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Written Ministerial Statements

Wednesday 9 July 2003

HOME DEPARTMENT

Assets Recovery Agency

The Parliamentary Under-Secretary of State for the Home Department (Caroline Flint): I am pleased to announce that copies of the first annual business plan for the Assets Recovery Agency have been placed in the Libraries of both Houses. The plan has been prepared by the Director of the Agency and has been approved by my right hon. Friends the Home Secretary and the Secretary of State for Northern Ireland.

The plan is the first by the new Agency and covers the financial year 2003–04, its first full year of operation. In accordance with the Proceeds of Crime Act 2002, the plan includes a statement of the Director's objectives for the financial year, performance targets, priorities, financial resources, and the proposed allocation of those resources.

I particularly welcome the emphasis on reducing crime through recovering criminal assets by working in partnership with other organisations. The plan also recognises the Agency's important role in Northern Ireland and the need to work with partner agencies there.

The Agency has a major role to play in recovering criminal assets and making sure that crime does not pay. The plan sets out how it will achieve this in 2003–04.

NORTHERN IRELAND

Regional Development Strategy

The Minister of State, Northern Ireland Office (Mr. John Spellar): Earlier today I placed in the Library the first annual report on the implementation of the regional development strategy for Northern Ireland 2025.

Significant progress has been made in the implementation of the strategy since its formulation in September 2001 by the devolved government in Northern Ireland. The strategy sets a regional brownfield target of at least 60 per cent. up to 2010. I am pleased that in Northern Ireland we are on target with 62 per cent. achieved in 2001–02. It is encouraging that we in Northern Ireland are playing our part to achieve the Government's brownfield targets.

The Department is building on the inclusive and participative consultation that led to the agreement of the strategy and is working closely with local groups of key stakeholders who are playing a positive and active part in its implementation. Over the coming months a series of seminars will be held throughout Northern Ireland to consider how best to develop existing

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arrangements affecting local growth and development and to produce agreed frameworks on the way forward. A first successful seminar was held on 20 June in the north-west, which addressed the sub-regional implementation of the RDS and also the impact of the National Spatial Strategy for Ireland (NSS) on development within the north-west.

Implementation, however, is not just about monitoring, important though that is. As we strive for the successful implementation of the regional development strategy, we need to learn from the experiences of regional and inter-regional developments elsewhere. The challenge is to turn the potential of the regional development strategy into positive actions that will bring about the improvements in Northern Ireland's environment, economy and society generally.

I will continue to oversee the implementation of the strategy and to report on progress on an annual basis.

A first successful seminar was held on 20 June in the north-west. This seminar addressed not only the sub-regional implementation of the RDS, but also the impact of the National Spatial Strategy for Ireland (NSS) on development within the north-west.

EDUCATION AND SKILLS

Children Act Report

The Secretary of State for Education and Skills (Mr. Charles Clarke): I have today published a report on the operation of the Children Act 1989, pursuant to my duties under section 83 of the Act. Copies are available in the Library and Vote Office. A copy of the document can also be found at the following website addresses: www.dfes.gov.uk/childrenactreport/. and http://www.doh.gov.uk/qualityprotects/index.htm.

TRADE AND INDUSTRY

Veterinary Medicines

The Parliamentary Under-Secretary of State for Trade and Industry (Mr. Gerry Sutcliffe): The Competition Commission's (CC) monopoly report on the supply in the UK of prescription-only veterinary medicines (POMs) was published on 11 April 2003. The CC found that greater competition should be brought to bear at the retail level, first, by encouraging entry by pharmacies and, secondly, by increasing the level of competition between vets and veterinary practices. In support of these findings, the report contained eleven recommendations for regulatory change, all but one of which were addressed to Government. The report also contained a number of proposed remedies under the Fair Trading Act 1973, which are being taken forward separately. I am today announcing the Government's response to the recommendations for regulatory change that were addressed to it.

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Recommendation 1: Dispensing of Veterinary Medicines

"The Secretary of State to consider changing the law to allow veterinary surgeons to dispense a veterinary prescription, whether or not the animal concerned is under their care".

The Government accepts this recommendation. It follows from the CC's proposed remedy, and is in line with the Marsh Report recommendation that the client should be offered a written prescription by the veterinary surgeon. It will allow the consumer greater freedom of choice where there are no pharmacies in a neighbourhood and should encourage more competition between vets, without adding any new risks to the animal under treatment. To implement this recommendation, national legislation will need to be amended. However, the Government recognises concerns that have been expressed that such a change could blur the lines of responsibility and conflict with the current understanding of clinical responsibility. It will, therefore, consult with interested parties to clarify these issues before amending the legislation.

Recommendation 2: Publication of Prices of Veterinary Medicines

"The Royal College of Veterinary Surgeons (RCVS) to modify its Guide to Professional Conduct to remove restrictions on veterinary surgeons' publishing the prices they charge for veterinary medicines".

This recommendation is directed at the RlCVS. However, the Government supports the recommendation in principle, as it favours price transparency.

Recommendation 3: Mandatory Centralised Route for Authorisation

"The Secretary of State to consider negotiating changes to the draft Council Regulation (proposed in COM (2001) 404 final) so as to allow all categories of veterinary medicine access to the centralised procedure, without making this mandatory for any further categories of medicine".

The Government accepts this recommendatioit– although it will be difficult to achieve it fully. The CC's proposal follows the UK's line in the Review 2001 negotiations on the European Commission's proposals to amend EC medicines legislation. This has been to allow applicants a choice of assessment procedure without making the centralised route mandatory for more products (products developed using biotechnological processes and products intended primarily for use as performance enhancers already have to use the centralised route). The present state of negotiations in Brussels is not to increase the range of products obliged to use the centralised route but to introduce optional access for all medicines which contain new active substances or are novel in some way. The possibility for generic products based on centralised authorisations will also be available. These changes, if agreed, will extend the availability of the centralised route, although not to the extent recommended by the CC.

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Recommendation 4: Adaptation of Marketing Authorisation Parallel Imports (MAPIs) for Mutually-recognised Veterinary Products

"The Secretary of State to consider establishing arrangements to allow any veterinary medicine authorised through the decentralised procedure in the UK to be imported into the UK from any other EC member state in which it is also authorised, without further individual marketing authorisation (MA) but subject to:

(i) prior notification to the Veterinary Medicines Directorate (VMD); and

(ii) the conformity of all labelling and inserts with the UK authorisation;

and to consider negotiating any changes to the Directive necessary to achieve this and to remove barriers to relabelling for this purpose".

The Government accepts this recommendation. There is already a system in place under EC legislation which controls parallel imports of medicinal products. This system requires the importer to apply for a MAPI. The CC thinks MAPIs are unnecessary for the parallel import of a mutually-recognised product already authorised in the UK. It feels the importer should simply be required to tell the VMD of their plans. The Government agrees that the MAPI system could be simplified for mutual recognition products. However, it recognises the importance of the unique marketing authorisation number for tracking trends from suspected adverse reaction reports and is concerned that this important control system would be undermined without an MA. The Government agrees that it is necessary to label the product in English for safety reasons—as is required now under the MAPI arrangements.

Recommendation 5: Classification of Veterinary Medicines

"The Secretary of State to consider amending the remits of the Veterinary Products Committee and the VMD to require them to recommend the lowest distribution classification consistent with their assessment of a product's safety, efficacy and quality".

This recommendation addresses a CC concern that companies seek a higher legal classification for their product because it requires the sale of the product by a vet or pharmacist and the company can charge a higher unit cost. The Government accepts this recommendation, which is in line with the normal assumption that legal classification should be based on the perceived risk of a product. National legislation is likely to require amendment.

Recommendation 6: Automatic Reviews of Distribution Classification

"The Secretary of State and VMD to consider instituting automatic review of distribution classification whenever a product's MA is renewed (or at similar intervals if the European Commission's proposal to make MAs permanent is adopted) and, unless there is good scientific reason to require additional information, to base such reviews on the product's existing dossier and accumulated field experience. An early benefit could result from an immediate review of the distribution classifications of ectoparasiticides (for the treatment of fleas) for companion animals, which could provide a

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particularly effective stimulus to competition from pharmacies in the supply of one of the most widely-used veterinary products".

The Government accepts this recommendation. The CC hopes this will reduce some of the current legal distribution categories, make more products more freely available and therefore increase competition and reduce prices. Such reviews are rarely carried out now, and only at the request of the MA-holder. We may be able to implement the recommendation administratively to some extent but, as with recommendation 5, amendment to national legislation may be required.

Recommendation 7: Animal Welfare and Cost Considerations

"In discharging its responsibilities for the licensing and distribution classification of veterinary medicines against the criteria of safety, efficacy and quality, the VMD should take account, where relevant, of the impact on animal welfare of the availability and accessibility to animal owners of veterinary medicines, including considerations of cost".

The CC believes that making veterinary medicinal products more freely available will lead to more pets being treated, and therefore better welfare. Government policy on the distribution of veterinary medicinal products can take the cost of a product into account, but cost and welfare will not override safety considerations. However, the UK does not have the powers under EU legislation to consider cost under the licensing assessment process which requires product applications to be judged on the grounds of safety, quality and efficacy. Provided these standards are met, it would be wrong for the Government to prevent a product being marketed because there was a cheaper alternative already available. Not all animals react in the same way to a medicine and it may be that the more expensive product will have a better result. This choice should be made together by the owner of the animal and the veterinary surgeon.

Recommendation 8: Channel of Distribution of Veterinary Medicines

"The Secretary of State, in negotiating the Draft Directive and Regulation, to keep in mind the importance of retaining member states' existing right to control the channels of distribution and supply of veterinary medicines, including those authorised through the centralised procedure".

The Government accepts this recommendation, which reflects the UK line in negotiations on Review 2001 changes to veterinary medicines legislation. However, implementation for centrally authorised products will be difficult, as such products are classified POM because their novelty means there is an increased risk. The only other distribution category which applies in all Member States is general sale, and it is a big step to move a product from prescription to general sale.

Recommendation 9: Establishing New Distribution Categories

"The Secretary of State to consider establishing one or more new distribution classifications of veterinary medicines to allow specific categories of persons (such as agricultural merchants and saddlers as well as veterinary

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surgeons and pharmacists) to dispense veterinary prescriptions for medicines so classified and to make corresponding changes to the law".

The UK's existing distribution system is designed to provide adequate controls on the distribution of veterinary medicinal products depending on the risks involved with the use of that product. The Government believes that the system currently strikes the right balance, and that rather than create additional distribution categories, it is preferable to concentrate on ensuring that veterinary medicines are classified according to the perceived risk of a product (hence its acceptance of recommendations 5 and 6). But the Government is concerned that, if adopted, the EC proposal to make POM all veterinary medicines for food- producing animals (including types at present sold by for example agricultural merchants and saddlers) would increase the risk of making such medicines more expensive and difficult to obtain, and could lead to animal welfare problems and increase the likely use of black market medicines with increased food safety risks. The Government therefore intends to review this recommendation in the light of agreed changes to EU legislation following the current review in Brussels.

Recommendation 10: MAs for veterinary medicines to be permanent

"The Secretary of State to support the European Commission's proposal to make MAs permanent (in the absence of adverse field experience or other comparable grounds for review)".

The Government notes this recommendation, which has now been overtaken by developments in Brussels. The European Commission has accepted a European Parliament proposal to require one 5-year renewal for each product.

Recommendation 11: Improvement of VMD practices

"The VMD should improve its procedures so as to minimise delays to product commercialisation, including examination of the ways in which it interacts with manufacturers prior to receipt of complete dossiers".

The Government accepts this recommendation, which is in line with the VMD's aim and practice. In recent years, the VMD has introduced streamlined procedures for dealing with applications and a new variation system. The VMD is currently reviewing its procedures for dealing with Animal Test Certificate applications and its fee system. Changes will be introduced in full consultation with customers.

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