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The Draft Trans–Pacific Partnership Agreement and its Implications for Public Health and Access to Medicines: The UNITAID Report

Published online by Cambridge University Press:  20 January 2017

Stefano Barazza
Stefano Barazza*
Affiliation:
Studio Legale Barazza, email: stefbar@gmail.com
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Abstract

This report provides an overview of the potential impact of the draft Trans–Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health

Type
Reports
Information
European Journal of Risk Regulation , Volume 5 , Issue 3 , September 2014 , pp. 366 - 373
Copyright
Copyright © Cambridge University Press 2014

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References

1 The text of the agreement is available online at http://www.mfat.govt.nz/Trade-and-Economic-Relations/2-Trade-Relationships-and-Agreements/Trans-Pacific/0-P4-Text-of-Agreement.php [last visited 10 August 2014].

2 Trans-Pacific Partnership Leaders Statement of 12 November 2011, available online at http://www.ustr.gov/about-us/pressoffice/press-releases/2011/november/trans-pacific-partnershipleaders-statement[last visited 10 August 2014].

3 The leaked draft agreement (“draft agreement”) is available online at http://wikileaks.org/Second-release-of-secret-Trans.html [last visited 10 August 2014]. Any reference to articles of the draft agreement, in the following footnotes, follow the numbering used in the Wikileaks release.

4 Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

5 See Andrew D. Mitchell, Tania S. Voon, and Devon Whittle, “Public Health and the Trans-Pacific Partnership Agreement”, Asian Journal of International Law (forthcoming), available online at http://ssrn.com/abstract=2393670 [last visited 10 August 2014].

6 Statement of the Office of the United States Trade Representative, available online at http://www.ustr.gov/tpp/Summary-of-US-objectives [last visited 10 August 2014].

7 Letter to the United States Trade Representative of 2 August 2011, available online at http://infojustice.org/wp-content/uploads/2011/08/Ten-Representatives-on-TPP-08022011.pdf [last visited 10 August 2014].

8 Article QQ.A.2 bis would further recognize the right of each country to adopt measures to promote the public interest in areas important for its social, economic or technological development, including public health and nutrition.

9 Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

10 Declaration on the TRIPS Agreement and public health, adopted at the Doha WTO Ministerial on 14 November 2001, WT/MIN(01)/DEC/2.

11 See Article QQ.A.5.

12 See Article QQ.A.6.

13 See Article QQ.E.1.

14 See Article QQ.E.14. The provision would be accompanied by safeguard measures aimed at preventing any abuse: such measures would include a five–year extension limit, not linked to the patent term, and an obligation to start the process of marketing approval within a predefined number of years from the date of the first marketing approval in another TPP country.

15 Article QQ.E.16.

16 See, respectively, Articles QQ.E.XX.1, 2, and 3.

17 UNITAID, “The Trans–Pacific Partnership Agreement: Implications for Access to Medicines and Public Health” (“Report”), March 2014, available online http://www.unitaid.eu/images/marketdynamics/publications/TPPA-Report_Final.pdf [last visited 10 August 2014].

18 Ibid, p. 3.

19 Ibid, p. 27.

20 Ibid, p. 28.

21 See Ex parte Markush, (1925) CD 126, 340 OG 839. A Markushtype claim recites alternatives with the formula “wherein the unyielding material is selected from the group consisting of A, B, and C”.

22 Ibid, p. 33.

23 Ibid, p. 40.

24 Ibid.

25 Ibid.

26 Further, market exclusivity is likely to impact the availability of traditional medicines, as happened in the case of colchicine in the United States (ibid, p. 42).

27 According to Bhardwaj, R., Raju, K.D. and Padmavati, M., “The Impact of Patent Linkage on Marketing of Generic Drugs”, 18(4) Journal of Intellectual Property Rights (2013), pp. 316 et sqq., at p. 316Google Scholar, patent linkage “involves linking generic drug marketing approval with the originator drug's patent status and refusing marketing approval until the relevant patent expires”.

28 See also A. Grover, “Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”, 31 March 2009, A/HRC/11/12, available online at http://www.ifhhro.org/images/stories/ifhhro/documents_UN_special_rapporteur/3_4_1_en.pdf [last visited on 10 August 2014].

29 Report, supra note 17, p. 44.

30 Ibid.

31 Ibid, p. 49.

32 Ibid.

33 Ibid.

34 See Article QQ.C.2.

35 Ibid, p. 51.

36 UNITAID observed that in some countries generic producers are required by law to use the same labelling and product information included in the packaging of the branded drug (ibid, p. 50).

37 Ibid, p. 52.

38 Ibid, p. 69.

39 Ibid.

40 Ibid, p. 70.

41 Ibid, p. 72.

42 Ibid.

43 Ibid, p. 73.

44 Ibid, p. 74.

45 Ibid.

46 Ibid, p. 88.

47 Ibid, p. 89.

48 Ibid, p. 91.

49 United States-Korea Free Trade Agreement, signed on 30 June 2007.

50 Ibid, p. 95.

51 Ibid.

52 Ibid, p. 97.

53 Ibid, p. 101.

54 Ibid, p. 103.