NPA supportive of temporary authorisation of the supply of unlicensed products in interest of public health
19 Oct 2020
The Department of Health and Social Care (DHSE) alongside the Medicines and Healthcare products Regulatory Agency (MHRA) recently published the outcome of a consultation on changes to the Human Medicines Regulations to support the rollout of COVID-19 vaccines.
The NPA, which responded to the consultation, said it is supportive of the proposal by the Joint Committee on Vaccination and Immunisation (JCVI) on advising the government to use a tested but unlicensed vaccine against Covid-19 in the interest of public health.
Helga Mangion, Policy Manager at the NPA said: “We are pleased with the reassurance from DHSE and MHRA of their commitment to robust scrutiny, objectivity and safety.
“In our submission we reiterated the need for their objectives to be reviewed on a regular basis in line with new research and pandemic progression.
“We foresee community pharmacies will also have a crucial role to play in ensuring as many people as possible get protected by any future coronavirus vaccine.
“Provided the appropriate safety, quality and efficacy measures have been put in place, the NPA is supportive of the deployment of effective and legal mechanisms for bringing this pandemic under control.”
The consultation which ran from 28 August to 18 September concluded that there will be three key changes to the proposals set out in the original consultation document, including; robust scrutiny of the impact of regulation 174A (which is the new power to impose conditions and dealing with their consequences); promoting objectivity by changing the ‘objective bystander’ test that relates to loss of immunity from civil liability; and creating an additional level of reassurance in relation to the expanded workforce.
The consultation outcome can be accessed by going to: www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/outcome/government-response-consultation-on-changes-to-the-human-medicines-regulations-to-support-the-rollout-of-covid-19-vaccines