(11 years ago)
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Lord Pearson of Rannoch
To ask Her Majesty’s Government when they will fulfil their commitment to establish a statutory register for practitioners supplying unlicensed herbal medicines.
Lord Pearson of Rannoch
My Lords, I declare an interest as unpaid patron of the UK’s Register of Chinese Herbal Medicine and as someone who is nearly cured by a course of Chinese herbs of a nasty skin complaint which western medicine finds difficult to deal with. I am also the leader of the United Kingdom Independence Party in your Lordships’ House and would be failing in my duty as such if I did not point out that our herbal medicine industry and those who depend on it owe their present predicament entirely to our membership of the European Union.
In that regard, my first question for the Minister is: why does the EU’s law of “subsidiarity” not apply in this case? Are the Government really saying that we as a nation are incapable of deciding for ourselves the rules governing the manufacture and use of herbal medicines, but instead have to be bossed around by Brussels?
The sorry saga starts with a new directive in 2001, number 83 of that year, which was amended by Directive 2004/24/EC. Article 5(1) of Directive 2001/83/EC contained a chink of light. It goes as follows:
“A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility”.
So the prospect arose of having to set up statutory regulation for our herbalists. Since then there have been two Department of Health committees and two public consultations, all of which have reported massively in favour of herbal medicines generally, and statutory regulation in particular. This is not surprising. A survey commissioned by the Government’s medicines regulator, the Medicines and Healthcare products Regulatory Agency—MHRA—found that 3 million of our people had consulted a practitioner of Chinese herbal medicine and 25 million had bought herbal medicines over the counter in the previous two years.
The happy result of all these expensive committees and public consultations was that in February 2011 the Secretary of State for Health, Mr Andrew Lansley, made the following commitment to the House of Commons:
“When the European Directive 2004/24/EC takes full effect in April 2011 it will no longer be legal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients. This Government wish to ensure that the public can continue to have access to these products. In order to achieve this, while at the same time complying with EU law, some form of statutory regulation will be necessary and I have therefore decided to ask the Health Professions Council to establish a statutory register for practitioners supplying unlicensed herbal medicines”.—[Official Report, Commons, 16/2/11; col. 84WS.]
That, you would have thought, was that. But it was not. The purpose of this debate is to discover why not. Why have the Government not set up the statutory regulation they so clearly promised they would?
Here I have to enter the world of rumour and conjecture because the department has behaved in an unusually secretive and unhelpful way. For months it has refused to answer those questions or indeed to meet Mr Michael McIntyre, chairman of the European Herbal & Traditional Medicine Practitioners Association, and myself, to discuss these questions and their answers—and indeed the solution.
As far as I can see, this paralysis has been caused by Poland. It seems that Poland had been misusing the “special needs” provision of Article 5(1) to permit imports of cheap unauthorised medicinal products which contained the same active ingredients, dosage and form as drugs that were currently authorised for sale in that country. So Poland had been approving the import and sale of unapproved drugs, which were not medically essential for a specific patient, and thus breaking EU law. The EU Commission took Poland to the Luxembourg Court, which duly found against Poland.
It appears that it is this judgment which sent our Department of Health into its present state of funk, although of course our position is entirely different and we told the department so. However, rumour had reached the department that the Commission regarded Mr Lansley’s statement and promise to set up statutory regulation as a rebellious ploy to get round its wonderful EU edict. If the UK went ahead, perhaps we would also end up in Luxembourg, where the result is of course a foregone conclusion.
Faced with this situation, Mr McIntyre decided to take independent legal advice from Mr David Reissner of Charles Russell LLP. Mr Reissner is an acknowledged expert in pharmacy and healthcare law. He is chairman of the Welsh pharmacy appeal panel and a deputy district judge. So he knows his stuff. His opinion is clear on two issues. The first is that herbalists have to be statutorily regulated if they are to be authorised health professionals and thus have access to manufactured medicines for individual patients under Article 5(1) of the directive. Secondly, it is wholly wrong to fear that the ECJ’s ruling against Poland for misuse of Article 5(1) could somehow be applied to us and block our own statutory regulation. The Polish case is irrelevant to our national position.
I sent this opinion to the noble Earl, Lord Howe, Parliamentary Under-Secretary of State at the DHS in your Lordships’ House, on 8 April and once again asked for a meeting at the department with Mr McIntyre and the relevant Minister who is, I think, Dr Dan Poulter MP. I hoped that such a meeting would have rendered this debate unnecessary, but answer came there none and when I pressed the noble Earl, he comforted me with the information that my letter might be fast-tracked and therefore answered within 28 days—not much help for this debate. What sort of world do these people live in?
Therefore, my second question to the Minister, the noble Baroness, Lady Northover, who has my sympathy as none of this is her fault, is: when will Dr Poulter and those who advise him meet Mr McIntyre, and perhaps myself, to sort the whole thing out? Would it not be helpful if a number of noble Lords who are to speak today and who are interested in this subject came too, or will the Government take the unusual step of refusing to meet parliamentarians? What reason can there possibly be for continuing to refuse such a meeting?
There is much at stake here for the millions who benefit from herbal medicines for a range of common ailments which are not particularly well managed by conventional medicine. If statutory regulation fails to go ahead, a wide range of herbal medicines supplied by practitioners to their patients will be lost. The directive has already stopped practitioners prescribing herbal medicines made by manufacturers and herbal suppliers for prescriptions to individual patients. Also stopped have been third-party herbal prescription services which supply individual prescriptions to named patients at the practitioner’s request. Without statutory regulation, all that remains are herbal medicines prepared by practitioners on their own premises. This will ultimately put a great many practitioners and their suppliers out of business. Statutory regulation will instead provide much needed support for these thousands of small and medium-sized enterprises.
Besides all that, herbal medicine is cost-effective and should be encouraged to go on reducing the growing NHS drug bill. That is, of course, why it is hated by the pharmaceutical companies which appear to go to any lengths to snuff it out. However, I will say no more about that now because I am on best behaviour. Statutory regulation will ensure that the public are protected from poorly trained or bogus practitioners and from substandard herbal remedies. Without it much activity may go underground. Of course, I admit that there is the occasional unfortunate case with herbal medicines but they are minuscule, microscopic and invisible compared with the thousands of patients who are mistreated under our National Health Service. Statutory regulation will also support the professional education which has been developed in this country to a high degree standard. It is also supported by the MHRA itself.
It only remains for me to thank other noble Lords who are to speak in this debate. In those, I include the noble Lord, Lord Taverne, whose enthusiasm for herbal medicine is, I am told, less than 100% wholehearted. However, we are a debating Chamber and differing views are, therefore, welcome. I conclude by saying to him and all those who doubt the efficacy of herbal medicine that aspirin is derived from the bark of the willow tree.
I look forward to the Minister’s answers to my two questions.
Lord Taverne
My Lords, I am grateful to the noble Lord, Lord Pearson, for raising this Question. Not entirely unusually, I do not altogether agree with everything that he has said. My view is that the Government should not establish a register for unlicensed herbal medicines. To quote that indefatigable battler against quack science, Professor David Colquhoun, herbal medicine means,
“giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety”.
My objection is that licensing will confer on practitioners supplying these medicines a spurious respectability and credibility that can do great harm.
Every time I raise the lack of evidence for alternative medicine in this House, someone gets up, as the noble Lord, Lord Pearson, has now done, and says, “But I was cured” by whatever it is—Chinese herbs or homeopathy. On the last occasion I raised it in the House, the noble Baroness, Lady Corston, praised homeopathy and said that she hoped that my well known views, which she seemed to suggest were somewhat eccentric, would be ignored by the Secretary of State for Health. They are not entirely eccentric views; they are the views of the scientific consensus.
The noble Lord, Lord Rees, spoke about homeopathy at a time when he was still president of the Royal Society. He said that if homeopathy worked other than as a placebo all the laws of science would have to be repealed. There is not, to my knowledge, a single fellow of the Royal Society who supports either homeopathy or Chinese herbal medicine. The most detailed, careful, scientific, blind trials have confirmed that view. Only recently, the Chief Medical Officer, Dame Sally Davies, said she was perpetually surprised that the National Health Service still funds homeopathy. I recommend to those who advocate alternative medicine the book Trick or Treatment? by Professor Ernst and Simon Singh. It is extremely well researched and a very objective treatment, which does acknowledge when there may occasionally be some possible benefit, but on the whole their views and conclusions are quite plain. There are many reasons why many people feel better after treatment—often because placebos do work, whether after taking a homeopathic dose or treatment with herbal medicine. Private practitioners of alternative medicine often have more time for patients and may be good at tender loving care, which is a very important feature of good medical care. Often, people get better anyway.
Anecdote is not scientific evidence. People say, “Well, does it matter if treatment works only as a placebo?”. It does matter. Faith healing sometimes works, if people believe sufficiently strongly. In parts of the world, so does witchcraft. However, it really matters if people who are seriously ill do not take scientifically proved treatment, or if pharmacists, for example, prescribe homeopathic pills for malaria. Dr Wakefield was believed because many mothers reported that their children showed signs of autism after taking MMR. I remember a “Panorama” programme which interviewed several parents who told how this happened to their children. The programme was extremely sympathetic to Dr Wakefield’s views, and stressed how kind Dr Wakefield listened so carefully to these parents, but completely ignored the overwhelming scientific evidence that there was no established link between MMR and autism. In fact, the anti-vaccination campaign was organised by a group of people who were strong believers in alternative medicine. Today, we see the consequences in Wales.
Quack medicine is not harmless. We should not make it respectable by statutory registration, which suggests that it is not only respectable but officially licensed. Although the noble Lord, Lord Pearson, as usual, put forward his views very charmingly, I know of no one in this House who puts forward misleading arguments more charmingly.
Lord Colwyn
My Lords, I am grateful to the Committee for the opportunity to say a few words in the gap. I declare an interest as a patron of the Foundation for Research into Traditional Chinese Medicine. I am also president of the All-Party Parliamentary Group on Alternative and Complementary Medicine.
It is always a pleasure to follow the noble Lord, Lord Taverne. His claim that there is no evidence of homeopathy’s efficacy and that herbal remedies are useless is not new to me or to the Committee. When compared with the risk of taking food supplements, an individual is about 900 times more likely to die from food poisoning and 300,000 times more likely to die from a preventable medical injury during a spell in a UK hospital. Adverse reactions to pharmaceutical drugs are 62,000 times more likely to kill a UK citizen than taking a food supplement and 7,750 times more likely to kill than taking herbal remedies.
In February 2011, following a series of meetings with Ministers from the Labour Party and with the new coalition Government, the Department of Health announced that it would introduce a statutory register of herbalists by the end of 2012. Statutory regulation is absolutely essential because it is the only way that herbalists can continue to have access to a full range of manufactured herbal medicinal products. It is unreasonable that interference from the European Commission should hold up the establishment of this register.
My noble friend Lord Howe said recently:
“The legislation around this policy is complex and there are a number of issues that have arisen which we need to work through. We appreciate that the delay in going out to consult on this matter is causing concern; however, it is important that any new legislation is proportionate and fit for purpose”.—[Official Report, 19/3/13; col. WA135.]
Can my noble friend explain what,
“going out to consult on this matter”
means? I hope that it refers to consultation with representatives of the practitioners, their suppliers and relevant departments in the administration of this area. If it means more delay and uncertain outcomes for a sector already plagued with uncertainty, it is unacceptable.
However, the situation is not that straightforward. This afternoon in Central Lobby, I heard a rumour that the Government have changed their mind. Apparently, they have decided to drop all plans for statutory registration and will rely on licensing mechanisms to ensure patient safety. I do hope that my noble friend can give the Committee an assurance that this is not true. Should there be any substance to that rumour, further discussion and negotiation must be an absolute priority.
Lord Hunt of Kings Heath
My Lords, I should first declare an interest and I refer the Committee to my health interest in the register.
I am delighted to speak in this debate. I had ministerial responsibility for the regulation of herbal medicines a long time ago, but it was at the time when we first discussed the European directive. While I actually agree with almost everything that the noble Lord, Lord Pearson, has said, I do not quite agree with his opening remarks about the benefits or otherwise of the European Union. However, he speaks with a great deal of wisdom about a problem that we face.
I usually agree with the noble Lord, Lord Taverne. I have always enjoyed his interventions in your Lordships’ House on the side of rational thinking. However, I must depart from him today. Whether or not herbal medicines are effective, and that is of course open to legitimate debate, the issue we face is that an MHRA survey has shown that about a quarter of the population use over-the-counter herbal medicines. If that is going to continue, as I suspect it will, surely there is a responsibility on the part of the Government to make sure that arrangements are in place to ensure that they are safe as far as they can be, and that those people who prescribe and dispense such medicines are appropriately qualified and regulated. If the statutory register is not now to go ahead, one is left with the problem of the public continuing to purchase such medicines, as I am sure they will, but without the necessary statutory regulation. It is therefore important that we get a clear view from the Government today as to whether they will continue with proposals on statutory registration.
We were left with a very difficult problem with the European directive. To an extent, the provisions around traditional herbal medicines dealt with herbal medicines that had been on the market for a good many years—some 15 years, I think. However, it does not deal with the issue of new herbal medicines coming to market. For instance, if they had to go through the whole panoply of clinical trials, the cost would be prohibitive for a market that traditionally comprises small businesses. Even the licensing provisions for new herbal medicines are likely to cost several thousands of pounds. Again, that is very difficult for an industry that is essentially small-scale.
As a result of herbal medicines being brought within the Medicines Act 1968, which has been replaced by the European directive on traditional herbal medicinal products, this now prevents third-party manufacturing of herbal medicines being prescribed to patients by practitioners, as well as individualised herbal medicines prescribed by practitioners and manufactured by a third party. Both have been essential components in the supply chain for the past 40 years, with many practitioners relying on such services. Now those practitioners have to prepare medicines on their own premises. That is a real problem if those practitioners are not to be statutorily registered, especially in terms of public confidence.
The noble Lord, Lord Pearson, mentioned the ECJ ruling against Poland. I thought that this ruling was in relation to the parallel import of medicines. For the life of me, I cannot see why that should have an impact on the proposal for the statutory registration of herbal medicines. I know that there is an issue with parallel imports which the Government are right to be concerned about, but this is not essentially a matter of parallel imports.
Not having a statutory register will not curtail the use of herbal medicines, but it will increase the scope for unqualified herbalists to offer treatments and for customers to purchase unprescribed medicines over the internet. I know that the fear of the noble Lord, Lord Taverne, is that statutory regulation would legitimise a practice which he has cast doubt upon. However, I would ask him to consider the other problem, which is that if 25% of us use herbal medicines, is it not better to accept that they will continue to do so and put some statutory safeguards around that practice?
The benefit of regulation is that practitioners would be regulated by an independent regulator. I understand it is likely to be the Health and Care Professions Council. Of course, the HCPC is in expansionist mode, having just taken on social workers, much against my and many others’ better judgment. If it can take on social workers, it can certainly take on herbal medicine practitioners. Of course, the benefit of that is that it can strike someone from the register, prevent them from being called a herbalist, and thus give more confidence to the public. The noble Lord, Lord Taverne, will say that I am arguing his point for him and I recognise that by having statutory regulation the public are likely to have more confidence, but I think it is better that way than allowing herbal medicines to be purchased over the internet with all the problems that can arise. Many legitimate herbalists may go out of business, which would be a great pity.
I will end by making two points to the noble Baroness. First, why is her department refusing to meet the campaigners and indeed the noble Lord, Lord Pearson? As a Minister, I always met parliamentarians if they wrote to me asking for a meeting. I am very surprised that Ministers in the department have refused to meet the noble Lord, Lord Pearson. That is extremely bad form. Certainly they should meet with Michael McIntyre. I do not understand why the department has run away from such a meeting.
Secondly, there are obviously some very strong rumours that the department is going to drop this proposal. If that is the case, all that I would ask the noble Baroness is this. Would it not be sensible to meet with the noble Lord, Lord Pearson, and Mr McIntyre before a final decision is made? It would be only fair if there was some debate before such a decision is announced.
Baroness Northover
My Lords, I thank the noble Lord, Lord Pearson, for securing this debate. I thoroughly enjoyed his speech, and as the last debate of the day, he made sure that we are all wide awake.
I recognise that the Government’s progress in establishing a statutory register for practitioners supplying unlicensed herbal medicines is of interest both to Members of this House, as has been demonstrated today, as well as to consumers and practitioners who use these products. I am glad that the noble Lord was assisted by a herbal remedy.
The issue of whether herbalists and traditional Chinese medicine practitioners should be statutorily regulated has been debated, as the noble Lord, Lord Hunt, will be well aware, since at least the House of Lords Science and Technology Committee report in 2000. The Government appreciate that there is, understandably, strong support from many herbal practitioners for the statutory regulation of this group, and the noble Lord, Lord Hunt, has made the case as well. In addition, many consumers of herbal medicines wish to access unlicensed manufactured herbal medicines. As noble Lords will be aware, on 16 February 2011, the Government announced that they intended to take forward the regulation of herbal medicine practitioners and traditional Chinese medicine practitioners specifically with regard to the use of unlicensed herbal medicines within their practice.
At the time that the decision to take forward the regulation of this group was made, the Government’s intention was to allow herbal practitioners to once again lawfully source unlicensed manufactured herbal medicines. That is something which practitioners have not been able to do since April 2011, when a European directive made it illegal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients.
Where the noble Lord, Lord Pearson, criticised the EU, others may well feel that the EU can offer a level of protection, depending on one’s point of view. Perhaps I can address here the issue of subsidiarity. The noble Lord suggested that this meant that it was not applying to herbal medicines. The principle of subsidiarity does indeed apply. The directive makes provision to facilitate the free movement of herbal medicines while ensuring a high level of safe public health. It was thought that the directive strikes the right balance of rules to facilitate free movement to the EU level, while maintaining flexibility through domestic implementing regulations.
Since the announcement in February 2011, the Department of Health has been working with officials in the devolved Administrations and the Health and Care Professions Council to look at establishing a statutory register for herbal practitioners supplying unlicensed herbal medicines, along with a strengthened system for regulating medicinal products, to enable consumers to have safe access to unlicensed manufactured herbal medicines.
This process continues to be complex and lengthy and, with regret, I must say that we are not in a position to consult on proposed legislation. My noble friend Lord Colwyn asked about what “going out to consult” meant. As announced in the Written Ministerial Statement in February 2011, any proposed statutory legislation has to go out to an open and public consultation. I hope that that clarifies the issue and reassures him. However, I am sure the noble Lord, Lord Pearson, will appreciate that it would be irresponsible for the Government to undertake to alter the status of a group of workers without first ensuring that the policy and final decision offers an appropriate form of regulation and ensures the proposals adequately address the risks posed to consumers of unlicensed herbal medicines.
My noble friend Lord Colwyn flags the serious dangers associated with all medicines. Nothing is risk-free, whether it is conventional or complementary medicine, or doing nothing at all. That is why it is important that there is careful regulation and consideration of all these areas.
We recognise the need to balance the economic wish of practitioners to continue to supply unlicensed herbal medicines and the wish of some consumers to have continued access to them against any risks identified. We understand that there is a strong desire in the field to bring the matter to a conclusion both for practitioners and the public. However, it is clear that there is a potential risk to public health where practitioners supply unlicensed herbal medicines which may be potent. For example, the Medicines and Healthcare Products Regulatory Agency has recently become aware that an unlicensed herbal product containing aconite, a prescription-only medicine in the UK which can cause serious and potentially fatal adverse reactions if consumed, is being marketed and prescribed by traditional Chinese medicine practitioners for the treatment of migraine. It is therefore crucial that the nature of the regulation in the sector is carefully thought through.
Lord Pearson of Rannoch
My Lords, does not the noble Baroness agree that in this case, which was flagged up in the Daily Mail the other day, statutory registration of the people who supply the product would be helpful?
Baroness Northover
Various noble Lords have made that point.
My noble friend Lord Colwyn asked whether the Government have in fact dropped the commitment to regulate. The Government recognise that there is a body of evidence about the public health risks associated with herbal medicines. It is important that the department does not proceed with the statutory regulation of any group, including herbal practitioners, unless we are sure that this will provide the necessary safeguards for patients. In other words, it is being looked at very carefully—whether the balance of regulation helps or hinders. Noble Lords have heard various views expressed.
Lord Taverne
Will my noble friend answer one question? Is registration supported by the Chief Medical Officer?
Baroness Northover
I am afraid that I cannot answer that very simple question. I may be inspired to do so shortly, but in the mean time I should say that this is a more complex area than that. Although I will be happy to come back to my noble friend, I think that there are a number of wider issues to look at.
Lord Hunt of Kings Heath
Perhaps I may also intervene briefly. I am most grateful to the noble Baroness for her answers, but can she be absolutely clear? Mr Lansley, when he was Secretary of State, announced an intention to implement a register by 2012. Does that mean that the Government are not going forward with it? I am not clear about this. The noble Baroness has said that she is not in a position to consult and has suggested that the Government are taking a new look at the relative risks. Can she help the Committee to understand whether in fact these rumours that the proposal has been dropped are correct?
Baroness Northover
I think that what I should do is continue with what I was going to inform noble Lords about. It may be that that will satisfy them in this regard. They are seeking an answer right now which I do not think I can give.
I should point out that while the Government are working through the issues relevant to this policy, this does not affect the availability of over-the-counter licensed herbal medicines. Significantly, there are now more than 240 products registered under the Traditional Herbal Medicines Registration Scheme. In addition, practitioners can continue lawfully to prepare herbal formulations on their own premises for use with their own patients. I also want to make it clear that the previous announcement made by the Government and any steps taken to regulate herbal practitioners should not be seen as an endorsement of the efficacy of herbal medicines either way. The Government do not have a view on the efficacy of herbal medicines that do not have a full marketing authorisation; in other words, a product licence. However, the Government do recognise that members of the public may wish to purchase complementary or alternative treatments, including herbal medicines. The Department of Health would always advise someone considering the use of complementary or alternative medicines to find a practitioner who is a member of an organisation that has set robust standards of qualification, an ethical code of practice, and a requirement for appropriate public indemnity insurance.
As I stated earlier, I regret that the Government are still not in a position to go out to public consultation on this matter, but we want to make sure that any proposals are proportionate and fit for purpose.
Lord Pearson of Rannoch
My Lords, in that case, perhaps the noble Baroness, before she finishes her remarks, would be good enough to answer the point made by me, the noble Lord, Lord Hunt, and other noble Lords. Will the Minister concerned and his officials meet interested Peers and Mr McIntyre? If not, why not?
Baroness Northover
Funnily enough, I was just going to get on to the point about a meeting. The noble Lord will be well aware that I am filling in for my noble friend Lord Howe. I am very sorry that it is me rather than my noble friend, with whom I am sure the noble Lord would rather have disputed this. However, my noble friend might very well be detained by the noble Lord, Lord Hunt, in the Chamber and so therefore he is potentially otherwise engaged. My noble friend Lord Howe is, as the noble Lord will know, most forthcoming in terms of engagement and meetings. I will pass on the request for meetings. I am informed that my noble friend has not refused to meet noble Lords—knowing my noble friend, I absolutely believe that—and the department will be in touch shortly. I hope that that reassures the noble Lord, Lord Pearson.
The noble Lord suggested that other speakers in this debate should be included. I was very struck by that, so I look forward to hearing reports of such a meeting, which clearly must include my noble friend Lord Taverne.
Lord Colwyn
My Lords, my recollection was, in February 2011, that it had been settled. We shook hands and congratulated each other on the fact that strategy regulation had been promised by the Government.
Baroness Northover
As I say, my noble friend Lord Howe is happy to meet people and no doubt this will be discussed further. Maybe I had better hurry up and conclude because I think I am about to go beyond time. Unless I hurry up, nobody will have a chance to say anything else.
Baroness Northover
No, we are all time-limited, as I know as a Whip. I am time-limited to 12 minutes. The fact that the debate can go up to an hour is neither here nor there.
I fully appreciate that this delay is causing concern among both practitioners of herbal medicines and consumers. However, I assure noble Lords that once the Government have worked through the difficult issues they face on this policy, an announcement will be made on their proposed way forward. I assure noble Lords that the Government are carefully considering this very important issue and that we anticipate being able to make a more substantive announcement shortly.