|Authorisation of Human and Veterinary Medicines
Richard Younger-Ross: I have no particular interest in herbal medicines. I have been persuaded only once to partake of some Chinese medicine by my wife; she said that I was overworking and that I needed a little more vigour. I had to take the tablets for three or four days and they were meant to give me a lift. On the list of ingredients—reading lists is always a mistake—was the deputy ingredient of liver of dog. If that did not depress me enough, I then read that the chief ingredient was liver of donkey. At that point, I decided that I did not need a lift and I would make any changes by myself.
There are questions about what we can advise people to eat to give them a lift or make them feel better. My hon. Friend the Member for Oxford, West and Abingdon clearly said that when people make a claim they must be able to justify it. Were an individual to buy a car which the manufacturer said did 100 mph, he would be disappointed if it did only 50 mph, but laws and regulations prevent that from happening. We must be careful in the case of other products that what people are being sold will do what is claimed.
There are fears that the practical effect of the proposals will far outstrip their benefits. I have considered examples of good EU legislation. The Under-Secretary of State for Environment, Food and Rural Affairs has debated shell fish quality with me before—we have good legislation on shell fish—
The Chairman: Order. I ask the hon. Gentleman to keep to the issue under debate.
Richard Younger-Ross: It is just that, although legislation might be good, legislators in Whitehall can then consider it and complicate it far more than anyone in Europe would. The industry has real fears that, despite the Ministers' good works, we shall end
Column Number: 35up with something that is far more complex than what exists for our European colleagues, or than what is needed. Civil servants' desire to give us the best, and to gold plate legislation as far as they can, is understandable, but such gold plating can be a bad way in which to approach legislation. I hear what the Ministers say about a minimum, and I hope that they ensure that we go back to Europe and reconsider that.
I do not remember whether it was four or six years ago, or whether it was during the time of the Labour Government or the outgoing Conservative Government, but the Department of Health had a real go at introducing legislation just like this. At that time, it said that the EU required us to introduce it. Those in the industry launched a big campaign and said that they did not think that it was necessary. The Department of Health backed down—the battle was too great—and agreed that there was no requirement in EU law, so it would not take on the new proposals. However, because of that, the industry fears that the proposed requirements will be too prescriptive.
Some products may be dangerous when combined with others, but some herbal medicines are not. We take sage out of the garden, boil it up and use it for a cough. We might combine it with other things to improve it. If I were to give that to my neighbour, would I fall foul of the legislation? We need a commonsense approach to many herbal medicines which are tried and tested, and which, when combined with each other, could not be construed as dangerous in any way, shape or form.
What my hon. Friend the Member for Oxford, West and Abingdon said about safety and testing was absolutely right, but we must decide what needs to be tested and why. Legislation that provides that everything must be tested would clearly be nonsense, because there are quite clearly products that are safe and usable that should be able to be used.
Finally, let us look at the objectives of the whole package. The Ministers have said that they have doubts and fears. When they go back and negotiate, will they ask what the basis is for many of the proposals and why these matters are being dealt with, and what other structures are being set up and why? The documents that we have been given—it is an overall package of legislation, and it is hard to know what refers to what—mention ''objectives''. They include the setting up of a legal framework that
That is the pharmaceutical industry, not the herbal industry. I think that we would all like to see the herbal products industry do well and prosper, and to see that what comes out of the proposals is, in the long term, safe for consumers and for the industry in the future.
Ms Blears: As my hon. Friend the Under-Secretary of State for Environment, Food and Rural Affairs said when he opened the debate, we genuinely welcome the opportunity to debate the proposals from the
Column Number: 36Commission to amend the European legislation that governs the regulation of human and veterinary medicines and to introduce a directive on traditional herbal medicines. Much of our debate has been on that.
These are complex subjects and I shall take the advice of the hon. Member for Bosworth and of my hon. Friend the Member for Bolton, South-East, who said that there is a huge amount of public concern about the matter. I do not underestimate that fact. These are matters of great detail and I certainly intend to take them extremely seriously. In our dealings, my hon. Friend the Under-Secretary and I are absolutely concerned to get the balance right between regulation, consumer choice, confidence and safety. Those are all very important to us.
We have had a useful and wide-ranging discussion. I thank hon. Members for their contributions, because this is an ongoing debate. I should like to reinforce the Government's position, perhaps with a little more information on how the negotiations are going and on what the Government's stance will be on certain areas as the directives proceed through Europe.
I turn first to the review of medicines legislation. As we have made clear, the Government support the overall objectives of the Commission's review. We recognise the need to take account of the experience of operating the system introduced in 1995 and to try to make changes to take account of the forthcoming Community enlargement. Some changes will need to be made to the existing committee structure, which will not be tenable after enlargement.
The specific objectives set out by the Commission for the review are laudable—no one would argue otherwise, with an exercise that sets out to guarantee a high level of public health protection for EU citizens and to provide fast access to innovative medicines. Nor would we oppose changes designed to ensure the competitiveness of the pharmaceutical industry in the EU. We are in a strong position, because of the size of our industry, to benefit significantly from proposals that would achieve that objective.
My hon. Friend and I have tried to make clear in our discussions today that the Government have concerns about the way in which the Commission has translated its objectives into specific proposals in certain areas. A particular concern—a matter that was raised in passing by the hon. Member for Oxford, West and Abingdon—is the proposal to have pilot projects on direct-to-consumer advertising in three areas: AIDS, asthma and diabetes. The pilot projects would be on providing information direct to consumers. We do not want to see any pilot project that breaches in any way, however limited, the fundamental principle that prescription medicines may not be advertised to the general public.
Equally importantly, we do not want an initiative that would prevent us from continuing to develop the good systems of providing proper product information and increasing knowledge to patients so that they are better informed. We are very concerned that a pilot project for five years for a limited range of diseases
Column Number: 37might prevent us from developing initiatives across the board.
Dr. Evan Harris: Why does the Under-Secretary not support that project? Is it because she does not want people to be better informed? Over-the-counter medicines can be advertised direct to the consumer. Or is she concerned that it might lead to increased demand for such products and make it more difficult for the NHS to get away with the implicit instead of the explicit rationing that is so widespread?
Ms Blears: The crucial point is the difference between information and advertising. Information to patients is something that we would all support, so that they can make informed choices. That information should be accurate and reliable. There is a world of difference between information and advertising that is designed to maximise take-up of a particular product. Therefore, we strongly oppose direct advertising of particular products and various claims that they might make.
We also have concerns about another matter that has not been raised in the debate, but I want to emphasise it. It is proposed to abolish the five-yearly licence renewals and replace them with three-yearly safety reports. We think that the five-yearly licence renewals provide a much more robust mechanism for looking at the licence generally.
The point raised by the hon. Member for North-East Hertfordshire about centralisation and how we propose to deal with the issue in the negotiations is very important. We do not believe that making a centralised procedure mandatory for all new active substances will improve the competitiveness of the EU pharmaceutical industry, nor provide fast access to innovative medicines for the citizens of Europe. In fact, it might have the opposite effect and make the EU, especially after enlargement, a less attractive place in which to develop and market new drugs. If companies have to go through the central procedure, they may be more reluctant to market in the EU.
We also believe that requiring companies to prepare every product for each of the 25 member states, with all the language implications and other obligations of the centralised procedure before it can be marketed anywhere in the EU, is an unwarranted hurdle for new medicines, which may delay access for citizens. In any event, the use of that procedure does not mean that a product has to be marketed in every member state. A company might decide not to do so, and the product would not be available even when it has got over all the hurdles of the centralised procedure. The proposal would seriously disadvantage the veterinary sector, in which the range of species and diseases is such that many veterinary medicines are just not needed in every single member state. We shall press that issue extremely hard in the negotiations.
I can tell the hon. Member for North-East Hertfordshire that we have pressed an argument for no change to the scope of the centralised procedure, and we are making progress. The balance of member states' views is in favour of the UK view to maintain the status quo, so companies would still have a choice whether to go through the central procedure or the
Column Number: 38mutual recognition procedure. We will continue strongly to promote our views; that is a high priority for the UK Government. There is some evidence that certain Members of the European Parliament, who were generally very disposed to the idea of centralised procedure, are reconsidering their support for further centralisation. I am pleased to be able to tell all hon. Members that that appears to be going our way in the negotiations, but we shall continue to press the matter extremely hard.
The proposed change to the definition of a medicinal product and the extension of the scope of medicine legislation is another important issue on which we will continue to press the Commission. We of course accept the need to ensure that so-called borderline products can be identified and, where necessary in the interests of public health, appropriately regulated as medicines. However, such a provision should not undermine perfectly acceptable legislation already in place to regulate a range of products such as food supplements, medical devices and others. Again, we will press very hard on those issues to ensure that we do not create a hierarchy of medicines that we do not believe would be helpful to us.
On the traditional herbal medicinal products directive, it is not surprising that MPs and constituents have been raising issues, because there has been a very big campaign. I would like to reassure Members that there are other views apart from those that have been heard most vociferously in the debate. As I say, 1 million leaflets have been published and I am concerned that people have received inaccurate information as a result of that campaign. The hon. Member for Oxford, West and Abingdon raised a concern as to whether Consumers for Health Choice is funded by the industry. I understand from its documents, which it has issued in Parliament, that it receives donations from its members and independent retailers. It also receives ''generous campaign support'' for its existing UK and Brussels work from leading companies such as Holland and Barrett, Solgar and Biocare, which are prominent brands in the UK. It estimates the cost of the UK roll-out of its public relations campaign at $100,000, and is looking for total campaign funding of $340,000. It is important that that should be placed on the record.
The directive will put in a place a systematic regime that will recognise the value of traditional herbal remedies. It will give such remedies a secure legal status, bring long-term stability to the market and assure the consumer of quality, safety, information and choice. Those are major advantages, and it would be short-sighted to spurn that opportunity. We are encouraged that many other member states appear to share that view. They have recently indicated that they too welcome the proposals in the directive, and we shall continue actively to participate in continuing negotiations. As I have said, it may be possible during the drafting of the text to improve the directive to set out more clearly how account can be taken of herbal traditions from outside the EU, accepting that there is a long history of Chinese and ayurvedic medicines.
Column Number: 39
|©Parliamentary copyright 2002||Prepared 18 June 2002|