New EU pharma strategy looks to future-proof healthcare sector, stimulate innovation and boost access to biosimilars and generics
It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry.
Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards.
"The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability of manufacturing capacities to adapt and support the production of medicines," said the Commission.
Aligned with the Horizon Europe program for research and innovation, the strategy will contribute to Europe’s Beating Cancer plan as well, it continued.
The Commission recognizes that the EU pharma sector acts as a driver of job creation, trade and science:
“Medicine producers made the biggest contribution to research investment in 2019, with over €37bn (US$44bn). The sector provides 800 000 direct jobs and a €109.4bn trade surplus.
“The EU is the second largest market in the world for pharmaceuticals, with many stakeholders involved, from start-ups to large companies, from producers of patented medicines to generics and biosimilars, from wholesalers and distributors to parallel traders, from medical device to software developers.
"Emerging biopharmaceutical companies account for over 70% of the research pipeline, contributing to a vibrant sector.”
Unmet medical needs
There is a growing consensus that policies need to be rethought so as to stimulate innovation in the EU pharma sector - in areas of unmet medical needs, in particular, according to the document.
Currently, investment does not necessarily focus on the greatest unmet needs, due to the absence of commercial interest or limitations of the science, it reads.
Treatments for important diseases, for example, neurodegenerative diseases and paediatric cancers are still lacking. In addition, there are over 7,000 known rare diseases, including rare cancers, of which 95% still have no treatment option, acknowledged the Commission.
Support for generic and biosimilar drugs
The review also stresses the importance of improving access to generic and biosimilar medicines.
“Generics and biosimilars provide a large number of patients with affordable treatments and allow health potential savings in costs through their positive effect on pricing competition, the document reads.
“The Commission will consider targeted policies that support greater generic and biosimilar competition, based on the sound functioning of the single market, appropriate market protection mechanisms, the removal of barriers that delay their timely entry to market and increased uptake by health systems. This may include further clarifying the provisions for the conduct of trials on patented products to support generic and biosimilar marketing authorization applications."
We need to strengthen our health systems and ensure access to safe, effective and high-quality medicines at an affordable price.
— European Commission (@EU_Commission) November 25, 2020
Watch as we present the pharmaceutical strategy for Europe with @MargSchinas and @SKyriakidesEU for a stronger #HealthUnionhttps://t.co/cfksMdlyMZ
Tackling AMR
Other shortcomings in EU healthcare concern the lack of development of new antimicrobials, treatments or vaccines for emerging health threats, including those similar to the present pandemic, noted the Commission.
Development of novel antimicrobials or alternatives is a prime example of unmet medical need, given the lack of therapeutic options to address antimicrobial resistance (AMR), it said.
“AMR decreases our capability to treat infectious diseases and threatens our ability to perform routine surgery. As underlined in the EU One Health Action Plan on AMR, it is a multifactorial problem of global concern, with serious health and economic ramifications.
“While measures to reduce excessive and inappropriate use, described elsewhere, must be pursued, they can have the unintended effect of reducing investment in new antibiotics. Current incentive models do not provide a sustainable solution; new business approaches are required, including new incentives to develop antimicrobials as well as new pricing systems.”
The flagship actions of the EU Pharmaceutical 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 an 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.
Reaction
EU biopharma industry federation, EFPIA, said the strategy contains a number of proposals that can help Europe stem the 25-year trend of cutting-edge science and investment leaving Europe for the US and China.
"But choosing the right policy option to address the right issue will be critical to prevent further loss of competitiveness as the EU endeavours to regain its position as a world leader in medical innovation."
The biopharma sector representatives also welcomed the recognition in the plan of the critical importance of incentives in driving research into areas of unmet medical need: "Learning the lessons from the COVID-19 crisis, the inclusion in the strategy of a series of measures to tackle antimicrobial resistance, including pull and even more importantly new types of incentives for novel antimicrobials, underlines the central role incentives play in finding answers to our health challenges."
