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