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TWN Info Service on Intellectual Property Issues
(May11/04) WIPO: South presents work programme on
patents and health Geneva, 19 May (Heba Wanis) -- The African Group and the Development Agenda Group (DAG) have presented a joint proposal to the sixteenth session of the Standing Committee on the Law of Patents (SCP) of the World Intellectual Property Organization (WIPO) detailing a work programme on patents and public health. The SCP is currently meeting in It also said that the African Group and the DAG "are of the view that the patent system should be consistent with fundamental public policy priorities, and in particular the promotion and protection of public health". "The issue of patents and its impact on public health has been the subject of discussion in many fora. In 2003, the 56th World Health Assembly of the World Health Organization (WHO) had urged Member States to reaffirm that public health interests are paramount in both pharmaceutical and health policies," and "to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)," it said. Furthermore, it added, the 2001 Doha Ministerial Declaration on the TRIPS Agreement and Public Health affirmed, inter alia, that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. "The WHO Global Strategy and Plan of Action (GSPOA) on Public Health, Innovation and Intellectual Property adopted in 2008 states that while international IP [intellectual property] agreements contain flexibilities that could facilitate increased access to pharmaceutical products by developing countries, they may face obstacles in the use of flexibilities. Thus, there is a need to address this problem and remove obstacles faced by developing countries in making full use of the public health related flexibilities. The GSPOA also states that IPRs [intellectual property rights] should not prevent Member States from taking measures to protect public health, and that international negotiations on issues relating to IPRs and health should be coherent in their approaches to the promotion of public health." "In this context, it will be pertinent for the Committee to discuss the issue of patents and health and draw up a work program that assists countries in adapting their patent regimes and make full use of the patent flexibilities," it added. As regards the Work Programme, South Africa said that the "proposed work program seeks to enhance the capacities of Member States, and particularly developing countries and least developed countries (LDCs), to adapt their patent regimes to make full use of the flexibilities available in the international patent system to promote public policy priorities related to public health. This work program is composed of three interlinked elements that are to be pursued simultaneously". "These three elements are respectively: (i) the elaboration of studies to be commissioned by the WIPO Secretariat, following consultations with the Member States at the SCP, from renowned independent experts; (ii) information exchange among Member States and from leading experts in the field; and (iii) the provision of technical assistance to Member States, and particularly developing countries and least developed countries (LDCs), in relevant areas, and building upon work undertaken in the first two elements of the work program." On the first element on "Studies", "Commission a framework study by leading independent experts to examine the challenges and constraints faced by developing countries and least developed countries (LDCs) in making full use of the public health related patent flexibilities both in the pre-grant and in the post-grant stage. "This study should also include: "a. A component on the law and practices with regard to compulsory and government use licenses in WIPO Member States. Such a study will also provide as detailed information as possible, as to Member States that have issued or that have attempted to issue compulsory and government use licenses, the details of the license issued, the challenges faced as well as the impact on public health. This should also include the provision of empirical data on the royalty rates set in each case. "b. An examination on the extent to which countries use exhaustion of rights to allow parallel trade in medicine. "c. An assessment of the benefits of mandatory disclosure of International Non-Proprietary Names (INNs) in the abstract or title of patent applications. This would enable an easier identification of the generic name of the medical product subject of the patent application. "d. Conduct a cost-benefit analysis of the admissibility of Markush claims (broad patent claims that may apply to a broad range of compounds). It could be worthwhile to analyse whether such claims based merely on theoretical inference can be considered to satisfy the criteria for patentability." On the second element, namely, information exchange,
"Invite the UN Special Rapporteur on the Right to Health, Mr. Anand Grover, to the seventeenth session of the SCP, to present his report to the Human Rights Council on Intellectual Property Rights and Access to Medicines. "Organize during SCP 17 and 18, experience sharing sessions on countries' use of patent flexibilities for promoting public health objectives. The specific health related flexibilities to be discussed in those sessions should be determined in consultation with Member States". "Organize a technical workshop on state practice involving the compulsory licensing of medical technologies, including the application of TRIPS Articles 30, 31 and 44. "Develop a database on the patent status in WIPO Member States of relevant diagnostic tools and medicines for at least 10 non-communicable and communicable diseases. Such information will also include information on the availability of generic versions of the tools and medicines. The list of 10 non-communicable diseases and communicable diseases will be identified in consultation with Member States with the support of the WHO. The database will be useful in identifying the patent status of medicines for both communicable and non-communicable diseases and how access to these medicines can be better ensured by making full use of the available flexibilities. It should be noted that this request is not new, where in 2003 the WHO had requested the WIPO Secretariat to provide information about the patent status of essential medicines." On the third element of technical assistance,
"Flowing from the outcomes of the studies and information exchange as contained in elements I and II above, the WIPO Secretariat, in consultation with Member States, should develop targeted technical assistance programs. "Develop a technical assistance module that explicitly demonstrate the difference between compulsory licenses that are granted under the procedures of Part II of the TRIPS Agreement, concerning patent rights, and those granted under Part III of the Agreement, concerning the remedies for infringement of those rights. These technical assistance programs would explain both approaches, and focus on the flexibilities afforded to both systems, noting that under the structure of the TRIPS Agreement, Article 44 compulsory licenses are not subject to the restrictions that exist for Article 30 and 31 of the Agreement. These targeted technical assistance programs would proceed from the study identified in paragraph 8 above." The joint proposal also noted that the proposed work programme has links to Development Agenda recommendations 1, 7, 9, 14, 31 and 40. Several delegations made some preliminary observations
following This led to an overview presentation by WIPO's division on Global Challenges on its work on patents and health, which included patent-scoping studies such as the recent study on patents related to pandemic influenza, cooperating with UNITAID for establishing a patent status database for the Medicines Patent Pool, and organisation of seminars and training events. Also, representatives from the WHO and the WTO shared their views on areas of cooperation between the three organisations on patents and health. In respect of this, Discussion on the work programme continues. +
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