Striking a balance on medicines.

Abstract

LATER this year, the Veterinary Medicines Directorate (VMD) intends to consult on updating the Veterinary Medicines Regulations. When the regulations were first introduced in 2005, the plan was to update them regularly – every two to four years – but it has now been 10 years since they were last reviewed. Given all that has happened since then, there is much to consider and the run up to the consultation is a good time for the veterinary profession to think about the changes it would like to see to ensure the balance between responsible use of medicines and access to the products needed to protect animal health and welfare is met. Although the consultation is still to come, the VMD has started setting out its stall. Medicinal products have not been immune to the supply chain issues that have affected many other commodities, with a variety of products becoming scarce or unavailable. The VMD has indicated that it wants all licensed medicines to remain available across the UK and to maintain the UK as a favourable environment for manufacturing and developing medicinal products. To encourage product development while still allowing drug availability at a reasonable cost, it plans to look at the licensing balance between proprietary and generic products. The VMD also wants to develop a more flexible approach to novel therapies. This is another balancing act, this time between the ability to react to new products but also maintain safety. It envisages that it will continue joint labelling between the UK and the Republic of Ireland and align with other countries globally on regulations to make launches of new products less of a strain for companies. Alignment makes sense to reduce the regulatory burden on those developing new products and should, in most circumstances, aid medicines' availability. However, there are cases where it might be better for the UK to make use of its new post-Brexit ‘freedom’ and diverge from its neighbours. The withdrawal of zinc oxide products for use in pigs, which Vet Record has reported on extensively (eg, VR, 19 June–3 July 2021, vol 188, pp 450–451), and the possibility that the UK may follow the EU in withdrawing amantadine from veterinary use (see p 11) are two examples where deviating from the EU could better protect animal health and welfare. Speaking at a debate hosted by the Veterinary Marketing Association at the House of Lords last month, Marian Bos, head of legislation at the VMD, said it was unlikely that medicines' prescribing categories would change and those currently able to prescribe or supply each category would be unaltered. This could be a disappointment to those who consider certain products should be more tightly regulated to ensure more responsible use. The VMD is considering e-leaflets to cut down on printed material, but Bos recognised that solutions would have to be found to accommodate those with poor internet access. Also, it is already difficult enough to get people to read instructions and removing product inserts from medicines' packaging could make it even harder. It was also clear from the debate that the VMD has very little desire to get involved in regulating medical devices, but this leaves another question – if not the VMD, then who should drive this important area that is in need of some regulation? “For vets on the ground what matters is having a timely, secure supply of necessary medicines for their patients BVA grants editorial freedom to the Editor of Vet Record. The views expressed in the journal are those of the authors and may not necessarily comply with BVA policy