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[e-drug] EU Ratification of TRIPs Health Amendment languishes

E-DRUG: EU Ratification of TRIPs Health Amendment languishes

[From BRIDGES Weekly Trade News Digest  2007; Vol. 11, Number 23. Copied as 
fair use]

One and a half years after governments agreed on how to amend WTO 
intellectual property rules to allow poor countries to import cheap 
generic versions of patent-protected medicines, only seven of the global 
trade body's 150 Members have ratified the controversial amendment.
For the amendment to enter into force on schedule, two-thirds of WTO 
Members - some 100 countries - need to ratify the changes through their 
respective domestic political procedures by 1 December. Thus far, only 5 
percent have done so: the US, Switzerland, El Salvador, Korea, Norway, 
India, and the Philippines. 

Members agreed on the formal changes to the WTO Agreement on Trade-related 
Aspects of Intellectual Property Rights (TRIPS) in December 2005. Although 
supporters hailed the deal as proof that the trading system could address 
humanitarian and development concerns, Médecins sans Frontières (MSF) 
warned at the time that the amendment, which would take the form of an 
'Article 31bis', was "based on a mechanism that has failed to prove it can 
increase access to medicines" (see BRIDGES Weekly, 7 December 2005, 

The mechanism in question was the temporary '30 August 2003 Decision' -- a 
waiver that spells out the conditions under which Members are allowed to 
issue compulsory licences to produce and export cheap generic copies of 
drugs still under patent to developing countries that lack the capacity to 
manufacture the medicines they need (see BRIDGES Weekly, 4 September 2003, 
http://www.ictsd.org/weekly/03-09-04/wtoinbrief.htm#1). These 
administrative conditions have been criticised for being so complex as to 
render the system useless: in the nearly four years since its adoption, 
the 30 August 2003 Decision has not once been used to import drugs, 
although some argue that it has strengthened governments' hand when 
negotiating lower drug prices with pharmaceutical companies. 

The 30 August 2003 Decision was supposed to be replaced by a negotiated 
amendment to the TRIPS agreement within six months. The amendment that was 
finally agreed to more than two years later essentially makes permanent a 
questionably effective - but changeable - status quo, by translating the 
temporary waiver into WTO law. 

Until the amendment is ratified by enough Members, the 30 August Decision 
will remain in force, even past the 1 December deadline. If missed, it is 
possible that this deadline could simply be extended.

The European Parliament is now debating whether to ratify the TRIPS 
amendment. Several parliamentarians are unhappy with it, albeit for 
opposite reasons: some want the rules tightened to prevent cheap generics 
from being diverted into rich country markets; others want to ease the 
administrative burden for countries trying to use the amendment, so as to 
safeguard access to medicines. 

The EU and its parliament do not have the power to unilaterally change the 
amendment; this would involve a new negotiation with all other WTO 
Members. However, Frederick Abbott, a professor of international law at 
Florida State University, told Bridges that "the most likely result of an 
attempted re-negotiation would be an impasse." Moreover, he said that it 
was far from clear that a new compromise would make it easier for poor 
countries to import affordable drugs. "There is about an equal chance, if 
there were renewed negotiations, that the rules would become more or less 
restrictive," he opined. 

Abbott pointed out that the amendment's lack of restrictions on the scope 
of diseases covered represented a major victory for developing countries, 
which could otherwise have seen their ability to import generics limited 
to drugs for, say, HIV/AIDS, malaria, and tuberculosis. The open scope of 
the amendment, he added, would be even more controversial in renewed 
negotiations following the Thai government's January decision to issue a 
compulsory licence for Plavix, a blood thinner used to treat a 
non-communicable heart disease (see BRIDGES Weekly, 

Nor does support from some members of the European Parliament mean that 
Brussels would push for relaxing the amendment's stringent administrative 
conditions -- indeed, the EU pushed for many of these restrictions during 
the original negotiations at the WTO. However, Abbot predicted that if the 
EU, with its 27 member states, ratified the TRIPS amendment -- pushing the 
total number of WTO Members that have done so to 34 -- more countries 
would follow. 

In a report on access to medicines commissioned by the EU, Abbott and 
Jerome Reichman, a law professor at Duke University, acknowledged that the 
TRIPS amendment was "not the straightforward and expeditious solution 
initially sought by developing countries." Nevertheless, they said that 
ratification by the EU would provide a "net benefit" in terms of access to 
medicines in developing and least-developed countries. Pointedly, they 
expressed "serious concerns that industry interests and supporting 
governments would use delay or failure of acceptance of the amendment as 
the basis for an aggressive lobbying campaign intended to undercut the 
vitality of the waiver."

The two legal scholars warned that making Article 31bis functional 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 said that 
the effectiveness of the amendment could be enhanced through regional 
cooperation on procurement and compulsory licencing, as well as the 
creation of funding mechanisms other than patent rights to encourage the 
development of new drugs. 

MSF's Alexandra Heumber urged the European Parliament to postpone 
ratification while negotiating with the Commission and EU member states to 
put in place policies to promote access to medicines. Echoing a point made 
by Abbott and Reichman, she said that WTO Members seeking to assist 
developing countries could use Article 30 of the TRIPS Agreement, which 
authorises governments to make limited exceptions to patent-holders' 
rights (so long as they do not "unreasonably conflict" with the patent's 

Irrespective of whether the amendment enters into force on time, Heumber 
noted that explicit political support from Western governments for the use 
of compulsory licencing would be essential.

Despite clear WTO rules protecting Members' ability to issue compulsory 
licences suspending patents (set out primarily in TRIPS Article 31), 
developing countries face considerable pressure from the pharmaceutical 
industry and some governments not to do so. This was demonstrated by the 
uproar over Thailand's and Brazil's separate decisions to issue compulsory 
licences for a handful of drugs (see BRIDGES Weekly, 9 May 2007, 
http://www.ictsd.org/weekly/07-05-09/story4.htm). Some European 
governments and political parties, including France, the UK, and Spain, 
did express support for the action taken by Brazil and Thailand.

Importantly, neither Brazil nor Thailand had to resort to the 30 August 
Decision to issue the licences: Brazil had the capacity to manufacture the 
HIV/AIDS drug efavirenz, and Thailand was planning to import generic 
copies of the same drug from India - where it is not patented - until 
generic production came online (see BRIDGES Weekly, 13 December 2006, 

In any event, Greg Perry from the European Generic Medicines Association 
points out that for the TRIPS amendment to have "any hope of success," 
developed countries will have to truly recognise that governments do not 
need to consult with patent holders when issuing a compulsory licence for 
national emergencies or public non-commercial use, and that governments 
have the right to define what constitutes an emergency. 
ICTSD reporting.

Alexandra Heumber
EU Advocacy Liaison Officer
Médecins Sans Frontières
Access to Essential Medicines Campaign
Rue Dupré, 94. 1090 Brussels
++32 (0) 2 474 75 09 (Dir off)
++ 32 (0) 479 514 900 (Mob)
++ 32 (0) 2 474 75 75 (Fax)

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