‘Pharma package’: Council and Parliament reach a deal on new rules for EU pharmaceutical sector
From the press release:
The package represents a far-reaching reform of the EU’s pharmaceutical legislation.
Regulatory protection
Under the text agreed by the co-legislators, companies placing a new medicine on the market benefit from an eight-year data protection period, meaning they have exclusive rights to data from pre-clinical tests and clinical trials.
They will also benefit from one year of market protection (the exclusive right to sell a product without immediate competition from generic medicines or biosimilars), which may be extended by an additional year for innovative medicines that satisfy two out of three conditions.
The ‘Bolar exemption’
The pharma package includes an intellectual property exemption allowing manufacturers to take the necessary steps (such as studies or trials) to ensure that generic versions of a medicine can be made available on day one after the intellectual property rights have expired.
The co-legislators have clarified the wording of this provision, and have maintained the Council’s extension of the scope to include submissions for procurement tenders.
Next steps
The provisional agreement now needs to be endorsed by both the Council of the European Union and the European Parliament, before being formally adopted and entering into force upon publication in the EU’s Official Journal.
The entire press release can be read here.
More information on the pharma package can be found here.
