Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns

0
39

Executive summary

The Human Medicines Regulations 2012 (HMRs) were amended in the final quarter of 2020 to add flexibility to some of the normal rules that would ordinarily govern vaccines and their supply to patients, in light of COVID-19. The changes were to facilitate the mass vaccination campaigns that have been taking place against both COVID-19 and seasonal influenza, once vaccine became available. Some of these provisions will cease to have effect on 1 April 2022 and action is needed to determine if they should be made permanent, extended for a further limited period or allowed to lapse. The first 2 of these options would require further amendments to be made to the HMRs.

The Secretary of State, in conjunction with the Minister of Health in Northern Ireland, is seeking views on proposals that support the influenza vaccination programme in the UK and the effective rollout of COVID-19 vaccines and any necessary subsequent booster vaccine doses. The proposed changes to regulations will help to ensure the NHS continues to have the added flexibility it requires to operate any necessary mass vaccination programmes for COVID-19 and influenza.

Any legislative amendments will be made using powers in Part 2 of the Medicines and Medical Devices Act 2021 and will need to be in force by 1 April 2022. As part of the development of the proposals outlined in this document, targeted engagement with those with practical experience of operating under these permissive changes to the HMRs has taken place.

This consultation focuses on provisions in the HMRs that are about:

  • increases to the vaccinator workforce in the NHS and in occupational health for NHS bodies

  • enabling vaccine final preparation, labelling and so on to take place without additional marketing authorisations or manufacturer’s licences being needed

  • allowing vaccines to be moved between premises at the end of the supply chain by NHS bodies and the medical services of Her Majesty’s Forces that do not hold wholesale dealer licences

  • allowing pharmacies who are running vaccination services to do so from premises other than their registered premises

Introduction

When the HMRs were amended late last year to facilitate the vaccine programmes for COVID-19 and influenza, a number of the changes were given an end date of 1 April 2022. This was either because they were exceptions to the ‘business as usual’ model which, under normal circumstances, we would not want to retain; or, because they were new and would require a review of the practical implications and safeguards following implementation. Given the experience arising from the pandemic, we needed to retain flexibility to deal with unknowns. This consultation seeks views in the light of the learning and experience that has taken place since the amendments were first made.

The Secretary of State, in conjunction with the Minister of Health in Northern Ireland, is seeking views on proposals that support the influenza vaccination programme in the UK and the effective rollout of COVID-19 vaccines and any necessary subsequent booster vaccine doses. The proposed changes to regulations help to give the NHS added flexibility to operate any necessary mass vaccination programmes. As outlined in detail below, some provisions may be extended permanently, while others may be extended for a further limited time period during which we come to understand more about the UK’s future vaccination requirements.

In the interests of pandemic preparedness, we are also seeking views on whether to retain these provisions so that they may apply to any future pandemic.

Medicines regulation in the UK

The HMRs set out a comprehensive regime for the authorisation of medicinal products; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. They also provide for enforcement powers for the authorisation and supervision of medicinal products.

Medicines regulation is a transferred matter in relation to Northern Ireland and a reserved matter (to the UK Parliament) in relation to Scotland and Wales. This why changes to the UK-wide HMRs, made under the Medicines and Medical Devices Act 2021, are made by the UK and Northern Ireland ministers. This consultation is being conducted in the names of the Secretary of State for Health and Social Care and the Department of Health in Northern Ireland.

The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, is the UK’s ‘licensing authority’ under the HMRs across the whole of the UK, acting on the authority of the Minister of Health in Northern Ireland and the Secretary of State for Health and Social Care.

Background to the issue

Vaccines have proven to be the first and best line of defence against the COVID-19 pandemic and for the prevention of seasonal influenza. We know that the NHS has found the flexibilities inserted into the Human Medicines Regulations 2012 (HMRs) crucial to delivering vaccination protection to the huge number of members of the public who wish to receive that protection. The provisions have enabled this to happen in locations as diverse as the Science Museum in London, a ‘park and ride’ car park in Leeds as well as in the traditional venues of local hospitals and GP practices. We understand that the NHS has used the full range of options available to them under the HMRs so that they can match available vaccinator staff with public demand and vaccine availability. The NHS has been able to safely vaccinate staff and deliver the vaccine campaigns and to do so with minimal disruption to normal GP and hospital services using these provisions.

The independent Joint Committee on Vaccination and Immunisation (JCVI) has advised the UK government on which COVID-19 vaccines the UK should use, and the priority groups to receive the vaccine and any necessary subsequent booster based on the best available clinical, modelling and epidemiological data. Influenza vaccination campaigns are devolved in Scotland, Wales and Northern Ireland. For example, the UK Health Security Agency (formerly Public Health England) delivers the national influenza immunisation programme in England. Every year, JCVI reviews the latest evidence on influenza vaccines and recommends the type of vaccine to be offered to patients.

The House of Commons and Science and Technology Committee and Health and Social Care Committee have published their report, Coronavirus: lessons learned to date, examining the initial UK response to the COVID-19 pandemic. It states:

in the UK alone, the successful deployment of effective vaccines has allowed, as at September 2021, a resumption of much of normal life, with incalculable benefits to people’s lives, livelihoods and to society.

The public heeded advice to get their influenza vaccination, where eligible, as well as their COVID vaccinations over the past year. Their desire to protect their health and the NHS led to an increase in demand for influenza vaccinations in addition to the already significant work delivering COVID vaccinations. We do not yet know if or when further COVID vaccinations may be needed in addition to the current first vaccination and booster campaigns but we need to ensure that the NHS can deliver it in addition to higher demand for influenza vaccine if the country needs it. We also know that there will be future pandemics so ensuring our preparedness is a key government priority.

This consultation

This consultation is seeking views on the temporary changes that were made to the UK regulatory framework for human medicines in late 2020. These provisions were introduced as part of the response to the COVID-19 pandemic by providing regulatory flexibility to support mass vaccination while protecting public safety. Decisions of detail regarding deployment, supported by the HMRs, 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 – as they do for their annual national influenza vaccination programmes, and would do for any future national distribution campaign for vaccinations for a pandemic disease. These proposals have no impact or interaction with the Northern Ireland Protocol.

This consultation exercise does not cover:

  • who would, or would not, be vaccinated as part of a COVID-19 or influenza vaccination programme, or how the NHS in each UK nation would commission or run it. The HMRs give each nation the option of doing so within a clear and supportive framework governing medicines, should they want to continue to use them. To a great extent, these proposals are enabling, essentially supporting a range of options that the NHS in each UK nation will have available to them

  • any changes to the lists of those healthcare professionals who can prescribe, supply and/or administer medicines for business as usual purposes. The Chief Professions Officers’ Medicines Mechanisms (CPOMM) programme undertakes this work and is run by NHS England and Improvement

This consultation is not seeking to change the devolved status of the regulation of medicines. The UK government is not seeking to change the current balance between what are treated as NHS issues and what are treated as regulatory issues.

Policy objectives

The overarching policy objective is to enable the continued deployment of safe and effective COVID-19 (including any necessary booster doses) and influenza vaccination at the pace and scale required now and in the future. To do this we are reviewing the amendments which were temporarily made to the HMRs in 2020 to facilitate the successful COVID-19 and influenza vaccination campaigns.

In considering these amendments, we are assessing whether they should be kept permanently (either as business as usual or in pandemic circumstances), extended for a further temporary period, or allowed to lapse. The provisions will currently cease having effect on 1 April 2022, unless further legislation is made to extend provisions or make permanent.

We are also gathering views on extending these provisions to future pandemics.

The proposals

The provisions which will no longer have effect from 1 April 2022 onwards if we take no further action broadly concern:

  • expanding the workforce

  • make provisions for wholesale dealing and end stage preparation of vaccines

  • easing final preparation of coronavirus vaccines

  • supply of coronavirus or influenza vaccines by a pharmacy

Expanding the workforce

Provisions were made 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. These included enabling additional healthcare professional groups to vaccinate health and social care workers in occupational health services and the public under Patient Group Directions. We also introduced the national coronavirus and influenza vaccination and immunisation protocol, which enables a wider range of staff to administer influenza and COVID-19 vaccines after appropriate training and, where appropriate, under supervision. An expanded workforce is required to ensure that the COVID-19 vaccine can be safely and rapidly deployed widely, given the capacity constraints of the workforce that can administer vaccines under business as usual arrangements.

An expanded workforce eligible to administer the influenza vaccine is still required, as demonstrated by the expanded influenza vaccination programme this winter. Thousands more received the influenza vaccine last year than received it the year before and we anticipate that this trend will continue beyond winter 2021 to 2022, so there is a need to ensure the workforce that can administer vaccines is of sufficient size.

There is a possibility that both the influenza vaccine and the COVID-19 vaccine 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.

We are seeking views on:

  • making permanent the provisions which have enabled an expanded workforce to lawfully administer coronavirus and influenza vaccines and/or immunisation medicines under NHS and local authority occupational health schemes, so that additional healthcare professionals in the occupational health workforce (midwives, registered nursing associates (England only), operating department practitioners, paramedics, physiotherapists and pharmacists) are able to administer these vaccines

  • making new changes to extend these provisions to the private sector

Vaccinations for health and care workers are often administered through occupational health schemes, and, prior to the 2020 temporary changes, the only people authorised to administer injectable prescription-only medicines as part of an occupational health scheme were doctors and nurses acting under written instruction of a doctor. The temporary changes expanded the workforce that can administer COVID-19 and influenza vaccinations under an NHS or local authority occupational health scheme. Occupational health vaccinators, meaning nurses, midwives, registered nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists could be utilised as part of the vaccination programme. We are proposing to make this change permanent.

Making this change permanent will help ensure we have the workforce needed to continue to deliver a mass COVID-19 vaccination programme (including any necessary subsequent booster doses), in addition to delivery of an upscaled influenza programme for NHS and social care staff. It better reflects the ability of a broader range of registered healthcare professionals to competently deliver occupational health scheme services. The same arguments for change may also apply to occupational health schemes in the private sector and consideration is being given to making new amendments so that these changes are applicable there too.

The relevant current provisions are regulations 32(2), 32(3) and 32(4) of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) & the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/349) which amend Schedule 17 (exemption for sale, supply, or administration by certain persons) of the HMRs.

The provisions are set to expire on 1 April 2022. If these particular changes to schedule 17 do lapse, we return to the position where only doctors and nurses operating under written instruction of a doctor are authorised to administer injectable prescription-only medicines in occupational health schemes. This could cause delays in vaccinating health and social care workers.

Question

Do you agree or disagree that the provisions which expand the workforce for NHS bodies or local authorities operating an occupational health scheme in relation to coronavirus and influenza vaccination and/or immunisation be retained permanently?

  • Agree

  • Disagree

  • I don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

If you disagree, would you a) allow the provision to lapse on 1 April 2022 or b) temporarily extend the provision to 1 April 2024? Please explain your choice (maximum 150 words).

Question

Is there any operational need to add any other professions to the list of those who can supply and administer in relation to COVID-19 and influenza under an occupational health scheme?

Please explain your answer (maximum 150 words)

Question

Should the changes be extended to occupational health schemes concerned with coronavirus and influenza vaccination and/or immunisation centres operating in the private sector as well those operating in the NHS and local authorities?

Please explain your answer (maximum 150 words)

Parenteral administration of prescription only medicines under a Patient Group Direction by NHS bodies and local authorities

We are considering making permanent the provision for parenteral (given by injection or infusion) administration of prescription only medicines under a Patient Group Direction (PGD) by NHS bodies and local authorities.

PGDs can be issued under regulation 229 (exemption for supply by NHS bodies and local authorities) of the HMRs by a number of specified NHS bodies, or bodies exercising public health functions. This enables medicines to be given to patients without a prescription by a registered healthcare professional who is qualified and authorised locally to work under that PGD. As a result of the 2020 changes, an appropriate practitioner (as defined in Regulation 214 of the HMRs) or a person acting in accordance with the directions of an appropriate practitioner is able to administer a parenteral medicine under PDGs issued in accordance with regulation 229.

Without this flexibility there would have been significantly fewer professionals able to administer vaccines leading to vaccine wastage, slower pace of administration of vaccines and/or more prescribers would have been diverted into the vaccination programme, creating an additional drain on healthcare capacity.

Regulation 5(a) and 5(b) of the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/1594) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020/350 made these changes to Regulation 229 of the HMRs.

Question

Do you agree or disagree that this provision to enable parenteral administration of medicines under a PGD should be made permanent for COVID-19, influenza and any future pandemic disease?

  • Agree

  • Disagree

  • I don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

If you disagree, would you a) allow the provision to lapse on 1 April 2022 or b) temporarily extend the provision to 1 April 2024? Please explain your choice (maximum 150 words).

National pandemic vaccination protocols and clinical supervision

We are considering adding a provision to the requirements for national pandemic vaccination protocols that requires a clinical supervisor, who must be a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol, to be supervising at all times when vaccinations are taking place under a protocol.

The changes made in 2020 introduced a new type of national protocol – new regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations). These require the approval by the Secretary of State and ministers in each of the devolved administrations. Under these protocols, those who are registered healthcare professionals who do not normally administer injectable vaccines, and people who are not registered healthcare professionals, are legally allowed to administer the COVID-19 or influenza vaccine.

Pandemic protocols under 247A have provided the flexibility to set out the training and competence requirements of vaccinators, clear roles and responsibilities for all stages in the process of preparing and administering the vaccines, and the clinical considerations they must follow. This has ensured that measures have been taken to ensure patient safety, including but not limited to clinical treatment of any potential reaction to the administered vaccine, such as anaphylactic shock.

The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/1125 and The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/349 inserted Regulation 247A to the HMRs to allow for new COVID-19 and influenza protocols.

The 247A pandemic protocol has been the preferred mechanism to enable the roll out of COVID-19 vaccinations during the pandemic. It allows the end to end vaccination process to be separated and for non-registered staff to support registered staff in the administration process. It also enables vaccination to take place at pace using workforce models, based on the Royal College of General Practitioners’ Delivering Mass Vaccinations During COVID-19, A Logistical Guide for General Practice (July 2020).

In practice, the pandemic protocols have included a clinical supervisor, who must be a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol, to be present and take overall responsibility for provision of vaccination under the protocol at all times and be identifiable to service users. Within regulation 247A itself, there is no express requirement that a clinical supervisor (by reference to specific healthcare professionals) must oversee all elements of supply under the protocol.

Question

Do you agree or disagree that the HMRs (Regulation 247A) should be permanently amended to require coronavirus and influenza vaccination activities carried out pursuant to pandemic protocols to be supervised by a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol?

  • Agree

  • Disagree

  • I don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

Make provisions for wholesale dealing and end stage preparation of vaccines

Situations arose during public health vaccination programmes where there were more vaccines than were needed in one healthcare organisation and too few in another separate healthcare organisation. The supply from one to the other would be classed as a wholesale distribution supply and, therefore, normally subject to having a wholesale dealer licence under regulation 18 of the HMRs. If such a licence is not held by the organisation because it is not required for normal business, this can lead to problems and delays with moving the vaccines between such service providers, and runs the risk that patients cannot access the vaccine that is necessary for public health protection and vaccines are wasted.

It is essential that we have the flexibility that vaccines can continue to be moved swiftly and safely within the healthcare system between NHS providers (and between the suppliers of medical services to the armed forces) to meet patient need and avoid wastage. The same considerations also apply to medicines to treat COVID-19 and influenza.

We are therefore considering the temporary extension of the provisions to:

  • change the rules that require holding of wholesaler dealer licences. This will allow for coronavirus and influenza vaccinations to be moved under NHS authorised arrangements between premises at the end of the supply chain by NHS bodies and the medical services of Her Majesty’s Forces that do not hold wholesale dealer licences (see regulation 19(4A) of the HMRs)

The amendments introduced in late 2020 also make changes to the rules around the requirement to have a wholesale dealer licence in the context of protocols under regulation 247 (exemption for supply in the event or anticipation of pandemic disease) (see regulation 19(4B) of the HMRs). Both these temporary changes provide that the supply of the products must be under ‘relevant arrangements’. These are defined as either arrangements for the provision of services as part of the NHS or armed forces health service (see regulation 19(4C)). The detail of these arrangements would need to be set out in the NHS (or armed services) arrangements for the provision of the vaccines and treatments, but further guidance would also be provided centrally. Guidance around maintaining safety and product integrity is required, but these will be product specific.

Throughout the COVID-19 vaccination campaign, on many occasions mutual aid has been used to rebalance the system between vaccine providers and to redistribute vaccines to the places where they could be used best and/or had the greatest need. The programme would have struggled without this flexibility and wholesale dealer licences were required at every point.

Under normal circumstances, the requirement for wholesaler dealer licences is an important safeguard. Continued flexibility for a further period would be of benefit to public health and we therefore propose to retain these provisions until 1 April 2024.

Regulation 4 of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/1125 & The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/349 amends regulation 19 of the HMRs to provide for this.

Question

Do you agree or disagree that the provision to enable providers of NHS services and medical services to HM Forces to distribute medicinal products to be used for vaccination or immunisation against coronavirus or influenza without the need for a wholesaler dealer licence should be temporarily extended to 1 April 2024 for COVID-19 and influenza?

  • Agree

  • Disagree

  • I don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

If you disagree, would you a) allow the provision to lapse on 1 April 2022 or b) permanently extend the provision? Please explain your choice (maximum 150 words).

Easing final preparation of coronavirus vaccines

We are considering the extension of provisions in the HMRs which:

  • relax some of the governance rules on the assembly, preparation and labelling of medicinal products and the need for manufacturers’ licences and marketing authorisations to enable the necessary actions taken by pharmaceutical companies and healthcare professionals to specifically prepare coronavirus vaccines for administration to the public. These relaxations were under the proviso that the actions were done under NHS arrangements or arrangements as part of the medical services of Her Majesty’s Forces

In the context of COVID-19, in practice this has allowed labelling with a new shelf life after thawing and preparation or reconstitution by the adding the recommended diluent. This has meant NHS teams have been able to use the skills and expertise of their staff in appropriate areas much more effectively and for various professions to focus on their areas of speciality, enabling safer systems of working, particularly at larger sites. The ability to prepare vaccines for administration flexibly at a range of sites within a safe system has proven to be very useful. As the vaccination campaign progressed, NHS Primary Care Networks have utilised the Enhanced Service Collaboration Agreement to share vaccines and enable a synergistic approach to delivery. Continuing this flexibility for a further period would be of benefit to public health and we therefore propose to retain these provisions until 1 April 2024.

Regulation 4 of the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/1549) inserts a new regulation 3A (Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products) into the HMRs to provide for this.

Question

Do you agree or disagree that the provisions to enable the preparation of COVID-19 vaccinations without the need for manufacturers’ licences and marketing authorisations (which, among other things, relax the rules on packaging and labelling) should be temporarily extended to 1 April 2024?

  • Agree

  • Disagree

  • I don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

If you disagree, would you a) allow the provision to lapse on 1 April 2022 or b) permanently extend the provision? Please explain your choice (maximum 150 words).

Supply of coronavirus or influenza vaccines by a pharmacy

We are also considering making permanent the temporary provisions of the HMRs which allow:

  • providers of retail pharmacies who are providing a coronavirus or influenza vaccination or immunisation service under patient group direction to provide that service away from their registered premises

Regulation 8 of the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/1594) and the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/350) inserts a new paragraph into regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the HMRs provide for this.

This flexibility was used on a regular basis by the majority of community pharmacy run COVID-19 vaccination sites, where the main site was located away from their normal registered premises. It also allowed many hundreds of pharmacies to offer pop-up clinics, in particular supporting groups of patients where bookings were not able to be made on the health service booking system of the relevant country (for example, 16 and 17 year olds), where there were particular infection clusters or in locations where there were clusters of unvaccinated patients. Additionally, this flexibility allowed teams to vaccinate residents and carers in care homes.

This flexibility was also used in the 2020 to 2021 seasonal influenza programme to support an increase in vaccinations from the previous year and is expected to be used more widely in 2021 to 2022 season.

Question

Do you agree or disagree that the provision which enables providers of retail pharmacies who are providing an immunisation or vaccination service for coronavirus or influenza under PGD to provide that service away from their normal registered premises should be made permanent?

  • Agree

  • Disagree

  • I don’t know

If you have evidence to support your answer, please provide details (maximum 150 words).

If you disagree, would you a) allow the provision to lapse on 1 April 2022 or b) temporarily extend the provision to 1 April 2024? Please explain your choice (maximum 150 words).

Extension of these provisions to all future pandemic scenarios

Future pandemics may arise from illnesses other than influenza or COVID-19, but may still lead to a requirement for a mass vaccination campaign. It may therefore be beneficial to enable the provisions discussed in this consultation document to be applicable in all pandemic scenarios. At this stage we are simply seeking views on this approach, in order to help formulate our plans. Any changes to our policy would require further future public consultation.

Question

Do you agree or disagree that the provisions listed above should be amended to include all future pandemic scenarios?

  • Agree

  • Disagree

  • I don’t know

Please explain your answer (maximum 150 words)

NI respondents: equality and rural screening

In Northern Ireland new policies must be screened under Section 75 of the Northern Ireland Act 1998, which places a statutory duty on public authorities, to mainstream equality in all its functions – so that equality of opportunity and good relations are central to policy making and service delivery. In addition, new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016, which requires public authorities to have due regard to rural needs.

Question

We do not consider that our proposals risk impacting different people differently with reference to their protected characteristics or where they live in NI. If you agree or disagree, we welcome views on this point (maximum 150 words).

Question

Do you think the proposals risk impacting people differently with reference to their [or could impact adversely on any of the] protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998?

Please explain your answer (maximum 150 words)

The Medicines and Medical Devices Act 2021 (the Act) came into force for these purposes on 11 April 2021. We propose to make legislative changes using powers in Part 2 of the Act, which provides powers to make, amongst other things, amendments to the HMRs.

This consultation is conducted in line with the consultation requirement in section 45(1) of the Act.

Section 2 of the Act provides that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 requires that when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to 3 factors:

  1. The safety of human medicines and that the benefits of doing so outweigh any risks

  2. The availability of human medicines

  3. The likelihood of the relevant part of the United Kingdom being seen as a favourable place which to:

As set out in section 2(3) of the Act, where regulations under section 2(1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

The appropriate authority is the Secretary of State for Health and Social Care in relation to GB and, in relation to Northern Ireland, it is the NI Department of Health and the Secretary of State jointly. The consultation obligation applies to both the Secretary of State and Northern Ireland Department of Health, and both will make the final decision on making any legislative changed under section 2(1).

Below we have assessed the proposals against each of the factors set out in section 2.

Safety

The overall aim of the proposed amendments is to enable the deployment of COVID-19 and flu vaccines at the pace and scale required.

The provisions introduced in The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 1125 2020) which support the mass supply and administration of COVID-19 and flu vaccines have played a key role in protecting public health. The COVID-19 vaccine has already had a significant impact on reducing hospitalisations and deaths, with UKHSA estimating that 127,500 deaths have been prevented so far. Flu vaccine efficacy varies year on year as the flu virus changes and is difficult to predict. However vaccination remains the best protection against the serious effects of flu and the annual national flu immunisation programme aims to provide protection to those who are most at risk from the complications of flu.

The House of Commons and Science and Technology Committee and Health and Social Care Committee report, Coronavirus: lessons learned to date, states that “the UK vaccination programme – from discovery of potential vaccines against COVID-19 to the vaccination of nearly 80% of the adult population by 1 September 2021 – has been one of the most successful and effective initiatives in the history of UK science and public administration. Millions of lives will ultimately be saved as a result of the global vaccine effort, in which the UK has played a leading part.”

The proposals outlined in this consultation aim to maximise patient and public health benefits of these vaccines by ensuring their wide-spread availability. Patient safety is at the heart of any public health vaccination programme, and is at the forefront of policies proposed in this consultation.

Where legislative changes are to be made, with the support of stakeholders, DHSC, NHSE/I and local NHS bodies, we have taken steps to ensure patient safety is paramount, ensuring that staff are fully trained for the roles they are undertaking and supervision is in place where required.

We believe that proposals to maintain an expanded workforce able to lawfully administer coronavirus and influenza vaccines under occupational health schemes, and to extend these provisions to private sector, will ensure we can continue to provide critical protections to health and care workers, while ensuring that vaccines continue to be administered by highly-trained, qualified staff operating under rigorous professional standards.

Similarly, provisions allowing for parenteral (given by injection or infusion) vaccines to be given under Patient Groups Directions by registered health professionals has been critical to supporting widespread protection from coronavirus and influenza amongst the general public. By making these provisions permanent, we can ensure the public health benefits are maintained as flu and coronavirus vaccinations continue to be provided, while maintaining rigorous standards of oversight for vaccines continue to be given safely and effectively.

Safety is equally at the heart of proposals that would require vaccination activities carried out under pandemic protocols to be supervised by a registered doctor, nurse or pharmacist. Protocols have provided critical flexibility to support widespread vaccine roll-out, and provisions for clinical supervision would ensure the ongoing use of protocols while ensuring high standards of clinical oversight are set out in legislation. Any additional workforce operating under the national protocol to administer vaccines will be trained and shown to be competent via an appropriately approved training programme to ensure patient safety.

We also believe that proposals to extend provisions relating to wholesale dealing, end-stage vaccine preparation and off-premises vaccine supply by retail pharmacies, have supported swift and safe distribution of coronavirus and flu vaccines, and will be critical to maintaining the ongoing public health benefits.

We have also considered environmental safety and impact of the proposals on the wider environment. Relaxing the rules on holding of wholesaler dealer licences has allowed for vaccines to be moved swiftly and safely directly to where they are most required, thereby meeting patient need and avoiding wastage.

Availability

The proposals outlined are intended to enable the supply and increase the availability of vaccines to the public and healthcare professionals.

In the 9 months since the largest vaccination programme in NHS history began, 77 million COVID-19 vaccinations have been delivered, with 4 in 5 adults already receiving both doses.

The proposed provisions will ensure the continued timely access to vaccines that the public need for COVID-19, flu and any future pandemic disease. The proposed provisions also support the long-term necessity of public vaccinations as we continue to manage coronavirus and flu infections into next year and beyond.

Proposals will also ensure the availability of these vaccines for health and care staff, by extending and expanding their supply in occupational health settings. This will be critical as we seek to ensure that all health and care staff receive their vaccinations for flu and COVID-19 as well as other vaccines that individual healthcare workers may need from time to time, for example hepatitis for surgeons. Vaccinations are crucial for health and social care workers in order to protect vulnerable people and patients. The provisions will be needed for health and social care workers to receive their flu vaccines next winter and beyond as well as COVID booster vaccinations.

Favourability

These provisions, which are enabling the NHS to deliver a mass vaccination campaign, have helped the United Kingdom to be seen as a favourable place to supply medicines. They have demonstrated that the UK has the adaptability to ensure that medicines can be supplied at scale and pace where necessary to protect patients and the public. Provisions, such as those providing flexibilities around wholesale dealing, have shown our ability to provide flexibility in the supply and distribution of medicines where that will deliver significant public health benefits. They have shown that the UK can and will make changes to ease the introduction of innovative safe treatments for its population.

We refer again to the Coronavirus: lessons learned to date report which states that the distribution of vaccines “sprang into large scale operation explosively and impressively, rather than slowly and inadequately; it made extensive use of existing NHS resources—hospitals, GPs and pharmacists…  The roll-out of the vaccine in England and the rest of the UK has been one of the fastest in the world.”

We believe that these proposals will influence the likelihood of UK being seen as a favourable place in which to conduct clinical trials or carry out research relating to human medicines.

Annex B: how to respond

The government invites responses on the specific questions raised. The questions can be found through the document.

Please respond through our online consultation survey.

If you have any queries on this consultation or require an alternative format please email hmrandimms@dhsc.gov.uk.

If you do not have internet or email access, then please write to:

Prescribing Policy and Charges Team

Department of Health and Social Care

Floor 2, Area G, Quarry House

Quarry Hill

Leeds

LS2 7UE

The consultation is open for a period of 3 weeks. Please submit your responses to the questions by 11:45am on 29 December.

Confidentiality of information

We manage the information you provide in response to this consultation in accordance with the Department of Health and Social Care’s Personal Information Charter.

Any information received, including personal information, may be published or disclosed in accordance with the access to information regimes (primarily the Freedom of Information Act 2000 (FOIA), the Data Protection Act 2018 (DPA 2018) and the Environmental Information Regulations 2004).

If you want the information that you provide to be treated as confidential, please be aware that, under the FOIA, there is a statutory code of practice with which public authorities must comply and which deals, among other things, with obligations of confidence. In view of this it would be helpful if you would explain to us why you regard the information that you have provided as confidential. If we receive a request for disclosure of the information you have provided, we will take full account of your explanation, but we cannot give an assurance that confidentiality will be maintained in all circumstances.

An automatic confidentiality disclaimer generated by your IT system will not, of itself, be regarded as binding on the department.

The department will process your personal data in accordance with the DPA 2018 and, in most circumstances, this will mean that your personal data will not be disclosed to third parties.

Annex C: privacy notice

The Department of Health and Social Care (DHSC) is the data controller.

What personal data we collect

The type of personal information we will collect is as follows:

How we use your data (purposes)

The data we collect is to inform the DHSC of the demographic of respondents. The department will process your personal data in accordance with the Data Protection Act 1998 (DPA) and in most circumstances this will mean that your personal data will not be disclosed to third parties. We may need to contact you if we have had a request under the Freedom of Information Act 2000 (FOIA). We will also email you to let you know if we have published a response to the consultation.

Under the General Data Protection Regulation (GDPR), the lawful basis we rely on for processing this information is:

Data processors and other recipients of personal data

Information we receive, including personal information, may be published or disclosed in accordance with the access to information regimes (primarily the Freedom of Information Act 2000 (FOIA), the Data Protection Act 2018 (DPA) and the Environmental Information Regulations 2004). Response data we receive, including personal information, from respondents who have informed us that they are in Northern Ireland will be shared with officials from the Department of Health in Northern Ireland.

International data transfers and storage locations

Any personal information collected will be stored in the UK and managed in line with the DHSC’s personal information charter.

Retention and disposal policy

We manage the information you provide in response to this consultation in accordance with the DHSC’s data protection policy. We will retain your data for 12 months after the consultation closes.

How we keep your data secure

Anyone managing and handling personal information understands that they are contractually responsible for following good data protection practice, is appropriately trained to do so and is appropriately supervised.

Your rights as a data subject

By law, data subjects have a number of rights and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 applies.

These rights are:

  1. The right to get copies of information – individuals have the right to ask for a copy of any information about them that is used.

  2. The right to get information corrected – individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected.

  3. The right to limit how the information is used – individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used.

  4. The right to object to the information being used – individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.

  5. The right to get information deleted – this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer

1st Floor North

39 Victoria Street

London

SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioners Office. Their website address is www.ico.org.uk and their postal address is:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Automated decision making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review, and new versions will be available on our privacy notice page on our website. This privacy notice was last updated on 26 October 2021.

Credit: Source link

#

LEAVE A REPLY

Please enter your comment!
Please enter your name here