COMPHACRISIS: The enforcement of EU Competition Law in the pharmaceutical sector: before, during, and after a health crisis (learning from the COVID-19 pandemic), HORIZON Europe-MSCA project, UCD School of Law, Ireland

 

COMPHACRISIS is carried out in line with the Pharmaceutical Strategy for Europe under the supervision of Professor Imelda Maher at University College Dublin (UCD). 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? Analysing the normal enforcement of competition law, evaluating the crisis enforcement of competition law, exploring the significant consequences of the crisis policies in the post-pandemic law and designing an Effective Health Crisis Competition Law Framework are specific objectives of COMPAHCRISIS. The European Union competition law enforcement and three member states (Germany, Italy, and Ireland) are reviewed in COMPHACRISIS. COMPHACRISIS leads to a new approach to understanding the importance of competition law in the pharmaceutical sector during and after a crisis and influences European policymakers and legislators.

 

COMPHACRISIS in CORDIS: 

https://cordis.europa.eu/project/id/101061575 

 

Paper Published in Journal of Antitrust Enforcement

I'm thrilled to announce that my latest paper, "The Evolution of EU Competition Law and Policy in the Pharmaceutical Sector: Long-lasting Impacts of a Pandemic," has been published in the prestigious Journal of Antitrust Enforcement by Oxford University Press.

You can access the full paper (open-access) here

About the Paper

This publication is a significant outcome of my #COMPHACRISIS project at the University College Dublin UCD Sutherland School of Law. In this work, I investigate the fascinating evolution of EU competition law and policy enforcement within the pharmaceutical sector, focusing on the impact of the COVID-19 crisis.

Key Highlights:

1. Pre-COVID Focus: The paper examines how, before the pandemic, EU competition authorities primarily focused on pay-for-delay agreements between originators and generic pharmaceutical undertakings.
2. COVID-19 as a Turning Point: During the pandemic, the European Commission developed soft laws, including temporary frameworks and comfort letters, to enable cooperation among undertakings for increased access to essential health products and COVID-19 vaccines.
3. Post-Pandemic Shift: The study explores the enduring effects of the pandemic on competition law and policy, extending beyond the immediate crisis period. It highlights initiatives such as the Pharmaceutical Strategy for Europe, the Single Market Emergency Instrument (SMEI), the Health Emergency Response Authority (HERA), the compulsory licensing proposal, and upcoming changes in pharmaceutical regulations.
4. Patient-Centered Approach: My research underscores a notable shift towards a more inclusive and patient-centred EU competition law and policy framework in the pharmaceutical sector.

Implications and Future Research

This publication contributes to the ongoing discourse on the intersection of competition law, public health, IP law and crisis management. The findings have potential implications for policymakers, legal practitioners, and researchers in antitrust law and pharmaceutical regulation.

I hope this research will spark further discussions and investigations into how we can create more resilient and adaptive legal frameworks in the face of global challenges, particularly in critical sectors like pharmaceuticals.

 

Bridging AI, Targeted Therapies, and EU Pharmaceutical Policy: My Experience at the MISFIRES ERC Research Showcase

May 2-3, 2024

UCD Quinn School of Business

 

It was a fantastic experience to share my work on "AI, Targeted Therapies and the Future of EU Pharmaceutical Law and Policy" in the MISFIRES ERC Research Showcase & Exhibition at UCD Quinn School of Business.

During my talk, I discussed the transformative role of AI across the pharmaceutical value chain. From drug discovery to post-market surveillance, AI is revolutionising how we approach medicine. I was particularly enthused to discuss how AI facilitates the development of targeted therapies, potentially leading to more effective and precise treatments tailored to individual patients.

Of course, with great innovation comes great responsibility. Much of my presentation focused on our legal and regulatory challenges as AI increasingly integrates into pharmaceutical research and development. The question that seemed to resonate most with the audience was: "To what extent can the EU's current legal and regulatory frameworks accommodate AI's innovative applications in the pharmaceutical industry?"

This led to a fascinating discussion about recent EU initiatives, including the New Pharmaceutical Strategy for Europe and the proposed EU AI Act. Policymakers are clearly working hard to keep pace with technological advancements, but there's still much work to be done.

The most energising part of the presentation was exploring the future of EU pharmaceutical law and policy. I proposed several avenues for consideration, including a human-rights-based framework for AI in pharma and new approaches to EU competition law in this sector. The Q&A session that followed was particularly engaging. Attendees raised thought-provoking questions about how we might prepare for future health crises in light of these technological advancements.

I look forward to further exploring these complex issues and contributing to developing a more innovative, accessible, and patient-centric pharmaceutical landscape in Europe. You can read the final report of the ERC project MISFIRES  here.

 

Fostering Collaboration: PatentsInHumans report highlights COMPHACRISIS

I’m pleased to note that COMPHACRISIS has been recognised in the ERC project PatentsInHumans's website and the project's first-year report. This underscores the importance of understanding the complex relationships between intellectual property, human rights, and ethical considerations in healthcare and biotechnology.

We’re particularly gratified that Professor Aisling McMahon's (the PI of PatentsInHumans) contribution as an invited speaker at our first COMPHACRISIS workshop at UCD was noted. I’m also honoured to have been invited to speak at the first PatentsInHumans workshop. These collaborative opportunities are invaluable, allowing researchers from similar and multidisciplinary fields to share insights and perspectives. We look forward to continued collaboration and knowledge exchange with the PatentsInHumans team and other researchers in this field as we work to address these complex and vital issues. You can read about the PatentsInHumans project here.

 

Keynote speaker: The MSCA Postdoctoral Fellowships Promotional Event

March 22, 2024

The Irish MSCA National Contact Point

 

I was honoured to be invited as a keynote speaker at the recent MSCA Postdoctoral Fellowships Promotional Event hosted by Dr. Yvonne Halpin, the Irish MSCA  National Contact Point. The virtual event, held on March 22nd, 2024, brought together researchers, organisations, and experts to discuss the upcoming MSCA Postdoctoral Fellowships call for 2024.

The webinar provided an excellent platform to share my experiences and insights as an MSCA Fellow. In my presentation, titled "COMPHACRISIS: My MSCA Fellowship Journey," I highlighted the transformative impact of this fellowship on my career. As a researcher with a background in Competition Law, Health Law, and Pharmaceutical Law, the MSCA fellowship has allowed me to expand my horizons and work on cutting-edge research projects which examine EU competition law enforcement in the pharmaceutical sector in the context of the COVID-19 pandemic.

One of the most valuable aspects of the MSCA Postdoctoral Fellowships, which I emphasized during my talk, is the opportunity for skill development and interdisciplinary collaboration. My journey from lecturing at Tehran University of Science and Culture to conducting research at UCD Sutherland School of Law exemplifies the international mobility and cross-sector exposure that the fellowship offers.

The event also featured insightful presentations from Professor Michel Destrade, an experienced MSCA supervisor from the University of Galway, and Dr. Francesco Paolo Mancini from the MSCA Unit at the EU Research Executive Agency. Their perspectives on supervision and programme management, respectively, provided a comprehensive and enlightening view of the MSCA ecosystem.

As we look forward to the 2024 call, I encourage researchers from all disciplines to consider applying. The MSCA Postdoctoral Fellowships are more than just funding; they're a gateway to a world of opportunities, collaborations, and impactful research. You can see the event’s recording and my slides here.

 

Discussant: Healthcare, Quality Concerns, and Competition Law Webinar

British Association of Comparative Law (BACL)

March 8, 2024

I'm excited to share my thoughts on the recent webinar I enjoyed participating in, hosted by the British Association of Comparative Law (BACL) on Friday, 8 March 2024. The event marked the launch of Dr. Theodosia Stavroulaki's book, "Healthcare, Quality Concerns, and Competition Law" (Hart 2023), and it proved to be an enlightening discussion on the intersection of healthcare and competition law.

The 90-minute webinar explored Dr Stavroulaki's comparative analysis of US, UK, and EU healthcare competition. Dr. Stavroulaki's research highlighted the differences in how competition law is applied to healthcare across different regions. This comparative approach opened up fascinating discussions on best practices and potential areas for policy harmonization. We also discussed each jurisdiction's various regulatory approaches and how these impact healthcare providers, insurers, and patients.

The discussion panel, which included me, Dr Sandra Marco Colino from the Chinese University of Hong Kong, and Dr Stavroulaki, was expertly moderated by Dr Mary Guy from Liverpool John Moores University. Our diverse backgrounds led to an exploration of the book's themes. It was particularly inspiring that this enlightening discussion took place on International Women's Day, featuring a panel of accomplished women in law. The event showcased the depth of expertise women bring to the field of healthcare and competition law and highlighted the importance of diverse perspectives in shaping policy and practice.

Dr. Stavroulaki's book provides a solid foundation for future work, and I'm excited to see how the ideas discussed will shape policy and practice in the coming years. I want to thank BACL for organising this event and to Dr Mary Guy for inviting me. I highly recommend getting a copy of "Healthcare, Quality Concerns, and Competition Law" for those who couldn't attend. It's sure to become a key reference in our field.

 

Guest Lecture: Competition Law Enforcement in the Pharmaceutical Sector

December 6, 2023

Queen's University Belfast

Invited by: Professor Marek Martyniszyn

 

I was honoured to deliver the final guest lecture of the year at Queen's University Belfast, focusing on EU Competition Law in the Pharmaceutical Sector. Professor Marek Martyniszyn from the School of Law graciously invited me.

I was thrilled to share my expertise with LLM students, particularly in light of recent global events. The lecture aimed to provide insight into EU competition law enforcement in the pharmaceutical sector, focusing on the impact and implications of the COVID-19 pandemic.

The session was structured into three main parts:

1. Pre-COVID period: We analysed the main features and trends of EU competition law enforcement in the pharmaceutical sector before 2019. This included discussions on landmark cases such as AstraZeneca, Lundbeck, and Servier. We also explored anti-competitive practices in the industry, including pay-for-delay agreements and abuse of dominance.
2. Crisis period: This section focused on the immediate impact of the COVID-19 pandemic on the pharmaceutical sector and its implications for competition law and policy. We examined the European Commission and national competition authorities' crisis enforcement measures, such as issuing cooperation guidance and comfort letters.
3. Post-crisis period: Looking to the future, we discussed how competition law in the pharmaceutical sector might evolve post-pandemic. This included reviewing main initiatives like the Pharmaceutical Strategy for Europe and the reform of pharmaceutical legislation. I also proposed a novel idea for an ex-ante regulation for the pharmaceutical sector based on the Digital Markets Act (DMA) experience: a Pharmaceutical Markets Act (PMA) that would impose obligations on pharmaceutical gatekeepers during a pandemic.

The student's engagement was exceptional, leading to discussions on real-world applications of competition law principles in this critical sector. Their questions and comments demonstrated a keen interest in understanding how competition law can balance the affordability of medicines with innovation in the pharmaceutical industry. See the guest lecture's outline  here.

 

Guest Lecture: Mass Tragedy, Mass Tort: Lessons Learned from the Thalidomide Disaster

September 30, 2023

University College Dublin (UCD),

 

I recently had the opportunity to lecture on "Mass Tragedy, Mass Tort: Lessons Learned from the Thalidomide Disaster" to UCD's School of Philosophy students.
The Thalidomide disaster in the late 1950s and early 1960s revealed severe inadequacies in medication safety laws around the world. Due to a lack of rigorous pre-clinical and clinical testing, the sedative thalidomide was prescribed to pregnant women and ended up causing severe congenital disabilities in over 10,000 children. The thalidomide disaster emphasised the need for tighter pharmaceutical restrictions. Countries implemented changes like pre-market clinical trials, long-term safety reviews, and centralised drug approval agencies.
In the lecture, I emphasised the difficulties of proving causality in mass torts cases, given the numerous circumstances and plaintiffs. Mass tort litigation systems attract criticism for inefficiency, consistency, liability/damage standards, and delivering corrective justice. I also discussed how the liability insurance sector and firms evolved by forming alliances to handle mass tort risks and expenses jointly.
Exploring this crucial case study that transformed pharmaceutical rules and mass tort litigation worldwide was fascinating, and it was a pleasure to teach again!

 

Public Health, Markets and Law, COMPHACRISIS MSCA Workshop

29 September 2023

UCD Sutherland School of Law

 

On September 29, 2023, COMPHACRISIS at UCD Sutherland School of Law, hosted a one-day workshop on Public Health, Markets and Law . Scholars from various disciplines including law, business, sociology, and public health medicine came together at the workshop to examine the overlaps between their fields as they relate to the health sector.

 Professor Imelda Maher, Sutherland's Full Professor of European Law and the Director of the Dublin European Institute  welcomed the participants and provided an overview of the day’s sessions.

This was followed by a keynote address by Ms Anna Vernet, Head of Unit at the EU Commission’s Directorate General for Competition (DGCOMP), on the role of antitrust enforcement in the pharmaceutical sector from an EU perspective.

The keynote session was chaired by Professor Helen Roche, Interim Vice-President for Research, Impact and Innovation at UCD.

Dr Mary Catherine Lucey chaired the morning session of Competition Law and the Health Sector. The first session featured presentations by Dr Hab. Łukasz Grzejdziak from the University of Strathclyde spoke on state aid for healthcare services and the relationship between market and solidarity. Dr Enrique Sanjuan y Muñoz from the Court of Appeal of Málaga and Dr Carmen de Vivero de Porras from the University of Málaga presented a case study on competition law enforcement in the pharmaceutical sector in Spain. In her paper, Dr Mary Guy from Liverpool John Moores University discussed public hospitals, state aid, and wider learning for competition and health care.

In the afternoon, the second session on ‘Public Health & Markets through a Multidisciplinary Lens’ was chaired by Mr Francis Jacobs, the former head of the European Parliament Liason office in Ireland and the current adjunct senior research fellow at UCD.

The second session included a presentation by Professor Cecily Kelleher from UCD College of Health and Agricultural Sciences on COVID-19 experience. She discussed how having a ‘One Health Approach to Policy and Practice’ could help to prepare for future public health crises. Professor Susi Geiger from UCD School of Business spoke about market failures and temporal frictions in the pharmaceutical industry. Mr Philip J Ryan from UCD SMARTlab presented on inclusive design for healthcare regulation.

The final session on ‘IP Law, Markets and Health’ was chaired by Dr Cliona Kelly, associate professor at UCD School of Law and featured a presentation by Professor Aisling McMahon from Maynooth University on patents, TRIPS and the private governance of public health.

Next, Dr Luke McDonagh from the London School of Economics presented on lessons learned from the Theranos case study, focusing particularly on the intellectual property aspects of the case.

 Ms. Sara Solhchi and Mr. Kian Biglarbeigi from  ATU and SBU universities in Tehran presented on artificial intelligence bias as a health law matter. The workshop concluded with remarks from Dr Mina Hosseini, MSCA postdoctoral fellow from UCD Sutherland School of Law, who summarised the critical discussions and insights from the day.

Through a series of three interdisciplinary panel discussions, the workshop offered thoughtful examinations of the relationship between competition law, intellectual property frameworks, and public health objectives. The discussions illuminated outstanding questions and areas for further study at this important crossroads of multiple fields as they relate to the healthcare industry.

This workshop is organised, funded and facilitated within the framework of the European Union’s Horizon Europe MSCA postdoctoral fellowship COMPHACRISIS under grant agreement No. 101061575.

 

Conference on the 25th Anniversary of the Biotechnology Directive

14-15 September, 2023

Maynooth University

 

On 14 and 15 September 2023, I attended the Conference on the 25th Anniversary of the Biotechnology Directive 98/44/EC: A Reflection on its Past, Present and Future, organised by the UK and Ireland Patent Scholars Network at Maynooth University. It was a fascinating event that brought together academics and practitioners in biotechnology and patent law.

Over two days, we heard from experts on a wide range of topics relating to the implementation and impact of the directive since it first came into effect in 1998. Dr. Mike Adcock (Durham University); Dr. Rob Aerts (Patent Attorney, ADM Germany GmbH, Hamburg); Mihail Dishev (University of Edinburgh); Dr. Mary Dobbs (Maynooth University); Professor Naomi Hawkins (University of Sheffield); Dr. Mina Hosseini (UCD); Dr. Ana Nordberg (Lund University); Dr. Luke McDonagh (London School of Economics); Professor Aisling McMahon (Maynooth University); Dr. Ella O'Sullivan (South East Technological University); Dr. Karen Walsh (Maynooth University); and Professor Esther van Zimmeren (University of Antwerp) were the conference speakers.

I was honoured to present my research on bio-pharmaceutical product hopping and cases of alleged excessive pricing. Using Humira as an example, my paper explored strategies drug makers have employed to extend patent protection and delay generic competition perpetually. The discussion after my talk provided helpful feedback to develop this work further.

I thank organisers Professor Aisling McMahon, Professor Naomi Hawkins and Dr Karen Walsh for organising such an informative program. I'm also grateful to Professor Esther van Zimmeren for her thoughtful comments on my presentation.

 

Public Health, Markets and Law Workshop Agenda

 

COMPHACRISIS is pleased to announce an upcoming full-day workshop, "Public Health, Markets and Law," to be held on Friday, September 29, 2023, at the UCD Sutherland School of Law in Dublin.

The workshop will feature a keynote address by the EU Commission-Directorate General for Competition, Head of Unit-Antitrust, Pharma and Health Services and three sessions throughout the day on topics such as competition law in the health sector, multidisciplinary perspectives on public health and markets, and IP law and healthcare markets. Each session will include three expert speakers presenting their papers, followed by Q&A discussions.

To attend this free and in-person workshop, registration is mandatory. Kindly send an email to comphacrisis@ucd.ie to complete your registration. We are thrilled to foster a dynamic, cross-disciplinary dialogue on the vital interplay between public health, markets, and law.

 

See the agenda here:  Public Health, Markets and Law Workshop Agenda | Zenodo

 

Global Health Solidarity, Permacrisis and the Pandemic Treaty

 May 2, 2023

Royal Irish Academy

I presented my paper at the Royal Irish Academy Conference (Human (In) Security in an Unsettled World) on 2 May 2023. In my presentation, I highlighted the shortcomings of global health solidarity during the COVID-19 pandemic, such as inequities in the distribution of vaccines, diagnostics and treatment, vaccine hoarding, excessive pricing of pandemic-related products, IP rights of vaccines, and the lack of effectiveness of COVAX and ACT-A Accelerator.
The World Health Organization (WHO) member states are currently negotiating a zero draft of the Pandemic Treaty, which aims to promote prevention, preparedness, and response to pandemics in a sustainable and equitably distributed manner. The Zero Draft includes provisions for access to technology, promoting sustainable and equitably distributed production, and transferring technology and know-how. It emphasises the need for equitable access to pandemic-related products and working to increase manufacturing capacity and promote technology transfer to capable manufacturers, particularly in developing countries.
Other provisions in the Zero Draft include regulatory strengthening, a WHO pathogen access and benefit-sharing system, strengthening and sustaining preparedness and health systems' resilience, protection of human rights, strengthening pandemic and public health literacy, and a One Health approach.
The Zero Draft also mentions the challenging debate of common but differentiated responsibilities and capabilities in pandemic prevention, preparedness, and response. States with more resources relevant to pandemics should bear a commensurate degree of differentiated responsibility concerning a global pandemic. Additionally, manufacturers who receive public funding for producing pandemic-related products must disclose prices and contractual terms for public procurement during a pandemic.
I also discussed potential challenges in implementing the Pandemic Treaty, such as resembling non-binding documents if it uses vocabulary that merely encourages or suggests that parties take specific actions rather than mandating them.
It was an honour to share my thoughts with a distinguished audience. It was great to share a panel with my co-panellists, Professor John Morrissey and Dr Barry Guihan, with the excellent chairing of Dr Claire Dorrity. You can find the slides of my presentation here. 

 

COMPHACRISIS: The Story of A Grant

Work Smarter Together Event

21 April 2023

UCD Agile

The Marie Skłodowska-Curie Actions (MSCA) postdoctoral fellowship is widely considered one of the most prestigious research fellowships in the world. This highly competitive program promotes mobility, career development, and knowledge transfer among researchers across Europe and beyond. I have been fortunate to receive this fellowship for doing my project COMPHACRISIS under the supervision of Professor Imelda Maher at UCD Sutherland School of Law. Recently, I had the opportunity to give a presentation entitled: COMPHACRISIS: The Story of a Grant at Work Smarter Together event organised by UCD Agile at University College Dublin, where I shared some insights into developing ideas, drafting excellence, impact and implementation sections, identifying weaknesses, and submitting a successful grant application. I also had the opportunity to share my journey, including my experience studying and working in Iran and how Marie Curie has been a source of inspiration and a role model for me since childhood. I deeply admire her success in a male-dominated field; having her name as my affiliation is an absolute honour. I invite fellow researchers and supervisors to download the slides from my presentation at the following link [https://lnkd.in/eC-DyJmw].

I hope these slides will be a helpful resource and provide valuable guidance to those considering applying for the MSCA fellowship.

 

COMPHACRISIS Kick-Off Seminar

30 November 2022

UCD Sutherland School of Law

I presented my first working paper titled "Past, Present, and Future of EU Competition Law Enforcement in the Pharmaceutical Sector: Learning From a Pandemic" at the University College Dublin (UCD) Sutherland School of Law Seminar Series on November 30, 2022. This presentation served as the official launch of my project at law schools, with many professors, postdocs, and PhD students in attendance. The law school's seminar series, held every Wednesday at 1 pm, allowed me to present my paper and receive colleague feedback. The presentation focused on the significant differences between normal, crisis, and post-crisis EU competition law and policy in the pharmaceutical sector.

I discussed landmark pre-pandemic anti-competitive practices and cases, including pay-for-delay agreements, abuse of dominance (such as abusing the patent system and manipulating the pharmaceutical regulatory system), excessive pricing, product hopping, disparagement practices, and anti-competitive aspects of off-label drug use.

During the COVID-19 pandemic, pharmaceutical manufacturers and other companies in the health sector were encouraged to collaborate in the manufacture and distribution of pandemic products and equipment due to the necessity of these efforts for citizens' welfare. European competition authorities and policymakers changed the normal enforcement of competition law during the pandemic, using tools such as comfort letters and temporary frameworks.

Looking to the future, I discussed how competition law in the pharmaceutical sector might change in the post-crisis era. Data-sharing, collaboration between competitors, IP rights of vaccines, anti-competitive practices, and accountability of pharmaceutical undertakings (especially pandemic champions) are essential concerns in this period. Initiatives like the Pharmaceutical Strategy for Europe, Single Market Emergency Instrument, WHO Pandemic Treaty, and Berlin Declaration - Bio-Pharmaceutical Industry Vision for Equitable Access in Pandemics might affect the future of competition law in the pharmaceutical sector. It was a successful presentation, and I received constructive comments from the attendees.