Scientific Foresight (STOA) By / October 17, 2022

Towards a public European health infrastructure: ‘A revolution is needed in the EU pharma ecosystem’

The proposal for a public European health infrastructure builds upon a Parliament resolution of 17 September 2020, calling 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.”

Written by Luisa Antunes, Scientific Foresight Unit (STOA).

On 28 September 2022, STOA organised a roundtable event to discuss the initiative to create a public European health infrastructure, proposed in a recent STOA study. The event was successful, gathering almost 100 participants in Brussels and over 200 online. It gathered a rich diversity of views, from representatives of the European Union (EU) and international bodies, civil society, academia and industry.

The proposal was born out of the reassessment of the EU’s response to COVID‑19 and the need to address preparedness to future epidemics and pandemics, as well as to answer current unmet public health issues, such as antimicrobial resistance and rare diseases. For Patrizia Toia (S&D, IT), STOA Panel member, the EU should step up as a world leader to guarantee public accessibility and equal distribution worldwide – issues the pharmaceutical market cannot handle alone.

The main authors of the study, Massimo Florio, Professor of Public Economics at the Department of Economics, Management and Quantitative Methods at Università degli Studi di Milano and Dr Chiara Pancotti, Partner and senior researcher at CSIL, analysed over 250 reports and consulted 56 experts from 48 organisations in several countries and fields (scientists, clinicians, non-governmental organisations, national public health and industry representatives, EU and other international bodies). The study addresses the issue of misalignment between public health priorities and the pharmaceutical industry’s research and development (R&D) agenda. The proposal for a European public infrastructure was met with an overwhelmingly positive response during consultations.

‘I have a brand for this: Biomed Europe.’

Professor Florio, economist and study author

According to the study authors, such a project would see the EU take the helm in organising a large-scale, pan-European initiative together with Member States and non-Member States, reminiscent of European Organization for Nuclear Research (CERN) for physics and the European Molecular Biology Laboratory (EMBL) for biology. The project could build on the example of the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA) in the United States. The mission would be to create, over the course of 20 to 30 years, a portfolio of non-profit research and development (R&D) projects for the public interest, with open global data sharing. This would differ from the EU Health Emergency Preparedness and Response Authority (HERA), as it would provide a procurement mechanism for emergency preparedness alone.

‘It is a matter of billions, not millions!’

Professor Florio, economist and study author, on the need for a potential European medicines infrastructure to reach critical mass to deal with health challenges by investing in open science and taking a new approach to intellectual property rights

With a proposed annual budget of €3.5 billion (similar to the NIH intramural sector – see below), or up to €7 billion (similar to ESA), a ‘Biomed Europe’ would be expected to deliver a portfolio of 80 to 150 innovative projects over a 20‑year period. The study proposes four policy options to deliver on this potential, revolving around two dimensions: scope of mission (restricted to infectious diseases or with a more diversified agenda), and scope of internal capacity (in-house vs decentralised).

Source: European pharmaceutical research and development: Could public infrastructure overcome market failures?, EPRS, 2021.

Policy option 3 presented in the study includes taking lessons from the US federal biomedical experience (NIH and BARDA). Presented by Dr Emily Erbelding, M.D., M.P.H., Director of the NIAID Division of Microbiology and Infectious Diseases (DMID) at NIH, the NIH’s mission is to conduct basic research. For this it receives US$43 billion annually, distributed across intramural (90 % of the budget) and extramural structures. In contrast, BARDA’s mission is to improve preparedness and response through public-private partnerships for advanced R&D of drugs and vaccines to address national health security issues, for which it receives US$3 billion annually. US investment in basic research for a period of over 10 years allowed a swift response to the COVID‑19 pandemic, with the development of the Moderna vaccine.

‘The most important venture capitalist in Europe is the European Investment Bank, including funding for BioNtech’

Professor Florio, economist and study author

‘A report from Politico shows the management of COVID‑19 has been entrusted to private actors.’

Nicoletta Dentico, Director of the Global Health Programme

‘There is something wrong about Moderna, Pfizer, BioNtech making tons of billions of profits from having monopolised results of more than 20 years of research supported by public funding.’

Dr Els Torreele, Policy Associate at the UCL Institute for Innovation & Public Purpose (IIPP)

Civil society representatives Dr Rosa Castro (European Public Health Alliance, EPHA) and Dr Els Torreele (University College London, UCL) welcomed the creation of a public European structure. They were particularly in favour of an initiative that addresses public health needs, ensures innovative and affordable products, guarantees fair returns to public investment and public ownership of knowledge, and that takes inspiration from and is open to international cooperation towards a global common agenda.

“30-40 yrs ago we chose a profitable #pharma model. But now, after #Covid19, we can all see that there is something wrong with companies making huge profits of the results of yrs of often publicly funded #research. It’s time to retain the ownership of these results” @ElsTorreele

Originally tweeted by STOA Panel (@EP_ScienceTech) on September 28, 2022.

‘There was an assumption that market incentives would somehow ‘trickle down’ and deliver on public health.’

Dr Els Torreele, Policy Associate at the UCL Institute for Innovation & Public Purpose

The priority, however, should be on defining its mission and governance rules. Paraphrasing economist Mariana Mazzucato, it is not about fixing market failures, but about defining how R&D pipeline stakeholders work together to serve public health needs.

Originally tweeted by EPHA (@EPHA_EU) on September 28, 2022.

The reactions from some participants were lukewarm. The importance of public-private collaboration was emphasised by industry representative Salah-Dine Chibout (European Federation of Pharmaceutical Industries and Associations, EFPIA), as well as academia representative Professor Rolf Apweiler, Director of EMBL-EBI, who suggested a pan-European, decentralised coordinated effort based on existing national and international infrastructures. Dr Jacques Demotes, Director General of the European Clinical Research Infrastructure Network (ECRIN), considers ‘infrastructure’ is not the correct name, and suggested creating an ‘institute’ that follows a ‘top-down’ mechanism and where private interest is separated from public health priorities.

Commission representatives from three Directorate-Generals chose to focus on existing EU-funded projects in the drug development pipeline, such as the COVID‑19 data platform, ACT EU, Horizon Europe, Innovative Health Initiative, EU FAB and IPCEI, all of which funded in collaboration with Member States. A common view was the need to build on existing platforms focusing on sustainability in cost and investment in strategic areas alone (e.g. infectious diseases, antimicrobial-resistant pathogens, orphan diseases and personalised medicine).

The audience reactions in the room and online were emphatic and constructive. Discussion covered patents and open data sharing, levels of investment and governance models.

The paradox is that we have an economist here who advocates for public health and public ownership of knowledge, and then European scientists who feel the need to include the private sector at all costs

Nicoletta Dentico, Director of the Global Health Programme

Background

The proposal for a public European health infrastructure builds upon a Parliament resolution of 17 September 2020, calling 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.” On December 2021 Council conclusions also took note of the importance of the Parliament’s resolution to ensuring the supply of medicinal products affected by market failures. More recently, in July 2022, the study was the object of an open letter to the EU institutions and governments, signed by researchers, medical professionals and health ministers, calling for the creation of a public European infrastructure that can develop vaccines and other therapeutics, for the common good. The project is now expected to be discussed in Parliament’s Committees Environment, Public Health and Food Safety (ENVI), Industry, Research and Energy (ITRE) and Special Committee on COVID-19 Pandemic: Lessons Learned and Recommendations for the Future (COVI).

Your opinion counts for us. To let us know what you think, get in touch via stoa@europarl.europa.eu.


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