The EU executive remains optimistic about reaching a positive outcome through ongoing negotiations with lawmakers in the review of the bloc’s pharmaceutical framework and won’t alter the original proposal despite requests from the European pharmaceutical sector.
Pharmaceutical firms have recently urged the Commission to strengthen intellectual property protections and introduce new incentives to support innovation, particularly in light of emerging trade tensions and demands for more favourable conditions.
Companies such as French Sanofi and Swiss giant Novartis have also lobbied in a letter for reduced price controls, arguing that current policies make the EU market less attractive compared to the US, where higher medicine prices are permitted.
To change the current proposal, the Commission would need to formally withdraw it and submit a new version, as the legislative process is now in the hands of the European Parliament and the EU Council.
A move the Commission currently does not intend to make.
“In very general and theoretical terms, if files remain blocked by the co-legislators for an extended period and there is no sign of progress, we could consider withdrawal,” a Commission spokesperson said on Wednesday.
“But that is not the case here. We are actively working with the co-legislators toward a positive resolution,” she added.
Industry pressure is partly driven by fears of a looming pharmaceutical trade war with the United States.
While tariffs have not yet been imposed, the Trump administration has initiated an investigation, which is a preliminary step toward implementing them. EU officials have also acknowledged concerns that such tariffs may soon become a reality.
Compounding the tension are reports that emerged earlier this week that the Trump administration may attempt to link US drug prices to those in other developed countries.
Pharmaceutical companies now fear that if European prices remain low, US prices could be forced down as well – hence the call to raise European prices to deter such moves.
In response to the uncertain trade environment, several major pharmaceutical firms have announced substantial investments in the US to preemptively mitigate the impact of any tariffs.
Novartis recently pledged a $23 billion commitment to US manufacturing, while Swiss-based Roche followed with a $50 billion investment.
“We fully recognise the strategic importance of the pharmaceutical industry, and reform is now in the hands of the co-legislators,” the spokesperson said.
Since the reform proposal was introduced in May 2023, discussions have progressed within the European Parliament but have seen little movement in the Council.
Nevertheless, the Commission remains hopeful. “I’m not aware that talks are going so badly. We are optimistic about adoption,” the spokesperson added.
She also highlighted recent initiatives such as the proposed Critical Medicines Act and a recent call between Commission President Ursula von der Leyen and pharmaceutical leaders, which opened a dialogue on industry concerns.
“The Commission is committed to addressing the needs of this key industry - not only from an economic perspective but above all for the health of our citizens,” she said. “We also aim to make the European market more attractive for pharmaceutical innovation and manufacturing.”
