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European Standing Committee C Debates

Authorisation of Human and Veterinary Medicines

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European Standing

Committee C

Tuesday 18 June 2002

[Mr. David Chidgey in the Chair]

Authorisation of Human and

Veterinary Medicines

4.30 pm

The Chairman: There are two Ministers present today. I understand that Mr. Morley intends to make the opening statement and Ms Blears will respond to the debate that follows questions.

The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs (Mr. Elliot Morley): Thank you, Mr. Chidgey. It is nice to serve under your chairmanship. This is the first time that you have chaired a debate in which I have participated and I look forward to your guidance.

I welcome the opportunity to debate the Commission's complex proposals, which suggest amending the regulatory requirements for both human and veterinary medicines and introducing a directive on traditional herbal medicines. I shall try to make my opening remarks brief because that is appropriate in a scrutiny Committee. Unfortunately, the matter is quite complex and I will have to say more than usual in order to allow Committee members to hear the Government's views, about which I am sure they will want to ask questions.

I am delighted to be joined by the Under-Secretary of State for Health, my hon. Friend the Member for Salford (Ms Blears). We are a double act, which is a new experience for me, as the documents cover veterinary medicines, for which I take responsibility in the Department for Environment, Food and Rural Affairs, and human medicines, for which my hon. Friend takes responsibility. She will be replying to the debate, which will give her an opportunity to pick up any points that have been raised, as well as joining me in answering questions.

I am sure that hon. Members will agree that the regulation of medicines is an important issue. We support the Commission's overall objectives for the review of medicines legislation. We have some concerns, which I am sure will come out in the debate, about the detail of the review, but its overall aim has the Government's support. The objectives are to guarantee a high level of public health protection for European Union citizens and provide fast access to innovative products; to complete the internal market for pharmaceutical products taking account of globalisation; to ensure the future competitiveness of the EU; to improve market surveillance; to meet the challenges of enlargement; to rationalise and simplify the system and make it more transparent; and to improve animal health by increasing the number of medicines available, which has been a problem in this country.

We have been able to adopt a positive position in discussions in the Council working group in Brussels

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on that important review. Members may welcome some background on the current legislative framework for the control of medicines and therefore the context in which both of those sets of proposals are set. There has been UK medicines legislation and national authorisation of human and veterinary medicinal products for the market for the past 35 years. Assessment of applications for a licence to market veterinary and human medicines in the UK and monitoring of their safety in use is undertaken in the case of animals by the veterinary medicines directorate and in the case of people by the Medicines Control Agency. Since 1965 a developing body of European legislation has progressively eroded and replaced elements of the Medicines Act 1968 such that most aspects of medicines regulation are now governed by a number of directives, which have recently been codified into a smaller number of regulations.

The most important of those regulations was introduced in 1995 and established the European Medicines Evaluation Agency, or EMEA. It also introduced the concept of a centralised licence issued by the European Commission, which is valid throughout the EU. The assessment of applications for a centralised licence and any other scientific work associated with the system remains the responsibility of member states. In that system two member states, the rapporteur and co-rapporteur, undertake the assessment of a product on behalf of the EU as a whole, but all member states have the opportunity to consider the reports in the relevant scientific committees.

It is important to recognise that EMEA is broadly a co-ordinating body that relies on the experience of national specialist bodies. In this country, the VMD and the MCA, which are recognised for their scientific and regulatory expertise, have a very good record. I am sure that most hon. Members know that EMEA's central European office is based in Canary wharf in London.

All the EU member states are involved in the operation of EMEA through their membership of the management board. In the past six years, the Commission has licensed about 2 per cent. of the products on the UK market. A system that ensures consistency of any nationally licensed product that is available in more than one state was introduced at the time that EMEA was established and became effective from 1 January 1998. It is known as the mutual recognition procedure. If a company wants to use it, it must identify one member state to lead the assessment, and all the other member states in which the company wishes to market the product must agree on certain aspects of the licence. However, the licences are national licences. I understand that the UK is often chosen to lead the assessments. Since 1995, companies have had to use the centralised procedure for biotechnology products and those that are considered to represent significant innovation but, at present, they can choose between the centralised procedure and the mutual recognition route of assessment for most other categories of application. The system has served us well but is changing, and the

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directive is part of the Commission's review of the matter.

I know that there is much interest in traditional herbal medicines. We want to ensure that consumers continue to have access to a wide range of safe, traditional herbal remedies of appropriate quality. The current regulatory framework does not provide adequate safeguards for the public, and we continue to find examples of products on the UK market that pose a risk to public health; for example, remedies with toxic herbal ingredients such as aristolochia, which is used in traditional Chinese medicines but is associated with renal failure and cancer.

We share the view of the House of Lords Science and Technology Committee, which conducted an inquiry into complementary and alternative medicine in 2000, that herbal remedies should be appropriately regulated as medicines. Therefore, we welcome the European Commission's proposals for a directive that introduces a more effective regulatory regime. My hon. Friend the Under-Secretary of State for Health will say more about that.

The explanatory memorandum has been circulated, and hon. Members may wish to refer to it during the debate. It sets out the proposals and the areas in which the Government have concerns. I shall try to keep my opening remarks as brief as possible, because I know that many hon. Members may wish to speak. My hon. Friend and I are happy to answer any questions. Clearly, some details about the operation of the directive are yet to be discussed and negotiated, and the Government wish to take up some concerns with the Commission. However, overall, we think that the directive takes the right approach and presents a range of benefits for consumers in this country and in the EU.

The Chairman: We now have until 5.30 pm for questions. Questions may be directed to either Minister, and they shall determine who will respond to each question. I remind Members that questions should be brief and should be asked one at a time. There is likely to be ample opportunity for all Members to ask several questions.

Mr. Oliver Heald (North-East Hertfordshire): I join in welcoming you, Mr. Chidgey, to your position. May I start by asking about the overall structure of what is proposed? Are Ministers satisfied that in imposing on veterinary medicines the strict approach that is proposed, there will not be a risk that safety will be compromised because animal medicines will simply not be brought forward as they have been previously, given the costs and bureaucratic nature of the proposal? Similarly, does not the same apply to herbal medicines? The strict controls imposed by the regulations is likely to mean that many products that are currently used safely will no longer be available to the public.

Mr. Morley: I understand that there is a very fair point about cost and administration in relation to new products. However, there is nothing new about that problem. We already have a problem with veterinary products. Because of national regulations, some products are available in some European countries

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but not here because the company concerned has taken a decision that the market in the UK is not really big enough for it to go through the regulatory proposals.

These proposals do not completely resolve that problem but they recognise and address it, particularly through the centralised procedure, although we have some concerns about that. We would much rather allow companies the choice between the centralised procedure and the mutual recognition procedure. The point is to try to keep administrative costs down and to strike a balance between ensuring that the costs are not exorbitant and ensuring that new products, whether they are veterinary or herbal products, are properly scrutinised in a transparent way, with proper regulation. That will be part of the ongoing debate that we shall have on this directive, but the point is recognised and we believe that, generally speaking, the directive goes in the right direction on it.

Mr. Michael Jack (Fylde): The organisation Consumers for Health Choice has written to members of the Committee. I am happy to pose its first question on its behalf. It says that, in its view, the directive on traditional herbal and medicinal products would effectively orphan several important categories of product by leaving them completely outside the regulatory framework. It says that even traditional herbal medicinal ingredients proven to be safe during the past 30 years will effectively be ruled out, even if they could comply with the pharmaceutical standards in the directive. Can the Under-Secretary of State for Health respond to that concern?


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Prepared 18 June 2002