AQW 25484/17-22

Mrs Pam Cameron
Democratic Unionist Party
South Antrim

Tabled Date: 09/11/2021
Answered On Date: 11/11/2021
Priority Written: No

Question:
To ask the Minister of Health what implications the Protocol on Ireland/Northern Ireland will have for approval and supply of the antiviral 'molnupiravir', now that it has been approved by the UK regulator.

Answer:

I can confirm that on 4th November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised Molnupiravir (brand name: Lagevrio) for use in the United Kingdom (UK) following a rigorous review of its safety, quality and effectiveness by MHRA and the UK government’s independent expert scientific advisory body, the Commission on Human Medicines.

The MHRA’s Conditional Marketing Authorisation for Molnupiravir is valid in Great Britain (GB) only. An emergency use authorisation has been granted for Northern Ireland (NI) to ensure access across the whole of the UK. Both authorisations were made on the basis of the same rigorous evaluation.

My Department is working with the UK’s Antivirals Taskforce as stock of the antiviral is limited and advice will be provided to the health and social care service about access to this treatment as soon as arrangements are confirmed.

My officials are working closely with the Department of Health and Social Care (DHSC) to mitigate outstanding issues relating to of the Protocol, including access to new and innovative medicines. Maintaining the continuity of medicines supplies for the citizens of NI is my Department’s absolute goal as well as a commitment to ensuring equity of access to treatments with the rest of the UK.