European Commission publishes reform of pharmaceutical legislation


The European Commission has adopted a proposal for a new Directive and a new Regulation revising and replacing existing EU pharmaceutical legislation, as well as introducing a Council Recommendation specifically on antimicrobial resistance (AMR). The revision aims to achieve the following main objectives:

• Ensure patients across the EU have timely and equitable access to safe, effective and affordable medicines

• Enhance the security of supply

• Continue to offer an attractive and innovation-friendly environment for research, development and production of medicines in Europe

• Make medicines more environmentally sustainable

• Address AMR and the presence of pharmaceuticals in the environment through a One Health approach.

Some of the key elements of the proposal include:

• New incentives to encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs, as well as facilitating earlier availability of generic and biosimilar medicines

• A simplified simplified regulatory framework, with the European Medicines Agency (EMA) providing better early regulatory and scientific support for developers of promising medicines and a reduction of EMA authorisation procedures to 180 days

• Regulatory protection of up to a maximum of 12 years for innovative medicines, combined with the existing intellectual property rights

• Addressing shortages of medicines and ensuring security of supply through the monitoring of shortages of medicines by national authorities and EMA, with a stronger coordinating role for the latter

• Tackling AMR through incentives in the form of transferable vouchers to companies that invest in novel antimicrobials.

Further information on the reforms is available at: