Counterfeit medicines were left off this year’s truncated World Health Assembly agenda but still managed to have an impact. The contentious, intellectual property-related issue arose during a discussion on the World Health Organization’s future plans, as several nations objected to a budget line referencing a programme to combat counterfeit drugs.

Use of the term “counterfeit” is taken by many countries to be dangerous, and by some as a sign that the WHO is overstepping its mandate into intellectual property enforcement rather than public health. The legal meaning of counterfeit under the World Trade Organization agreement on IP rights links to trademark violations, and the concern is that its use at the WHO will distract from public health problems such as poor quality medicines.

But “WHO will not do the work of WIPO [World Intellectual Property Organization] or the WTO” by becoming involved in IP, WHO Director General Margaret Chan told Intellectual Property Watch on Tuesday.

Counterfeit medicines appeared in the medium term strategic plan, which outlines WHO’s expected activities for the years 2008 through 2013. The medium term strategic plan was adopted Friday, and several sources from member states, civil society, and industry said that Chan promised during the meeting to amend the budget document to remove references to counterfeits.

The World Health Assembly (WHA) met from 18-22 May.

But member states seemed uncertain as to exactly how the director general plans to handle their objections, and are waiting to see an updated draft of the WHO medium term strategic plan.

Meanwhile, nongovernmental agencies discussed the issue at a side event hosted by Health Action International, the Third World Network, Knowledge Ecology International and the Médecins Sans Frontières Access to Essential Medicines campaign.

Members Object to Counterfeit in WHO Plan

In particular, the medium term plan says WHO will help countries implement the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) strategy.

IMPACT drew criticism from developing countries at the WHO Executive Board meeting in January for having potential conflicts of interest, as its main participants were developed nations and pharmaceutical industry representatives (IPW, WHO, 27 January 2009).

“Since IMPACT was questioned during the last EB meeting,” references to it should be removed, said the delegation of Thailand on Tuesday.

In addition, WHO, “by constitutional mandate is requested to dissociate and unlink itself on the issue of pharmaceutical quality, which is a health threat to the population, from the issues of intellectual property rights violation, which are the explicit goals and ambitions of the IMPACT,” Thailand said in its statement.

Further, the Thai statement said some studies on the magnitude and scale of counterfeit medicines had been “based on selection-biased samples in favour of the high magnitude.” It added that WHO should reference work from authors who have no conflict of interest and who are not sponsored by industry.

Suriname supported Thailand, telling Intellectual Property Watch they were concerned about shipments of legal generics being confiscated in European harbours.

India also objected to the use of counterfeit, and both India and Suriname said that because counterfeit medications have yet to be discussed in the annual assembly, they should not be in the strategic plan.

Brazil also agreed, saying to Intellectual Property Watch that using “counterfeit” at WHO – when it has a legal definition in the WTO as a trademark issue – has the effect of “exporting trademarks to WHO.” Brazil prefers terms such as substandard, falsified, or poor quality drugs.

A delegate from Canada said separately that translation is a key issue. The need to find a word that is clear in all six of the UN’s languages provides an additional challenge. “Falsification,” explained a separate delegate, is different from “counterfeit” in English – but in Spanish, the two words mean the same thing.

Chan: WHO to ‘Stay In Public Health’

“Counterfeit,” Chan told Intellectual Property Watch, “has a specific context where it was used in relation to IP,” and this has caused some to think WHO is getting into intellectual property. “WHO will stay in public health.”

Counterfeit is also sometimes used to refer to substandard medicines, or medicines with a low proportion of active ingredients, but many stakeholders object to this as confusing.

Substandard drugs, said Chan, are a “major public health problem” for three reasons: They can kill people; they can create antibiotic resistance; and they can compromise the credibility of the health authorities and doctors who prescribe medication.

“It is important to engage on the public health aspects of substandard drugs,” she told Intellectual Property Watch.

This is, she added, a global regulatory issue. It requires work with UN agencies and involves also groups like INTERPOL, the international police agency. “But when we work with them, we are not the police,” she emphasised, “WHO provides technical expertise.”

“If member states decide” that the problem should be called ‘substandard’ drugs, then “I have no problem,” she added.

NGOs Seek to Distinguish Counterfeit from Substandard

The danger, said Michelle Childs of MSF, is that using counterfeit could lead to a “hijacking of public health concerns.” Substandard medicines (legitimate medicines that do not meet quality standards) and fake medicines are both public health problems, she added, but the term counterfeit is not appropriate. The terminology “diverts from health concerns and proposes solutions that are more related to IP protection than health.”

She was speaking at the 21 May side event on the topic of “opportunities and threats for access to safe, effective and affordable medicines.”

The issue is one of confusion, and of “public health being used as a front to push forward an IP enforcement agenda,” Sangeeta Shashikant of the Third World Network concurred.

Bigger issues, said Carine Werder of MSF, include drugs that have an under- or over- concentration of active ingredients, are contaminated, or are of poor quality or stability. Sometimes this arises because export standards for drugs are less rigorous than standards for drugs intended for domestic markets.

Werder added she was “really troubled by the attempts to associate generics with substandards.”

Developing countries need to be attentive, said Sunjay Sudhir, a counsellor at the mission of India, for potential problems related to access to medicines. These include drug seizures, the definition of ‘counterfeit,’ the related role of IMPACT, and the “mushrooming” of anti-counterfeiting legislations in countries.

Counterfeit problems, said Johann van Wyk, a counsellor at the mission of South Africa, should not be solved by enforcement alone. Registration and distribution also should be used. It is, he added, “very interesting to see separation of the concept of enforcement from public health.”