Article 31(f) of the TRIPS Agreement1 states that compulsory licenses shall be authorized 'predominantly for the supply of the domestic market' of the Member State authorizing the use of such license. In other words, the importing country cannot grant compulsory licenses with a view to supplying a third country market. In the meantime, developing countries have long argued that the above-stated article is hampering access to medicines as only very few developing countries have a significant manufacturing capacity2. This was first mentioned in Paragraph 6 of the Doha Declaration3 as follows:
"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."
Subsequently, I mplementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health 4 (hereby the Decision 2003) was introduced in August 2003 in order to provide for Member States to waive from the obligation set out in Article 31(f); allowing for the first importing country to manufacture, export and import pharmaceutical products to third countries in need 5 .
The Decision 2003 was followed by the Decision 2005 6 incorporating Article 31bis to the TRIPS Agreement aiming at making the waiver permanent 7 . The amendment will not be in force until two thirds of WTO Members formally accept it. The amendment will be open for acceptance until '31 December 2015 or such later date as may be decided by the Ministerial Conference 8 '. This deadline may well be extended once more as several deadlines have been adopted in the past in an effort to constrain WTO Members to expedite acceptance 9 . However, a majority has not been met as of today 10 .
Turkey, alongside with countries such as Israel, Mexico, Singapore, United Arab Emirates, has declared that the system will only be used in case of national emergencies or other circumstances of extreme urgency11.
Turkey expressed its intention to join the club on the account of the fact that "... it is quite probable that our country [Turkey], with a significant manufacturing capacity, will make use of the Paragraph 6 system as an exporter country12." The joint approval of the Council of Ministers and the President was published on the Official Gazette which corresponds to an official acceptance of the Decision 2005. Subsequently, the instrument of acceptance has been duly notified to the World Trade Organization13.
First and foremost, it should be borne in mind that this is not an actual implementation of the mechanism into the domestic law. However, a Draft Law14 amending the current legislation on protection of patent rights15 (hereby the Draft Law) – which has been included in the parliament agenda in 2013 and is awaiting to be evaluated by the MPs – will provide that a new section be added among other grounds for granting compulsory licenses, namely, failure to work the invention, dependency of patents and public interest. The wording of the Draft Law enables 'the exportation of compulsory licenses to third countries facing public health related problems provided that the conditions in the Regulation are met'. The Regulation is not available yet however it appears to be as vital as the underlying Draft Law.
For instance, Turkish Law requires prior negotiations under all circumstances16 – which may be time consuming and thus be considered as an obstacle with regard to making drugs accessible in case of emergencies. Such procedure may also put generic manufacturers into a disadvantageous position in the event that they do not have prior contacts or experience17. Such difficulties raised by formalities may be diminished by a well-functioning Regulation as in Regulation (EC) No 816/2006 of the European Union18, according to which a separate fast track operates in the event of national emergency, other circumstances of extreme urgency and public non-commercial use.
In light of all the foregoing, it is acknowledged in the Decision 2003 that the domestic supply clause is a hindrance to providing cheaper medicines and that a permanent waiver to the TRIPS Agreement would be a means to overcome such problem. Turkey, a "pharmerging" market, took a stand in line with said Decision and will take this intention one step forward once the mechanism will actually be implemented into the domestic law.
1 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Marrakesh, 15 April 1994.
2 Carlos M. Correa, "Trade Related Aspects of Intellectual Property Rights, A Commentary on the TRIPS Agreement", (New York: Oxford University Press, 2007), 303.
3 Declaration on the TRIPS Agreement and Public Health , Doha, 14 November 2001.
4 World Trade Organization, Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, Decision of the General Council of 30 August 2003.
5 Roy Love, "Corporate Wealth or Public Health? WTO/TRIPS Flexibilities and Access to HIV/AIDS Antiretroviral Drugs by Developing Countries", Development in Practice, Vol. 17, No. 2, April 2007, 208-219.
6 World Trade Organization, Amendment of the TRIPS Agreement, Decision of the General Council of 6 December 2005.
7 World Trade Organization, Press/426, INTELLECTUAL PROPERTY: Members OK amendment to make health flexibility permanent, 6 December 2005. http://www.wto.org/english/news_e/pres05_e/pr426_e.htm Date of Access: 12.05.2014.
8 WT/L/899, World Trade Organization, Amendment of the TRIPS Agreement – Fourth Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement, Decision of 26 November 2013.
9 WT/L/711, World Trade Organization, Amendment of the TRIPS Agreement – Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement,Decision of 18 December 2007.
WT/L/785, World Trade Organization, Amendment of the TRIPS Agreement – Second Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement, Decision of 17 December 2009.
WT/L/829, World Trade Organization, Amendment of the TRIPS Agreement – Third Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement, Decision of 30 November 2011.
10 World Trade Organization, Intellectual Property: Members accepting amendment of the TRIPS Agreement. http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm Date of Access: 11.05.2014
11 See note 7 above.
12 Law No. 6471 of 30.04.2014, OG No: 28654, 23.05.2013.
13 See note 10 above.
14 Draft law amending Decree-Law No. 551 on the Protection of Patent Rights, http://www2.tbmm.gov.tr/d24/1/1-0756.pdf (Only available in Turkish) Date of Access: 12.05.2014
15 Decree-Law No. 551 of 06.24.1995 on the Protection of Patent Rights, OG No: 22326, 27.06.1995. http://www.wipo.int/wipolex/en/text.jsp?file_id=314870 Date of Access: 12.05.2014.
16 Ünal Tekinalp, "Fikri Mülkiyet Hukuku", 5th ed. (Istanbul: Vedat Kitapcilik, 2012), 616-618.
17 Katri Paas, "Compulsory licensing under the TRIPS Agreement – a cruel taunt for developing countries?", E.I.P.R. 2009, 31(12), 609-613.
18 Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, OJ 2006 L/157/1.
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