World Health Organization Issues Statement On Generic Drug Seizures

The World Health Organization on Friday issued a statement on a high-profile debate over Dutch authorities’ recent delay of several shipments of legitimate generic pharmaceuticals passing through the European country on their way to patients in developing countries. The goods were said to be held on mistaken suspicion of being counterfeit medicines.

“Recent events related to the handling of medicines in transit and the potential consequences for the supply of medicines in developing countries are of major concern to the organisation,” it said in a statement posted to its website on 13 March. “Ensuring that the interests of trade and health are appropriately managed, also means that the flow of legitimate medicines, including generic medicines, is not impeded.”

WHO also said it considers access to medicines to be critical; said it is conducting ongoing consultations on the matter even as it appears to be under bilateral discussion between the parties involved; and said it remains open to providing assistance on request of the member states.

“WHO considers equitable access to safe and affordable medicines as vital to the attainment of the highest possible standard of health by all,” the statement said.

The issue has garnered international attention, especially after a shipment from India to Brazil was stopped in the Netherlands, and have escalated with the revelation that the seizures include a shipment bound for Nigeria ordered by UN drug purchasing agency UNITAID that involved former US President Clinton’s foundation. Concerns arose that authorities are acting on behalf of developed-nation patent holders to interfere with generics trade, and questions have been raised about the rights of a transit country (IPW, Public Health, 6 March 2009).

The United Nations body said in its statement that it is “continuing to follow developments and consulting with member states and relevant international intergovernmental organisations.” It also said it “understands” that there is ongoing dialogue among the parties concerned to resolve the matter.

“Given the public health impact of this issue, WHO remains ready to provide, upon request, technical and policy support to member states,” it said. WHO has been somewhat reluctant in the past to become actively involved in trade matters.

WHO was coming under increasing pressure by non-governmental organisations to respond to letters of 18 and 19 February sent by 17 [note: corrected] key public health and consumer advocacy groups such as Médecins Sans Frontières (MSF) and Oxfam concerned about interrupted or higher priced supplies of essential medicines in poor countries. On 13 March, the group Knowledge Ecology International posted to its blog asking about WHO’s silence, compared with the fast reply by the World Trade Organization to a similar letter on the same day.

[Editor’s Note: the post to KEI’s blog contained comments from nearly a dozen NGOs, including MSF, Oxfam, the TransAtlantic Consumer Dialogue (TACD), IQsensato and Health Action International. The comments suggested that WHO’s inaction: shows a lack of leadership and an inability to stand up on politically sensitive issues, is suggestive of a larger systemic problem, and is tantamount to consent to an anti-competitive effort by brand-name producers and customs and trade officials to embargo generic drugs.]

WHO said in its statement that its member states “reaffirmed their commitment to these principles” in May 2008, with the adoption of a resolution on a global strategy and plan of action on public health, innovation and intellectual property (WHA61.21). The resolution expressed the governments’ commitment to “improving the delivery of and access to all health products and medical devices by effectively overcoming barriers to access,” WHO said.

The issue was raised in the meeting of the WHO Executive Board in January 2009 and was a subject of discussion in the recent WTO Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS).