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While there is a presumption toward publication to support of transparency and accountability, detailed information may not be published if, for example, it would constitute a breach of data protection, or disclosure would prejudice commercial interest.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 (25/01/2008) regarding: Medicines (Jersey) Law 1995 – Application for Manufacturer’s Licence.

Decision Reference: MD-HSS-2008-0006
Decision Summary Title :	Medicines (Jersey) Law 1995 – Application for Manufacturer’s Licence		Date of Decision Summary:	18th January 2008
Decision Summary Author:	Paul McCabe – 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 Manufacturer’s Licence		Date of Written Report:	18th January 2008
Written Report Author:	Paul McCabe – Chief Pharmacist		Written Report : Public or Exempt? (State clauses from Code of Practice booklet)	Public
Subject: Medicines (Jersey) Law 1995 – Application for Manufacturer’s Licence
Decision(s): The Minister granted a manufacturer’s licence to the Jersey Blood Service for a period of 5 years, and in accordance with the provisions set out in the attached supporting document.
Reason(s) for Decision: An application for the grant of a manufacturer’s licence had been received from Mr Mark Littler on behalf of 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 grant of a manufacturer’s licence and sign and seal the licence.
Signature: Senator Ben Shenton		Position: Minister for Health and Social Services
Date Signed: 25 January 2008		Date of Decision (If different from Date Signed):

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

STATES OF JERSEY

HEALTH AND SOCIAL SERVICES DEPARTMENT

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

Issue

The Minister is requested to consider the granting of a manufacturer’s licence to the Jersey Blood Service (JBS).

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. The Health and Social Services Committee has on previous occasions, and most recently in January 2006, granted a licence for this activity. The current licence expires on 31st January 2008 and an application, in accordance with the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) (Jersey) Order 1997, has been received seeking licensing of the JBS for a further period of 5 years.

The current licence, effective from 31st January 2006, was granted for a period of 2 years, on the understanding that a formal agreement with the National Blood Authority will be reached in order to satisfy the outstanding quality management issues previously identified. (These issues related to the manpower availability to deliver the required quality management programme and the effectiveness of the computer system to eliminate risk in the process.)

In addition, at the time the existing licence was granted, the full impact of new EU and UK regulations controlling the manufacture and supply of blood products was unclear and this contributed to the view that a 2 year licence was more appropriate at that time. The introduction of new legal requirements governing the control of blood safety and quality in Jersey is therefore being considered to bring Jersey legislation in line with that of the EU and UK.

Progress Since Previous Application

Following the approval of the current 2 year licence, the Jersey Blood Service (JBS) made a formal approach for assistance to the National Blood Service (NBS) via its Chief Executive Officer. Consequently, Richard Bedford, NBS Director of Processing, Testing and Issue was asked to work with JBS to evaluate the situation and assist in defining and implementing a strategic way forward which would satisfy the outstanding quality management issues previously identified. This work paved the way for the “PULSE project” which was completed in October 2007.

The PULSE project involved a number of strands:-

Purchase of PULSE, the computer system used by the National Blood Service (NBS) to control and manage their collection, testing and issue operations to standards required by the Medicines and Healthcare Regulatory Agency. (MHRA).

Purchase of Quality Management Consultancy and PULSE implementation support from the NBS, to guide the JBS to a successful implementation and to comply with the standards of best practice in UK and Europe.

Purchase of equipment and appointment of staff to allow the JBS to prepare certain new blood products in accordance with revised guidance from the NBS in order to further decrease the risk of transmitting variant Creutzfeld-Jacob (vCJD) and further decrease the occurrence of Transfusion Related Acute Lung Injury (TRALI) compared to previously used blood products.

The Jersey Blood Service now complies with European and UK best practice regarding blood manufacture. However, as Jersey legislation regarding the manufacture of blood products has not yet been amended to take account of the new EU and UK recommendations, the JBS does not satisfy all the provisions contained in Articles 6 and 21 of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) (Jersey) Order 1997 relating to the qualifications and experience required by an individual whose functions relate to the control of quality

It is proposed in the application that arrangements employed by the JBS for quality management will be in accordance with the revised EU and UK regulations and involve a senior scientist from the JBS who is not involved in the processing of blood working in collaboration with a Quality Management Consultant from the NBS. In addition to the programme of internal audits planned by the Quality Management Consultant, it is the intention of the JBS to be audited to Medicine and Healthcare Products Regulatory Agency (MHRA) standards in 2009/10.

In order to be compliant with EU and UK best practice guidance, the Jersey Blood Service has therefore requested that Articles 6 and 21 of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) (Jersey) Order 19971 are excluded from the standard provisions applicable to this licence and replaced with the provisions contained in Article 9 of Directive 2002/98/EC of the European Parliament2.

The Medicines (Jersey) Law 1995 is expected to be amended in due course to implement the revised EU and UK. regulations and guidance relating to blood safety

Recommendation

The Minister is requested to grant a manufacturer’s licence to the Jersey Blood Service for a period of 5 years in accordance with the provisions outlined above.

References

www.jerseylegalinfo.je/law/display.aspx?url=lawsinforce%5cconsolidated%5c20%5c20.625.85_medicines(standardprovisionsforlicencesandcertificates)order1997_revisededition_1january2006.htm)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:033:0030:0040:EN:PDF)

Paul McCabe

Chief Pharmacist

18th January 2008