European Commission proposes ‘single market’ for meds

Proposals include new regulatory protection periods for innovative drugs | Changes are aimed at improving patient access to therapeutics and boosting the EU pharma industry.

The European Commission (EC) has proposed the largest reform to EU pharmaceutical legislation in 20 years, which includes new regulatory protection periods for cutting-edge treatments and a ‘single market’ for medicines.

In an announcement yesterday, April 26, the EC said the proposals would include a new directive and regulation, which would revise and replace the existing pharmaceutical legislation. It is part of the Commission’s Pharmaceutical Strategy for Europe, initiated in November 2020.

The main objectives of the reforms are to ensure patients across the EU have timely access to affordable medicines; to offer an innovation-friendly framework for the research, development and production of medicines in Europe; to reduce authorisation times for medicines so they reach patients quicker; and to make medicines more environmentally sustainable.

Alongside these aims, the Commission is also proposing a council recommendation to tackle antimicrobial resistance (AMR).

New regulatory protection

As part of the new legislation, the EC is proposing regulatory protection of up to a maximum of 12 years for innovative medicines, combined with existing IP rights. To create a single market for medicines, the reform will “move the current system away from its ‘one-size-fits-all’ regulatory protection towards a more effective incentives framework for innovation that also promotes public health interests,” the Commission said.

To achieve this, it proposes a minimum period of eight years of regulatory protection, that can be extended if medicines meet certain criteria; if they are launched in all member states, address unmet medical needs, if comparative clinical trials are conducted, or if a new therapeutic indication is developed.

Other key elements of the proposal include: