On 25 November 2020, the European Commission adopted a Pharmaceutical Strategy for Europe with the stated aim of ensuring that “patients have access to innovative and affordable medicines” and “to support the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical industry”.
This Pharmaceutical Strategy for Europe is seen as a key component of building a stronger European Union, for which European Commission president Ursula von der Leyen had advocated in her September 2020 State of the Union Speech, which would ultimately help the region establish a “future-proof and crisis-resilient” pharmaceutical system.
Four main objectives
- Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, 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, and addressing security of supply;
- Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
In terms of concrete policy objectives and changes, the most notable action to be expected is the proposal for a revision of the basic pharmaceutical legislation for the European Union, with a targeted proposal date set for 2022.
Revision of the current legislation on medicines for rare diseases and children is already well underway, with the Commission having published their evaluation in August 2020. Some of the key findings within the document include, positively, that the number of medicines for patients with rare diseases and for children has increased and has become available to both patient populations faster. However, on the flip side, it was concluded that both regulations have not adequately managed to support development in areas where the need for medicines is greatest.
Other key initiatives include the fostering of more cooperation between national authorities on pricing, payment and procurement policies, and the creation of a robust digital infrastructure, including a proposal for a European Health Data Space, targeted also for this year.
While the Strategy is still in its nascent stage, it is important to look at it against the backdrop of the Commission’s other plans for building a European Health Union, which includes a number of proposals for extending the mandates of the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (in light of the COVID-19 crisis), and to essentially take on a more coordinating role with clinical trials and vaccine effectiveness and safety; and the European Centre for Disease Prevention and Control to include aspects like state-of-the-art epidemiological surveillance as well as a network of reference laboratories for advice on new pathogens.
There is also a proposal expected regarding the establishment of an EU Health Emergency Response Authority (proposal expected 2nd semester this year), which would have the ability to develop new medicines based on horizon scanning and to build surge EU manufacturing capacities.
Takeaways from the Pharmaceutical Strategy for Europe Workshop
During the Pharmaceutical Strategy for Europe Workshop held on 14-15 July 2020, a number of insights emerged. For instance, participants – both industry and non-industry – called for a reduction of “the fragmentation in the development of medicines” and “data silos”, as well as “increasing connection with industry”. They generally agreed that “it was important to keep innovation in the EU” but only “moderate optimism was expressed as to the EU’s position as an innovation hub”, rather worryingly. As to be expected, the summary document from the Workshop also highlighted that “nonindustry stakeholders were in favour of balancing incentives with obligations to ensure access, while industry stakeholders emphasised that incentives are necessary to allow for risky investments and ensure innovation”.
One of the problems raised by the Commission during the workshop was about the increasing reports of medicine shortages across Europe, particularly in oncology, but also within the generics market, especially across the Eastern Europe. It was also mentioned that the market models used for generics may be unsustainable.
Another topic highlighted for further discussion was the question of a ‘fair price’ from a European perspective.
In September 2020, the Commission also published a factual summary report of all the replies received to the Roadmap they had published on the Pharmaceutical strategy.