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10.45 am
The Minister for Public Health (Ms Tessa Jowell): I shall begin not exactly by registering an interest, but by pointing out that my brother is a senior executive in Glaxo Wellcome. For that reason, I do not take part in departmental discussions or decisions about pharmaceutical licensing. I am responsible for complementary medicine, but I want the House to be aware of that fact in the context of my responding to this debate on a matter that would normally be handled by my noble Friend Baroness Hayman.
I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on taking this opportunity to raise a matter that is of great cross-party concern. I hope that, in the time available, I can generate a little more light than heat and put the record straight on a number of important issues for those hon. Members here today and for the many people who are enormously concerned about the issue.
First, let us deal with the facts of the current controversy. I am concerned that much of the criticism of the proposals has been an unwarranted cause of worry and worse for manufacturers, retailers and consumers alike. I say that as someone who has ministerial responsibility for complementary medicines and who recognises the
enormous public interest in this new and developing area of medicine, which is of potential benefit. We should be clearer and more systematic about the evidence for the benefits that many people anecdotally report. I approach this debate by making clear my sympathy for complementary medicine in general and my understanding of many people's enthusiasm for and reliance on methods of complementary medicine.
As has been clear throughout the debate, the problem is the lack of a legal definition of the term "dietary supplement". Many of the products described as such inhabit an increasingly grey area between foods and medicines. As the law stands, those products for which claims are made for the treatment or prevention of disease, or which are administered to restore, correct or modify physiological functions, fall within the definition of a medicine and are subject to the requirements of the Medicines Act 1968 and the appropriate European directive. Such products normally require a marketing authorisation--that is, a licence--before they can be sold or supplied.
Products that are licensed as medicines are excluded from the definition of food in the Food Safety Act 1990. Products that are not licensed are automatically regarded as foods and are subject to the general provisions of the 1990 Act, which effectively requires that they should not cause harm, and to the Food Labelling Regulations 1996, which control the labelling and advertising of food. Among other things, the regulations prohibit claims in labelling or advertising that a food has the property of preventing, treating or curing a human disease, and lay down conditions for the use of nutritional claims and certain descriptions that may mislead.
As regards policy, the Government have stated on a number of occasions that we believe that the quantity of vitamins and minerals in supplements sold under food law should be limited only in cases in which it is necessary to protect the public. Any limits should be based on safety considerations, judgments about which are made on the basis of expert scientific advice.
I would not pretend for one moment that such advice might never give rise to controversy, but the boundary between categories of product can be difficult to determine. Garlic, evening primrose oil and vitamins in general may be dietary supplements or medicinal products. The determining factor is whether they are sold with claims to treat or prevent disease. If they are, and if the manufacturer wishes to continue to make those claims, he must apply to the MCA for a licence for the product.
It may be helpful to remind the House of the responsibilities of the MCA. The agency has a duty, on behalf of the licensing authority, to implement and enforce the provisions of the Medicines Act 1968 and other medicines legislation. It does so to protect public health, and specifically to make sure that the medicines that sick people use are safe, of high quality and effective. The MCA has a very important role in protecting consumers.
Part of the MCA's duties involve deciding whether a product is or is not a medicine. The criteria against which it makes those decisions is a matter of European Union law.
Dr. Brand:
Does the Minister think it appropriate for the MCA to be both the prosecution and the jury in
Ms Jowell:
I do not accept that point. The routes by which matters of concern are raised with the MCA are many and varied. Many of the grounds on which inquiries are raised about products that are in a grey area are identified by public concern or by general practitioners, such as the hon. Gentleman himself, on behalf of their patients.
Unless EU law changes, there will be no change in the status of products sold as food or as herbal remedies exempt from licensing. Those products will continue on open sale without the need for licensing. It is claimed that if the consultation proposals became law, the MCA would sweep supplements and herbal remedies from the shelves unless they were licensed. Those claims are completely unfounded.
What would the proposals do? They would make the process by which medicines are classified more transparent, consistent and credible among the wider public. That is important because the present purely administrative arrangements for classifying medicines are sometimes criticised by manufacturers on the ground that they have not had a full and fair hearing. It is the Government's view that decision-making processes should be as open as possible. We believe that introducing a new statutory process, on top of the agency's present administrative arrangements, will make for greater clarity and transparency.
The Government also believe that if manufacturers are given greater access to the classification process, they will be able to have faith in decisions under it, and it is important that they should have that faith. We believe that introducing a statutory right for manufacturers to participate in the process and put their arguments and cases to a review panel would effectively address the criticisms sometimes made about the alleged secrecy of the present classification arrangements.
At the same time, the proposals would improve the effectiveness of the MCA's compliance and enforcement processes by reducing the scope for delay and evasion. In that way, we would demonstrate the UK's commitment to full implementation and enforcement of medicines legislation. We believe that introducing a new offence of non-compliance with a final decision will bring greater precision to compliance and enforcement activity. The proposed presumption in favour of the MCA in any subsequent proceedings should also strengthen the effectiveness of enforcement activity.
Let me say something about what the proposals do not do. They do not give the MCA a new and unaccountable power to decide whether or not a product is a medicine. The MCA already has that power, as the Court of Appeal confirmed last year. The MCA exercises its powers in accordance with EU and UK law, legal precedent and its published guidance. The MCA also has the power, on behalf of Ministers, to seek to enforce its decisions in the courts.
I want to deal with some specific criticisms levelled at the proposals. It is suggested that the consultation exercise is too short and secret. In fact, the initial eight-week timetable was within the MCA's normal six to eight-week limit. We have extended the consultation period for an
additional month, and implementation of the proposals is not tied to a target date of 1 April. We have already said that we are prepared to listen further, and so we should.
A second criticism is that the statutory review procedure would not be independent of the MCA. We propose that the members of the review body should be officers of the MCA. As the Court of Appeal has recognised, the MCA is a specialist body with accumulated experience in relation to medicinal products, which has had to develop a consistent policy for similar products. Under EU law, it is the licensing authority's duty as the competent authority to make final decisions on classification.
The third criticism is that the proposal to introduce a new offence of non-compliance with a final MCA decision is unnecessary. In any subsequent legal proceedings, the MCA's decision would be deemed correct, unless the manufacturer could show that it was unreasonable. The proposals are said effectively to prevent a manufacturer having any chance of a successful defence in court, but that is not the case. The European Court of Justice has recently agreed that the courts should not have to reassess the merits, as distinct from the legality and reasonableness, of the MCA's final decisions. Accordingly, we do not accept that it should be necessary for the courts to reassess the merits of MCA decisions.
If the MCA were to take proceedings because a manufacturer would not comply with a final decision, our proposed change would shift the burden of proof to the manufacturer, who would have to prove that the decision was unreasonable. We believe that that is justified. The decision would have been arrived at only after thorough and open assessment and review. Manufacturers will have repeated opportunities to make their case.
Perhaps the most alarming claim has been that dietary supplements will have to be licensed from 1 April as prescription-only medicines. That is emphatically untrue. The proposals will not affect the status of dietary supplements, and the idea that they would be available only on a doctor's prescription is equally unfounded.
We will consider carefully the criticism that the shift in the burden of proof in proceedings is oppressive and lacking in natural justice. We recognise that manufacturers would find it extremely difficult to prove a final decision by the MCA to be unreasonable. We are sensitive to the need to show that justice is done. Consequently, we will look particularly carefully at this part of the proposals, to ensure that they go no further than our obligations as the licensing authority require.
In conclusion, we want the people of the United Kingdom to have confidence--
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