trade-related policies and access to medicines ictsd consultation on trade policy coherence and...

Trade-related Trade-related policies and access policies and access

to medicinesto medicines

ICTSD Consultation on trade policy ICTSD Consultation on trade policy coherence and access to medicines coherence and access to medicines

GenevaGenevaNovember 7November 7thth 2006, 2006,

Road mapRoad map

The contextThe context ICTSD’s Project on trade-related policy ICTSD’s Project on trade-related policy

coherence and access to medicinescoherence and access to medicines– Objectives of the projectObjectives of the project– General methodologyGeneral methodology– Relevant policies and parameters Relevant policies and parameters – Outputs and outcomes Outputs and outcomes

The contextThe context

MDGs: “MDGs: “To Combat HIV/AIDS, Malaria and other diseases”To Combat HIV/AIDS, Malaria and other diseases”

WTO: the TRIPS and Public Health Declaration WTO: the TRIPS and Public Health Declaration

The Amendment process to Art. 31 f) of the TRIPS The Amendment process to Art. 31 f) of the TRIPS Agreement Agreement

Proposals in the WTO Negotiating Group on Market Proposals in the WTO Negotiating Group on Market Access (industrial goods) and various requests in the Access (industrial goods) and various requests in the special sessions of the Services Councilspecial sessions of the Services Council

The CIPIH Report The CIPIH Report


WHO Assemblies Resolutions 2006WHO Assemblies Resolutions 2006

– ““to consider the interplay between international trade to consider the interplay between international trade and health; to take advantage of the potential and health; to take advantage of the potential opportunities and address the potential challenges opportunities and address the potential challenges that trade and trade agreements may have for that trade and trade agreements may have for health” health”

– to apply or establish, where necessary, coordination to apply or establish, where necessary, coordination mechanisms involving ministries of finance, health mechanisms involving ministries of finance, health and trade, and other relevant institutions, to address and trade, and other relevant institutions, to address public health related aspects of international trade” public health related aspects of international trade”

– and (…) to continue collaborating with the competent and (…) to continue collaborating with the competent international organizations in order to support policy international organizations in order to support policy coherence between trade and health sectors”coherence between trade and health sectors”


What is trade related policy coherence? What is trade related policy coherence? – ““Trade policy coherence involves the systemic promotion of Trade policy coherence involves the systemic promotion of

mutually reinforcing policy actions across government agencies mutually reinforcing policy actions across government agencies creating synergies toward achieving agreed objectives”creating synergies toward achieving agreed objectives” (OECD) (OECD)

What is access to medicines?What is access to medicines?– ““Drugs and medicines that satisfy the health needs of the Drugs and medicines that satisfy the health needs of the

majority of a country’s population and ought to be available at majority of a country’s population and ought to be available at all times, in adequate dosage, and at prices that all individuals all times, in adequate dosage, and at prices that all individuals can afford” (WHO)can afford” (WHO)

The need for a two fold perspective in trade policy coherence:The need for a two fold perspective in trade policy coherence:

– the transformation and adequate implementation of the transformation and adequate implementation of international trade obligations into national law and policy international trade obligations into national law and policy bearing in mind national development goals (i.e. health welfare); bearing in mind national development goals (i.e. health welfare);

– the adequate design of domestic policies given the policy space the adequate design of domestic policies given the policy space available in WTO Agreements and FTAs.available in WTO Agreements and FTAs.

ICTSD’s project on trade related policy ICTSD’s project on trade related policy coherence and access to medicinescoherence and access to medicines

Objective of the Project:Objective of the Project:

““enhancing trade related policy coherence in order to enhancing trade related policy coherence in order to facilitate facilitate thethe

creation of an enabling framework for creation of an enabling framework for sustainable access to sustainable access to essentialessential

medicines in developing countries” medicines in developing countries”

More specifically the project seeks to:More specifically the project seeks to:

– Provide a better understanding of the interface between Provide a better understanding of the interface between different trade-related policies impacting access to different trade-related policies impacting access to essential medicines in selected developing countries essential medicines in selected developing countries

– Identify mechanisms and policy options for improving Identify mechanisms and policy options for improving trade-related policy coherence in promoting access to trade-related policy coherence in promoting access to medicines in selected developing countriesmedicines in selected developing countries

General methodology:General methodology:

– The specific objectives of the project will be achieved through applied The specific objectives of the project will be achieved through applied policy, legal and economic research and informal multi-stakeholder policy, legal and economic research and informal multi-stakeholder dialogues at the national leveldialogues at the national level

– The project will focus on 3-4 developing countries in Latin America, Asia The project will focus on 3-4 developing countries in Latin America, Asia and Africaand Africa

– Pre-selected countries could include: Ghana, Jordan, Peru and South Pre-selected countries could include: Ghana, Jordan, Peru and South AfricaAfrica

– Engagement by national governments and relevant stakeholders is Engagement by national governments and relevant stakeholders is needed for the success of the projectneeded for the success of the project

Trade-related policy coherence Trade-related policy coherence and access to medicinesand access to medicines

Some trade related policies to be analyzed:Some trade related policies to be analyzed:

• Market access in goodsMarket access in goods:: 1.1. Applied tariffs on bulk active ingredients, finished Applied tariffs on bulk active ingredients, finished

pharmaceutical products and medical devicespharmaceutical products and medical devices2.2. Existence of exemptions, waivers or reductions in special Existence of exemptions, waivers or reductions in special

casescases3.3. Non tariff barriersNon tariff barriers

• Domestic taxes and price regulations:Domestic taxes and price regulations: 1.1. VAT, other domestic taxes VAT, other domestic taxes 2.2. Price controls schemesPrice controls schemes

• FDI regimes:FDI regimes: 1.1. Enabling environmentEnabling environment2.2. Investment definition and standards of protectionInvestment definition and standards of protection3.3. Use of performance requirementsUse of performance requirements

• Competition law and policyCompetition law and policy


Some trade related policies to be analyzed:Some trade related policies to be analyzed:

• Market access and regulation in health related services:Market access and regulation in health related services: 1.1. Medical and dental servicesMedical and dental services2.2. Midwife and nursing services Midwife and nursing services 3.3. Hospital services Hospital services 4.4. Other human health services Other human health services 5.5. Health insuranceHealth insurance6.6. Data transfer Data transfer

• Intellectual property regulationIntellectual property regulation:: 1.1. Parallel importsParallel imports2.2. Compulsory licenses Compulsory licenses 3.3. Test data exclusivity Test data exclusivity 4.4. The linkage between marketing approval and patent protectionThe linkage between marketing approval and patent protection5.5. Second usesSecond uses6.6. Exceptions and limitationsExceptions and limitations

• Government procurement regulation:Government procurement regulation:1.1. Preferences (price, quality, reliability, local Preferences (price, quality, reliability, local

manufactures/providers) manufactures/providers) 2.2. TransparencyTransparency

Trade related policy coherence Trade related policy coherence and access to medicinesand access to medicines

Other parameters to be taken into the consideration within Other parameters to be taken into the consideration within the general framework but not subject to policy analysis the general framework but not subject to policy analysis include:include:

– Geographical and environmental related factorsGeographical and environmental related factors– Political and macroeconomic stabilityPolitical and macroeconomic stability– The rule of lawThe rule of law– Population and cultural / anthropological factorsPopulation and cultural / anthropological factors– Purchasing capacityPurchasing capacity– Overall disease burdenOverall disease burden– Availability of health infrastructureAvailability of health infrastructure– Availability of human resources in the health sectorAvailability of human resources in the health sector– Supply capacity in the drug sectorSupply capacity in the drug sector– Level of (health related) technological developmentLevel of (health related) technological development– Existence of health service delivery systemsExistence of health service delivery systems



Outputs: Outputs:

– Prepare a methodological note and expert consultations: Prepare a methodological note and expert consultations: Identify trade-related policies that have an impact on access Identify trade-related policies that have an impact on access

to medicines to medicines Explore ways to measure impact in an empirical mannerExplore ways to measure impact in an empirical manner

– Undertake national case studies: Undertake national case studies: Map national trade-related policies at the national level Map national trade-related policies at the national level Identify areas where synergies or lack of coherence Identify areas where synergies or lack of coherence Evaluate impact to the extent possibleEvaluate impact to the extent possible

– Organize national dialogues: Organize national dialogues: Expose national stakeholders to the findings of the studiesExpose national stakeholders to the findings of the studies Generate policy recommendations based on the dialogueGenerate policy recommendations based on the dialogue

– Prepare synthesis report: Prepare synthesis report: Comparative analysis of national experiences Comparative analysis of national experiences Compilation of findings and policy recommendations arising Compilation of findings and policy recommendations arising

from the dialoguesfrom the dialogues

ICTSD’s project on trade-related policy ICTSD’s project on trade-related policy coherence and access to medicinescoherence and access to medicines

Outcomes: Outcomes:

– Clearer understanding of national trade-related policies and Clearer understanding of national trade-related policies and their impact on access to medicines by relevant their impact on access to medicines by relevant stakeholdersstakeholders

– Identify of mechanisms and policy options for improving Identify of mechanisms and policy options for improving trade-related policy coherence in promoting access to trade-related policy coherence in promoting access to medicinesmedicines

– Ultimately, if stakeholders decide to take action based on Ultimately, if stakeholders decide to take action based on the recommendations made, there could be domestic policy the recommendations made, there could be domestic policy reform and adjustment for thereform and adjustment for the creation of an enabling trade- creation of an enabling trade-related framework for attaining related framework for attaining sustainable access to sustainable access to essential medicinesessential medicines

– Other international organizations that could also assist in Other international organizations that could also assist in the process of reform and adjustment process include the the process of reform and adjustment process include the WHO, UNCTAD, WTO, WB and various civil society WHO, UNCTAD, WTO, WB and various civil society organizationsorganizations

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