Written by Luisa Antunes.
Today’s EU pharmaceutical market is unsustainable, due to the fragmentation of EU players and public dependence on private interests. A recent Panel for the Future of Science and Technology (STOA) study proposes a solution involving the creation of a public European medicines infrastructure, a body that would control of the entire drug cycle, from its inception to its delivery.
The forthcoming STOA workshop will discuss how such a structure should be developed. This event is part of a series of STOA activities (including publications and events) addressing the EU health response to the Covid‑19 pandemic, with a view to fostering preparedness to counter future health threats.
Today’s EU public health system is unsustainable
The Covid-19 pandemic exposed gaps in the EU public health system: from non-standardised Member State data reporting and uncoordinated Member State crisis responses, controversial vaccine contracts and slow national vaccine rollouts, to a fragmented network of institutional actors in health.
The EU’s response to Covid-19 improved upon some of these issues. We saw the launch of the EU4Health programme and the pharmaceutical strategy for Europe initiative, the reinforcement of the roles of EU agencies the European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency (EMA), and the creation of two new EU structures, the European Health and Digital Executive Agency (HaDEA) and the Health Emergency Preparedness and Response Authority (HERA), the latter of which has a mission to stockpile and distribute vaccines and other medical countermeasures to the 27 EU Member States.
However, some have argued that these solutions are limited and do not address the root of the problem – the unsustainability of the present EU pharmaceutical system. A STOA study analysing 200 literature sources and interviewing 60 experts identifies the main market and policy failures at the heart of the problem, including:
1. a mismatch between public and private research and development (R&D) priorities;
2. a mismatch between public sector ‘open’ science and private copyright regimes;
3. an excessive flow of public subsidies towards the private sector;
4. private monopoly control over access to and the cost of medicines.
A solution is therefore sought that can repurpose the massive public investment in pharmaceutical R&D for an effective and sustainable public EU ecosystem.
With its resolution of 17 September 2020, the European Parliament 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 (…), in order to complete and guarantee security of supply and prevent possible shortages of medicines’.
The November 2021 Council conclusions negotiated under the Slovenian Presidency of the EU and signed off by all 27 EU Health Ministers took note of the importance of Parliament’s resolution to ensure the supply of medicinal products affected by market failures.
In July 2022, an open letter to EU institutions signed by researchers, doctors and by Italian ex-ministers of Health Rosy Bindi and Giulia Grillo, called for the creation of a public European infrastructure that can develop vaccines and other therapeutics, for the common good.
Developing a public European medicines infrastructure
According to the authors of the STOA study, a European medicines infrastructure would focus on serving public interest by developing effective, affordable and safe medicines that are free from private intellectual property rights and where public funds are reallocated to public-interest projects. Such a structure would allow the development of new antimicrobials and medicines used to cure rare diseases (‘orphan medicines’), areas traditionally left out of private strategies.
Unlike HERA, which does not have the mandate to directly implement pharmaceutical R&D projects, this new structure would have the authority to control the full drug lifecycle, from research to development, production and distribution. It would centralise EU public health R&D in a manner equivalent to other EU structures. It could take inspiration from the United States’ health federal agencies, the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), with their reinforced budgets and scope. It would remain open to collaborations with scientific and public health centres at national and EU levels and with pharmaceutical companies, based on transparent contracts.
A European medicines infrastructure could be developed in one of four models, depending on the level of autonomy – from public/private partnerships to fully public – and R&D capacity – and from a focus on infectious diseases to a wider focus on public health.
The upcoming STOA workshop
On 28 September 2022, the European Parliament will organise a roundtable discussion on the purpose and feasibility of creating a European medicines infrastructure. The event will gather experts from research, industry, civil society governmental and non-governmental organisations to discuss the development models for such a structure.
Ahead of the workshop, participants have shared their views. EU research fragmentation is a main contributor to the issue, advises Karin Sipido of KU Leuven. Rolf Apweiler, from EMBL, highlights the importance of ‘open’ science and accessible data sharing for health crisis response. Rosa Castro, from EPHA, supports EU coordination for areas of low commercial profitability, and includes HERA in such a structure. For Salah Dine Chibout, from Novartis, public and private bodies have complementary roles and should continue to collaborate in clinical trial stages. Global vaccine access and distribution remains unequal, due to private monopoly control, notes Els Torreele,in an appeal for new policies and governance rules.
In conclusion, the industry is a key player in pharmaceutical R&D and innovation. However, overwhelming evidence points to a structural disconnect between public health priorities and private strategies, which lead to market and policy failures that do not benefit the public interest. A European medicines infrastructure could offer a new approach to fixing these issues. The forthcoming workshop will contribute to the ongoing public discussion.
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