Working Group report lays out WHO role in 'counterfeit' medicines

After three days of debate, an intergovernmental working group has delivered its preliminary report on the World Health Organization's future role in the fight against substandard and counterfeit medicines.

The report from the Working Group of Member States on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products - available to view here - includes a number of recommendations aimed at clarifying WHO'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).

Last year, the WHO agreed to set up the intergovernmental working group after months of controversy in which it was accused of being overly influenced by the intellectual property interests of the branded pharmaceutical industry.

According to the initial report, the WHO should concentrate its efforts on substandard and SSFFC medical products in three areas, concluded the working group, namely: information and awareness creation; norms and standards; and providing technical support to countries.

For SSFFCs, its role should centre on raising high-level awareness among regulators, governments and other stakeholders, developing a global surveillance and alert system, gathering reliable data on SSFFC products and acting as a "global convener" from a public health perspective.

It should also develop sampling, surveillance and other tools to help fight trade in SSFFCs, and expand its guidelines on Good Distribution Practice to include the Internet, importers and brokers. Finally, technical support should focus on measures such as identifying gaps in national legislation and regulatory structures, training programmes and support for establishing national quality control laboratories.

IMPACT retained

The relationship with IMPACT has been at the forefront of many of the deliberations regarding the WHO and counterfeit medicines but - for now at least - the status quo is maintained. Calls by some Member States to dissolve the organisation failed to engender enough support to win through to the final document, as other States acknowledged the benefits achieved by the initiative in some countries.

Overall, no consensus on WHO's future relationship with IMPACT was reached, although the agency has already taken steps to distance itself somewhat from the day-to-day running of IMPACT. For example, it is no longer hosting the group's secretariat, which is currently residing at the headquarters of Italian drug regulator AIFA.

Terminology and definition issues remain largely unresolved, and hopes that the working group might unite behind the use of the term 'falsified' in place of 'counterfeit' were not realised. For now, the SSFFC catch-all term looks set to be retained.

"Differences remained among Member States on the appropriate terms to be used to represent medical products of compromised quality, safety and efficacy," notes the report.

A new definition for falsified medical products was also proposed by some Member States, as follows:

"A falsified medical product gives a false representation of its identity and/or source and/or record keeping for traceability; pretends to have been assessed and approved by the competent regulatory authority, pretending to be a genuine quality product; has an intention to deceive by a fraudulent activity; is falsified for profit motives, disregarding public health and safety; and that disputes concerning patents or trademarks must not be confused with falsification of medical products."

However, it failed to win widespread support so did not make it through to the recommendations in the report.

Some members also said an intergovernmental negotiating body should prepare 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."

The working group will deliver the report officially to the World Health Assembly in May, and has also recommended that the deadline for completion of its review be extended.