NGOs fire a broadside at WHO over counterfeits role

Nearly 50 non-governmental organisations (NGOs) have sent an open letter to the Director General of the World Health Organization, Dr. Margaret Chan, to express their concern about the WHO's role in the fight against counterfeit medicines.

The NGOs, which include the likes of Oxfam, Health Action International and Medico International, claim that "WHO’s involvement in the issue of 'counterfeits' will have adverse consequences for access to affordable medicines while failing to address the very real problem of proliferation of pharmaceuticals with compromised quality, safety and efficacy."

At the heart of their concerns is IMPACT's newly-proposed definition of counterfeit medicines, which is based on an older (1992) definition from WHO but has additional elements aimed at bringing the definition up to date.

"WHO’s use of the term 'counterfeit' to refer to a range of pharmaceutical quality and safety problems is most concerning," says the letter, which claims the term is already enshrined in the World Trade Organization's TRIPS (Trade-Related aspects of Intellectual Property rightS) agreement and refers to trademark and intellectual property violations.

They also claim IMPACT's role is skewed by its close ties with groups with an intellectual property rights agenda, "such as Interpol, OECD, the World Customs Organisation (WCO), the World Intellectual Property Organization (WIPO), the European Commission and the multinational pharmaceutical industry."

Fanning the flames of the controversy were several cases in which generic medicines en route from India to markets in Latin America were detained by customs whilst in transit through the European Union - allegedly at the request of pharmaceutical brand owners - on the grounds that they violated intellectual property rights. India and Brazil have now started an official complaint procedure with the WTO over the issue (see also India, Brazil file WTO complaints over generic drug seizures).

In the letter, the NGOs say they want the WHO to distance itself from IMPACT, for example by no longer functioning as the consortium's secretariat, and explore the use of other terminologies "to capture the problem of pharmaceutical with compromised quality, safety and efficacy."

That position echoes overtures made at a recent WHO open forum in Basle, Switzerland, which provided an opportunity to present the progress made by the IMPACT working groups and get feedback from member states on the activity. The topic of the definition surfaced at this meeting, and some member states questioned whether WHO has the mandate to work in this area at all.

Of course, that debate is drawn relentlessly back to the definition issue. If the IMPACT definition covers IP-related issues then it is argued that WHO has no mandate, as other groups such as the World Trade Organization already cover these issues. However, if as the WHO maintains the definition excludes any IP issues but focuses on public health, the agency has a duty to act.

Survey of national legislation

The WHO has been working hard to tackle the definition controversy head on, and recently completed a survey of its member states to identify the terminology used in their national legislation.

A complete report is not yet available as there is a lot of translation work to be done, but early results reveal that the majority of member states use the term 'counterfeit' in health legislation, and in many cases base it on the 1992 WHO definition.

A handful of WHO members states use the term falsified, while other terms uncovered in the exercise include 'illicit, 'illegal', 'unregistered', 'unauthorised' and 'adulterated', according to the WHO.

Once completed, the survey results will be evaluated to help inform whether there is any need to amend the working definition of a counterfeit medicine. Meantime, the WHO says it has also developed a draft definition of 'substandard' medicines which has been circulated to member states for comment.

The topic of counterfeit medicines is back on the agenda of the World Health Assembly next week (17-21 May), after discussion on the topic was postponed from the 2009 WHA, which was cut short as a result of the swine flu pandemic. SecuringPharma.com will update you on the developments as they happen.


Related articles:

WHO monitoring programme will look for substandard drugs

Counterfeit definition still dogs WHO executive

Political stand-offs 'holding back efforts to fight counterfeits'

NGOs slam EU customs seizures

EU generic seizures still happening, say charities

WHA bumps counterfeits from agenda as flu shortens assembly