BIA view on UK Government Statutory Instrument for the rollout of COVID-19 and flu vaccines
The UK Government has recently published its formal response to the consultation on changes to the Human Medicine Regulations (HMRs) to support the effective rollout of a COVID-19 vaccine and the upscaling of flu vaccination programme in the UK. This blog post explains the position the BIA took during the expeditated consultation process.
The BIA is supportive of the Government’s general approach given the immediate impact of the pandemic to public health and economic wellbeing of the nation and the need to deal with the biggest threat the UK has faced in peacetime history. Therefore, it is prudent and sensible to be reviewing and strengthening existing regulations to tackle the pandemic. Given the speedy nature of this consultation we were not able to consult as formally within our membership as we would usually do. Our feedback was therefore focused on specific areas of concern or where greater clarity may be required.
Temporary authorisation of the supply of unlicensed medicines, including vaccines
Regulation 174 of the HMRs allows the UK licensing authority to give a temporary authorisation for the supply of an unlicensed medicine in response to a public health emergency. A COVID-19 vaccine would only be authorised in this way if the licensing authority was satisfied that there was sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine. The BIA supports the introduction of regulation 174A which states that conditions may be attached to those temporary authorisations. This enables the licensing authority to define the safeguards that are a pre-requisite for the safe supply and use of the product and without which authorisation would not be valid. The changes also provide for the consequences of breach of those conditions. It is worth noting that government agreed in its response to add a requirement that regulation 174A will be formally reviewed a year after first use to ensure robust scrutiny of the impact of this new regulation. The BIA supports the provision of this review.
There are some additional issues for consideration.
The Medicines and Healthcare Products Regulatory Agency (MHRA), including the National Institute for Biological Standards and Control (NIBSC), must be given the resources they need for evaluating the COVID-19 vaccines, but also the large step up in other regulatory activities that the end of the transition period will bring to them. The Government is making a really significant ask of the Agency in handling both a significant number of new vaccines, and a large amount of novel and duplicative processes and oversight work from January 2021 at the end of the Brexit transition period.
At the end of the Brexit transition period, NIBSC will be a stand-alone National Control Laboratory, carrying out its own independent certification of batches of biological medicines before they are released onto the Great Britain market. It has recently announced that it is one of seven international laboratories that have been selected by CEPI (the Coalition for Epidemic Preparedness Innovations) to create a centralised laboratory network to standardise the measurement of immune responses generated by COVID-19 vaccine candidates.
Capacity needs are particularly pressing for Northern Ireland (and we are mindful that Northern Ireland has a unique and separate legal identity – both in terms of regulation and also in the context of the Northern Ireland protocol of the Withdrawal agreement) given the uncertainty about medicine supply at the end of the transition period. As such it is imperative that the MHRA and EMA can continue their collaboration to successfully deliver emerging vaccines to the population in the UK and EU, and establish enhanced safety monitoring of the new COVID-19 vaccines so that appropriate regulatory action is taken as quickly as possible.
Protection from liability
Government proposed to clarify the scope of immunity from civil liability which regulation 345 of the HMRs puts in place for certain products whose unlicensed use is recommended by the licensing authority in response to certain public health threats, and the consequences on immunity should there be a breach of the conditions for the temporary authorisation. Manufacturers of a recommended product have been given that partial immunity until now, but not pharmaceutical companies placing a product on the market who outsource manufacture of their products. The Department of Health and Social Care considers that the partial immunity should be extended to both pharmaceutical companies that do their own manufacturing and those that don’t. Similarly, partial immunity is already given to registered health care professionals who treat patients with temporarily authorised products, and the DHSC considers that this should be extended to people who are not registered health care professionals but who may be asked to administer COVID-19 or influenza vaccines under the new immunisation protocols that are also created by this statutory instrument. These are steps we support.
With many novel vaccine candidates likely to be delivered in the coming months, the objective state of scientific and technical knowledge, including the most advanced level of such knowledge at the time of rollout of the unlicensed vaccine, is likely to be less for novel vaccines compared to those authorised through the marketing authorisation procedures. As such the rationale for changes or derogation from certain processes should be explained to the public, and kept time limited and under constant review.
The approach on loss of immunity, where conditions are breached, are a key part of this Statutory Instrument. The Government in its response agreed to change the ‘objective bystander’ test from a reasonable person with an interest in placing medicinal products on the market (and so a reasonable pharmaceutical company) to a reasonable person who has ‘relevant expertise in the subject matter of the breach’. Establishing and defining “relevant expertise” in the subject matter of the breach is not straightforward in what are a range of innovative technologies being manufactured, validated, tested, and deployed in exceptionally compressed timeframes during a global pandemic. We understand the need for some definition to be in legislation but if any case were to come before the UK Courts regarding this matter the BIA would seek to provide an amici curia brief on what would be reasonable for an objective bystander with specialist knowledge to have done, at the time it was done, which we hope would be given due weight by the courts. In years to come much more will be known about the novel vaccine technologies being deployed during the pandemic, and expertise levels will grow. The test must reflect what is a reasonable level of expertise known at the time of the decision, not what could be known from future scientific evidence. Hindsight is the only perfect science and of course it is not available on the day any decision is actually made.
Public trust and confidence in new, emerging vaccines
Vaccine regulation is a core component of ensuring confidence from patients, public health experts and other stakeholders. It is vital to strike the appropriate balance between speed to and method of deployment of vaccines and the emerging understanding of a novel disease and how any vaccine works in a broad population. It is acknowledged that the safety data at the time of any temporary authorisation may be limited. The BIA strongly advocates providing citizens with objective, accurate and factual information about the importance of COVID-19 vaccines, explaining the role such vaccines can play in bringing the ongoing pandemic to a close, and the regulatory steps and decisions taken by the MHRA in approving, or not, vaccine candidates.
The UK Government must balance the public health and economic need of responding to this pandemic with the vital long term need for public trust in vaccines to be maintained, being mindful of the particular challenge already of insufficient take-up of key childhood vaccines. Operating in concert and collaboration with globally leading laboratories and international regulatory authorities, proactively communicating to the UK public, whilst maintaining global standards and referencing WHO recommendations where appropriate, provide the UK with the best roadmap to follow at this particularly challenging time.
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 have been laid before Parliament on 16 October, and come into force on the twenty-first day after that date.