The Council of the European Union has delivered its newest set of proposals meant to shake up European pharma regulations and sharpen the region's competitive edge, but the plan isn't exactly what EU drugmakers had hoped for.

Under the goal of ensuring access to “safe, effective and affordable medicines,” the Council on June 4 introduced several amendments to previous legislation that had been proposed in 2023. 

Besides the goal of boosting access, the proposal is aimed at increasing the competitiveness of Europe’s pharmaceutical industry by “reducing the regulatory burden and simplifying the regulatory framework," according to a press release from the Council.

Altogether, the “pharma package,” issued in the form of a directive and a regulation, represents “the biggest reform to EU’s laws on medicines in over two decades,” according to the Council.

With the new amendments, key data generated in the development of medicines would be protected from competitors for eight years. New drugs would also have one year of regulatory market protection, which could extend to two years if “certain pre-defined key objectives” are met, according to the release. 

Currently, orphan medicines can enjoy a 10-year period of market exclusivity in Europe. Otherwise, the EU currently follows a framework that allows eight years of data exclusivity, two years of market protection and a year of extra exclusivity for drugs in new indications. 

The data protection period for an innovative drug in the EU begins after the product's marketing authorization and restricts potential competitors from using the originator's trial data in their own regulatory applications. In addition to this period of exclusivity, copycats can’t launch on the market until the expiration of the originator's period of market protection, which starts after the data protection period ends.

Elsewhere in the new proposals, EU member states would be able to require drugmakers to make their products available in “sufficient quantities” to cover the needs of their respective patient populations.

“The mandate agreed today is a vital step toward ensuring that all Europeans have timely and equitable access to safe, affordable, and effective medicines,” Polish Minister for Health, Izabela Leszczyna, said in the Council’s release. “At the same time, it strengthens the competitiveness and sustainability of our pharmaceutical sector and supports improved regulatory conditions to boost clinical research and to address public health needs.”

The Council is now set to begin negotiations with the European Parliament on the package, after which the rules would be adopted into law. The new set of changes come on top of those proposed by the European Commission in 2023, which most notably aimed to shorten the period of regulatory exclusivity for most new medicines from ten years to eight.

That plan received plenty of pushback from the European Federation of Pharmaceutical Industries and Associations (EFPIA), with the industry's reception to this package being no different.

In a statement, EFPIA called the latest revisions a “missed opportunity” to position Europe’s life sciences sector “at the forefront of global competition” amid the current “unpredictable” global environment. The group specifically called out the reduced intellectual property protection period, which could discourage investment, threaten the development of innovative treatments in Europe and make the region “less attractive” to the industry overall.

“If Europe is to remain competitive and continue to deliver cutting-edge healthcare solutions, it must provide a predictable and globally competitive environment for research, development and manufacturing,” EFPIA said.

The heat around Europe’s drug market competitiveness has only increased since 2023, especially as the United States government threatens pharma import tariffs. In April, EFPIA urged for “rapid, radical” policy changes to counter potential tariffs, warning of a pharma investment exodus that could come as a result of the potential U.S. policy.