COVID-19 EXPERT LEGAL INSIGHTS

Regulation and Uptake of the COVID-19 Vaccine

4 December 2020

The government has now approved the supply of the Pfizer-BioNTech COVID-19 vaccine. The reason they have been able to do this so quickly is because they have taken advantage of the temporary authorisation regime laid out by the Human Medicine Regulations of 2012 and 2020. The 2012 Regulations were updated in 2020 specifically to facilitate the smooth rollout of the COVID-19 vaccine. In the public consultation preceding the introduction of these updated regulations, several respondents raised concerns regarding unlicensed vaccines and immunity from civil liability. In practice, very little is known about these regulations and their application. This article seeks to shed some light on the temporary authorisation regime and suggest a means of alleviating concerns in the context of “vaccine hesitancy”.
 

The Human Medicines Regulations 2012 and 2020

The Human Medicines Regulations 2012 (“2012 Regulations”) were implemented to consolidate the law pertaining to the authorisation and production of medical products under the EU Directive 2010/84/E. This year, the government reviewed the regulations and proposed amendments in anticipation of the mass rollout of COVID-19 vaccines.

The Department of Health & Social Care held a virtual public consultation on the proposed changes to the 2012 Regulations from 28 August to 18 September 2020. The public consultation elicited an unusually high number of responses, 191,740 completed questionnaires[1], which demonstrates the deep anxiety surrounding the issue and the importance of the government handling it with care. A number of consistent themes emerged, including concerns over the safety of ‘unlicensed vaccines’ and the ‘proposed extension of immunity from civil liability’. The Human Medicines Regulations 2020 (“2020 Regulations”) came into force on 16 October 2020.

Regulation 174

Regulation 174 of the 2012 Regulations[2] enables the temporary authorisation of unlicensed medicines (including vaccines) in response to a public health emergency.[3] This is the regulation that is being used by the government to authorise the Pfizer-BioNTech vaccines[4]. With the 2020 Regulations, the government has amended Regulation 174 by inserting Regulation 174A, which provides for the appropriate licensing authority to attach certain conditions to any authorisation.

While it is not entirely clear what these conditions would be, the government has stated that: “one of the conditions that could be applied to an authorisation could be a specific time limit. We expect an authorisation using regulation 174 to be short term, kept under review and to automatically cease when the product is granted a full licence.”[5] Therefore, with this new addition, it is clear that the government has anticipated the concerns about the authorisation of unlicensed vaccines for any prolonged period.

Regulation 174A also requires the Secretary of State to conduct a review after a year. Such a review must consider any adverse implications that the regulation may have had on the medicine market or patient safety. The Secretary of State must then publish a report outlining its findings.

Regulation 345

Regulation 345 of the 2012 Regulations provides immunity from civil liability for any loss or damage resulting from the use of unlicensed products. This regulation provides immunity from civil liability for:

  1. any holder of an authorisation for the product;
  2. any manufacturer of the product;
  3. any officer, servant, employee or agent of a person within paragraph (a) or (b); or
  4. any healthcare professional.

With the 2020 Regulations, the Government has extended immunity to include distributors of the vaccine and those who administer the vaccine but are not healthcare professionals. At the same time, the 2020 Regulations make provision for the removal of immunity where there has been a “significantly serious breach” of a condition attached to the authorisation process. However, what constitutes a “significantly serious breach” is not made explicit and its interpretation would ultimately be a decision for the courts.

Vaccine Hesitancy and a Compensation Programme

The World Health Organisation has identified an increase in “vaccine hesitancy”: the reluctance or refusal to vaccinate despite the availability of vaccines[6]. This has concerning implications generally, but particularly in the context of the current pandemic.

In order to address vaccine hesitancy, one option available to the government, which has not yet been taken advantage of, is extending the existing Vaccine Damage Payment programme to cover any potential issues arising from COVID-19 vaccines. The Vaccine Damage Payments Act 1979 was introduced in response to claims by parents that their children were disabled as a result of vaccines recommended by the Government at the time.[7] The Act is still used today as a way to provide compensation in the form of a one-off tax-free payment.

Currently, the Vaccine Damage Payments Act 1979 covers many vaccinations including mumps, measles and rubella, and in 2009 was extended to include the H1N1 virus (swine flu). In order to extend the list to include COVID-19, the Secretary of State would need to issue a new statutory instrument to that effect.

The potential for negative health effects may be minimal. However, the extension of the scheme could increase public confidence in the government and the vaccinations themselves[8]. Trust plays an essential role in vaccine uptake and thereby pre-emptive action by the government could have considerable benefits in the long run.

Another option that appears to have been discounted is making COVID-19 vaccines compulsory, with an opt-out being available if you have a “reasonable excuse”. This would clearly be complicated to legislate and regulate. It also raises a number of potential issues under the Human Rights Act 1998 and Article 8 of the European Convention on Human Rights. Nonetheless, given the public emergency we are in, it is an option that merits consideration.

Conclusion

As the new COVID-19 vaccines have been granted temporary authorisation under Regulation 174 of the Human Medicine Regulations 2012, questions have emerged around how the government proposes to ensure the safety of the vaccines and their distribution. The Human Medicines Regulations 2012 and 2020 offer protection both to those in the supply chain of vaccines and those who are involved in the distribution. Furthermore, the new review function offers assurances that the functioning of the regulations will be monitored and reported on within a year of use. Nonetheless, a unified compensation scheme may help foster trust between the government and the public at a vital time to encourage vaccine uptake.


[7] Gareth Millward, A Disability Act? The Vaccine Damage Payments Act 1979 and the British Government’s Response to the Pertussis Vaccine Scare, Social History of Medicine, Volume 30, Issue 2, May 2017, Pages 429–447, https://doi.org/10.1093/shm/hkv140

[8] https://www.law.ox.ac.uk/sites/files/oxlaw/vaccine_compensation_arrangements_.pdf

Further Information

Should you have any questions about the issues covered in this blog, please contact a member of our Public Law team.

 

About the Authors

Stephen Parkinson is Kingsley Napley's Senior Partner. Stephen is a highly experienced and versatile litigator with extensive experience in advising companies, organisations, and individuals caught up in criminal and regulatory investigations or public inquiries. His previous client list has included numerous individuals at the top of their fields, whether in business or politics.

Agatha Barta is a Paralegal in Kingsley Napley's Public Law team.

 

 

Latest blogs & news

Mandatory Covid-19 Vaccinations for Care Home Workers

This week, the Government announced that Covid-19 vaccinations will be made compulsory for care home staff, raising strong emotions on both sides of the argument.

Coaching, Teaching and Support Work in Lockdown: Safeguarding and Data Protection considerations when working with children online

The COVID-19 crisis has forced sports clubs, schools, universities and charities to rapidly change their approaches to coaching, teaching and support work. The regulations on social distancing have forced organisations to innovate; services which had previously been offered mostly or wholly in person were rapidly shifted online during “lockdown 1” and will return online at least for the duration of “lockdown 3”.  If the vaccine rollout has the desired effect there will no doubt be some return to “traditional” methods, but it seems very unlikely that the changes brought about by the pandemic will be completely reversed.  In this blog, Claire Parry from Kingsley Napley’s Regulatory team and Fred Allen from the Public Law team look at the challenges organisations face engaging with children online.

Regulation and Uptake of the COVID-19 Vaccine

The government has now approved the supply of the Pfizer-BioNTech COVID-19 vaccine. The reason they have been able to do this so quickly is because they have taken advantage of the temporary authorisation regime laid out by the Human Medicine Regulations of 2012 and 2020. The 2012 Regulations were updated in 2020 specifically to facilitate the smooth rollout of the COVID-19 vaccine. In the public consultation preceding the introduction of these updated regulations, several respondents raised concerns regarding unlicensed vaccines and immunity from civil liability. In practice, very little is known about these regulations and their application. This article seeks to shed some light on the temporary authorisation regime and suggest a means of alleviating concerns in the context of “vaccine hesitancy”.

Parliamentary scrutiny in the time of Coronavirus

As a new nationwide lockdown comes into effect, Stephen Parkinson and Charlie Roe from our Public Law team, consider the often limited role of Parliament in scrutinising restrictive regulations throughout the COVID-19 pandemic.

The inquest process during COVID-19 restrictions

Inquest proceedings, like other legal proceedings in the UK, have been significantly affected by social distancing restrictions and advice arising from the COVID-19 crisis. This blog looks briefly at the impact of the Coronavirus Act 2020 on proceedings, and examines the Chief Coroner’s guidance notes to coroners working during the crisis.

The future public inquiry into COVID-19

The devastation wrought by COVID-19 has led to profound questions about the UK government’s response to the pandemic. Calls for a public inquiry are continuing to mount and are likely to prove difficult to resist. This blog considers the framework for such inquiries, and the key issues likely to form the core of its terms of reference.

COVID-19 and contact tracing apps: A test of public confidence in data privacy?

Dominic Raab announced last week that the current UK lockdown would last for at least another three weeks. These restrictions are unlikely to be relaxed until a large scale plan is in place to track and restrict the spread of the virus. Part of this plan will involve the use of the NHS “contact tracing” app, which we have been told is in an advanced stage of development.

COVID-19 related insights:

COVID-19 related insights:

Our COVID-19 statement

We recognise that these unique times are presenting unprecedented challenges for our clients and we are here to support you in any way we can.

Click to view

Can you get out of or suspend a contract because of Coronavirus?

Alex Torpey covers the key things to look out for if you are relying on the Force Majeure clause.

Watch the video on LinkedIn

Overcoming the challenges of co-parenting for separated and divorced parents

Rachel Freeman, Partner in our Family Law team, addresses some issues that we are seeing arise for separated parents in the current crisis.

Read the blog

Tech in Two Minutes - Episode 7 - The Coronavirus challenge for tech coworking spaces

Andrew Solomon speaks about the challenge for tech companies and coworking spaces during the current COVID-19 pandemic.

Listen to the podcast

The legal basis for lockdown

Alun Milford, Partner in our Criminal Litigation team, provides an in-depth look at the legal basis behind the current lockdown.

Read the blog

Managing your Migrant workforce in the COVID-19 crisis

On Friday 3 April, immigration partner and head of department, Nick Rollason, hosted a webinar looking at urgent issues employers are facing during the COVID-19 crisis and answered some of the key questions being raised.

Watch the webinar recording

Furlough leave and the Coronavirus Job Retention Scheme: key legal considerations for Employers

On Thursday 9 April, Andreas White, Partner in our Employment Law Team, delivered an overview of the scheme with a focus of the key legal issues for UK employers.

Watch the webinar recording

Coronavirus and the perils of signing your Will

Will instructions have apparently risen by 30% since COVID-19 reached our shores. What effect does COVID-19 have on Will signings? James Ward and Diva Shah in our Private Client team blog.

Read the blog

The juggling act of a single mother, home school teacher and head of a family team

Charlotte Bradley, Head of our Family Law Team, reflects on how the COVID-19 crisis has affected working parents like her.

Read the blog

The future public inquiry into COVID-19

Calls for a public inquiry are continuing to mount and are likely to prove difficult to resist. In this blog, Sophie Kemp considers the framework for such inquiries, and the key issues likely to form the core of its terms of reference.

Read the blog

Share insightLinkedIn Twitter Facebook Email to a friend Print

Email this page to a friend

We welcome views and opinions about the issues raised in this blog. Should you require specific advice in relation to personal circumstances, please use the form on the contact page.

Leave a comment

You may also be interested in:

Skip to content Home About Us Insights Services Contact Accessibility