Medicines (Jersey) Law 1995: Amendment: Law drafting instructions relating to medicinal tests on animals

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A decision made 5 November 2015:

Decision Reference: MD-HSS-2015-0035
Decision Summary Title :	Medicines (Jersey) Law 1995 – Authorisation of Medicinal Tests on Animals		Date of Decision Summary:	15th October 2015
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 – Authorisation of Medicinal Tests on Animals		Date of Written Report:	15th October 2015
Written Report Author:	Chief Pharmacist		Written Report : Public or Exempt? (State clauses from Code of Practice booklet)	Public
Subject: Medicines (Jersey) Law 1995 – Authorisation of Medicinal Tests on Animals
Decision(s): The Minister approved a proposed amendment to the Medicines (Jersey) Law 1995 to allow for medicinal tests on animals when part of a restricted procedure licensed under the Animal Welfare (Jersey) Law 2004.
Reason(s) for Decision: There is a potential conflict between the Medicines (Jersey) Law 1995 and the Animal Welfare (Jersey) Law 2004 such that it would be unlawful under the provisions of the Medicines (Jersey) Law 1995 to administer medicines to animals as part of a restricted procedure licensed under the provisions of the Animal Welfare (Jersey) Law 2004
Resource Implications: None
Action required: The Law Draftsman to be requested to prepare the necessary amendment on the basis of a drafting brief to be provided by the Chief Pharmacist.
Signature:		Position: Minister for Health and Social Services
Date Signed:		Date of Decision (If different from Date Signed):

Medicines (Jersey) Law 1995: Amendment: Law drafting instructions relating to medicinal tests on animals

STATES OF JERSEY

HEALTH AND SOCIAL SERVICES DEPARTMENT

Medicines (Jersey) Law 1995

Authorisation of Medicinal Tests on Animals

Issue

The Minister is requested to consider amending the Medicines (Jersey) Law 1995 to provide that the use of medicines in tests or trials on animals can be undertaken as part of a restricted procedure authorised under the provisions of the Animal Welfare (Jersey) Law 2004.

Introduction

The Medicines (Jersey) Law 1995 currently prohibits absolutely the administration of any medicinal product to any animal by way of a medicinal test on animals. The Animal Welfare (Jersey) Law 2004 provides for the establishment of a scheme where certain restricted procedures may be carried out on animals subject to, and in accordance with, a licensing scheme under the Animal Welfare (Jersey) Law 2004.

However, due to the absolute prohibition on the use of medicines in any test or trial on animals provided for by the Medicines Law it is not possible under the Animal Welfare Law to authorise or licence a restricted procedure such as a clinical trial of a medicine in animals to determine, for example, the effectiveness and safety of that medicine.

The Medicines (Jersey) Law 1995 defines “medicinal test on animals” as

a) the administration of a medicinal product of a particular description to one or more animals, where there is evidence that medicinal products of that description have effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals, and the product is administered for the purpose of ascertaining whether, or to what extent, it has those or any other effects, whether advantageous or otherwise;

(b) the administration of a medicinal product to one or more animals in circumstances where there is no such evidence as is mentioned in sub-paragraph (a), and the product is administered for the purpose of ascertaining whether, or to what extent, it has any effects relevant to a medicinal purpose;

(c) the administration of any substance or article, other than a medicinal product, to one or more animals for the purpose of ascertaining whether it has any effects relevant to a medicinal purpose, whether there is evidence that it has effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals, or not.

Background

The conflict between the Medicines Law and the Animal Welfare Law was first highlighted in 2008 when Durrell sought to undertake some research into the optimal dose of an anaesthetic in a rare species of Mountain Chicken Frogs. At this time legal advice was sought and confirmed that due to the provisions of the Medicines Law such a test or trial would be unlawful irrespective of any authorisation given under the provisions of the Animal Welfare Law.

At that time, while it was possible to have a mechanism to grant an authorisation or licence for certain restricted procedures under the Animal Welfare Law, no mechanism for the granting of an authorisation had yet been established in regulations.

It was consequently agreed that when regulations were being drafted under the Animal Welfare Law to establish a system to authorise or licence certain restricted procedures, the Medicines Law would be amended to permit the use of medicines in any authorised or licensed restricted procedure. This would then provide a resolution to the conflict between the two Laws.

The Environment Department are now close to finalising regulations to establish a licensing scheme for restricted procedures under the Animal Welfare Law and therefore an amendment to the Medicines (Jersey) Law is now required.

Recommendation

The Minister is requested to approve an amendment to the Medicines (Jersey) Law 1995 such that medicines may be administered to animals as part of a restricted procedure authorised or licensed under the Animal Welfare (Jersey) Law 2004 and direct the Chief Pharmacist to liaise with the Law Draftsman accordingly.