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Implementing appropriate local oversight of manufacturing and prescribing

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WQ.188/2025

WRITTEN QUESTION TO THE MINISTER FOR HEALTH AND SOCIAL SERVICES

BY DEPUTY I. GARDINER OF ST. HELIER NORTH

QUESTION SUBMITTED ON MONDAY 28th APRIL 2025

ANSWER TO BE TABLED ON TUESDAY 6th MAY 2025

Question

"Will the Minister state what plans, if any, he has to enhance the general regulatory framework for medicinal products (including medical cannabis and medical technology) and, in particular, to implement measures to improve the oversight of the manufacturing and prescribing of such products to ensure local alignment with internationally-recognised regulatory standards?"

Answer

The regulation of medicinal products falls under the provisions of the Medicines (Jersey) Law 1995. The Medicines Advisory Council is a statutory body that advises on matters relating to this legislation.

Controlled drugs are subject to additional regulation under the Misuse of Drugs (Jersey) Law 1978. The Advisory Council for the Misuse of Drugs is a statutory body that advises on matters relating to this legislation.

While both pieces of legislation remain functional, it is recognised that aspects of each require development to ensure they remain fit for purpose in a rapidly evolving regulatory landscape. This review and development work is underway and ongoing.

In terms of the practical regulation of medicines and medicinal products, this function is led by the Chief Pharmacist's team. To support this work, a Memorandum of Understanding (MoU) is in place with the UK medicines regulator, the MHRA, thereby drawing on the expertise of an internationally recognised National Regulatory Authority to provide specialist technical input to our processes.

Jersey aligns its medicines regulatory framework with the UK's MHRA to ensure legal, operational, and market compatibility with UK systems. All medicines placed on the Jersey market should be authorised by the MHRA and manufactured in accordance with EU-GMP standards, ensuring high-quality, safe, and effective products.

It is important to note that prescribing is a clinical decision made by appropriately qualified and professionally registered prescribers. All prescribers practising in Jersey are registered with the Jersey Care Commission (JCC). Should any concerns arise regarding an individual prescriber, these would be addressed through the appropriate professional regulatory body.

It is recognised that the regulation of the wider clinical environment, including the operation of clinics that specialise in prescribing unlicensed Cannabis Based Medicinal Products (CBPMs), is important to ensure appropriate standards. In this respect, it is intended that such clinics should in due course fall under the remit of the Regulation of Care (Jersey) Law 2014 and the Jersey Care Commission.

In summary, I am satisfied that our current regulatory arrangements, drawing on the support of the MHRA, are appropriate and robust. Any future enhancements to Jersey's regulatory framework will be considered carefully, with a view to maintaining patient safety, supporting clinical independence, and ensuring appropriate oversight.