The Marsh Report

Report of the Independent Review of Dispensing and Product Classification

NOAH’s View

NOAH and its members generally welcome the Report, which contains a number of useful recommendations. In particular, it is good to see an official report which recognises the important benefits of medicines and the need to improve ease of access while maintaining appropriate controls. We do however have doubts that implementation of its recommendations would lead to a lowering of the total cost of animal care.

There is a danger, which we are pleased that the Review team avoided, that in focusing too closely on costs, that the value of clinical intervention and the medicines used is overlooked, as are the benefits from more effective use of medicines. NOAH is keen to ensure that this does not happen, because to lose sight of the benefits that animal medicines bring, and the advice given by all the trained and qualified practitioners and suppliers, would be very much to the detriment of animal health and welfare.

The Recommendations

Recommendations 1 and 2

We recommend (5.29) that once recommendation 14 below 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.

While we welcome moves to increase transparency and flexibility in dispensing, it is likely that professional fees will have to be increased to offset any reductions in prices charged by vets for medicines, so the total cost of animal care is unlikely to be significantly reduced. The rise in fees may further reduce on-farm veterinary presence and impair disease surveillance.

It has been suggested that the proposal for RCVS to set prescription charges is not only outside their remit, but probably illegal too

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.

No comment.

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.

Where products are authorised in the UK and another member state, a parallel import system is already available in UK law.

Where the product is not authorised in the UK, importing an animal medicine would require a change in both UK and EU law. NOAH welcomes moves towards a single market, but there are difficult issues which need to be resolved first, notably the requirements for pharmacovigilance reporting and legal liability, before changes to the law should be considered. For example, who should users contact if they have a problem with the use of an imported product and where should they obtain advice from? A British subsidiary of an international animal health company may have no knowledge or experience of its sister subsidiary’s product authorised in another member state.

Recommendation 5

We recommend (5.19) that farmers and veterinarians join with pharmacists, agricultural merchants and farm management advisors to create health plans for farm animals, within which medicines can be supplied at least cost.

NOAH is in favour of proposals which improve the effective and responsible use of medicines on farm. However, if implemented, such a recommendation would be unlikely to reduce the costs of medicines, though more effective and responsible use could result in greater value for owners of animals. The majority of farm assurance schemes already require a farm health plan – we particularly welcome the idea of a number of disciplines working together with farmers and breaking down traditional inter-professional rivalries.

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.

NOAH supports the principle of CPD (indeed, companies already invest considerably in training their own staff, and in education for vets, farmers, merchants etc). However, ultimately the end user will bear such additional costs, so the total cost of animal care may be increased by such a proposal.

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 medicines on the market.

We welcome the inclusion of this recommendation, but believe that this should be extended further. There is no scientific justification for having to set MRLs for each species at all – the now extensive experience built up by the CVMP confirms that there are no safety concerns in having a single MRL for a pharmacologically active ingredient which is immediately applicable to all species.

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.

NOAH is firmly opposed to this suggestion. The best treatment and the medicine of choice for any animal is one that has been tested adequately for safety, quality and efficacy in that species in the territory in which it is to be used, bearing in mind relevant factors such as known toxicity, drug reactions and formulation. The text suggests that "this may result in some loss of market in the UK for new medicines [but] we believe this would be minor compared with the global market". However, the recommendation is for a change in EU law, so it would be the whole of the EU market that would be affected – a major segment of the global market for companion animal medicines.

It would not just be new medicines that would be affected – many existing products would be likely to see sales falling significantly. Many of these are small turnover products anyway, and it would therefore become uneconomic to maintain them on the market, and many existing products would be lost to animal medicine. Such a change would also be a huge disincentive to development of new products. We fear that the ultimate loser would be animal welfare. The cost of research and development is not just for new medicines: each new requirement for additional data to renew an existing product’s marketing authorisation requires new expenditure on new data – this must be paid for out of return on sales – no sales, no product renewal.

The recommendation is misleading in referring to "generic treatments" – what we assume is meant is human medicines, which, as mentioned above, have not been subject to testing for quality, safety and efficacy for the animals under consideration. Just because products have the same active ingredient does not mean they are identical, and human products may contain excipients that make them unsuitable for animal use. There will be no dosage information on which vets can rely, unless they parasitise work done by animal medicine companies which is not being funded by sales of human medicines – even then, different formulations may mean that such dosage information is inappropriate when using a human medicine. Poor dosing, especially with antibiotic products, could impact on animal welfare, and increase the pressure for development of resistance. There is considerable national and international pressure to ensure that antibiotics are used responsibly so that both animal and human health is protected and this recommendation would undoubtedly compromise those efforts, and the attainment of responsible use. Veterinary surgeons themselves could be at professional risk as they would not have the back-up or support of the company’s veterinary advisors in an emergency. The use of unlicensed medicines also means that there is no effective pharmacovigilance system to monitor potential adverse reactions – important as no testing will have been done with animal use in mind.

Finally, and very importantly, this proposal is a fundamental threat to the whole system of control of animal medicines. If it is considered safe to give animals human medicines, then why should companies bother carrying out expensive studies on safety, quality and efficacy, and in that situation, one might ask, is there now any need for an authorisation system for animal medicines at all?

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.

We agree that it is logical to create a new category of registered premises, rather than requiring pet shops to register as saddlers. Clearly any such system would have to continue to be effectively policed, as these products are not on "free sale", and records must be kept. NOAH has worked with AMTRA and the Pet Care Trust to establish a suitable qualification which could be the basis of such a system.

Provided appropriate training has been undertaken, then, logically any PML companion animal products should be available from such premises, not just wormers.

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.

Proposals to address the status of sporting and leisure horses to allow their treatment across Europe are to be welcomed – lack of medicines for horses has the potential to be a significant welfare problem. However, this is a very complex problem: there is already a system of horse passports in EU law, but major changes to other pieces of EU law and specifically to legislation controlling the authorisation of veterinary medicinal products are also needed to fully resolve this issue. NOAH, particularly through FEDESA, is working to try to address this, notably through the Review 2001 process of European veterinary legislation.

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 the classification given to authorised products.

We support this recommendation in principle, but there needs to be a harmonised approach to classification across the EU before this can be effective. NOAH supports the efforts of FEDESA (mirrored by the European farmers and co-operatives association COPA-COGEGA) to achieve a harmonised three-tier system of product classification across Europe through the Review 2001 process.

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.

We fully support this recommendation. VMD has made significant contribution to the development of the mutual recognition procedure, including formation of the Veterinary Mutual Recognition Facilitation Group, and has reduced the number of questions it asks in cases of incoming mutual recognition. However, VMD continues to ask considerably more questions than most other member states about products already authorised in accordance with European law in other countries. We believe that all member states need give greater recognition to the concept of the "competent authority" as defined in the legislation, and to the benefits of animal medicines rather than focusing on theoretical and often very small risks – the alternative is fewer authorised animal medicines being available, and use of human medicines, untested in animals, instead: an absurd result, which is not in the interests of animal welfare, owners, or the veterinary profession, and is at odds with Government’s duty to protect society.

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.

We do not support this recommendation. For VMD/VPC to review all 2000 authorised products would require huge resources, a cost industry would be required to pay. Furthermore, any review should not be of "therapeutic product groups", but of individual products – each authorised product, use or pack size should be considered scientifically on its own merits. A wide range of factors including pack size, strength, formulation, route of administration, label warnings, and excipients can all impact on the appropriate classification – there is no scientific justification for an automatic link between products which happen to contain the same active ingredient. We welcome the recognition of this earlier this year with the changed approach of the POM and GSL Orders, which now list individual products rather than active ingredients.

VMD recently issued a consultation on a procedure for reviewing classification of individual products, which we broadly welcomed. This includes scope for third parties to apply for a product’s classification to be changed, and we suggest that this is a much more efficient way of identifying any potential anomalous classifications.

Recommendation 14

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 pharmacists, registered agricultural merchants or other registered outlets against a written prescription from a veterinarian.

We can see some merit in the POM(A) category (broadly equivalent to Veterinary Surgeon Only in Ireland) of products restricted to use by or under direct supervision of a vet, although in practice this already exists within the labelling of relevant products.

However, we do not believe that a move to incorporate PML into a broader POM category would bring any benefits at this time, and would be likely to lead to confusion and potentially loss of confidence in a system which calls a product "Prescription Only" but allows its sale without a prescription. The public are used to the concept of POM for human medicines and this proposal for animal medicines would cause considerable confusion.

NOAH is broadly supportive of the idea of increasing farmer knowledge of effective and safe use of animal medicines, though most of the newer generation of farmers have already received some sort of formal training. Again it is clear that such a proposal would potentially lead to increased costs of animal care, as farmers would have to pay for training and examination in order to be able to give the required demonstration of competence. In the wider debate on the future of UK farming, it has been suggested that livestock farmers should be licensed. Clearly if this idea were to be pursued, then discussions on demonstrating competence or animal health plans would need modifying to ensure a seamless package of regulation.

Although not in the recommendations, suggestions in paragraph 5.27 that the concept of training and health plans be extended to horse and pet owners are quite impractical, and should be rejected.

The EU Commission already proposes to clarify what a "prescription" means in EU law, and we fear that incorporating the middle tier within POM, while apparently politically convenient, could ultimately lead to the loss of that route of distribution. As indicated in comments on Recommendation 11, European industry, farmers and co-operatives believe that a three-tier system would best balance the needs of availability and control and would replicate the three tier (POM, P, GSL) which already exists in human medicine throughout the EU. We would urge Ministers to put renewed efforts into seeking such a result in Europe, rather than changing the UK system at this time.