In 2005, WTO members agreed to amend the TRIPS Agreement to ensure that the temporary waiver in the 30 August WTO decision, which itself met the requirement of paragraph 6 of the Doha Declaration on the TRIPS and Public Health Agreement of 14 November 2001, was maintained. This decision created a mechanism for WTO members to grant compulsory licences for the export of generic patented medicines to countries with insufficient or no production capacity in the pharmaceutical sector. The 2005 Ministerial Declaration indicates that one of the related problems is that many bilateral and regional trade agreements do not allow for the so-called Bolar regime. This provision, also known as “early work,” allows the use of a patented invention or process and/or data without authorization to facilitate the administrative authorization of a generic drug before the patent expires. This allows a generic drug to reach the market more quickly, which speeds up access to cheaper drugs. Under trips plus measures, a patent holder must approve the authorization to market a generic version for the duration of the patent. Correa C: Consequences of the Doha Declaration on the TRIPS and Public Health Agreement. Health Economics and Drugs: Essential Drugs and Medicines Policy Series 12. 2002, Geneva, WHO, [mednet2.who.int/sourcesprices/doha-implications.pdf] The issue of access to medicines remains a crossroads between the gradual globalization of intellectual property rights (IPD) and the high demand for medicines to meet the critical public health needs among the world`s poor.
Campaigns by governments in many low- and middle-income countries (CCIs) and non-governmental organizations (NGOs) have focused on the potential of trade agreements, in particular the Trade-Related Intellectual Property Rights (TRIPS) agreement, to impede the availability of affordable medicines. In 2001, the TRIPS and Public Health Declaration (doha Declaration) confirmed the right of World Trade Organization (WTO) member states to interpret and implement TRIPS in a way that supports public health protection and, in particular, access to medicines [1]. Although it was initially well received, the interpretation of a specific paragraph of the Doha Declaration on Compulsory Licensing quickly caused consternation [2].