News and Analysis • Volume 11 • Number 6 • October 2007
TRIPS Amendment Vote Delayed in EU
Parliamentarians are holding off a vote on a new public health provision until EU governments guarantee that they will not seek to hinder developing countries’ access to affordable drugs.
The European Parliament’s international trade committee on 9 October once again prevented the ratification of a controversial amendment to WTO intellectual property rules aimed at easing poor countries’ access to patented drugs (for details of the amendment, see page 9). The committee cited a continuing failure by EU member states to guarantee that they would help developing nations manufacture and import affordable medicines.
On 12 July 2007, EU parliamentarians across the political spectrum passed a resolution making their consent to the amendment conditional on the Union’s member governments promising political and financial support for developing country public health programmes. Foremost among the demands was an explicit joint statement from the European Commission and EU member states that the latter would remain free to use all exceptions in the TRIPS Agreement under their domestic patent laws to authorise the production and export of generics to address developing countries’ public health needs. They also asked the statement to “ensure that the Commission refrains from taking action to interfere with these proceedings.”
The parliamentarians’ mistrust of the member states’ true commitment to facilitating developing countries’ access to generics stems partly from a sharp exchange between EU Trade Commissioner Peter Mandelson and Thai Health Minister Mongkol Na Songkhla over Thailand’s decision to issue compulsory licences for two HIV/AIDS drugs and one heart disease treatment (Bridges Year 11 No.1 page 17).
In a letter dated 10 July, Commissioner Mandelson expressed concern that the Thai government might be taking ‘a new approach’ to access to medicines. Pointing to Bangkok’s statement asserting that pharmaceutical companies “should offer their drugs for no more than 5 percent above the generic cost,” he argued that a ‘systematic policy’ of applying compulsory licences would be ‘detrimental to the patent system’. Such an approach, he maintained, carried the risk of scaring away pharmaceutical investment, and did not appear to be justified by TRIPS rules and associated flexibilities.
The EU trade chief encouraged the Thai government to seek ‘direct discussions’ with the patent-holding companies, particularly with France’s Sanofi-Aventis, the makers of Plavix, a blood thinner used to treat a non-communicable heart disease. Minister Mongkol countered that the 5 percent premium applied only to the three medicines for which compulsory licences had been issued to secure generics for government health programmes. He emphasised that it was not applicable to the private market for the three drugs or to any drugs not under compulsory licence. Nor was the premium a criterion used to determine whether to issue compulsory licences, he said, asking Mr Mandelson for evidence to support his allegations that this was the case. Bangkok has maintained that it had tried to negotiate lower prices with the companies in question – although it is not required to do so by WTO rules – but to little avail (see related story in Bridges Year 11 No.2 page 17).
Mr Mandelson’s letter has been heavily criticised by parliamentarians, as well as civil society organisations. Médecins sans Frontières and Oxfam noted that his message to Thailand differed markedly from the guarantees sought by the European Parliament. “We are surprised that your intervention made in the name of the European Union comes at the very moment the European Parliament is requesting the Council and the Commission to find ways to solve issues around access to medicines,” they wrote in a letter to the trade commissioner.
The European Council, the Commission and the Parliament were to hold a ‘trialogue’ to discuss this request on 17 October. A parliamentary vote on the TRIPS amendment ratification is scheduled for 22 October.