Proposals At WHO Would Boost Drug Safety, Replace Anti-Counterfeiting Taskforce

Discussion at the annual World Health Assembly on counterfeit medicines may prove lively as stakeholders continue to raise concerns that the term “counterfeit” will confuse protecting patients from unsafe drugs with protecting trademarks from infringement. And an industry-led event in the lead-up to the WHA said counterfeit medicines pose great risks and will require a coordinated international response. [Updated]

Three draft resolutions have so far been tabled for the discussion, that now appears to be scheduled for Wednesday afternoon [updated Wednesday morning]. These is a Union of South American Nations (UNASUR) proposal for an intergovernmental working group to discuss the issue of “falsified” drugs, and a proposal from India and Thailand on measures to ensure access to safe, effective, quality medicines. These proposals are available here [pdf, UNSASUR] and here [pdf, India and Thailand]. The UNASUR proposal was submitted in Spanish, and proponents say the word for falsification was incorrectly translated as “counterfeit”; a corrected version using the word “falsification” instead is being prepared.

[ Update: A new document signed by 40 African countries on counterfeit medical products is available as of 19 May. The draft resolution cites a concern that counterfeit medicines “continue to move in international commerce, representing a major threat to public health, especially in the poorer areas of developing countries,” and asks that they remain an integral part of WHO standard-setting for quality, safety and efficacy. It also asks that WHO help governments implement programmes against counterfeit medicines and aid in detecting cases and disseminating information.

“The primary focus of combating” counterfeits is the protection of public health, it adds. It encourages states ensure drugs meet regulatory standards, assist in finding and prosecuting cases of counterfeit products, and promote awareness of the dangers of acquiring drugs from unauthorised places “including internet sites.” Member states are meeting on these issues during the day. ]

Meanwhile, French pharmaceutical association les enterprises du médicament (Leem) in cooperation with the Organisation Internationale de la Francophonie held 16 May a briefing on counterfeit medicines, with the health ministers from several other francophone African countries were also in attendance.

At it, a representative of the WHO gave the organisation’s position on the delaying of generic medicines in transit through the European Union, and presented initial results of a WHO survey on national use of the term “counterfeit.”

New Proposals On Drug Safety

A new intergovernmental working group should be established to “consider and implement cooperation at the regional and subregional levels and between countries, with a view to preventing and controlling falsified medical products from a public-health perspective,” says the resolution of UNASUR.

The group should focus on education of consumers, strengthening the medical production and regulation chain, and strategies to improve information sharing as well as the regulatory capacity of health systems, the proposal adds.

India and Thailand’s draft resolution suggests an alternative way to approach work on dangerous drugs: by focussing on measures to ensure safety and quality.

The International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was “not approved by any governing body of WHO,” and should be replaced with “an effective programme to address the issues of quality safety and efficacy” of medicines, it says.

“Noting that the term and definition of “counterfeit” relates to infringement of intellectual property rights” and that “infringement of intellectual property rights is being confused with the issues of quality, safety and efficacy” the resolution calls for measures to ensure affordable access to needed medicines.

It asks member states to ensure that public health does not become a victim of intellectual property enforcement, and asks WHO to avoid becoming involved in matters of IP infringement. It also asks for the WHO to support member states if requested in strengthening the technical capacity and knowledge of national drug regulatory authorities.

French Industry Meeting on Counterfeit

Counterfeit medicines are a danger that requires an internationally coordinated effort to combat, said panelists at the Leem event on 16 May.

The use of the term “counterfeit” has caused controversy at the WHO (see IPW, WHO, 12 May 2010 and 27 January 2009) for further details. It is feared by some that the term will confuse IP issues with health issues; many developing countries and civil society groups would prefer a focus on sub-standard drugs – which would include poor quality or expired drugs, as well as those that are fake.

Panellists included: Hans Hogerzeil, the director of the WHO Essential Medicines and Pharmaceutical Policies; Aline Plançon, a criminal intelligence officer from the international police organisation Interpol who is leading a joint project between Interpol and IMPACT; Komlan Mally, Togo’s minister of health; André Mama Founda, Cameroon’s minister of health; Jacques Franquet, director of economic and property safety and security at pharmaceutical company Sanofi-Aventis; Marc Gentilini from the Fondation Chirac; and Florence Veber of the French ministry of foreign and European affairs. But no representatives of public health advocates were evident at the event.

Counterfeit “is a crime” said Plançon, adding that the intent is not to change existing legislation but to find concrete actions to stop it.

There are those that question IMPACT, but in reality there is no reason it should stop the production of generic medicines that meet regulatory standards, said Wiltzer.

Veber said combating counterfeit needed to involve the political level (as in the project directive of the Council of Europe), legislation, capacity building against falsified medicines, and education of citizens. Ensuring access to good medicines, she added, is the other side of the fight.

WHO: Counterfeit “Greater Health Risk”

“In numbers, counterfeit medicines are less common than substandard medicines, but the health risks are much greater and increasing,” Hogerzeil said in a presentation to the 16 May event.

Hogerzeil also presented the initial results of a WHO survey of national uses of the word counterfeit (IPW, WHO, 11 December 2009), which he said brought responses from 60 countries. The WHO definition focuses on public health and leaves IP to other agencies, and IMPACT’s definition excludes patent disputes, as well as non-authorised products and quality problems in legitimate products, he said. Also, a recent International Federation of Pharmaceutical Manufacturers and Associations statement said that counterfeits have nothing to do with patents.

Of these responses, 34 countries use the word counterfeit in their national legislation, but definitions are varied. Others use the words falsified, illicit, illegal, unregulated, unauthorised, or adulterated. Of those countries with laws on the matter, in 31 they are regulatory, in eight they are related to intellectual property, in six to crime, and in six others the legislation is still in preparation, said Hogerzeil’s presentation.

Hogerzeil also commented in his presentation on generic drug delays through the European Union, calling them “unfortunate, as they mix counterfeit issues with patent disputes.” The WHO has asked the Netherlands and the EU for an explanation, and urged them to resolve and prevent the problem in the future.

WHO also welcomed a recent start of consultations that could lead to a dispute panel at the World Trade Organization on the issue, he said in the presentation.