WHA session on counterfeits still bogged down by IP issues

Hopes of progress on the thorny issue of counterfeit medicines at the just-concluded World Health Assembly in Geneva remain largely unfulfilled, although the working group set up to tackle the problem has been given another year to complete its work.

A resolution drawn up by the elaborately-titled working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFCs) was approved by WHA's Committee A on 21 May, but failed to make the cut at the main assembly on May 24.

The key elements of the report are aimed at clarifying the World Health Organization's role in: ensuring the availability of quality, safe, efficacious and affordable medical products; the prevention and control of medical products of compromised quality, safety and efficacy such as SSFFCs; and the agency's relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) - a consortium of industry groups, regulators, police, customs and other stakeholders.

The text of the report has not deviated from the version prepared at the end of the Working Group meeting in February/March (see Working Group report lays out WHO role in 'counterfeit' medicines). 

The WHO agreed to set up the working group on SSFFCs last year on the back of accusations it was overly influenced by the intellectual property interests of the branded pharmaceutical industry. As a result, it was argued, the trade in legitimate generic drugs of assured quality was coming under threat. 

Proponents of that view cited several cases in which generic medicine shipments made in India were detained in transit through the EU, even though they were not patented in the country of destination.

Once again, separating IP rights from issues relating to public health and access to safe, effective and genuine medicines remained at the heart of the deliberations in Geneva. For example India - on behalf of the 11 countries of the WHO South-East Asian region (SEAR) - said in a statement that some parties are causing "deliberate confusion between intellectual property considerations and quality related issues."

"The meeting held between 28 February and 2 March this year provided the first steps in the right direction by clearly differentiating between public health and IPR issues," it continued, adding that the WHO should terminate its involvement with IMPACT, which it asserted "has a predominant IPR agenda."

The WHO - which provided secretariat services to IMPACT - has already distanced itself from IMPACT by moving its offices away from its headquarters in Geneva to Italy, but SEAR wants it to terminate all links to the consortium until the outcome of next year's World Health Assembly.

Industry group the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) welcomed the approval of the resolution and the debate covered during the committee meeting, saying: "the decisions taken on fake medicines provide a viable basis to build on existing work."

The IFPMA reiterated its view that the WHO has a crucial leadership role to play in "helping to ensure that medicines everywhere are of high quality, safe and efficacious, and that they are also what they purport to be."

"It remains … in the longer term vital to establish a platform for international collaboration to protect patients from the dangers of fake medicines," it said.