My Lords, Amendment 67A, put forward by the noble Baroness, Lady Jolly, relates to veterinary devices. This is a proposed new clause seeking to ensure that the Secretary of State sets up a working group to review the regulation of veterinary devices within six months of this Act passing.
There is currently no specific legislation for veterinary medical devices. The market is small and manufacturers may choose to market their products for dual use—for humans and animals. The medical devices regulations are intended only for human devices. However, we consider that the regulatory framework is also suitable for ensuring the quality and safety of equipment for veterinary use. The Bill allows us only to amend or supplement the existing veterinary regulations in the manner described in Clauses 9 and 10. Those clauses do not provide authority for regulations to introduce
substantial new standalone requirements for veterinary medical devices. If a medical device is packaged with a veterinary medicine, the marketing authorisation application would need to set out relevant information on that device. The device would therefore be assessed together with the veterinary medicine before a marketing authorisation is granted. Therefore, this type of medical device falls under the regulation of veterinary medicines.
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The Royal College of Veterinary Surgeons’ code of professional conduct states that vets must provide care that is appropriate and adequate. If the actions of a vet, by using a device, do not meet these standards, the RCVS could take action to protect animal health and welfare, including removing the veterinary surgeon from the register. I hope that this reassures the noble Baroness that her amendment is unnecessary; after all, the Bill is not aimed at regulating veterinary medical devices, and the RCVS’s professional supervision of vets provides reassurance that vets will provide appropriate care when using devices.
In Amendment 67B, the noble Baroness, Lady Jolly, raises the important point about considering the impact of the Bill on veterinary medicines. I recognise the desire to make sure that any regulations we make under the Bill have a positive impact on veterinary medicines, and in particular on safety, availability and their development and supply in the UK. On the noble Baroness’s good point about the different sizes of human and animal devices, I would be glad to commit to writing a clarification. I can assure her that her amendment is not necessary, as we have already included all these considerations explicitly on the face of the Bill in Clause 8(2).
I would like to speak to Amendment 131, tabled in my name, which inserts a new clause after Clause 41. The new clause obliges the Secretary of State to report to Parliament on the operation of any regulations made under Part 2 of the Bill that were in force during the two-year reporting period. I say to the noble Lord, Lord Patel, that this rolling process of two-yearly reports on regulations is quite different from the initial round of consultations, which will abide by the usual Cabinet Office rules and values applying to consultations. These very important obligations, our commitment to public consultation and, indeed, parliamentary scrutiny of the regulations, when they are made, will provide ample and regular opportunity for reviewing the impact of our regulations on veterinary medicines and others besides.
Amendment 106, in the name of the noble Baroness, Lady Thornton, would require the provision of an annual report to Parliament and the devolved Administrations on the operation of any information system established under Clause 16. I completely understand that her intent is to keep Parliament and the devolved Administrations informed about the information system. It is unlikely that that system will have been established and fully operational long enough to provide an annual report within 12 months of the Bill being granted Royal Assent. Regulations will be made to establish an information system under the powers in Clause 16(1), but this will not happen immediately.
Comprehensive engagement with all stakeholders, as well as public consultation, is required to develop the information system and establish the content of the regulations. That would include details of what information will be collected. It would be premature to specify in the Bill, by virtue of a reporting requirement, what data the information system must collect in advance of the required consultation. Discussions have already begun at official level on how to develop the information system so that it works well for all partners. The government amendment to Clause 41 that I have proposed requires consultation with the devolved Administrations in the development of the regulations. This will give a specific footing to support the existing working arrangements.
I have heard the calls for greater visibility of the Government’s plans for regulatory change, beyond even a debate on an affirmative statutory instrument, such that Parliament is given greater opportunity to reflect and be satisfied that we have taken the right steps to support UK patients. Amendment 131, in my name, seeks to achieve a number of important outcomes in support of the effective and appropriate use of key delegated powers in the Bill. It provides an answer to that concern.
We discussed earlier in Committee the amendments tabled by the noble Lord, Lord Patel, and the noble Baroness, Lady Thornton, to seek draft consolidated legislation within a set period. Amendment 131 places an obligation on the Secretary of State to report on the operation of any regulations made under Clauses 1(1), 8(1) and 12(1) every two years. This reporting obligation is both forward-looking and backward-looking. That is because the report must include a summary of any concerns raised or proposals for change made regarding the operation of the regulations during consultation, and the Secretary of State’s response, including any plans for further regulation. The report must be laid before Parliament.
This will have two significant effects. First, it offers an opportunity to inform Parliament on how the regulations are operating, with reference to concerns and proposals made by consultees. Secondly, Parliament will have early indication of possible plans for further regulatory changes under Clauses 1, 8 and 12. It would be an indication of the Government’s intended direction of travel and, naturally, I do not doubt Parliament’s capacity to offer views on that direction of travel.
Amendment 131 works alongside the other amendments in my name, changing the consultation obligation and providing clarity on how the considerations have been given regard to so far in developing the consultation proposals for regulatory change. In combination, these amendments will ensure significantly greater transparency and opportunity for oversight and scrutiny throughout the policy development and, later on, the operation of the regulations made under the powers we are seeking.
The noble Lord, Lord Patel, made points on consultation. Although we are not tabling a specific list of consultees, we are guided by the very clear and demanding government guidelines on this.
I hope that the noble Baroness, Lady Jolly, will feel able to withdraw her amendment, and that others will not feel compelled to move theirs.