My Lords, I am pleased to move Amendment 62 in the name of my noble friend Lady Thornton. It amends Clause 9 of the Bill dealing with manufacture, marketing, supply and field trials. This is a probing amendment. It would give the Secretary of State the responsibility to make provisions, in respect of the cascade, risk-based decision-making process, allowing vets to prescribe unauthorised medicines when they are unable to get hold of suitable authorised medicines.
The cascade provision for the medical treatment of animals will be vitally important if there are problems with the supply of veterinary medicines in the event of no deal. The British Veterinary Association has underlined the importance of maintaining the cascade, and of the Veterinary Medicines Directorate reviewing the cascade to consider whether it would be possible to allow greater flexibility on the use of medicinal products licensed elsewhere in the EU and those of other partners within the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicine Products, known as VICH.
I am always struck by how much one learns during the course of working on legislation in the House of Lords, and how much is new that one was previously unaware of but should have been. The cascade system for prescribing unauthorised medicines is a good example for me. It is a vitally important procedure, underpinned by 2019 guidance from the Veterinary Medicines Directorate, whereby vets are permitted to use their clinical judgment where there is no suitable veterinary medicine authorised in the UK for the specific condition in the animal being treated. Cascade gives vets access to a wider range of medicines to treat animals within their care and to prevent unavoidable suffering that could happen were a vet unable to prescribe a suitable alternative.
The cascade goes through the various stages of decision-making in the treatment of animals in descending order of suitability, commencing with the desired outcome of using an available authorised UK veterinary medicine and going through other stages, including the use of clinically suitable alternatives of, for example, human medicines authorised in the UK or in another member state for use in animals. The final provision is for the
use of a medicine prescribed by the vet responsible for treating the animal and prepared specially on the occasion of the treatment being required—known as “extemporaneous preparation”. This has to be prepared by a vet or a pharmacist or a person holding an appropriate manufacturer’s authorisation.
In exceptional circumstances, where no suitable veterinary medicine is available either as an authorised product or under the cascade, a vet may treat an animal with a medicine authorised in a country outside the EU via the Special Imports Scheme. Clearly, the guidelines and appropriate primary legislation will need to be amended in the light of our forthcoming exit from the EU—or if there is no deal. So can the Minister tell the Committee what preparations are being made in respect of this very important matter?
Prescribing decisions under the cascade are made on a case-by-case basis. The prescribing vet is personally responsible for the choice of product, is subject to the Royal College of Veterinary Surgeons’ code of professional conduct and must always obtain the owner’s consent for their animal to be treated under the cascade. Accurate record keeping is also required under the guidelines. Supplies of products used under the cascade and associated records can be examined during inspections of vets’ premises by the VMD and the RCVS. Under the last tier of the cascade, extemporaneous preparations —also known as veterinary specials—can legally be prescribed, supplied and used, recognising that they carry a higher risk than authorised medicines.
So this is an important scheme and the maintenance of the veterinary medicines cascade is a vital issue in the medical treatment of animals post Brexit, particularly in the event of no deal, as I said. I look forward to the Minister’s explanation of the action being taken to ensure that the cascade is maintained, continued and, if possible, simplified in line with the BVA’s recommendations. We need assurance that the Government will not use the powers in this Bill to diverge from the cascade after it is passed.
Finally, the BVA has underlined that, if it is to remain as one of the leading agencies in Europe and beyond, the Bill must be used to establish a national authorisation procedure for veterinary medicines, on the same scientific and evidence-based technical requirements as adopted by the EU, firmly rooted in the established standards set for quality, safety and effectiveness. The association has emphasised that, to have an influential voice in global veterinary regulatory affairs, it is vitally important for the UK to seek full membership of the international technical requirements registration body, the VICH, to which I referred earlier. I look forward to the Minister’s response on this vital issue.