Manufacture, marketing, supply and field trials

Medicines and Medical Devices Bill – in a Public Bill Committee am 3:45 pm ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 3:45, 8 Mehefin 2020

I beg to move amendment 13, in clause 9, page 6, line 11, at end insert—

‘(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”

This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a process where veterinarians can dispense different medicines to animals, such as human medicines, should appropriate conventional animal medicines not be available.

I have buried the lede, obviously, by talking about the cascade already; but I am interested to hear a little more detail about the Minister’s vision for the cascade. It is obviously an entrenched principle across the European Union, and an industry standard. It has a significant impact on the lives of animals and, by proxy, humans as well. It seems to me an important principle, but it is not on the face of the Bill. The Government would, on Royal Assent, have the immediate ability to diverge away from the cascade quite quickly, but I wonder about the safety of that and whether that is in the Government’s plans. It was not in the impact assessment, so I am keen to scope out whether we expect the cascade to continue to be a principle in this country, and, if so, whether we expect our cascade to reflect closely the one used by our EU counterparts.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

A clause or so back, the hon. Gentleman gave us a snapshot of what a cascade is, and I do not think I could put it better. My notes say that veterinary surgeons can prescribe gabapentin, a human medicine, to treat chronic pain in animals, particularly if it is of a neuropathic origin, as there is no equivalent in veterinary medicine. As the hon. Gentleman said, the cascade is about making sure that there is something in the veterinarian’s bag to enable appropriate care to be given to animals.

I am grateful to the hon. Member for Nottingham North and to the hon. Member for Central Ayrshire, who I think also signed the amendment, for raising the important issue of the prescribing cascade. However, not only is the amendment not necessary, but I argue that it could be unhelpful in certain instances. I recognise the desire to ensure that the use of prescribing cascades is regulated. The cascade enables veterinary surgeons to have access to a wider range of medicines to treat animals under their care and, in particular, to prevent the unacceptable suffering that might occur if they could not prescribe those alternatives.

The provisions with regard to the cascade are set out in schedule 4 to the Veterinary Medicines Regulations 2013 and the Bill already confers discretionary powers that would allow the appropriate authority to decide, following consultation, whether and how cascade requirements in the existing regulations might be amended in the future. That is provided for in clause 9(1), for the professionals to decide, arguably.

The amendment as drafted would appear to obligate the Secretary of State to update the regulations with regard to the cascade, as opposed to making those changes when it is appropriate to do so, and evaluate the cascade above other important aspects of the veterinary medicines regulatory framework. Although the cascade is important, it is our position that the regulations should be updated when it is clear and necessary to do so, rather than operating under a compulsion to do so for any one element, as putting it in the Bill might lead to. In that light, I ask the hon. Gentleman to withdraw it.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care)

I am happy to withdraw the amendment on that basis. The point of putting it in was to shoehorn the subject into the conversation, which was obviously effective. I did not hear from the Minister whether she felt that we are likely to continue to reflect the EU arrangements on that. Given that it is novel and specific to this area of medicine, and given that it is not risky, but diverges from what we consider basic medical practice in humans, it is of interest to people.

Perhaps now is not the moment to hear about the Government’s plans to reflect, or not, the judgments made by EU colleagues in future, but I hope that, over time, we can continue to have that conversation because I think there is public interest in that. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

On amendment 13, I will write to DEFRA to seek clarification for the hon. Gentleman if that would be helpful. As we move through the Bill in the spirit of co-operation, I am more than happy to continue the conversation.

Clause 9(1) provides that amendments may be made to the Veterinary Medicines Regulations 2013 about the manufacture, marketing, supply and field trials of veterinary medicines. The Committee will note that in large part, clause 9(1) makes very similar provision to clause 2(1). I will take each subsection of clause 9(1) in turn.

Subsection (1)(a) sets out that the regulations made under the power in clause 8(1) may make provision about authorisations to manufacture veterinary medicines. The subsection means that it will be possible to update the rules around manufacturing authorisations—for example, to reflect the latest scientific advances in manufacturing and to address the manufacture of novel and innovative veterinary medicines. The subsection is therefore needed to future-proof the regulatory regime.

Subsection (1)(b) allows provision to be made about authorisations to import veterinary medicines, which is needed to continue to secure supply chains for those medicines entering the UK. By updating our existing regulatory framework, we can maximise the availability of veterinary medicines, while taking care that our approach does not place an additional burden on those who import medicines. Such a change can benefit animal owners, as it can lead to quicker access to veterinary medicines, a point that my hon. Friend the Member for Penrith and The Border brought up on Second Reading. We could use the subsection to allow additional professions, for example veterinary nurses, to import certain types of veterinary medicines with appropriate controls.

Subsection (1)(c) allows for provision to be made about authorisations to distribute veterinary medicines by way of wholesale dealing, which would ensure that we can provide further assurance on the quality and security of the full distribution chain for veterinary medicines. We could, for example, amend the application process for a wholesale dealer’s authorisation, supplement the requirements that must be met by the holder of such an authorisation, or amend the exceptions to the requirements for an authorisation.

The subsection could also be used to change the requirements for a wholesale dealer’s authorisation to cover new and novel products that may have new or additional storage and distribution requirements. That would maintain the quality and security of the distribution chain for such veterinary medicines and ensure that they are stored appropriately and safely throughout.

Subsection (1)(d) allows for provision to be made about marketing authorisations for veterinary medicines. This would help to ensure that the UK remains an attractive place for the pharmaceutical industry to bring to market both new and established medicines, and that UK animal owners do not have to wait for new, innovative or generic veterinary medicines. As an example, regulations could offer statutory rewards or incentives for certain types of applications for marketing authorisation.

Subsection (1)(d), combined with paragraphs (a), (b) and (g), could also be used to make changes to the regulations about using an authorised medicine outside the terms of its marketing authorisation if there is clinical need and benefit. If there is no suitable veterinary medicine authorised in the UK to treat a condition in a species, a vet can treat an animal under his or her care in accordance with the prescribing cascade, which is where a medicine can be used to treat a disease outside of its authorisation or to treat a different species from those it is authorised for. The cascade is set out in the Veterinary Medicine Regulations 2013.

Subsection (1)(e) provides that regulatory provision may be made about manufacturing, importing or distributing active substances. This power could be used to ensure that the supply chain for active substances that are used in veterinary medicines remains secure. The quality of the active substance is critical to assure the safety, quality and efficacy of the finished veterinary medicine. Regulations could, for example, provide for a registration scheme for manufacturers, importers and distributors of active substances.

Paragraphs (f) and (g) allow for provision to be made about the categories of person who may supply veterinary medicines, and about the requirements that must be met in relation to the supply of these medicines. Proposals for new powers to supply or prescribe medicines will be carefully developed with the relevant professional bodies, such as the Royal College of Veterinary Surgeons, and will be subject to consultation. That reflects the Government’s desire to make veterinary medicines as accessible as possible while not compromising animal safety or the safety of the person administering the medicine.

Subsection (1)(h) allows for provision to be made about the registration or accreditation of persons who sell or offer to sell veterinary medicines over the internet. The power could be used to make the voluntary UK-based internet retailer accreditation scheme mandatory, which could provide further assurance for UK customers and prevent customers from unwittingly buying illegal medicines. This power, in conjunction with clause 10, could also be used to enforce the scheme with appropriate sanctions, including the ability to suspend or revoke an online supplier’s registration. It would also enable us to extend existing inspection powers and criminal offences in the regulations to cover any new scheme.

Subsection (1)(i) allows for provision to be made about the circumstances in which a veterinary medicine can be administered. Regulations could, for example, make provision restricting or prohibiting the administration of substances that adversely affect public health or consumer safety. Such regulations could be used to incorporate our priorities on antimicrobial resistance into secondary legislation—for example, through restrictions on the preventative use of antibiotics and provision encouraging responsible use of antibiotics.

Subsection (1)(j) allows for provision to be made about the notification and reporting requirements in relation to veterinary medicines that have been placed on the market. Regulations could be used to make provisions about the reporting of adverse reactions to veterinary medicines. Reporting is used to ensure that emerging risks in connection with a veterinary medicine are identified and acted upon as early as possible—for example, to make reporting requirements more proportionate and reduce unnecessary burden for the pharmaceutical industry.

Subsection (1)(k) allows for provision to be made about the labelling and packaging of veterinary medicines, or the information that must be supplied with them or made available in relation to them. It could, for example, be used to introduce pictograms on labels for veterinary medicines. Pictograms are standardised pictorial symbols for a word or phrase and could be used to replace or supplement some of the written labelling requirements for veterinary medicines.

Subsection (1)(l) allows for provision to be made about veterinary medicines advertising. For example, we could include a definition of advertising within the Veterinary Medicines Regulations 2013. This could provide clarity to industry, make it easier for companies to comply with requirements and provide a legal definition for enforcement purposes. We could also use this subsection to amend or supplement restrictions to advertising—for example, to ensure that animal owners are protected from misleading information and prescribers are able to make prescribing and supply decisions without undue influence from the pharmaceutical industry.

Subsection (1)(m) allows for provision to be made about animal test certificates granted under the Veterinary Medicines Regulations 2013 for research purposes. An animal test certificate is required to carry out a field trial of a veterinary medicine. Such trials are used to evaluate the safety and/or efficacy of a veterinary medicine under conditions of field use and would usually be conducted on client-owned animals.

This subsection could be used to make provision to simplify the application process for a certificate, or to allow us to introduce reduced data requirements for applications for animal test certificates for exotic or minor species. Companies must provide data to support the safety of the test product after administering it to the target species. Simplified data requirements for minor species would provide a clearer set of requirements for the industry and ensure that our systems compare favourably to those of other countries without compromising animal safety.

Question put and agreed to.

Clause 9 accordingly ordered to stand part of the Bill.