Pointed Exchange Of Views At WHO Briefing On Counterfeit Drugs

Work to address counterfeit medicines continues at the World Health Organization, but a meeting late last week revealed ongoing concerns about the way it is being conducted.

No one argues that dangerous drugs should be left on the market; the issue is what kinds of drugs pose the most danger, and how they can be spotted. The use of the word ‘counterfeit’ is controversial in several countries and has raised concerns from public health non-governmental groups as well, as it carries a definition related to trademark law at the World Trade Organization.

This means that discussions on counterfeit, they argue, could veer dangerously far away from public health concerns and into the arena of intellectual property enforcement, which is neither part of WHO’s mandate nor ultimately beneficial for public health. Instead, the focus should be on substandard drugs, and generally on the quality, safety and efficacy of medicines.

Others say that the WTO’s definition of counterfeit does not apply to the WHO, and have made statements that ‘counterfeit’ is not equivalent to legitimate drugs such as lower-cost generics.

“There is plenty WHO could do to help [governments] reinforce their health surveillance machinery,” said the delegate of Brazil, speaking at a 26 March briefing on the work of WHO and WHO initiative the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

“The falsification of medicines, in Brazil, is a serious offence against public health” and those who “falsify, corrupt, adulterate or alter a product intended for medical use” can be imprisoned for 10-15 years, the Brazilian delegate said.

But, “of course we don’t use the word counterfeit.” There is no consensus on what exactly that word means at WHO, said Brazil, and if a definition is to be achieved it must be done through a “full-fledge, member-driven and open-ended” process involving WHO governing bodies.

“We have concerns regarding the use of the term ‘counterfeit’,” India agreed in its statement to the meeting. These concerns include its association with trademark, and the danger that quality, safety and efficacy issues could be viewed through the lens of intellectual property. India called this a “deliberate confusion” on the part of those seeking to increase IP enforcement regimes.”

The Indian delegate also said that IMPACT “lacks legitimacy” to define WHO’s work on dangerous medicines as it has neither a mandate of operation from member states, and that its sources of funding and decision making are not transparent.

“India does not regard IMPACT as a public health initiative because it does not frontally deal with [quality, safety and efficacy] issues,” an Indian delegate said in a statement, suggesting instead that the work of IMPACT might be better placed at WTO or perhaps within the plurilateral Anti-Counterfeiting Trade Agreement under negotiation.

Another problem is there are “no figures about the burden of the problem we are talking about,” said Fernando Muñoz of the Chilean mission, who also represents Chile on the WHO Executive Board.

There are no figures on seizures of counterfeit drugs, the amount of counterfeit drugs that exist, the countries that are most effective, and what drugs are most frequently counterfeit, Muñoz told Intellectual Property Watch, despite a counterfeit drugs discussion which has been happening at WHO since 1988.

Countries should be in a position to ensure their population that the drugs on the market are safe and effective, said Muñoz. “This is a real priority” and the WHO “should devote most of their effort to this issue.”

This means working towards strengthening the capacity of drug regulatory systems, Muñoz added. Capacity building and improving laboratory infrastructure are also activities WHO could support, suggested Brazil.

These figures are difficult to tally, a European delegate said to Intellectual Property Watch, as there may be misrepresentation of not only the nature of the medicine but also its place of origin.

However, looking at labels could be a low-cost way to identify at least some false drugs, said the European delegate. It is “cheaper to identify a mislabelled product than do the chemical analysis required to determine if it is also substandard,” the delegate explained, adding it would be difficult to test chemically all products that cross a country’s border.

‘Combating counterfeit medicines’ is still an important part of the WHO draft medicines strategy for 2008-2013 [pdf]. While still using the ‘counterfeit’ terminology, the WHO strategy says, “national drug policies that prioritize economic over public health aspects of medicine manufacturing” are likely to increase incident of fake drugs, as are “extremely fragmented distribution channels; extraterritorial trade zones which are substantially out of regulatory and enforcement oversight; inadequate access to health services and unreliable pharmaceutical supply channels that create opportunities for informal operators; and illiteracy and poverty.”

The WHO will report on these matters to the World Health Assembly in May.

Also arising at the meeting is an issue that has regularly been discussed at the World Trade Organization: the delay of generic drug shipments, mostly from India, in European ports (see, for example, IPW, 30 October 2009, 9 June 2009, and 6 March 2009).

India said in a statement that seizures of generic medicines were one consequence of the confusion between counterfeit and generic medicines, and said the EU had in March given them information about 26 seizures in 17 European countries over IP violations but that India was still waiting to hear if substandard medicines were discovered. Europe countered that there had been no mistaken seizure of legitimate generic drugs since 2008.