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TWN Info Service
on Intellectual Property Issues (May10/08) Member States to
assess WHO's role in "counterfeits", IMPACT London, 25 May (Sangeeta Shashikant) -- Member States of the World Health Organization (WHO) participating in the World Health Assembly agreed on 21 May to take charge and assess WHO's role in "counterfeits" and its relationship with the International Medical Product Anti-Counterfeit Taskforce (IMPACT). The agreement follows many tense moments during the Assembly when many developing countries expressed misgivings over the WHO Secretariat's role in "counterfeits", as its use in a dual context (i. e. in the context of IP as well as health) results in the undermining of affordable generic medicines. A clash over these issues coupled with three draft resolutions presented on the matter during the Assembly, which held its annual week-long session from 17-21 May, led to an agreement to set up an intergovernmental working group that gives Member States a direct say over WHO's role and activities in dealing with medical products with compromised quality, safety and efficacy (QSE). [The three draft resolutions presented at the Assembly were the draft resolution by the Union of South American Nations (UNASUR) (A63/A/Conf. Paper No. 4 Rev. 1); draft resolution by the South East Asian countries (SEARO) (A63/A/Conf. Paper No. 7); and draft resolution by the Africa Group (AFRO) (A63/A/Conf. Paper No. 5).] The agreed decision on the matter, titled "Substandard/spurious/falsely-labelled/falsified/ counterfeit medical products", reflects a conflict over terminology that has yet to be resolved. The title is a compromise between countries that wish to prevent equating the term "counterfeit" to medical products with compromised QSE and countries that wish to retain use of the term "counterfeit" to refer to QSE issues. Several countries were also conscious of the need for distinct terminologies to refer to the various QSE problems and to avoid conflating all QSE problems under a specific terminology. In the preambular section, the agreed decision reaffirms "the fundamental role of WHO in ensuring safety, quality, and efficacy of medical products" and notes "the work of WHO in ensuring safety, quality and efficacy of medical products". Substantively, the agreed decision: --"DECIDES to establish a time-limited and result-oriented working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products comprised of and open to all Member States; --"REQUESTS the Director-General to convene and facilitate the work of the working group; -- "DECIDES that the working group will examine, from a public health perspective, excluding trade and intellectual property considerations, the following: "(a) WHO's role in measures to ensure availability of quality, safe, efficacious and affordable medical products; "(b) WHO's relationship with the International Medical Products Anti-Counterfeiting Taskforce; "( c) WHO's role in the prevention and control of medical products of compromised quality, safety and efficacy such as substandard/spurious/falsely-labelled/falsified/ counterfeit medical products from a public health perspective, excluding trade and intellectual property considerations; "(d) Any issue or issues raised in the proposals in documents A63/A/Conf. Paper No. 4 Rev. 1, A63/A/Conf. Paper No. 5 and A63/A/Conf. Paper No. 7, starting with those issues referred to in items A, B, C above; "DECIDES that the working group shall make specific recommendations in relation to the issues set out in paragraph 3 above and report to the Sixty-fourth World Health Assembly; and shall report on this decision to the Executive Board, at its 128th session". According to IP Watch,
following the adoption of the decision, In a press release, Health Action International Global said that the "WHA has made a clear stand on the problems associated with IMPACT, and on the inappropriate use of the counterfeits' discourse in a public health context, in general". It added that "the conflation of IP enforcement with public health objectives, such as quality and safety of medicines undermines access to medicines" and "This is now understood by all stakeholders and reflected in this resolution". Commenting on the adoption of the decision, James Love, Director of Knowledge Ecology International, a Washington-based NGO, said: "Today, the World Health Assembly took first steps to addressing a failure at the WHO -- the privatization of policy making on drug quality and patient safety. The large pharmaceutical companies that have funded WHO work in this area have made a number of mistakes, without adult supervision. We hope this resolution will lead to changes." Also commenting on the agreed decision, K. M. Gopakumar of Third World Network viewed the resolution as setting the foundation for intergovernmental deliberations on QSE, stating that "it makes the starting point of the deliberations clear: that is, issues of intellectual property infringement are distinct from issues of quality, safety and efficacy". He added that "the intergovernmental working group is an opportunity for Member States to de-link concepts and initiatives associated in any way with intellectual property rights and IP enforcement from issues of quality, safety and efficacy". De-linking IP from issues of QSE, and WHO from IMPACT also forms the backbone of the draft resolution presented by the South East Asian countries (SEARO) -- (A63/A/Conf. Paper No. 7). The draft resolution expresses concern about reports of medical products with compromised quality, safety and efficacy, and stresses the need to ensure the availability of safe, efficacious, quality and affordable medical products. Further, the draft resolution drops the term "counterfeit" in favour of "falsely labeled" and "substandard", noting that the term "counterfeit" relates to infringement of intellectual property rights and should not be equated with medical products with compromised quality, safety and efficacy, and recognizing that "issues of protection and enforcement of intellectual property rights are distinct from issues of quality, safety and efficacy of medical products". It also notes that the term "counterfeit" is defined in the TRIPS Agreement as "any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation" (see Article 51, Footnote 14(a) of the TRIPS Agreement). The draft resolution also expresses concern "about numerous incidences of intellectual property enforcement measures that have resulted in unwarranted seizures of generic medicines, affecting timely access to efficacious, affordable medical products to peoples of developing countries, including least developed countries" and recognizes the need to promote measures that "do not themselves become barriers to timely availability of affordable medical products and production of generic medical products". It also recognizes that "IMPACT or its Terms of Reference have not been approved by any WHO governing body and there are conflicts of interest in its composition". Moreover, the draft resolution urges Member States to: take measures to strengthen national drug regulatory authorities; address basic causes for the circulation of medicines with compromised QSE such as weak regulatory capacity, unethical drug promotion, high prices of medical products; take measures to remove barriers to access to QSE and affordable medical products; implement trade, intellectual property and other policies without constraining policy space for health; refrain from applying measures to enforce IPRs, such as the seizure of medical products in transit, that result in creating barriers to legitimate trade of generic medicines and impeding access to medical products, particularly in developing countries; and to promote close collaboration among the national drug regulatory authorities to share information, inspection techniques and testing methods. The draft resolution also requests the Director General to: support Member States upon request, in strengthening their national drug regulatory authorities with a focus on enhancing their capacity, technical knowledge, infrastructure, facilities, and promoting robust systems to ensure that medical products available in their jurisdiction are of quality, safe and efficacious; support the development of new techniques and test methods for the use of national DRA (drug regulatory authorities) to ensure QSE of medical products; replace WHO's involvement in IMPACT with an effective programme to address the issues of QSE and to ensure that the new programme avoids conflicts of interest, is evidence-based, transparent and Member-driven; advocate that WHO does not get involved with IP infringement and other measures that could potentially undermine availability of QSE and affordable medical products and production of generic medical products; and to create measures to ensure that intellectual property enforcement does not inhibit access to affordable medical products. Ecuador, on behalf of the Union of South American Nations (UNASUR), also presented a draft resolution (A63/A/Conf. Paper No. 4 Rev. 1) that sought to replace the term "counterfeit" with the term "falsified" medical products and proposed the establishment of an intergovernmental working group to discuss and implement cooperation among countries, in the sub-regional and regional levels, to prevent and combat falsified medical products, under the public health perspective. According to the proponents of the draft resolution, the intergovernmental working group proposal was to ensure that WHO distances itself from IMPACT and that actions taken on QSE are Member-driven. The UNASUR draft resolution also reaffirms the important role of "health authorities" in strengthening the supply chain of safe, quality and effective medical products and proposes that the intergovernmental working group examine: education measures such as training of consumers and public health sector stakeholders; measures to strengthen the chain of production and distribution of medical products specifically in relation to regulation and inspection; action strategies at the national, sub-regional and regional levels providing for mechanisms to improve sharing of information and experiences between countries; strategies to improve the capacity of the health sector to apply health regulation measures. According to the draft resolution, the intergovernmental working group would also be authorized to form technical subgroups of an ad hoc and provisional nature and to invite experts to examine specific issues. The draft resolution
presented by the The draft resolution urges Member States to: reaffirm their commitment to develop, implement and monitor national policies and to take all necessary measures in order to ensure access to medical products that meet regulatory standards; establish and enforce legislation and regulations that prevent counterfeit medical products from being manufactured, exported, imported or traded in international transactions as well as to regulate and monitor the supply and distribution systems; establish effective mechanisms of coordination and collaboration, including exchange of information among health, law enforcement and other relevant authorities in order to improve prevention, detection, investigation and prosecution of cases of counterfeit medical products; promote awareness among health professionals and consumers of the risks posed by the use of counterfeit medical products including those acquired through unauthorized outlets including Internet sites. The draft resolution requests the Director General to: continue to address counterfeit medical products as an integral part, within the existing framework, of standard setting for quality, safety and efficacy; to provide support to Member States in developing and implementing policies and programmes aimed at combating counterfeit medical products, including facilitating the exchange of information at the international level and the development of tools, guidelines, training and awareness initiatives, and methodology for evaluation and monitoring; continue the development and dissemination of independent and timely information on instances of counterfeit medical products; cooperate with Member States, at their request, and with international organizations and other relevant parties in detecting, monitoring and analyzing cases of counterfeit medical products and their impact on public health. However, during the
formal deliberations, The developed countries defended the WHO's work on "counterfeits", as well as the work of IMPACT. The distinct approaches and views over WHO's role in QSE issues led members of the SEARO and UNASUR to propose setting up an intergovernmental working group to address Member States' concerns over WHO's activities, as well as to direct its work on QSE. This proposal formed the basis for further negotiations that led to the agreed decision. +
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