Mass Tragedy, Mass Tort: Lessons Learned from the Thalidomide Disaster
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.
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
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); Professor Esther van Zimmeren, (University of Antwerp) were the conference speakers.
I was honoured to present my research on biopharmaceutical 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 firstname.lastname@example.org 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
COMPHACRISIS: the Story of a Grant
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 Conference 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.
Global Health Solidarity, Permacrisis and the Pandemic Treaty
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.