4Veterinary medicinal products
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Committee’s assessment |
Politically important |
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Not cleared from scrutiny; scrutiny waiver granted; further information requested |
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Document details |
(a) Draft Regulation on the manufacture, placing on the market and use of medicated feed; (b) Draft Regulation amending Regulation 726/2004 on Community procedures for the authorisation and supervision of medicinal products; (c) Draft Regulation on veterinary medicinal products. |
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Legal base |
(a) Articles 43 and 168(4)(b), Ordinary Legislative Procedure, QMV; (b) Articles 43 and 168(4)(c), Ordinary Legislative Procedure, QMV; (c) Articles 43 and 168(4)(b), Ordinary Legislative Procedure, QMV |
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Department |
Environment, Food and Rural Affairs |
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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
4.1The 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.
4.2The revisions aimed to:
- increase the availability of veterinary medicinal products;
- reduce administrative burdens;
- stimulate competitiveness and innovation;
- improve the functioning of the internal market; and
- address the public health risk of antimicrobial resistance (AMR).
4.3Noting the Government’s broad support for these proposals, the then Committee reported the proposals to the House as politically important in October 2014. Our predecessors then engaged in correspondence with the responsible Ministers.
4.4Discussions proceeded very slowly until new impetus was given to the proposals by the Estonian Presidency. In the most recent letter, the Parliamentary Under Secretary of State (Lord Gardiner of Kimble) reports that consideration has accelerated. Agreement is expected at the Agriculture Council on 13 December.
4.5The Minister indicates UK support for the overall package. He notes that the main concern for the UK is 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.
4.6The Government also has 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 indicates support in principle, especially for antibiotics where carry-over may contribute to antibiotic resistance, there are concerns about increased costs. The UK’s concerns are shared by other Member States and so the Minister remains hopeful that a sensible agreement can be reached.
4.7The other significant provisions in the proposals are those pertaining to tackling anti-microbial resistance. The proposed provisions are in line with UK policy.
4.8On the UK’s exit from the EU, the Minister comments that it was now highly likely that the UK would leave the EU before the updated legislation must be applied. The medicated feed proposal is due to be applied one year after entry into force and the veterinary medicines proposal is due to be applied three years after entry into force. Noting that the UK is already at the forefront of the fight against antimicrobial resistance and this will continue to be a priority beyond the UK’s EU membership, the Minister indicates that the Government would look carefully at the Regulations and the elements that it may be sensible to implement after the UK has left the EU.
4.9We consider 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 are of particular concern to us.
4.10We note overall UK support for these proposals, but that the Government has concerns about proposed new restrictions on prescribing veterinary medicines and about the provisions on carry-over under the medicated feed proposal. We would welcome an update on the agreement reached on both of those issues at the Council meeting. We would also welcome a summary of the agreed provisions on anti-microbial resistance.
4.11The Minister noted in correspondence that it was unlikely that the legislation would need to be applied before the UK’s withdrawal from the EU, noting the one year and three year deadlines for the medicated feed and veterinary medicines proposals respectively. Given that the medicated feed proposal (document (a)) will need to be applied one year after entry into force, we ask the Government whether it accepts that this might need to be applied during a post-Brexit implementation period as proposed by the Prime Minister?
4.12On the UK’s withdrawal from the EU, we would welcome responses to the following additional points:
- the amount of trade in veterinary medicines and medicated feed between the UK and EU-27;
- the implications for the UK of separation from the EU’s veterinary medicines regulatory framework, including the restrictions to tackle anti-microbial resistance, the proposed new common database and the requirements on authorisations and mutual recognition; and
- whether the UK would be likely to choose to maintain alignment with EU standards post-Brexit in any case.
4.13We waive these proposals from scrutiny in advance of the Council meeting on 13 December. They remain under scrutiny pending responses to the issues raised above and an explanation of progress as well as the Government’s expectations for negotiations with the European Parliament. We would welcome a response within four weeks.
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
4.14Details on the background and content of the proposals, as well as on the Government’s position, were set out in our Report of 22 October 2014.37 The key points are summarised below.
4.15When the then Committee considered the proposals at its meeting of 22 October 2014, it retained the proposals under scrutiny, noting the Government’s support for them but awaiting further information on the progress of negotiations. Since then, our predecessors received update letters on 4 March 2015, 7 July 2015, 11 May 2016, 2 February 2017 and 28 March 2017.
Medicated Feed (document (a))
4.16Medicated feeds containing antimicrobials and anti-parasites are an important way of treating disease in groups of farmed animals, especially pigs and poultry, as well as in domestic pets. The existing EU rules governing their manufacture, placing on the market and use were adopted before the creation of the single market. The freedom it provides Member States as regards national transposition has given rise to a number of problems.
4.17The proposed revision would retain many of the previous provisions, whilst seeking to achieve greater clarity by measures such as: prohibiting the use of medicated feed containing microbials with the intention of preventing disease in food-producing animals, thus taking account of the severe public health risk posed by antibiotic resistance; and establishing maximum levels, related to the degree of risk involved, for the “carry-over” of active substances between different types of feed manufactured on the same production line.
Veterinary Medicines (documents (b) and (c))
4.18The EU rules which currently apply to the production, marketing, distribution and use of veterinary medicines are set out in two main instruments:
- Directive 2001/82/EC, which stipulates that such a medicine cannot be placed on the market of a Member State unless the competent authority has issued an appropriate marketing authorisation (“national authorisation”), and sets out the basis on which an authorisation granted in one Member State may be valid in other Member States (“mutual recognition”); and
- Regulation (EC) No. 726/2004, which sets out a centralised procedure under which products are simultaneously authorised by the Commission in all Member States on a pan-European basis.
4.19The Commission proposed (document (c)) to repeal Directive 2001/82/EC, and put in place an up-to-date and proportionate body of legislation (as a Regulation) tailored to the specific needs of the veterinary sector. The new Regulation would also incorporate the centralised procedures for the granting of authorisations by the Commission. As a consequence, Regulation 726/2004 should be amended in order that it is focused wholly on human medicines (document (b)).
4.20Much of the existing framework would be retained, with the application of a benefit-risk assessment continuing to be a key element in determining whether a product should be authorised, but the proposal would introduce a number of changes, including:
- the Commission would be empowered to establish rules excluding or restricting the use of certain antimicrobials in the veterinary sector;
- new restrictions would be imposed on the supply of antimicrobial veterinary medicines, a system would be set up to record and report on their use, and, where there is no authorised veterinary medicine for a particular species or disease, rules would be established for prescriptions, principally in order to address concerns relating to antibiotic resistance;
- rules would also be established for online sales (which would be encouraged in order to improve access to veterinary medicines);
- packaging and labelling simplifications;
- changes to the lengths of marketing authorisations—10–14 years for the initial authorisations, with particular flexibility for smaller markets, and renewals of unlimited duration;
- a single product database for all authorised veterinary medicines; and
- a harmonised EU procedure would be introduced for the authorisation of the clinical trials used to demonstrate a product’s quality, safety and efficacy, and food producing animals used in such trials would not be permitted to enter the food chain, unless the product administered has already been authorised.
The Minister’s letters of 20 July 2017
4.21On the medicated feed proposal (document (a)), the Minister explained that the Estonian Presidency had proposed reopening discussions on the proposals in September 2017. The European Parliament had adopted its first reading position with 93 amendments to the proposal and focused on the controls surrounding the prescribing of antibiotics and the level of carry-over in batches of medicated feed.
4.22Regarding the other proposals, a third “read-through” had continued under the Maltese presidency and the Estonian presidency had stated its intention to finalise the Council’s position by October 2017 in order to start the negotiations with the European Parliament as soon as possible.
The Minister’s letters of 1 November 2017
4.23The Minister confirmed that discussions on the medicated feed proposal were re-opened in September. A Council position was expected to be agreed by the end of the year.
4.24Progress on the other proposals had been slower than desired by the Presidency, but agreement was also still expected by the end of the year.
4.25The Minister noted that removal of the veterinary aspects from Regulation 726/2004 on community procedures for the authorisation and supervision of medicinal products (document (b)) meant that it would be necessary to update the arrangements for adoption of tertiary legislation (delegated and implementing acts) related to human medicines to ensure consistency with the Lisbon Treaty.
4.26On 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 comes into force. He added:
“ The UK is already at the forefront of the fight against antimicrobial resistance and this will continue to be a priority beyond our EU membership. We will look carefully at the Regulations and the elements that it may be sensible to implement after the UK has left the EU.”
The Minister’s letter of 30 November 2017
4.27The Minister notes that the Estonian Presidency has accelerated these negotiations, which have now lasted more than three years.
4.28He notes that restricting the act of prescribing certain medicines to vets only is a new development in the negotiations, included in the latest draft text. The Minister explains that, under existing arrangements in the UK, “Suitably Qualified Persons” (SQPs) are able to write prescriptions for veterinary medicines classified as “POM-VPS”38 but that the latest proposed changes would prohibit this. He adds:
“At the time of writing, there are just short of 7000 trained and qualified SQPs registered in the UK and approximately 320 medicines classified as POM-VPS. These products generally prevent (i.e. vaccines) or treat endemic livestock diseases or parasite infestations, both internal (i.e. worms) or external (e.g. fleas, lice etc) that do not require a prior veterinary diagnosis (in the UK, SQPs also sell and give advice on similar products, classified as NFA-VPS, authorised for use in companion animals.)”
4.29The Minister explains that, throughout the negotiations, the Government has made the case for provisions at EU level that are compatible with the existing, well-functioning UK distribution system for veterinary medicines. Circumstances vary across EU member states, although the UK is alone in openly allowing non-vets (i.e. SQPs) to prescribe certain veterinary medicines.
4.30On anti-microbial resistance, measures are being introduced in both the veterinary medicines and medicated feed proposals to reduce the risk to the development of antimicrobial resistance:
“The routine use of antibiotics to prevent disease will not be permitted. The Commission has proposed that the treatment of a group of animals to eliminate or minimize an expected outbreak of disease (metaphylactic use) will be allowed but routine prophylactic use (a medicine or course of action used to prevent disease) will not. There will need to be a change to a number of Summary of Product Characteristics (SPCs—detailed descriptions of a medicine’s properties and the conditions for using it) as some antibiotics are currently indicated for preventative use. The proposals are consistent with the UK Antimicrobial Resistance strategy.”
4.31Regarding proposals in the medicated feed legislation on limits for the “carry-over” of medicines into non-target batches of feed, the Minister indicates support in principle, especially for antibiotics where carry-over may contribute to antibiotic resistance. The concern for the Government is the potential impact of the proposed carry-over limits on the economics of medicated feed production. While carry-over can be reduced, explains the Minister, by flushing the plant with un-medicated feed, this then becomes a waste product and therefore an added cost of production. Also of concern to the Government is the capacity of commercial labs to detect or quantify trace amounts of carried-over medicines when conducting regulatory compliance testing. Investing in such analytical capability may further add to the cost of manufacturing medicated feed. The Government’s position is that carry-over should be kept to a minimum but the levels of permitted carry-over for each substance must be set according to sound science from the outset. The UK, and the majority of Member States, have argued for workable limits to be set and the UK remains hopeful that a sensible agreement can be reached.
4.32While the UK continues to resist inclusion of the specific provisions highlighted above, the UK can still support the proposal as a whole.
Previous Committee Reports
Fifteenth Report HC 219–xv (2014–15) chapter 2 and chapter 3 (22 October 2014).
38 Prescription Only Medicines able to be prescribed by a vet, pharmacist or suitably qualified person
11 December 2017