1. 1 IMPACT: the International Medical Products Anti-Counterfeiting Taskforce Peter Munyi LLM Christa Cepuch BSc Phm UNSR EAC Consultation, Nairobi 10 – 12 Sept 2010

2. 2 PLAYING WITH WORDS CAN BE DANGEROUS “ … the IP enforcement campaign is characterised by strategic obfuscation; its message is intentionally misleading…” Sell, Susan (2008)

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4. 4 WHAT IS IMPACT? Est 2006 “A voluntary groupings of governments, organisations, institutions, agencies and associations from developing and developed countries … aimed at building coordinated networks across and between countries in order to halt the production, trading and selling of fake medicines around the globe.“ Mission: “To promote and strengthen international collaboration to combat counterfeit medicinal products...” SEE TERMS OF REFERENCE Goals: “.................Develop technical and administrative tools to support establishment or strengthening of international, regional and national strategies.” Norm setting?

5. 5 WHO’s ROLE IN IMPACT Participants: IGOs such as WHO; EC; Interpol, IFMPA, WIPO, WCO, OECD, EC, NMRAs (governmental institutions and agencies); WHO collaborating centres; NGOs active in combating counterfeit medicinal products (?); international associations representing manufacturers...... etc. WHO is just one of the voluntary participants Secretariat: “subject to...human and financial resources, secretarial support for the IMPACT will be provided by WHO....” “IMPACT documents...issued by WHO will be disseminated with appropriate disclaimers...” “the secretarial support... will be financed by voluntary contributions from participants.”

6. 6 IMPACT WORKING GROUPS Working Groups  Legislative and Regulatory Infrastructure to intern alia, develop model legislation and initiatives aimed at law-makers in orders to promote adoption of new legislation  Regulatory Implementation  Enforcement  Technology  Communication

7. 7 LEGISLATIVE AND REGULATORY INFRASTRUCTURE Some of the outcomes of the IMPACT WG on Legislative and Regulatory infrastructure: 1. Principles and Elements of National Legislations (a)Barriers to enforcement (b)Definitions, including defining counterfeiting... (c)Responsibilities (d)Sanctions and types thereof (e)Illegal acts 2. Submit comments to WHO by 31.12.2009 3. Prepare for discussions at WHA63 in May 2010

8. 8 WHA63 on IMPACT At WHA63, a resolution was adopted for an intergovernmental WG (IGWG) on counterfeit medicinal products, with participation being open to all member states with a mandate to examine WHO’s:  role in ensuring availability of safe... affordable medicines;  relationship with IMPACT;  role in prevention and control of substandard / spurious / counterfeit medicines This IGWG to report to WHA64 (May 2011)

9. 9 COUNTERFEIT: IMPACT – 1 (IP enforcement.. and.. public health)  Two paragraphs and four notes “… a product with a false representation (a) of its identify (b) and / or source (c). This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients / components (d), with wrong ingredients / components, without active ingredients, with incorrect amounts of active ingredients or with fake packaging…” (continues)

10. 10 COUNTERFEIT: IMPACT – 2 (IP enforcement.. and.. public health) (continued…) … Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches of, or quality defects or non-compliance with GMP / GDP in legitimate medical products must not be confused with counterfeiting…”

11. 11 COUNTERFEIT: IMPACT - 3 (IP enforcement.. and.. public health)  Provides opportunity for supporters of strong IP regimes to use public health issues as a front to enforce IPRs (e.g. through public health agencies such as NMRAs)  Fear mongering and alarmist as a public relations campaign: fanged cobra (!) representing counterfeit medicines (?)

12. 12 the public’s reaction !

13. 13 THANK YOU!! MERCI BEAUCOUP!! ASANTENI SANA!!