Documents considered by the Committee on 21 March 2018 Contents

2Veterinary medicinal products

Committee’s assessment

Politically important

Committee’s decision

Document (b) cleared from scrutiny; Documents (a) and (c) not cleared from scrutiny; further information requested

Document details

(a) Proposed Regulation on the manufacture, placing on the market and use of medicated feed; (b) Proposed Regulation amending Regulation 726/2004 on Community procedures for the authorisation and supervision of medicinal products; (c) Proposed Regulation on veterinary medicinal products.

Legal base

(a) Articles 43 and 168(4)(b) TFEU, Ordinary Legislative Procedure, QMV; (b) Articles 114 and 168(4)(c) TFEU, Ordinary Legislative Procedure, QMV; (c) Articles 114 and 168(4)(b) TFEU, Ordinary Legislative Procedure, QMV

Department

Environment, Food and Rural Affairs

Document Numbers

(a) (36338), 13196/14 + ADDs 1–3, COM(14) 556; (b) (36340), 13240/14, COM(14) 557; (c) (36344), 13289/14 + ADDs 1–3, COM(14) 558

Summary and Committee’s conclusions

2.1The European Union has in place a set of rules regulating the production, marketing, distribution and use of veterinary medicines and medicated feed. In response to concerns that the current rules were burdensome, were failing to deliver a functional single market and did not assure the availability of products, especially for small markets, the Commission proposed revisions in 2014.

2.2Among other objectives, the revisions aimed to: increase the availability of veterinary medicinal products; improve the functioning of the internal market; and address the public health risk of antimicrobial resistance (AMR).

2.3We last considered these proposals at our meeting of 6 December 2017, when we waived all of them from scrutiny in advance of the 13 December Council meeting. We considered the proposals to be very important, with potentially significant Brexit considerations. The provisions relating to AMR, bearing in mind trade in animal products, and to restrictions on prescribing were of particular concern to us. We requested a summary of the agreed provisions on AMR and looked forward to an update on the two issues of greatest concern to the Government—proposed new restrictions on prescribing veterinary medicines and the provisions on carry-over of medicines into non-target batches of medicated feed.

2.4On the UK’s withdrawal from the EU, we sought further information on: the volume of trade between the UK and EU-27; the implications for the UK of separation from the EU’s veterinary medicines regulatory framework; and whether the UK would be likely to choose to maintain alignment with EU standards post-Brexit in any case.

2.5We have since received two letters from the Government. The first, from Lord O’Shaughnessy at the Department for Health, explains developments on the proposal to delete veterinary medicines provisions from the human medicines Regulation (document (b)). The Minister reports that negotiations on this essentially procedural proposal are at an advanced stage and he requests that the proposal be cleared from scrutiny.

2.6The second, from the Parliamentary Under-Secretary of State for Rural Affairs and Biosecurity (Lord Gardiner) responds to the Committee’s queries on the other documents. In particular, he notes that the issues of greatest concern to the UK have been addressed. Regarding the impact of Brexit, the Minister makes a number of points:

2.7Inter-institutional (“trilogue”) negotiations have begun and are expected to conclude in the autumn.

2.8We note the satisfactory progress of negotiations on the proposal to amend the human medicines Regulation and are content to clear that proposal (document (b)) from scrutiny.

2.9We are grateful for the response provided on the two veterinary medicines proposals. It is welcome that solutions were negotiated on the issues of greatest concern to the UK—i.e. proposed new restrictions on prescribing veterinary medicines and the provisions on carry-over of medicines into non-target batches of medicated feed.

2.10Regarding anti-microbial resistance (AMR), we note the Minister’s assurance that the UK will seek to adopt similar measures to those in the proposals, as appropriate, post exit. We would welcome a clearer analysis when the Minister next writes, including the summary of the agreed provisions on AMR as we requested in our report of 6 December 2017. It would also be helpful to understand which (if any) of those proposals it would not be “appropriate” to adopt and what the impact of such a course of action might be. We are separately considering the Government’s wider approach to AMR post-Brexit through our scrutiny of the Commission’s “One Health Action Plan” against AMR.16 That document remains under scrutiny and we await a further update from the Department of Health.17

2.11We retain documents (a) and (c) on veterinary medicines under scrutiny and look forward to an update on the progress of negotiations between the European Parliament and the Council well in advance of any final agreement.

Full details of the documents

(a) Draft Regulation on the manufacture, placing on the market and use of medicated feed: (36338), 13196/14 + ADDs 1–3, COM(14) 556; (b) Draft Regulation amending Regulation 726/2004 on Community procedures for the authorisation and supervision of medicinal products: (36340), 13240/14, COM(14) 557; (c) Draft Regulation on veterinary medicinal products: (36344), 13289/14 + ADDs 1–3, COM(14) 558.

Background

2.12Details on the background and content of the proposals, as well as on the Government’s position, were set out in our Reports of 22 October 2014 and 6 December 2017.18

2.13After publication of the proposals in 2014, discussions proceeded very slowly until the Estonian Presidency in the second half of 2017. At our meeting of 6 December 2017, we considered a letter from the Minister reporting expected agreement at the Agriculture Council on 13 December.

2.14At that stage, the Minister indicated UK support for the overall package. He noted that the main concern for the UK was the requirement that veterinary medicines be dispensed only by qualified vets. This would mean that that the UK system allowing “Suitably Qualified Persons”, as well as vets, to prescribe certain categories of veterinary medicines would need to be re-considered. The system is an important one for farmers in remote areas of the UK where there are insufficient numbers of vets.

2.15The Government also had some concerns regarding proposals in the medicated feed legislation (document (a)) on limits for the “carry-over” of medicines into non-target batches of feed. While the Minister indicated support in principle, especially for antibiotics where carry-over may contribute to antibiotic resistance, there were concerns about increased costs. The other significant provisions in the proposals were those pertaining to tackling anti-microbial resistance. The proposed provisions were in line with UK policy.

2.16On the UK’s exit from the EU, the Minister commented that it was now highly likely that the UK would leave the EU before the updated legislation needed to be applied. Noting that the UK is already at the forefront of the fight against antimicrobial resistance and this would continue to be a priority beyond the UK’s EU membership, the Minister indicated that the Government would look carefully at the Regulations and the elements that it may be sensible to implement post-Brexit.

2.17At our meeting of 6 December, we considered these proposals to be very important, with potentially significant Brexit considerations. The provisions relating to anti-microbial resistance, bearing in mind the trade in animal products, and to restrictions on prescribing were of particular concern to us.

2.18We sought an update on the provisions agreed regarding: the prescribing of veterinary medicines; carry-over under the medicated feed proposal; and on anti-microbial resistance.

2.19On the UK’s withdrawal from the EU, we sought responses to the following additional points:

2.20We waived the proposals from scrutiny in advance of the Council meeting on 13 December.

Lord O’Shaughnessy’s letter of 13 February 2018

2.21The Minister writes to provide an update on negotiations to amend Regulation 726/2004 on the regulation of human medicines, and to seek the Committee’s agreement to lift scrutiny in order for the UK to formally vote in support of the final proposal in due course. The lifting of this scrutiny, he says, would be subject to any significant changes to the text during ongoing trilogue negotiations, in which case he would write again to confirm that scrutiny remained lifted ahead of a final vote in Council. No substantial changes are expected.

Removal of references to veterinary medicines

2.22The Minister explains that Regulation 726/2004 is currently being amended to remove references to veterinary medicines, which are being consolidated into separate legislation (documents (a) and (c)). The amended Regulation 726/2004 will remain in force and continue to provide the underpinning legislation for the European Medicines Agency (EMA), as well as setting out the procedures for the authorisation and supervision of human medicines at a centralised EU level. He clarifies that Regulation 726/2004 does not influence procedures for the authorisation and supervision of human medicines nationally licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA), which comprise approximately 90% of medicines licensed for the UK market.

2.23The Minister notes that the vast majority of changes to Regulation 726/2004 are technical textual amendments which remove references to veterinary medicines and have no wider implications for the regulation of human medicines. He has no concerns about these consequential amendments.

Update of decision making procedures

2.24The Minister adds that, in addition to these consequential amendments, the Commission has used this opportunity to update Regulation 726/2004 to incorporate the new decision-making procedures set out in Article 290 (delegated acts) and 291 (implementing acts) of the Treaty on the Functioning of the European Union (TFEU). He explains that implementing acts (IA) cover implementation methods, whereas delegated acts (DA) enable the Commission to amend or supplement elements of the basic legislation. Both acts are subject to scrutiny by Member States and the European Parliament.

2.25The Minister reports that the Commission has proposed the use of IAs throughout the Regulation for all instances where the EMA and Commission are deciding to grant, vary, suspend or revoke a marketing authorisation under the centralised procedure. He notes that there was debate as to how far the scope of each of the DAs should be explicitly set out in the Regulation itself. This is a particular issue in setting the procedures for the approval of conditional marketing authorisations and variations of centrally licensed medicines. Conditional marketing authorisations allow medicines to be put on the market for a limited period without comprehensive clinical data, e.g. when the patient benefit is deemed greater than the risk of allowing on the market, while variations allow manufacturers to make changes to their medicine once it is on the market. The UK, says the Minister, successfully negotiated for the scope of this authority to be included in Regulation 726/2004 itself, to add clarity to the legislation and limit the breadth of what could be changed by DA.

EMA fees

2.26The Commission originally proposed that the structure and level of EMA fees should be set using an IA. The UK, among other Member States, argued that this should continue to be decided through the Ordinary Legislative Procedure (OLP). The Commission separately launched an evaluation of the fee-setting methodology, and the Council working group therefore decided to postpone this decision until after the publication of the Commission’s analysis in 2018. At this point, the Commission will submit a legislative proposal, to be adopted through OLP, on the structure and level of EMA fees. Therefore, any resulting change is now outside of scope of this round of amendments to 726/2004.

Lord Gardiner of Kimble’s letter of 28 February 2018

2.27As requested by the Committee in our Report of 6 December 2017, the Minister provides an update on negotiations. Regarding the proposed new restrictions on prescribing veterinary medicines, he says that the text agreed by the Council in December addressed the UK’s concerns about the potential impact of the proposals on the UK system of suitably qualified persons—those individuals trained and authorised to prescribe lower risk veterinary medicines.

2.28Concerning the provisions on carry-over under the medicated feed proposal, these no longer contain arbitrary limits on carry-over pending the completion of the necessary risk assessments by the European Food Safety Agency.

2.29The Minister goes on to clarify that, as currently drafted, the medicated feed regulation will come into effect 36 months after the date of its entry into force (in line with the veterinary medicines legislation and rather than the proposed 12 months), so it is probable this will be after the end of any post-exit implementation period agreed with the EU.

2.30On the other points raised by the Committee in relation to the UK’s exit from the EU, the Minister says:

2.31Finally, the Minister notes that trilogue discussions have commenced and are expected to conclude in the autumn.

Previous Committee Reports

Fourth Report HC 301–iv (2017–19) chapter 4 (6 December 2017); Fifteenth Report HC 219–xv (2014–15) chapter 2 and chapter 3 (22 October 2014).


16 Communication from the Commission: A European One Health Action Plan against Antimicrobial Resistance (AMR), COM(17) 339.

17 Thirteenth Report HC 301–xiii (2017–19), chapter 1 (7 February 2018).

18 Fourth Report HC 301–iv (2017–19) chapter 4 (6 December 2017); Fifteenth Report(HC 219–xv (2014–15), chapter 2 and chapter 3 (22 October 2014).




Published: 27 March 2018