[e-drug] EU Parliament on Access to medicnes and TRIPS

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: EU Parliament on Access to medicnes and TRIPS
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[A lot of talk, but so far no European company has been interested to use the special compulsory license for export. Very few developing countries have expressed interest in this method also. Only one (heavily supported) Canada-Rwanda license has been issued so far. One wonders whether this WTO "concession" will do anything to improve access to ARVs in poor developing countries. Copied as fair use. Thanks to Alexandra for spotting. Wilbert Bannenberg, E-drug moderator]

Financial Times Article 

MEPs ease access to generic drugs 
By Andrew Bounds in Strasbourg 

Published: October 25 2007 04:57 | Last updated: October 25 2007 04:57 
More poor countries will gain access to cheap generic drugs to deal with epidemics after European lawmakers agreed to the ratification of a key world trade protocol, the European parliament said on Wednesday. 

The European Union agreed to back full flexibility for poor countries to waive patents to deal with health emergencies such as HIV/Aids and malaria under a 2003 protocol to the trade-related intellectual property (Trips) agreement of the World Trade Organisation.  After months of talks between governments and MEPs, the EU also pledged to exclude protection of intellectual property rights for drugs from bilateral trade deals with poor countries, without defining which countries qualified.

 The parliament also set up a €2m ($2.8m, £1.4m) a year fund for technology transfer and research.  “The European Union is not asking, and does not foresee asking, to negotiate pharmaceutical-related provisions, affecting public health and access to medicines,” said a statement agreed with MEPs. 

MEPs said this would encourage more countries to follow Rwanda, which is the only country to have used the provision so far.  Gianluca Susta, the Italian Liberal MEP who led negotiations with member states, and Peter Mandelson, the trade commissioner, said: “We won this battle. However, the struggle for real access to medicines against HIV/Aids is still not over.  “Bureaucracy and reluctance from most developed countries are often a major impediment. I am sure there will be other opportunities to come back to this and strengthen our position even further.” 

The EU has been embroiled in a high-profile dispute with Thailand, which has forced Sanofi-Aventis, the Franco-German drugmaker, to make a malaria treatment available at cheaper prices to patients of its public health system.  Mr Mandelson‘s spokesman said he would continue to “seek clarification” in such cases, adding that the Commission did not consider Thailand a poor country. 

The US and many other developed countries have yet to ratify the protocol because they fear the impact on drug company profits.  The European pharmaceutical industry welcomed the ratification but said compulsory licensing was only part of the solution.  “The main problem of lack of access is not related to intellectual property, so an IP-based solution will not provide the answer,” said EFPIA, the drug companies’ lobby group.   It pointed out that 95 per cent of medicines are not patented. “Where some essential medicines do have patents, voluntary licences have been granted to generic companies in Africa,” it said.  It also said a 2001 industry initiative, the Accelerated Access Initiative, had provided anti-retrovirals to more than 800,000 people living with HIV in developing countries by May 2007. 

It is thought to be the first time the parliament has extracted concessions from EU countries over an international agreement. “This is a historic victory,” said Erika Mann, a German Socialist MEP.  

Copyright The Financial Times Limited 2007 
"FT" and "Financial Times" are trademarks of the Financial Times. 

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Intellectual Property Watch 
24 October 2007 

Parliament Paves Way for EU Adoption Of WTO Health Amendment 
By David Cronin for Intellectual Property Watch

BRUSSELS - The European Union has pledged not to include any intellectual property provisions that would curb access to medicines in a series of free trade agreements it is negotiating with least-developed countries. 

The commitment has been given as part of a deal struck between the EU’s three largest political institutions, paving the way for the Union to ratify a December 2005 decision from the World Trade Organisation aimed at boosting the supply of affordable drugs to the poor. 

Until now, members of the European Parliament (MEPs) have delayed approval of the decision that would give permanent effect to a 2003 waiver from the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS). The waiver was designed to allow countries lacking production capacity to address public health emergencies by importing cheap generic versions of patented drugs produced under a compulsory licence. 

On 23 October, however, MEPs announced that they had won assurances from the European Commission (the EU’s executive branch) and the Council of Ministers (which bands together the Union’s 27 governments) on several points of concern. 

Under the deal, the Commission has undertaken not to include any IP-related clauses that could impede the public’s access to medicines in the free trade deals - or Economic Partnership Agreements (EPAs) as they are called - it hopes to conclude with almost 80 African, Caribbean and Pacific (countries) by the end of this year. 

EU member states also have been told that they are free to produce generic versions of patented medicines and to export them to poor countries that lack the ability to manufacture them. The Commission has been requested not to interfere in any way with an EU state that produces generic medicines in such cases.
And the EU has committed to provide financial support to developing countries so that they can improve their medical production and research facilities. 

Peter Mandelson, the European commissioner for trade, said that he wished to “dispel misunderstandings” about his position on the EPAs. “Let me confirm that in those agreements and other bilateral agreements with poor developing countries, we will not ask for provisions that affect access to medicines,” he added. 

When the 2005 decision was reached, the WTO set 1 December 2007 as a target for ratification by the two-thirds of its member states needed for it to enter into force. On Tuesday, the WTO TRIPS Council agreed to recommend a two-year extension of the deadline to 2009 (IPW, WTO/TRIPS, 23 October 2007). 

So far just 11 of the organisation’s 151 countries have ratified it – or 7 percent of its total membership. These are the United States, Switzerland, El Salvador, South Korea, Norway, India, the Philippines, Israel, Japan, Australia and Singapore. 

During previous debates held over the past few months, several MEPs had suggested that the waiver is too complex to have any substantial effect in ensuring greater availability of drugs for major killers such as HIV/AIDS. 

Since the waiver was agreed in 2003, Rwanda is the only poor country to announce that it intends to make use of it to import an AIDS treatment.
Canada is the only rich country to say it will avail of it to manufacture the medicines sought in Rwanda. 

But MEPs sounded a more upbeat note this week, while Mandelson made a commitment that an evaluation of the waiver will be produced every three years. 
“Saying ‘No’ would give a negative signal to poorer countries,” said Gianluca Susta, an Italian Liberal tasked with drafting the Parliament’s official stance on the dossier. He argued that the assembly should “do everything it can” to make sure “the guarantees are put into practice.” 
Michel Rocard, a French Socialist and former prime minister, said “everyone’s euphoric as we all seem to agree.” 
Still, he argued that “doubts have to be allayed on the tenacity” of EU governments and the Commission in upholding the guarantees they have made.  Parliament Gains Voice in Trade Issues  Greek Conservative Georgios Papastamkos claimed the Parliament had “chalked up a political victory” by asserting its power on an issue of trade, a policy area in which it has far less power than the Commission or EU governments. 

This sentiment was echoed by German Social Democrat Erika Mann. “This is a historic victory and extraordinary step forward for the European Parliament,” she said. “For the first time, our assembly has been able to obtain tangible results from the Council of Ministers in a domain considered by the member states as their private hunting grounds.” 

But Carl Schlyter, a Swedish Green, took issue with Mandelson for indicating that he only wishes to have ‘poor developing countries’ exempt from IP provisions relating to pharmaceuticals, rather than all developing nations.  Schlyter referred to a letter sent by Mandelson to Thailand in July, in which the Commission expressed concern over suggested that the Bangkok government was planning to systematically use compulsory licensing to override patents on any branded medicines that it deemed to be too costly.
Although Mandelson claimed that he was not trying to meddle in Thailand’s health policy, his letter was criticised by MEPs and anti-poverty activists. 
Thailand is officially recognised as a ‘middle-income country’ by the United Nations.  “Developing countries that are not the poorest have a great need to protect public health,” argued Schlyter. “They need our support.” 

Portuguese Socialist Francisco Assis said that a “clash of values” occurs when IP issues are placed alongside those of poverty.  “On the one hand, we have a model for protecting intellectual property and providing an incentive for research,” he added. “On the other hand, there are people who don’t have resources. Are we going to let them suffer and die because they don’t have the right pills?” 

While Assis argued that the agreement between the EU institutions “certainly isn’t going to solve” some of the underlying problems on inadequate healthcare for the poor, he described it as a “step in the right direction.”

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