After two years of negotiations, the European Union reached an agreement on Thursday to overhaul its pharmaceutical legislation—last updated two decades ago—under which the European pharmaceutical industry maintains lengthy patent and exclusivity periods.
The European Council and the European Parliament struck a deal designed to improve patients’ access to medicines and build the competitiveness of Europe’s life sciences sector.
“We are strengthening incentives for priority antibiotics, reducing red tape for the life science industry, and safeguarding the availability of essential medicines,” said Sophie Løhde, Danish Minister for the Interior and Health, in a statement.
Proposed by the European Commission in 2023, the overhaul aims to foster innovation across member states and reinforce the security of medicine supply chains.
A EU senior official told reporters that the deal is a “generational reform” and a timely step to give Europe a modern regulatory framework, better fit for modern processes and innovation.
“Measures improving access to medicines, whilst incentivizing areas of unmet medical needs, are crucial parts of this reform,” Tiemo Wölken, negotiator from the Parliament and Member of the Socialist and Democrats Party said.
The agreed rules set a baseline of eight years of data protection for manufacturers, higher than the six years in the Commission proposal. They also introduce one additional year of market exclusivity – during which generics and biosimilars cannot be sold – once a product receives marketing authorization in the EU.
Companies can obtain up to three extra years of protection if they meet specific conditions: developing a medicine that addresses an unmet medical need, offers a significant clinical benefit over existing therapies, or contains a new active substance with trials conducted across several EU countries.
Altogether, companies may benefit from a capped 11 years of market protection under certain conditions.
“Europe cannot afford to prolong monopolies while asking too little in return from industry,” said Jaime Manzano from Salud por Derecho, a Spanish nonprofit working on health.
The NGO European Cancer Leagues (ECL) argues that “EU negotiators ultimately maintained the status quo” with the agreed data protection times.
“Treating cancer is impossible without timely access to safe and effective medicines. The Pharma Package is an important milestone to finally give patients across Europe fair access to the vital drugs they desperately need, but it does not close all the gaps to further reduce costs,” said Toma Mikalauskaite, policy lead at the ECL.
Addressing unmet needs
While patient groups warn that protections remain too high, lawmakers say the package also creates fresh incentives for critically needed drugs.
“We need new, innovative therapies for unmet medical needs, for conditions currently without treatment, rare diseases, pediatric medicines, new antibiotics,” Adam Jarubas, negotiator from the Parliament and member of the European People’s Party, said.
The development of new antibiotics offers another route to extended market protection. Under a new “AMR voucher” system, manufacturers producing antibiotics to combat antimicrobial resistance can receive an additional year of patent protection.
The 12-month extension may be used once and applied to either the antimicrobial or another authorized medicine developed by the company—excluding “blockbuster” drugs with annual gross sales exceeding €490 million in the previous four years.
Seeking to improve access to medicines, the deal also envisions an exemption to allow generics and biosimilar medicinal products to enter the market: the “Bolar exemption”.
This provision lets generic and biosimilar manufacturers run studies and prepare regulatory files on a patented medicine without being sued for patent infringement, as long as they are only preparing for approval and not yet selling the product.