Fees, offences, powers of inspectors, costs

Medicines and Medical Devices Bill – in a Public Bill Committee am 4:00 pm ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 4:00, 8 Mehefin 2020

I beg to move amendment 14, in clause 10, page 6, line 35, at end insert—

‘(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of veterinary medicines.

This amendment is substantially the same as amendment 11, but it relates to veterinary medicines rather than to human medicines. So, assuming that the answer will be pretty much the same as for amendment 11, I do not really want to labour the point.

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

The short answer is probably yes, but I will just give the hon. Gentleman half a page of explanation.

I recognise that, as before with amendment 10, amendment 11 would ensure transparency, in essence, on fees that stakeholders may have to pay with regard to veterinary medicines, such as fees for marketing, manufacturing and distribution. The fees relating to veterinary medicines are set out in schedule 7 to the Veterinary Medicines Regulations 2013, and the power in the Bill is to amend the fees where necessary, rather than to create anything new. Indeed, it is unlikely that any new or amended fees would be introduced within three months following Royal Assent. The fees are already published online and are publicly available on the gov.uk website, as I mentioned earlier.

Therefore, the amendment would create an obligation for the Secretary of State simply to republish the existing fee regime, which is already publicly available; hence the continuity element. Any proposal to amend fees or to introduce new fees would be subject to consultation. In addition, potential impacts on businesses or organisations based in the UK would be evaluated through an impact assessment, which would also be made publicly available during the consultation process.

In light of that explanation, I cordially ask the hon. Gentleman to withdraw his 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Amendment, by leave, withdrawn.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

Clause 10 provides that regulations made under clause 8(1) may make provision about charging fees, criminal offences and powers of inspectors. It enables the recovery of costs incurred in the administration of improvement or seizure notices under the Veterinary Medicines Regulations 2013.

We need to ensure that the regulator—the Veterinary Medicines Directorate, which I will now call VMD for ease—can continue to effectively regulate and confirm compliance with new or updated elements of the 2013 regulations. Therefore, it may be necessary to make appropriate changes to fees, offences and inspectors’ powers before making any such change; as I have constantly said, consultation will take place if that is the case.

The VMD is required to recover the costs of the regulatory services that it provides from fees and charges. It is important that existing fees can be amended or that fees can be introduced to meet the cost of functions exercised by the VMD. An essential part of protecting animal, human and environmental safety is ensuring compliance with the Veterinary Medicines Regulations 2013. The existing regime imposes criminal sanctions for breaches of the regulatory framework. This clause would allow for making the breach of requirements or prohibitions introduced under clause 8(1) a criminal offence, punishable by imprisonment of up to two years.

VMD inspectors play a critical role in ensuring compliance with the 2013 regulations, helping to ensure that medicines are safe and effective for animals by monitoring their manufacture and supply. Inspectors already have powers to enter premises at a reasonable time to ensure compliance with the 2013 regulations. Clause 10 would allow for the extension of existing powers of entry and inspection to new prohibitions and requirements introduced by regulations made under the Bill.

Subsection (2) provides that regulations made under clause 8(1) may not confer a power of entry to premises used wholly or mainly as a private dwelling, unless those premises or any part of them are approved, registered or authorised for the sale of veterinary medicines under the 2013 regulations.

I commend clause 10 to the Committee.

Question put and agreed to.

Clause 10 accordingly ordered to stand part of the Bill.

Clause 11 ordered to stand part of the Bill.