Recommendation 1: We recommend (5.33) that veterinarians having made a diagnosis and prescribed medicine, should be required to provide a written prescription, at either no additional charge or at a fee to be determined by the RCVS acting in the public interest. Clearly this recommendation would not apply where emergency treatment is needed, for treatments during surgical procedures or for the use of anaesthetics.

1. The review team considered that a requirement placed on a veterinary surgeon to issue a written prescription when treatment involves a veterinary medicinal product classified as a Prescription only Medicine (POM) is crucial to the issue of customer choice. Following publication of the Report of the independent review team, concerns have been expressed about introducing a requirement which might add to the cost of a veterinary consultation. It might also have implications for the way in which POMs are dispensed within veterinary practices. The options appear to be:

• Strengthening professional guidance for the issue of a prescription on request of the client. The review team collected evidence that some veterinary surgeons were refusing to issue prescriptions or even indicating that, unless clients continued to buy POMs from the practice, they would no longer provide them with a service. This option would work only if the veterinary profession undertook to make the change and it was applied across the board.

• Introduce legislation to require veterinary surgeons to supply a written prescription. The legislative route would raise questions about proposed exemptions e.g. what constituted "emergency treatment" which the report identifies as an exceptional circumstance, and interpretation, e.g. can a veterinary surgeon attending an emergency, dispense a full course of treatment and claim an exemption from the need to supply a prescription.

2. A further issue is that the determination of a fee by the RCVS (or any other body) may contravene competition law.

3. The Government accepts that the client should be able to choose where he/she buys a POM for their animals. To achieve this the client should be offered a written prescription by the veterinary surgeon. The Government would prefer to introduce this change by strengthening the professional guidance, rather than by legislation.

4. The Government accepts that veterinary surgeons should be able to charge for providing a prescription in the same way as they can charge for any other service they provide. Fees are normally set between the veterinary surgeon and the client and this would apply to a fee for writing a prescription.

Recommendation 14: We recommend (5.28) that the Minister should consider moving in the longer term towards adopting a system of classification that has two major categories Prescription-only Medicines and General Sale List products. We would suggest that the POM category should be divided into three sub-groups as follows:

POM (A) - medicines which may be administered only by a veterinary surgeon or under his/her direct supervision. In the latter instance the veterinary surgeon should be present at the time of administration and in a position to render assistance if necessary.

POM (B) - medicines which may be sold or dispensed by a veterinary surgeon to animals under his care after a prior clinical examination of the animal or animals; or sold or dispensed in a pharmacy in response to a written veterinary prescription.

POM (C) - medicines which may be sold or supplied by veterinarians for administration to animals under their care, or by pharmacists or, providing the purchaser can demonstrate evidence of competence in their use, by registered agricultural merchants. For this group of products a prior clinical examination of the animal(s) is not a requirement, however in cases where no evidence of competence is available the products in this category should only be made available by pharmacies, registered agricultural merchants or other registered outlets against a written prescription from a veterinarian.

5. This recommendation recognises that the UK’s distribution arrangements for veterinary medicines differ from those in a number of other member states. In the long term, the review group felt it would be advantageous to examine the feasibility of moving to a system more closely aligned to the European model. The recommendation would effectively split the current POM classification into two between medicines which need to be administered by a veterinary surgeon or under his or her direct supervision with the veterinary surgeon present and those which do not. The current Pharmacy and Merchants List (PML) classification would be incorporated as POM(C) and products in this category would be sold by pharmacies and agricultural merchants to competent farmers (those who had been trained or had otherwise demonstrated competence) without prior examination of the animals and without a prescription. However, where no evidence of competence is available, a written prescription from the veterinary surgeon would be required.

6. The present classification and distribution system in the UK has worked well for many years. There is no evidence that it has led to abuse of veterinary medicines or to residue violations that would harm the consumer. As part of its proposals following the review of medicines legislation in Europe (Review 2001), the European Commission has subsequently proposed changes to the distribution system for veterinary medicines, most significantly, that all medicines for food producing animals should be classified POM. If this was accepted by a majority of member states then the independent review team’s proposal could serve as a model and retain the benefits of the current distribution arrangements. The Government will however argue for more flexibility in the Commission’s proposals so that Member States can take advantage of existing arrangements as long as consumer protection and animal welfare can be demonstrably assured.

Recommendation 2: We recommend (5.29) that once recommendation 14 above is implemented, prescriptions written by veterinarians should be dispensed by any suitably qualified person, including the prescribing veterinarian, other veterinarians, pharmacies and, in the case of POM (C) products, by persons holding AMTRA, SQP qualifications and employed by registered agricultural merchants or other registered retail outlets.

7. This recommendation is designed to follow up the implementation of recommendation 14 on a new system for classifying veterinary medicinal products. It broadly continues the status quo as far as the law is concerned. An exception would be that a veterinary surgeon would be allowed to dispense POMs to clients for animals not under his/her care on presentation of a prescription written by the veterinary surgeon who has the animals in question under his/her care.

8. The Government supports this recommendation which would give the client the widest choice of appropriately qualified people to dispense a prescription. Implementation would require amending legislation.

Recommendation 3: We recommend (4.18) that veterinary practices apply improved business practice in the operation of their pharmacy services with a view to reducing costs.

9. The major concern of the review team was poor control management of stocks of veterinary products. This recommendation does not call for any regulatory action but the adoption of a better quality of management practices in relation to the provision of pharmacy services operated within veterinary practices.

10. The Government supports this recommendation which is aimed at the veterinary profession. The professional bodies are keen to promote good pharmacy practice and the Government hopes that they will develop codes of practice as necessary. It encourages veterinary surgeons to take up the training available in order to help them improve their provision of pharmacy services.

Recommendation 4: We recommend (5.13) that the VMD should permit the import of medicines authorised in other member states, provided that they are properly labelled in English and sold via the approved distribution system within the United Kingdom.

Comment

11. The Government understands that the Review Group was seeking greater use by the Veterinary Medicines Directorate (VMD) of an existing provision in the relevant EC Directive which permits a member state to authorise the placing on the market of products authorised in other member states where the domestic animal health situation so requires. The current EU legislative requirement is that a product must be authorised in the UK (or any Member state) even if it is authorised elsewhere in the Union before it can be placed on the market. The normal route to bring additional products onto the UK market is to have them authorised under the mutual recognition arrangements following an application to the VMD. The VMD has acted flexibly in cases when this route is not practicable. For example, the VMD already operates a system of Special Treatment Authorisations which allows the import of medicines authorised elsewhere for treatment on a "named patient" basis. It has also used an exemption arrangement where no authorised product exists in the UK.

12. The recommendation is not proposing the importation of products authorised in other member states without controls, only that the product should be labelled in English and sold in the approved distribution system. As Community law currently stands, this would not be allowed because the overriding principle is that before a medicinal product can be ‘placed on the market’ in a member state, it must be authorised in that member state.

13. This recommendation seeks to improve the availability of veterinary medicines. The VMD already uses the flexibilities allowed in the current legislation and will continue to do so. The Commission has made proposals under Review 2001 to introduce additional flexibility by extending the so-called cascade arrangement to allow the use by veterinary surgeons of a product authorised in another member state. The Government will be seeking clarification from the Commission on how it would operate in practice.

14. The concept of farm health plans is already incorporated into Farm Assurance schemes. Codes of practice for prudent use of veterinary medicinal products developed by the BVA and by the Responsible Use of Medicines in Animals (RUMA) Alliance both promote the use of farm health plans. What is new in the recommendation is the inclusion of other suppliers of veterinary medicinal products into the process. The veterinary surgeon plays a pivotal role in planning for disease prevention. Pharmacists or AMTRA-trained suitably qualified persons can provide information on the medicines that they can lawfully supply.

15. This recommendation does not require any legislation or regulatory action. The Government would encourage the various interests involved to work together to stimulate the development of farm health plans with the objective of improving the health of flocks and herds thereby reducing the need for therapy.

Recommendation 6: We recommend (5.19) that continuous professional development should be required of all involved in the prescription and dispensing of animal medicines and for all who have responsibility for the care of animals. A formal record of training undertaken and the level reached should be available on request. When courses are available, the requirement for training should be extended to farmers and farm workers with responsibility for animals, and sales of medicines to them should be subject to written evidence of competence in their use.

16. The recommendation is unambiguous in requiring continuous professional development (CPD) and extending the concept of CPD to demonstrate competence on the part of animal keepers.

17. However, a number of questions arise out of this recommendation:

• should the issue of requiring CPD for veterinary surgeons, pharmacists and agricultural merchants be left to the bodies which are responsible for professional standards [RCVS, Royal Pharmaceutical Society of GB and the Animal Medicines Training Regulatory Authority (AMTRA) - respectively]? Or should the Government legislate?

• the recommendation begins with a general requirement for training so that ‘all who have responsibility for the care of animals’ are competent to administer veterinary medicinal products. This raises the question of whether the owners of horses, dogs, cats and other pets should be considered as falling within the requirement. The Government considers that this should be ruled out on practical grounds and the requirement restricted to keepers of farm livestock and farmed fish.

• who would carry out the training and assessing competence of animal keepers? The Government believes that the provision of this training should be by the private sector. Bodies such as AMTRA and the National Proficiency Training Council (NPTC) are experienced in providing this type of service. Nevertheless it would be useful to have views as to how this issue and the provision of training should be addressed.

• the final issue is whether there should be legislation to ensure that the purchaser (or user) of a veterinary medicinal product held an appropriate certificate of competence. Such a condition is currently attached to the purchase of sheep dips and views would be welcomed on whether this requirement should be extended.

Interim Response

18. The Government acknowledges the benefits that are gained from CPD. However, making CPD a requirement raises a number of issues on which it would welcome the views of interested groups.

Recommendation 7: We recommend (5.16) that the Minister supports the proposals made by the European Commission to allow the extrapolation of MRLs for major species to be used to calculate MRLs for minor food producing species and so increase the availability of veterinary medicinal products on the market.

19. The guideline on extrapolation of maximum residue limits (MRLs) has been recommended by the EU’s Committee for Veterinary Medicinal Products which advises the Commission and has been supported by the Commission in a communication to the Council and Parliament. The UK has been in the forefront of this initiative.

20. The Government proposes to support this recommendation.

Recommendation 8: We recommend (4.28) that the Minister encourages the European Commission to amend the existing legislation to allow veterinarians to prescribe generic treatments for companion animals where, after consultation with the owner, they come to the conclusion that this is the best treatment for the animal concerned.

21. The existing EC legislation includes a so-called prescribing cascade which includes a provision for a veterinary surgeon to prescribe a human medicine for treatment of an animal in cases where no authorised veterinary medicinal product is available. The recommendation seeks to extend the flexibility to permit the prescribing of a (generic) human medicine even if there is an authorised veterinary medicinal product available. Concerns were expressed to the review team about the costs of veterinary treatments. Prices of authorised veterinary products are generally higher than those of human generic products produced for the National Health Service.

23. Veterinary medicines are authorised for use in particular animal species and it would be necessary for the veterinary surgeon to explain the risks to the client before embarking on the treatment of a patient with a product not authorised in that species. Of particular significance would be the need to ensure accurate dosing in cases where tablets have to be broken in order to treat small animals.

23. EC law requires that, whenever it is available, an authorised product will be used and any change will require a negotiated amendment to this legislation. Because of the importance of having products authorised for the species in which it is used the Government is minded to reject this recommendation.

Recommendation 9: We recommend (6.5) that the role of registered agricultural merchants and saddlers in the dispensing of cat and dog wormers classified as PML medicines be extended to suitably registered pet shops, provided that all sales in these outlets are made by people who are suitably qualified having passed courses established by AMTRA. We see no need for the pet shop to register as a saddler as is currently the case.

24. As UK law is currently constructed, a pet shop business which wishes to sell PML horse, cat or dog wormers would first have to register with the Royal Pharmaceutical Society of GB as a saddler. The report says, this seems to be an unnecessary complication and it is possible to create an additional ‘Pet Shop’ category in the PML Order with a right to sell these products, provided the business is registered and has a suitably qualified person to advise on their use.

25. The VMD was already working to make the changes proposed by this recommendation. It plans to consult on changes to the PML Order which would implement this recommendation later in 2001. Subject to comments, the earliest implementation date would be 1 April 2002.

Recommendation 10: We recommend (4.29) that the Minister encourages the European Commission to develop a proposal for a written record to be kept of medicines administered to a horse by its keeper. This could be in the form of a "horse passport". It would allow medicines, for which an MRL had not been established, to be administered to a companion, recreational or sporting horse. It would also enable a starting date to be determined to ensure that an adequate withdrawal period could to be set should it, at some time in the future life of the horse, become destined for human consumption.

26. Horses are classified as food animals under European law and this recommendation is intended to allow the treatment of horses not intended for human consumption with authorised veterinary medicinal products, the active ingredient of which does not have an MRL. The underlying issue is how can the consumer be protected against potentially harmful residues of the active ingredient in the event that the treated horse unexpectedly enters the food chain. The Commission has extended the horse passport system and requires a record of treatment to be kept but it is likely to be some time before all horses have full records of treatments and proper controls will be in place. Proposals in Review 2001 would extend the prescribing cascade to horses not intended for human consumption so that for the purposes of the prescribing cascade, such horses would be regarded as pets.

27. The Government has a long-standing objective of securing a wider range of authorised products to treat horses not intended for human consumption. It supports the development of effective controls which will permit this. The VMD will continue the process of discussion and negotiation on this issue which is currently taking place in Brussels.

Recommendation 11: We recommend (5.6) that if, as a result of its review of the operation of the centralised procedure the European Commission should open it up to a wider range of products, the Minister should urge that it also introduces a mechanism for reviewing of the classification given to authorised products.

28. This recommendation is timely as the Commission is proposing in Review 2001 that new chemical entities currently excluded from authorisation under the centralised procedure, must be so authorised in future. The concern underlying the recommendation is that products authorised under the centralised system are automatically classified POM and that this will carry over to the extended arrangements. There is an industry concern that there is no review mechanism for products authorised in this way.

29. Review 2001 includes a proposal for the POM classification to apply for 7 years but there is no review mechanism in the proposals.

30. The Government acknowledges the concerns of industry on this issue whilst recognising the benefits that can be gained from using the centralised procedure and from POM status for newly authorised novel products. It is, therefore, minded to argue that an appropriate classification should be decided on a case-by-case basis and that a mechanism should be available for reviewing a product’s classification.

Recommendation 12: We recommend (5.9) that the VMD examine closely its own procedures for dealing with applications under the decentralised procedure, to ensure that no obstacles are placed in the path of mutual recognition.

31. The recommendation is addressed to the VMD but the efficiency of the mutual recognition procedure is dealt with by the Veterinary Mutual Recognition Facilitation Group (VMRFG) which was established by the UK. Recent surveys indicate that mutual recognition is functioning more effectively and that the UK is not regarded as an obstacle. Review 2001 includes a proposal to make VMRFG a legal entity which should provide it with more powers to improve further the mutual recognition process.

32. The Government is committed to making the European authorisation systems work. The VMD was instrumental in establishing the VMRFG and continues to play an active role in its work. The Government will support continuing assessment of the performance of the mutual recognition procedure through regular surveys.

Recommendation 13: We recommend (5.22) that the VMD should set in train a review of existing classifications applied to therapeutic product groups of medicines to ensure their consistency and that it should be willing to consider requests for the revision of a product’s classification from any party which offers evidence of the appropriate nature and quality.

33. The review team took evidence which indicated that, for certain types of product such as flea treatments for pets, the UK takes a more restrictive view than other member states on how they may be sold. A further complication since the review team reported is that Review 2001 contains provisions to make all medicines for food producing animals POM and for the classification to last 7 years. No review mechanism is proposed.

34. The Government accepts that the classification of veterinary medicinal products should be open to review on the same grounds under which the initial classification was set i.e. safety, quality and efficacy.

VETERINARY MEDICINES DIRECTORATE
DECEMBER 2001