The annual conference of the Royal Pharmaceutical Society's Agricultural and Veterinary Pharmacists Group was held in Milton Keynes on November 6 and 7. Steven Kayne reports
Mr Ray Anderson (director of policy at the Veterinary Medicines Directorate) gave the conference an overview of the present state of European legislation with respect to animal medicines.
Mr Anderson told delegates that, at present, there was a review of legislation being carried out by the EU Commission in Brussels. He explained that the collation and consolidation of amendments to Directive 81/851 was merely a technical exercise and no new directives were expected to emerge. Member states would be invited to submit written comments in due course. It was likely that the VMD would convene a meeting to discuss the matter and he would ensure that the Agricultural and Veterinary Group was kept informed.
Mr Anderson then spoke about the distribution and general availability of medicines in Europe. Distribution was being discussed by a working party that last met in February, demonstrating a relatively low priority in the Commission's programme of legislation. Mr Anderson said that harmonisation of criteria for prescription-only medicines was proving difficult to achieve. It was possible that member states with controlled distribution in categories other than POM, for example P or PML, would be able to continue using these categories for medicines that might otherwise be POMs.
Turning to the availability of medicines, Mr Anderson mentioned the concern being expressed by many interested parties over the withdrawal of certain medicines on December 31, 1999. This was likely because some companies were unwilling to submit data to enable a maximum residue limit (MRL) for animals in the food chain to be set. The companies believed that the cost of generating the extra data required could not be justified by the commercial value of the product under threat. Mr Anderson said that there was also a reluctance to develop new products where financial returns were unlikely to justify the cost of seeking authorisation, particularly for minor uses or minor species. A further concern was that MRL information could involve making commercially sensitive data widely available with a consequent loss of market advantage. To mollify this, the Commission was looking at the possibility of providing a measure of commercial protection by offering exclusive rights of exploitation to companies that submitted data to establish MRLs.
Other possible methods of dealing with the problem were to:
The next area covered by Mr Anderson was pharmacovigilance. A number of measures were being considered, including more detailed guidelines on reporting suspected adverse reactions with additional responsibilities being placed on member states and marketing authorisation holders. Currently, arrangements were voluntary, but power could be given to member states to compel reporting by veterinary practitioners and others, although Mr Anderson thought that this was likely only as a last resort. Pharmacists could provide such information effectively.
Mr Anderson then outlined the ambitious programme of legislation required to complete implementation of the various European Directives in the UK. This included initiating record keeping, procedures for veterinary practitioners and pharmacists, allowing manufacturers to rely on a Summary of Product Characteristics (SPC) rather than having to provide an additional data sheet, and continuous licensing for manufacturers and wholesalers rather than the five-year renewals currently necessary. The regulations relating to residues would also be updated. There would be new POM and GSL orders which would permit better arrangements for changes in legal classification, and an exemption from the need to hold marketing authorisations for products considered to be safe for administration to "little furry creatures and aquarium fish".