The UK government is proposing to expand the scope of patient group directions (PGDs) to allow pharmacists to administer unlicensed vaccines, including any Covid-19 vaccine.
The move is part of a wide ranging consultation on changes to the Human Medicines Regulations (HMRs) which the government is planning to support the roll-out of a Covid-19 vaccine in the UK.
The government is proposing three amendments to the HMRs to increase the number of persons able to deliver vaccinations to ensure that a Covid-19 vaccine can be rolled out as soon as it becomes available. The amendments would:
1. Expand the scope of PGDs to allow the administration of any medicine, including Covid-19 vaccines, which has been temporarily authorised under regulation 174 of the HMRs. Currently a PGD cannot be used to administer anything that does not have a full marketing authorisation from the MHRA.
2. Introduce a new type of national protocol to allow healthcare workers (registered and unregistered) who do not normally vaccinate, to administer a licensed or temporarily authorised Covid-19 or influenza vaccine. This protocol would be written similarly to a PGD and would provide the flexibility to define the training and competence requirements of vaccinators, and the clinical considerations they must follow.
3. Expand the workforce legally allowed to administer vaccines under NHS and local authority occupational health schemes to include midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists.
The government says this will help ensure there is the workforce needed to deliver a mass Covid-19 vaccination programme.
Although the preferred route for the supply of a new vaccine for Covid-19 is through the usual marketing authorisation process, the government is also consulting on a proposal to allow a temporary authorisation for the supply of an unlicensed vaccine under regulation 174 of the HMRs.
A Covid-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine.
The measure means that if a suitable vaccine candidate became available before the end of the Brexit transition period, but had not yet been licensed by the European Medicines Agency, regulation 174 could be used to enable temporary UK-only deployment.
The government also wants to clarify the scope of regulation 345 of the HMRs so that it applies not just to manufacturers and healthcare professionals but also to a company placing an unlicensed medicine on the market with the approval of the licensing authority.
Regulation 345 provides that key actors in the medicines supply chain cannot generally be sued in the civil courts for the consequences resulting from the use of an unlicensed product, or a new use of a licensed product, that the licensing authority is recommending in order to deal with a specific health threat.
Medicines regulation is a devolved matter in relation to Northern Ireland and a reserved matter to the UK Parliament in relation to Scotland and Wales. The consultation, which started on 28 August, closes on 18 September, but the government says respondents who miss the deadline and still want to make comments should contact email@example.com.