MEPs adopt proposal to improve EU pharmaceutical legislation

Article summary

The Environment, Public Health and Food Safety Committee has adopted its proposals to improve EU pharmaceutical legislation, to promote innovation and enhance the security of supply, accessibility and affordability of medicines. The European Commission put forward a 'pharmaceutical package' to revise the EU's pharmaceutical legislation on 26 April 2023, which included proposals for a new directive and a new regulation, to make medicines more accessible and affordable. MEPs are now proposing to introduce a minimum regulatory data protection period of seven and a half years, alongside two years of market protection, following a marketing authorisation to boost innovation and are also proposing stricter requirements, which will include restrictions on prescriptions and dispensation to the amount needed for the treatment and limitations on the duration for which they are prescribed. The proposed new rules will also put obligations on companies to submit an environmental risk assessment when requesting a marketing authorisation, and want an environmental risk assessment working party to be created...