AQW 5303/22-27


Dr Steve Aiken OBE
Ulster Unionist Party
South Antrim


Tabled Date: 26/10/2022
Answered On Date: 27/10/2022
Priority Written: Yes


Question:
To ask the Minister of Health for an update on the ongoing divergence issues related to medicines and the Northern Ireland Protocol.


Answer:
My Department has been consistent in seeking to preserve equity of access to medicines for the people of Northern Ireland in line with the rest of the United Kingdom.
To secure prescription-only medicines supply to Northern Ireland the Northern Ireland MHRA Authorised Route (NIMAR) was implemented in January 2022. NIMAR has allowed branded prescription-only medicines authorised for Great Britain to be supplied into Northern Ireland if there is clinical need and no licenced alternatives are available.
In April 2022, the European Commission provided legislation on medicines and the Northern Ireland Protocol which addressed some of the issues raised by my Department to the United Kingdom government. However, there remain issues associated with the implementation of the Northern Ireland Protocol for medicines that risk divergence between Northern Ireland and Great Britain.
Northern Ireland continues to comply with the European Union acquis in respect of medicines and medical devices while Great Britain does not. Therefore, unlike Great Britain, Northern Ireland must comply with the Falsified Medicines Directive and rely upon European Medicines Agency (EMA) authorisations for Centrally Authorised Products which include vaccines and innovative medicines.
In relation to Centrally Authorised Products, differences in regulatory approval timelines and authorisation conditions between Northern Ireland and Great Britain are increasing in frequency and complexity. This is placing at risk my Department’s long standing policy link with the National Institute for Health and Care Excellence (NICE), for the managed entry of new medicines in Northern Ireland.
NICE recommendations are based on the Medicines and Healthcare products Regulatory Agency (MHRA) authorisations for novel medicines. Any divergence between MHRA and EMA authorisations means that only partial endorsement of NICE guidance is possible in Northern Ireland in line with the EMA licence.
I have raised these issues with the Department of Health and Social Care (DHSC) and my officials will continue to work closely with DHSC as there is the immediate need for a solution for those issues not addressed by the April 2022, European Commission legislation.