European pharmaceutical strategy
„I want you to look at ways to help ensure Europe has the supply of affordable medicines to meet its needs. In doing so, you should support the European pharmaceutical industry to ensure that it remains an innovator and world leader.“ (Mission letter of Stella Kyriakides, European Commissioner for Health and Food Safety).
On 25 November 2020, the Commission adopted a “Pharmaceutical strategy for Europe”.
People across the EU expect to benefit from equal access to safe, state-of-the-art 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 terms of creation of highly skilled jobs and investment in innovation.
Digitalization and innovation in the use of real world data open new possibilities in how medicines are developed and used. However, innovative therapies do not reach all patients across Europe quickly and patients might not have access to medicines they need due to shortages. The unprecedented coronavirus pandemic further demonstrated how important it is to have a crisis-resistant system and ensure availability of medicines under all circumstances.
At the same time, Europe’s population is ageing and 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 third countries for importing medicines and their active ingredients and issues such as Anti-Microbial Resistance and environmental sustainability of medicines is a concern.
The Pharmaceutical strategy for Europe aims to address these issues by creating a future proof regulatory framework and support industry in promoting research and technologies that actually reach patients and fulfil their therapeutic needs while addressing market failures. It will also take into account the weaknesses exposed by the coronavirus pandemic and factor-in appropriate actions to strengthen the system.
Europe's Pharmaceutical Strategy has four main objectives:
- Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, rare diseases);
- 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, address medicines shortages;
- Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
Although the Strategy is much more than a crisis-response instrument, it draws lessons from the initial response to the COVID-19 pandemic, and makes Europe's pharmaceutical sector better prepared and more resilient.
This initiative is in line with the new Industrial Strategy for Europe and the priorities outlined in the European Green Deal, Europe’s Beating Cancer Plan, the European Digital Strategy.
The flagship actions of the Strategy include:
- A revision of the basic pharmaceutical legislation* (target date for a proposal: 2022) with a view to making this framework future-proof and innovation friendly;
- A proposal for a EU Health Emergency Response Authority (proposal: 2nd semester 2021);
- A revision of the regulations on medicines for children and rare diseases
- Initiating a structured dialogue with and between all actors in the pharmaceutical manufacturing and public authorities to identify vulnerabilities in the global supply chain of critical medicines and shape policy options to strengthen the continuity and security of supply in the EU;
- Cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and health system's sustainability;
- The creation of a robust digital infrastructure, including a proposal for a European Health Data Space (target date for a proposal: 2021);
- Support to research and innovation, notably via Horizon 2020 and EU4Health;
- Actions to promote innovative approaches to EU R&D and public procurement for antimicrobials and their alternatives and measures to restrict and optimize their use.
There was a call for reduction of the fragmentation in the development of medicines, reducing data silos and increasing connection with industry. The strategy is an opportunity to support the EU ecosystem and for the EU to take a leading global role in development and production of medicines, as well as having a stronger role on the global stage and coordination with other countries. It was noted that the issue of affordability is not easy to resolve but important for the sustainability of healthcare systems. Other aspects suggested to be considered were: taking the experience of COVID-19 in the design of clinical trials; the role of academia and other research organizations; identifying essential medicines; the links between medicines with medical devices, such as combination products and companion diagnostics; action on reasonable pricing and joint procurement of medicines; health literacy.
During the Strategy creation, one of the main issues is the accessibility and encouraging innovation focused on the patient and unmet medical needs. Unmet medical needs should be addressed throughout the lifecycle of a medicine from research to access decisions on health technology assessment, pricing and reimbursement and should not only cover diseases for which there is no treatment. Prevention was highlighted as an important element of a future pharmaceutical policy.
Incentives were recognized as an important tool to ensure development of medicines. Nonindustrial stakeholders were in favor of balancing incentives with obligations to ensure access, while industry stakeholders emphasized that incentives are necessary to allow for risky investments and ensure innovation.
The pharmaceutical strategy aims to ensure greater access and availability of the medicines in the EU based on a strong political mandate to tackle this issue. Furthermore, the European Commission has launched a study that will provide data on the causes of medicine shortages and identify possible future actions to further address this risk. The Commission also aims to enhance oversight of global manufacturing and clarify responsibilities to ensure the quality of medicines
To ensure affordability, there was consensus that a mix of approaches should be considered and it is essential to ensure that EU citizens have equal and timely access to affordable medicines.
Patient, consumer and health professional organizations highlighted the importance of transparency and stepping up information sharing efforts with Member States such as through the EURIPID co-operation (European Integrated Price Information Database Collaboration) as well as more clarity on reimbursement criteria in different countries.