The Government has changed position and decided to row in behind the pharmaceutical industry to oppose contentious reforms of the sector being debated at European Union level, following intense lobbying from pharma companies.
Proposed EU reforms would cut a minimum eight-year window companies have to exclusively sell new drugs they produce before cheaper generic competitors can enter the market.
Pharmaceutical companies have fiercely opposed any reduction in the minimum eight-year window, where they have “protection” over their research and data from clinical trials.
Ireland had previously sat in a middle camp which supported attaching some conditions to the length of this period in a bid to improve access to new medicines in smaller and poorer EU states.
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Minister for Enterprise Peter Burke said the Government now supports the position pushed by the pharmaceutical industry that there should be no change. “We are prepared to accept eight years,” he said in Brussels on Thursday.
The industry has waged a large lobbying campaign over recent years, to oppose the attempt to change the current system. Other countries with big pharma sectors, such as Germany, Denmark and Italy, have also backed the industry position.
Industry executives had argued the proposed changes would discourage companies from investing in research to develop new products, as they would have less certainty about making their money back afterwards.
Mr Burke said the Government recognised there was a need to strike a balance between improving access to medicines and supporting companies, to ensure a strong “pipeline” of new drugs being produced. There needed to be “certainty” for the sector, he said.
Pharma firms had stepped up pressure on the Government in recent months to back up the industry in the EU debate.
Industry giants such as Pfizer, MSD, Eli Lilly and Johnson & Johnson all have large manufacturing bases in the Republic, making the sector a big employer and corporate tax contributor.
Diplomats from the EU’s 27 states debated the proposed reforms at a meeting on Wednesday, which broke up without agreement.
A compromise had been tabled that would give companies seven years of protection over their drug research, with the ability to win back an extra year if the medicines addressed some unmet need, or they carried out their clinical trials in at least two EU countries.
EU states will vote on whether to support this compromise or leave the number of years companies can exclusively sell new drugs untouched.
The European Commission, the EU executive body that proposes laws, first proposed cutting the minimum window of protection from eight to six years, with the option to win back time by rolling out the new drugs in all 27 states.
The fact Ireland has switched positions will be a big boost to the group of pro-industry countries, who oppose any change to the existing system of regulatory protection.
“It is clear which way the scale is tipping. If Europe wants to be attractive for companies, we need to create the right conditions. The question is how far should we go,” one EU official involved in the negotiations said.
The dispute is one element of a much wider overhaul of regulations on the pharma sector, set out in proposed new EU legislation that runs to 700 pages.
Fears about looming trade tariffs US president Donald Trump has threatened to introduce on pharmaceutical imports put extra pressure on the Government, to back the industry in the EU negotiations.
Pharmaceutical products account for about four fifths of the Republic’s €73 billion in annual exports to the US, meaning 25 per cent tariffs on such trade would have big economic consequences for the State.
