A group of public interest organisations from across the globe have asked the member States of World Health Organisation (WHO) to agree on WHO disassociating from International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and discontinue using the term “counterfeit” to refer to medical products of compromised quality, safety and efficacy (QSE).
As many as 55 groups, many from India, and a few prominent activists have sent the joint letter to the chairperson of the WHO working group on substandard/spurious/falsified/falsely-labelled/counterfeit (SSFFC) medical products which started at Geneva on last Tuesday.
“We are deeply concerned with the lack of human and financial resources allocated to WHO’s programme on medicines. We urgently call on WHO member states to restore WHO’s independence and to reassert its leadership by ensuring that WHO’s medicines programme receives the funds it needs particularly from WHO’s regular budget to fulfil its responsibilities to Member States,”’ the letter said.
One of the important objectives of the Working Group is to bring clarity with regard to the terminologies and definitions pertaining to medical products with compromised QSE.
The term “Counterfeit” is defined by the WTO-TRIPS Agreement as referring to a specific category of trademark violation1 and in some legislation to all other intellectual property (IP) violations as well. Against this background WHO’s use of the term “Counterfeit” to refer to compromised medical products would result in confusion and also offer a convenient route for proponents of an extended IP agenda to press for inappropriate IP enforcement standards in developing countries under the false premise that such standards will deliver quality assured pharmaceuticals to the people, the groups said.
“The WHO Secretariat has also recently agreed that the term 'counterfeit' is 'perceived as associated with intellectual property rights' rather than with 'public health'. Thus we urge Member States to agree in the upcoming Working Group to discontinue using the term 'counterfeit' to refer to medical products of compromised QSE,” the letter said.
“On WHO’s relationship with IMPACT, we reiterate that WHO should disassociate itself from IMPACT. Significant concerns have been raised about participation in IMPACT’s activities especially the central role played by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in IMPACT’s activities, the lack of transparency surrounding IMPACT’s activities, and lack of accountability as IMPACT has operated outside the purview of WHO member states. Concerns have also been raised about IMPACT’s link to entities (e.g. OECD, MNCs, WCO, Interpol) which are very much engaged on matters pertaining to IP enforcement under the banner of “anti-counterfeiting activities,’’ the letter said.
Another key concern pertains to outputs of IMPACT particularly its Principles & Elements for National Legislation Against Counterfeit Medical Products which includes a call for addressing counterfeit medical products inter alia by establishing or enhancing intellectual property legislation; contains provisions that could result in TRIPS plus implementation as well as non-tariff barriers for trade in medical products which could undermine access to affordable medicines, become entry barriers for generic industries particularly of developing countries and affect use of flexibilities such as parallel importation of good quality medicines. These elements also promote measures that have led to seizures/detainment of good quality pharmaceuticals in transit at European ports on request of MNCs on suspicion of IP violations, which resulted in delayed treatment for developing country patients, they said.
“Noting these concerns and the wide recognition that IMPACT lacks credibility and legitimacy, we strongly urge WHO Member States to agree that WHO disassociates itself from IMPACT and to stop hosting IMPACT’s website or rely on the documents produced by IMPACT as a basis for its work on QSE,” the groups said.
The list of civil society groups included India-based associations like All India Drug Action Network (AIDAN), Asha Kiran Samudayak Samiti (CBO), Center for Trade and Development (Centad), Centre for Safety and Rational Use of Indian Systems of Medicine, Consumer and Civic Action Group, Diverse Women for Diversity, Initiative for Health & Equity in Society, LOCOST, Research Foundation for Science Technology & Ecology , SATHI, and many international organisations like Third World Network and Oxfam, having presence in India.
Source:Pharmabiz
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