Parliament Delays WTO IP Health Deal Till EU Boosts Bilateral Drug Access

By David Cronin for Intellectual Property Watch
Members of the European Parliament (MEPs) have voted to delay approval of a World Trade Organization agreement on patents for medicines, pending European Union governments giving greater political and financial support to poor countries seeking to boost the supply of affordable drugs.

The 785-strong Parliament adopted a resolution on 12 July setting out its position on a protocol amending the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The assembly is required to give its assent to the protocol before it can be ratified by the EU’s 27 governments.

Agreed by the WTO in December 2005, the protocol would give permanent effect to a 2003 waiver from the TRIPS agreement. The waiver was designed to allow poor countries lacking production capacity to address public health emergencies by importing cheap generic versions of patented drugs produced under a compulsory licence.

Yet the Parliament’s resolution, which is being supported by MEPs from across the political spectrum, notes that no country has so far invoked the 2003 waiver in order to import medicines.

Speaking at a session of the Parliament in Strasbourg on 11 July, French Socialist MEP Kader Arif said that the waiver had proven “too complex and ineffective.”

The Parliament’s resolution apportions some of the blame on patent rules for the scarcity of medicines in countries faced with pandemics such as HIV/AIDS. It says that before TRIPS entered into force in 1994, the ability of some middle-income countries to produce low-cost generic medicines increased and even highly impoverished states were able to import such drugs, irrespective of whether they had been patented.

The resolution urges EU institutions to provide “concrete financial support” to build up the capacity of poor countries to manufacture medicines and political support for states who wish to use flexibilities in the TRIPS agreement that allow them to override patents in cases of emergency or for non-commercial purposes.

It also voices concerns about reported attempts by the EU’s executive arm, the European Commission, to insert intellectual property provisions that go beyond TRIPS into the Economic Partnership Agreements (EPAs), the free trade deals currently being negotiated with African, Caribbean and Pacific countries by the end of this year.

But Olli Rehn, the commissioner for EU enlargement, told Parliament members that the Commission was committed to avoiding inclusion of any provision in the EPAs that could affect access to medicines. Rehn was deputising for Peter Mandelson, the commissioner for trade.

Rehn argued that the EU had been instrumental in securing agreement from almost 150 WTO members on the protocol. Describing it as “representing a balance that was difficult to strike,” he said that it “can help save lives without undermining the patent system, which is one of the main incentives to research and development for new medicines.”

Rehn sought to downplay the significance of the fact that the temporary waiver has not yet been used. “The mechanism can operate without any compulsory licence being granted,” he said. “The usefulness of compulsory licences is mainly in the leverage they give to developing countries in pricing negotiations with pharmaceutical companies.”

He also called on pharmaceutical companies to use a system known as tiered pricing, in order to sell medicines cheaper in poor countries than in rich ones.
Rehn pointed out that the EU had allocated €455 million in recent years on research and development into ‘poverty-related’ diseases. “The Commission is doing a lot to help developing countries, in particular least-developed countries, enhance their access to affordable medicines,” he said. “Is that enough? Probably not. Is the Commission ready to do more? Yes, provided it has the resources.”

The WTO IP and health protocol requires the assent of two-thirds of WTO members by 1 December 2007 if it is to enter into force. El Salvador, India, Norway, the Philippines, South Korea, Switzerland and The United States are the only countries to have ratified it so far.

Portugal’s Europe Minister Manuel Lobo Antunes, whose government holds the EU’s rotating presidency, said that the protocol would allow the amendment of WTO rules “to improve the situation for millions of people in developing countries.”

But Vittorio Agnoletto, a left-wing Italian MEP, suggested that representatives of other EU institutions were not taking the access to medicines issue seriously.

“If this hasn’t worked in three years, do you have a magic wand?” he said. Accusing EU governments and the Commission of a “total indifference” to the health needs of the poor, he said that they were asking “pharmaceutical companies to do charity work just because we’re not able to ensure access as a right.”
Swedish Green Carl Schlyter said that while patents are supposed to provide incentives for research and development, “12 million people a year die from tropical diseases because they don’t have access to drugs.”

“When you need medical treatment, you can’t face a situation where you have to decide between medicines and food for your family,” he added. “Yet millions of people face this on a daily basis.”

Italian Liberal Gianluca Susta said that EU institutions could “not sit back and turn a blind eye” on how the temporary waiver had failed to deliver on access to medicines. He called on the EU to ensure greater funding to the production of medicines in poor countries.

David Martin, a British Labour deputy, lamented how four years after the temporary waiver was granted “not a single drug has been supplied to a single patient.”

“We are not asking for renegotiation,” he said. “We are asking the Commission to commit itself to give technical and political support in order to utilise the mechanism.”

The humanitarian organisation Médecins Sans Frontières (MSF) welcomed the Parliament’s stance.

“We know the bad consequences a patent can have for access to affordable medicines,” said Alexandra Heumber, MSF’s EU advocacy liaison officer. “So it is positive that there is a strong consensus in the Parliament on this. The MEPs are trying to move the Commission and EU governments towards finding a solution.”

David Cronin may be reached at info@ip-watch.ch.