§ Motion made, and Question proposed, That this House do now adjourn—[Mr. Tinn.]
§ 11.17 p.m.
§ Mrs. Joyce Butler (Wood Green)Almost exactly 10 years ago, from 12th March until 30th May 1968, I took part in the Committee stage of the Medicines Bill. As the Member who had been responsible for raising the subject of the thalidomide tragedy for the very first time in this House, I was wholeheartedly in favour of the purpose of the Bill.
I supported the comment of the then Minister of Health, Kenneth Robinson, when he said in Committee:
it is relevant to say that there was no thalidomide tragedy in the United States of America, where the Food and Drugs Administration exercises broadly the sort of control that we are seeking to exercise under the Bill."—[Official Report, Standing Committee D, 12th March 1968, c. 50–1.]Nevertheless, it is important to note that it was accepted from the very beginning that substances used by unorthodox practitioners, including herbal and homoeopathic substances, were in a very special category.In recognition of this, in the 10 years that have elapsed since the first stages of the Bill in Parliament and the making of current regulations, the Department's expert advisers and representatives of unorthodox practitioners have had discussions to ensure that these traditional remedies are protected as, indeed, that Act provides that they should be.
However, there are inevitably a number of difficulties, and the problem about which I am concerned arises from what 1176 is fast becoming the notorious Order 2127—other aspects of which have been debated in the House on several occasions recently. The paragraph of this order which concerns unorthodox practitioners is paragraph 3(1)(d), which prohibits them from giving injections of all but a very limited list of medicinal products. This cuts right across their common law right to give medicines by injection, provided that those medicines are not on the list of scheduled drugs.
One difficulty about this appears to be that the Department has not been able to find any obvious way of distinguishing between untrained lay persons and trained and qualified natural therapeutics practitioners who have the knowledge, training and experience which the lay person does not have.
As I understand it, the particular injections which these qualified natural practitioners have hitherto given, and which Order 2127, after a specified period of six months, will prevent them from administering, fall into five different categories.
The first of these categories is the injection of homeopathic substances that are basically no more than a saline solution and which have been found to work with a high measure of success, especially in cases requiring prompt treatment.
The second is the injection of herbal substances such as echinacea preparations, which are principally concerned with achieving therapeutic effects by bringing about a healing reaction on the part of the patient. These are particularly valuable to the acute rheumatoid patient.
The third is injections of the herbal preparation viscum album, used to combat fibrotic conditions. It is helpful in early osteoarthritis of the hip and in cases of degenerative inter-vertebral discs.
The fourth is local anaesthetics in the vicinity of a lumbar nerve route affected by a compressed disc, by which the remission of pain can bring about relaxation and improvement of the muscle spasm which is longer lasting even than the analgesic effect of the injection itself.
The fifth is injections of vitamins of the B group or of iron. Vitamin B12 is particularly important, since many patients seem to have a particular requirement for 1177 it and benefit greatly from its administration by injection, whereas if it is taken orally it seems to have little value.
This list of categories may sound somewhat obstruse, but the fact is that homeopathic, naturopathic and osteopathic practitioners have been able to produce, with these substances and others, quite remarkable improvements in a wide range of arthritic conditions which orthodox methods have been unable to cure.
I have had a considerable number of letters testifying to the beneficial effects of such treatment in apparently hopeless cases. Some have also been passed on to me by my hon. Friend the Member for Watford (Mr. Tuck), who is unfortunately not able to be in the House tonight but is very concerned about this matter, as the Minister knows. Many other hon. Members share the concern that I am expressing because they themselves have benefited in this way, and I think that all of us have constituents who had previously been regarded as incurable but are now able to live normal lives and to continue in employment as a result of such treatment.
It so happens that there was an interesting sidelight on this debate at my advice session last Saturday, when I had a visit from a young man suffering from tennis elbow—not a condition we hear very much of these days. He was in great pain. He had been to the doctor for treatment before Christmas and was furious with me, as his Member of Parliament, because the earliest appointment that the local hospital consultant could give him was 16th May.
With hospital waiting lists like this, one would have thought that the Ministry would be more concerned to increase and not restrict the effective help available for such conditions, particularly as every visit to an unorthodox practitioner saves the hard-pressed Health Service money, and also, of course, saves sickness and unemployment benefit by getting people fit again and enabling them to return to work.
The fact remains, that, despite its undoubted value to the community, this side of unorthodox practitioner work will come to an end at the end of the six-month suspension period of the order unless some way can be found of enabling it to con- 1178 tinue. Because I hope to have some constructive results from this debate, I hope that my hon. Friend has been able to consider the possibility, about which I recently wrote to him, of trying to devise a system of licensing of unorthodox practitioners to use the substances required on the same lines as the licensing of unorthodox practitioners for the making, manufacture or assembling of various medical substances which already operates.
That was one suggestion. Another, which is less satisfactory, would be to add the substances about which I have been speaking, and which unorthodox practitioners wish to continue to use, to paragraph 4(4) of the order, which already lists various substances which can be used for injection by anyone and which are not "prescription only" medicines. Yet another suggestion might be a possible addition to Schedule 4 to the order, to include recognised unorthdox practitioners as a group of those exempted in the parental administration of certain substances.
A further suggestion is that my hon. Friend the Minister might look at Section 60 of the Medicines Act 1968, which provides for the restricted sale, supply and administration of certain medical products in such a way that any regulation made under the section may specify the qualifications and experience which an applicant for a certificate must have. The Minister might care to look at this to see whether it could be useful in enabling unorthodox practitioners to continue to use non-dangerous substances in a way that the present order forbids.
As far as I understand, no evidence has been forthcoming of any harmful results of such injections by unorthodox practitioners. On the contrary, all the evidence of which I am aware is of benefit and help. If the Minister has evidence of harm, he has not so far produced it, except to talk of possible allergic reactions. Will he make quite clear tonight? If he has none, I hope that he will say so.
I should like to refer to a point that my hon. Friend the Member for Warley, East (Mr. Faulds) put to me. He has asked me to express his regret at not being able to take part in the debate. The point about which he is particularly 1179 concerned is that homeopathic practitioners are now restricted in the sending of medical packages through the post. That is a great restriction on their practice. I hope that my hon. Friend the Minister will comment on that as well when he replies to the debate.
I find it very difficult to understand the restrictions which the Ministry is now imposing on safe unorthodox medicine. There seems to have been a hardening of its attitude recently, a cursory dismissal of the needs of those who choose to seek the help of homeopathic and naturopathic practitioners, and a disregard of accepted common law rights. I hope that my hon. Friend will reverse this regrettable new trend and that he will now find a way to take appropriate action to restore to those suffering pain and disability the full service from the unorthodox practitioners which they were able tee receive before the order was made.
§ 11.29 p.m.
§ Mr. David Mitchell (Basingstoke)I am most grateful to the hon. Lady for allowing me to intervene very briefly in the debate to reinforce the points that she has made.
The hon. Lady referred to the common law rights of the individual. If people wish to treat themselves or to be treated in an unorthodox way, is not that their individual right? If it is asserted that only the State may decide in what way we shall be treated, surely we have crossed that perilous line to the point where it is assumed that the State possesses the citizen body and soul. I do not believe that the Minister intends to do that, but there is an awful danger that he will be doing it with the order—which he has temporarily withdrawn—if he does not meet the points so ably put by the hon. Lady.
I give a practical example to reinforce what the hon. Lady has said. The last town mayor of Basingstoke suffered from an arthritic hip condition—a fact that was not generally known to the public. The orthodox medical treatment for the condition is cortisone—a drug that has a number of side effects, which are unacceptable to the citizen concerned.
The mayor would have been laid up and unable to perform his duties but for the work of an osteopath and acupuncturist who has an "unorthodox" practice in 1180 Basingstoke. I am not sure whether I am permitted to give his name, because of the ethic of the profession. He treated the mayor with injections of tincture of mistletoe. These were most effective and enable him to carry on his duties as town mayor throughout the year, and no one even knew that he would have otherwise have been crippled by this unhappy condition.
The case of the first citizen of Basingstoke is an example which catches the eye more than that of an ordinary citizen, but the fact remains that countless thousands of people throughout the country owe their ability to carry on a reasonable working life to "unorthodox" practitioners.
I beg the Minister to ensure by one means or another that they may carry on doing what they have traditionally done, giving the treatment that they have traditionally given, because this has been for many people the difference between living life reasonably and being crippled or in pain.
§ 11.32 p.m.
§ The Minister of State, Department of Health and Social Security (Mr. Roland Moyle)My hon. Friend the Member for Wood Green (Mrs. Butler) has throughout her parliamentary career been a staunch supporter of the rights of the individual, and in particular the rights of individuals to seek treatment from the practitioner of their choice.
Certainly she has always championed the cause of the minority in areas such as herbal remedies, health foods and dietary supplements. It is therefore most appropriate that she should be the one to initiate this debate on medicines for parenteral administration of the more heterodox sort.
Tonight she has, in the words of the Order Paper, drawn attention to "the difficulties of osteopaths"—difficulties consequent upon the introduction of measures to implement various sections of Part III of the Medicines Act on the first day of this month. In the course of her speech she has made it clear that her concern is not solely with people who practise osteopathy alone but also, perhaps primarily, with those who practise osteopathy in conjunction with other forms of treatment. The common thread is that none of the practitioners in mind 1181 is statutorily registered. That fact alone creates difficulties, but I should like first of all to say a little about the multiplicity or organisations representing the practitioners involved and the relationships between them and their views as I understand them.
Taking osteopathy on its own first, there is the General Council and Register of Osteopaths, which has its own training school, the British School of Osteopathy. The four-year course run by the school is entirely concerned with osteopathy and no training is given in the use of medicines. Perhaps for that reason and possibly for other reasons the General Council and Register has made it clear to the Medicines Commission and my Department that it has no objection to the restriction on medicines for parenteral administration introduced in the Medicines (Prescription Only) Order 1977. Similarly, the Chiropractors' Association has indicated that the restriction gives rise to no concern. I would not wish to make too much of the point, but the attitude of these two bodies obviously suggests that the use of medicines is not universally regarded as a necessary adjunct to the practice of osteopathy.
There are other bodies which I understand represent osteopathy alone that I should also mention. These are the College of Osteopathy, the Society of Osteopaths and the Osteopathic Association of Great Britain. I understand that none of these bodies favours the restriction in the prescription-only medicines order. Then there are the organizations representing mixed disciplines—the British Naturopathic and Osteopathic Association, of whose training college at Hampstead, the British College of Naturopathy and Osteopathy, my hon. Friend is patron. These bodies, and the British Committee for Natural Therapeutics, representing a variety of organisations, are greatly concerned about the effect of the prescription-only order on the practices of their members. The cause of this anxiety has already been mentioned, but I should like to state the problem as I see it.
First, there is the Medicines (Prescription Only) Order 1977 which came into operation on 1st February. The main purpose of this order is to specify the 1182 descriptions and classes of medicinal products which may be sold by retail—or supplied in equivalent circumstances—only in accordance with the prescription of a doctor, dentist or veterinarian. Included in this group are medicines that are injected as opposed to being administered orally by topical application or by insertion. The effect of this provision is to place a number of injectables currently used by what I suspect is a relatively small group of non-statutorily registered practitioners into the prescription-only category for the first time. This provision in itself is not, perhaps, all that onerous, but it has to be read in conjunction with Section 58(2)(b) of the Medicines Act, which prohibits the administration of prescription-only medicines by anyone who is not a doctor, dentist or veterinarian or a person acting in accordance with the directions of such a practititioner.
A further provision in the prescription-only order exempts certain prescription-only medicines from the restriction on administration, but this general exemption does not extend to medicines for parenteral administration.
Finally, by virtue of the restrictions in a related instrument—the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1977—the non-statutorily recognised practitioner is prevented from obtaining the medicines concerned. This leads to substantial restrictions on the persons to whom my hon. Friend has referred.
The purpose of applying these controls was not, as has been suggested, to sweep away the rights of these non-orthodox practitioners to use medicines of this kind: nor was it to put them out of business nor to deny their patients the liberty of seeking treatment from practitioners of their choice. It is not a question, as the hon. Member for Basingstoke (Mr. Mitchell) said, of individuals deciding how to treat themselves. It is a question of what treatment individuals should give to other individuals. It is general practice, not only in medicine and related fields but throughout professional life, to place restrictions on the way in which one person can treat another.
The Medicines Act is designed to control medicinal products, and the provisions of the prescription-only order and 1183 of the other instruments implementing sections of Part III of the Act were drawn up on the basis of recommendations made by the Medicines Commission, the independent body set up to advise the Health and Agriculture Ministers on the execution of the Act and the exercise of powers under it. The Commission's advice was given in relation to medicines and with considerations of public safety in mind.
The Commission took the view that for reasons of safety provision should be made to restrict to prescription only the sale and supply as a class of all preparations intended for parental administration. It did so because it is not a subject for question that medicines administered parenterally are more hazardous than those administered in other ways. They are usually more potent than those in other pharmaceutical forms; their effects are more rapid because they usually go straight into the bloodstream; and, generally speaking, their potential for adverse reactions is greater.
There are other dangers. For example, the danger of contamination or infection is greater. The possibility of accidental injection into the vein or artery arises, and the ability of non-medically trained personnel to cope with such a situation is in doubt. Furthermore, the resuscitation equipment needed to cope with an incident of this kind is unlikely to be available except under medical supervision.
Those factors were taken into account in bringing the legislation into operation. Nevertheless, as the House knows, we received last-minute representations to make an amendment order, which came into operation on 11th February. This has the effect of providing temporary exemption for medicines which became prescription-only medicines for the first time on 1st February. It also has the effect of allowing non-statutorily recognised practitioners to continue for a period of six months to administer parenterally those medicines which became prescription-only for the first time by virtue of the order that we are discussing tonight.
There is an interim period during which the views of the various non-statutorily registered practitioners can be considered. The message that I want to give the House tonight is that we shall take the opportunity of the next six 1184 months to look again at this problem in the light of what has been said this evening in particular, and also in the light of representations that have been made.
I appreciate that the practitioners with whom we are concerned are not seeking a permanent exemption which would allow them to administer parenterally any medicine. Their claim, as I understand it, is that they wish to be allowed to continue using the medicines which prior to 1st February they could lawfully use in the course of their practice. They may, therefore, be able to show that the number of medicines involved is quite small and that the hazards associated with these medicines is not as great as with the bulk of medicines in this category. If so, those are factors which I should want to take into account.
However, as my hon. Friend said, the difficulty caused by the absence of recognition will remain. Statutory recognition has wide implications and consequences, and there is, clearly, an objection to such recognition in subordinate legislation under the Medicines Act. There will, of course, of necessity be considerable difficulty in defining the group of persons who have acquired the skill in the technique of administering medicines parenterally. I think that my hon. Friend alluded to that.
My hon. Friend made a suggestion about the way in which this difficulty might be overcome, and we shall certainly consider it very carefully, but the establishment of a link with the special arrangements that exist for the grant of manufacturers' licences to non-orthodox practitioners clearly presents problems. These arrangements relate to the assembling and mixing of relatively harmless products and to products prepared or packed on the supplier's premises, and it is by no means clear that it would be right to extend such arrangements to cover the medicines in question.
There are various other factors to consider. I am conscious of the contribution made by osteopaths and others to the welfare of patients, and I am concerned that the interests of these practitioners should be properly observed. On the other hand, I have to try to balance them against the safety considerations to which I have referred. I am most anxious 1185 to avoid anything that might increase or even maintain the risk to which patients taking medicines are exposed. I think that medicines are hazardous products. More and more as we consider this problem we realise that, and the prescription-only medicines are obviously the most hazardous group.
I promise my hon. Friend and the hon. Member for Basingstoke that in the next six months I shall strive to obtain the right balance between these conflicting factors. We shall have the advice of the Medicines Commission which, as my hon. Friend the Under-Secretary of State, made clear in his speech to the Sixth Standing Committee on Statutory Instruments, has expressed its readiness to reconsider the question of the use of prescription-only medicines by non-statutorily recognised practitioners.
This development, in conjunction with the temporary exemption, means that the practitioners concerned can continue practising as previously for the time being and that in the meantime the Medicines Commission will be reviewing its earlier recommendations. I promise to draw the Commission's attention to the representa- 1186 tions made to me tonight with a view to ensuring that my hon. Friend's comments are taken fully into consideration by the Commission. It means that we shall have another opportunity to examine the problem, and I hope that we shall be able to produce an answer that is more acceptable to my hon. Friend, although at present I am not in a position to counsel optimism in that respect.
§ Mrs. Joyce ButlerI thank my hon. Friend for his reply and for that assurance. He referred to some of the possible dangers of unorthodox practitioners using injections and to their having used injections for a long time. Is there any evidence to suggest that adverse reactions have occurred?
§ Mr. MoyleI have received that present representation from my hon. Friend, and I shall examine the evidence. There is also the question of anticipation of potential dangers. That is a principle to which we must have regard in producing new regulations.
§ Question put and agreed to.
§ Adjourned accordingly at thirteen minutes to Twelve o'clock.