On 26 April 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation.
Adopted on 25 November 2020, the Pharmaceutical Strategy for Europe (reader-friendly version) aims at creating a future proof regulatory framework and at supporting the industry in promoting research and technologies that reach patients to fulfil their therapeutic needs while addressing market failures. It will also consider the weaknesses exposed by the coronavirus pandemic and take appropriate actions to strengthen the system.
It will be based on 4 pillars, which include legislative and non-legislative action:
- ensuring access to affordable medicines for patients, and addressing unmet medical needs (in the areas of antimicrobial resistance and rare diseases, for example)
- supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines
- enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, addressing medicines shortages
- ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards
This initiative is in line with the new Industrial Strategy for Europe (reader-friendly version) and the priorities outlined in the European Green Deal, Europe’s Beating Cancer Plan, the European Digital Strategy.
Challenges facing the sector
People across the EU expect to benefit from equal access to safe, modern and affordable therapies. Medicines play an important role in this regard, as they offer therapeutic options for diagnosis, treatment and prevention of diseases. Europe’s pharmaceutical sector is a major contributor to the EU economy in creating highly skilled jobs and investment in innovation.
Digitalisation and innovation in using real world data open new possibilities in how medicines are developed and used. However, innovative therapies do not reach all patients across Europe at the same speed and patients might not have access to the medicines they need due to shortages. The unprecedented coronavirus pandemic further demonstrated how important it is to have a crisis-resistant system and ensure the availability of medicines under all circumstances.
At the same time, Europe’s population is ageing and the EU faces a rising burden of diseases and emerging health threats such as COVID-19. Moreover, health systems and patients have difficulty bearing the cost of medicines. The EU is also becoming increasingly dependent on non-EU countries for importing medicines and their active ingredients; issues such as antimicrobial resistance and environmental sustainability of medicines are also a concern.
The strategy, through its objectives described above, is a policy instrument that aims to tackle these important challenges and adapt the EU pharmaceuticals system in the years to come.
The main flagship action of the Communication on a Pharmaceutical Strategy for Europe has been the reform of the EU pharmaceutical legislation. Therefore, in April 2023 the proposals for a new Directive and a new Regulation revising and replacing the existing pharmaceutical legislation, including the legislation on rare diseases and children, was finally disclosed.
- Roadmap/Inception impact assessment for the revision of the general pharmaceutical legislation
- Structured dialogue on security of medicines supply
- Pilot project ‘Market Launch of Centrally Authorised Products’
- Study on medicines shortages
- Study on optimising public procurement of medicines
Since the publication of the strategy roadmap in June 2020, the Commission has conducted a series of consultations and meetings to inform the designing of the strategy.
The Commission has taken account of the positions and priorities raised by interested parties and the public and has been working closely with Member State authorities in the context of its consultative committees.
Additional consultation activities are planned in the implementation phase.
Consultation activities related to the revision of the general pharmaceuticals legislation:
- Consultation strategy
- Online public consultation
- Thematic Workshops 2021
- Stakeholders dialogue on the pharmaceutical package – 10 May 2023
Consultation activities related to the Communication on a Pharmaceutical Strategy for Europe:
- Online public consultation
- Stakeholders workshop of 14/15 July 2020
- Have your say web page
- Factual summary of the feedback to the roadmap
- Report of the analysis of the Online Public Consultation
- Synopis report of all consultation activities annexed to the Communication
- Consultation strategy
- Pharmaceutical Strategy for Europe: Reader-friendly version
- Communication from the Commission: Pharmaceutical Strategy for Europe
- Press release
- Video: Pharmaceutical Strategy for Europe – safe and affordable medicines for all
Other related information
- Pharmaceutical Strategy roadmap
- Industrial Strategy for Europe
- European Green Deal
- Europe’s Beating Cancer Plan
- European Digital Strategy
- Revision of the legislation on orphan and paediatric medicines
- Human Pharmaceutical Committee meetings
- Safe and Timely Access to Medicines for Patients (STAMP) expert group