Impact of Anti-Counterfeiting Measures on Access to Generic ARVs

1. Impact of Anti-Counterfeiting Measures on Access to Generic ARVs Noah Metheny, Esq., MPH Director of Policy July 25, 2012 AIDS 2012

2. Outline • Issue #1: Global context of anti-counterfeiting measures • Issue #2: Definition of counterfeit medicines: Conflation of generics with counterfeit medicines and impact on access • Successful Civil Society Responses • Alternative Solutions • Ongoing Challenges

3. Issue #1 How are anti-counterfeiting measures framed and operate in global context?

4. Issue #1 • “Counterfeit” is not a public health term, but rather an intellectual property (IP) term [see Issue #2] • Need to understand within the larger context of IP enforcement agenda • Need to reframe within a public health context, while fulfilling human rights obligations (guarantee right to health and life, including access to quality, essential, and affordable medicines)

5. Issue #1 • Real question with anti-counterfeiting measures: Is IP enforcement the best way to tackle issues of quality, safety and efficacy (QSE)? • Thesis: Issues of QSE should not be addressed through IP enforcement measures because of the barriers it creates for accessing generic ARVs, but rather within public health and human rights frameworks

6. Issue #2 What do we mean by “counterfeit medicines”?

7. Issue #2: TRIPS “ ‘Counterfeit Trademark Goods’ shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation” (Article 51, ftnt 14a) willful trademark infringement

8. Issue #2: The Kenyan Anti-Counterfeiting Act of 2008 “Counterfeiting means taking the following actions without the authority of the owner of any intellectual property right subsisting in Kenya or elsewhere in respect of protected goods: a) The manufacture, production, packaging, re-packaging, labeling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such a degree that those other goods are identical or substantially similar copies of the protected goods; b) The manufacture, production, or making, whether in Kenya or elsewhere, the subject matter of that intellectual property, or a colourable imitation thereof so that the other goods are calculated to be confused with or to be taken as being the protected goods of the said owner or any goods manufactured, produced or made under his license; c) The manufacturing, producing or making copies, in Kenya or elsewhere, in violation of an author’s rights or related rights.” (Part I)

9. Issue #2: East Africa Community Draft Anti-Counterfeiting Bill • Counterfeit goods are “goods that are the result of counterfeiting (including goods generally known as pirated goods), and includes any means used for purposes of counterfeiting.” And counterfeiting is defined as a) “The manufacturing, producing, or making, whether in the Community or elsewhere, of any goods whereby those protected goods are imitated in such a manner and to such a degree that those other goods are substantially identical copies of the protected goods without the authority of the Owner of any Intellectual Property Right subsisting in the Community in respect of Protected Goods; b) The manufacturing, producing, or making or applying to goods, whether in the Community or elsewhere, the subject matter of that Intellectual Property Right, or a colourable imitation thereof so that the other goods are calculated to be confused with or to be taken as being the Protected Goods of the said Owner or any goods manufactured, produced or made under his license without the authority of the Owner of any Intellectual Property Right subsisting in any of the Partner States In respect of the Protected Goods.” (Section 2)

10. Issue #2: ACTA • Beyond willful trademark infringement contained in TRIPS • Stricter Border Measures • More Severe Punishment • Pro-IP judicial Presumptions ALL LEADING TO IMPEDING ACCESS TO GENERIC ARVS

11. Issue #2 Take Aways • Counterfeit definitions are overly broad, general, and imprecise • TRIPS-Plus: beyond technical meaning contained in TRIPS • Serious threat to accessing generic ARVs • Violation of public health principles and human rights (e.g. right to health and right to essential medicines)

12. Civil Society Response: Kenya • July 2009: 3 people living with HIV filed a petition challenging 2008 Act in July 2009 • April 2010: High Court granted a preliminary injunction in favor of PLHIV petitioners • April 2012: High Court ruled the Act was too broad and could interfere with the flow of legal generic medicines to patients

13. Civil Society Response: ACTA • Activists organized protests against ACTA throughout Europe in Feb. 2012, drawing thousands of protestors • Activists, academics, and allies publicized and educated the general public and its representatives about the multiple problems with ACTA • European Parliament rejects ACTA by a vote of 478 to 39 (July 4, 2012)

14. Non-TRIPS+ Solutions • Other ways (other than IP enforcement) to address quality, safety and efficacy issues that ensures public health and human rights • Clearer/narrower definition of counterfeit (willful trademark infringement) • More support for NDRA and RDRA • Lower prices for ARVs (remove economic incentive to counterfeit: no profit in producing/selling counterfeits if affordable drugs available)

15. Future Challenges • Continued pressure to tackle QSE issues via IP enforcement agenda • Tension between IP framework (enforcement of a private right) vs. human rights/public health concerns • Sustained and present civil society involvement and engagement • Proper forums to deal with QSE issues? • Other bi/multilateral efforts to push for TRIPS+ provisions, including anti-counterfeiting measures (e.g. Canadian-EU FTA) • Role of international organizations? (e.g. WTO, WHO, etc)

16. THANK YOU!