WHO Members To Work To Disentangle Problem Of Fake Medicines, IP Issues

A designated working group will meet for the first time this week to discuss the World Health Organization’s role in the safety, quality and efficacy of medical products, but some countries are concerned about what they consider to be the unwelcome intrusion of intellectual property rights issues into the debate.

The working group on “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products is meeting from 28 February – 2 March and should make specific recommendations to the 64th World Health Assembly (WHA), from 16-24 May.

At the last WHA in May 2010, decision WHA63.10 [pdf] established the working group. The first meeting of the group was to be held from 9-11 December but was postponed. During the WHO Executive Board meeting in January (IPW, WHO, 19 January 2011), WHO members raised strong concerns about the working group they had mandated in May 2010 that had neither been convened nor met yet, only four month away from the WHA.

One of the key issues in the debate is what some countries claim to be confusion between intellectual property right issues and health issues at the WHO. Although countries unanimously recognise the threat posed by substandard or falsified medicines for global public health, some countries have said that intellectual property rights enforcement concerns should not guide solutions.

The definition of those substandard medicines is itself the subject of discord and a compromise was found at the last WHA, between parties wanting to avoid using the word counterfeit and parties arguing counterfeit drugs are a particular threat to be addressed as such. The issue is currently being designated as substandard/spurious/falsely-labelled/falsified/counterfeit medical products (IPW, WHO, 21 May 2010).

At the heart of some of the discontent is the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), administered by WHO and describing itself as a partnership of major anti-counterfeiting players, and including Interpol, the World Customs Organization, as well as pharmaceutical manufacturers associations, and drug regulatory authorities.

According to its website, IMPACT has five working groups, including one working on enforcement measures, one on technology and one on legislative and regulatory infrastructure. Some countries have voiced concerns that IMPACT’s primary focus was on IP rights enforcement.

Some countries submitted draft resolutions at the last WHA. In their joint draft resolution, India and Thailand stated that “the term and definition of ‘counterfeit’ relates to infringement of intellectual property rights and should not be equated with medical products with compromised quality, safety and efficacy.” The draft resolution also pointed out that the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement definition of counterfeit trademark goods was the following: “’counterfeit trademark goods’ shall mean 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.”

The draft resolution called for measures to remove barriers to access to quality, safe, and affordable medical products, and asked to “replace WHO’s involvement in the IMPACT with an effective programme to address the issues … and to ensure that the new programme avoids conflicts of interests, is evidence-based, transparent and member-driven.”

Ecuador on behalf of the Union of South American Nations also submitted a draft resolution, including a list of topics to be examined by the working group, such as the strategies to improve the capacity of the health sector to apply health regulation measures.

Another draft resolution was submitted by a number of African countries, including a request “to provide support to member states in developing and implementing policies and programmes aimed at combating counterfeit medical products.”

At the January Executive Board meeting, the Indian delegate said intellectual property rights were at the heart of IMPACT but were not in the mandate of WHO. IP rights are diverting WHO from its mission of global public health, he said, asking that the work of IMPACT be suspended for the moment until the working group could evaluate its work. India is a leading manufacturer of generic medicines.

During her opening speech at a recent symposium co-organised by the WHO, WTO, and the World Intellectual Property Organization on access to medicines, patent information and freedom to operate, Margaret Chan said countries needed better access to generic medicines.

In a column piece published on 25 February in Intellectual Property Watch, Eduardo Pisani, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), encouraged WHO member states to agree on a common term to define medicinal products that are not what they purport to be [corrected], build a long-term platform for international collaboration, by either refining the existing IMPACT, or creating a new platform while in the meantime ensuring continuity of the work of IMPACT with the participation of the WHO (IPW, Inside Views, 25 February 2011).