Despite the popularity of generic and biosimilar drugs in Europe—the latter of which have struggled to catch on in the U.S.—the continent is suffering from a sourcing problem that could put patient access to critical medicines at risk.
Now, as trade pressures and geopolitical uncertainties mount—and as certain generics manufacturers pull back from the market—it’s imperative that the EU swiftly strengthen and adopt new policies that provide “targeted support for sustainable and resilient manufacturing,” Michal Nitka, chief of Teva’s Europe generics and global over-the-counter businesses, said in a recent email interview.
Meanwhile, the bloc should also tackle the economic, regulatory and environmental pressures that have made production of generic medicines in Europe less attractive in recent years, Nitka added.
While newly proposed legislation like the Critical Medicines Act (CMA)—meant to shore up availability, supply and production of essential drugs in the bloc—is a step in the right direction, those efforts must be bolstered through long-term incentives, clearer funding mechanisms and better coordination across the EU as a whole, the Teva executive said.
Nitka highlighted his concerns on Europe’s essential medicine autonomy in a speech at the Medicines for Europe Annual Conference in Brussels last week.
The European market has long prioritized patient access through generics and biosimilars, but recent years have exposed the toll that pricing pressures, rising production costs and new regulatory and environmental policies have taken on the industry. Together, the factors have made the production of some generic medicines “unsustainable,” Nitka told Fierce.
According to Teva’s own research, 46% of critical generics in the EU rely on a single supplier, and a whopping 83% of those drugs depend on suppliers that hold more than 60% of the market share.
“The race to the lowest price and an onerous market environment has discouraged investment,” Nitka said of the situation.
Oncology, cardiology and mental health drugs, alongside antibiotics, represent the drug classes most vulnerable to shortages in the EU, he explained, citing similar conclusions drawn by a 2021 study from the European Commission.
“Patients depend on reliable access to affordable, high-quality treatments, but the ongoing consolidation of suppliers and withdrawal of critical medicines threatens this access,” he warned.
European generic prices have fallen some 8% over the last 10 years, while consumer prices have increased by roughly 30%, the Teva executive noted.
In order to attract more production in the bloc and establish a diversified manufacturing base, the EU ought to revise procurement programs to better reflect “the true value of medicines for Europe’s healthcare systems,” according to Nitka. He also suggested legislation that eases the entry of new generics and biosimilars as well as a review of the region's environmental policies.
Europe’s CMA, which the EC proposed in March, could represent a start toward accomplishing some of those goals. The measure would, among other things, enable strategic projects for critical medicines and their ingredients.
As for other measures that could help improve the situation, Nitka highlighted the need for pan-European “harmonization and coordination” of the bloc’s national medicine stockpile requirements.
“Stockpiling must be proportionate, solidarity-based, and publicly funded, as manufacturers cannot bear these costs alone,” he said.
Lastly, Nitka noted the prices of generic drugs “often remain frozen despite rising costs." In turn, the executive suggests that the bloc allow price adjustments “at least in line with inflation” to maintain a stable supply of essential medicines in Europe.
Generics aside, branded drug makers have also taken the EU to task this year, with multiple pharma CEOs in the European Federation of Pharmaceutical Industries and Associations warning the EC in April that that the bloc needs to deliver “rapid, radical policy change,” lest pharmaceutical R&D and manufacturing retreat to more favorable environments like the U.S.