WHO: No Evidence Of Misleading On Counterfeit Medicines

There is no evidence that the World Health Organization has been misled or misled its members on the issue of fake or dangerous drugs, representatives of the UN organisation told journalists today. Nor is the WHO yet ready to drop use of the term ‘counterfeit’ to describe such medicines despite generic producing nations complaints about possible confusion over the term.

They also addressed concerns over the behaviour of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which some WHO members this week are urging be replaced with a more accountable approach (IPW, WHO, 20 May 2010).

Specific work is needed on counterfeit medicines, said Hans Hogerzeil, the director of the WHO programme on Medicines Policy and Standards. With substandard medicines, drug regulatory authorities know who to go to when a quality problem is discovered, said Hogerzeil. But with counterfeit, false or fake medicines the identity of the producer is not known, and they easily cross national borders, so normal regulatory approaches cannot be used, he explained.

“Every honest industry is interested in stopping this,” said Hogerzeil, as is every government because counterfeiting harms both patients and the legitimacy of the health system. IMPACT grew out of a request by drug regulatory agencies that WHO work on this area, said Hogerzeil, though he did not specify which countries’ agencies.

African countries are very supportive of the programme as they “have a real problem” with low regulatory capacity and porous frontiers, he said.

If IMPACT is abolished “that leaves us vulnerable” said Nigeria in a committee meeting this morning, adding strong measures were needed to counteract counterfeits.

But Kenya yesterday gave an intervention saying IMPACT had provided guidance for negotiation of harmful counterfeit legislation with their trade ministry rather than their health industry (IPW, WHO, 20 May 2010), and had been targeting other countries with similarly harmful model legislation.

“We were very surprised to hear that, we were not aware of it at all,” Hogerzeil told the press conference in response to an Intellectual Property Watch question.

“Perhaps people are mixing up different organisations in which acronyms resemble each other,” said said Lembit Rägo, coordinator of quality assurance and safety: medicines in the Medicines Policy department at the WHO.

“There is IMPACT, there is ACTA [the Anti-Counterfeiting Trade Agreement], there are other organisations,” he added, saying “we haven’t had any evidence” of this happening.

Had Kenya used text from the WHO they “never would have had a problem,” added Hogerzeil. The text prepared by IMPACT “is actually extremely clear and would have prevented this problem.”

Other protests with regards to use of the term ‘counterfeit’ were attributed to a “communication problem” at WHO due to the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which defines counterfeit as a trademark issue. Many governments have therefore objected to the use of the term, saying it could cause confusion between the protection of intellectual property – limted to trademarks – and the protection of public health.

“Now countries are saying this is a hidden agenda,” said Hogerzeil, though the WHO has been using the word ‘counterfeit’ since 1988.

On giving up the term counterfeit, “we’re not ready to do that yet,” said Hogerzeil. The director general has said she is willing to find an alternative term but “will not do it in an emotional moment in the assembly.”

Good Data Hard to Find

It is “difficult to measure properly statistically the extent of the problem” said Hogerzeil, adding that each country counts counterfeits differently and generally only measures suspicious packages rather than taking a representative sampling. This means there is no way to determine if figures previously quoted from WHO are accurate.

Pharmaceutical industry representatives yesterday told journalists that data is difficult to ascertain but that the number of reported incidents of counterfeit medicines is on the rise.

One of the critical issues that has come up with regards to counterfeit is delays in generic drug shipments in transit through Dutch ports (IPW, Public Health, 12 May 2010). WHO “deplores that this has happened,” said Hogerzeil, calling it “improper, unfortunate use of counterfeit terminology or counterfeit legislation to work in a patent infringement issue” but said that the issue belonged at the World Trade Organization, where a trade dispute case has been opened.

Discussions on counterfeit drugs have been moved to this afternoon as governments continue to work toward consensus in informal meetings.