Alarm Escalates Over Delayed Generic Drug Shipments As Action Sought

Health advocates on Friday further escalated their alarm over recent seizures by the Dutch government of shipments of legitimate generic pharmaceuticals passing through Europe on their way to developing countries. The European Commission has defended its actions as permissible under its own and international rules, but is being asked to look more carefully at those rules.

Oxfam International, Health Action International (HAI) and Knowledge Ecology International (KEI) on Friday issued a strongly worded statement calling on the European Union to review and modify its regulations (Council Regulation [EC] No 1383/2003 of 22 July 2003) [pdf] on counterfeiting that are prompting the seizures.

The groups said they “condemn the unacceptable seizure of legitimate generic antiretroviral medicines in transit from India to Nigeria by Dutch customs authorities.” The shipment’s delay could lead to HIV-positive Nigerian patients missing “critical treatment,” said Sophie Bloemen of HAI, who also urged the EU to reconsider inclusion of its regulation in regional free trade agreement negotiations. If it does not, “this could prove disastrous for access to medicines in their regions,” she said.

Judit Sanjuan of KEI called the seizures “unacceptable,” and asked that WTO Director General Pascal Lamy mediate in the dispute, as he indicated a willingness to do in a letter to KEI and other groups this week. NGOs also are awaiting a reply on the issue from World Health Organization Director General Margaret Chan.

The issue was front and centre at the 3 March meeting of the WTO Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (IPW, WTO/TRIPS, 5 March 2009).

NGOs held a press briefing on Wednesday at the United Nations in Geneva to bring the issue to journalists’ attention. Alexandra Heumber, IP policy adviser for Médecins Sans Frontières (MSF) said in a statement: “Blurring the lines between counterfeit drugs and quality generic drugs is leading to a dangerous situation – a situation where legitimate trade in generic drugs is blocked – a situation which is making a mockery of the EU’s support of the [WTO] Doha Declaration, to put health above commerce.

The latest shipment to be raised this week involved AIDS drugs for UN agency UNITAID and the Clinton Foundation established by former US President Bill Clinton.

The European Commission made a statement in its defence to the Tuesday TRIPS Council meeting, saying the shipments were “temporarily detained,” not “seized.” The Commission representative insisted the EU that there has been absolutely no intention to hamper legitimate trade in generic medicines or to create legal barriers to trade, and said the EU customs regulation “is fully in line with the WTO and TRIPS requirements, in terms of scope and coverage of customs intervention.”

There appears to be a variation between the Commission and MSF on whether the regulation allows customs officials to determine if shipments are fake and can be destroyed.

The Commission also said that a two-month EU customs operation called MEDI-FAKE late last year targeted illegal medicines and involved 6 million items, which confirmed a “significant and worrying level of trade in illegal medicines indicating a potentially serious public health and safety issue, which fully justify the control of medicines in transit suspected to infringe IP rights.”

KEI President James Love said in the Wednesday briefing that the Anti-Counterfeiting Trade Agreement (ACTA) negotiation being led by developed countries is contributing to concerns and should not be being negotiated in secret. He noted that the new Obama administration is not fully in place yet and it is difficult to judge whether there will be a shift in policy on these issues.

The Third World Network (TWN) said statements at the TRIPS Council meeting are “basically a wake-up call for all developing countries that they should not be misled into thinking that this is a battle against compromised medicines.” TWN’s Meena Raman told the Wednesday press briefing, “As anti-counterfeiting initiatives proliferate the problems of access are likely to worsen.”

All sides appear to be headed for more discussion on the matter.