It was only in 2005 that the first country granted a compulsory licence under the derogation for reasons of protection of public health. As countries struggle to stockpile the antiviral drug Tamiflu (oseltamivir), ® fearing a possible flu pandemic, international pressure has been exerted on patent holder Roche to grant voluntary licenses allowing manufacturing by other companies. As a country that could be one of the countries most directly affected by a pandemic, Taiwan has decided to use the flexibilities reaffirmed in the Doha Declaration to ensure access to Tamiflu®. However, the government admitted reservations that indicated caution on its part. Despite a clear public health justification for the measure, the Taiwanese government has continued to seek to minimize potential damage to its image as a commercial economy. For example, production would be for domestic purposes only, limited to the end of 2007 and subject to “reasonable” royalties for Roche. In addition, Taiwan would consume all medicines supplied by Roche before using locally produced supplies, and the compulsory licence could be revoked once an agreement on a voluntary licence had been concluded. As tipo`s deputy director general explained, “Under these circumstances, the Ministry of Health will not have to use tamiflu® from sources other than Roche, unless a pandemic strikes early next year and stocks run out quickly.” [25] For least developed countries that are members of the WTO, the declaration states that they will not have to protect undisclosed patents and information rights for medicines until 2016. For these rights, the least developed countries therefore have 10 years to apply the provisions of the TRIPS Agreement. The paper provides an overview of policy debates between Governments, non-governmental organizations and international organizations since 1995, and in particular since 2003, on access to medicines and trade agreements. The provisions on the protection of public health contained in the Doha Declaration and paragraph 6 are reviewed in the light of implementation difficulties and measures to protect intellectual property rights (IPRs) under certain regional and bilateral trade agreements.
According to Article 33 of the TRIPS Agreement, “the term of protection shall not end before the expiry of a period of twenty years” from the date of filing. This is the period during which the product can be marketed with exclusive patent rights. However, the duration of the term of protection can be shortened by two administrative procedures – the patent examination procedure and the marketing authorisation procedure. In order to avoid an “unjustified shortening” of the term of protection, the TRIPS Agreement stipulates that a patent must be granted within a “reasonable time” (Article 62(2)). Prior to compliance with the TRIPS Agreement, unjustified circumcision was not a problem, as U.S. law granted the term of protection from the date of grant of the patent. As a result of compliance with the TRIPS Agreement, the U.S. Patent Term Guarantee Act was passed in 1999, allowing for an extension of the term of protection if a patent is not granted within three years.
The declaration also refers to the exhaustion of intellectual property rights and thus to the right of members to allow parallel imports (for an explanation, see the brochure. In 2008, it was decided to extend the deadline for the adoption of the amendment to the TRIPS Agreement. The deadline has been extended to 31 December 2009 or “to a later date to be decided by the Ministerial Conference”. [3] The General Council further extended the deadline in 2011 until 31 December 2013. [4] In addition to the above-mentioned obstacles to the implementation of TRIPS flexibilities, public health advocates are very concerned about the spread of so-called “TRIPS-plus” measures. While efforts to advance trade liberalization through multilateral channels have stalled since 2003, major industrialized countries have continued negotiations on bilateral and regional trade agreements outside the WTO. To stimulate economic growth through trade, LMICs governments have agreed to such measures in exchange for access to potentially lucrative export markets for key sectors such as agriculture and textiles. However, for the public health community, provisions to protect access to medicines have been negotiated in a variety of ways. WTO: Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, 4th Session, Doha. 14 November 2001[www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf] The lack of appropriate legislation in many LMICs to enshrine protection under the TRIPS Agreement, the Doha Declaration and the IDDT remains a major challenge. National legislation is essential because many provisions are only permitted if they are enshrined in law.
At present, many LDCs enjoy stricter protection of intellectual property rights than that required by TRIPS [20]. Out of thirty African LDCs, only two do not grant patents for medicines [34]. In addition, LMICs can only claim available flexibilities and increase their purchasing power if appropriate national drug policies are in place, supported by a legal framework on issues such as the use of generics, drug prices and taxation. While this paper supports the above recommendations, there is also a need to address the broader context of inequalities in power and influence within the global economy. The issue of access to medicines reflects the existing global trading system, which is officially regulated by the 149 MEMBER States of the WTO, but which in practice is the product of strong inequalities within and between countries. First, it is necessary to recognize the powerful personal interests that underpin the globalization of intellectual property rights, both on the part of governments and businesses, which often work together to promote common goals. Drahos and Braithwaite themselves describe the TRIPS Agreement as the product of a corporate program whose negotiation process is strongly distorted in favor of such interests [53]. While the Doha Declaration and paragraph 6 decision were hard-won agreements by public health advocates, Faunce asks to what extent are the agreements real commitments to improve access to medicines or vaguely worded documents that have been drafted from the beginning to reveal little? [54] In 2005, WTO Members agreed to amend the TRIPS Agreement to make permanent the temporary waiver contained in the WTO Decision of 30 August, which in turn met the requirement of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 14 November 2001. This decision established a mechanism for WTO members to grant compulsory licenses for the export of generic versions of patented medicines to countries with insufficient or no production capacity in the pharmaceutical sector. The 2005 Ministerial Declaration states: Third, the term of patent protection under TRIPS-plus measures has been extended. Bilateral agreements between the United States and Jordan, Chile and Australia and proposals under the FTAA effectively extend the term of patent protection [49].
A related form of patent renewal is “evergreening,” a term that refers to patent protection of inventions, as opposed to drugs, which may actually have multiple patents. A “new use” for existing compounds or a change in dose or shape can serve as a basis for applying for an extension of the patent protection period and thus prevent the production of generic versions of the drug. Although this is not allowed under the TRIPS Agreement, many free trade agreements contain “new use” clauses. Even if a “new use” application is not accepted, the application procedure can lead to significant delays, especially if the applications are involved in litigation concerning possible patent infringement [46]. In short, the flexibilities available under the TRIPS Agreement to protect public health are being eroded as a result of the negotiations and the TRIPS-plus Agreement. Major industrialized countries seeking to protect the interests of transnational pharmaceutical companies have adopted a “divide and rule” strategy. There is a need to reflect on how the public health community should act to prevent the goal of access to medicines from being further compromised. .
