S00973488 Scrip 12 October 2007
EU bodies try again for agreement on TRIPS amendment
European officials are to meet on October 17th to try to reach agreement on EU ratification of the August 2003 TRIPS decision on compulsory licensing.
The August 2003 mechanism allows drugs produced under compulsory licence to be exported to countries without the necessary manufacturing capacity. An amendment making it a permanent part of TRIPS must be ratified by the end of the year.
In September, the European Parliament’s international trade committee decided to postpone a vote on whether the EU should ratify the amendment. The committee said it had not received adequate reassurances from the European Commission and Council of Ministers that they supported not just the August 30th mechanism but all the flexibilities provided by TRIPS (Scrip No 3294, p 4).
It also believes the commission is trying to include provisions in economic partnership agreements with developing countries that go beyond the requirements in TRIPS. It has asked the council to ensure the commission does not do this.
But the committee says that a recent letter from the council presidency has still not addressed its concerns, and on October 9th it voted for a delay in ratification. All political parties backed the delay, apart from the European People’s Party (EPP), said the NGO, Medecines Sans Frontieres.
The three bodies will meet for negotiations on October 17th to discuss the committee’s concerns. MSF says it hopes the committee will receive enough of a commitment from the commission and council to allow it to vote for ratification on October 22nd.
Full Title: SCRIP – World Pharmaceutical News – http://www.scripnews.com
FILED 12 October 2007 COPYRIGHT Informa UK Ltd 2007
Governments (Still) Pondering How to Make Drugs Accessible
by David Cronin
1149 parole
30 ottobre 2007
20.33
All Africa <javascript:void(0)>
Inglese
(c) 2007 AllAfrica, All Rights Reserved
Brussels, Oct 30, 2007 (Inter Press Service/All Africa Global Media via COMTEX) — The struggle to make medicines affordable to the world’s poor, especially in Africa, is raging on at the highest levels. Last week the European Commission took a landmark decision on generic drugs and next week a high-level intergovernmental meeting will look at ways to prevent patents from blocking access to drugs.
In an agreement announced last week (on October 23), European Union (EU) governments were told that they are free to make available generic versions of patented drugs for export to poor countries which lack their own manufacturing facilities.
And next week, between November 5 and 10, a little-known group — the intergovernmental working group (IGWG) on public health, innovation and intellectual property rights — will meet in Geneva, Switzerland, to work on a plan of action.
This follows a 2006 World Health Organisation (WHO) report which found that unless there is greater clarity about some of the surrounding issues, patents will still be invoked by drug firms in a way that continues to deprive the poor of potentially life-saving medicines.
The humanitarian group Medecins Sans Frontieres (Doctors Without Borders or MSF) is urging EU representatives to play an active role in framing this blueprint.
In last week’s decision, the EU’s executive, the European Commission, has undertaken not to hinder any of its 27 member states if they should decide to produce generic drugs as cheaper alternatives to patented drugs. The latter are normally too expensive for the vast majority of people in poor countries.
The accord was reached between members of the European Parliament (MEPs) and representatives of EU governments and the Commission. It will allow the Union ratify a World Trade Organisation (WTO) decision officially designed to increase the supply of medicines to poor countries.
The decision will give permanent effect to a 2003 waiver from the WTO’s Trade Related Intellectual Property Rights (TRIPS) agreement. The waiver was designed to allow poor countries which lack production capacity to address public health emergencies by importing cheap generic versions of patented drugs produced under a compulsory licence.
The EU decision was originally made in December 2005 but MEPs had declined to approve it until they won concessions from the other main EU bodies.
As part of the agreement, the Commission has also undertaken not to insert any intellectual property provisions specifically related to pharmaceuticals in the free trade deals known as economic partnership agreements (EPAs) which are currently being negotiated with the almost 80 African, Caribbean and Pacific (ACP) countries.
Yet, while campaigners for access to medicines have applauded the deal, they point out that other measures must ensue if the severe shortage of essential drugs in Africa is to be reduced.
The United Nations has estimated that 25.8 million people were HIV positive in sub-Saharan Africa in 2005. In Tanzania, Ethiopia, Ghana, Lesotho, Mozambique, Nigeria, Tanzania and Zimbabwe, 90 percent of those who needed the anti-retroviral drugs (ARVs) to treat AIDS could not obtain them.
Price is a major factor behind lack of access. Generic competition has helped to lower the price of a yearly supply of ARVs to 99 dollars per person — down from 15,000 dollars six years ago. Yet the "second-line treatments" needed by people who have developed resistance to their previous prescription are often several times more expensive than the older drugs in Africa.
"We won this battle, proving that it is crucial for the European Parliament to be united," said Italian Liberal Gianluca Susta, one of the MEPs who negotiated the deal.
"However, the real struggle for access to medicines against HIV/AIDS is still not over. Bureaucracy and reluctance from developed countries are often a major impediment. I am sure there will be other occasions when we have to return to this and reaffirm our stance," said Susta.
Despite the assurances given by the European Commission that it will not insert provisions inimical to public health in the EPAs, concerns remain about other clauses related to intellectual property which are contained in draft EPAs prepared by EU officials.
Many African countries are not currently focused on intellectual property in the EPA talks, given that the Commission has revised a plan to have comprehensive deals finalised by the end of this year. On October 22, the Commission signalled that EPAs signed during 2007 will instead be mainly limited to trade in goods, leaving discussion on other issues to a later date.
Still, analysts have questioned why some of the intellectual property clauses suggested by the Commission for the EPAs are almost identical to provisions in EU law. Some argue that applying stringent rules in this area will not be conducive to industrial development in Africa.
"It’s really not necessary to include IP (intellectual property) provisions," said Fleur Claessens from the non-governmental organisation the International Centre for Trade and Sustainable Development in Geneva. "We would like to keep them out of the EPA debate."
But an African diplomat involved in the negotiations said he believed that better copyright rules than those now applying are necessary. "Nobody wants to flout intellectual property rules outright," said the diplomat, speaking on condition of anonymity.
"If an inventor comes up with a telephone and sees a photocopy of it the following day, that’s not good. The kind of intellectual property rights you have in Europe will not be good for us. What will be good for us is something we decide ourselves," the diplomat said.
Commenting on the two developments, MSF campaigner Alexandra Heumber told IPS that "from a political point of view, it’s really good that the European Parliament has accepted the deal. It shows that MEPs have been very committed to access to medicines.
"On the other hand, the EU needs to change the system because we see that the patent system is insufficient in providing medicines to developing countries. The EU must adopt a pro-public health policy in the IGWG," Heumber said.
MSF is pushing for an international fund to finance research and development on neglected diseases. Just 1 percent of the nearly 1,400 new medicines approved between 1975 and 1999 were for treating tropical ailments and tuberculosis, despite these diseases comprising 10 percent of the world’s "disease burden".
Another idea being discussed is that of "pooling" patents, whereby drug firms would agree to combine their patents and license them to one another or to third parties. Such an approach to intellectual property is already common in the technology field, for example where common standards are required for DVDs or for audio and video files on the internet.
The WHO is exploring whether it could host an international patent pool system under which agreements would be negotiated between pharmaceutical firms and governments in poor countries.
Documento AFNWS00020071030e3au001gy
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.
UE: PE; SI MOBILITA PER FARMACI ACCESSIBILI A PAESI POVERI.
CLG
343 words
23 October 2007
22:07
ANSA-Health Service
Italian
(c) 2007 ANSA.
(ANSA) – STRASBURGO, 23 OTT – La commissione commercio internazionale del Parlamento europeo ha dato il suo via libera a schiacciante maggioranza alla ratifica dell’accordo Trips, Trade Related Aspects of Intellectual Property Rights, che prevede la possibilità per i paesi del sud del mondo di avere accesso o di produrre medicinali per malattie come l’Aids, la malaria e la tubercolosi e che normalmente sono protetti da brevetto, dopo avere avuto assicurazioni dalla presidenza di turno e dalla Commissione Ue che l’Ue si impegnerà per una effettivo accesso a questi farmaci.
La decisione della commissione di approvare la raccomandazione di Gianluca Susta (Margherita), che dovrebbe essere sostenuta dall’aula domani, mette fine a un braccio di ferro durato mesi, durante i quali i parlamentari hanno negato per quattro volte il loro ‘parere conforme’ senza avere avuto assicurazioni precise nell’ambito dell’accordo negoziato in sede Wto e che deve essere ratificato entro il primo dicembre.
La Commissione ed il Consiglio hanno accettato di prevedere finanziamenti per il trasferimento tecnologico nell’ambito del bilancio 2008, (la richiesta è per cinque milioni di euro), di non trattare all’interno degli accordi bilaterali con i paesi ACP (Africa, Caraibi e Pacifico) eventuali condizioni meno favorevoli in materia di accesso ai farmaci, e di non prevedere ostacoli o sanzioni agli Stati Ue che decidono di agevolare l’accesso ai farmaci per paesi in via di sviluppo.
Secondo Susta "anche quello che dovrebbe essere ovvio in realtà non lo è". "Solo con le dichiarazioni che abbiamo strappato in questi giorni si può dire che si apre una stagione migliore per l’accessibilità ai farmaci dei paesi più poveri e che l’Unione Europea si è smossa dall’immobilismo in questa direzione".
Vittorio Agnoletto ha definito "sgradevole" un’iniziativa del commissario Ue al commercio internazionale Peter Mandelson che, ha riferito, ha scritto al governo della Thailandia per chiedere il ritiro di una legge che limita il prezzo dei medicinali con brevetto. (ANSA).
2007-10-23_123131010 @NS48382
Document ANSAHE0020071023e3an000b5
Release: Immediate
Strasbourg, 23 October 2007
Intellectual Property and access to medicines:
EP green lights agreement in exchange of Council’ support to developing countries
Following a prolonged and successful negotiation with the EU Commission and Council, the European Parliament, led by rapporteur Gianluca Susta (ALDE/La Margherita), has finally endorsed an amendment to the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement on Intellectual Property aimed at allowing developing countries to make or buy copycat versions of patented drugs giving to treat diseases like AIDS and malaria.
The EP vote had been delayed three times as MEPs did not want to green light the modification without a prior strong commitment by the Council and Commission on the real application of the Trips Agreement by the EU, in particular, on the use of all the flexibilities contained in the Agreement.
The solution came only on Monday after a last minute statement by the Portuguese Presidency which commits the EU to really make access to medicines easier both on a bilateral and multilateral level.
As with regard to the transfer of technology to facilitate and increase the production of pharmaceutical products by the developing countries themselves, the Portuguese Presidency has also endorsed the European Parliament’s proposal to mainstreamed funds from the next EU budget.
Commenting, Gianluca Susta MEP, said:
"We won this battle proving that it is crucial for the European Parliament to be united. However, the struggle for real access to medicines against HIV/AIDS is still to 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".
For more information please contact:
Neil Corlett: +33-3-88 17 41 67 or +32-478-78 22 84
Paolo Alberti: +33-3-88 16 40 82 or +32-476-95 51 44
also consult: http://
www.alde.eu
EUROPEAN PARLIAMENT ENDORSES TRIPS AMENDMENT
The European Parliament on 24 October endorsed an amendment to WTO intellectual property rules aimed at easing poor countries’ access to essential medicines, after the EU’s 27 member governments promised to help developing nations manufacture and import affordable drugs.
Legislators from across the political spectrum had thrice postponed voting on the amendment, pending additional pledges of monetary and political support for developing country public health programmes from EU member states and the European Commission (see BRIDGES Weekly, 18 July 2007, http://www.ictsd.org/weekly/07-07-18/story3.htm).
Council statement enables passage
MEPs’ assent was finally secured when the Portuguese presidency of the EU Council, which represents all member governments, read out a statement in a plenary session of parliament committing to several of their demands. The parliament had earlier received similar guarantees from the Commission, officials said.
Alexandra Heumber, a Brussels-based access to medicines campaigner for Médecins Sans Frontières (MSF), said she was pleased with the outcome, though cautioned that the Council’s statement "needs to be put into practice."
Following months of wrangling, the parliamentary vote clears the way for EU member states to ratify the amendment to the WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) agreed by the global trade body in December 2005.
The TRIPS amendment would make permanent a procedure established in 2003, which spells out the conditions under which it is legal for WTO Members to issue compulsory licences for the production and export of cheap generic copies of patented medicines to poor countries unable to manufacture them.
Council reaffirms TRIPS flexibilites
The Portuguese presidency’s statement declared that EU members "support the use of the so-called flexibilities built into the TRIPS Agreement" — and reaffirmed in the 2001 Doha Declaration on TRIPS and Public Health — for poor countries "to be able to provide essential medicines at affordable prices under their domestic public health programmes."
It added that "the European Union is not asking, and does not foresee asking, to negotiate pharmaceutical-related provisions (sometimes referred to as TRIPS + provisions), affecting public health and access to medicines," either in its ongoing economic partnership agreement (EPA) negotiations with the African, Caribbean, and Pacific countries, or in future accords with "poor developing countries and LDCs."
A pledge not to oppose developing country governments that use WTO flexibilities in order to produce or import generics for public health purposes had been one of MEPs’ key demands. Earlier this year, the European Commission had publicly questioned the appropriateness of compulsory licences issued by Thailand for two HIV/AIDS drugs and one heart disease treatment, even though the WTO-legality of Bangkok‘s decision was hardly contested.
However, the Council’s specification of "poor" developing countries could conceivably exclude nations such as Thailand and China, which the World Bank classifies as ‘lower-middle-income economies,’ or Brazil and South Africa, which are ‘upper-middle-income economies’.
Notably, the Portuguese presidency’s statement recognised that the TRIPS amendment "represents just a part of the solution to the problem of access to medicines and public health." "We look favourably upon initiatives encouraging the transfer of technology, research, capacity strengthening, regional supply systems and help with registration, in order to facilitate and increase the production of pharmaceutical products by the developing countries themselves," it added, also alluding to budgetary support. MEPs had argued that such complementary measures would have to accompany the amendment if it were to promote public health.
While the European Parliament’s international trade committee had initially hoped for a joint declaration with the Council emphasising the EU’s commitment to the use of TRIPS flexibilities, it settled for the Portuguese presidency’s statement, which may ultimately be submitted in writing. MEPs voted heavily in favour of the amendment, although some Communists and Greens abstained because they wanted a more formal declaration.
The successful extraction of additional promises from member states was seen as a step forward for the parliament, which has often played second fiddle to the Council and the Commission in setting the direction of EU policy.
Erika Mann, trade spokesperson for the Socialist Group, described the compromise as "an historic victory and an extraordinary advance for the European Parliament." "For the first time, the [parliament] has managed to secure tangible results from the Council of ministers in an area regarded by the member states as their exclusive reserve," she added.
MSF pleased, but cautious
MSF’s Heumber also suggested that the back and forth over the TRIPS amendment marked "really the first time that the European Parliament took such a strong position, negotiating with the Council and the Commission" to push pro-public health policies. She said that it had forced the EU to engage in a broader debate on access to medicine.
However, Heumber noted that the EU had made similar statements in the past, and that the proof of its sincerity would lie in the health-related policies it pursues henceforth. She said that one potential test of Brussels’ latest promises would be for it to provide "strong political support" to the World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).
This WHO committee is in the process of developing a new plan aimed at galvanising innovation that targets health problems that predominantly affect poor countries. Health activists say that these problems are poorly served by the patent-based innovation model, since research and development costs cannot practicably be recouped from high drug prices. Some see the IGWG’s deliberations as an opportunity to consider alternatives to the patent system, for example prize funds, as a means of encouraging and rewarding pharmaceutical innovation. Heumber observed that de-linking research and development costs from drug prices for diseases that disproportionately affect developing countries would obviate at least some of the potential for tension over compulsory licences and patent rights.
TRIPS Council extends amendment deadline
In a related development in Geneva, WTO Members on 23 October agreed to push back the deadline for ratifying the TRIPS amendment by two years, to the end of 2009. As per the original agreement in 2005, the amendment needs to be ratified by two-thirds of the WTO Membership – some 100-odd countries – in order to enter into force on schedule this December. Thus far, however, only 11 Members have done so. If all of the EU’s member states ratify, the total would rise to 38.
Rwanda and Canada are currently in the process of trying to use WTO procedures identical to those in the potential TRIPS amendment in order to allow a Canadian company to export generic copies of a patented HIV/AIDS drug to the African country (see BRIDGES Weekly, 10 October 2007, http://www.ictsd.org/weekly/07-10-10/story4.htm).
ICTSD reporting.
Archiviato sotto: Politica europea e italiana