Medicines (Veterinary Drugs) (Jersey) Order 2011

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While there is a presumption toward publication to support of transparency and accountability, detailed information may not be published if, for example, it would constitute a breach of data protection, or disclosure would prejudice commercial interest.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 on 27 April 2011:

Decision Reference: MD-HSS-2011-0014
Decision Summary Title :	Medicines (Veterinary Drugs) (Jersey) Order 2011		Date of Decision Summary:	8th April 2011
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 (Veterinary Drugs) (Jersey) Order 2011		Date of Written Report:	8th April 2011
Written Report Author:	Chief Pharmacist		Written Report : Public or Exempt? (State clauses from Code of Practice booklet)	Public
Subject: Medicines (Veterinary Drugs) (Jersey) Order 2011
Decision(s): The Minister made the Medicines (Veterinary Drugs) (Jersey) Order 2011
Reason(s) for Decision: The Minister accepted a request from the States Veterinary Officer and recommendation from the Medicines Advisory Council that the Medicines (Jersey) Law 1995 be amended to provide a mechanism which permits the importation of unlicensed veterinary medicines subject to certain conditions
Resource Implications: None
Action required: The Minister to sign, date and seal the Order To forward the signed and sealed Order to the Publications Editor at the States Greffe
Signature:		Position: Minister for Health and Social Services
Date Signed:		Date of Decision (If different from Date Signed):

Medicines (Veterinary Drugs) (Jersey) Order 2011

STATES OF JERSEY

HEALTH AND SOCIAL SERVICES DEPARTMENT

Medicines (Jersey) Law 1995

Importation of Unlicensed Veterinary Medicines

Issue

The Minister is requested to consider a request from the States Veterinary Officer for authorisation of the importation of unlicensed veterinary medicines in certain circumstances. The importation of this unlicensed veterinary medicinal product is generally prohibited by Article 8(3) of the Medicines (Jersey) Law 1995. An amending Order has been drafted to permit the importation of specified veterinary drugs without a product licence.

Background

There are an increasing number of instances when, due to manufacturing or distribution problems, a veterinary medicine authorised or licensed for use in the UK and Jersey becomes temporarily unavailable. While there is often an alternative authorised medicine for the same indication this is not always the case. In such cases it may be necessary to obtain supplies of a veterinary medicine authorised in another jurisdiction containing the same active ingredient in order that animal care is not compromised.

Recently a number of such instances have occurred and stocks of the affected medicines held by veterinary surgeons in the Island have become depleted.

Legal Position

Article 8(3) of the Medicines (Jersey) Law 1995 provides that no person shall import any medicinal product except in accordance with a product licence. There are exemptions in the Law to provide for the importation of unlicensed human medicines when the importation is by or to the order of a doctor or dentist for administration to a particular patient of his or hers.

The Law does not contain a similar exemption in relation to veterinary medicines and veterinary surgeons and therefore the importation on unlicensed veterinary medicines is completely prohibited.

The Minister may, by Order, declare that the restrictions on importation of an unlicensed veterinary medicine, imposed by Article 8(3) of the Medicines (Jersey) Law 1995, shall not apply in such circumstances as may be prescribed.

The Medicines Advisory Council has been consulted and recommends that the Medicines (Jersey) law 1995 be amended to provide a mechanism to allow the importation of unauthorised veterinary medicines in certain circumstances.

An amending Order, The Medicines (Veterinary Drugs) (Jersey) Order 2011 has been drafted, which permits the importation of specified veterinary drugs without a product licence subject to certain conditions, if the importation is authorised by the Minister for Health and Social Services.

Recommendation

The Minsiter is recommended to make the Medicines (Veterinary Drugs) (Jersey) Order 2011 which will come into effect the day after it is made.

Paul McCabe

Chief Pharmacist

8th April 2011