Documents considered by the Committee on 20 June 2018 Contents

10Veterinary medicinal products

Committee’s assessment

Politically important

Committee’s decision

Cleared from scrutiny; further information requested

Document details

(a) Proposal for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed ; (b) Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products

Legal base

(a) Articles 43 and 168(4)(b) TFEU, Ordinary legislative procedure, QMV; (b) Articles 114 and 168(4)(b), Ordinary legislative procedure, QMV

Department

Environment, Food and Rural Affairs

Document Numbers

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

Summary and Committee’s conclusions

10.1The Commission proposed revised rules in 2014 to increase the availability if veterinary medicinal products, improve the functioning of the internal market in these products and addressed the public health risk of antimicrobial resistance (AMR).

10.2We last considered these proposals at our meeting of 21 March 2018, requesting further information about the agreed provisions on AMR and seeking clarity on which (if any) of those provisions the UK might choose not to adopt.92 The legislation will not apply until mid-2021 at the earliest, meaning that the UK will not be required to implement it during the post-Brexit withdrawal period ending on 31 December 2020.

10.3The Parliamentary Under-Secretary of State for Rural Affairs and Biosecurity (Lord Gardiner of Kimble) has responded to us, outlining the agreed AMR provisions in both proposals (see “Background” section below).93 The Minister indicates that the detail represents a significant increase in regulatory oversight of veterinary antiobiotics compared with current requirements but that there is a strong focus on scientific evidence or advice in underpinning measures for addressing AMR. As such, the Government supports both the overall objectives and the objectives of the specific provisions. Given that some of those remain subject to negotiation, though, the Minister considers it would be premature to take a firm view on which provisions, if any, it would not be appropriate to implement.

10.4The Minister reports that most of the changes negotiated during the trilogue negotiations have been of a technical nature, but that a new provision has been added which would have the effect of requiring producers from third countries that export animal and animal products to the EU to follow the detailed EU rules on the use of antibiotics. This would represent a significant restriction on imports to the EU. There was concern from the UK and some other Member States that the new provision might not be compatible with the requirement under Article 5 of the World Trade Organisation (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), which requires WTO Members to base their SPS measures on a scientific assessment of risk.94

10.5In response to concerns expressed by the UK and other Member States, the text now includes a proviso on the measure’s compatibility with EU obligations under international agreements. Application of this provision will be supplemented with detail adopted through a delegated act.

10.6The Minister asks the Committee to consider clearing the document from scrutiny ahead of final adoption of the compromise and a ministerial vote in due course.

10.7We are aware that, since the Minister wrote, trilogue negotiations between the EU institutions have concluded and that the proposals are expected to proceed for formal adoption in the near future. We understand that they remain largely as outlined by the Minister in his letter.

10.8The Minister’s summary of the AMR provisions is helpful, further to our request for that information. On the question of which of those provisions the UK might choose not to apply post-Brexit, we note that this matter has effectively been overtaken by the new clause requiring producers from third countries that export animal and animal products to the EU to follow the detailed EU rules on the use of antibiotics. This means, of course, that discussion of the relevant delegated act will be very important.

10.9We 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.95 That document remains under scrutiny and we await a further update from the Department of Health and Social Care.96

10.10We are now content to clear this document from scrutiny. We would welcome confirmation of the final agreement reached, including the specific provisions pertaining to restrictions on third country imports. We expect the Minister to set out the potential impact of this provision on the UK post-Brexit and we would also welcome an indication of the timeline for proposal and adoption of the relevant delegated act.

Full details of the documents

(a) Proposal for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed : (36338), 13196/14 + ADDs 1–3, COM(14) 556; (b) Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products: (36344), 13289/14 + ADDs 1–3, COM(14) 558.

Background

10.11The Minister identifies the following AMR-specific provisions in the veterinary medicinal products proposal (document (b)):

10.12The antibiotic related provisions in the current draft proposal on medicated feed cover:

Previous Committee Reports

Twenty-first Report HC 301–xx (2017–19), chapter 2 (21 March 2018); 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).


92 Twenty-first Report HC 301–xx (2017–19), chapter 2 (21 March 2018).

93 Letter from Lord Gardiner of Kimble to Sir William Cash, dated 4 June 2018 (received 7 June 2018).

94 SPS measures can be applied to protect human, animal or plant life or health within the territory of a country from risks arising from plant pests (insects, bacteria, virus), additives, residues (of pesticides or veterinary drugs), contaminants (heavy metals), toxins or disease-causing organisms in foods, beverages or feedstuffs, and diseases carried by animals.

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

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




Published: 26 June 2018