MEPS FROM GOVERNMENT coalition parties have taken opposing sides in a row between Brussels and big pharma over plans to cut the price of medicines by reducing patent protection on new drugs, boosting access to cheaper generic medicines.
Fianna Fáil MEP Billy Kelleher says the plan will hit investment in research and development (R&D) – and Ireland’s multi-billion euro tax take from the pharmaceutical sector – and he hopes the state will oppose it. He has signed amendments that would reverse the European Commission’s proposal.
However, Green Party MEP Grace O’Sullivan is backing Brussels, telling The Journal that ”to oppose this proposal is to prioritise pharmaceutical company profits over the affordability of medicines for sick people”.
The Commission and the EU pharma lobby are at loggerheads over planned reform of the EU’s general pharmaceutical legislation which would cut regulatory data protection on newly developed medicines from eight to six years. This would allow cheaper, unbranded versions of the same drugs to come to the market more quickly.
The proposals will hit pharma firms’ bottom line and the industry has claimed R&D funding will leak from the EU to the US and China if Brussels gets its way.
It’s not yet clear how the Irish government will vote on the matter in negotiations among member states.
Independents4Change MEP Mick Wallace supports the Commission proposal, saying “some steps at last are being taken to prioritise public health over profitability”.
Fine Gael’s Seán Kelly, like Kelleher, opposes the plan, saying there needs to be “a balance between making medicines affordable and patent protection that secures…innovation and research”.
Kelleher argued that “from an Irish Government point of view, this piece of legislation cannot be solely viewed through a health lens” given it will affect the state’s “offering to multinationals” and its tax base.
“Fifty thousand well-paying jobs are directly connected to the massive pharmaceutical sector in Ireland with billions in taxes of all forms flowing into the state’s accounts every year. The pharmaceutical sector is as important as the tech sector to Ireland’s prosperity,” Kelleher said.
O’Sullivan said the current system allows pharma companies to enjoy monopoly positions in the market for years and the EU does not currently require transparency about R&D costs, meaning companies can charge excessive prices “even if they have long earned back their initial investments”.
“We need to reduce the amount of time big pharma companies can enjoy their monopolies and we need to put in place strong regulation that requires full transparency. This will make medicines more available and at a cheaper price,” O’Sullivan said.
Under the Commission’s proposal, companies that launch their drugs in all 27 EU countries will gain an extra two years of protection from competition.
Companies can also buy extra time by meeting other criteria, including if a drug meets an “unmet medical need” – but the pharma lobby says these conditions are complex and unobtainable.
Kelleher claimed the high rate of attrition in the development pipeline of new drugs from concept stage to market approval proved that “anything that diminishes that reward for risk could discourage investment”.
“We have to ensure we don’t risk making Europe, and by extension Ireland a cold place for investment,” Kelleher said, adding that patients would ultimately lose out if fewer breakthrough medicines, vaccines and medical technologies came to market.
Wallace said the Commission’s proposal would enable earlier access to biosimilar and generic versions of drugs and provide “greater accessibility, affordability and availability of medicines for patients”.
However he noted that the significant divergence of views between the Parliament’s various political groupings meant that the proposal may not be resolved before this summer’s European elections.
Kelly said: “Although Ireland is among the smaller countries in the EU, it hosts operations of all the world’s top 10 pharmaceutical companies. This success comes off the back of over 50 years of consistent policy, meaning that the review of pharmaceutical legislation in the EU will be very important to Ireland.”
Kelleher, Kelly, Wallace and O’Sullivan are all in different political groups within the European Parliament.
Kelleher, O’Sullivan and Wallace sit on the committee leading the European Parliament’s work on the file, which is happening in parallel to member state negotiations.
The Department of Health, which is coordinating the government’s position, was contacted for comment.
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