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10/11/20141 International Politics of Intellectual Property Rights: An African Perspective Enga Kameni, Access to Medicines Coordinator, and Doctoral Candidate,

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Presentation on theme: "10/11/20141 International Politics of Intellectual Property Rights: An African Perspective Enga Kameni, Access to Medicines Coordinator, and Doctoral Candidate,"— Presentation transcript:

1 10/11/20141 International Politics of Intellectual Property Rights: An African Perspective Enga Kameni, Access to Medicines Coordinator, and Doctoral Candidate, International Development Law Unit, Centre for Human Rights, Faculty of Law, University of Pretoria, South Africa LL.M Student, Harvard Law School or NB: Some materials sourced from Cecilia Oh and Tenu Avafia.

2 Overview  August 30 Decision  Free Trade Areas  Anti Counterfeiting Legislation 10/11/20142

3 3 Overview  FTAs and TRIPS-plus provisions  US-SACU FTA (failed) and EU-ACP EPA negotiations  How will they affect access to medicines and prices?  Lessons learnt and possible strategies

4 10/11/20144 TRIPS Plus provisions  Strengthen IP rights protection beyond the minimum standard of the TRIPS Agreement  TRIPS-plus provisions have the general effect of extending the patent life beyond that required by TRIPS

5 10/11/20145 TRIPS plus provisions  TRIPS plus provision can be found in -Unilateral national policy making -WTO accession process -Regional and bilateral free trade agreements  Difference between unilateral incorporation of TRIPS-plus in national laws vs. obligations agreed to under the WTO process and FTAs: -Unilaterally adopted national provisions may be changed -But FTA provisions and WTO accession agreements can be enforced by trading partners

6 10/11/20146 TRIPS-plus in Africa  Failed US-SACU FTA -Started in 2002, but failed due to divergent views -No evidence that talks would resume  EU-ACP EPA negotiations - Brief background

7 10/11/20147 Intellectual property rights in EPAs  Cotonou Agreement does not require inclusion of substantive IP provisions in EPAs  But the first full EPA – EU Cariforum EPA – includes -Context, objectives and principles: parties to ‘ensure increasing levels of protection’ -Absence of transition periods for LDCs -Harmonisation and regional patents -Requirement to join and comply with WIPO treaties; e.g. PCT -Border measures -Enforcement

8 10/11/20148 Lessons and Strategies  JUST SAY NO  For EPAs, the Cotonou Agreement does not require the inclusion of IP as a substantive issue  There is no requirement under the Cotonou Agreement to include any substantive provisions on IP in EPAs

9 10/11/20149 Lessons and strategies What’s the real deal?  Demand independent and critical evaluation of economic and social implications of any IP negotiation  Is there equal bargain – preferential market access in exchange for increased IP protection?

10 10/11/ Lessons and strategies  No secrets  Many FTAs are negotiated in secret, with the public having no access to the terms of negotiations  There should be a transparent and public process of consultation on FTA negotiations

11 10/11/ Lessons and strategies Strength in numbers  TRIPS-plus provisions affect and interest a broad range of stakeholders therefore, broad-based support should be canvassed  There should be mobilization of, and collaboration with, civil society organisations, patient groups and parliamentarians  Technical support from appropriate UN agencies should be requested

12 Paragraph 6 Doha Declaration “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement” “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement” “We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002”

13 30 th August “Solution”  Decision reached on 30 August waiver of Article 31(f) for countries producing under a CL -entire production can be exported -BUT many procedures have to be followed by exporting and importing countries -many view the procedures as cumbersome and a disincentive to use the decision  Note that there is “Chairman’s Statement” with some clarifications and additional obligations…...the legal status of which is unclear.

14 When does the Decision Apply ?  Product is patented in Exporting country (Supplying Country) for e.g. India  To produce and export, India has to issue a CL  Decision applies 100 % production 100 % production >50% of production exported >50% of production exported (the predominant portion) If less than 50%, the decision does not apply

15 Using the Decision As An Importing Country (1) Who can Import ? : Decision says only “eligible importing members” See Sect (1) (b) defined as: i) any LDC (automatically qualifies and no need for notification) i) any LDC (automatically qualifies and no need for notification) ii) other WTO members that has notified TRIPS Council of its intention to use the system as an importer ii) other WTO members that has notified TRIPS Council of its intention to use the system as an importer - This is a “one time” notification - Notification is declaratory…No need approval

16 Using the Decision As An Importing Country (2) Another notification to TRIPS Council (S. 2 (a) (notification is declaratory need to be approved) (i)specify names and expected quantities of products (not the exact quantities) (ii)confirm establishment of insufficient or no manufacturing capacities for the products specified (self – assessment) ***This requirement does not apply to LDCs. Assumed not to have manufacturing capacity (iii)confirm grant or intention to grant a CL if product is patented in that country (in accordance with Art. 31 TRIPS Ag.)

17 Using the Decision As An Exporting Country (1)  Grant of CL and conditions attached to it (S. 2(b)  To produce only amounts necessary to meet the needs of the eligible importing member and  Entire production must be exported  Clear identification of products through specific labelling or marking.  Distinguishing products through special packaging and/or special colouring/shaping of products themselves  Notification to TRIPS Council of: (S. 2 © )  Grant of CL and the conditions including:  name and address of licensee  products for which licence granted  quantity for which licence granted  countries to which product to be supplied  duration of licence  To post on Website (before shipment) details of: (S 2 © )  Quantities being supplied to each destination  Distinguishing features of products as required

18 Other Relevant Provisions  S. 6(i) in the 30 August Decision -with a view to harness economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products  another system is established…for where a regional trade agreement exist and at least half of the current membership are LDCs e.g. SADC, etc….  e.g: Tanzania imports from India under this Decision and re exports to Swaziland ….under SADC FTA arrangement

19 Rwanda’s paragraph 6 notification No country had used 30 August 2003 Mechanism for almost 4 yearsNo country had used 30 August 2003 Mechanism for almost 4 years Rwanda in Document org IP/N/9/RWA/1 on 19 July 2007 changed thisRwanda in Document org IP/N/9/RWA/1 on 19 July 2007 changed thiswww.wto orgwww.wto org Initiated by Rwanda Centre for Treatment and Research on Aids (TRAC)Initiated by Rwanda Centre for Treatment and Research on Aids (TRAC) Intention to import packets of combination therapy of AZT, 3TC & NVP from Apotex, (generic company) in CanadaIntention to import packets of combination therapy of AZT, 3TC & NVP from Apotex, (generic company) in Canada LDC status precludes notification as eligible importing countryLDC status precludes notification as eligible importing country Some stakeholders puzzled because Canada was not cheapest sourceSome stakeholders puzzled because Canada was not cheapest source MSF has been importing the same generic product from IndiaMSF has been importing the same generic product from India

20 Rwanda’s paragraph 6 notification Apotex obtained CL to export in September year after Health Canada approved the drugApotex obtained CL to export in September year after Health Canada approved the drug In May 08, announcement that Apotex would produce combination for US$0.195 per tabletIn May 08, announcement that Apotex would produce combination for US$0.195 per tablet Cheapest previous source was India at US$0.246 per tabletCheapest previous source was India at US$0.246 per tablet Delay caused both by process of getting CL issued as well as internal government procurement proceduresDelay caused both by process of getting CL issued as well as internal government procurement procedures Shipment arrived in Kigali 1 st week of October 2008Shipment arrived in Kigali 1 st week of October 2008 Apotex publically stated that it would be hard pressed to repeat the endeavorApotex publically stated that it would be hard pressed to repeat the endeavor

21 Reflections on 30 August Agreement Only 1 country has used Decision in more than 5 yearsOnly 1 country has used Decision in more than 5 years Process of obtaining medicines through Decision slowProcess of obtaining medicines through Decision slow 15 months from notification to delivery in Rwanda15 months from notification to delivery in Rwanda Would this solution work for public health emergency e.g. Swine flu?Would this solution work for public health emergency e.g. Swine flu? If decision ratified by 2/3rds of WTO membership, it becomes permanentIf decision ratified by 2/3rds of WTO membership, it becomes permanent About 30 ratifications at presentAbout 30 ratifications at present Is this something that African countries should ratify?Is this something that African countries should ratify?

22 Definition of Counterfeit, Section 2  (a) the manufacturing, producing, packaging, re-packaging, labelling or making, whether in Uganda or outside Uganda, of any goods by which those protected goods are imitated in such manner and to such a degree that those other goods are identical to or substantially similar to protected goods; 10/11/201422

23 Definition of Counterfeits  (b) the manufacturing, producing or making, whether in Uganda or outside Uganda, of the subject matter of that intellectual property, or a colourable imitation of it so that the other goods are likely to be confused with or to be taken as being the protected goods of the owner or any goods manufactured, produced or made under his or her licence; 10/11/201423

24  (b) the manufacturing, producing, or making of copies, in Uganda or outside Uganda, in violation of the author s rights or related rights;  (c) in the case of medicines, includes the deliberate and fraudulent mislabeling of medicines with respect to identity or source, whether or not such products have correct ingredients, wrong ingredients, have sufficient active ingredients or have fake packaging 10/11/201424

25 Critique  Why another law when Uganda has an IP law?  any person manufacturing say a drug under a compulsory licensing scheme through appropriate Patent law provisions given without the authority of the owner would be involved in counterfeiting. The implication of such an interpretation is clearly grave to manufactures of generic medicines who do so through necessary limitations on the owner’s IPR’s  Confusion on the definition of generics, fake and substandard medicines  Pressure from EU and big pharma 10/11/201425

26 Thank you 10/11/201426


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