WHO Working Group Gives Guidelines To Fight Bad Medicines; IMPACT In Exile

After three days of intense negotiations on the role of the World Health Organization in the fight against low standard or falsified medicines, delegates provided recommendations for the UN agency. A subject of dissent was the relationship between the WHO and its taskforce against counterfeit medicines, with some countries calling for a suspension of the taskforce’s work, though in the end no consensus was found.

The report of the working group came out today with recommendations from the member countries for future work of the WHO in this area. The report is available here [pdf].

The working group on “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products met from 28 February – 2 March with the mandate to make specific recommendations to the 64th World Health Assembly (WHA), to be held on 16-24 May. The working group was attended by 93 member states.

Delegates worked overtime yesterday to write and agree on the report reflecting discussions of the working group, namely the WHO’s role in the prevention and control of medical products of compromised quality, safety and efficacy, the role of WHO in measures to ensure the availability of good-quality, safe, efficacious and affordable medical products, and WHO’s relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), including future steps to be taken by the organisation.

The report said that WHO should continue to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems which include national medicine policies, health risk management systems, and sustainable financing.

The document defined the function of WHO as “information sharing and awareness creation, norms and standards and technical assistance to countries on country situation assessment, national policy development, and capacity building.”

On the WHO role in the prevention and control of medical products of compromised quality, safety and efficacy, according to the report, some members said they wanted to set up an intergovernmental negotiating body to draw up a legally binding instrument at the international level to fight “the manufacture, export, import, or trade of counterfeit medical products on international markets and in international trade.”

On substandard medical products, the working group was referred by the WHO to the current WHO definition [pdf], which was developed by the 45th Expert Committee on the Specifications of Pharmaceutical Preparations in October 2010.

The expert committee had provided the following definition: “substandard medicines are pharmaceutical products that do not meet their quality standards and specifications.”

A working document [pdf] from the same expert committee defined a counterfeit medicine as a medicine “which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging.”

SSFFC Here to Stay

Terminology of products of compromised quality gave way to a lot of discussions, with an attempted consensus on the term “falsified” medicines during discussions of the working group. But in the end, the wording agreed on at the 63rd World Health Assembly in May 2010 won back the favour of the delegates: “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products, abbreviated as SSFFC.

IMPACT Secretariat Exiled In Italy

Yesterday, delegates discussed the relationship of the WHO with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Many countries have criticised the work of IMPACT as prioritising intellectual property protection rather than focusing on public health issues.

Meanwhile, the IMPACT secretariat has “temporarily” been quietly hosted since September 2010 by the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation, based in Rome, according to a press release (in Italian)

IMPACT just issued a book detailing the activities and the history of the taskforce, through a compilation of documents that were prepared between 2006 and 2010, and a summary of working papers by each of the five IMPACT working groups (communication, legislative and regulatory infrastructure, regulatory implementation, enforcement, and technology).

According to the publication, which is available online [pdf] on the AIFA website, no editing took place “in order to maintain authenticity of previously adopted documents.” That is part of an effort at demonstrating transparency, according to an IMPACT source.

Most WHO member countries are in favour of IMPACT, the source said, with the European Union an active defender of the taskforce.

A number of regulators coming from capitals attended the meeting, which was interpreted as a good sign by some developing countries, some sources told Intellectual Property Watch, as it is a welcome shift from the intellectual property focus to the technical aspect of the fight against substandard medicines.

The relocation of the IMPACT secretariat outside of the WHO is taken as a sign of some distance between the taskforce and the WHO secretariat, these sources said.

According to the report, the working group considered the future role of WHO in the area of SSFFC with a particular focus on information and awareness creation, norms and standards, and technical support to countries. The report gives a list of activities that should be developed by WHO to fight SSFFC.

On WHO relationship with IMPACT, the report said no consensus was found after a general discussion, with members seeking disengagement and others continued engagement with the taskforce.

The working group, chaired by Darlington Mwape of Zambia, asked that the upcoming World Health Assembly consider extending the period set out in Decision WHA 63 [pdf], establishing the working group.

The report also said that “mechanisms adopted by WHO to fulfil its mandate should ensure transparency and inclusiveness in their conception and composition, avoiding the emergence of conflicts of interest in the actors involved and should guarantee oversight of its activities and accountability.”

Chatham House Recommendations

London-based think tank Chatham House has circulated the summary [pdf] of a closed-door roundtable it held on the issues of counterfeit, falsified and substandard in December that shows there is support for changing the WHO/IMPACT definition from “counterfeit” to “falsified”. “If that change were made,” the summary said, “then the meaning of ‘counterfeit’ medicines would revert to that referred to in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Right (TRIPS) – a wilful form of trademark infringement.”

Some countries participating in the roundtable signalled they could not endorse a definition that could imply WHO involvement in IP enforcement, Chatham House said. A proposed solution was to exclude trademark issues from the WHO definition of falsification, leaving that to the TRIPS definition of counterfeiting, and that “civil trademark infringement was not relevant.”

William New contributed to this report.