Government of Jersey

Information about the publication of Ministerial Decisions

A formal published “Ministerial Decision” is required as a record of the decision of a Minister (or an Assistant Minister where they have delegated authority) as they exercise their responsibilities and powers.

Ministers are elected by the States Assembly and have legal responsibilities and powers as “corporation sole” under the States of Jersey Law 2005 by virtue of their office and in their areas of responsibility, including entering into agreements, and under any legislation conferring on them powers.

An accurate record of “Ministerial Decisions” is vital to effective governance, including:

demonstrating that good governance, and clear lines of accountability and authority, are in place around decisions-making – including the reasons and basis on which a decision is made, and the action required to implement a decision
providing a record of decisions and actions that will be available for examination by States Members, and Panels and Committees of the States Assembly; the public, organisations, and the media; and as a historical record and point of reference for the conduct of public affairs

Ministers are individually accountable to the States Assembly, including for the actions of the departments and agencies which discharge their responsibilities.

The Freedom of Information Law (Jersey) Law 2011 is used as a guide when determining what information is be published. While there is a presumption toward publication to support of transparency and accountability, detailed information may not be published if, for example, it would constitute a breach of data protection, or disclosure would prejudice commercial interest.

A decision made 31 May 2018:

Decision Reference: MD-HSS-2018-0022
Decision Summary Title :	Medicines (Jersey) Law 1995 – Application for extension of Manufacturer’s Licence		Date of Decision Summary:	22nd May 2018
Decision Summary Author:	Chief Pharmacist		Decision Summary: Public or Exempt? (State clauses from Code of Practice booklet)	Public
Type of Report: Oral or Written?	Written		Person Giving Oral Report:
Written Report Title :	Medicines (Jersey) Law 1995 – Application for extension of Manufacturer’s Licence		Date of Written Report:	22nd May 2018
Written Report Author:	Chief Pharmacist		Written Report : Public or Exempt? (State clauses from Code of Practice booklet)	Public
Subject: Medicines (Jersey) Law 1995 – Application for extension of Manufacturer’s Licence
Decision(s): The Minister extended the current manufacturer’s licence to the Jersey Blood Service, on the same terms and conditions as the existing licence, for a period of 3 months to provide for the manufacture of blood components in emergency circumstances up until 31st October 2018
Reason(s) for Decision: An application for the extension of the manufacturer’s licence has been received from the Jersey Blood Service in accordance with the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) (Jersey) Order 1997
Resource Implications: None
Action required: Minister to approve the application from the Jersey Blood Service for the extension of the manufacturer’s licence and sign and seal the licence.
Signature:		Position: Minister for Health and Social Services
Date Signed:		Date of Decision (If different from Date Signed):

Medicines (Jersey) Law 1995 – Application for Extension of Manufacturer’s Licence

STATES OF JERSEY

HEALTH AND SOCIAL SERVICES DEPARTMENT

Medicines (Jersey) Law 1995 – Jersey Blood Service Application for Extension of Manufacturer’s Licence

Issue

The Minister is requested to consider extending the current emergency manufacturer’s licence to the Jersey Blood Service (JBS) for a further period of 3 months while refurbishment works are completed.

Background

Article 9(2) of the Medicines (Jersey) Law 1995 requires that manufacturers of medicinal products be licensed. The preparation of products by the Jersey Blood Service (JBS) from blood collected from donors constitutes manufacture of a medicinal product, and consequently requires the JBS to be licensed as a manufacturer.

On Expiry of the previous licence on 31st January 2018 routine collection and production of blood components was temporarily suspended while an upgrade of facilities was undertaken. Since 1st February blood has been sourced from the UK. However, in order to provide resilience in the event that supplies are disrupted the ability to collect blood and produce blood components locally needs to be maintained.

The current licence granted on 24th January 2018 was for a period of 6 months and expires on 31st July 2018. This licence was to enable the collection of blood and production of blood components to be undertaken in emergency circumstances should supplies from the UK be compromised while the planned upgrade of facilities locally is undertaken.

The upgrade of facilities has taken longer than originally envisaged and a three month extension to this 6 month licence has been requested to run through to 31st October 2018.

Accordingly an application, in accordance with the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) (Jersey) Order 1997, has therefore been received seeking an extension of the existing license on the same terms and conditions for a further period of 3 months

Recommendation

The Minister is requested to extend the current manufacturer’s licence to the Jersey Blood Service for a further period of 3 months, expiring on 31st October 2018, to provide for the manufacture of blood components in emergency circumstances and subject to the same conditions provided for by the existing licence.