Ireland has pivoted to oppose contentious European Union reforms aimed at broadening access to new drugs and medicines, following a blitz of lobbying from big pharmaceutical companies over recent months.
The proposed reforms would cut back a current eight-year window pharma companies have to exclusively sell new drugs they produce, before cheaper generic competitors enter the market.
Taoiseach Micheál Martin, Ministers and senior civil servants have all been on the receiving end of a significant push from the pharma sector, to get Ireland to adopt a pro-industry position in the EU debate.
Irish health officials had been keen on the reforms improving access to new drugs. Allowing generic drugmakers into the market earlier would potentially result in cheaper prices for the Health Service Executive when buying medicines for public patients.
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Speaking on Thursday, Minister for Enterprise Peter Burke confirmed the Government had shifted its stance. It now “accepted” companies should retain the current eight years of market dominance over new drugs they developed, he said.
This means Ireland has joined Denmark, Germany, Italy, Sweden and several other EU countries who support the pharma industry’s position, heading into a vote in Brussels in the coming weeks.
A compromise that would encourage companies to conduct more clinical trials in EU states, to earn back one lost year of protection from generic rivals, is the other option on the table in the vote.
The original idea was to allow companies win back extra years of “protection” over their research and data from clinical trials if they rolled out new drugs across the EU more quickly.
[ US tariffs on pharmaceuticals risk shortages of lower-cost generic drugsOpens in new window ]
Pharmaceutical firms staunchly oppose the proposals, which they claimed would make companies less likely to develop new medicines in Europe.
Several pharma giants based in Ireland, such as Pfizer, Eli Lilly, Novo Nordisk and Johnson & Johnson (J&J), stepped up pressure on the Government to back the industry line, new logs of lobbying disclosures show.
Much of the lobbying focused on getting the ear of Mr Martin and Department of the Taoiseach secretary general John Callinan.
Oliver O’Connor, head of the Irish Pharmaceutical Healthcare Association (IPHA), argued that there were alternative ways to improve access to new medicines, in recent correspondence to several departments.
The industry group chief wrote to Mr Martin directly, calling for the Government to take account of the major role the pharma sector played in Europe’s economy, lobbying disclosures show.
A lobbyist from J&J raised the matter with Robert Watt, Department of Health secretary general, on the margins of a think tank event in Dublin earlier this year. The pharma firm followed up in writing afterwards, making the case for “protecting” the existing system.
When the new Government was formed both Minister for Health Jennifer Carroll MacNeill and Mr Burke got letters of congratulations from the head of J&J’s Irish operations, Michaela Hagenhofer.
The US pharma company asked that support for companies’ intellectual property rights “be reflected” in Ireland’s position at the European level, according to filings disclosing the lobbying.
Danish pharma giant Novo Nordisk, which makes the blockbuster weight-loss drug Ozempic, also made representations. The head of Novo Nordisk’s Irish operation, Nina Therese Hovland, lobbied Minister for Finance Paschal Donohoe at a dinner hosted by consulting firm EY.
United States president Donald Trump‘s threat of coming trade tariffs on pharmaceutical imports has put pressure on the Government to signal it supports the sector, which is a major employer and corporate tax contributor.
Mr Martin met a delegation representing the Irish and European pharma industry in Government Buildings in mid-April. Lobbying logs show the meeting discussed trade tariffs and the EU reforms.
