Bridges Weekly Trade News Digest • Volume 11 • Number 26 • 18th July 2007
European Parliament Delays Vote On TRIPs Amendment, Pending New Support For Affordable Drugs
The European Parliament has delayed the ratification of an amendment to WTO intellectual property rules aimed at easing poor countries’ access to patented drugs, demanding that EU member states first take concrete steps to help developing nations manufacture and import medicines at affordable rates.
The parliament’s international trade committee announced on 17 July that promises of monetary and political support from the EU’s 27 member governments remained insufficient.
Five days earlier, European Parliament members from across the political spectrum passed a resolution identifying the complementary policies they deemed necessary to ensure that ratifying the amendment would promote access to medicines in poor countries. They also demanded that the EU stop seeking WTO-plus intellectual property protections for pharmaceuticals in bilateral and regional trade negotiations with developing countries.
However, EU member states’ inadequate response to these objectives made it impossible to approve the amendment, the trade committee said. With the committee’s decision pushed back to10 September, the issue will not come up for a parliament-wide vote later that month or in October. Under EU procedures, the European Parliament must assent to the potential amendment before each of the member states can ratify it.
WTO Members agreed on the formal changes to the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) in December 2005. For the amendment to enter into force on schedule, two-thirds of WTO Members - some 100 countries - need to ratify the changes by 1 December. Thus far, however, only seven have done so (see BRIDGES Weekly, 27 June 2007).
The amendment makes permanent a 2003 waiver from TRIPS rules setting out the conditions for Members to legally issue compulsory licences for the production and export of cheap generic copies of patented drugs to poor countries.
Echoing civil society critics of the proposed amendment such as Médecins sans Frontières (MSF), several members of European Parliament (MEPs) have complained the waiver on which it is based is so complex that it has never once been used to export medicine.
The resolution MEPs adopted on 12 July stressed that the TRIPS amendment "represents just part of the solution to the problem of access to medicines and public health." In it, they urged the Council of EU member governments to "support the idea… that other measures to improve healthcare and infrastructure are equally indispensable."
The entry into force of the TRIPS Agreement in 1994 had hampered developing countries’ ability to produce and afford generic drugs, the resolution suggested, and the amendment’s mechanism was difficult, if not impossible to use effectively.
Arguing that "EU policy should aim at maximizing the availability of pharmaceutical products at affordable prices in the developing world," the parliament called on the European Commission and member states to commit funding for transfer of pharmaceutical-related technology to poor countries. It also asked them to boost financial support for the development of drugs to treat diseases that disproportionately affect developing countries, and to play a more active role in the World Health Organisation’s intergovernmental working group (IGWG) that is seeking to develop alternatives to patents to spur pharmaceutical innovation (see BRIDGES Weekly, 23 May 2007).
Financial assistance aside, the resolution also called for the European Commission and member states to provide political support for governments that seek to "provide essential medicines at affordable prices under their domestic public health programmes" by using flexibilities in TRIPS rules permitting the suspension of patents in exchange for a royalty payment.
Such support is not always forthcoming in practice. Alexandra Heumber, a spokesperson for MSF in Brussels, said that compulsory licences for HIV/AIDS medicines recently issued by Brazil and Thailand provided Brussels with an opportunity to reaffirm its support for the use of the flexibilities highlighted in the 2001 Doha Declaration on TRIPS and Public Health. Instead, however, the European Commission questioned their decisions, even though they were well in line with WTO rules (see BRIDGES Weekly, 31 July 2007).
MSF believes that compulsory licensing and the ensuing generic competition could help make expensive second-line HIV/AIDS treatment more widely affordable in developing countries such as Thailand. Heumber noted that after Thailand suspended the patent on HIV/AIDS drug efavirenz, enough of the medicine was imported in a single day in January to allow 20,000 additional patients to be treated.
Several of the parliament’s demands echoed recommendations made by Frederick Abbott, a professor of international law at Florida State University, and Jerome Reichman, a law professor at Duke University, in a report on the TRIPS amendment commissioned by the EU. In that paper, they warned that making the amendment functional for access to medicine would require vigilant and deliberate government action, including a "combination of political will, good lawyering, financial support for appropriate implementation efforts and collective action." They wrote that the effectiveness of the amendment could be enhanced through regional cooperation on procurement and compulsory licensing, as well as the creation of funding mechanisms other than patent rights to encourage the development of new drugs.
In a recent interview with Bridges, Abbott suggested that attempts to re-negotiate the TRIPS amendment would likely end in a stalemate, and potentially risked producing even more restrictive provisions.
Targeting EU policy vis-à-vis bilateral free trade agreements, the parliament asked member states to explicitly mandate the Commission not to "negotiate pharmaceutical-related TRIPS-plus provisions affecting public health and access to medicines, in the framework of the negotiation of the Economic Partnership Agreements with the ACP [African, Caribbean, and Pacific] countries and other future bilateral and regional agreements with developing countries."
This prompted EU Enlargement Commissioner Olli Rehn to insist that the EU was "committed" to not including provisions affecting access to medicine in either the EPAs or other trade agreements. Intellectual Property Watch reports that Rehn, speaking in the place of Trade Commissioner Peter Mandelson, said that the fact that the waiver had not been used was not very significant, since it had strengthened the hand of developing countries in price negotiations with pharmaceutical companies. However, the study by Abbott and Reichmann said that on the basis of draft agreement texts in the EPA negotiations, the European Commission had been pushing for intellectual property provisions that risked impairing the availability of generic drugs.
MSF’s Heumber welcomed the "strong coalition" of support from all political groups for the resolution, describing it as proof that the parliament was aware that many policies would need to be pursued to safeguard access to medicine for patients in the developing world. She reiterated that all governments that signed on to the Doha Declaration on TRIPS and Public Health should support developing nations’ efforts to use compulsory licences in order to support public health programmes.
ICTSD reporting; "Parliament Delays WTO IP Health Deal Till EU Boosts Bilateral Drug Access," INTELLECTUAL PROPERTY WATCH, 12 July 2007; "EU pledges easier drug access for poor nations," REUTERS, 11 July 2007.