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Counterfeits haveharmful effects on

patients' health and can kill

Counterfeits frustrateefforts to deal with high

burdens of disease

Counterfeits undermine the

credibility of healthcare systems

Increasedinternational

collaboration isessential to beat

counterfeiting

What are counterfeit medicines?Counterfeit medicines are deliberatelyand fraudulently mislabelled withrespect to identity or source: theirquality is unpredictable as they maycontain the wrong amount of activeingredients, wrong ingredients or noactive ingredients. In all cases counter-feit medicines are manufacturedsecretly with no possibility of control.

Counterfeiting occurs both with brand-ed and generic products. It has beenfound that counterfeiters copy or imi-tate existing products but they alsomanufacture products that are com-pletely invented.

A global public health crisisCounterfeit medicines represent anenormous public health challenge.Anyone, anywhere in the world, cancome across medicines seemingly pack-aged in the right way but which do notcontain the correct ingredients and, inthe worst-case scenario, may be filledwith highly toxic substances. In somecountries, this is a rare occurrence, inothers, it is an everyday reality.

Counterfeit medicines range from ran-dom mixtures of harmful toxic sub-stances to inactive, useless prepara-tions. Occasionally, there can be «highquality» fakes that do contain thedeclared active ingredient. In all cases,contents of counterfeits are unreliablebecause their source is unknown and,by definition, always illegal. Fakedrugs can cause harm to patients andsometimes lead to death.

Any kind of product can be and hasbeen counterfeited: expensive lifestyleand anticancer medicines, antibiotics,medicines for hypertension and cho-lesterol-lowering drugs, hormones,steroids and inexpensive generic ver-sions of simple pain killers and antihis-tamines. In developing countries themost disturbing issue is the commonavailability of counterfeited medicinesfor the treatment of life-threateningconditions such as malaria, tuberculo-sis and HIV and AIDS.

Counterfeit medicines can harmand killThe regular use of substandard orcounterfeit medicines can lead to ther-apeutic failure or drug resistance. Insome cases, it can lead to death. In2004, fake medicines led to a trail ofdeath in Argentina.

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KEY FACTORS THAT MAKECOUNTERFEITING POSSIBLE

Inadequate legislation andenforcement: The main reason forcounterfeiting medical products is thehuge sums of money that can bemade because of the lowmanufacturing costs. However, inmany countries legislation orenforcement are inadequate andcounterfeiters face extremely low risksof being punished.

Insufficient penal sanctions makecounterfeiting attractive for criminals.

Transactions involving many inter-mediaries increase opportunities forcounterfeiters to infiltrate the regulat-ed distribution system.

Expansion of trade and deregula-tion offer greater opportunities tointroduce fake products into officialchannels.

Ineffective cooperation amongstakeholders: health authorities, cus-toms, police, industry and trade needto establish effective cooperation andexchange of information in order todetect and stop counterfeiters.

Lack of political will: in some coun-tries counterfeiters are not disturbedby authorities if their export capacitytakes priority over the public healthvalue of medical products.

Lack of awareness among healthprofessionals and consumers hin-ders detection and reporting, evenwhen patients experience treatmentfailure.

WHAT PRIORITY ACTIONSHOULD COUNTRIES TAKE?

Strengthen legislation ensuring thatcounterfeiting medical products is acrime and that punishment is com-mensurate to the consequences that ithas on personal health and on thecredibility of national health care deliv-ery systems.

Strengthen regulatory oversight ensur-ing that all manufacturers, importers,exporters, distributors and retailers com-ply with the appropriate requirementsthat are necessary for a secure distribu-tion chain for all medical products

Improve collaboration among govern-mental entities (such as health, police,customs, local administrative units,judiciary) that need to work togetherin order to effectively combat counter-feiters.

Develop a communication strategy toensure that health professionals, thegeneral public and the media areaware of the dangers associated withcounterfeit medicines.

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Veronica Diaz was a healthy 22-yearold woman, living in Viedma,Argentina, who had mild anaemia andwas given injections of an iron-basedpreparation. In December 2004, shebecame very sick and died of liver fail-ure after receiving the seventh of a 10-injection treatment. The medicinesauthority of Argentina, ANMAT, deter-mined that she had been given a high-ly toxic counterfeit. Authorities wereunable to determine the source of thecounterfeit product due to falsifiedpaper work. While most of the coun-terfeit production throughout Argent-ina was recovered and four peoplewere prosecuted, the highly fragment-ed distribution system prevented therecall from being 100% successful. InMay 2005 another woman died and a22-year old pregnant woman wasinjected with the same counterfeit. Shesurvived but gave birth to a 26 weekpremature baby. To date, Argentineanlaw does not consider counterfeitingmedicines per se a crime.

The size of the problem Currently, the sources of informationavailable include reports from non-governmental organizations, pharma-ceutical companies, national drug reg-ulatory and enforcement authorities,

ad hoc studies on specific geo-graphical areas or therapeutic groups,and occasional surveys. These sourcesof information emphasize the com-plexity of making estimations.

Although precise and detailed data oncounterfeit medicines is difficult toobtain, IMPACT stakeholders estimateproportions ranging from around 1%of sales in developed countries to over10% in developing countries, depend-ing on the geographical area. Thatrange takes into consideration bothregional disparities in the presence ofcounterfeits, and specific global mar-ket value shares. Apart from the hugedifferences between regions, variationscan also be dramatic within countries,i.e. city versus rural areas, city versuscity.

Counterfeiting is greatest in thoseregions where the regulatory and legaloversight is weakest.

• Most industrialized countries witheffective regulatory systems and mar-ket control (e.g. USA, most of EU,Australia, Canada, Japan, NewZealand) have an extremely low pro-portion, i.e. less than 1% of marketvalue

• Many countries in Africa and parts ofAsia and Latin America have areaswhere more than 30% of the med-icines on sale can be counterfeit, whileother developing countries have lessthan 10%; overall, a reasonable esti-mate is between 10% and 30%

• In many of the countries of the for-mer Soviet Union the proportion ofcounterfeit medicines is above 20% ofmarket value

• Medicines purchased over theInternet from sites that conceal theirphysical address are counterfeit in over50% of cases.

The estimated ranges do not aim atproviding an exact figure but rather anindication of the different possible lev-els of prevalence around the world.Even one single case of counterfeitmedicine is not acceptable because,in addition to putting patients at riskand undermining the public confi-dence in their medicines, it also betraysthe vulnerability of the pharmaceuticalsupply system and jeopardizes thecredibility of national authorities(health and enforcement alike).

Counterfeiting grows moresophisticatedFake medical products are increasinglypresent even in better controlled mar-kets, as shown in the following exam-ples:

• April 2007: the United States Foodand Drug Administration (FDA) issuedan alert about a counterfeit antiretro-viral medicine.

• 2006: The Dutch Healthcare Inspect-orate warned consumers not to buyoseltamivir, a flu medication, throughthe Internet, after counterfeit capsuleswere found in the Netherlands contain-ing lactose and vitamin C, and noactive substance.

• 2006: In the United Kingdom, offi-cials seized 5000 packets of counter-feit flu medication oseltamivir.

Hormones & steroids (18%)

Antibiotics (28%)

Other (14 therapeutic classes, 33%)

Analgesics & antipyretics (6%)

Antimalarials (7%)

Antiasthma & antiallergy (8%)

Reports of counterfeit drugs by therapeutic classreceived by WHO 1999-2002

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• 2006: In the United Kingdom aRecall Alert was issued on counterfeitatorvastatin, a cardiovascular medi-cine.

• 2004: In France, counterfeit contactlenses were detected by the regulatoryauthorities after receiving complaintsfrom patients.

Internet salesIn industrialized countries and to someextent in poorer countries, Internet-based sales of pharmaceuticals are amajor source of counterfeit medicines,threatening those who seek cheaper,stigmatized or unauthorized treat-ments. Some Internet pharmacies arecompletely legal operations, set up tooffer clients convenience and savings.They require patient prescriptions anddeliver medications from governmentlicensed facilities. Illegal Internet phar-macies conceal their real identity, areoperated internationally, sell medica-tions without prescriptions, and deliverproducts with unknown and unpre-dictable origins.

Key challenges to haltingcounterfeit medicinesCounterfeiting medicines is a crime car-ried out using deception and othertechniques typical of organized crime.Health authorities are not equipped toadequately address this situationalone. In order to combat counterfeit-ers, it is necessary to develop andestablish appropriate mechanisms ofeffective collaboration between healthauthorities and police, customs, thejudiciary, manufacturers, wholesalers,retailers and health professionals.

Some policy-makers have argued thatdrug regulation represents an unnec-essary barrier to trade and should bereduced to a minimum. Pharmaceut-

icals, however, are not a standard com-modity. Consumers and prescribers areunable to assess their quality, safetyand efficacy independently and inef-fective regulatory oversight can havedeadly consequences for patients.

The production of counterfeit drugsdoes not require large infrastructuresor facilities. The majority of the coun-terfeiters apprehended so far carriedout their activities in ordinary homes,small cottage industries, or in back-yards.

Counterfeiting of medicines is a hugelylucrative business due to the continuedhigh demand for medicines and lowproduction costs. The absence of deter-rent legislation in many countries alsoencourages counterfeiters since thereis no fear of being apprehended andprosecuted.

In many countries people have inade-quate access to health services, reli-able pharmaceutical supply, healthinsurance or social security systems. Inthese situations, far too common inpoor areas of developing countries,people have to pay out of pocket fortheir medicines and therefore seekcheaper sources. Counterfeiters takeadvantage of this and abuse popula-

tions in real need by providing fakemedicines.

WHO leads the global effort tocombat counterfeit medicinesIn order to mobilize awareness andaction in the fight against fake drugs,in February 2006, WHO created thefirst global initiative, known as theInternational Medical Products Anti-Counterfeiting Taskforce (IMPACT).IMPACT is comprised of all 193 WHOMember States on a voluntary basisand includes international organiza-tions, enforcement agencies, nationaldrug regulatory authorities, customsand police organizations, nongovern-mental organizations, associationsrepresenting pharmaceutical manufac-turers and wholesalers, health profes-sionals and patients’ groups. Thesegroups have joined to improve coordi-nation and harmonization across andbetween countries so that eventuallythe production, trading and selling offake medicines will cease.

Who is supporting the work ofIMPACT?The World Health Organization spear-headed the creation of the WHOIMPACT coalition, which is supported bynational medicines regulatory authori-ties of WHO Member States and a num-

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IMPACT - International Medical Products Anti-Counterfeiting Taskforce | 5

Where do these medicines come from?

ber of other stakeholders. These include:Interpol, Organisation for Economic Co-operation and Development, WorldCustoms Organization, World Intellect-ual Property Organization, World TradeOrganization, European Commission,Council of Europe, International Fed-eration of Pharmaceutical Manufact-urers and Associations, European Gen-eric Medicines Association, World Self-Medication Industry, Asociación Latino-americana de Industrias Farmacéuticas,Commonwealth Secretariat, ASEANSecretariat, International Federation ofPharmaceutical Wholesalers, EuropeanAssociation of Pharmaceutical Full-lineWholesalers, International Pharmaceut-ical Federation, International Council ofNurses, World Medical Association,International Alliance of Patients’Organizations, ReMed, PharmaciensSans Frontières, the United States

Pharmacopeia, German Pharma HealthFund.

To accomplish this mandate,IMPACT focuses on the followingfive key areas:

Legislative and regulatoryinfrastructureIn most countries, national legislationis often not equipped to deal with theextremely serious consequences ofcounterfeit medicines and penalties forcounterfeiters are too light to act asdeterrents. Stronger legislation clearlyidentifying counterfeiting medicalproducts as a crime will help toempower police, customs officials andthe judiciary. IMPACT stakeholders arelooking at existing laws in countriesand aim, by the end of 2007, to pres-ent effective models countries canreplicate and adapt to meet their own

needs. These models will cover all theadministrative, civil and penal aspectsof legislation aimed at combatingcounterfeit medical products.

Regulatory implementationIMPACT stakeholders are working atways to help national authorities totake action and implement legislativemeasures on counterfeit medical prod-ucts. These include a broad variety ofactivities such as guidance for improv-ing control on importation, exportationand distribution of medical products,tools to assess national situations andneeds, model approaches to proce-dures to managing cases of suspectedcounterfeit products, models for estab-lishing effective exchange of informa-tion at national and international lev-els, and for establishing effective coor-dination among health authorities,police, customs, judiciary, manufactur-ers, distributors, health professionalsand other expressions of the civil soci-ety to ensure proper detection, regula-tion, control, investigation and prose-cution. IMPACT will develop projectsto help countries with weak regulatorysystems to strengthen them by improv-ing collaboration and drawing fromthe experience, capacity and resourcesof all IMPACT stakeholders.

Enforcement By working with the World CustomsOrganization, INTERPOL, and informalnetworks of enforcement officers, thePermanent Forum on InternationalPharmaceutical Crime, IMPACT offersan important opportunity for improv-ing contact and mutual understandingamong enforcement officials of differ-ent countries in order to improve coor-dination of operations and exchangeof information. IMPACT is also a toolfor enforcement officers to establishcommunication with health authoritiesand other stakeholders. The enforce-ment working group is working also atdeveloping training materials forenforcement officers of countries thatneed to improve their technical skills inthe detection of suspected counterfeits

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Can you tell which one is fake?

weaknesses in radio-frequency identi-fication (RFID) (including its cost, pri-vacy concerns, logistics throughout thedistribution system, etc.) and IMPACTfound consensus on the fact that fullimplementation of RFID can only beenvisaged in a distant future; as aconsequence, alternatives need to besought for individual pack codingtoday.

Technologies are particularly importantfor product authentication. The manydifferent models for authenticationinclude those aligned to end user veri-fication (e.g. patient, doctor) and thosefocusing on the point of dispensing,with the pharmacist playing a vitalrole. The working group’s view is thatauthentication of medicines shouldonly go as far as the pharmacist andthat the burden of verifying that aproduct is authentic must not fall onpatients.

CommunicationIMPACT is developing the most coordi-nated and effective mechanismsrequired to both respond and alert keyaudiences, stakeholders and the gen-eral public about counterfeits in com-munities and across countries. Thisentails improving countries’ capacityto estimate the prevalence of counter-feit medical products and strengthen-ing international information networksto exchange information and issue

alerts from country to country andregion to region. Increased publicinformation is essential for patients,dispensers and doctors, who have aright to know if there are suspectgoods on the market, but must alsocontribute to detecting counterfeits byreporting and helping to investigatesuspicious cases. Special initiatives arebeing prepared to make Internet usersaware of the risks they run when pur-chasing medicines from unknownsources and to alert and inform peoplein extremely disadvantaged areas.

IMPACT’s vision is that all counterfeitmedical products will be eradicatedfrom the supply chain by 2015. A com-munications campaign is required tocreate awareness and increase com-mitment from those who can influencechange across the medicines supplychain. Different levels of engagementare required from the various stake-holders. This entails addressing, withspecific strategies and goals, govern-ment institutions, industry (manufac-turers and wholesalers), health-careprofessionals, patients and the media.

and collection of appropriate evidencefor prosecution.

TechnologyBy using the broad partnership rangingfrom health agencies to pharmaceuti-cal manufacturers and distributors,IMPACT will help to assess technolo-gies aimed to prevent, deter or detectcounterfeit medicinal products. Thisassessment takes into account: a) cost;b) scalability; c) specific country needsand situations; d) feasibility; and e)regulatory implications. This work aimsat demonstrating the benefit of chosentechnological approaches to thepatient.

There is no such thing as a “world-wide” applicable technology, andtherefore different approaches areneeded when considering counterfeitmedicines in the developing world ver-sus the developed world. For develop-ing countries the priority is to strength-en their capacities to tackle the infor-mal trade of medicines such as streetmarkets, smuggling, theft and otherunregulated or illegal activities. Bothdeveloping and developed countriesshould implement technologiesappropriate to their situation andseek those that are compatible acrossborders.

Although it has been proposed as apromising solution, there are multiple

1. Counterfeiting medicines, including the entirerange of activities from manufacturing to provid-ing them to patients, is a vile and serious criminaloffence that puts human lives at risk and under-mines the credibility of health systems.

2. Because of its direct impact on health, counter-feiting medicines should be combated and pun-ished accordingly.

3. Combating counterfeit medicines requires thecoordinated effort of all the different public andprivate stakeholders that are affected and arecompetent for addressing the different aspects ofthe problem.

4. Counterfeiting medicines is widespread and hasescalated to such an extent that effective coordi-nation and cooperation at the international levelare necessary for regional and national strategiesto be more effective.

5. National, regional and international strategiesaimed at combating counterfeit medicines shouldbe based on:

a) political will, adequate legal framework, andimplementation commensurate to the impact ofthis type of counterfeiting on public health andproviding the necessary tools for a coordinatedand effective law enforcement.

b) inter-sectoral coordination based on writtenprocedures, clearly defined roles, adequateresources, and effective administrative and opera-tional tools.

c) creating an awareness about the severity of theproblem among all stakeholders and providinginformation to all levels of the health system andthe public.

d) development of technical competence and skillsin all required areas.

e) appropriate mechanisms for ensuring vigilanceand input from health-care professionals and thepublic.

6. The WHO should lead the establishment of anInternational Medical Products Anti-Counterfeiting Taskforce (IMPACT) of governmen-tal, nongovernmental and international institu-tions aimed at:

a) raising awareness among international organi-zations and other stakeholders at the internation-al level in order to improve cooperation in com-bating counterfeit medicines, taking into accountits global dimensions.

b) raising awareness among national authoritiesand decision-makers and calling for effective leg-islative measures in order to combat counterfeitmedicines.

c) establishing effective exchange of informationand providing assistance on specific issues thatconcern combating counterfeit medicines

d) developing technical and administrative toolsto support the establishment or strengthening ofinternational, regional and national strategies.

e) encouraging coordination among differentanti-counterfeiting initiatives.

IMPACT shall function on the basis of existingstructures/institutions and will in the long termexplore further mechanisms, including an interna-tional convention, for strengthening internationalaction against counterfeit medicines.

CONCLUSIONS AND RECOMMENDATIONS OF THEWHO INTERNATIONAL CONFERENCE ON COMBATING COUNTERFEIT DRUGS

DECLARATION OF ROME18 FEB 2006

The participants of the WHO International Conference‘Combating Counterfeit Drugs: Building Effective International Collaboration’,

gathered in Rome on 18 February 2006

DECLARE

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Support, additional information: www.who.int/impact

IMPACT Contacts

Chair Dr Howard Zucker, Assistant Director-General,Health Technology and Pharmaceuticals, WHOzuckerh@who.int

Vice-Chairs Prof Dora N. Akunyili, Director General, National Agency for Food and DrugAdministration and Control (NAFDAC), Nigeriadnakunyili@yahoo.com

Ms Ruth Lee, Health Sciences Authority, Singapore, and Member of the Permanent Forum on International Pharmaceutical Crimeruth_lee@hsa.gov.sg

Chair of Working Group on Legislative Dr Konstantin Keller, Federal Ministry of Health, Germany and Regulatory Infrastructure konstantin.keller@bmg.bund.de

Chair of Working Group on Regulatory Dr Ilisa Bernstein, Director of Pharmacy Affaires, Food and Drug Administration, USAImplementation Ilisa.Bernstein@fda.gov

Co-Chairs of Working Group Ms Aline Lecadre, Interpolon Enforcement a.lecadre@interpol.int

Mr Eric McIntosh, Therapeutic Goods Administration, AustraliaEric.McIntosh@health.gov.au

Chair of Working Group on Technology Dr Harvey Bale, Director General, International Federation of PharmaceuticalManufacturers and Associationsh.bale@ifpma.org

Chair of Working Group on Communication Mr Ton Hoek, Secretary-General, International Pharmaceutical Federation, FIPhoek@fip.org

Executive Secretary Dr Valerio Reggi, Coordinator, Medicines Regulatory Support, Department of TechnicalCooperation for Essential Drugs and Traditional Medicine, WHOreggiv@who.int