ADVERTISEMENTThree large NGOs signalled concern on Monday that Big Pharma is seeking to impact reforms of the EU drug framework by persuading the European Commission to introduce new incentives to support innovation amid growing global trade tensions.
The Association of European Cancer Leagues (ECL), the European Consumer Organisation (BEUC), and the International Association of Mutual Benefit Societies (AIM) also warned in a joint statement addressed to the EU executive that the rising costs of innovative medicines continue to place them out of reach for many patients, deepening health inequalities across Europe.
The organisations also called on governments to prioritise patients and consumers by ensuring affordable access to safe and effective medicines.
Since the Commission introduced the pharmaceutical reform proposal in May 2023, discussions have moved forward within the European Parliament but have made little progress in the EU Council.
The EU executive said it remains optimistic about achieving a positive outcome through ongoing negotiations with lawmakers. EU member state representatives are scheduled to meet again next week to continue negotiations on the package.
According to meeting minutes obtained by Euronews, discussions among EU diplomats on Monday touched on security of supply, parallel trade, and innovation, but the thorny issue of regulatory protection was not explored in detail.
Following a meeting with Commission President Ursula von der Leyen, pharmaceutical industry CEOs reiterated calls for stronger intellectual property protections.
Periods of regulatory data protection prevent competitors from using data submitted by companies to prove new drugs are safe and effective, which helps them to produce cheaper generic or biosimilar equivalents.
Meanwhile, the civil society groups are advocating for a reduction in the baseline regulatory data protection period—currently set at eight years—to allow earlier entry of generics and biosimilars into the market. They argue this change could save European health systems approximately €1.13 billion annually.
“Treating cancer is impossible without access to affordable medication and care. The core objective of the EU pharma reform must remain clear: ensuring all cancer patients can access life-saving medicines when they need them most,” said Toma Mikalauskaitė, policy lead at the ECL.
Pharmaceutical companies, however, are pushing for more favourable conditions. Their demands are not solely driven by concerns over a potential pharmaceutical trade war with the United States but also stem from domestic US policy shifts.
There are growing fears among pharmaceutical firms that if EU drug prices remain low, it could influence US drug pricing policies—especially amid discussions that began under the Trump administration to benchmark US drug prices against those in other developed nations.
Companies worry that lower European prices could lead to downward pressure on US prices, prompting them to lobby for price increases in Europe.
Major firms such as France’s Sanofi and Switzerland’s Novartis have also lobbied through a joint letter, arguing that stringent price controls in Europe are making the EU market less attractive compared to the United States, where significantly higher drug prices are permitted.
