Report on the Medicines and Medical Devices Bill: Legislative Consent Motion

Appendix 3 – AERA Committee report on the LCM

Medicines and Medical Devices Bill

Committee for Agriculture, Environment and Rural Affair

Consideration of Part 2 Veterinary Medicines

Background

1. At its meeting 5th March, the Committee considered a letter from the Minister of Agriculture, Environment and Rural Affairs regarding the Medicines and Medical Devices Bill. That letter noted that this is a UK Government Bill making its passage through Westminster, that it is predominantly focused on human medicines and medical devices with one section dealing with veterinary medicines. The letter noted that the Bill had a number of provisions that dealt with transferred matters and that the legislative consent of the Assembly would be required.

2. On the 27th May 2020, the Minister of Health tabled a Legislative Consent Memorandum in the NI Assembly on this Bill. It was referred to the Committee for Health for consideration under Standing Orders 42A. On the 2nd June the Committee for Health asked the Committee for Agriculture, Environment and Rural Affairs to consider and comment on the Legislative Consent Memorandum as it related to Part 2 Veterinary Medicines. The Committee for Health explained that the deadline for response was extremely tight, requested comment by 10th June and that the legislative consent debate in the Assembly was anticipated to be on 16th June.

3. The Committee for Agriculture, Environment and Rural Affairs considered the four clauses that make up Part 2 Veterinary Medicines. It received written briefings and took oral evidence from DAERA on Thursday 11th June. The written evidence is attached at Appendix A. The Committee agreed its report on Friday 12th June.

4. Due to the complexity of the Bill, its technical nature and the limited time available to scrutinise it, the Committee wishes to be clear that it has not had the opportunity to explore in full the implications of the clauses for this jurisdiction. The time constraints have not allowed it to consult with relevant stakeholders. The Committee did however ask and received assurances that after the enactment of the Bill, the existing regime would remain largely the same.

The Bill and provisions for Veterinary Medicines

5. The Medicines and Medical Devices Bill has two main purposes. First, it seeks to provide a mechanism for strengthening and maintaining the regulatory system for both human and veterinary medicines, clinical trials and medical devices after the UK leaves the EU. Secondly, the Bill aims to consolidate the enforcement framework relating to medical devices and to introduce a new civil sanction regime. The Explanatory Notes that accompany the Bill explains the existing regulatory regime for veterinary medicines as follows: -

“Veterinary medicines are currently regulated by the Veterinary Medicines Regulations 2013 (SI 2013/2033) which implement various pieces of EU legislation. These regulations help ensure animal welfare, and protect the safety of treated animals, people handling the medicines, consumers of produce from treated animals, and the environment. They do this by regulating the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.”

6. The provisions of the Bill that deal with veterinary medicines are transferred, and as such, would fall within the legislative competence of the Northern Ireland Assembly. Veterinary medicines are not devolved in the other jurisdictions.

7. The Bill will also enable support the veterinary medicines regulator - Veterinary Medicines Directorate (VMD) to developing innovative regulation.

8. Part 2 of the Bill covers Veterinary Medicines and the following clauses are relevant

• Clause 8: Power to make regulations about veterinary medicines
• Clause 9: Manufacture, marketing, supply and field trials
• Clause 10: Fees, offences, powers of inspectors, costs
• Clause 11: Interpretation of Part 2 and supplementary provision

9. Part 4 of the Bill covers Regulations made under Part 2 and therefore, is also relevant. It has the following clauses

• Clause 38 Power to make consequential etc. provisions
• Clause 39 Scope of powers of Northern Ireland departments
• Clause 40 Consultation
• Clause 41 Procedure

10. The EU Veterinary Medicines Regulations 2013 were made on a UK wide basis. They will be transposed into UK law. After the transition period, the Bill will allow DAERA to amend the Veterinary Medicines Regulations 2013 in relation to this jurisdiction. Members noted that DAERA can also amend the provisions acting jointly with the relevant UK Minister. The written briefing from DAERA explained

“The Bill provides a power to amend or supplement the Veterinary Medicines Regulations 2013 (the 2013 Regulations). It provides that any change to the 2013 Regulations in relation to NI can be made by DAERA acting alone or DAERA and the Secretary of State for the Environment, Food and Rural Affairs acting jointly. The Bill provides that any changes relating to Northern Ireland must be subject to the scrutiny of the Northern Ireland Assembly irrespective of how they are made (see Clause 41). Most changes are subject to the affirmative resolution procedure (i.e. they require the approval of the NI Assembly), although there are a few changes which are subject to the negative resolution procedure before the Assembly.

11. DAERA explained that this is essentially an enabling Bill, that it does nothing in itself, but enables amendments to be made by secondary legislation and that it is considered appropriate to retain this flexibility going forward.

12. The Committee discussed clause 9(2) with DAERA officials. Under the Protocol, this administration must remain aligned with EU Regulations on Veterinary Medicines. However, the Explanatory Note to the Bill states that Clause 9(2)

“provides the means for making corresponding or similar provision to the new EU Regulations as the UK sees fit.”

13. DAERA officials noted that this refers mainly to new EU Regulations coming forward in 2022. Because this jurisdiction must adhere to the Protocol and remain aligned with the EU, this provision in clause 9(2) was unnecessary. It was a dormant power. DAERA had indicated to DEFRA that they would prefer that it was not included, had asked for it to be removed but accepted that this was unlikely to happen and indicated that they could “live with it”.

14. Further consideration of this issue by the Committee yielded that the only circumstances in which the provision in clause 9(2) might be used were if the NI Assembly voted, in four years, to remove the Protocol.  However, DAERA officials noted that even in this scenario, it was difficult to see how this power would be exercised, because at that point, the 2022 EU Regulations would have been incorporated into the veterinary medicine regime.

15. Written briefing from DAERA referred to a Common Framework that is being developed to maintain a consistent and common approach between all four jurisdictions in the area of animal health and welfare issues. It is expected that this will include the regulation of veterinary medicines post transition i.e. after 31st December 2020. The Committee noted that it had not yet considered this Common Framework and that this left a gap in knowledge that it was unable to address due to a lack of time.

16. Members took note of clause 8(2)(c) (see below) and questioned the meaning of the word “attractiveness”. DAERA officials agreed to provide further clarity on this as a matter of urgency.

(2)  In making regulations under subsection (1), the appropriate authority must have regard to—

(a)  the safety of veterinary medicines in relation to animals, humans and the environment;

(b)  the availability of veterinary medicines;

(c)  the attractiveness of the relevant part of the United Kingdom as a place in which to develop or supply veterinary medicines.

17. The duty to consult was discussed with officials. Clause 40 provides that DAERA, as the appropriate authority for veterinary medicines, must consult with such persons, as it considers appropriate when making regulation using the powers in this Bill.

18. At its meeting on 11th June 2020, the Committee discussed and agreed that it content with the Legislative Consent Motion as it related to the veterinary medicine provisions in the Bill. However, it does ask that DAERA

• ensures that the Committee is consulted in advance of its intention to make regulations acting jointly with a UK Minister;
• informed the Committee of new veterinary medicines to be introduced under the term of the Protocol, but not introduced into GB and vice versus;
• provides detailed briefing on the Common Framework for Animal Health as soon as possible.

Appendix A - Written briefings from DAERA

Letter from Departmental Assembly Liaison Officer

Central Service and Contingency Planning Group, Department for Agriculture, Environment and Rural Affairs
Central Management Branch

Assembly Section
Room 430, Dundonald House
Upper Newtownards Road
Ballymiscaw
Belfast BT4 3SB

Stella McArdle 
Clerk to the Committee for Agriculture, Environment and Rural Affairs
Room 243 Ballymiscaw
Parliament Buildings 

5 June 2020

Dear Stella

RE: Medicines and Medical Device Bill - Legislative Consent Motion

The purpose of this letter is to ask the Committee to consider the Legislative Consent Motion (LCM) (Appendix A) for the Medicines and Medical Devices Bill (the Bill) (Appendix B), a UK Bill which is currently making its way through Westminster.

The Department of Health {DoH) is the lead Northern Ireland (NI) Department on the Bill and most of its provisions relate to matters which fall within its auspices. The Bill does, however, contain some technical provision on veteterinay medicines. Veterinary medicines is a matter which falls within the remit of the Department and you will recall that I previously wrote to you on 25 February 2020 to inform you of the Minister for Health's intention to lay a LCM on the Bill. The LCM was laid with the Assembly Business Office on 27 May and requires the Committee's consideration to proceed to debate.

Background

The Bill was introduced in the House of Commons on 13 February 2020. Its main purposes are to:

• provide a mechanism for strengthening and maintaining the regulatory system for medicines (both human and veterinary), clinical trials and medical devices after the UK leaves the EU; and
• consolidate the enforcement framework relating to medical devices and introduce a new civil sanction regime.

Relevant provision

There is a body of EU law regulating veterinary which is supported by domestic legislation in the UK, namely by the Veterinary Medicines Regulations 2013 which are UK wide. The Bill creates powers to amend or supplement the 2013 Regulations (see Clause 8 of the Bill). The powers are needed because existing legislative powers under section 2(2) of the European Communities Act 1974 are to be repealed at the end of the transition period. The Bill provides similar powers in respect of domestic legislation relating to human medicines.

The Bill allows the Department to amend lhe 2013 Regulations in relation to Northem Ireland. The 2013 Regulations were made on a UK wide basis and it is considered appropriate to retain this flexiblilty going forward. The Bill also, therefore, provides that the Department can amend them acting jointly with the relevant UK Minister.

Need for a LCM

Human medicines and veterinary medicines are transferred matters and, as such, the Bill requires a LCM. The relevant LCM was agreed by the Executive meeting on 22 April 2020. Prior to that meeting, issues were raised by both Minister Poots and Minister Dodds regarding how certain provisions in the Bill sat with the NI Protocol.

There is provision in the Bill which provides that the Department, acting alone or jointly with the relevant UK Minister, can make legislation that corresponds or is similar to an EU Regulation on veterinary medicines (see Clause 9(2) of lhe Bill). Under the NI Protocol, the relevant EU Regulation will automatically apply to NI and there will be a requirement for NI to fully ahgn with it. This provision was considered potentially unnecessary and arguably out with the spirit of NI Protocol. A similar issue arises in respect of provision in the Bill on human medicines.

Since the Executive meeting, Department officials have engaged with colleagues in Departmental Solicitors Office, DoH and the UK Department of Health and Social Care (DHSC) (which leads on the Bill) on the matter. Unfortunately, the DHSC is not minded to amend the Bill as it is of the view that the powers conferred in it can be exercised compatibly with the NI Protocol. The Minister for Health has accepted that the need to bring forward the legislation at this stage is paramount and has advised Ministerial
colleagues that he has laid the LCM for the Bill in the Assembly on the basis of the DHSC advice. The NI provisions are needed to ensure that there are no gaps in the powers to make legislation on veterinary medicines in the future. On balance, the Department considers that it can accept that any issues regarding potential compatibility in the NI Protocol would, in practice, only arise if the Department were to exercise the relevant power conferred by the Bill and the need to oomply with the Protocol would prevent it from
exercising the power in any event.

Timing

The Bill passed its Second Reading in the House of Commons on 2 March 2020 and it is expected that the Reporting stage will take place there on week commencing 22 June 2020. It is necessary to have the Assembly's approval prior to then and, subject to the Committee's views, the LCM is expected to be debated before the Assembly very shortly.

I, therefore, ask the Committee to agree the Memorandum to allow lhe DoH to progress the LCM through the NI Assembly.

Yours sincerely

Michael Oliver
Departmental Assembly Liaison Officer

Email Correspondence

Sent: 9 June 2020
To: Stella McArdle, Clerk to the Committee for Agriculture, Environment and Rural Affairs
Subject: Medicaines and Medical Devices Bill - Legislative Consent Motion

Hi Stella,

Further to our telephone conversations, please see the information below:

1. Will new veterinary drugs with UK approvals be unavailable for use in NI unless there is also an EU approval?

Marketing authorisation approvals granted in UK or EU before the end of the transition period will remain valid in NI after 31 December 2020. For market authorisations in NI to apply after the transition period, these will have to be authorised centrally in the EU (from applicant based in EU member state), or be authorised in UK for NI under the requirements of the EU Medicines Directive.

2. Will consent/approval be sought from the NI Assembly in cases where either is seeking amendments to the veterinary medicines legislation for market authourisations etc. or DAERA is seeking amendments acting jointly with the Secretary of State for the Environment, Food and Rural Affairs?

The Bill provides a power to amend or supplement the Veterinary Medicines Regulations 2013 (the 2013 Regulations). It provides that any change to the 2013 Regulations in relation to NI can be made by DAERA acting alone or DAERA and the Secretary of State for the Environment, Food and Rural Affairs acting jointly. The Bill provides that any changes relating to Northern Ireland must be subject to the scrutiny of the Northern Ireland Assembly irrespective of how they are made (see Clause 41). Most changes are subject to the affirmative resolution procedure (ie they require the approval of the NI Assembly) although there are a few changes which are subject to the negative resolution procedure before the Assembly.

3. Is the issue of Veterinary Medicines included in any of the Common Framework Agreements being drafted for use by UK at the end of the transition period to ensure consistency and a common approach by Defra and the devolved Administrations in respect of devolved matters?

Yes, in conjunction with the Devolved Administrations, Defra is developing a Common Framework to maintain a collaborative approach to animal health and welfare issues, including the regulation of veterinary medicines, post transition.

I hope this answers all of your questions sufficiently and apologies for the time it took me to ensure I was giving you accurate information (as explained it is a new area of work for me). Your understanding was very much appreciated.

Regards,
Alastair