By Rhiannon Frowde
On 2nd December 2020, the UK Government announced that it would be the first country in the world to approve the use of the Pfizer/BioNTech COVID-19 vaccine, following regulatory approval by the Medicines and Healthcare products Regulatory Agency. By contrast, the European Medicines Agency has urged caution in moving forward too quickly with the approval process, and will only decide by December 29th whether to provisionally authorise the vaccine.
This blog considers some of the challenges and barriers to effective deployment and use of these vaccines, such as the historically long regulatory approval process, rates of voluntary uptake, the availability of workforce, and potential liability issues should regulatory approval prove premature and precipitous. The focus is on the role of the law in the UK to mitigate these issues.
Background
At the start of December 2020, there were 13 vaccines in the final stages of testing worldwide, with early trials indicating their effectiveness in reducing morbidity and mortality, and growing evidence that they may also reduce transmission, with the potential to create herd immunity, leading to a resumption of “normalcy” [1]. Promising such results, vaccines may be key to alleviating the COVID-19 crisis, and as such, it is pertinent to consider how the law may support their effective deployment and use.
Dr Raine, Chief Executive of the MHRA, stated that the UK’s quicker decision has stemmed from the MHRA teams working in parallel, operating under a ‘rolling review’, analysing data as it comes in. Despite this, she held that “the same stringent standards” had been met and “no corners had been cut”.
What can the law do?
The following are some of the key measures which may be taken, although these are not exhaustive.
Expedite the market approval process
In the UK, medical products, must typically be licensed before they can be marketed, however this is normally a long process which can take many months. Such a delay is intolerable during a pandemic where thousands are dying daily worldwide. Two key measures are available and have been employed in expediting the approval process: licensing directly in the UK, without waiting for EU approval, and granting temporary approval prior to licensing.
Prior to reforms of the Human Medicines Regulations 2012 (the 2012 Regulations) in October 2020, the only body with the power to grant a license was the European Medicines Agency (EMA) which could take up to a year. The Medicines and Healthcare products Regulatory Agency (MHRA) now has the power to grant licenses without waiting for the EMA. It is through these powers that the Pfizer vaccine was approved in the UK.
Contrary to claims made by the Health Secretary, Matt Hancock, that this is “because of Brexit”, the MHRA and EMA currently remain bound together, and the UK is subject to decisions made by the EMA until the end of the transition period from the EU.
The approval process for the vaccine was further expedited under Section 174 of the 2012 Regulations which permits the temporary authorisation of ‘unlicensed’ medicinal products to tackle public health threats, such as the spread of a pathogen.
These powers do not mean steps to ensure safety may be skipped; all vaccines, licensed or not, must meet clinical trial requirements. Rather, they afford temporary authorisation pending the granting of a licence. It is the review of the trial data by the regulatory bodies that has been expedited, confirming that the product meets the necessary efficacy and safety requirements, and that, for most people, the benefits significantly outweigh the disadvantages. For the Pfizer vaccine, this is occurring on a rolling basis as new data becomes available.
Moreover, the reforms introduced safeguards for the use of these powers, including the requirement to review the impact of any authorisation within a year from use, and that temporary authorisations may be subject to conditions (e.g. specifying who the product is suitable for, setting batch testing and quality assurance standards, ensuring appropriate storage is in place). As the basis of the MHRA’s decision remain unknown, it is not yet clear what safeguards are in place for the Pfizer vaccine and whether these are satisfactory.
Should any unforeseen consequences arise, liability will be limited. As the decision to distribute unlicensed products will be made at a nationwide level, Section 345 holds that key actors in the medical supply chain will be immune from civil liability. As such, unless products are defective or do not meet safety standards (as defined by Section 2 of the Consumer Protection Act 1987), only the Government itself will be liable. This encourages vaccines to be made available as early as is safely possible, while still offering some routes of recourse.
It will be important that, in the interests of public confidence, if the government chooses to exercise either of these options, the reasons for regulatory divergence are fully disclosed, especially in its interpretation of safety and efficacy if this differs from the EMA’s. At present, this has not been done.
Promote public confidence
Public confidence in vaccines is a major factor in promoting voluntary uptake. At present there is no legal basis for a compulsory vaccination programme in the UK, and with vaccination rates at a current low, measures to reassure the public and encourage vaccination will be important. A number of regulatory methods may be employed to promote this, including requirements for governmental and manufacturer transparency, promotion of reliable information, and the regulation of disinformation.
Transparency, such as the publishing of clinical trial protocols and governmental trade deals, is important as it allows external scrutiny, building confidence in a process which has experienced waning trust following cases of research fraud and weak methodologies in COVID research spaces. There should be transparency across all aspects, including pricing and agreements of the whole COVID vaccine developments process, which may be enforced through the introduction of novel regulations.
Measures to promote reliable information regarding the vaccine to the public will also be welcome. For example, following the reforms to the 2012 Regulations, a COVID-19 vaccine may be promoted as part of national vaccination or treatment campaigns.
Following from this, the circulation of disinformation has contributed to diminished public confidence. Social media, in particular, has been highlighted for spreading conspiracy theories, such as a belief that the vaccination injects a microchip into the patient. Measures which may be taken include imposing legal requirements upon social media companies to flag unsubstantiated claims as misleading or disputed.
While criminal sanctions and penalties are available in some countries for the spreading of disinformation, imposing these would be a significant threat to principles of free speech and administration of the rule of law.
Increase Workforce Capacity
With 40 million doses of the Pfizer vaccine available, it is important that there is sufficient capacity to support a mass vaccination campaign across the UK. Methods of maximising opportunities for persons to receive each vaccine may include regulatory reform, expanding the range of trained personnel who may administer vaccines. Under these measures it is not yet clear, and will be important to clarify, the scope of protection from civil liability for this additional workforce.
Concluding thoughts
The importance of alleviating the current public health crisis cannot be understated. With the Pfizer vaccine rolling out as early as the 7th December 2020, and a number of other vaccines on the horizon, it is important that the law supports their effective deployment and use. From measures to expedite deployment and to increase opportunities for access through a greater workforce, it will be important to maintain transparency throughout to promote public confidence and consequently voluntary adoption.
[1] M Perkis, G Leung, ‘What can we expect from first-generation COVID-19 vaccines?’ (2020) 396(10261) The Lancet 1467 <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31976-0/fulltext> accessed 30 November 2020.
Rhiannon Frowde recently graduated with an LLM in Medical Law and Ethics from the University of Edinburgh.
