Do not implement proposed changes to Human Medicine Regulations

We reject all of the UK Governments proposals outlined in their Consultation document from Aug 28th 2020 that proposes changes to Human Medicine Regulations to support the roll out of COVID-19 vaccines that would simplify the temporary authorisation, supply, use and promotion of unlicensed products.

We reject this because we believe allowing these changes to go ahead will cause much more harm than good. More information at https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines

The Department’s public consultation from 28 August to 18 September proposed changes to the Human Medicine Regulations, the proposed changes will support the effective rollout of a COVID-19 vaccine and the upscaling of influenza (flu) vaccination programme in the UK. Once an effective vaccine is developed, it’s important they are made available to patients as quickly as possible to enable an end to the spread of the virus - the biggest threat this country has faced in peacetime history. It is for this reason the UK government is working to a scientifically led, step-by-step action plan for tackling the pandemic – taking the right measures at the right time to protect the UK.

Any rollout of a vaccine will only happen once strict safety standards have been met as patient safety is of utmost importance. The proposals suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible, without sacrificing any essential safeguards or undermining any essential safety and efficacy standards required of a vaccine.

The consultation has received a huge number of responses, and we welcome the views of all individuals, organisations and stakeholders who participated. As part of the consultation process, the Department, in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), held a number of stakeholder meetings with health and social care professional bodies and pharmaceutical industry representatives as examples. We are now in the process of analysing all responses, are considering any changes to the legislation in light of those responses and will respond to the to the consultation in due course.

Safety is the utmost priority of any public health vaccination programme, and this remains the case here. The preferred route to enable deployment of a new vaccine for COVID-19 is through the usual marketing authorisation (product licensing) process, and therefore any temporary authorisation of the supply of an unlicensed vaccine would be by exception and the timing of this would depend on the public health need.

In addition, any healthcare workers administering vaccines will be trained to the highest standards, will have experience of safely administering vaccines and follow all required clinical considerations via NHS and PHE approved training programmes. This will ensure that all measures are taken to ensure patient safety, including but not limited to clinical treatment of any potential reaction to the administered vaccine, such as anaphylactic shock for example.

The changes will make it possible to: ● Allow a wider range of trained professionals to administer a Covid-19 and flu vaccine;

● Strengthen existing regulations that allow for the temporary licencing of medicines and vaccines, on an exceptional basis pending the grant of a full licence - any use of medicines and vaccines will have met the required safety standards before being deployed.

● To extend the indemnity to companies producing the vaccine, in order to protect them from legal liability in civil cases but this proposal does not give them blanket immunity.

The UK has a world class national immunisation programme which is constantly reviewed and updated to reflect the changing nature of infectious diseases and provide the best protection for the public. All vaccines used in the UK are thoroughly tested, meet strict safety criteria and are carefully monitored after they are introduced into the national programme. Our evidence-based immunisation programmes are informed by the advice of our work leading expert committee – the Joint Committee on Vaccination and Immunisation (JCVI), which reviews a wide range of scientific and other evidence, keeping the vaccine schedule safe and relevant.

Immunisation offers everyone a chance at a healthy life from the earliest beginnings and into old age. It saves millions of lives every year and is widely recognised as one of the world’s most successful and cost-effective health interventions. High uptake of a Covid-19 vaccine is the best way we have, to protect our health, our jobs, and our economy at large.

Department of Health and Social Care