Consultation outcome

Government response: consultation on changes to the Human Medicines Regulations to support the rollout of COVID-19 and flu vaccines

Updated 5 August 2021

1. Introduction

The government hosted a public consultation from 28 August to 18 September on changes to the Human Medicines Regulations to support the rollout of COVID-19 vaccines. This is the formal government response to that consultation.

The amendments consulted on will:

1. strengthen existing regulations that allow for the temporary licencing of medicines and vaccines, on an exceptional basis, pending the grant of a full licence
2. extend the current immunity from civil liability to companies producing the vaccine, rather than just healthcare workers and manufacturers. This will protect them from legal liability in civil cases but does not give them blanket immunity from civil liability
3. allow a wider range of trained personnel to administer COVID-19 or flu vaccines
4. ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a COVID-19 vaccine, can be promoted as part of national vaccination or treatment campaigns
5. make short-term provisions to facilitate the swift and safe transfer of COVID-19 and flu vaccines under NHS or armed services' authorised arrangements by providing an exemption from the need for a wholesale dealer's licence

In total, there were 191,740 completed consultation responses received. The government welcomes the participation of all individuals and organisations who contributed to the consultation. We received responses from a range of people including individual members of the public, NHS and health service delivery bodies, organisations representing health care professionals, pharmaceutical companies and patient groups.

We have analysed the responses and noted specific questions on these proposals. This response will seek to address the main points raised in these responses and more detailed guidance will be available in due course, which will further addresses some of the more detailed points raised.

Summary of changes

The Department of Health and Social Care (DHSC) has analysed the responses and considered the feedback received.

As a result of the responses received, DHSC will be making 3 key changes to the proposals set out in the original consultation document. These changes will:

1. Ensure robust scrutiny of the impact of regulation 174A takes place by making it a requirement that the impact of this regulation will be formally reviewed after a year of any first use. (Regulation 174A permits the attaching of conditions to the temporary authorisation of an unlicensed medicine or vaccine under regulation 174.)

2. Promote objectivity by changing the 'objective bystander' test that relates to loss of immunity from civil liability where conditions are breached to make this a person who has 'relevant expertise in the subject matter of the breach', in place of the original reference to pharmaceutical companies.
3. Create an additional level of reassurance in relation to the expanded workforce by making it clear that the new national protocol should include, where appropriate, the requirements for the supervision of an additional experienced vaccinator.

Aside from these changes, and some drafting improvements reflecting comments received, the government is proceeding with the changes to the Human Medicines Regulations (HMRs) proposed in our consultation. We will be laying legislation which brings these into force soon.

Analysis

All responses were analysed using a topic modelling and tagging system. This involves identifying the emerging topics in the responses and labelling them in the topic groups identified. This identified key themes in the responses across each of the 5 proposals as well as generating summaries which showed the key sentiments and views expressed within each of the main themes.

Where respondents made specific suggestions relating to the legislation itself, these were identified and read in detail. Any key questions were identified and noted for the response.

Breakdown of respondents

A total of 191,740 responses were received. There were 188,040 completed responses to the consultation received through the GOV.UK page.

• 99% of responses were from individuals. 1% were on behalf of organisations
• of those who responded on behalf of organisations, these were split into private sector (27%), charity/third sector (13%), NHS or health service delivery (12%), other public sector (9%), social care (8%). Other categories made up the remaining 31%
• 13% of respondents stated that they work for the NHS
• 29% of respondents stated that they were responding as a health care professional

In addition, there were 3,700 responses received via email.

Clarity on proposals

Several respondents expressed concerns that the proposals outlined in the consultation document would make vaccines mandatory or push through an untested vaccine. We note the views raised by these respondents, but wish to emphasise that the proposals we consulted on:

• do not create powers to make receiving a COVID-19 vaccine mandatory for the UK population
• do not create powers to rush through development of a vaccine. Any vaccine authorised for use will have been through extensive clinical trials and a thorough assessment of the evidence on safety, efficacy and quality
• do not create powers to rollout an untested vaccine for the UK population

As these issues raised are not proposed within the measures outlined in this consultation, we do not intend to respond further to these points in this document.

2. Attaching conditions to a temporarily authorised vaccine

The existing Human Medicines Regulations contain a provision (regulation 174) that enables the temporarily authorisation of the supply of an unlicensed medicine (including vaccines) in response to a public health emergency.

Many respondents to the consultation expressed concern about this existing provision, rather than the proposal we consulted on, which is to clarify that conditions can be attached.

We wish to emphasise that these conditions ensure product safety, quality and efficacy, and could range from specifying exactly whom the product is suitable for (eligibility criteria, both who can and who can't receive the product), setting standards, and ensuring appropriate storage is in place throughout the supply chain. Ensuring safety will be the central aim in applying any conditions to the authorisation.

Several respondents emphasised that a temporary authorisation of an unlicensed vaccine should only be used in exceptional circumstances where a licensed alternative is not available. A smaller number of respondents said that only licensed products should be used.

The government's preferred route to enable deployment of a COVID-19 vaccine remains through the usual licensing routes available. A decision to temporarily authorise the sale or supply of an unlicensed vaccine or medicine will be rare and only in exceptional circumstances at the request of the Secretary of State (SoS) for Health and Social Care. A product will only be supplied once the SoS, in taking the advice of the independent regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), is satisfied there is robust evidence to demonstrate safety, quality and efficacy. This decision would be made public. Anyone receiving the vaccine would be provided with specific information relating to the product.

Many of the responses to the consultation raised issues around safety, risks, possible side effects and harm as a result of receiving a temporarily authorised unlicensed vaccine. Several respondents said that full testing was needed. The need for a full review was emphasised to ensure safety of this proposal.

We want to emphasise that safety is central to the development of any COVID-19 vaccines, and that unlicensed does not mean untested. All vaccines must undergo robust clinical trials in line with international standards, with oversight provided by the MHRA. No vaccine will be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.

Change 1: based on consultation feedback, additional changes have been made to the Human Medicines Regulations amendments (HMRs) to require a public review to be done as soon as practicable after a year of the first use of regulation 174A to evaluate the whole process.

There were also concerns raised that the process for temporary authorisation meant fast-tracking a vaccine and therefore by-passing necessary processes to uphold safety standards. There was some concern that methods for shorter and smaller clinical trials needs consultation and review.

COVID-19 vaccines are being developed in a strategic and co-ordinated way that allows some stages of the process to happen in parallel to condense the time needed, but it does not mean steps and the expected standards of safety, quality and efficacy have been bypassed.

Some respondents sought clarification about how long a temporary authorisation of an unlicensed vaccine would last. The existing regulation makes clear than any authorisation under regulation 174 must be temporary. 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.

Some respondents emphasised the importance of careful and neutral communications on a temporarily authorised vaccine, to ensure the public receive accurate information. DHSC, in collaboration with NHS England and Improvement (NHSE-I) and Public Health England (PHE) are currently developing plans to ensure the public in England receive high quality information from trusted sources on any COVID-19 vaccine when it is deployed.

3. Extending immunity from civil liability

Our proposals clarify the scope of immunity from civil liability, so that it clearly applies not only to manufacturers and healthcare professionals but also to the company placing an unlicensed medicine such as a vaccine on the market with the approval of the licensing authority. The proposals also clarify the consequences of immunity, should there be a breach of the conditions imposed by the licensing authority.

Many respondents expressed concerns about the accountability of pharmaceutical companies under the new proposals. Some said that any company or organisation that is shown to have been negligent regarding safety and testing should be held accountable.

The extended immunity to the pharmaceutical company will be forfeited following any sufficiently serious breaches of the conditions set by the government.

EU and UK law currently recognises it is unreasonable to ask manufacturers and healthcare professionals to take on the liability for specific consequences of a government's decision to authorise the supply of an unlicensed product if that's in adherence with the government's conditions.

These changes are designed to provide equal treatment to the key partners in the supply chain and to ensure safety and adherence with the government's authorisation conditions.

A number of respondents said that having a pharmaceutical company as the objective bystander was inappropriate. Some suggested this should be someone with specialist knowledge instead.

Change 2: based on the feedback received, we are changing the 'objective bystander' test that relates to loss of immunity from civil liability where conditions are breached to make this a person who has 'relevant expertise in the subject matter of the breach', in place of the original reference to pharmaceutical companies.

Any decision to roll out mass vaccination programmes for temporarily authorised COVID-19 vaccines, or any pandemic disease treatments, will be taken nationally, not by the individual companies manufacturing or marketing the product.

A number of respondents expressed that they were broadly supportive of the proposals, but that it is vital that individual health care professional supplying and administering the vaccination are also protected under the specified circumstances.

The limited immunity from suit provided by regulation 345, which we proposed to extend to pharmaceutical companies, already applies to health care professionals.

Some respondents said they were concerned that the proposals created a lack of incentive to uphold safety standards. Safety procedures for vaccines are now more rigorous than ever. Any vaccine must first go through the usual robust testing and development process and be shown to meet the expected high standards of safety, quality and efficacy before it can be deployed.

Some respondents expressed concern about the individual's rights if they are harmed by a vaccine.

The government will look to ensure that, should an individual be harmed by a COVID-19 vaccine, they would receive the support they need.

4. Expansion of the workforce

We proposed to expand the workforce eligible to administer vaccines, to ensure that the UK has the available workforce to administer COVID-19 vaccines and influenza vaccines. We proposed doing this by:

a. Expanding the scope of Patient Group Directions (PGDs) to allow the administration of any medicine, including COVID-19 vaccines, which have been temporarily authorised using regulation 174. PGDs allow some registered health professionals to supply and/or administer specified medicines to a pre-defined group of patients, without them having to see a prescriber.

b. Introducing a new national protocol, which will allow those who are registered health care professionals who do not normally vaccinate, and people who are not registered health care professionals, to safely administer a COVID-19 or influenza vaccine.

c. Expand the workforce legally allowed to administer vaccines under NHS and local authority occupational health schemes, so that additional healthcare professionals in the occupational health workforce will be able to administer vaccines.

Respondents who stated that they were NHS and health service delivery professionals were broadly supportive of these proposals.

Some respondents suggested that a national protocol should define what levels of professional supervision should be in place to support a person undertaking vaccination.

Change 3: based on this feedback, we are making additional changes to these proposals to create an additional level of reassurance in relation to the expanded workforce by making it clear that the new national protocol should include, where appropriate, requirements for the supervision of an additional experienced vaccinator.

Several respondents emphasised the importance of comprehensive training for personnel administering vaccines.

A comprehensive training package is being put together by NHS England and NHS Improvement (NHSE-I), with professional groups and Public Health England (PHE). New vaccinators will have to undergo both a comprehensive training programme and competency assessment to ensure they can safely administer vaccines to patients under the clinical supervision of an experienced health care professional. This training will include how to deal with possible adverse reactions to a vaccine.

Other respondents made it clear that informed consent needed to be sought from those receiving a vaccine.

Vaccinators will be required to obtain informed consent from patients, as is standard practice. This will include explaining the possible risks involved in having the vaccination. If this relates to an unlicensed vaccine, vaccinators will also inform the patient of any implications of this.

A smaller number stated that only registered health care professionals should be allowed to administer the vaccine.

An expanded workforce is required to ensure that the COVID-19 vaccine can be safely deployed widely as soon as it should become available, given the capacity constraints of the current workforce that can administer vaccines. There is a possibility that both the flu vaccine and the COVID-19 vaccine programmes will be delivered at the same time, and we need to make sure that in this scenario there is sufficient workforce to allow for this. All new vaccinators will have to undergo a comprehensive training programme and competency assessment.

A number of respondents asked for clarity on who exactly would be involved in the expanded workforce. Several organisations expressed enthusiasm for the proposals and offered their services in being part of an expanded workforce to support the rollout of COVID-19 vaccines. We sincerely thank those organisations for their offer of support on a hugely important programme.

Decisions of detail regarding deployment will be taken in most cases by the NHS in each of the 4 nations of the UK, as they decide the best way to roll out any COVID-19 vaccination programme in each nation. For example, one UK nation might want to train student nurses and doctors to administer COVID-19 vaccines or flu vaccines whereas another UK nation may not choose that route. The proposals allow each administration a clear and supportive legal framework to select their preferred deployment option.

The creation of a new national protocol will set out who can operate under it, the training and competency requirements of any vaccinator, and any clinical considerations that must be followed. Decisions on who exactly would be included under a new national protocol have not yet been taken, but we are in the process of confirming procedures for deciding this with relevant bodies, such as PHE and NHSE-I.

Clarity was requested on whether the introduction of a new national protocol would preclude the use of a Patient Specific Direction (PSD) where necessary. PSDs are signed by a prescriber for medicines to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis. The new national immunisation protocols will not prevent vaccinators relying on other, familiar lawful ways to vaccinate such as PSDs.

Some respondents requested clarity over whether Patient Group Directions (PGDs) will be able to be extended to workforces operating outside the health sector directly.

The proposed changes to the HMRs in relation to PGDs are very limited and are specifically to make it possible for professionals who already use these to be able to use them for temporarily authorised products. We are not extending the workforce that can administer under PGDs.

5. Promotion

We proposed to make amendments to ensure that vaccines and treatments used in response to a public health emergency, such as the COVID-19 pandemic, could be promoted as part of national vaccination or treatment campaigns.

Some respondents expressed concerns about individual pharmaceutical companies advertising these products to the public. This included comments on advertising bias, and the generation of profit from promoting the vaccines which many stated would be unethical.

These proposals are not designed to facilitate promotion by individual pharmaceutical companies. Rather, they are designed to facilitate government-backed public or healthcare professional information campaigns relating to the use of these medicines.

The campaigns have a critical public health role and are not intended to promote or 'sell' the vaccine, which will be free at point of care. The promotion of unlicensed medicines will remain prohibited, unless it is in accordance with the safeguards proposed in this consultation. Pharmaceutical company materials must be approved in advance by ministers. They would only permit a medicine supplier to participate in public or healthcare professional campaigns relating to the use of a given product. They would not allow the supplier to promote a product independently unless the limitations required for any medicinal product are adhered to. If the campaigns relate to Scotland or Wales, a clarificatory amendment has been made to make it clear that the Scottish and Welsh governments will be consulted before approval is given. Northern Ireland is already a joint signatory to the legislation.

Some respondents stated that promotion should be balanced and informed, put forward the benefits and risks, and address vaccine myths.

DHSC, in collaboration with NHS England and Improvement (NHSE-I) and Public Health England (PHE) are currently developing plans to ensure the public in England receive high quality information from trusted sources on any COVID-19 vaccine when it is deployed.

Some respondents emphasised that any promotion or advertising by suppliers should fall within the principles set out in the Association of the British Pharmaceutical Industry (ABPI) code of practice for the Pharmaceutical Industry, 2019. These proposals do not change the important role of self-regulation in the control of medicines advertising.

There was some confusion as to whether the proposals related to advertising to qualified prescribers or to the general public. To clarify, these proposals relate to both advertising to the public and materials targeted at health care professionals.

6. Wholesale dealers' license exemption

There are already situations that arise during public health vaccination programmes where there may be excess vaccines in one healthcare organisation and too few in another, separate healthcare organisation. The supply from one to the other is classified as wholesale distribution supply and, therefore, subject to having a wholesale dealer's licence under regulation 18 of the HMRs. Holders of a wholesale dealer's licence include commercial companies, the NHS and pharmacy businesses.

We consulted on providing an exemption from the need for a wholesale dealer's licence to allow the swift and safe transfer of COVID-19 and flu vaccines, and other medicines for treatment in a public health emergency.

Several respondents said that this proposal was unethical as it would generate profit.

This exemption would not be for further general trading of medicine, for example, to another wholesaler or for export. This exemption would apply only to the situation where an "end point user" (the NHS contracted service providers officially responsible for administering the medicine to patients) has surplus stock and wants to transfer it to another end user that needs the medicines in response to public health need.

Some respondents asked for more clarity around who the amendments would apply to, for example, what was meant by an "NHS contracted service provider".

The exemption will be available for NHS organisations, NHS contracted service providers, and the medical services of the armed forces only that are an end point user. This is will be those who are responsible for administering the medicine to patients and operating under:

• in England, the health service as defined by section 275(1) of the National Health Service Act 2006
• in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978
• in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006, and
• in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009
• arrangements for the provision of services as part of the medical services of Her Majesty's Forces

A number of respondents emphasised the importance that this change did not negatively impact storage of the vaccine if it was being transported between premises. Vaccines and some other medicines are subject to controlled storage requirements. For example, strict temperature limits. Therefore, the transfer of any medicine will be properly controlled, and appropriate records maintained of correct storage and transfers. The detail of this will be set out in the NHS (or armed services) arrangements for the provision of the vaccines.