Leading international public health advocates have sent letters to the heads of the World Health Organization and World Trade Organization calling on them to act to prevent possible circumvention of international trade rules for intellectual property rights relating to shipments of legal generic drugs bound for developing countries.

The concern arose after the governments of India and Brazil spoke out at a high-level WTO meeting about intercepted shipments of such drugs by Dutch authorities.

The letters dated 18 February also were sent to the heads of the World Customs Organization (WCO), World Intellectual Property Organization, WTO General Council and WTO Council for TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights).

The letters, available on the Knowledge Ecology International (KEI) website, assert that between October and December there were four shipments seized and held by the Netherlands as they were passing through the country. The issue is ripe to explode as generics exports are seen as vital to economies such as India’s, are critical to the survival of patients in developing and least-developed nations, and fears have been stoked that developed-nation pharmaceutical industries and governments are working to construct new ways to slow generics trade that competes with their brand-name markets.

As stated in the letters, the concern has cropped up in several national and international contexts, including WHO’s foray against counterfeit medicines, WTO’s past attempts to amend its intellectual property rules, and the WCO’s rocky effort to increase customs involvement against counterfeit and pirated goods. Also on the forefront are national efforts, new custom rules being developed by the European Union, and the fast-tracked negotiation of an Anti-Counterfeiting Trade Agreement led by the nations holding the majority of the world’s IP rights – the United States, Europe and Japan. KEI recently released text it claimed is part of ACTA, showing possible stronger customs measures for IP enforcement. There also is talk of strengthening enforcement activities at WIPO.

For developed nations, new measures are needed to slow ever-rampant global piracy and counterfeiting. But to developing countries, the anti-counterfeiting initiatives being undertaken by the rich, rights-holding nations are seen as a potential source of new restrictions and trade barriers to products and services from poorer trading partners. The delay of legitimate generics passing through a country like the Netherlands out of concern that they might be counterfeit is exactly the sort of action that might confirm developing country fears.

India and Brazil told the WTO General Council in early February (IPW, WTO/TRIPS, 3 February 2009) that under international rules, transit countries do not have the right to block goods passing through. They cited Article V of the General Agreement on Tariffs and Trade (GATT), which the letters quote as defining any territory that goods pass through as “in transit”, which the nongovernmental groups say are exempt from normal restrictions associated with patents or other intellectual property rights when in route to a legitimate market. Holland violated that notion when it seized generics from India heading to Colombia, Peru and Brazil, they claim.

“The European Union rules and actions are clearly in conflict with WHO resolution WHA61.21, which states that ‘international negotiations on issues related to intellectual property rights and health should be coherent in their approaches to the promotion of public health’,” the letter to WHO Director General Margaret Chan said. It also cites a provision in the resolution to take into account the impact on public health of adopting measures reaching beyond the TRIPS agreement, which they argue the EU measure does.

They further raised concern about the risks to the work of development and public health agencies such as WHO, UNAIDS, the Global Fund, and UNITAID. They urged WHO to “immediately undertake an assessment of the risks to public health programs” from such seizures and “goods-in-transit” provisions in current or proposed trade agreements. WHO is called upon to interview developing country governments, UN agencies and others. And if WHO determines EU regulations to contain threats to public health, it should communicate its concerns and provide technical advice to the EU, with the request that the EU re-examine its provisions.

The other letter to the WTO and the rest addressed similar issues, citing TRIPS Article 51 on “suspension of release by customs authorities,” Article 41.1 of TRIPS which states that enforcement measures should not create barriers to legitimate trade, and Article 42.2 which says procedures must be “fair and equitable.” It also cites WTO accords such as the 2001 Doha Declaration on TRIPS and Public Health, which reinforces the right of WTO members to protect public health and access needed medicines.

A major concern has been the seeming blurring of the definition of counterfeit, substandard and generic medicines in some of the initiatives. The seizures serve to reinforce that concern as well.

“Oxfam International is concerned with what appears to be confusion between counterfeit medicines that kill people and generic medicines that save lives,” said Elise Ford, Oxfam International’s head of the EU office.

To honour its international commitments, the European Union “should immediately review and modify its counterfeiting regulation, if the regulation wrongfully allows European countries to seize legal generic medicines that are merely transiting through Europe,” Ford said. “It is nonsensical that a regulation intended to save lives could instead be jeopardising the ability of doctors and nurses in developing countries to protect them.”

The letters assert that brand-name companies Merck and DuPont led Dutch authorities to act to intervene in the shipments. “So far, far too little attention has been directed at these corporate criminals who are acting with impunity to thwart lawful generic competition even in countries of export and import (India and Latin America) where their patents and marketing rights have no effect,” said Brook Baker of Health GAP. He called the “embargo of medicines” a direct violation of the Doha Declaration and “an unconscionable violation of the human right of access to essential medicines enshrined in multiple international treaties.”

The letters were signed by 16 groups (counting four regional branches of one group). The groups are: BUKO Pharma-Kampagne, Consumers International, Consumers Union, Essential Action, Health Action International, Health GAP, IQsensato, Knowledge Ecology International, Medico International, Oxfam International, Third World Network and US PIRG.

TRIPS Council Meeting

The issue of the seizures could come up at the 3-4 March TRIPS Council meeting, although this was unclear at press time. The meeting agenda is likely to address the same topics as recent meetings, and there is expected to be a special session on a mandate to establish a register of geographical indications.

Two other proposals could find a way into the meeting as well: extension of higher level GI protection to other products than just wines and spirits, and an amendment of the TRIPS agreement to include a requirement for the disclosure of origin of genetic resources in patent applications.

On GI extension and CBD amendment, proponents are answering questions and offering clarifications on their previous proposal from last July, a government official said. While the Doha Round talks generally are moving slowly at this point, the expectation is that the WTO director general or a designee will reconvene discussions on these two TRIPS issues at some stage, sources said.