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9.57 am
Mr. Philip Hammond (Runnymede and Weybridge): I congratulate the hon. Member for South Derbyshire (Mr. Todd) on securing this important debate and am grateful for the opportunity of stating the Opposition's view on the issue. I am grateful also to you, Madam Speaker, for allowing me to speak early in the debate. I apologise to the House and to the Minister for the fact that I shall have to leave before the debate ends, so that I may attend a Standing Committee. It is only one of the drawbacks of being somewhat short-handed on the Opposition Benches.
The British approach to dietary supplements, both by the current Government and the previous Government, has always been safety focused, concerned with the safety of consumers rather than with their dietary need. We strongly support that position. Although the direction in which the Medicines Control Agency is travelling has caused the industry some concern, the line taken in principle by the Government seems to be--as the Minister of State, Ministry of Agriculture, Fisheries and Food said, and as my hon. Friend the Member for South Holland and The Deepings (Mr. Hayes) quoted--that dietary supplements are "drugs masquerading as foods".
The British approach now has to be placed within the European context. Within the European Union, there is clearly a significant interventionist tendency focusing on dietary need--which often is expressed in terms of multiples of recommended daily allowances--rather than on safety. The European Union is therefore moving towards developing medicines standards in which not only safety and quality, but efficacy, have to be proved.
Safety must be the paramount consideration. Any substance, however it is classified, should be subject to removal from open sale if it is harmful. However, any such judgment must be based on sound science. We must have no repeat of the B6 fiasco. Therefore, the regulatory framework governing dietary supplements has to be the servant, not the master, and ensure that only safe products are on sale and that only justifiable claims for those products are made. It must not have the effect, however unwitting, of removing from sale products that are perfectly safe, that make no unjustifiable claims and that are widely used.
The great fear, which the hon. Member for South Derbyshire has expressed, is that extending medicines legislation to cover products that common sense tells us have little similarity with complex pharmaceutical compounds--the Medicines Control Agency has already publicly acknowledged that it is taking that action by embarking on action against products that are "medicinal in function", even if there is no concern about their safety--with all the associated costs of satisfying medicines standards, and introducing an efficacy hurdle, will effectively remove the products from sale by administrative action. Such a move would be a sledgehammer to crack a nut.
We must ask ourselves whether there is any evidence of serious safety risks from these products. Is any damage being done to consumers? Is the NHS suffering a burden of additional cost in treating ill effects caused by the products? Quite the opposite, I suggest, even if in some cases, as I think the hon. Member for South Derbyshire suggested, the benefits of taking them may be as much psychological as physiological.
I should like to suggest two possible ways of dealing with the problem. First, I question whether it is sensible to define everything as either a food or a medicine. Might it not be sensible to create a third category for supplements, with no requirement to prove the efficacy of the product--in other words, no requirement to prove need--but with a streamlined procedure for dealing with any science-based safety concerns? Secondly, if there is to be greater regulation of supplements, might we as a minimum consider introducing some grandfather rights so that products not hitherto subject to an efficacy test but on sale in substantial amounts throughout the country can continue to be sold unless they are demonstrated to be unsafe?
Dr. Peter Brand (Isle of Wight):
Is the hon. Gentleman aware that many prescribed drugs are on the pharmaceutical register only through grandfather rights? Digitalis and aspirin never went through the rigorous tests that are now mandatory, and they probably would not have passed them.
Mr. Hammond:
I take the hon. Gentleman's point. It is with that analogy in mind that I suggest that if the regulations are tightened it will be appropriate to protect the existing industry and consumers, where there is no suggestion of a safety hazard, by introducing a system of grandfather rights that would allow products to remain on sale.
The burden of proof in relation to an established product must lie with the accuser, in line with the long tradition of British justice. In any regulatory regime, the Medicines Control Agency cannot act as policeman, prosecutor, judge and jury in its own case. The consultation document MLX 249 takes a worrying step in that direction. That, as the Minister will be aware, seems to be part of a trend. Amendments to the Medicines (Advertising) Regulations 1994, which have also been laid and are due to be considered by a Committee of the House, appear to be headed in the same direction. They would extend the powers of the MCA and give it the right to act as judge and jury in its own case.
Other European Union countries operating under the same directive have managed to allow sales of supplements and herbal products either as foods or
medicines, with a simplified regime. Any licensing regime in the United Kingdom must be appropriate to the products involved. The objective must be the safety of the consumer, not a constraint on his, or perhaps in this case I should say her--it often is a woman--buying only what she needs as opposed to what she wants. If we adopted that test, we would ban half the goods on sale in the high street today.
The regulatory burden must be proportional to the risk, and so far I have seen little evidence of any risk. Action can be justified only to protect the public, not to conform to what, for most of us, is an alien concept of state intervention to allow us to do only that which is good for us, as opposed to preventing us from doing that which is positively harmful.
We need as light a touch to the regulatory regime as is consistent with the safety of consumers. I think that the Government recognise that principle. As always, within the limits of the paramountcy of public safety, we should support an established industry which has many valuable small firms within it that make an important contribution to the economy. Above all, any regulatory change must ensure continued access to existing products from a diverse range of suppliers in a competitive marketplace, unless there is clear and compelling scientific evidence that demonstrates that they are unsafe.
The expert group on the safety of vitamins and minerals established after the B6 fiasco has only just begun its deliberations. As the hon. Member for South Derbyshire said, it has probably another year or 18 months of work ahead of it. I urge the Government to allow the group to consider the wider issues, and to withdraw the proposed regulatory changes outlined in MLX 249 until that group has finished its work and reported its conclusions so that the Government may come to an informed decision.
Dr. Brian Iddon (Bolton, South-East):
I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on his timely Adjournment debate. I have nothing to declare other than an interest in the topic that has been created by workers in a factory in my constituency who make health products and by hundreds of constituents who wrote to me during the B6 saga. I do not use health products myself, although I must confess to having been brought up during world war two on a lot of spoonfuls of cod liver oil and rosehip syrup. I made a lot of pocket money by collecting rosehips from hedgerows in the fields where I used to play as a young lad.
It is worth reminding the House that the B6 saga was a long struggle and I congratulate the Minister of Agriculture, Fisheries and Food on referring the subject to the group that has already been mentioned by other hon. Members. I had intended to go over the history of B6, but in view of the time, I shall go to the crux of the debate.
I pointed out during the Adjournment debate on vitamin B6 that, whereas medicines and foodstuffs are closely regulated, the group of products that we are discussing
this morning fall into a regulatory no man's land and attempts to use medicines law or foodstuffs law to regulate them will cause and have already caused problems.
MLX 249, which is partly causing the present controversy, is a proposed amendment to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994. It was issued recently by the Department of Health. A consultation letter was sent out on 6 November last year by the Medicines Control Agency and responses were requested by 31 December 1998. Note the very short time for consultation over one of the busiest holiday periods of the year. I shall come back to that in a moment. The proposal was to put the regulation in place by statutory instrument by 1 April. The MCA claims that it wants to make the decision-making process more transparent and put the classification process for medicinal products on a statutory basis.
MLX 249 relies for its existence on European directive 65/65, which was incorporated in UK law in 1995. That led to MAL 8, which is the MCA's interpretation--I underline that word--of the directive. Other countries have interpreted the same directive differently. Although the directive excludes foodstuffs, it has produced a broad definition of a medicine, which supersedes that given in the Medicines Act 1968, causing panic throughout the health food industry. The definition is:
In a court action last year, the MCA used directive 65/65 and MAL 8 to remove melatonin from the shelves of health product stores and supermarkets. The industry is very worried that many other products will follow suit.
In a letter to me dated 2 February this year about MLX 249, my noble Friend Baroness Hayman, Under-Secretary of State at the Department of Health, said:
In response to a parliamentary question on 18 January this year, my right hon. Friend the Minister for Public Health admitted that at that time her Department had
"Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying"--
I underline the next word--
"physiological functions in human beings or animals is likewise considered to be a medicinal product"
according to directive 65/65. Note the use of the word "physiological" instead of "pharmacological". The definition could classify water as a medicine, along with many other substances.
"The proposed legislation has no bearing on herbal remedies exempt from licensing".
She goes on to say that
"all the current exemptions from licensing for medicinal products will continue to apply."
However, at a meeting in Committee Room 18 on 19 February this year, John Neale, manager of the borderline unit at the MCA, took an apparently contradictory view when he said:
"The proposals will improve the MCA's prospects of success in court"
and
"make it extremely difficult for a manufacturer to prove a product is not a medicine".
He also said:
"We already have all the powers we need to do our job".
The health products industry regards such remarks as a threat to their business.
"received 69 letters from hon. and right hon. Members and 278 representations from other interested bodies and individuals. Three representations broadly support the proposals. The remainder are critical of the proposals to some degree."--[Official Report, 18 January 1999; Vol. 323, c. 380.]
In the time available for the debate, I am not able to refer in equal detail to the MCA's other proposed new regulations, MLX 239, on advertising, and SI 267, which was laid subject to negative resolution.
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