Written by Luisa Antunes.
The European Commission plans to launch its revised EU pharmaceutical package in the first quarter of 2023. Ahead of its release, two recent STOA studies offer insight to inform upcoming Parliamentary discussions. Fragmentation of EU health research and development, lack of transparency and a translation gap between public investment and clinical output are among the weaknesses identified. Possible solutions include the creation of large-scale European biomedical infrastructure, and a series of targeted strategies to improve EU health research coordination and reprioritise areas of unmet therapeutic need.
Health is a fundamental human right, and equitable access to healthcare a cornerstone of EU and Member States’ policies. The COVID-19 pandemic evidenced weaknesses in the organisation of EU health research and development (R&D). Among the issues identified are access to and affordability of medicines, treatment options for rare diseases, antimicrobial resistance and environmental and economic sustainability.
In 2021, the European Parliament adopted a resolution on a pharmaceutical strategy for Europe. It recognises the existence of inequities between Member States in access to healthcare services; antimicrobial resistance as a serious health threat requiring a coordinated response; an unfit-for-purpose system of incentives for R&D on medicines for unmet diagnostics and therapeutic needs; shortages and lack of industry transparency on the pricing and costs of medicines; and an ineffective intellectual property system.
The upcoming EU pharmaceutical strategy package, planned for adoption by the Commission in the first quarter of 2023, aims to tackle this issue. Members of the European Parliament will be asked to vote on the revision of the EU’s general pharmaceuticals legislation and on the revision of the legislation on medicines for rare diseases and children. Topics to be discussed include how to ensure access to affordable vaccines, diagnostics and treatments, how to foster innovation in areas of unmet therapeutic needs, how to improve supply chains, and how to adapt to new scientific developments. The proposals are a stepping stone towards building a stronger European health union
STOA contribution to the debate
Ahead of the release of the Commission proposals, the European Parliament’s Panel for the Future of Science and Technology (STOA) has released two reports that analyse the current EU health R&D model. The studies offer policy options to address the overarching issue of unmet therapeutic needs caused by a fragmented EU health research system and the misalignment between public health priorities and industry outputs.
The first study, written by the Department of Economics of the University of Milan and led by Prof. Massimo Florio, proposes the creation of a public European biomedicines infrastructure to tackle market failures and ensure a proper return on investment, while addressing the pricing of medicines and intellectual property rights. This proposal follows from an analysis of over 250 literature reports and consultations with around 50 experts from academia, industry, and governmental and non-governmental organisations in the EU. Such infrastructure would ensure a portfolio of new medicines and related biomedical technologies, from research to the delivery stage, in partnership with third-party research centres at Member State, European and international level. With a proper R&D capacity, 80 to 150 innovative projects could be delivered over the course of 20 years, for an estimated yearly budget of €7 billion. Four possible policy options are presented (see Figure 1), with differing levels of R&D capacity and mission scope. Such an initiative could answer the identified issues of shortages and high costs and prices of pharmaceuticals, lack of transparency, and unmet therapeutic needs, by taking back public ownership rights to innovations that are exclusively in the public interest. It would also centralise public investment in public interest areas of low economic return, such as rare medicines and antimicrobials.
The second study, requested from the Department of Cardiovascular Sciences of KU Leuven and led by Prof. Karin Sipido, analyses the structure and organisation of public funding for EU health research, through literature review and consultations with experts. The study identifies several systemic weaknesses. Funding instruments have increased in diversity and complexity over the last decade, with a shift in priority towards more application and implementation. However, clinical therapeutic studies lack continuity, and there are stark inequalities in infrastructure and workforce investment between Member States. The EU lags behind global leaders, due to a lack of coherent investment, long-term strategy, competitiveness and leadership in biomedical innovation.
The report proposes a set of seven policy options to achieve increased coherence and translational throughput, from basic research to implementation, while considering environmental and economic challenges. These include strengthening cross-border collaboration, increasing programme synergies, and building stronger EU leadership, among other things through the appointment of an EU health adviser. Similarly to Prof. Florio’s study, Prof. Sipido’s study proposes the creation of an EU health institute for research coordination.
Potential impacts and developments
Both STOA studies identify a translational gap between public health needs and production outputs, diagnosing current public funding policies as inadequate in terms of return on investment. Such analyses are in line with the aforementioned Parliament resolution on a pharmaceutical strategy, and feed into the discussion on revising EU pharmaceutical legislation, including that on medicines for rare diseases and children (the ‘orphan and paediatric regulations’) and on market incentives for innovative antimicrobials.
The two studies propose the creation of an EU body as a policy option in order to coordinate EU health research and innovation and address structural weaknesses in the current R&D system. Such a priority was first recognised by a 2020 Parliament resolution on the shortage of medicines, which called on the Commission and Member States to ‘examine the possibility of creating one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health’ and, subsequently, in the December 2021 European Council conclusions, which noted the importance of Parliament’s resolution to ensure the supply of medicinal products affected by market failures.
Another piece of legislation implicated in this process is the proposed regulation on the European Health Data Space (EHDS), as far as it affects access to data and harmonisation between Member States, where a further STOA study on genome editing could be of added value.
Read this ‘at a glance’ note on ‘Towards a new EU pharmaceutical strategy‘ in the Think Tank pages of the European Parliament.