With the introduction of a new Pharmaceutical Strategy for Europe, the EU Commission initiates widespread reforms

New Pharmaceutical Strategy to be a cornerstone of the European Health Union

The new Pharmaceutical Strategy for Europe, announced by the EU Commission on 25 November, is expected to become a main pillar of the European Health Union, which EU Commission President Ursula von der Leyen recently identified as a priority.

The new strategy addresses weaknesses, identified by the Commission, in the areas of research, production and distribution of medicines in Europe, which the COVID-19 pandemic has both aggravated and highlighted. Citing access to affordable medicines as a key challenge, the Commission aims to support the European pharmaceutical industry in seeking innovations, meeting new economic and environmental challenges and assuming a leading role worldwide.

The many measures envisaged cover the entire pharmaceutical ecosystem and some parts of the medical-devices industry. The strategy goes hand in hand with other Commission initiatives, such as the Green Deal, the EU Commission's strategic approach to sustainability in the pharmaceutical sector and the EU Action Plan on Intellectual Property.

Access to medicines, innovation and sustainability as objectives

The main stated objectives of the pharmaceutical strategy include:

• Ensuring patient access to affordable medicines and addressing medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
• Promoting the competitiveness, innovation and sustainability of the EU pharmaceutical industry and the development of high quality, safe, effective and environmentally friendly medicines;
• Improving crisis preparedness and response mechanisms, and addressing the security of supplies; and
• Ensuring a strong EU voice on the world stage by promoting high standards of quality, effectiveness and safety.

Concrete initiatives to reform the regulatory framework for pharmaceuticals

The pharmaceutical strategy now adopted is not limited to good-sounding programmes. In its 24-page strategy paper, the Commission identifies concrete approaches and measures to implement its guiding principles. This includes legislative acts, which cover the entire life cycle of a pharmaceutical product: research and development, clinical trials, authorisation, manufacturing, assessment of health technologies, pricing and reimbursement, access, intellectual property protection and the introduction of medicines to the market, including generics and biosimilars. The strategy will also ensure that the latest scientific trends and digital technologies, such as advances in biotechnology and the use of artificial intelligenc.

Concrete initiatives and the implementation timeline identified in the paper include:

• Medicines for children and rare diseases: Revision of legislation to improve the treatment landscape and address needs through tailored incentives (2022);
• Health Technology Assessment (HTA): Working with the European Parliament and Council to adopt the European HTA Regulation (2021);
• Intellectual property: Review of the incentive system to promote innovation, access and affordability of medicines across the EU (2022);
• Patents, Supplementary Protection Certificates: Optimising the system for greater transparency and efficiency (2022);
• Generic drugs and biosimilars: Revision of pharmaceutical legislation to address competition and improve access to generic and biosimilars (2022);
• Competition law: Review of pharmaceutical legislation to ensure that markets function competitively (2022).
• Health data: Legislative proposal for a European Health Data Space (2021);
• Personalised medicine, genomics and digital tools: Review of pharmaceutical legislation to promote cutting-edge products, scientific developments (e.g. genomics or personalised medicine) and technological change (e.g. data analysis and digital tools) (2022);
• Artificial intelligence: Support for the development of high-performance computing and artificial intelligence for innovation in the research and development of medicines (2021-2022);
• Clinical trials: Implementation of a regulatory framework for clinical trials (2021);
• Authorisation of medicinal products: Revision of the legal framework for authorisation conditions to make life-cycle management more efficient (2021-2023);
• Electronic product information (ePI): Development and implementation of ePI legislation applicable to all EU pharmaceuticals (2022);
• Production and supply chain: Review of pharmaceutical legislation to improve the security of supplies and remove bottlenecks through specific measures (2022);
• Supply chain and sustainability: Revision of manufacturing and supply provisions in pharmaceutical legislation to improve supply-chain transparency and environmental sustainability (2022).

Implementation expected soon

According to the Commission, the guiding ideas and measures of the strategy will soon be put into action. Consultations with member states at the political level are to take place beginning December 2020. Implementation will then begin promptly, and will include evaluating basic pharmaceutical legislation, such as a review of laws regulating EMA fees and legislation on pediatric and orphan medicines.

Further steps will follow. Given the dynamic nature of the COVID-19 pandemic and the weaknesses it has exposed in the pharmaceutical system, there is political pressure to implement the strategy, and it should not be long before the first legislative proposals are published.

Pharmaceutical and medical companies should include these developments in their strategic planning as soon as possible.

When the strategy is implemented, it will be interesting to see how quickly plans become concrete proposals and concrete proposals become laws on the way to a new European health union.

For more information on this strategy and how it could affect your medical business, contact your regular CMS partner or CMS expert: