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:
- Earlier availability of generic and biosimilar medicines, with market authorisation procedures simplified;
- Stronger obligations for companies regarding shortages of medicines, including earlier reporting of shortages and withdrawals, and prevention plans (an EU-wide list of critical medicines will be established, and supply chain vulnerabilities assessed);
- Better enforcement of current environmental requirements.
Commenting on the proposals, Stella Kyriakides, commissioner for health and food safety, said that the reform “ensures that Europe remains attractive for business, and our pharmaceutical industry a global innovation powerhouse”.
“Building a single market for medicines is a necessity both for our citizens and our companies,” she said.
AMR countermeasures
The EC is proposing a so-called One Health approach to combating AMR, through the prudent use of antimicrobials, targets to reduce their use and better infection prevention—particularly in hospitals.
Improved public awareness, training of relevant professionals and recommended targets are also part of the plan.
The proposals will now be submitted to the European parliament and council.
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