Herbal Medicine (Regulation) Debate
Full Debate: Read Full DebateDavid Tredinnick
Main Page: David Tredinnick (Conservative - Bosworth)Department Debates - View all David Tredinnick's debates with the Department of Health and Social Care
(11 years, 5 months ago)
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I am extremely grateful to have the opportunity in this debate to raise the issue of herbal medicine with my hon. Friend the Minister. The issue has been on the agenda for many years, and I hope that by the end of the debate we can shed light on where we are going. I look forward to my hon. Friend’s remarks.
On Friday, I was at the Royal Society summer science exhibition. The Royal Society is our oldest and, some would say, most distinguished scientific society. Its fundamental purpose is to promote and support excellence in science and to encourage the development and use of science for the benefit of humanity. The Royal Society has played a part in some of the most fundamental, significant and life-changing discoveries in scientific history, and it continues to make outstanding contributions to science in many research areas. I will refer to what I saw at the exhibition and to what it has to say to us about herbal medicine generally.
If I may say in passing, Mr Speaker might like to visit the Royal Society because it has a wonderful gold mace that is the mirror image of the Mace that is carried into the Chamber. The mace was a present to the Royal Society from Charles II. Among the Royal Society’s former presidents are Sir Christopher Wren and Edmond Halley. The Royal Society has a wonderful line and body of knowledge, so I set great store by it. We must take note when the Royal Society seriously considers herbal medicine and related methods of delivery.
I was particularly struck by the Royal Society partnership grant project with Boroughbridge high school in Harrogate under the direction of Colin Inglis, the school’s biology tutor, and overseen by Professor Kerr, the consultant microbiologist at Harrogate and District NHS Foundation Trust. The project looked at several simple plants and herbs available in our gardens, from greengrocers and from garden centres to see what their impact could be on E. coli and other bugs—I will focus on E. coli. Working over not a very long period of time, the project found that E. coli growth is inhibited by the use of thyme, lavender and geranium set in essential oils. They said that they were able to identify the minimum inhibitory concentration of those oils derived from herbs and plants—the lowest concentration of essential oil that inhibits the growth of E. coli. When I discussed that with the directing staff, they said that the next step would be to determine the concentration that would kill E. coli—the minimum bactericidal concentration. That simple project in a school in Harrogate has huge ramifications, because it shows how easily-found common herbs and plants can be used in the furtherance of medicine.
In the evening at the Royal Society there was a panel discussion on “Nature’s Marvellous Medicine,” and those addressing the audience were not ill-informed: Professor Dianna Bowles, emeritus professor in the department of biology at York university; Professor Roderick Flower, professor of biochemical pharmacology at the William Harvey research institute; and Professor Monique Simmonds, director of the Kew innovation unit, where she studies the chemistry of plants and fungi—of course, Kew Gardens is currently classifying all British herbs. They are not ill-informed people, and they were speaking about what could be done with herbs and plants.
The chief medical officer, Dame Sally Davies, recently said that resistance to antibiotics risks health “catastrophe” that would rank with terrorism and climate change. She said that Britain’s health system could slip back by 200 years unless the “catastrophic threat” of antibiotic resistance was successfully tackled. The Select Committee on Science and Technology, of which I am a member, might address that in this Parliament. Dame Sally Davies said:
“This is a growing problem, and if we don’t get it right, we will find ourselves in a health system not dissimilar from the early 19th century.”
Although hospital infections from bugs such as MRSA are greatly reduced, they are being replaced by infections with other bacteria. Antibiotic use is rising, not least in agriculture, and resistance is steadily growing in fish and farm animals—I remember raising the matter in this House 20 years ago or more—and there are problems with farmers, particularly in the third world, feeding antibiotics to chickens. I said then that such use could have catastrophic consequences, and now we know that, in some parts of the world, cattle have been fed antibiotics as a prophylactic, so it is no wonder that the new chief medical officer is focusing on that.
It is perhaps also significant that Professor Christopher Thomas, the professor of molecular genetics at the university of Birmingham, added to Dame Sally’s remarks:
“We need new ways to kill resistant bacteria or reduce their carriage of resistance genes. Novel approaches that might have appeared unrealistic a few years ago need to be explored.”
I suggest that one of those areas that needs to be explored is better use of herbs and plants in medicine. In a sense, and this is not an original phrase, we need to go back to the future to find those solutions. If I have anything further to say about Dame Sally’s release, it is that it does not provide any solution other than to suggest that we need to go for more antibiotics. The problem is that some doctors are saying that no antibiotics will work in 20 years’ time. The Government have a catastrophe management team—that is not the official title—and I think that issue should be added to its list.
Today, we are not specifically debating common plants that are available as foods or in the garden. Such plants are covered by different regulations. What we are debating is the future of herbal medicine in this country. If I may, I will set out the stall on what has happened in recent years. We have to go back to the House of Lords Science and Technology Committee report of 2000 that considered herbal medicine and other medicines that are not currently used in mainstream health care. The written evidence from the Department of Health stated:
“There is scope for the larger professions to follow the osteopaths and chiropractors in gaining statutory self-regulation, and this would undoubtedly serve their professions well.”
I served in the Committee stages of the Osteopaths Act 1993 and the Chiropractors Act 1994, and the difference that statutory regulation has made to those professions in providing safe services for patients and giving assurance to doctors such as the Minister is extraordinary. They came in from the cold.
The Government then identified acupuncture and herbal medicine as specific therapies for which they wanted to achieve statutory regulation. I shall not dwell on acupuncture, as we must focus on herbal medicine. In her evidence to the Lords Science and Technology Committee inquiry, the then Under-Secretary of State for public health, the right hon. Member for Normanton, Pontefract and Castleford (Yvette Cooper) said:
“I think we would support their moves towards statutory regulation…We would strongly encourage them to continue the process towards proper self-regulation and statutory regulation as well…We do think that in the area of acupuncture and herbal medicine it is perhaps more important than in other areas.”
In its report, the Committee said:
“It is our opinion that acupuncture and herbal medicine are the two therapies which are at a stage where it would be of benefit to them and their patients if the practitioners strive for statutory regulation under the Health Act 1999,”
which is an enabling Act that, if I remember correctly, provides for different disciplines to come in via statutory instrument,
“and we recommend that they should do so.”
Regulation was recommended because those herbal professionals met the agreed criteria for statutory regulation that the Lords had come up with. There was a risk to the public through poor practice, and they had a voluntary regulation system and a credible evidence base. Regulation would ensure that appropriate training was established, resulting in competent practitioners with an understanding of the evidence base for their therapy along with an appreciation of the limitations of the treatments that they could provide. Safe practitioners would understand when to refer. Effective regulation would therefore seek to safeguard the public from incompetent practitioners and identify practitioners suitably qualified to use a range of potent herbal remedies not appropriate for over-the-counter sale. There are some powerful remedies.
The next stage in the saga is the European Union’s intervention. However, I want to make one point at the outset before we consider European directives. The proposal for statutory legislation pre-dates all the arguments about European directives, such as the traditional herbal medicinal products directive and others. The policy had broad cross-party support, and the distinguished Lords Committee, which included members such as Lord Walton of Detchant and Lord Baldwin, had proposed it. Distinguished men came up with that proposal. We were going down that route anyway.
Then the European Union became involved, with directives. We must address the directives, but we are not dealing only with them; we are dealing with a policy that was already in train. The objective of proper regulation had been there before the European Union directive 2001/83/EC, amended by directive 2004/24/EC, which said:
“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”—
a key phrase—
“and for use by an individual patient under his direct personal responsibility”.
That meant that herbal practitioners would have to be classed as authorised health care practitioners in order to be able to continue using their herbal products.
In January 2002, the Department of Health, along with the Prince’s Foundation for Integrated Health and the European Herbal and Traditional Medicine Practitioners Association established the herbal medicine regulatory working group—HMRWG. The group and subsequent groups were chaired by Professor Mike Pitillo, a well-respected man whom I knew and who devoted many years of his life to the issue. His efforts were and are still appreciated by all who knew him; sadly, Mike died in February 2010. God bless him; he put so much into the issue on behalf of the community. The working group’s remit was to make recommendations on the regulation of herbal medicine practitioners and the reform of section 12(1) of the Medicines Act 1968. In 2003, the group published its report, “Recommendations on the Regulation of Herbal Practitioners in the UK”.
In effect, the group’s work on the issue of possible reforms to the regime of unlicensed herbal medicines supplied under section 12 represented the first stage in the exploration process envisaged by the Government. It needed to be seen as distinct from but complementary to the wider European negotiations on the then proposed directive on traditional herbal medicinal products, which related to industrially produced traditional herbal remedies sold over the counter directly to the public.
Working in parallel to the group was the acupuncture regulatory working group, which I need not discuss. The HMRWG concluded that the two professions should be regulated together, thereby addressing the high practitioner costs of running two separate registers. The Department of Health ran a consultation on regulation of the two professions, published in 2004 as “Regulation of Herbal Medicine and Acupuncture: Proposals for Statutory Regulation”. The results of the consultation were published in February 2005 as “Statutory Regulation of Herbal Medicine and Acupuncture: Report on the Consultation”.
The Medicines and Healthcare products Regulatory Agency ran a simultaneous consultation on section 12(1) reform—MLX 299, “Proposals for the Reform of the Regulation of Unlicensed Herbal Remedies in the United Kingdom Made Up to Meet the Needs of Individual Patients”—and published its results in January 2005. In 2005, if colleagues recall, we had a general election. There were delays at the Department, unsurprisingly, and pending developments in health care regulation as part of the Foster review stalled further work for nearly a year.
However, in early 2006, the Government set up the steering group on the regulation of acupuncture, herbal medicine and traditional Chinese medicine in order to consider how to proceed with the regulation of those professions. That involved yet another consultation process. On 12 June 2008, the steering group’s report was presented to the then Minister, the right hon. Member for Exeter (Mr Bradshaw). On 16 June, the steering group, chaired by the late Professor Pitillo, held a press conference at the King’s Fund to report on the document.
All the reports and consultations found massively in favour of herbal medicines generally and statutory regulation in particular. After that tortuous process, they arrived at that conclusion.
I am enjoying my hon. Friend’s speech immensely. No one else in the House knows as much about herbal medicine as he does. He speaks for the nation. In its survey, the MHRA found that as many as 3 million people had consulted a practitioner of Chinese herbal medicine, and as many as 25 million had bought herbal medicines over the counter during the previous two years of its survey.
I am grateful to my hon. Friend, who is ever supportive. He has tabled questions and acted for his constituents on this issue, as he always does. He is right. Three quarters of the population of the United Kingdom have used traditional Chinese medicine, herbal medicine, phytotherapy or one of the other disciplines sometimes classed as complementary. There is a huge swell of people out there who want such medicines. Going back to Dame Sally’s remarks, people are now frightened of using antibiotics; they are worried about overuse and that, when they really want them, they might not be effective. We have a crisis not only of effectiveness but of confidence. People who tend to go down the herbal medicine route have a lot of confidence, however, because they are dealing with nature and natural products that have been used over the years. Properly administered, those products do not have side effects and they are not prone to becoming ineffective.
I congratulate the hon. Gentleman, who is knowledgeable on the subject. Would it be helpful if he outlined what he feels might happen if the Government do not do what they said that they would do and what we all want to see happen on regulation?
I am grateful to the hon. Lady, with whom I discussed the debate earlier, and I will be coming on to the options available to the Minister. In fairness to him, I know that he has been focused on the matter, with his colleague in the Lords, the noble Earl Howe, a distinguished Minister. However, before I look at the solutions and some of the obstructions and problems—why we are not getting a solution—I will first go through where the Government are now.
On 16 February 2011, the then Secretary of State, my right hon. Friend the Member for South Cambridgeshire (Mr Lansley), made a written statement on the regulation of herbal medicine. Subject to parliamentary procedures, he aimed to have legislation in place by 2012—importantly, when the European law kicked in—and he stated:
“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”—
the strong regulatory body—
“to establish a statutory register for practitioners supplying unlicensed herbal medicines.”—[Official Report, 16 February 2011; Vol. 523, c. 84WS.]
Progress, however, has been slow.
Before I get to the solutions, as prompted by the hon. Member for Vauxhall (Kate Hoey), let me emphasise that, although a Health Minister is responding to the debate, we should not be under any illusion that only the Department of Health is affected. If we do not got things right, we will see a large number of small businesses folding, because the whole supply chain of herbal medicine will collapse. That is extremely unsatisfactory.
Furthermore—I will not stray into this territory for long, Mr Bone, in case you are thinking of calling me to order—when the Science and Technology Committee went to Harwell to look at the European Space Agency, at its work on satellites and at what we are doing with the global positioning system in Europe, we looked at the Catapult centre, which is an organisation backed with hard cash by the Government to drive science forward. That is fine, and I asked them whether it was picking winners, but while I was listening in the state-of-the-art space centre, I was thinking, “But what about the small businesses we already have?” What will we do about the people who are providing a service to the community in health care? What will we do with them if their livelihoods are under threat?
My hon. Friend’s excellent speech has come to the nub of what could be a huge crisis. 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. Potentially, thousands of small and medium-sized herbal enterprises could go out of business.
My hon. Friend illustrates the point. The European directive on traditional herbal medicinal products now prevents third-party manufactured herbal medicines being prescribed to patients by practitioners, as well as individualised herbal medicines prescribed by practitioners and manufactured by a third party. One of the communities in the herbal medicine diaspora most affected is that of traditional Chinese medical practitioners. The directive has already had a negative impact on the availability of Chinese herbal medicine in the UK and Europe. The problem lies in the fact that the directive stipulated that, to prove traditional usage, there must be a 30-year history of usage, of which 15 years must be in the European Union. That can be difficult, because many Chinese medicines have been used for thousands of years in China—Chinese medicine goes back 3,000 years at least—but not in the European Union or the UK.
The directive was also conceived before we had the vast opening up of trade with China. Probably, no one envisaged what was going to happen. I will touch on that, because I was speaking to the Foreign Secretary about it last week. We now have a situation in which, once stocks of some Chinese medicines run out, it will not be possible to buy many of the formulations currently available.
Is this another example of the European Union interfering in all sorts of areas about which our own country should be able to make up its mind? Is this not another opportunity to say that we need to get some powers back from the European Union or leave it altogether?
The hon. Lady is right. We all saw the headlines in the Sunday papers, and the coalition Government are intending to do just that. I hope that we can get some powers back. One of the solutions that I will propose—I know that you have an impartial role as Chair, Mr Bone, but I have heard mention of the European Union pass your lips in the past—may not even involve the European Union.
To finish with the Chinese problem, we are dealing with an international issue. We are trying to develop trade with China and have just opened a lot of trade missions there—the Department for Business, Innovation and Skills and the Foreign Secretary are backing such attempts—and we see it as a great area, but the Chinese are not happy about the idea that they have western medicine in their country, but we do not make full use of Chinese medicine over here. I have spoken to people about that. The idea that we will have a sweeping of the shelves of Chinese medicine will not play well in the international domain. We have had some controversial issues—the Government’s approach to the Dalai Lama was not overwhelmingly well received by some people in China, although many in this country support what has happened over there. If the Foreign Secretary has not yet been in touch with the Minister, he might well do so, because our international position with China is affected.
Recently, somehow, we have got to an impasse. I have had some helpful conversations, but there have been all sorts of suspicious signals and it is no secret that some practitioners have found it hard to get to the Department; some of the herbal medicine governing bodies have complained that they have not had easy access. Things do not feel quite normal, because the flow of information has not been what we might have expected. I have been told that the problem that stalled the process occurred in Poland.
In short, the European Court of Justice ruled that Poland was importing and selling unapproved drugs. It ruled against the Poles. Apparently, that has brought everything to a grinding halt in the UK. I sent the Minister a copy of the opinion that I received from the European Herbal and Traditional Medicine Practitioners Association, which was provided by David Reissner, a partner with Charles Russell lawyers and an acknowledged expert in pharmacy and health registration. There is no better person to give an opinion. In his letter he says:
“In my view the Poland case was primarily about whether financial considerations could be used as a justification for permitting the use of medicines that do not have a market authorisation. My conclusion is that the statutory regulation of herbal practitioners is still compatible with the ability by such practitioners to be authorised health-care professionals”—
that is a key phrase—
“who can order specials for individual patient use, relying on the exemption in Article 5.1 of EC Directive 2001/83.”
He continues:
“I also confirm that it is my opinion that statutory regulation is the only way to ensure that herbal practitioners are considered to be authorised health-care professionals within the meaning of Article 5.1 of the Directive.”
To ensure that I understand, is my hon. Friend saying that Poland has effectively been caught out misusing the special needs provision in article 5.1, whereas the Department of Health proposed a perfectly legitimate scheme under the same article but has been put into a state of paralysis by the European Commission’s judgment?
That is pretty much right. The fact is that the Poles were trying to get round the system, were caught out and European law was applied effectively, but we are not in the same situation. I am sure the Minister has looked at the matter carefully, so will he please tell us his view? As far as I can see, there is absolutely no justification for using Poland and that view is widely held in the Community.
The key reason why the issue has got stuck has nothing to do with health care but is to do with the turf war and vested interests. I suspect that there are people in the medical establishment who do not want statutory regulation because they think it would interfere with the status of their own profession. When I talked to the Department for Business, Innovation and Skills about this, there seemed to be some confusion because it thinks that we might be going down a route of more regulation unnecessarily, but, sine qua non, there will be no herbal sector if we do not do something about it. Not doing something is not an option. We cannot just leave the matter as it is. I am pretty sure that vested interests in the medical establishment are trying to block this.
I said in the House recently that I had had a chance meeting with Lord Wilson of Tillyorn who was the last but one Governor of Hong Kong and introduced statutory regulation of herbal medicine there. I asked him what the objectives had been and whether he had problems with the medical establishment, and he said that he did. There are two issues: health care and vested interests. That is worrying because those vested interests may be very powerful. Returning to what Dame Sally, the chief medical officer, said and what I learned at the Royal Society last Friday, I ask those vested interests to back off because antibiotics are not working. We need to find something else and herbal medicine is one way forward. It has been suggested that there would be a legal challenge, presumably by people who are generally hostile to herbal medicine and increasingly misguided and misinformed. The Royal Society is the premier scientific body in this country, and the game is changing.
Herbal medicine is extremely cost-effective and could help the country to tackle the ever-rising drugs bill in the national health service.
I have seen evidence in Europe that when doctors combine the two, the allopathic drugs bill can be reduced because herbs tend to be less expensive. That may worry manufacturers, and it has long been said that they are actively campaigning against this. They would be wise to accept that working with natural medicine is good for sales of conventional medicine.
Order. I apologise that I forgot to say at the beginning that I intend to start the wind-ups no later than 10.40, and that two Members have written to me asking to participate in the debate.
You are ever courteous, Mr Bone, and I will not detain the Chamber much longer. I am acutely aware of not taking up other people’s time.
The Minister has three options. The Health Practitioners Council was the original idea. The Professional Standards Authority for Health and Social Care oversees the regulatory work of other organisations but is not as robust. A special licensing system for practitioner-prescribed products is a possibility, provided they are not traded between member states, and that may be a way out of the problem. We must find a solution, or there will be a disaster in the long term. I have used Chinese herbs and herbal medicine for many years, and I find them extremely safe and effective. I want people in this country to be able to use herbs. The key objective for the Minister is to ensure that the maximum number of products is available safely through regulated practitioners.
The hon. Gentleman puts it very well. That is what happens, not only in the pharmaceutical industry, but with doctors, who have a very narrow view of what health is, in my opinion. That makes it all the more important that we ensure that alternative medicines are available. It is great that we have an heir to the throne who believes that some of this is really important. I wish that the Department would listen to His Royal Highness Prince Charles, because some of what he says on the matter is absolutely right.
The other issue that I want to raise is about the Health and Care Professions Council, which I think the Minister has overall responsibility for. It is based in my constituency and does a brilliant job. However, recently, it seems as though the Department’s general view on what it does and how it works has changed. We have been trying to get sports therapists registered for a very long time. Everyone agrees that that should happen. The HCPC, which is meant to be the body that gives advice, has gone and said, “This must be registered. We must do this.” Sport England wants it to happen, as does anybody involved in sport; yet somewhere in the Department, there is a block. I actually do not think that it is Ministers; I think that it is officials. Officials do not care who is in government; they do what they want to do; and they will continue to pull a line. It seems as though the Minister or the new Secretary of State could be dangerously close to heeding advice from officials to drop the whole thing. I worry very much about that.
When I was working on my speech for today, I looked at the lists of those who are regulated by the Professional Standards Authority for Health and Social Care and the Health and Care Professions Council and I could not for the life of me work out why some were on one list and some on the other. There is another debate to be had on that issue.
I hope that the Minister will give us some clarification on that.
Many campaign groups, including Consumers for Health Choice, are very clear that they want the Secretary of State and the other Ministers to ignore the siren call from officials and fulfil their promises. This is very simple. When the register was announced back in February 2011, it was warmly welcomed by virtually everyone. Consumers were pleased that the register allowed an exception for herbal practitioners from the traditional herbal medicinal products directive—an EU law that became fully applicable in April 2011 and would have meant the banning of all unregistered herbal medicinal products. People will remember the campaign that was held across the country. All MPs got many letters of protest from constituents and from herbal shops and health shops. At the time, the position was that virtually all herbal medicinal products would have been banned. A register would have allowed practitioners to access unlicensed products, thus preserving choice in relation to safe and effective products for thousands of consumers. We all want people to be safe, but that has to be within the broad band of common sense and experience, not because a particular official decides that they do not like a product.
The industry was very pleased. Obviously, the practitioners were delighted that they could still use products that they had used for many years and would not see their consumers drift away, disappointed by a restriction stopping them buying things. All the manufacturers and retailers were pleased for the same reason. It was a win-win situation, so where is the register? The reality is that, because campaigners were reassured by the Government’s words—perhaps people should have been more cynical about the promises of a Government of any sort; that is why there is such a disconnect between the public and politicians—we relaxed the pressure to introduce the register. Of course, the Government got distracted by the huge and messy Health and Social Care Bill and we lost the then Secretary of State. That is where we are now.
I am very concerned and I want to hear the Minister give us an assurance today that this proposal has not been dropped, that the officials are not getting their way and that the register will be introduced as quickly as possible, so that everyone can exercise choice about what they use—choice about their health and how they treat their body—in a way that is not dominated by directives from the European Union.
Indeed, Mr Bone, as you say, you have no views on anything when you are impartially chairing the debate, but I am sure you pay keen interest to the topics raised, in your position as Chair and otherwise.
I pay tribute to my hon. Friend the Member for Bosworth (David Tredinnick) for securing the debate, which I am sure is of interest to the consumers and practitioners who use herbal medicines, as well as to the many Members who attended the debate today. None of us disagree with the principles articulated here—we can all sign up to them—but good government is about working through the practicalities of proposals to ensure that they become good laws, as I will discuss later.
There have been many good and worthy contributions to the debate. The hon. Member for Strangford (Jim Shannon) showed his strong support for herbal practitioners in his constituency, and he was right to say that things in Government do not happen in a flash but have to be properly thought through. I want to reassure him that some of the products he mentioned—he talked about the benefits of vitamin E, for example—are freely available from herbal practitioners, and indeed from pharmacists and other places.
There were other strong contributions from my hon. Friend the Member for Kettering (Mr Hollobone), who is no longer in his seat, and the hon. Member for Vauxhall (Kate Hoey). The hon. Lady made her case eloquently, and I would be happy to meet with her at a later date to discuss sports therapists further, but I would not wish to intrude on Mr Bone’s patience by talking about the issue today and I hope she will forgive me for that.
I pay particular tribute to my hon. Friend the Member for Bosworth for his principled and long-standing support for herbal practitioners and his interest in alternative therapies, homeopathy and many other such issues. Today he has demonstrated his extensive knowledge of the topic under debate, and of alternative therapies in general. I am sure I am right in saying that he is the most informed Member of Parliament on many of these issues, and it is a great tribute to him that he has secured the debate today. I am sure that herbal practitioners and alternative therapists would wish to pay tribute to his great work and his advocacy on their behalf, and on behalf of his constituents.
My hon. Friend is right to highlight the chief medical officer’s challenge about the future of antibiotics, but we can make a clear distinction between those remarks and the subject of today’s debate. I am sure that the chief medical officer would not wish her remarks to be associated with a call for a greater use of herbal medicine—that was clearly not outlined in her paper. Although it is important that we always consider ways—via traditional medical routes or otherwise—of improving people’s health and providing the right therapies, the paper clearly laid out the long-standing challenges as being about antibiotic resistance, and it would be wrong, therefore, to allow the two issues to be confused.
By way of background, it is worth highlighting that although we support patient choice some herbal products have caused harm to consumers. There are a number of reasons why that might happen: the herb may be intrinsically toxic; the product may be accidentally or purposefully contaminated by harmful materials or heavy metals; people may choose herbal products for serious conditions when medicines with a solid evidence base would be more appropriate; and, if herbal products are taken together with conventional medicines, the interactions may be unpredictable. It is right, therefore, that we support the responsible use of medicines and have a licensing system.
Directive 2004/24/EC on traditional herbal medicinal products was introduced to harmonise the European Union internal market and remove barriers to free movement. The directive deals with products manufactured on an industrial scale, and makes all operators in the market comply with the same set of rules, facilitates free movement and ensures increased product safety, which, I am sure we agree, has a positive impact on patient safety and public health.
The question of whether herbalists and traditional Chinese medical practitioners should be statutorily regulated has been debated since the House of Lords Science and Technology Committee first reported on the matter in 2000. The hon. Member for Vauxhall and my hon. Friend the Member for Bosworth outlined in their remarks that there is a lot of background and history. The previous Government grappled with the issues, and the current Government are also considering how to address and fulfil the commitments made by the previous Health Secretary, my right hon. Friend the Member for South Cambridgeshire (Mr Lansley). Hon. Members will be aware that on 16 February 2011 the Government announced their intention to take forward the regulation of herbal medicine practitioners and traditional Chinese medicine practitioners, specifically with regard to the use of third-party products in their practice.
Herbal products broadly fall into three categories. The first are the 310 herbal medicines that already have a marketing authorisation or a traditional herbal registration—in other words, a product licence. Those 310 medications are currently available for use and are effectively licensed. They are safe and widely used, and have undergone all relevant testing and checks. The second category, which is the one we are addressing today, covers products manufactured by a third party. Such products have been illegal since April 2011, following the implementation of the EU directive. The third category is products made up by a practitioner on their own premises following an individual consultation. Although such products are not affected by the directive, some of the herbal ingredients may be restricted by the Human Medicines Regulations 2012.
The previous Health Secretary’s concerns about the second category—products manufactured by a third party—prompted the decision to take forward statutory regulation of such products. The Government’s intention was to allow regulated herbal practitioners lawfully to source third-party manufactured herbal medicines, with appropriate safeguards in place to minimise the risks associated with the products, but since April 2011 the European directive has made it illegal for herbal practitioners in the UK to source such products for their patients.
Following the EU judgment in the case of the Commission v. Poland, which my hon. Friend the Member for Kettering mentioned, we have reassessed the risks. That case actually concerned unlicensed conventional medicines being used because they were cheaper, and although there is a clear distinction between those products and herbal remedies we had to look at what else the judgment said. It looked at the specials regime and, critically, it emphasised how strictly the regime must be applied. The judgment has a knock-on effect for what we propose for the use of herbal medicines manufactured by third parties without a licence, and it therefore needs careful consideration because there is a very high risk that we would be found to be in infraction of the European directive. We therefore need to consider further herbal products manufactured by a third party, and I will return to that point later.
The Government would, of course, like to find a way through the issue that supports responsible businesses and ensures public safety. Since the announcement in February 2011, the Department of Health has been working with officials in the devolved Administrations and with the Health and Care Professions Council to establish a statutory register for herbal practitioners. Alongside that, we have been considering a strengthened system for regulating medicinal products, to enable consumers to have access to a greater range of third-party manufactured herbal medicines. The process continues to be complex and lengthy, and it has been further complicated by the judgment in the European Union v. Poland case.
We acknowledge that there is strong support from some groups of herbal practitioners for the statutory regulation of the sector, but not all practitioners are in favour. I am sure, therefore, that hon. Members 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 offered an appropriate form of regulation and ensured that the proposals adequately addressed the risks posed to consumers of third-party manufactured herbal medicines.
As I stated earlier, complex issues are involved. We are discussing how to ensure that our proposals are fit for purpose and proportionate, and that they properly protect the public. I want to assure the hon. Member for Vauxhall that the matter has not been dropped. We absolutely support the principles outlined by my right hon. Friend the Member for South Cambridgeshire in his written ministerial statement to the House, and I fully appreciate that the delay is causing anxiety and concern to practitioners of herbal medicine and to consumers.
To ensure that we take forward the matter effectively, we want to bring together experts and interested parties from all sides of the debate to form a working group that will gather evidence and consider all the viable options in more detail, particularly because of the Polish case. I am aware of the concerns of my hon. Friend the Member for Bosworth about making timely progress, and I would therefore very much welcome his direct involvement in the working group to ensure that the interests of practitioners are properly looked after. We can meet when the House returns to work out how to take forward the proposal.
I hope that my commitment to setting up a working group will reassure my hon. Friend and all hon. Members that the Government are carefully considering this important issue. We recognise and agree with the principles, but the practicalities are such that we must have legislation that is fit for purpose—that does not trigger infraction proceedings from the European Union, but protects the public. That is vital in all health care matters, whether in relation to traditional medicines or to herbal medicines and alternative therapies. For that reason, we want to set up a working group and to work with my hon. Friend, and herbalists and others, to ensure that the legislation is fit for purpose. I look forward to discussing that with him in due course.
Before my hon. Friend sits down—I think that he was about to do so—may I thank him for his remarks? I am sure that knowing there is some progress is welcome, but I remind him that there have been many working groups in different guises over a long period, and the image that springs to mind is of the long grass. I am grateful to him for suggesting that I might be part of the process, but I want to be reassured that we are in the short grass. Lastly, is there general agreement with the devolved Administrations or is that a sticking point?
I reassure my hon. Friend that I am not aware of any points of disagreement with the devolved Administrations, but I will write to him and provide reassurance if there are any issues of which I am unaware. My understanding is that there is a unified position across all of the different health Departments.