By Kaitlin Mara
A World Health Organization report and draft resolution on counterfeit medical products drew energetic debate last week, though no compromise has yet been found to bridge disagreements over the consultation process behind the counterfeit report and over the risk of confusing intellectual property violations with potentially dangerous misrepresentation of medicines.

Members agreed at the WHO Executive Board meeting on 23 January that the WHO secretariat would do further reporting in order to address the public health dimensions of counterfeit medicines [Note: the report also will address the problem of substandard medicines], and submit additional informational text – without resolution – for further discussion at the World Health Assembly in May. If consensus is not reached at that time, member states may consider the possibility of an intergovernmental working group to meet between sessions.

The WHO Executive Board met from 19 to 27 January.

While all member states stressed on 23 January the importance of protecting public health against risks caused by spurious medications, some questioned whether the draft resolution (released on 18 December and available here [pdf]), would protect the public interest or instead focus undue attention on protecting the rights of IP holders. Others wondered if a focus on counterfeit would not distract from other public health issues, such as substandard batches or quality defects in legitimate drugs.

Chief among the concerns raised are substantive discussions over the precise definition of counterfeiting within the context of the WHO, and procedural discussions over the work of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Formed in 2006, IMPACT is a collaboration of anti-counterfeiting agents. The technical work of the group [pdf] heavily influenced the draft report, but some developing countries felt their voices were not adequately represented in the group.

WHO Director General Margaret Chan told the board that new reporting by WHO will address issues raised by member states in the 23 January discussion. It also will look to the parallel process on the WHO Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property to see if its text – already negotiated to consensus – can inform IP questions with regard to counterfeit medical products.

The Trouble with “Counterfeit”

“Counterfeit is an infringement of an IP right [and] injures a rights holder of a trademark,” said Paraguay on behalf of the Group of Latin American and Caribbean countries (GRULAC) at the opening of the discussion. “The typification of this infringement does not include health criteria.”

The legal meaning of counterfeit within the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which explicitly links it with trademark violation, was cited by several member states and non-governmental agencies as a serious concern. For more background see IPW, WHO, 16 January 2008.

The concern is that the association both opens the door for the WHO to get involved in IP enforcement and creates the risk that generic producers could face IP challenges. A recent case involving a shipment of generic hypertension drugs going from India to Brazil that was stopped in the Netherlands has given weight to that concern. Instead, many nations are asking for aid to build the capacity of their drug regulatory authorities, and to focus attention on spurious, falsely labelled and substandard drugs.

A report by non governmental agency the Third World Network entitled “WHO: Approach to “counterfeit” drugs may affect access to medicines” lays out some of the concerns on ways the WHO’s definitions might restrict the use of generics.

Others mentioned what Egypt called a “lack of clarity concerning defining issues.” “We do not know what counterfeit means in the context of the WHO mandate,” said Brazil, adding that this is the “one capital sin in the process” and “we cannot proceed [with the negotiation] until we understand that.”

Others were concerned over what turned out to be a mistake in the original WHO report, which stated that “disputes about, or violations of, intellectual property rights are not to be confused with counterfeiting.” The IMPACT group’s version said “patents” rather than “intellectual property rights.”

“We are disturbed that the WHO originally circulated a document that significantly widened the scope of exclusions to all IP,” said the United States.

WHO issued a correction [pdf] changing the wording back to “patents.”

“The falsification of medicine” is seen as “a heinous crime” said Brazil, and WHO is the forum for finding ways to ensure the quality, safety and efficacy of medication. But it is not, the delegate added, the forum for discussions on the enforcement of IP rights – though IP policy discussions as defined in the Global Strategy do have a place.

That IP enforcement is better handled at one of the dedicated international agencies was a view echoed by other delegations, including Argentina, Bangladesh, Egypt, Thailand, Uruguay.

Two developing countries separately told Intellectual Property Watch this was similar to an earlier push to give IP enforcement power to border guards via the World Customs Organization, another international agency not normally involved in IP policy (IPW, Enforcement, 8 January 2009; 25 April 2008).

But “enforcement is not our intention,” a delegate from a developed country that supported the original report told Intellectual Property Watch. While actions to stop counterfeit medications “might indirectly help trademark owners,” the main purpose is public health and there is “not a hidden agenda.”

“IP rights are a tool we, as enforcement, use to fight against counterfeit medical products when we find it appropriate, but the main focus is on saving the patients,” said Aline Plançon, project manager of a joint cooperation between IMPACT and international police organization INTERPOL. She has worked full time with the WHO since March 2008 on combating counterfeit medical products. “We also use drug regulation laws, or money laundering laws – what ever legal tools are available,” she said. An industry representative agreed, saying “trademarks are useful for fighting false labelling.”

The delegation of Switzerland suggested that as changing the word “counterfeit” might not be politically feasible, the use of the full phrase “counterfeit medical product,” using a WHO-specific definition, could potentially reduce confusion.

The IMPACT Process

Hungary on behalf of the European Union said it “actively support WHO’s effort and leadership role in the IMPACT task force,” the US said the group had filled its role of combating counterfeit “exceptionally,” and the UK congratulated the group on its “significant contribution to raising awareness and engaging relevant stakeholders.”

But others were not as confident. The IMPACT board “is mainly developed countries and the pharmaceutical industry and is under-representing developing countries,” said Indonesia, speaking on behalf of the South East Asia Regional Office (SEARO).

The members of the IMPACT board, according to its latest brochure [pdf], hail from the governments of Australia, Germany, Nigeria, Singapore, and the United States. Also members of the board are representatives of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the International Pharmaceutical Federation, as well as two employees of WHO and one of INTERPOL.

A major complaint is that the task force undertook negotiations outside the WHO, and was thus did not follow the member state driven process by which documents are normally drafted. Bangladesh was “concerned [that] any decisions should be discussed and decided by member states.” Brazil, Indonesia (on behalf of SEARO), Thailand, and Venezuela expressed similar sentiments.

There is “worry in Egypt about IMPACT,” said a delegate from the nation, as it “doesn’t have a mandate from any of WHO’s governing bodies.” Chile asked where funding for the group came from, and why its meetings were held “everywhere except Geneva,” and Argentina said it rejects the international harmonising of mechanisms to control counterfeit.

Switzerland acknowledged questions on motivation, mandate, inclusiveness and financing of IMPACT but also pointed out that the quality of the technical work of IMPACT was not being questioned. Further “not having a resolution in May would send a message to producers and distributors of counterfeit products that they should go on doing so.” The chair agreed, saying he was concerned “about having no resolution from the [Executive Board]” because it “gives great comfort to the counterfeiters.”

And, said Plançon, who is coordinating enforcement the group’s work from WHO, “the group is open and any state can join if they wish to.” Calling the fight to stop counterfeiting “a race” against organised criminals, she said, “if you want to make a practical difference, you can’t spend weeks discussing minutia. The more we lose the more they gain.”

Impairing Legitimate Drugs?

A developing country diplomat pointed out to Intellectual Property Watch that access to quality drugs at affordable prices was not mentioned in the report, suggesting the promotion of legitimate drugs was not an equal priority.

Separately Brazil said “we don’t know the impact of high prices on counterfeiting” and Oman asked for information on the length of patents and the level of illicit drug trade.

Focusing on counterfeit may distract from other, more important issues, said one nongovernmental source. These might include trade in medications which are not fraudulent but are low quality because there has been a production or storage problem, or because there are lower quality controls on drugs exported out of a country.

Substandard medications have a much greater effect on public health than do counterfeits, said Egypt. A recent study by Médecins Sans Frontières (MSF) [pdf] comes to the same conclusion.

“This is not supposed to be a political game,” said a delegate from Africa. What we need, the delegate added, is funding to increase the capacity of regulatory authorities, to stop the influx of poor quality drugs for which Africa is a “dumping ground.”

Kaitlin Mara may be reached at kmara@ip-watch.ch.