activities drastically. Since 2005 there have been no activities regarding the ARV price issue. However, there has been ongoing discussion on the introduction of a price mechanism to control drug prices in general. The government is in the last phase of decision-making about the implementation of a reference pricing system (GVS), with some stakehol-ders thinking that this would eventually have a positive effect on ARV drug prices.

CuraçaoInitiated by the country HIV coordinator, stakeholder meetings were organized to discuss the ARV price issue. Included were key stakeholders from Curaçao, including the treating physician, the hospital pharmacist, the hospital immunologist and health policy makers from the GGD. The SVB and the Inspectorate of Public Health were also represented. In Septem-ber 2005, a selection of these stakeholders wrote a letter to alarm the island council about their concerns with regards to ARV prices. They insisted on the establishment of a powerful working group for price negotiations with distributors. They further demanded strong political commitment and support, and a fund to cover ARV expenses for the uninsured. The same stakeholders stated that if the working group efforts were not proved to be successful, steps would be taken to lift patent laws. To date there has been no change to the status quo. The last stakeholder meeting took place at the end of 2005.

Curaçao stakeholders place the ARV price issue as a priority. However, in the past few years there have been no concrete activities and, in contrast to the strong lobby in 2005, there has been very limited lobby and advocacy activity to address the issue.

St MaartenStakeholders interviewed from St Maarten have been active in efforts to obtain access to affordable care. They continue to implement strong lobbying and have established active relations with regional organizations including the PANCAP. In the past it was possible to refer uninsured PLWHA to the French part of the island, where they would have access to free treatment. Since the change of French government in 2007, these cross border referrals were no longer allowed.

Presently, stakeholders in St Maarten are actively searching for creative solutions to the ARV price issue. These include a search for loop-holes in the law that would enable the introducti-on of generic ARV drugs. Furthermore St Maarten is actively exploring the possibilities to get access to affordable care after separation from the Netherlands Antilles, including associate CARICOMmembershiptobeabletoprofitfromregionalpriceagreements.

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Table 6.18.

ACTIVITIES AND ACHIEVEMENTS CONCERNING THE HIGH ARV PRICES

ACTIVITIES ACHIEVEMENTS

Netherlands Antilles

Lobby for inclusion in regional ARV price agreement

Not successful, ended prematurely

Price negotiations with pharmaceutical industries

Partly successful, 80% price reduction for Stocrin and Crixivan.

Contact with Clinton FoundationNo contract due to lack of time, resources, complicated procedure

Attempt to introduce generic ARV drugs

Not achieved due to change of political powers

Aimed introduction of reference pricing system

Not yet achieved, in last phase of decision-making

Coordination/ mobilization island stakeholders

Partly successful, several stakeholder group meetings between 2002-2005

Advise on concrete price control meas-ures by Inspectorate of Health (2005)

Dispensing fee has been introduced by SVB

Curaçao

Stakeholder group meetingsTemporarily successful, letter of alarm has been written

Letter of alarm to commissioner of health

Not successful, not followed by concrete action

Advise on concrete price control meas-ures by DEZ/BZV (2002)

Measures not implemented

St Maarten

Active lobby and advocacyOngoing agenda setting of the ARV price issue

Working on regional partnerships Possiblefutureprofit

Searching for creative solutions Still in the process

Additional researchAdditional research has been done to verify and further investigate issues broached by the interviewed stakeholders. As most discussion included descriptions of personal activities or observationsthereislittlethatcanbeconfirmedfromafactualperspective.However,therehave been activities at island level to control drug prices in general, that were not mentioned by any of the interviewed stakeholders. Described in a report of DEZ and BZV (2002) are concrete measures that should be implemented to control the expenses of medication in general. These measures included exemption from import taxes, introduction of a reference pricing system (GVS), restrictions on wholesaler and retail mark-up and introduction of dis-pensing fees. In a post graduate course for the Netherlands Antilles Foundation for Clinical Higher Education, the Inspectorate of Health has recommended similar measures (23). Ho-wever, other than introduction of dispensing fees by SVB and FZOG none of the measures have been implemented so far.

Since 1995 there has been an ongoing discussion on implementing reference-based pricing; a policy mechanism used to control pharmaceutical expenditures. It establishes a common reimbursement level for a group of comparable or interchangeable drugs. The basic idea of reference-based pricing is that governments can reduce drug costs without affecting quality ofcarebyencouragingtheuseoflessexpensivebutequallyefficaciousdrugswhilemain-taining the freedom of manufacturers to set prices, and of physicians and patients to choose the products they prefer (34, 35). At the time of this research, the proposal for implementa-tionofGVSintheNetherlandsAntilleshadreachedthestageofbeingapprovedbyafinaladvisory board.

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6.3.2. What ways to improve access to affordable ARV drugs do stakeholders sug-gest?The same 23 stakeholders interviewed were asked if they had any suggestions about ways to improve access to affordable ARV drugs. Many suggestions that were given are in line with what has already been tried or done in the past. Additional background research has been conducted (reports, interviews with experts, literature review) to further explore the given answers.

Most stakeholders believe that improved collaboration is an essential basis for success; col-laboration at island level for coordinated lobby and price negotiations, as well as between country and island level for coordinated activities, sharing of information, and adjustment of policy and legislation. Many suggest the establishment of a strong working group with representationofthegovernmentandofthefield(i.e.treatingphysiciansandpharmacists).Thisworkinggroupshoulddefineacollaborativestrategyforlobbyandadvocacyactivities.Furthermore, they should restart negotiations with pharmaceutical companies, emphasizing that the ‘GNI per capita’ gives a misleading view of the socioeconomic status of the Nether-landsAntilles,duetounequaldistributionofincome.Thereisasignificantamountofpovertyin the Netherlands Antilles, and HIV is concentrated in the poorest, most vulnerable groups of the population. Other arguments used in negotiations should include those related to high mobility and migration as well as HIV prevalence. One should also strongly emphasize the significantpublichealthrisks,fortheuninsuredpopulationespecially.

Stakeholders reported that strong leadership is necessary to coordinate such a working group. All stakeholders agreed that the central government should take this leading role. But not only strong leadership is expected from the central government. Stakeholders also thought that they should promote the right message to pharmaceutical companies, and to the world in general. As discussed above, by paying ARV related costs without dispute, the Netherlands Antilles gives the impression that it is able to easily manage the high ARV prices. Instead, the Netherlands Antilles should ring the alarm bell and state that it is not possible to ensure adequate and universal treatment to PLWHA under these conditions. Without ad-equate treatment the Netherlands Antilles will not be able to control further growth of the HIV/AIDS epidemic. According to some stakeholders the Netherlands Antilles should even go as far as threatening to introduce generic versions of ARV drugs that are still under patent, and thus ignore the local patent laws, as to be able to provide sustainable and affordable care.

However, none of the stakeholders thought it likely that the central government would make such a statement. They believed that the central government does not acknowledge the problem. Some stakeholders supposed that providing accurate data on HIV prevalence and incidence through cohort studies (especially within vulnerable groups), and studies about ac-cess to care and treatment for PLWHA, will motivate the central government to take action. A few thought that increased local or international pressure might be helpful to set the ARV price issue on the political agenda. Some saw a clear role for the Dutch government to put pressure on the central government and to provide technical assistance. Others believed that the Netherlands Antilles is responsible for its own public health issues, and assumed that the Netherlandswillthereforebeunwillingtointerfereinthisspecificissue.

Stakeholders had various other suggestions about what could or should be done to get access to affordable care. All stakeholders, including those of the central and island govern-ments, were convinced that wholesaler and retail mark-ups should be limited. One method discussed to achieve this is through reducing wholesaler/retail risks by ensuring that bills arepaidinatimelymanner,forinstancethroughdirectpaymentorpre-financingbyinsur-ance companies. Another suggestion brought up by several stakeholders was introducing separate maximum wholesaler and retail mark-ups for ARV drugs, as is done with those that

44

exist for contraceptive and anti-diabetic drugs, since it can be argued that ARV drugs are a primary health need. Alternatively, some thought that exemption from import taxes (for ARV drugs, or drugs in general) would also have positive effects on ARV prices. A few stakehold-ers, mostly at central governmental level, were expecting a solution for prohibitive medica-tion prices in the introduction of the reference-based pricing system.

Manyarguedthatthemonopolyofwholesalerstosupplyaspecificproductshouldbechal-lenged, to give space for competition between wholesalers. Also related to competition, some suggest that parallel import should be stimulated. At central level some stakeholders have mentioned centralized import and distribution by an appointed institute, e.g. SVB or BZV,therebybypassingthewholesalersentirely.Atfieldlevelstakeholdersalsosupportedcentralimport,butdefineditinadifferentway;theyspokeofcentralizedimport,wherebythepharmacy procures from a central institution, like a pharmacy in the Netherlands, also by-passing local wholesalers. In this perspective the International Dispensary Association (IDA)21 had also been mentioned. Another suggestion for facilitating bypass of local wholesalers was to accept all products that are registered in the Netherlands. It will then be easier to buy unregistered products in the Netherlands if local wholesalers charge prohibitive prices. For the hospital pharmacy this would not make any difference, since the hospital pharmacy is legally allowed to import unregistered products.

There are several stakeholders who referred to the patent law system. They thought that there is inadequate knowledge on the local patent laws and suggested research on this issue tosortoutifthereareoptionsfortheNetherlandsAntillestoprofitfromloop-holesand/orflexibilitiesprovidedbythelaw.Incasethereareoptionsmanystakeholderswouldpromotethe introduction of generic ARV drugs to be able to reduce HIV/AIDS treatment expenses. Opponents of the introduction of generic ARV drugs expressed fear for the introduction of lowqualitydrugs,despitetheexistenceofaWHOprequalificationscheme.

Stakeholders in St Maarten supported introductions of generic ARV drugs, but also strongly promoted increased regional collaboration. According to stakeholders in St MaartenCARICOM membership would give entrance to regionally negotiated ARV price reductions. Furthermore, they suggest the establishment of a government fund for HIV care and treat-ment for the uninsured population.

Single suggestions about how to tackle the ARV price issue, included decentralisation of care; one stakeholder thought that treatment should not be limited to a single treatment institute like in Curaçao. Multiple treatment centres will enhance competition. Another stake-holder believes that there is no other solution than to accept reduced standards of HIV care. Though the Netherlands Antilles generally compares itself to the Netherlands in terms of standard of care, it should realize that it does not have the same opportunities and resources as the Netherlands. Prescribing physicians in the Netherlands Antilles should thus choose to prescribethecheapestalternativesoffirstandsecondlinetreatment.

As shown in the table below, only a few of the suggestions above can be introduced without the intervention of the central government. While wholesaler and retail prices can be reduced at island level, this would prove very difficult without strong backing from the centralgovernment.

22 TheIDAFoundationisaisanot-for-profitsupplierofqualityassuredandqualitycontrolledessentialmedicines and medical supplies at the lowest possible price to low- medium income countries.

23

23

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Table 6.19.

SUGGESTIONS OF STAKEHOLDERS TO TACKLE THE ARV PRICE ISSUE

WHO? WHAT?

Central level

Strong leadership

Take responsibility for HIV/AIDS problem and access to care

Accurate statistical data on HIV prevalence, incidence and access to care

Alarm, threaten to import generics

Conduct in-depth research on patent laws

Improved collaboration with islands, clear division of tasks

Strong political back-up for negotiations with pharmaceutical companies

Price negotiations based on arguments of unequal division of income and high mobility

Advocate on the basis of a major public health problem for the uninsured

Eliminate monopoly held by wholesalers

Reducewholesalers/retailrisksbypre-financingthroughsocialsecurity

Centralized import and distribution through appointed institute (insurance company)

Automatic registration of products registered in the Netherlands

Exemption from import duties

Reference-based pricing system

CARICOM membership

Government fund for HIV care and treatment

Decentralisation of care

Island level

Joint lobby and advocacy strategy

Reduce wholesaler/retail mark-ups

Introduce separate maximum wholesaler/ retail mark-ups for ARV drugs

Field level

Stronger collaboration between the islands and regional actors

Centralized import through pharmacy in the Netherlands

Parallel import

Accept reduced standards of care

International level International pressure and support (especially from the Netherlands)

Additional researchThrough (policy) reports, interviews with experts and review of existing literature, the proposed actions to provide access to affordable ARV treatment were further explored. The following gives an insight into the frequently suggested actions, with background information and viability of implementation in the Netherlands Antilles.

Procurement Strategies‘Centralized import’ is suggested by several stakeholders at both central and fieldlevel. However, both levels interpret differently the term ‘centralized import’. At central level it is interpretedas‘importbyasingleprocurementagent’,andatfield level it isdefinedas‘procurementfromasinglesource’.Availableliteraturedescribescentralized

46

procurement systems as procurement and distribution to the health facilities by a single agent, with the idea that larger procurement volumes make favourable prices. Decentralizedprocurementsystemscanhavesimilarprofitsbynegotiatingmedicationprices centrally (36).

Centralized import suggested at central level would include an agent, other than a local wholesaler,forinstanceSVB.Bychoosingthisspecificagent,pricescanbenegotiatedand drugs can be procured and distributed through a single agent. Local wholesalers would then be bypassed, which would likely have a favourable effect on ARV drug prices. Centralized import as suggested at field level, through procurement from asingle source, preferably a pharmacy in the Netherlands, implies that local wholesalers would also be bypassed. At most this would lead to a 37% reduction if procurement prices in the Netherlands and the Netherlands Antilles are comparable22. The option to negotiate favourable ARV prices, based on arguments discussed above, is lost through this strategy. In the case that the procurement agent would be the HIV/AIDS Group fromtheIDAFoundation,priceswouldbedefineddependingonthereceivingcountry.Unfortunately, according to its own mandate IDA Foundation does not supply to high-income countries. Additionally, patent laws would be a restriction to import generic ARV’s. Finally, IDA Foundation sets a yearly minimum order amount of 15.000 US dollars for ARV drugs (personal communication, Combée, 2008).

‘Pooled procurement’, is a procurement strategy which is more frequently described in the current literature. Pooled procurement is an example of an innovative approach for ensuring a consistent and sustainable supply of essential medicines. Also known as ‘group purchasing’, pooled procurement is defined as ‘purchasing done by oneprocurementofficeonbehalfofagroupoffacilities,healthsystemsorcountries.Groupmembers agree to purchase certain drugs exclusively through the group’ (37). The conceptofpooledprocurementiscurrentlybasedonfourmodels,reflectingthelevelof collaboration and integration among the parties concerned, which can range from information sharing to collective purchasing, decentralized or centralized mechanisms. These models are:

Informed buying – defined as information sharing, in which purchasers orcountries share information on prices and suppliers but procurement is done individually.Coordinated informed buying –alsodefinedas informationsharing,wherebypurchasers or countries conduct joint market research, share information on supplier performance and prices, but procurement is done individually.Group contracting – member countries negotiate prices collectively and select suppliers based on the agreement, while the actual purchase can be conducted individually.Central contracting and procurement – this generally involves a central buying unit established by the member countries to act as their procurement agent in the tendering and award of contracts.

None of the models above are currently implemented in the Netherlands Antilles. Implementation of ‘informed buying’ is something that has been suggested in the field.Anexampleof‘groupcontracting’ istheregionalpricenegotiationscoordinatedby PANCAP in 2002, from which the Netherlands Antilles were excluded. Examples of ‘central contracting and procurement’ is procurement through participation in the PAHO Strategic Fund (SF) (also known as the ‘Regional Revolving Fund for Strategic Public Health Supplies’) or in the HIV/AIDS initiative of the Clinton Foundation (CHAI):

22Takingfreightandinsuranceintoaccounttheprofitwouldbelessthan37%.

24

24

.

.

.

.

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CHAI’s mission is to work with governments and other partners to increase the availability of high-quality AIDS care and treatment for people in need. This is accomplished through lowering the cost of treatment, by providing strategic and targeted technical assistance where it is most needed, and by establishing major initiatives to enable widespread access to HIV-related care (38). Participation in CHAI’s procurement consortium has been considered in the past. Both the National HIV coordinator and stakeholders from St Maarten, explored the option to participate in the initiative. According to these stakeholders, efforts for further involvement seized because of the complicated administrative procedure and the assumed need to lift patent laws before being able to participate in the initiative. Moreover, it was not clear whether procurement consortium agreements would apply to high income countries, like the Netherland Antilles.

ColleenConnell,CHAICaribbeanRegionalManager,confirmed thatparticipationof high income countries in CHAI procurement consortium is decided on a case-by-case basis. In a senior management meeting in December 2008 it was decided, that the Netherlands Antilles is allowed to participate if it wishes. However, an agreement would be invalid after dismantling of the Netherlands Antilles. Therefore, it was recommended to wait until after dismantling of the country; Curaçao will then be allowed to participate in the procurement consortium. Possible participation of St Maarten could be discussed in a next meeting, which will be later this year. However, Mrs Connell believes that procurement through Curaçao could be a more efficientoptionforStMaarten.

For participation in the Procurement Consortium, a Memorandum of Understanding (MOU) needs to be signed by the Netherlands Antilles government (or by Curaçao after the dismantling process). The hospital pharmacy, or any other procurement agent, is then allowed to procure generic drugs at CHAI negotiated prices, on behalf of the Central or Curaçao government. Since CHAI does not negotiate prices for innovator drugs, only Zidovudine (already off-patent) would then become available at CHAI prices. In contexts were a percentage mark-up is included in the patient price, as is the case for the hospital pharmacy on Curaçao, there would be no incentive for the procurement of lower priced drugs. In these cases participation would not be effective (Personal communication, Connell, 2009).

The Netherlands Antilles already has experience with the PAHO Revolving Fund for vaccines. The PAHO Strategic Fund, created after the successful experience of the Vaccine Revolving Fund, is a mechanism created to promote access to quality essential public health supplies in the Americas. The Strategic Fund links the procurement of medicines and essential public health supplies with technical processes in planning and programming. Through the Fund member states can purchase products included in the Strategic Fund product list. Strategic fund suppliersarepre-qualifiedbyPAHO/WHOandareselectedbasedon thequalityof their products and prices offered, as well as on their performance history. Thus, all products on the product list meet PAHO/WHO quality standards. To obtain low product prices the Strategic Fund negotiates with different international suppliers. As a procurement mechanism, the Strategic Fund allows participating members to utilize a common fund for payment of authorized purchases of essential public health products. Members make reimbursement to the fund for the cost of each purchasewithinaspecifiedperiodoftime.Memberstatesallocate3%procurementservice charge to the Fund.

According to Christopher Rerat, PAHO Sub Regional Advisor, the Netherlands Antilles and other Dependent Territories may participate if they sign the MOU, a

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decision not yet made by the Dependent Territories. If signed, appointed institutes can place orders on behalf of the Netherlands Antilles’ government (Personal communication, Rerat, 2008).

According to James Fitzgerald, PAHO Regional Advisor, innovator brand providers lately have the tendency to check the unit price locally available, before deciding on theirmanufacturersellingpriceforaspecificorder.Thus,pricesforinnovatordrugssuppliedbytheStrategicFundnotalwaysbring insignificantprofit. It isadvisedto still negotiate on differential pricing. For generic products this situation does not occur (personal communication, Fitzgerald, 2009). However, considering the specificfundingmechanismlinkedtothisoption,itcouldbeinterestingtoconsiderparticipation in the Strategic Fund.

Price negotiationsFor ARV drugs, due to their patent status in the Netherlands Antilles, only single-source procurement is possible and prices depend on the offers of the patent-holding company. Companies work with a differential pricing system, with some companies using strict eligibility criteria, others determining prices on a case-by-case basis. The Netherlands Antilles have a difficult negotiating position for reasons described above (paragraph6.2.2). However, past and recent attempts in the Netherlands Antilles have showed that price negotiations can be successful. Important bargaining tools include the proportion of the population infected with HIV, the impact of population mobility in the region, the social and economic consequences of the HIV/AIDS epidemic, and the limited financialresourcesavailabletocombatthedisease.TheWorldBank’stechnicalguideon HIV/AIDS Medicine and Related Supplies: Contemporary Context and Procurement (2004) gives some practical guidelines on how to bargain for lower prices. To enhance bargaining power the purchaser needs to collect available information on production costs and prices. This is especially important for prices offered by single-source suppliers. International price comparisons can provide useful benchmarks of the lowest prices available worldwide (39).

Reduction of add-onsThe vast majority of stakeholders at all levels are convinced that wholesaler and retail mark-ups are too high. A reduction of wholesaler and retail mark-ups has been suggested frequently by both the Inspectorate of Health and DEZ. In the previously discussed BZV/DEZ report, a reduction of maximum wholesaler add-on from 37% to 20%, as well as a reduction of retail add-on from 50% to 25%, is recommended. These recommendations are based on a 7% yearly rise of production costs and a 2% yearly increaseinprofitrateforthewholesaler(equaltotheyearlyinflationrate).Thereportalso recommends introducing a dispensing fee in place of a retail mark-up (22). Indeed a dispensing fee (7-10 ANG) has been introduced by some insurance companies (SVB and FZOG). Another company will soon follow (BZV). Other measures to reduce wholesaler and retail mark-ups have never been implemented. There is great resistance from the side of the wholesalers and retailers, who claim they need these add-ons to compensate forsignificantbusinessrisks,suchasbillsthatareleftunpaidforconsiderableamountsof time, and expensive drugs that are not used before the expiration date. SVB, BZV and the Inspectorate of Health have been discussing the possibility of direct payment or pre-financing by insurance companies, leading to a reduction of wholesaler/retailrisks and consequently leading to a reduction of add-ons. These discussions came to a standstill in November 2007 due to internal affairs involving one of the stakeholders. Another option to reduce wholesaler and retail add-ons is to promote ARV treatment a primary health need. For other primary health needs, including contraceptive and anti-diabetic drugs, a maximum wholesaler and retail mark-up is introduced and they are exempted from import taxes. This option would require coordinated lobbying at both the central and local government. If both levels can be convinced that ARV treatment

49

isindeedaprimaryhealthneed,itwouldthenneedefficientcollaborationbetweentheinvolved parties at central and local level, to adequately adjust legislation and execute a reduction of maximum wholesaler and retail mark-ups. Exemption from import taxes for all drugs will have added positive effects on drug prices. In the above mentioned report of BZV/DEZ exemption of import taxes is not recommended since on balance it is not considered a cost-cutting measure for the central en local government; whereas for insurance companies on the contrary, it is.

Regional collaborationThere are several regional networks that address the ARV price issue. One such network is the Pan Caribbean Partnership Against HIV/AIDS (PANCAP), coordinated by CARICOM. Its mandate is to coordinate the regional HIV/AIDS response, to support programmes, and to mobilize resources, so as to create supportive environments for the prevention of HIV transmission and for mitigating the impact of the epidemic Curaçao and St Maarten are both ‘partners’ in this Pan Caribbean Partnership (40). Because dependent territories, including the Dutch and English overseas territories of the Caribbean (OCT) and the French Departments of the Americas (FDA), face problems related to their constitutional status, a PANCAP FDA/OCT Special Working Group was established, following a European Commission’s recommendation in 2005 for the establishment of a Task Force on HIV/AIDS with a view to facilitating support to the FDA/OCT.ProblemsencounteredbyFDA/OCTincludedifficultiesbenefitingfromPANCAPfunds and lack of involvement in key PANCAP decision-making. One of the actions of Special Working Group was to undertake a high-level PANCAP mission to the FDA/OCTtoincreasethevisibilityofPANCAPandtosensitizekeyofficialsonitsstructure,mandate and operations. The mission was to include high-level regional policy makers, representatives of key implementing partners and technical experts whose primary role would be to provide information on the social and economic implications of HIV/AIDS in the region(41). However, the high-level mission to Curaçao, Bonaire and Aruba that was due in August 2007 was cancelled, reportedly because the minister of Health of the Netherlands Antilles had other priorities at the time of the planned mission. Both at central and local level there have been no actions to arrange an alternative mission, which could suggest limited interest in intensifying partnership within PANCAP. It is still unclear whether closer collaboration within CARICOM would have positive effects on the accessibility of regional support and funding, as suggested by some stakeholders, is unclear. In 2005 the Netherlands Antilles requested ‘observer membership’. According to the Directorate of Economic Affairs, the Netherlands Antilles has been granted observer status for one of the four CARICOM Councils (the Council for Human and Social Development, COHSOD) in October 2007. Associate CARICOM membership has also been considered; Associate membership will allow the Netherlands Antilles to cooperate on a series of issues, including the environment, social development, education, culture, customs and health care. The advantage and disadvantages of associate CARICOM membership are still under investigation (Personal communication, Plantijn, 2008).

Flexibilities of patent lawsThe creation of the World Trade Organization (WTO) and the conclusion of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in 1994 has lead to an ongoing international debate on access to essential medicine. Drug patents give the patent holder the right to prevent others from making and selling that drug, thus creating a monopoly. The period of patent protection generally extends over a period of 20 years. Due to lack of competition during this period, the patent holder has the freedom to set prices. This system leads to patented drugs being unaffordable to the majority of people living in developing countries (42). Despite the fact that the TRIPS agreement includes safeguards to limit the negative effects of patent protection, it is unclear whether and how countries can make use of these safeguards. During the WTO conference in Doha

50

in 2001, a declaration on TRIPS and Public Health was adopted by the WTO ministerial. The -so called- DOHA declaration prioritizes public health over commercial interests, by acknowledging the absolute right of countries to take measures to protect public health. If intellectual property law impedes a country’s ability to fulfil this right, it is allowedto override the patents (43). TheDeclaration describes the flexibilities that countriescan use to protect public health, including the use of ‘compulsory license’ and ‘parallel trade’. It is made clear that the use of compulsory license is not limited to an emergency situation, pandemics or specified diseases such asHIV/AIDS. Each country has thefreedom to determine on which grounds such licenses are granted (Doha declaration, article 5, 2001) (44). It is thus up to governments themselves to ensure that patents do not constitute a barrier to access to medicines.

DespitetheflexibilitiesbuiltintotheTRIPSagreement,mostdevelopingcountrieshavenotyetmadeuseofthesesafeguardmeasures.Tobeabletomakeuseoftheflexibilities,countries need to integrate public health perspectives into their national patent laws. Furthermore, an efficient and coordinated decision-making process involving health,tradeandintellectualpropertyagenciesisrequiredforaneffectiveuseoftheflexibilities.Many countries lack an appropriate administrative and legal infrastructure (45).

In the Netherlands Antilles the Kingdom Act on patent (ROW) is in force. By recent amendment of this Act, patents for all ARV drugs used in the Netherlands Antilles (except for Zidovudine) have become valid in the Netherlands Antilles as of April 2007. Therefore, introducing generic ARVs would be an infringement of the law. In accordance with the DOHA declaration, measures to protect public health are integrated in the Kingdom Act, including the possibility to make use of a compulsory license. According to the report of the patent attorney any (legal) person in the Netherlands and Netherlands Antilles can apply for a compulsory license for the sake of general interest (Article 57 ROW 1995). Applying for a compulsory license is an administrative procedure; a request needs to befiledtotheMinisterofEconomicAffairsoftheKingdomoftheNetherlands(whichisthe Dutch minister of Economic Affairs). Generally, it is necessary for a party seeking a compulsory license to have tried to obtain a voluntary license23 from the patent holder. However, in case of emergency or other circumstances of urgency this is not required (30).

The patent attorney assumes that the chances of obtaining a compulsory license in general are not very high, as it should be demonstrated that the license is necessary in the general interest. Until now, such license has never been granted in the Netherlands. However, if it can be argued that people in Netherlands Antilles do not have access to HIV treatment, because of patents, this may constitute to a situation ‘requiring’ a license.

Parallel import (PI) has also been suggested by some stakeholders as a means to gain access to affordable ARV drugs. Parallel import refers to the import and resale in a country, without the consent of the patent holder, of a patented product that has been legitimately put on the market of the exporting country. The sale of the patented drug in the exporting country is deemed to ‘exhaust’ the patent holder’s right in the importing country (45). Parallel import can be useful if the patent holder has put the product on the market elsewhere at a lower price. The extent to which parallel import is possible depends on the ‘regime of exhaustion’ adopted in the national legislation. Though not yet executed in the Netherlands Antilles, parallel import is possible. One obstacles to parallel import is the law requiring a wholesaler to show the original manufacturing bill; this has been introduced to reduce the risk of counterfeit products. Furthermore, before

24 A voluntary license is a license voluntarily acquired from the patent holder that allows the procure-

ment of the generic version of the patented drug, against the payment of a fee.

25

25

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parallel products can be imported into the Netherlands Antilles these products need to go through the process of registration, which will take about 3 months and costs about 500 ANG per registered product for a registration-period of 5 years. The difference between the current product price and the price of the parallel products needs to be sufficienttomakeeffectiveuseofthisflexibility.

Reference-based pricingSome stakeholders consider a reference-based pricing system (GVS) a solution for prohibitive drug prices. As mentioned before, there has been ongoing discussion on implementing GVS since 1995. A proposal for implementation of GVS in the Netherlands Antilleshad,atthetimeofthisresearch,reachedthestageofbeingapprovedbyafinaladvisory board. The GVS is based on the Dutch GVS system, implemented in 1991. Due to the fact that the GVS showed to have a negative effect on price competition, and price limits were often used as ‘focal point’ for price setting by pharmaceutical companies, the Netherlands is presently in the process of releasing the price limits to induce price competition. For those drugs that are not subject to price competition, price limits will continue to exist (46).

Through members of the GVS committee I received a proposal for implementation of the GVS, which is not yet public. From the proposal it is still unclear how price limits will bedefined.AccordingtoonemembertheGVSwillnotbeeffectiveforHIVmedication,at least not in Curaçao, since the GVS will not be in effect for drugs provided by the hospitalpharmacy.TheinspectorateofHealthconfirmedthatHIVmedicationwillnotbeon the list for which price limits will be executed.

Political responsibilityAccording to the Island Regulation Netherlands Antilles (ERNA) article 2 E health care regulations are primarily the responsibility of the central government. Executive tasks are the responsibility to appointed institutes and services at island level. Responsibility for health care regulations will shift to the islands in the near future due to the upcoming dismantling of the Netherlands Antilles. In practice, the islands’ responsibilities concerning the issue of high ARV prices are not always clear. Where the central government initially took strong leadership in efforts to reduce ARV prices, government involvement stopped in 2005 without adequate handover to the islands. The islands have assumed the HIV/AIDS issue by writing separate National Strategic Plans. However, ARV price control and price negotiations are not included as objectives, as these tasks are stillconsideredresponsibilityofthecentralgovernment.Officially,executingtasksarenot within the mandate of the central government, though certain decisions, including signing of an MOU with PAHO strategic fund, the Clinton Foundation or introduction of a pooledprocurementsystem,canexclusivelyormoreefficientlybetakenbythecentralgovernment, and not by the islands separately. The ARV price issue has thus become a topic in the in the midst of a political vacuum.

International pressure and supportSome stakeholders argue that international pressure and support is essential to put the ARV price issue higher on the political agenda. Others are ambivalent about international involvement as they expect that the Netherlands will only refer to the autonomy of the Netherlands Antilles in terms of health care, when asking for (financial) support. InDecember 2007, John Leerdam, a Dutch member of parliament, concerned about the HIV epidemic in the Netherlands Antilles, submitted a motion to support the Netherlands Antilles improving their HIV prevention, care and treatment programs in collaboration with NGOsactiveinthefield(31200IVNr.18).TheStateSecretaryofKingdomAffairs,AnkeBijleveld, has rejected the motion by stating that the Netherlands Antilles is autonomous in terms of health care. In addition, she emphasizes that measures are already being taken as the Netherlands Antilles is presently upgrading its disease control mechanism

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to international standards by implementing the International Health Regulations, with thesupportofDutchexperts.TheseregulationsdonotfocusspecificallyonHIV/AIDS,but on infectious disease surveillance and control in general. Finally, she referred to the European Funds that have been allocated for the dependent territories for implementation of HIV/AIDS programs. An amount of € 6,7 million is allocated for the British Overseas Territories, the Netherlands Antilles and Aruba. Though this fund has been in the pipeline since 2002, it is still not clear whether the fund is open for submission of proposals.

The State secretary nor refers to the 2001 UNGASS Declaration on HIV and AIDS, nor to United Nations Millennium Development Goals (MDG), that includes the goal ‘Have halted by 2015 and begun to reverse the spread of HIV/AIDS’ and ‘Achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it’. In 2007 the Dutch governmentplannedto increase itsbudget forfightingAIDSworldwide.However,nobudgetisallocatedforfightingHIV/AIDSintheNetherlandsAntilles.

Commitment made by Heads of State and Representatives of Governments at the United Nations General Assembly Special Session on HIV/AIDS, in order to mobilize a comprehensive response to the global challange of HIV and AIDS, including action to address stigma and vulnerability, prevention, care and treatment.

26

26

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7. DISCUSSION

ThehighcostsofARVdrugsintheNetherlandsAntilleshavebeenidentifiedasamajorob-stacle to accessing antiretroviral drugs. Especially for the uninsured, ARV treatment is readily unaffordable. For the insured population treatment is available and accessible, though me-dication stock outs have occurred in the recent past. Insurance companies are experiencing increasingdifficulties inensuring fullcoverageofcare. Moreover, thehighcostshaveanimpact on the quality of care, the prescription of appropriate antiretroviral therapies and on interventions that aim to control the epidemic.

In this study we aimed to develop a clear picture of prices, price compositions and afforda-bility of ARV drugs in the Netherlands Antilles, as well as of the factors contributing to driving up ARV prices. Most importantly, we intended to explore procurement and policy options that couldhaveapositiveimpactonARVprices,givingtransparencyintothecomplexfieldofdrug procurement and pricing, and to provide tools on how to tackle the ARV price issue.

7.1 ARV costs, price composition and affordability

ARV procurement prices in the Netherlands Antilles are composed of the import price (CIF price) plus add-ons, including import taxes, VAT and wholesaler’s mark-up. These add-ons are similar in Curaçao and St Maarten, with the exception of import tax, which is not applied in St Maarten. Despite the minimal differences in add-ons, ARV procurement prices on the sepa-rate islands of the Netherlands Antilles differ substantially. Based on the analysis of 2007 price data, procurement prices in St Maarten were overall 30% higher than in Curaçao. This overall price difference is due to the fact that at the time of the data collection, St Maarten was not yet includedinGilead’sGlobalAccessProgram,anddidnotprofitfromsimilarpricereductionsasCuraçao. Looking at prices charged to patients, overall costs in St Maarten are 11,4% lower than in Curaçao, which is caused by the fact that the hospital pharmacy applies a percentage mark-up,whileStMaartenchargesafixeddispensingfeeperprescriptionlinepermonth.

International price comparisons can provide important information on product-price variati-ons worldwide and within the region. The international reference prices available through the MSH International Drug Price Indicator Guide, used for this study, are useful benchmarks of the lowest prices available worldwide and they provide a tool for informed price negotiations. Although it is not realistic to expect prices as low as the international reference price for the Netherlands Antilles, it could be argued that paying up to 71 times more than the international reference price (as is the case for Nevirapine 200 mg in Curaçao) is disproportionate.

Comparison of the local unit prices to those available in Barbados and Aruba, provides inte-resting information on prices available in the region. Countries like Barbados and Aruba are comparable to the Netherlands Antilles in terms of country size and GNI. However, overall ARVpricesintheNetherlandsAntillesare5timeshigherthaninBarbados.Thiscouldreflectstronger negotiating skills, but it could also be caused by other cost-cutting measures, inclu-ding the use of generic equivalents of ARV drugs. It could be interesting to explore the option of procuring through Barbados (parallel import). Overall prices in Aruba are similar to prices available in the Netherlands Antilles. Procurement through Aruba is therefore not expected to be rewarding.

TheNetherlands isasignificantsourcefordrugsupply,andprices intheNetherlandsarecommonly used as a local reference price. Despite differential pricing applied on various drugs in the Netherlands Antilles, prices are only slightly lower than those available in the Netherlands. Supplementary costs for freight, insurance and VAT add to the prices available

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in the Netherlands. As a result, drug supply through the Netherlands is not likely to bring in significantprofit.Onthecontrary,priceswouldevenexceedthoseavailableintheNether-lands Antilles today. Treatment regimes in both Curaçao and St Maarten are considered unaffordable when using the WHO/HAI criteria for affordability. Now that St Maarten is included in Gilead’s Global Access Program, this will change for treatment regimens including Tenofovir or Truvada.

7.2 Underlying causes of the high ARV prices

The underlying causes of high ARV prices are various. GNI per capita in the Netherlands Antil-les is relatively high. The country is considered wealthy, and is ranked on the World Bank list accordingly.Consequently,theNetherlandsAntillesexperiencesdifficultiesnegotiatingpricereductions. Moreover, the Netherlands Antilles is a small market, which greatly limits negotia-ting power.

A major factor contributing to high prices is the fact that the Netherlands Antilles is part of the Dutch Kingdom. Its semi-dependent status has direct and indirect negative effects on ARV prices: First of all, the Netherlands Antilles is not separately ranked on neither the UNDP HDI listnortheIMFlistfordevelopingeconomies,whichmakesitmoredifficulttooptfordifferentialpricing. Moreover, the Netherlands Antilles is often not included in regional programs and are generally excluded from donor funding. Finally, the Kingdom Act on patent laws are enforced in the Netherlands Antilles. Through a recent amendment to this Kingdom Act the European Patents were extended to the Netherlands Antilles, enforcing patents that were previously not enforced. Each government has the right to protect public health, and to ensure that patents do not constitute a barrier to accessing to medicines. It can do so by granting compulsory license. However, due to their semi-dependent status it is not the local Minister of Economic Affairs that can grant the license but the Kingdom Minister of Economic Affairs, which makes the procedure much more complicated and less likely to be successful. Lobbying for com-pulsory license has not been executed. Knowledge on patent laws at all stakeholder levels is verylimited.EventhelocalIntellectualPropertyOfficedidnothaveacompleteunderstan-ding of local patent laws. Due to confusion around intellectual property rights no generic ARV drugs have entered the Netherlands Antillean market, not even during the period when import of these drugs did not mean infringement of the law (before April 2007). In addition to theapparentlimitedknowledgeofpatentlaws,thereissignificantfearofintroducinglower-quality products when allowing generic ARV products on the market. However, the WHO prequalificationlistofgenericproducts(includingARVs)ofgoodquality,safetyandefficacy,should take away this fear (47).

Local factors having an impact on ARV prices include high wholesaler and retail mark-ups, aswellasinefficiencyintheprocurementsystem,usinglocalaswellasexternalsourcesfordrugsupply.Lackofpoliticalcommitmentandeffectiveleadershipcontributessignificantlytothese factors. The central government does not prioritize HIV/AIDS and the ARV price issue, and has reneged on its leading and coordinating role in addressing this topic, with ARV price negotiationsandprocurementfullydelegatedtostakeholdersinthefield.Thelackofactiveinterest of the central government might be interpreted as not being alarmed by the situation, sending out an incorrect and worrying message to the international community.

7.3 Policy options to improve access to affordable treatment

In the past there have been various attempts to gain access to better prices for ARV drugs, including lobbying for inclusion in regional price reduction schemes, price negotiations with manufacturers, collaboration in regional organizations and introduction of generic ARV drugs. At island level there was also strong lobbying going on: St Maarten established regionalcontactsforadvocacyandsupport,andnegotiatedsignificantpricereductions.Acollective of stakeholders in Curaçao lobbied for a powerful working group to negotiate price

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reductions with manufacturers, more political commitment and support, and for a fund to cover expenses for the uninsured. They even threatened to introduce generic drugs, which at that time would have been legal.Most activity addressing the ARV price issue took place in 2004-2005. Some efforts were effective, while others were abandoned due to lack of time, staff or resources. While much was initiated, very little led to success. Stakeholders at island level describe the feeling of walking into a high wall each time they thought they had found a solution. The inactivity of the central government was often blamed for creating this wall. Presently the central government is working on price control mechanism; a reference pricing system. This could have been effective, if only ARV drugs were to be included in the list of drugs on which reference pricing will be applied, but it seems as if this will not be the case.

There are several options suggested by stakeholders that might be effective in reducing ARV medication prices:

7.3.1. Options that may effect the import price

Price negotiations are the starting point for reducing prices of patented, and thus single-source drugs. As differential pricing is not obvious for the Netherlands Antilles, negotiators need to be highly creative in arguing why the Netherlands Antilles should get access to reduced ARV prices. Arguments should include HIV prevalence, intense population mobility and migration in the region, income distribution, and the fact that it is the most deprived populations affected by HIV/AIDS. Moreover, it must be shown that treatment is unaffordable based on the fact that treatment costs exceeding 1 day’s wages of the lowest paid unskilled government worker. Finally, international and regional price comparisons showing disproportionate pricing for specific products, greatly enhance bargaining power. MostrecentlyStMaartenwasabletonegotiatesignificantpricereductions,itscasestrengthenedby comparing its procurement prices with the prices in Aruba. We could call this -informed buying- a form of pooled procurement, in which parties share information on prices.

Price negotiations with manufacturers is time consuming, involving intensive study of international or regional reference prices. It is preferably executed by a stakeholder at central level who can negotiate for each island of the Netherlands Antilles, as was done by the former HIV coordinator in 2004-2005. Central contracting and procurement could bemoreefficient.Thisgenerallyinvolvesacentralbuyingunittoactasprocurementagentin the tendering and award of contracts. One such agent is the PAHO Strategic Fund (SF). Another such fund is the HIV/AIDS initiative of the Clinton Foundation (CHAI). SF can provide innovator brand drugs. However, not always at evidently reduced prices. Participation in the CHAI Procurement Consortium will give access to negotiated prices, though for generic products only.

Assuggestedbysomestakeholdersatfieldlevel,acommercialstructure,likeapharmacyin the Netherlands can be an adequate equivalent to a central procurement agent. However, because prices in the Netherlands are similar if not higher than in the Netherlands Antilles, as is discussed above, it would not be effective to proceed executing this approach.

Central procurement agents deliver directly to the health structure that has placed an order, without the involvement of local wholesalers. The option of installing a central purchasing agent –rather than a central procurement agent-, as suggested by some stakeholders at centrallevel,wouldnothaveanyaddedeffect,andmayactuallybelessefficient:acentralpurchasing agent, will not be able to negotiate similar price reductions as a central procurement agent, the latter having greater negotiating power, due to larger procurement quantities.

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Another solution to unacceptably high ARV prices, is to introduce generic equivalents of ARV drugs. As discussed above, there are patent laws valid in the Netherlands Antilles that restrict this option. Generic ARV drugs would be allowed for treatment of individual patients, but bulk procurement would mean infringement of the law24. Thus, generic ARV drugs can only be introduced under compulsory (or voluntary) license. It is the governments responsibility to ensure that patents do not constitute a barrier to accessing medicines. Therefore, it should grant compulsory license in case of need. The HIV epidemic in the Netherlands Antilles can be considered as such. Due to its constitutional status, compulsory license for the Netherlands Antilles can only be granted by the Kingdom Minister of Economic Affairs, who is in fact the Dutch Minister of Economic Affairs. It seems unlikely that this Minister would grant such a license, but it will certainly shake the foundations of international trade regulations. A rapid reduction in procurement prices could then be expected.

AnotherflexibilityinthepatentlawthatcanbeusedtoreduceARVpricesisparallelimport;Parallel import can be useful if the patent holder has put the product on the market elsewhere at a lower price. As is mentioned earlier it might be rewarding to explore the prospect of procurement through Barbados. However, regulations that request presentation of original manufacturer’sbillsfirstneedtobelifted.

Whether associate CARICOM membership may effect procurement prices, has not become clear through this study. However, the complexity of regional politics and the broad range political and commercial motives involved in deciding on associate CARICOM membership, makethisapproachsignificantly lessattractiveforfurtherexploration. It isaslowpoliticalprocess without the certainty of clear-cut and direct effects on ARV drug prices.

7.3.2. Options that may effect price componentsWholesalers and retailers in the Netherlands Antilles can respectively charge up to 37% and 50% mark-up on HIV medication. These remarkably high mark-ups are often criticized but not yet seized through effective alteration of laws and regulations. It is often assumed that conflictsof intereststand inthewayofdrasticmeasurestoscaledownthesecharges.Areduction of the maximum wholesaler mark-up from 37% to 20%, and a reduction of retail mark-up from 50 to 25% has been recommended by BZV/DEZ. In addition, they proposed the introduction of a dispensing fee, which should eventually replace a retail mark-up (22).

The only cost cutting measure that has been implemented so far is the dispensing fee (7 ANG) introduced by SVB in 2006. Other insurance companies are presently implementing thesamemeasure.Thedispensingfeehassignificantlyreducedgovernmentexpensesondrugs in general; in stead of paying a percentage mark-up retailers can only charge 7 ANG per prescription line. Retailers in St Maarten have great objection against the amount; 7 ANG isnotenoughtocompensateforsignificantbusinessrisks,includingexpensivedrugsthatare not used before the expiration date. This is often the case with ARV drugs. This argument was only taken into account for the hospital pharmacy of the St Elisabeth Hospital; as the hospital pharmacy is often dealing with expensive and rarely used medication, they were exemptedfromthedispensingfeeandcanstillchargeupto50%mark-upforspecificdrugs,including ARV drugs. This exemption does not apply to the hospital pharmacy connected to theStMaartenMedicalCentre,asthispharmacyisofficially‘aprivatepharmacyinsidethehospital’ and not a ‘hospital pharmacy’.

25 It is unlikely that a manufacturer would take serious measures when the Netherlands Antilles would introduce generics for public use, since this would harm their reputation. It would rather be the whole-salers who would object (for commercial reasons) (personal communication, van Spengler, 2009)

27

27

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By introducing the dispensing fee, retail mark-ups are controlled, but only for retailers dealing with ARV drugs in St Maarten, and not for the ARV supplying hospital pharmacy in Curaçao. Wholesaler mark-ups have also left unchanged. An option to reduce wholesaler and retail add-ons is to promote ARV treatment to a primary health need. For other primary health needs, including contraceptives and anti-diabetic drugs, a maximum wholesaler and retail mark-up is introduced. Additionally, these drugs are exempted from import taxes. Exemption of import taxes in general would have added positive effects on drug prices. However, it is not recommended by BZV/DEZ since per balance it is not considered a cost-cutting measure for the central en local government. For insurance companies on the contrary, it would be an adequate measure.

To tackle high wholesaler and retail charges without increasing wholesaler’s business risks, unpaid bills in particular, the possibility of direct payment or pre-financing by insurancecompanies, has been discussed by SVB, BZV and the Inspectorate of Health. Reduction of wholesaler/retail risks may consequently lead to a reduction of add-ons. It might be interesting to continue discussing this option.

7.3.3. Options for further lobby and advocacy

It is the central government’s mandate to protect public health and identify public health risks. However, with the upcoming change in constitutional status of the Netherlands Antilles, the central government is gradually releasing tasks and duties, leaving HIV/AIDS and the ARV prices issue for responsibility of others; HIV/AIDS is not considered a priority on the political agenda of the central government. Even if aware and willing to tackle the ARV price issue, the islands are not able to introduce effective measures, without strong political backing from the central government. Therefore, effective lobby by stakeholders, patient groups or non-governmental organizations is essential to revive attention of the central government.

Effective lobbying startswith raising awareness.Politicians first need tobe aware of theARV price issue and its infaust consequences for public health, before they can commit themselvestotacklethese issues.PoliticalcommitmenttofightHIV/AIDS, isessential forinstalling effective measures to cut down ARV prices, as part of an affordable and accessible HIV/AIDS care program. Committed national leaders, in close collaboration with the island authorities, have power to create policies and legal frameworks to support successful implementation of such a program. They would initiate and coordinate the various activities needed to realize public health targets. In addition, they would promote local and regional collaboration regarding these issues, to increase exchange of knowledge and strategies, and wouldsearchforregionaland/orinternationalsupport,tostrengthentheirforcesinthefightagainst HIV/AIDS.

In this perspective, active participation in regional networks is of primary importance. Like for any small country in the Caribbean region, it is not easy for the Netherlands Antilles tofighthighARVpricesonitsown.RegionalHIV/AIDSnetworksareestablishedtotacklethese –small scale- issues with collaborate force. In 2005, a network of Caribbean countries managed to negotiate significant regional price reductions for ARV medication throughPANCAP. Another example, the PANCAP FDA/OCT Special Working group, has joint forces inaddressingHIV/AIDS relatedproblems thatarespecific for thedependent territories intheCaribbean.AsanactiveparticipanttheNetherlandsAntillesmightnotonlybenefitfromcollaborating with regional partners who deal with identical public health problems, but it also means a better position for lobbying for similar price reductions as other regional countries have negotiated through PANCAP.

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The government should also search for support at Kingdom level. Recent rejection of a motion to support the Netherlands Antilles might be showing that the State secretary of Kingdom Affairs is still unaware about the increasing HIV/AIDS problem within the Kingdom of the Netherlands. There is a failure to intervene, despite the Dutch commitment to the United Nations’ Millennium Development goals. It is argued that the Netherlands Antilles is autonomousintermsofhealthcareissues,whichistrue,butstillnotajustificationofbeinginactive while facing a growing public health threat. Other autonomous countries, including other Caribbean and African countries, are perfectly addressed in the Dutch Policy for HIV/AIDS and Sexual and Reproductive Health and Rights 2008 (48).

Moreover, HIV/AIDS is not only a local problem for the Netherlands Antilles, but also constitutes public health risks for the Kingdom of the Netherlands. Due to freedom of travel within the Kingdom of the Netherlands, the HIV virus can spread rapidly. A Dutch study has identified‘bridgepopulation’;individualswithhighriskoftransmissionofSTI/HIVbetweencountry of origin and the Netherlands (49). Another study showed high HIV prevalence (0.8-3.2%) under the Netherlands Antillean population in Rotterdam (50).

By strongly advocating on the steadily growing HIV/AIDS epidemic, on excessive ARV prices making HIV treatment unaffordable and even inaccessible at times, on quality of care being at stake, while ARV drug resistance is rapidly developing, the State Secretary can no longer turn a blind eye towards this problem. The argument that the general population in the Netherlands might also be at risk through transmission by a high risk ‘bridge population’ might alarm the State Secretary even more.

Stating that the Netherlands Antilles is autonomous in terms of health care can only be justified,iftheNetherlandsAntilleshastheprospectofdealingwiththeissueindependently.Indeed,thegovernmentcansetfirmlimitationstothemaximumwholesalerenretailmark-up,promote the treatment of HIV/AIDS to a primary health need, with its consequent limitations to maximum wholesaler and retail mark-up and exemption of import taxes. Furthermore, it can re-uptake coordination of price negotiations with manufacturers, conduct research on regional ARV prices and consider the use of a central procurement agent. However, due to the fact that the Netherlands Antilles is part of the Kingdom of the Netherlands, they have limited negotiation power, have limited access to donor funding, and are often not included inregionalprograms,whichmakes itdifficult for theNetherlandsAntillestotakeeffectivemeasures. Moreover, the Netherlands Antilles cannot protect public health by granting a compulsory license.

Politicians at Kingdom level should realize that the amendment of the Kingdom act on patents entirely excludes the Netherlands Antilles from autonomously dealing with public health threats caused by unaffordable and inaccessible care, and is thus in conflictwiththe DOHA agreements. In addition, limiting access to affordable care and treatment can be considered a violation of human rights, and does not correspond at all with the commitment to the UNGASS Declaration on HIV and AIDS and the Millennium Development Goals. The Kingdom should come up with adequate solutions, including exploring the option of amendment or addendum to the Kingdom Act on patents. In addition, the Kingdom should actively support the central government in tackling the issue of high ARV prices by initiating a political dialogue, by providing technical support and by lobbying for acquiring international funding.LiftingHIV/AIDStoaKingdomAffairmaygreatlyfacilitatethefightagainstHIV/AIDSin the Kingdom of the Netherlands.

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8. CONCLUSIONS AND RECOMMENDATIONS

Without sustained access to antiretroviral drugs, the challenge of treatment cannot be met—and the ravage of the epidemic will continue. In the Netherlands Antilles the high costs of ARVdrugshasbeenidentifiedamajorobstacletoaccesstoantiretroviraldrugs,aswellasto the implementation of interventions that aim to control the epidemic.

ThisstudyshowedthatARVdrugpricesintheNetherlandsAntillesaresignificantlyhigherthan international and regional reference prices. Overall drug prices are comparable to those in the Netherlands, which is unreasonable considering the large discrepancy in financialresources between the countries.

It isbeyonddisputethat local factorssignificantlycontributetohighARVprices includingasmallmarket,lackofcompetition,highwholesaler-andretailmark-upsandinefficiencyoftheprocurement system. In addition, the complex constitutional situation creates a trap in which theNetherlandsAntilleshasdifficultynegotiatingpricereductions,isexcludedfromfundingmechanisms open to lower income countries, and has to deal the Kingdom Act on Patents, while not having the option to protect public health by granting compulsory license.

Strong political commitment and effective leadership is needed to tackle the issue of high drug prices. The double-layered political structure is source of confusion about tasks and responsibilities. Responsibility for the issue is often pushed back and forth, leading to inactivity at all levels. In this study several approaches to tackle the ARV price issue have been discussed, which have led to the list of recommendation below. These not only involve the commitment of the central government, but also of local authorities and stakeholders, as well as politicians at Kingdom level.

The extensive list of recommendation shows that there are various policy options that might improve access to affordable care. Unfortunately, none of them present the ‘Egg of Columbus’. Instead, they are steps in a complex process towards achieving this goal. The steps are often linked, meaning that one approach might not be successful without implementing a second approach. Therefore, strong collaboration between all levels would be the most important factor for success.

The central government should:a.Instigatetheislandauthoritiestosetfirmlimitationstothemaximumwholesaler1. en retail mark-up. Prepayment by insurance companies might facilitate introduction of this measure;

b. Exempt ARV drugs from all duties and taxes;

c. Or instead of the above, promote HIV/AIDS treatment a primary health need, with its consequent limitations to maximum wholesaler and retail mark-up and exemption import taxes;

Introduce the dispensing fee in the SEHOS pharmacy. Taking into consideration that 2. 7guildersmightnotbesufficientfeeforretailersthatmerelysupplyexpensivedrugs;

a. Establish an authority to continuously monitor ARV prices, and conduct regional 3. price comparisons;

b. Establish and coordinate a working group of stakeholders for effective price negotiations. Price negotiations should be based on available information on production costs, -prices, and price comparisons with countries similar in population size and GNI per capita;

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Sign an Memorandum of Understanding (MOU) with PAHO Strategic Fund for 4. procurement of ARV drugs;

Actively participate in regional networks and partnerships for exchanging knowledge, 5. as to ensure that knowledge on the complex issues of intellectual property and drug pricing is adequately gathered and shared;

a. Strong advocacy on the HIV/AIDS epidemic, high ARV prices, and consequent 6. risks for public health at regional and international level, as to provoke technical and/orfinancialsupport;

b. In addition, strong advocacy on the fact that the constitutional situation presents barriers to differential pricing, funding streams and measures to protect public health, through compulsory license (a so called ‘catch-22 situation’);

Where patents are an obstacle to access, initiate the process of compulsory license, 7. which should go through the Kingdom Minister of Economic Affairs;

Take adequate measures to enable parallel import;8.

Consider signing an MOU for participation in the Procurement Consortium of CHAI9.

The island authorities and stakeholders should:Raise political awareness on the HIV/AIDS epidemic, high ARV prices, and 1. consequent risks for public health;

Commit political leaders to there responsibility to protect public health;2.

Setfirmlimitationstothemaximumwholesalerenretailmark-up(DEZ);3.

Stimulate collaboration between the islands in order to exchange knowledge and 4. strategies;

Create or participate in a working group for ARV price negotiations;5.

Prepare for future autonomy by developing ARV price reduction strategies6.

The Kingdom of the Netherlands should:Provide assistance and expertise in unravelling the complex policy options and 1. identifying the most feasible ways of making HIV/AIDS drugs affordable;

Initiate a political dialogue to enhance political commitment;2.

Lobby for future inclusion in regional HIV/AIDS programs and donor funding;3.

a.ReflectonthepossibilityfortheNetherlandsAntillestomakeuseofcompulsory4. license to protect public health;

b. Support the Netherlands Antilles in granting compulsory license in case this is considered the only option to achieve access to affordable care;

Make HIV/AIDS a Kingdom affair; 5.

Make sure that policy followed is coherent with policies to pursue the Millennium 6. Development Goals

The upcoming dismantling of the Netherlands Antilles will cut away the level of the central government. Curaçao and St Maarten will become autonomous countries within the Kingdom of the Netherlands. Despite these constitutional changes, the content of the recommendations above will not change, only the authority that will be in charge. For Curaçao and St Maarten this will mean that they will be dealing with the ARV price issue independently. Considering the presentconfusionontasksandresponsibilities,dismantlingmightevenimproveefficiency.

Human rights commitments, require that governments take all necessary steps to come as close as possible to providing access to HIV prevention, treatment, care and support to everyone who needs it by 2010 (51). To make ARV drugs available at affordable prices, also

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for the uninsured, will be an important step towards securing these commitments. In addition, itisacrucialstepinthefightagainstfurtherspreadingofthediseasebyremovingobstaclesfor implementation of a comprehensive HIV/AIDS program of high quality.

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ACKNOWLEDGEMENT

There is a large number of people that I would like to thank for their input and support. Without the help of these people it would not have been impossible to conduct this research.

At first I would like to thank all peoplewho I could depend on for their knowledge andexpertise on the topics discussed in this report. They have provided technical support, critical feedback, and guided me step by step through the research process. These people include Anke Heezius (Patent Attorney), John van Schendel (Legislation Lawyer), Wilbert Bannenberg (Public Health specialist), Victor van Spengler (Intellectual Property Consultant), Martin Auton and Marge Ewen (HAI global), Catherine Hodgkin (KIT), and Diederik de Savornin Lohman (Human Rights specialist).

Much of the inside information on the local situation, the execution of regulations and policies, I gathered through contact with local stakeholders. From them, I would especially like to thank Gerard van Osch, Sherlyne Eisden, Peter Fontilus, Norbert Bernardina, George Vos and Joan Brewster for their continuous interest, and input for this research. Without these people it would have been hard to get a complete understanding of the situation.

Of course this project would not have been successful without the participation of stakeholders in Curaçao and St Maarten, who were willing to share their thoughts and ideas on the issue of high ARV prices. These people, other than the people mentioned above, include Joan Smart-Berkel, Humphrey Davelaar, Ben Whiteman, Mario Kleinmoedig, Izzy Gerstenbluth, Theo Braeken, Ashley Duits, Francis Faulborn, Zaira Barriento, Michel Simon, Wim Groenewoud, Carel Dambrink, Joriene Wuite, Ruth Boyard-Brewster, Joep Groenendijk and Suzette Moses.

Drug price analysis would not have been possible without the kind cooperation of pharmacists in Curaçao, St Maarten and Aruba, which are Francis Faulborn, Derek Levens, Joep Groenendijk, Tamara Landino, Carel Dambrink and Regine van Drie.

Stakeholders in Aruba I would like to thank for their warm welcome and willingness to provide information. I would especially like to thank Edwin Abath, for facilitating the research process, inaveryefficientmanner.

Ofcourse,Iwouldliketothankmyformercolleaguesinthefield,butalsoattheDoktersvandeWereldOfficeinAmsterdam,fortheirhands-onsupport,inspirationandmotivation.Iamespecially grateful to Arianne de Jong, Willemien Meiberg, Thirza Stewart and Paloma Abbad, who stood by me throughout the whole process, and helped me out wherever possible.

A cooperative reading committee was indispensable for critical feedback on the research report. This reading committee consisted of Joep Lange, who also provided the idea for this research, Todd Swarthout (who even continued reading while handling an emergency mission in Nigeria), Ivan Wolffers, Veerle Combée, Angela Ongoco and Howard Teunisse. Notonlyforsupportingthisresearchfinancially,butalsofortheinspiringandstrategicinputfor this research I would like to thank the partners from the AIDS foundation.

Most importantly, I would like to thank all my friends and family, my parents and Samantha in particular,fortheirpatienceandsupport.Iwilldefinitelyspendmoretimewiththemfromnowon, and promise not to pick up any ambitious plans for the coming year.

Last but not least, I would like to thank Governor Frits Goedgedrag and the Director of Cabinet Dick de Windt, for their ongoing interest and support to the Dokters van de Wereld project.

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iratio

n: 2

019.

03.0

1

n.a.

(SP

C: 3

0020

3G

rant

ed:

2005

.08.

03Va

lid o

f: 20

19.0

3.01

F (BM

S li

cens

ed it

s p

rod

ucts

roy

alty

fr

ee t

o tw

o ge

neric

m

anuf

actu

rers

)

3. D

idan

osin

e (D

DI)

(Vid

ex)

(Bris

tol M

yers

Sq

uib

b)

25 m

g,50

mg,

100

mg,

150

mg,

200

mg

10 m

g/m

l12

5 m

g,20

0 m

g,25

0 m

g,40

0 m

g

Tab

let

Tab

let

Tab

let

Tab

let

Tab

let

Ora

l Sus

pen

cion

Cap

sule

Cap

sule

Cap

sule

EP

216

510

(Ant

i-H

TLV

III c

omp

ositi

on)

Gra

nted

: 199

3.10

.27

Lap

sed

: 200

6.8.

21

EP

524

579

(imp

rove

d o

ral d

osin

g fo

rmu-

latio

ns (t

able

ts))

Gra

nted

: 199

8.03

.01

Exp

iratio

n: 2

012.

07.1

9

n.a.

(SP

C: 9

4000

5La

pse

d p

er

2007

.05.

04)

F (Gen

eric

ver

sion

av

aila

ble

in U

S b

y B

arr

Lab

orat

orie

s)

AR

V D

RU

G P

ATE

NT

S IN

TH

E K

ING

DO

M O

F T

HE

NE

TH

ER

LAN

DS

66

4. L

amiv

udin

e(3

TC

)(E

piv

ir)(S

hire

Bio

chem

Inc)

Gla

xo G

roup

Ltd

100

mg,

150

mg

10 m

g/m

l

Tab

let

Tab

let

Sol

utio

n

EP

382

526

(Sub

stitu

ted

-1,

3-ox

athi

-ol

anes

with

ant

ivira

l pro

per

ties)

Gra

nted

: 199

6.05

.15

Exp

iratio

n: 2

010.

02.0

7

EP

517

145

(cry

stal

line

oxot

hiol

ane

der

ivat

ives

)G

rant

ed: 2

002.

01.3

0E

xpira

tion:

201

2.06

.01

n.a.

(SP

C 9

6002

5G

rant

ed:

1996

.12.

02E

xpira

tion:

20

11.0

8.08

)

F (Gen

eric

ava

ilab

le

in U

S b

y R

anb

axy

Lab

orat

orie

s)

5. S

tavu

din

e (d

4T) (

Zer

it)

Yale

Uni

vers

ity

15 m

g,20

mg,

30 m

g,40

mg

1 m

g/m

l

Cap

sule

Cap

sule

Cap

sule

Cap

sule

Sol

utio

n

EP

273

277

(pha

rmac

eutic

al c

omp

ositi

on)

Gra

nted

: 199

2.06

.24

Exp

iratio

n: 2

007.

12.1

0

n.a.

(SP

C 9

6002

4G

rant

ed:

1997

.02.

05Va

lid o

f: 20

07.1

2.11

Exp

iratio

n:

2011

.05.

07

F (Gen

eric

ava

ilab

le

from

Ayr

obin

do

Pha

rma)

6. Z

idov

udin

e (Z

DV

)(R

etro

vir)

The

Wel

com

e fo

und

atio

n

100

mg,

250

m

g10

mg/

ml

300

mg

Cap

sule

Cap

sule

Syr

upTa

ble

t

EP

196

185

EP

199

451

EP

291

633

EP

306

597

EP

594

223

All

pat

ents

hav

e la

pse

d

No

pat

ents

Gen

eric

ava

ilab

le

from

s R

oxan

e,

Aur

obin

do

and

R

anb

axy

7. F

DC

* of

ZD

V +

3TC

(C

omb

ivir)

Gla

xo g

roup

Ltd

300

mg

+ 1

50

mg

Tab

let

EP

513

917

(Ant

ivira

l com

bin

atio

ns)

Gra

nted

: 200

1.03

.07

Exp

iratio

n: 2

010.

05.1

0O

pp

ositi

on p

end

ing

bef

ore

EP

O

EP

941

100

Lap

sed

: 200

7.05

.01

n.a.

(SP

C 9

8001

8Va

lid o

f: 20

12.0

5.11

Exp

iratio

n:

2013

.03.

17G

rant

ed:

1998

.09.

09

F (Gen

eric

ava

ilab

le

from

CIP

LA)

8. F

DC

* of

ZD

V +

3TC

+

AB

C

The

Wel

com

e fo

und

atio

n

300

mg

+ 1

50

mg

+ 3

00 m

gTa

ble

tE

P 8

1763

7 (s

yner

gist

ic c

omb

inat

ions

)G

rant

ed: 2

002.

07.1

7E

xpira

tion:

201

6.03

.27

n.a.

(SP

C 3

0019

5E

xpira

tion:

20

19.1

2.16

)

F

67

9. F

DC

* of

d4T

+ 3

TC +

N

VP

Trim

une

(CIP

LA)

30 m

g +

150

m

g +

200

mg

40 m

g +

150

mg

+20

0 m

g

Tab

let

Tab

let

Pat

ente

d b

y C

IPLA

Pat

ent

num

ber

/dat

e of

gra

nt u

nkno

wn

F Ava

ilab

le fr

om

CIP

LA

10. F

DC

* of

TD

F +

em

tric

-ita

bin

e(T

ruva

da)

Em

ory

Uni

vers

ity

245

mg

+20

0 m

g

EP

513

200

(met

hod

s an

d c

omp

osi-

tions

for

pre

par

ing

antiv

iral n

ucle

osid

e an

alog

s)G

rant

ed: 2

004.

04.0

8E

xpira

tion:

201

6.01

.30

EP

872

237

(idem

; sel

ectio

n in

vent

ion)

Gra

nted

: 200

7.01

.17

Exp

iratio

n: 2

011.

01.3

0

EP

984

013

(ant

ivira

l act

ivity

and

res

olu-

tion

of c

omp

ound

)G

rant

ed: 2

004.

06.3

0E

xpira

tion:

201

2.02

.19

n.a.

(SP

C 3

0014

8Va

lid fr

om:

2011

.01.

31E

xpira

tion:

20

16.0

1.30

)

F Gen

eric

ava

ilab

le

from

Ran

bax

y

11. T

enof

ovir

(TD

F (V

iread

)

Gile

ad S

cien

ces

Inc.

300

mg

245

mg

Tab

let

EP

915

894

(nuc

leot

ide

anal

ogue

s) G

ran-

ted

: 200

3.05

.14

Exp

iratio

n: 2

017.

07.2

4

EP

998

480

(nuc

leot

ide

anal

ogon

and

sy

nthe

sis)

Gra

nted

: 200

2.11

.27

Exp

iratio

n: 2

018.

07.2

2

EP

123

4590

(ena

tiom

eric

pur

e co

mp

o-si

tion)

Gra

nted

: 200

5.02

.09

Exp

iratio

n: 2

018.

07.2

2

EP

124

3593

(ena

tiom

eric

pur

e co

mp

os-

tion)

Gra

nted

: 200

5.09

.21

Exp

iratio

n: 2

018.

07.2

2

n.a.

(S

PC

300

202

Ap

plie

d –

not

yet

gr

ante

d)

F

68

12. E

favi

renz

(EFV

) (S

tocr

in)

Mer

c &

Co.

Inc.

50 m

g10

0 m

g20

0 m

g30

mg/

ml

600

mg

Cap

sule

Cap

sule

Cap

sule

Syr

upTa

ble

t

EP

582

455

(Ben

zoxa

zino

nes

as in

hib

itors

of

HIV

rev

erse

tra

nscr

ipta

se)

Gra

nted

: 200

0.11

.02

Exp

iratio

n: 2

013.

08.0

2

n.a.

(S

PC

970

013

Valid

of

2013

.08.

02E

xpira

tion:

20

14.0

5.27

)

F Gen

eric

ap

pro

ved

in

the

US

13. N

evip

arin

e (N

VP

) (V

ira-

mun

e)

Boe

hrin

ger

Inge

lhei

m

200

mg

10 m

g/m

lTa

ble

t O

ral S

usp

ensi

on

EP

429

987

(5,1

1-D

ihyd

ro-6

H-

dip

yrid

o[3,

2-b

:2’,3

’-e]

[1,4

]dia

zep

ines

an

d t

heir

use

in t

he p

reve

ntio

n or

tre

at-

men

t of

HIV

infe

ctio

n)

Gra

nted

: 199

9.03

.17

Exp

iratio

n: 2

010.

11.1

5

n.a.

(S

PC

990

022

Valli

d o

f: 20

10.1

1.15

E

xpira

tion:

20

13.0

2.04

)

F Gen

eric

ap

pro

ved

in

the

US

14. A

mp

rena

vir

(Age

nera

se)

Vert

ex P

harm

aceu

tical

s

50 m

g15

0 m

gC

apsu

leC

apsu

le

EP

659

181

(Sul

lfona

mid

e in

hib

itors

of

HIV

-asp

arty

l pro

teas

e)

Gra

nted

: 199

9.04

.07

Exp

iratio

n: 2

013.

09.0

6

EP

846

110

(TH

F- c

onta

inin

g su

lfona

mid

e in

hib

itors

of a

spar

tyl p

rote

ase

) G

rant

ed: 2

002.

08.2

8E

xpira

tion:

201

6.04

.17

EP

885

887

(Sul

fona

mid

e in

hib

itors

of

HIV

-Asp

arty

l pro

teas

e)G

rant

ed: 2

003.

05.2

8E

xpira

tion:

201

3.09

.06

n.a.

(S

PC

300

039

Gra

nted

: 20

01.0

7.16

Exp

iratio

n:

2015

.10.

19)

F Gen

eric

s av

aila

ble

15. I

ndin

avir

(IDV

) (C

rixiv

an)

Mer

ck &

Co.

Inc.

100

mg

200

mg

333

mg

400

mg

Cap

sule

Cap

sule

Cap

sule

Cap

sule

EP

541

168

(HIV

pro

teas

e in

hib

itors

use

-fu

l for

the

tre

atm

ent

of a

ids)

Gra

nted

: 199

8.03

.11

Exp

iratio

n: 2

012.

11.0

1

F No

gene

ric v

ersi

on

foun

d

69

16. F

osam

pre

navi

r (T

elzi

r/Le

xiva

) (G

SK

)70

0 m

gTa

ble

t-

exp

ecte

d t

o b

e p

aten

ted

– n

ot fo

und

F No

gene

ric v

ersi

on

foun

d

17. L

opin

avir/

riton

avir

(LP

V/r

) (K

alet

ra)

Ab

bot

t L

abor

ator

ies

133.

3 m

g +

33

.3 m

g

80 m

g/m

l +

20m

g/m

l

Cap

sule

Sol

utio

n

EP

882

024

(Ret

rovi

ral p

rote

ase

inhi

biti

ng

com

pou

nds)

G

rant

ed: 2

002.

02.0

6E

xpira

tion:

201

6.12

.05

F No

gene

ric a

vai-

lab

le

18. R

itona

vir

(r) (

Nor

vir)

Ab

-b

ott

Lab

orat

orie

s

100

mg

8 m

g/m

l

Cap

sule

Ora

l Sol

utio

n

EP

674

513

(Ret

rovi

ral p

rote

ase

inhi

biti

ng

com

pou

nds)

G

rant

ed: 1

996.

09.2

5E

xpira

tion:

201

3.12

.15

n.a.

(S

PC

300

060

Gra

nted

: 20

02.0

2.20

Exp

iratio

n:

2016

.03.

19)

F unkn

own

19.N

elfinavir(NFV

)(Vi-

race

pt)

Ago

urou

n P

harm

aceu

tical

s In

c.

250

mg

50 m

g/g

Tab

let

Ora

l Pow

der

EP

722

439

(HIV

pro

teas

e in

hib

itors

) G

rant

ed: 2

002.

08.1

4E

xpira

tion:

201

4.10

.06

F No

gene

ric v

ersi

on

foun

d

20. S

aqui

navi

r (S

QV

) (In

vi-

rase

)

F. H

offm

an-L

a R

oche

200

mg

500

mg

Sof

t C

apsu

le,

Cap

sule

Tab

let

EP

432

695

(Am

ino

acid

der

ivat

ives

)G

rant

ed: 1

995.

05.1

7E

xpira

tion:

201

0.12

.09

n.a.

(S

PC

: 970

0113

Gra

nted

: 19

97.0

6.27

Exp

iratio

n:

2011

.10.

09)

F (Roc

he is

will

ing

to

pro

vid

e im

mun

ity t

o ge

neric

man

ufac

-tu

rers

)

* FD

C =

Fix

ed D

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Com

bin

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n

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