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”.
 

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.