European Union member states have endorsed a sweeping reform of the bloc’s pharmaceutical regulations after more than two years of gridlock and what officials describe as “unprecedented” lobbying by the pharmaceutical industry, particularly in Ireland.
The so-called “pharma package” was backed by nearly all EU ambassadors at a meeting in Brussels on Tuesday, with only Malta abstaining. The package now moves to the European Parliament for negotiations.
At the heart of the reforms is a contentious change to rules around clinical data protection — the period during which generic drug manufacturers are barred from accessing data used in drug approvals. That period, which currently stands at eight years, had been the central point of disagreement among member states.
The European Commission had initially proposed cutting the protection to six years, aiming to allow generic manufacturers earlier access to data and boost affordability of medicines. However, under a compromise proposed by the Polish EU presidency, the eight-year period will be retained, with additional conditional extensions.
Under the deal, pharmaceutical companies could gain an extra year of market exclusivity by conducting trials in multiple member states and an additional year for developing medicines that address unmet medical needs.
Ireland, home to a large pharmaceutical sector, shifted its position during negotiations. Initially supportive of the shorter protection period, the Irish government eventually backed the eight-year status quo following strong industry lobbying. Minister for Enterprise Peter Burke recently acknowledged the change, saying Ireland sought to “balance access to medicines” with incentives for innovation.
“We have to ensure we remain at the cutting edge of medical development, but also deliver affordable and timely access to medicines for our citizens,” Burke said.
Officials say the reforms also include other practical measures, such as simplifying rules for multilingual and multi-country medicine packaging. These changes aim to cut production costs and facilitate cross-border distribution.
The package comes amid growing concern about the United States’ regulatory instability, with large-scale staff layoffs at the Food and Drug Administration (FDA) and a perceived hostile stance toward science under President Trump. EU officials say this spurred urgency among member states to complete the legislative overhaul.
Despite the breakthrough, sources in Brussels acknowledged the deep divisions between countries prioritising medical research and those focused on lowering drug costs. Intense lobbying reportedly reached the highest levels of several governments, including Ireland’s Taoiseach and Tánaiste.
If final agreement is reached with the European Parliament, the legislation could be formally adopted by the end of 2025.
