1. ACTA & Public Safety: Counterfeit Agreement Peter Maybarduk Public Citizen pmaybarduk@citizen.org October 28, 2010

2. ACTA & Public Health Two major public health interests implicated:  Access Risks for access to medicines  Safety The parties cite protecting consumers from unsafe products as a primary benefit of ACTA But:  ACTA’s scope is too broad: inclusion of civil IP infringements threatens competition at no benefit to safety  And simultaneously too narrow: ACTA only reaches those fake products that also infringe a trademark  Wrong tool: ACTA creates opportunity costs for more effective and comprehensive safety measures, including regulatory efforts

3. Border measures EU seizures of generics Police measures, ahead of judicial process A2M movement successful in improving ACTA’s border measures ACTA measures initially akin to Europe’s controversial rule

4. ACTA’s border measures now Patents out of ACTA’s border measures “For the purpose of this Agreement” Parties “may” apply provisions to goods in transit Applied “in a manner that does not discriminate [unreasonably] between IP rights.” But it is very important to discriminate between the distinct and discrete IP rights Unfortunately ACTA’s border measures still do not generally exclude civil infringements

5. Counterfeit

6. Drug regulationIP enforcement WTOWHO WTO

7. “Counterfeits” confusion Private rights  misappropriation counterfeiting (WTO)  unauthorized copy piracy Patents infringement Public health Counterfeit medicine = deliberately mislabeled (WHO)

8. “Counterfeits” confusion Private rights  misappropriation counterfeiting (WTO)  unauthorized copy piracy Patents infringement Public health Counterfeit medicine = deliberately mislabeled (WHO) All “intellectual property rights.”

9. “Counterfeits” confusion Private rights  misappropriation counterfeiting (WTO)  unauthorized copy piracy Patents infringement Public health Counterfeit medicine = deliberately mislabeled (WHO) All “intellectual property rights.” Fallacy #1: Any infringement can be loosely considered a fraudulent & “counterfeit” good.

10. “Counterfeits” confusion Private rights  misappropriation counterfeiting (WTO)  unauthorized copy piracy Patents infringement Public health Counterfeit medicine = deliberately mislabeled (WHO) All “intellectual property rights.” Fallacy #1: Any infringement can be loosely considered a fraudulent & “counterfeit” good. Fallacy #2: Similar remedies can be applied in similar manners and degrees for infringement of the distinct rights.

11. “Counterfeits” confusion Private rights  misappropriation counterfeiting (WTO)  unauthorized copy piracy Patents infringement Public health Counterfeit medicine = deliberately mislabeled (WHO) Counterfeits endanger public health. All “intellectual property rights.” Fallacy #1: Any infringement can be loosely considered a fraudulent & “counterfeit” good. Fallacy #2: Similar remedies can be applied in similar manners and degrees for infringement of the distinct rights.

12. “Counterfeits” confusion   patents All “intellectual property rights.” Fallacy #1: Any infringement can be loosely considered a fraudulent & “counterfeit” good. Fallacy #2: Similar remedies can be applied in similar manners and degrees for infringement of the distinct rights. Medical counterfeits endanger public health & safety (true). Fallacy #3: Tougher enforcement of (all) IPRs is a necessary, (primary) and effective means to fight fraud & protect health & safety.

13. Drug regulationIP enforcement WTOWHO WTO

14. ACTA’s bad precedent Treating competition like criminality Overly broad and aggressive IP enforcement rules justified by claims to public safety Opportunity costs for better public safety measures

15. Trends Some titular anti-counterfeiting initiatives focus squarely and broadly on IP enforcement, not directly on public safety.  ACTA, EAC Some TRIPS+ enforcement measures advanced in part on public health & safety rationales.  EC Council Reg 1383/2003 (cue Prof Flynn), US interagency effort Some health framework anti-counterfeiting initiatives risk incorporating IP enforcement agenda  WHO IMPACT (joint venture with IFPMA) In each case, potential public health costs.

16. Drug regulationIP enforcement WTOWHO WTO

17. Drug regulationIP enforcement WTOWHO WTO