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Pharma package: EU seals deal on overhaul of two-decade-old medicines law |
EU legislators struck a deal at around 5 a.m. on Thursday to overhaul the bloc’s 20-year-old pharmaceutical rules, concluding more than two years of negotiations after a final trilogue that ran for over 10 hours.
Sophie Løhde, Denmark’s health minister, said the agreement underscored the EU’s commitment “to both innovation and to ensuring that patients in Europe have access to the medicines they need.”
The breakthrough came after negotiators settled the most contentious elements of the package, including data- and market-protection periods and the scope of the Bolar exemption.
Under the agreement, companies will receive a stable eight-year data protection periodduring which rivals cannot rely on originator data. A total of three years of market protection may then be granted, during which generic companies can access the data but are not permitted to market it.
That market protection will be split into three one-year increments, each tied to specific criteria — for instance, an additional year if a product is launched within 90 days of its approval.
Securing a common position on these incentives took EU governments two years.
Lawmakers also backed a transferable exclusivity voucher for companies developing priority antibiotics. The voucher grants an extra year of market protection for a product of the company’s choosing, though it cannot be used for medicines with gross annual sales above €490 million over the previous four years.
On the Bolar exemption, co-legislators agreed to allow generic manufacturers to participate in public procurement tenders before an originator’s patent expires, expanding the steps generics may take ahead of market entry.
The provisional deal – which still requires formal approval by EU capitals and the European Parliament – also introduces a mandatory six-month notification requirement for anticipated shortages, reflecting lessons from the Covid-19 crisis.
Rapporteur Tiemo Wölken, an S&D MEP from Germany, said the reform would “streamline our regulatory system by speeding up marketing authorisation and improving approval pathways.”
The package shortens the European Medicines Agency’s timeline for issuing scientific opinions in the marketing authorisation procedure from 210 to 180 days.
Once published in the EU’s Official Journal, most of the legislation will take effect after 24 months