BIICL is undertaking a project to assess the impact of COVID-19 on emergency products in the medical sphere.
This is a topical theme engaging important public health considerations, and involving the analysis of the law and regulation of products such as ventilators, medicines, medical devices, vaccines and related health products.
A Product Liability Forum event was organised on this theme on 4 May 2020. Speakers included Pr. Geraint Howells, Marcus Pilgerstorfer QC, Dr Peter Feldschreiber, Jeff Bucholtz of King & Spalding (Washington DC), Pr. Jean-Sebastian Borghetti, Paris II, John Wilkinson (formerly MHRA) and Pr. Eleonora Rajneri (University of Piementonti Orientale).
Various research outputs have also been generated by this project, including a blog piece by Pr. Duncan Fairgrieve, Pr. Geraint Howells and Marcus Pilgerstorfer QC.
A major paper was published by Pr. Duncan Fairgrieve, Dr Peter Feldschreiber, Pr. Geraint Howells and Marcus Pilgerstorfer QC, "Products in a Pandemic : Liability for Medical Products and the Fight against Covid-19." This paper can be downloaded here. It will be published in the European Journal of Risk Regulation.
Acceptability of a COVID-19 vaccine
Another strand of this work involves a particular focus on the COVID-19 vaccine, with an analysis of the social acceptance, legal and ethical implications of a potential COVID-19 vaccine.
This project examines the issue of the acceptability of emergency vaccines and remedies for adverse reactions by adopting an interdisciplinary methodology, examining the historical, legal, regulatory and economic, and ethical perspectives to this important issue.
This interdisciplinary project brings together three different centres of expertise: legal (BIICL and University of Manchester); ethics (University of Manchester) and social sciences / history of medicine (University of Oxford/Dublin). The core research team is made up of Prof. Duncan Fairgrieve (BIICL), Prof. Geraint Howell s and Prof. Søren Holm (School of Social Sciences, University of Manchester), Dr Samantha Vanderslott (Oxford Vaccine Group and Oxford Martin School, University of Oxford) and Dr Claas Kirchhelle (University College Dublin; Oxford Martin School University of Oxford).
For press reports of this work, see the article by Lionel Laurent in Bloomberg Opinion about the important topic of p ublic trust in CV-19 vaccines. And an article by Francesco Guarascio at Reuters entitled "Britain to cover COVID-19 vaccine side-effects under damages scheme", and published on 4 December 2020 : Britain to cover COVID-19 vaccine side-effects under damages scheme | Reuters.
Briefing paper on bespoke compensatory scheme for possible adverse effects caused by a Covid-19 vaccine
As part of the interdisciplinary project on COVID-19 vaccines, a briefing paper was published on 11 November 2020 arguing in favour of a new UK national compensatory scheme for possible adverse effects caused by a COVID-19 vaccine(s). In the paper, the authors draw upon historical, ethical, and legal perspectives to show that such a bespoke compensation scheme needs to be launched "without delay" and would play a significant role in ensuring the acceptability of COVID-19 vaccines to the general public.
A series of seven principles which they argue should govern the creation of such a scheme, premised on the notion that compensation should be automatically made available where a COVID-19 vaccine has been found to cause harm, without the need for the patient to establish and prove a defect in the product or fault of the manufacturer. The paper can be downloaded here.
Articles on Covid-19 vaccines and compensation
An article on Covid-19 vaccines & compensation and entitled "In favour of a bespoke Covid-19 vaccines compensation scheme" was published in The Lancet on 3 February 2021 co-authored by Prof. Duncan Fairgrieve (BIICL), Prof. Geraint Howells and Prof. Søren Holm (School of Social Sciences, University of Manchester), Dr Samantha Vanderslott (Oxford Vaccine Group and Oxford Martin School, University of Oxford) and Dr Claas Kirchhelle (University College Dublin; Oxford Martin School University of Oxford) To view the article, see here.
This interdisciplinary group of academics also co-signed a Letter to editor of The Times, published on 7 December 2020, about vaccine safety and criticising the UK Government's decision to extend the Vaccine Damage Payments Scheme to Covid-19. It was argued that a bespoke scheme, in line with the recommendations of Cumberlege Review, would have been the better way forward. A copy of this letter can be downloaded here.
The Group also published an open letter with Oxf in The Independent in May 2021 accompanied by article by the Independent Science Editor here.
International Conference on Acceptability of Covid-19 vaccines and no-fault vaccine compensation schemes
An international conference was convened on 6 July 2021 on vaccine compensation schemes bringing together distinguished speakers working on the topic from four continents, and with the co-operation of representatives of WHO / COVAX vaccine programme. The event examined the provision made for the small numbers of those who have suffered adverse reactions after administration of one of the Covid-19 vaccines. The focus was on the compensation schemes established at a national and international level (including the COVAX / GAVI scheme) to provide compensation and support for those affected.
Speakers included Prof. Jean-Sébastien Borghetti, Université Paris II (Panthéon-Assas), Prof. Samuel Dahan, Queens University Canada, Cornell Law School, Prof. Richard Goldberg, Durham Law School, Prof. Sam F. Halabi, University of Missouri and O'Neill Institute for National and Global Health Law, Georgetown University, Prof. Geraint Howells, NUI Galway and University of Manchester, Alex Forrest, Chubb, Dr. Jennifer Keelan, University of Toronto, Prof. Eleonora Rajneri, University of Piementonti Orientale, Prof. Marco Rizzi, University of Western Australia and Prof. Normann Witzleb, The Chinese University of Hong Kong.
Response to Government Consultation on modification of medicine licensing rules to support the rollout of COVID-19 Vaccines
The UK Government is considering making changes to the Human Medicine Regulations in order to grant a temporary authorisation to CV-19 vaccines without going through the full safety process found in the normal medicine licensing rules.
A group of specialists, including Prof. Duncan Fairgrieve, have commented on these proposals in a submission made to the UK Government's Open Consultation.
The submission can be downloaded here.
For further information, please contact Prof. Duncan Fairgrieve.