Topics and Briefing Documents

Review 2001 - An Overview

What Is Review 2001?

In accordance with the European Regulation that set up the European Medicines Evaluation Agency (and also set out the Centralised procedure for licensing animal medicines), the European Commission was required to carry out a review after five years of the legislative procedures for control of medicines, including those for animals.

With strong and active support from NOAH, the European federation for animal health FEDESA worked on an extensive set of proposals for change, to improve the systems which the industry thought weren’t working as well as they could. Much of this work was done with the active collaboration of other European bodies, such as the Federation for Veterinarians in Europe, in a bid to improve the availability of animal medicines to keep animals healthy. As a result, not only has the Commission carried out a review (which it was obliged to do) but has proposed extensive changes (which it was not required to do).

The final proposals from the Commission have now been sent to the European Parliament and Council of Ministers. These proposals will be debated in parallel (under the "Co-Decision Procedure") by these two bodies.

A summary of what NOAH welcomes in these proposals, and what it would like to see changed is set out below:

Improving the availability of animal medicines

The proposals contain many good points, which should work to improve the availability of medicines, while still affording good protection for public and animal health. These include:

• Replacement of the "mutual recognition" system of approval by a "decentralised" procedure
• Quicker assessment - tighter deadlines for authorities to carry out assessments
• Better data protection
• Arbitration procedure improved - should reduce disagreements between member states & streamline process
• Mutual Recognition Facilitation Group given official status - further move to improve consistency
• Enhanced pharmacovigilance- replacing the costly and burdensome 5 year renewal process
• Minor species improvements - reduced data requirements, more data protection, and extension of exemptions for minor pet species to rabbits and ferrets
• Residues requirements made more practical, particularly in relation to analytical methods
• Improved legal process - more power to the system, less opportunity for unscientific political interference

Proposals that could hinder medicines availability

However, the proposals also include some ideas which would jeopardise the availability of medicines, including:

• POM for food animal products - all products (from teat dips upwards) for food-producing animals, including horses, would have to be POM forever, removing the option for PML or GSL
• Requirement to market - authorisations would be withdrawn if a company doesn’t market a product during any two-year period - problem for sporadic diseases, certain vaccines, authorisations held for export purposes, co-marketing contract difficulties, problems at manufacturing plant etc.
• No choice of registration route - requirement to use Centralised procedure for all new active substances, even if already in human use
• Business flexibility - problems for co-marketing
• Forced harmonisation of old products - for "harmonisation" read "loss of indications and longer withdrawal periods"

The Timetable

On 26 November 2001, the Commission’s final proposals were sent for consultation in Parliament and Council via the "Co-Decision procedure". The proposals will be considered by the Environment Committee of European Parliament.

The first Council working group meeting is scheduled for 17 December 2001. Agreement may take up to two years to reach, so no changes to the law can be expected before 2004 or 2005. However, this is a major and very rare opportunity to have a significant impact on the legislation which will control our industry for the next decade.

NOAH activity

NOAH has been active in working with its European federation FEDESA for almost two years on this project, with significant input into the Commission’s review process. This has resulted in quite a number of positive proposals from the Commission. Now the proposals are published, through membership of FEDESA’s Medicines Availability Steering Committee (MASC), Communications Committee, Technical & Regulatory Committee, and Regulatory Procedures Ad Hoc Group, NOAH and the UK will continue to have considerable input into FEDESA activity.

POM Proposals

Probably the issue key to the UK animal medicine issue is the proposal to make all medicines for farm animals POM. On this issue, an Animal Health Alliance of concerned UK organisations has been formed to fight the proposals.

A key success following extensive lobbying was the announcement by Lord Whitty that the UK government has committed to seeking an amendment to give sufficient flexibility to allow national systems of distribution to continue. This has been repeated several times by other DEFRA ministers. A NOAH-inspired survey carried out by FEDESA confirms that there are non-POM food-animal products in all member states.

There is strong and unanimous support for the non-POM sector from all national associations and all corporate members of FEDESA.

The Commission argues that the reason for the change is not public health related, but to ensure consistency with another Directive on who is responsible for residues - the vet or the farmer? We consider the Commission’s interpretation to be wrong, and will be making this point strongly.

The proposals from the Commission require all products for food-producing animals, including horses, would require a veterinary prescription. However, they define "veterinary prescription" as a "prescription for veterinary medicinal products issued by a professional person qualified to do so". How this may actually be interpreted in practice may well be worthy of further consideration.

Review 2001 is not happening in isolation: the Independent Review of Veterinary Dispensing (the Marsh report) covers similar ground.