The enforcement of EU Competition Law in the pharmaceutical sector: before, during, and after a health crisis (learning from the COVID-19 Pandemic)

Project Information

COMPHACRISIS

Grant agreement ID: 101061575

DOI

10.3030/101061575

Project closed

EC signature date 11 July 2022

Start date 1 September 2022

End date 30 September 2024

Funded under

• Marie Skłodowska-Curie Actions (MSCA)

Total cost

No data

EU contribution

€ 215 534,40

Coordinated by

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland

Periodic Reporting for period 1 - COMPHACRISIS (The enforcement of EU Competition Law in the pharmaceutical sector: before, during, and after a health crisis (learning from the COVID-19 Pandemic))

Reporting period: 2022-09-01 to 2024-09-30

Summary of the context and overall objectives of the project

During the COVID-19 pandemic, we faced new, complex questions about how competition laws should operate in a crisis. The urgency to protect public health brought up a tough balance: on the one hand, the need for fair competition in the market, and on the other, the pressing demand for collaboration among pharmaceutical companies to produce effective vaccines (and also the intellectual property dimensions of producing the pandemic-related products which are related to another dimension of the problem: innovation). The COMPHACRISIS project explored how EU competition laws apply to the pharmaceutical industry, especially in light of the COVID-19 pandemic. The main question of the research is: what are the significant differences between normal, crisis and post-crisis EU competition law and policy in the pharmaceutical sector? COMPHACRISIS set out to study the pharmaceutical markets by looking at how EU competition law worked before COVID-19 (before 2008 and 2008-2019), how it adapted during the pandemic years, and what it looked like in the post-pandemic era. Reviewing the evolution of EU competition law enforcement during these three periods, COMPHACRISIS proved that the enforcement toolbox is now diverse. From emphasising the pay-for-delay agreements before the pandemic to new cases on cartels, disparagement practices and evergreening, it seems that competition law enforcement in the post-pandemic world is different from before. The project's outcomes had and will have substantial scientific, policy, and societal impacts. COMPHACRISIS supported the EU's pharmaceutical strategy through publications, presentations, international workshops, direct and indirect contact with policymakers, competition law enforcers and regulators and offered evidence-based recommendations to help competition authorities handle future health crises more effectively. The project looked for ways to improve access to affordable medicines in emergencies, make pharmaceutical markets more transparent and responsible, and boost overall preparedness in the healthcare system for future crises (at the national, EU and international levels).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The COMPHACRISIS project explored the application of EU competition law enforcement in the pharmaceutical sector through seven structured work packages. In the initial planning stage (WP1), the project established a robust online presence, including X (Twitter) (@minacompetition), LinkedIn, Blue Sky and a dedicated project page on www.minahosseini.com/comphacrisis. WP2 focused on the pre-crisis period, offering an in-depth look at EU competition law enforcement in the pharmaceutical sector before COVID-19, examining critical cases and policies. In the Crisis phase (WP3), the MSCA fellow explored competition law enforcement during COVID-19, conducting nine semi-structured interviews with stakeholders, including EU officials, national competition authorities, academics, and industry experts (after obtaining ethical approval from the UCD Ethics Office). A key milestone was the first COMPHACRISIS international and interdisciplinary workshop hosted at UCD in September 2023. The post-crisis analysis (WP4) expanded the scope to cover EU post-pandemic initiatives, including the new EU compulsory licensing proposal, the new EU pharmaceutical reform package, and the implications of the EU AI Act on healthcare. The researcher presented WP 2, WP3 and WP4 findings at seven international conferences, including the University Association for Contemporary European Studies Annual Conference (UACES 2023 & 2024) and the Society of Legal Scholars Annual Conference ( SLS 2023). She also delivered 15 guest lectures at prestigious institutions such as Fordham University, Università di Bologna, Queen's University Belfast and Instituto Brasileiro de Concorrência eInovação. The MSCA fellow published three peer-reviewed articles (in the Journal of Antitrust Enforcement, Competition Policy International, and Irish Studies in International Affairs), four forthcoming book chapters, two upcoming journal articles, and several blog posts. Additionally, the researcher organised four webinars for UCD students, postdocs, and potential applicants for grant writing and MSCA fellowships. In September 2024, she held the second workshop, "Healthcare at the Crossroads," at UCD. Throughout the project, the researcher undertook an extensive training program (WP6) covering advanced research methods, project management (achieving QQI certification with distinction), research integrity and teaching and learning. WP7 handled project management, ensuring efficient administration, documentation, and compliance with reporting requirements (including submitting three reports on career development, data management and communication). Additionally, a special symposium issue in the Journal of Law, Medicine & Ethics, stemming from the project's findings, is forthcoming in 2025. The project's outcomes are widely shared through policy recommendations, publications, the Zenodo COMPHACRISIS community and open-access channels. Social media engagement (3+ posts weekly across platforms) and research data sharing via Zenodo have sustained the project's visibility.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Scientific impact:
The COMPHACRISIS project has made considerable progress in delivering scientific impact and contributing to the state of the art by analysing EU competition law enforcement in the pharmaceutical industry before, during, and after the COVID-19 pandemic. This includes examining landmark cases and policies in the pre-crisis period (up to 2019), crisis period (2020-2021), and post-crisis period. Dr Hosseini has published several articles in prestigious journals, presented her work at numerous international conferences and organised two international workshops at UCD. Notably, a Symposium of papers presented at the first and second international COMPHACRISIS workshops is planned for publication in the Summer of 2025. The COMPHACRISIS project established relationships with other relevant EU-funded projects, including the ERC PatentsInHumans (Maynooth University) and the ERC MISFIRES (UCD Business School) and connected with the interdisciplinary research network (EUHealthGov) in the UK, enhancing its reach and impact. Key innovation output is a qualitative paper based on nine semi-structured papers with a conceptual framework to guide competitive law enforcement during and after health crises.
Economic/societal impact:
The project is also making strides in economic and societal impact by influencing policy responses in the post-COVID environment, enhancing the efficacy of antitrust policies in the pharmaceutical sector by advocating for an access-based, patient-centric framework in competition law enforcement, particularly during public health crises and engaging with academics, industry stakeholders and the general public. The project contributes to education and capacity building in the field through guest lectures, mentoring, and public engagement activities. The fellow tracks several key performance indicators (KPIs) based on the COMPHACRISIS's Communication, Dissemination and Exploitation Plan to monitor and evaluate the project's impact.

COMPHACRISIS at UACES2023 and MISFIRES Event at UCD

COMPHACRISIS Grant writing events at UCD and MSCA Ireland

COMPHACRISIS Presentations at Bologna and Maynooth

COMPHACRISIS Invited talks at QUB and Brazil

COMPHACRISIS International workshops, Sep2023 and Sep2024, UCD, Dublin