Counterfeiting An overview of problems and dangers Dr

Counterfeiting: An overview of problems and dangers Dr Sabine Kopp Quality Assurance and Safety: Medicines World Health Organization

Problem: Counterfeiting medicines is a major public health concern World Health Organization

What is a counterfeit medicine? ¨ Different definitions in different countries!!! World Health Organization

WHO Definition of a counterfeit medicine A product that is: ¨ deliberately and fraudulently mislabelled with respect to source and/or identity. Counterfeiting can apply to both ¨ generic and branded products. World Health Organization

WHO Definition of a counterfeit medicine ¨ Counterfeit products may include: – products with the correct ingredients – with the wrong ingredients – without ingredients – with incorrect quantities of active ingredients – with fake packaging World Health Organization

What's a counterfeit medical product? World Health Organization

WHO receiving reports on cases of counterfeit medicines (1982) ¨ Majority of the reports did not distinguish between substandard and counterfeit medicines ¨ Most cases were not validated or confirmed ¨ Most sources of the counterfeit medicines were unknown World Health Organization

World Health Organization

Counterfeiting: increasingly sophisticated business World Health Organization

Counterfeit Lipitor (20 mg tablets) Text should be facing downwards as above World Health Organization

What is the problem? ¨ Counterfeiting medicines is a lucrative "business" and seems emerging, affecting both developing and developed countries ¨ The real magnitude of the problem is unknown: – Existing data not comprehensive – All parties concerned reluctant to make data AVAILABLE or REPORT World Health Organization

Is there a health risk ? • Under treatment or non-treatment Public health risk: ineffective medicines • Intoxication: harmful ingredients • No quality assurance • Adverse reactions not monitored: an effective product recall not possible • Erosion of public confidence in medical care and health systems • Waste of money • …. World Health Organization

What are the main factors encouraging counterfeiting of medicines globally? (I) ¨ Social value of medicines not given priority consideration when defining national drug policies ¨ Manufacturing without GMP compliance ¨ Poor storage and distribution condition World Health Organization

What are the main factors encouraging counterfeiting of medicines globally? (II) ¨ Lack of government commitment to create strong medicines regulation: – Weak legislation – MRAs week in terms of resources, expertise, and enforcement ¨ Presence of unregulated markets, manufacturing & distribution outlets World Health Organization

National regulatory and inspection systems – --> approx. 1/3 of WHO Member States have well developed regulatory systems, approx. . 1/3 have none ¨ In developed countries – well organized, controlling national market – dossiers evaluation and inspections – different approaches used, few MRA ¨ In developing countries – – often difficulties of resources capacity? application of national and international guidelines… --> or non-existent …. World Health Organization

What are the main factors encouraging counterfeiting of medicines globally? (III) ¨ High prices and price differentials, health care providers and patients looking for cheaper sources ¨ In developing countries: scarcity or erratic supply of medicines ¨ Lack of respect for trademark and other international agreements ¨ Corruption World Health Organization

What are the main factors encouraging counterfeiting of medicines globally? (IV) ¨ "Denial" of existence of problem by governments, industries, regulators, etc. ¨ International aspect of manufacture and supply of pharmaceuticals -> difficult to control multi-jurisdictional ¨ New trade arrangements – – opening of boarders for trade through free ports trade through several intermediaries promotion and trade through Internet World Health Organization

WHO’s work in combating counterfeit medicines: Three strategies ¨ 1. Providing tools, international norms, standards and guidelines to assist that drugs circulating in national and international commerce are safe, efficacious and of good quality ¨ 2. Providing support to Member States to build national regulatory capacity ¨ 3. Developing global activities to combat counterfeit medicines World Health Organization

Pre-ICDRA Conference on Counterfeit Drugs, Madrid, 13 -14 February 2004 ¨ ICDRA only for regulators, forum for 100+ f regulatory authorities all around the World ¨ Pre-conference on counterfeit drugs was open to all stakeholders, participants included: • International organizations, e. g. Interpol, WIPO + WCO • Regulators (Australia, US, Thailand, China, Vietnam, the Netherlands. . ) • Industry Associations – IFPMA, WSMI • Other NGOs World Health Organization

Milestones in WHO's work in Reports from WHO Member States: the anti-counterfeiting area early 80's 1988: Resolution WHA 41. 16 requesting WHO to initiate programmes for the prevention and detection of the exportation, importation and smuggling of counterfeit pharmaceutical products. World Health Organization

1992: first international meeting on counterfeit drugs – organized by WHO, CIOMS* and IFPMA definition of 'counterfeit drug' and called all parties involved in manufacturing and distribution as well consumers to collaborate with governmental institutions in combating counterfeit drugs * Council for International Organizations of Medical Sciences World Health Organization

1994: resolution WHA 47. 13 requesting WHO to assist Member States in their efforts aimed at combating counterfeit drugs. 1996: WHO Project on Counterfeit Drugs 1999: Guidelines for the Development of Measures to Combat Counterfeit Drugs, guidance that is far from being achieved in the majority of WHO Member States. 2000: WHO, IFPMA, EGA, Pharmaciens Sans Frontières working group on counterfeits 2001: WHA Technical Briefing World Health Organization

1994 -2004: several ICDRA* request WHO to assist member states to adopt measures to combat counterfeit medicines Madrid 2004: ICDRA requested WHO to work at a draft international convention on counterfeit medicines 2005 -06: No consensus among Member States on an international convention on counterfeit medicines February 2006: Rome conference recommended * International Conference of an international establishment of Drug Regulatory Authorities taskforce World Health Organization

July 2006: To. R and name (IMPACT) endorsed at meeting in Rome September 2006: Circular Letter announcing the establishment of IMPACT to Member States November 2006: First IMPACT General Meeting, Bonn, Germany - nomination of IMPACT Chair and Vice-Chairs, nomination of Chairs of IMPACT five Working Groups, and establishment of a work plan for 2007. December 2007: Second IMPACT General Meeting, Lisbon, Portugal – endorsement of "Principles and Elements for National Legislation against Counterfeit Medical Products" http: //www. who. int/entity/impact/events/Final. Principlesfor. Legislation. pdf World Health Organization

¨ 3 -5 December 2008: Third IMPACT General Meeting, Hammamet/Tunisia ¨ 19 -27 January 2009 EB/WHO ¨ 18 -23 May 2009 World Health Assembly World Health Organization

IMPACT's conceptual framework 1) IMPACT: voluntary coalition of stakeholders that has the purpose of coordinating international activities aimed at combating counterfeit medical products; 2) IMPACT stakeholders reflect the fact that combating counterfeiting of medical products cannot be successfully achieved by the health sector alone but requires coordinated effort and effective collaboration among health sector, enforcement, border control, justice (all at different administrative levels), as well as health professionals, manufacturers, importers, distributors, media, patients/consumers; World Health Organization

3) IMPACT is led by WHO to keep focus on the public health implications of counterfeiting rather than on IPR-related aspects. 4) IMPACT output include recommendations, policy advice, and reference and training materials that reflect consensus reached among IMPACT stakeholders. World Health Organization

Who is/should be in IMPACT ? All 193 WHO Member States and all major international stakeholders, such as: European Commission World Health Organization

How does IMPACT work? Secretariat: WHO 5 working groups, focusing on the areas where weaknesses have been identified and action needs to be taken at national and international level: legislative and regulatory infrastructure regulatory implementation enforcement technology communication World Health Organization

Issues that came up during the last 12 months ¨ Concerns that the fight against counterfeit medicines may have a negative impact on generics ¨ Use of the counterfeit argument for limiting free trade / competition / parallel trade ¨ Use of the term "counterfeit medicinal product" in patent disputes ¨ Concerns from some parties that technical measures would be too costly, e. g. for OTC and Generics World Health Organization

Internet and medicines http: //www. who. int/medici nes/docs/Medicines-on. Internet-Guide. html In addition to English, already available in many languages such as Spanish, Italian, Estonian, Arabic etc. World Health Organization

Questionnaire on Pharmaceutical etrade in 2000 (58 out of 191 responded ) ¨ ¨ Only 5 countries declared to specifically regulate promotion and sale through the Internet, but… ¨ Wide range of sanctions: - revocation of licence - confiscation of drugs - prison (1 month -7 years) - financial sanctions ¨ Very few countries effectively control exportation ¨ Importation via Internet is often accepted for ‘personal use’ – Published in WHO Drug Information Vol. 15 No. 3 & 4, 2001 p 180 World Health Organization

What to recommend to patients ? • Buy medicines from licensed pharmacies • Examine the package to see if sealed • Check the label for: name, manufacturer, expiry date and instructions of use • Avoid buying loose tablets, capsules or injections • Insist on having a receipt • See your doctor/healthcare provider if symptoms persist • If you suspect counterfeiting, report to your pharmacy and healthcare provider or medicine control authorities World Health Organization

Conclusions ¨ Fighting counterfeit medicines – Working together with all parties concerned, nationally and internationally, is the key! World Health Organization

Further questions ? ? ? uhttp: //www. who/medicines World Health Organization