Select Committee on European Communities Report



43.  PROPOSAL FOR A COUNCIL REGULATION (EC) AMENDING REGULATION (EC) NO. 1221/97 LAYING DOWN GENERAL RULES FOR THE APPLICATION OF MEASURES TO IMPROVE THE PRODUCTION AND MARKETING OF HONEY (8774/98)

Letter from Lord Tordoff, Chairman of the Committee, to Jeffrey Rooker MP, Minister of State, Ministry of Agriculture, Fisheries and Food

  I sifted the above document to Sub-Committee D for information only. The Sub-Committee would however like me to raise certain points with you.

  Under the previous administration, the Committee reported the Commission's initial proposal on the production and marketing of honey (Session 1996-97, 3rd Report, HL Paper 55). I would draw your attention especially to paragraphs 40-52 of that report. Lord Donoughue then replied on behalf of your administration, and this was published in Correspondence with Ministers (Session 1997-98, 11th Report,HL Paper 60, p 78). At that time, the Government disagreed with the Committee that more public funds should be used to assist research and practice in combating varroa. Lord Donoughue considered that only present research projects should be funded, without expansions. Your latest memorandum does not alter that approach.

  The Sub-Committee would like to stress that use should be made of the EC aid available to make an additional commitment to the Government's programme to combat the consequences of varroa. The amount scheduled to come to the United Kingdom (approximately 474,000) is far in excess of what was considered at earlier stages. Further research into the disease could be sponsored without affecting the resourcing of other research projects. Additionally, there is currently in the United Kingdom only one licensed treatment for varroa. Manufacturers are discouraged from applying for licences for further treatment as the cost of application cannot satisfactorily be set against profits from sales. Beekeepers are concerned that the widespread use of a single treatment will encourage resistance to develop rapidly. Part of the EC aid might be directed to assisting manufacturers to licence their products.

  The Sub-Committee was surprised to learn that it is now contrary to EC law for beekeepers to import for use in the United Kingdom treatments which have been licensed in other Member States. Would the Government like to comment on this unsatisfactory development?

30 July 1998

Letter from Elliot Morley, Minister for Fisheries and the Countryside, Ministry of Agriculture, Fisheries and Food, to Lord Tordoff, Chairman of the Committee

  Thank you for your letter of 30 July to Jeff Rooker.

  I understand the point the Committee has made about increasing expenditure on bee health related Research and Development to help combat varroa. This has been reiterated by the considerable number of beekeepers who have written to us either direct or to Members of Parliament on the same subject.

  You will know that any funding we receive from the Commission is not "free money"; the UK Exchequer has to find around 70 per cent. To convert this into pounds sterling, for the first year of the scheme, of the £474,000 we hope to receive, the actual net benefit to the UK is only around £140,000. For the second year (when the UK's reimbursement has been scaled back substantially by the Commission) this net benefit falls to less than £90,000.

  These sums in themselves are not enormous but did prove helpful in defending our expenditure in this area during the Comprehensive Spending Review. You will appreciate that all budgets were under intense scrutiny during the Review and bee health was no exception. An announcement on future spending will be made later in the year. In addition, our research and development in this area is entirely directed at varroa. We have recently placed a contract worth around £400,000 over five years to conduct a project into the use of biological control mechanisms.

  Turning to the issue of the prohibition on the import of veterinary medicinal products, it might be useful if I set out some of the background to this issue.

  In the ECJ case C-297/94 Bruye"re v. Belgium, the Court extended the scope of Directive 81/851/EEC to prohibit the import of veterinary medicinal products which are not authorised in a Member State, with a view to marketing or administering them there. It had previously been the Veterinary Medicines Directorate's (VMD) interpretation, based on earlier case law and with the Commission's agreement, that veterinary medicines not marketed in the UK were not subject to the provisions of the Directive since they were not being offered for sale.

  The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994 were amended to implement the judgement into UK legislation, coming into force on 1 February 1998. They make it an offence to import into the UK a veterinary medicinal product, such as Apistan, not authorised here, for the purpose of administering it to an animal. The implementation of the prohibition on the administration of imported unauthorised veterinary medicinal products was carried out by the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997.

  Papers, formally consulting on the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997, were issued on 12 February 1997. Four beekeeping organisations were part of this consultation, including the British Beekeepers Association and the Bee Farmers Association.

  The VMD is aware that there is a lack of authorised veterinary products available for use in the beekeeping industry and this has meant for many years that beekeepers have used substances which have been developed for other, often industrial, purposes which they have found, probably accidentally, to have particular curative properties. It appreciates that beekeepers have relied on these non-medicinal curative properties. It appreciates that beekeepers have relied on these non-medicinal curative substances to allow them to carry out a duty of care to their bees and to fulfil welfare requirements. The Residues Regulations would prohibit the administration of these non-medicinal curative substances only where, if transmitted to honey, they would be likely to be harmful to human health. If the substance is not harmful, the Residues Regulations would not prevent it from being administered.

  In respect of most of these non-medicinal curative substances it will be clear whether or not they present a danger to consumers. If an issue of safety were to arise, the Department would seek expert advice from bodies such as the Department of Health's Committee on Toxicology of Chemicals in Food, Consumer Products and the Environment (the COT) as to whether the use of a substance had the potential to result in food residues which might be harmful to consumers. If they so advised, the Residues Regulations would give Ministers the powers to enforce the prohibition of the administration of that substance. Experience has shown, however, that full reporting of results by the VMD, with an open discussion of the issues followed by appropriate liaison with the relevant sections of the trade, can be effective in helping to ensure consumer safety and in lessening the need for immediate enforcement action.

  The question of any applications for authorisation of new veterinary drugs is one for the pharmaceutical and beekeeping industries. Any such application would be assessed against the statutory criteria of safety, quality and efficacy. It is not, however, always necessary for a new and separate authorisation application to be made in a particular Member State. It is open to any Marketing Authorisation Holder (MAH) wishing to market a veterinary medicinal product in more than one Member State to use the mutual recognition procedures. This can be achieved by asking the second of subsequent Member States to mutually recognise the marketing authorisation granted, in accordance with Directive 81/851 EEC and Directive 81/852 EEC, by the Reference Member State (RMS). In practice, the MAH will need to first liaise with the Member State they wish to act as RMS. The RMS will then advise the applicant and co-ordinate the mutual recognition of the authorisation with the other Member States in which the applicant wishes to market the product.

  The VMD do understand the problems the beekeeping industry faces from its diverse structure and small production units. In this respect, all other industries which are subject to statutory residue testing will be required to pay for the full costs of their individual programmes. Ministers have agreed, however, that MAFF will continue to pay for the costs of the honey programme.

  I hope this information is helpful.

30 September 1998

Letter from Lord Tordoff, Chairman of the Committee to Mr Elliot Morley MP, Minister for Fisheries and the Countryside, Ministry of Agriculture, Fisheries and Food

  Thank you for your letter of 30 September concerning beekeeping and honey: Sub-Committee D took note of its contents at its meeting on 14 October. The Sub-Committee is grateful for your clarification of the funding question, and pleased to learn that MAFF is concentrating its resources on combating varroa, if with little EC assistance. The Sub-Committee is not, however, happy with your suggestion that applications for authorisation of new veterinary drugs are a matter for the pharmaceutical and beekeeping industries alone. It considers that the Government should be more concerned to promote the introduction of alternative treatments. To reiterate the point already made by the Sub-Committee, part of the money spent on researching varroa could be used to license an additional treatment. This would help to end the use of inappropriate treatments to which you drew attention in your letter.

  Finally, it seems to the Sub-Committee that the ban on the use of veterinary medicines licensed in one Member State and used in another imposed following the ECJ judgment in C-297/94 is contrary to the aims of the single market. Is there any prospect of this seeming anomaly being corrected? This would remove the need for the licensing in the UK of varroa products which are already licensed for use in other Member States, and so avoid any cost to the Government or the pharmaceutical and beekeeping industries.

  The Sub-Committee will be keeping this subject under review.

8 December 1998

Letter from Jeff Rooker MP, Minister of State, Ministry of Agriculture, Fisheries and Food, to Lord Tordoff, Chairman of the Committee

  Thank you for your letter of 8 December to Elliot Morley about beekeeping and honey.

  Now that Apistan has been approved for use in the UK the question of MAFF paying to license a new treatment is largely academic. But it is still not a question I would endorse. In no other case has the Department sought to fund statutory licensing requirements for commercial companies and I would not wish to set a precedent here.

  You also raise the issue of the use in a Member State of veterinary medicines authorised in another Member State. Council Directive 81/851/EEC prohibits the marketing or administration of veterinary medicinal products unless they are subject to a marketing authorisation valid in the Member State concerned. Similar provisions have applied in the UK since the coming into force of the 1968 Medicines Act. Such authorisations are only issued where scientific assessment of data produced by the applicant demonstrates that the product meets the statutory requirements of safety, quality and efficacy taking account of the circumstances and conditions of intended use. These may, of course, vary in different Member States. However, the wording of the Directive was interpreted by the UK, with the agreement of the Commission, as applying only to products which were placed on the market in the UK. On this basis the "personal import" of products which were authorised in another Member State in accordance with the Directive and their use in the importer's own animals were permitted. This approach was taken against the background that administration of unauthorised pharmacologically active substances to most food-producing animals was prohibited by separate legislation controlling residues of veterinary medicines and such "personal imports" were always intended to be exceptional. In case C-297/94, the European Court of Justice ruled that the Directive's provisions applied to veterinary medicinal products whether or not they were placed on the market, thus prohibiting "personal imports".

  So far as the Single Market is concerned, there has in recent years been much movement towards the harmonisation of authorisation procedures in the Member States and the criteria against which products are assessed. However, there remains a need for Member States to take account of circumstances and conditions of use that may affect the safety, quality or efficacy of veterinary medicines within their territory. In 1995, two new procedures, designed to make it easier for companies to market veterinary medicines within the Community, were introduced. The centralised procedure allows companies producing eligible products to apply for a single marketing authorisation which is valid throughout the Community (there is provision for Member States to apply restrictions on use in their territory where these are justified and considered necessary). In addition, the decentralised procedure allows companies who hold a marketing authorisation in one Member State to apply for it to be recognised in one or more other Member States. These procedures were introduced to avoid the need for companies wishing to market veterinary medicines in more than one Member State to submit separate applications and supporting data to each Member State concerned under its own national procedures. Indeed, since 1 January 1998, national authorisation procedures may not be used for veterinary medicinal products which are already authorised in one or more Member States.

8 January 1999


 
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