Herbal Medicine (Regulation)

Philip Hollobone Excerpts

Tuesday 9th July 2013 Westminster Hall

[David Tredinnick (Bosworth) (Con)]

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.

[Mr Philip Hollobone (Kettering) (Con)]

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.

[David Tredinnick]

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.

[David Tredinnick]

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?

[Mr Hollobone]

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.

[David Tredinnick]

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.

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[David Tredinnick]

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.”

[Mr Hollobone]

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?

[David Tredinnick]

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.

[Mr Hollobone]

Herbal medicine is extremely cost-effective and could help the country to tackle the ever-rising drugs bill in the national health service.

[David Tredinnick]

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.

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[Jim Shannon]

My hon. Friend has gone to the crux of the debate in those few words. It is about getting a balance between allowing people to continue to use their herbal medicines and ensuring that they do not indulge in anything outside that.

I beg your indulgence, Mr Bone, because I would like to take this opportunity to highlight the save our supplements campaign, which has been well publicised. We should all be aware of the goals of that campaign and the ramifications for today’s topic of regulation. The issue that is causing concern in health shops is maximum permitted levels. It has been suggested to me that interference by Brussels—the shadow of Europe is almost like the grim reaper who hangs over everything that we do in the House—will set low doses for dietary supplements, so removing choice from consumers and adversely impacting on high streets.

[Mr Hollobone]

It would not be a Westminster Hall debate without a contribution from the hon. Gentleman, and I am enjoying it hugely. I am all for bashing Brussels and agree that there is no need for the EU to interfere with the issue, but the EU has given this country a way to address the matter through the establishment of a statutory register, which the present Government undertook to do by the end of 2012. Surely, there is complicity in the Department of Health, and we need the Department to explain why it has not fulfilled that undertaking.

[Jim Shannon]

I thank the hon. Gentleman for his valuable intervention, which gets to the crux of the matter and makes a point that I will come to later. We have an opportunity to address the issue, and I hope that the Minister can put the record straight when he responds.

Some high street health food shops are struggling to compete with internet retailers, which often offer a cheaper price, even though, more often than not, the product is inferior. Again, that uncertainty must be addressed. We have been made aware of the facts through previous speeches and interventions on the subject. For example, in a statement on the regulation of herbal medicine and traditional Chinese medicine, the Secretary of State said that he aimed

“to have the legislation in place in 2012.”—[Official Report, 16 February 2011; Vol. 523, c. 77WS.]

We are very aware of that and are wondering why it has not been done. Will the Minister indicate what is going to happen?

I have not been in Westminster long—I am one of the new intake from 2010—but I realised early on that things do not happen in a flash. However, “subject to parliamentary procedure”, should, in my opinion, not involve such a delay. I share the concern of my constituents and of Members present that the issue has been hijacked by EU regulations. In conjunction with the hon. Member for Bosworth, I reiterate that that was never the intention. Let us get the legislation working in Westminster and ensure that it delivers for our constituents.

The idea of the legislation is to ensure that people are licensed to sell and offer advice and that the trade is as safe as can be. On the issue that my hon. Friend the Member for East Londonderry (Mr Campbell) referred to, the girls in my office, who are always trying to get me, as an MP, to slow down and take better care of myself—that is what they tell me anyway—told me that they went to the local health food shop and were amazed at the wealth of knowledge that the lady who helped them had. She clearly was tremendously knowledgeable, and someone could spend the afternoon discussing what the best herbal medicine for them is. It turned out that that lady had a degree in herbal medicine and was able to suggest many different things.

There is a very real fear that should the legislation not go through and should our health food shops continue to suffer from our inaction, or from the Government’s inaction, such closures will mean that more people will order online with no face-to-face interaction or advice. They will not be told that they should not take certain supplements if they are on other medications, or that two supplements may counteract each other. The problem will not only mean fewer jobs on high streets, but potentially more pressure on our GPs in surgeries, as they try to figure out symptoms that may have been caused merely by people taking the wrong combination of supplements. In other words, the expertise and knowledge of people in herbal medicine shops is critical.

Not many of us question the benefits of supplements, especially in the busy lives that we lead, which often mean that we cannot eat as healthily as we would otherwise like. However, who here knew that taking the blood thinner warfarin with a multivitamin containing vitamin K would put people’s health in jeopardy? The lady in the health food shop did, and she was able to advise people who came to her about it. What happens when there is no local shop? Will GP calls be taken up with queries from, for example, people suffering from nausea, dizziness and so on, who find out, after extensive and expensive tests, that when they read in their magazine that vitamin E encourages glossy, thick hair, they had not realised that the aforementioned symptoms could be caused by too much vitamin E. That did not appeal to me, but if I had thought that vitamin E would have given me glossy black hair, or even roots, I would have bought it by the gallon. However, unfortunately, that was not the case. When people are buying supplements in health food shops, they ask what they are taking and are given advice. I hope that the point I am trying to make can be seen; it is very clear.

It is my belief that regulation by those who are knowledgeable is essential, and that should not be diluted by trying to ensure that the latest round of EU tick-box regulations are checked. The issue merits Government attention and a full debate process, and we are glad to have this opportunity in Westminster Hall. I again congratulate the hon. Member for Bosworth on securing this critical debate. I will support him in continuing to bring the issue to the Government’s attention to see action in terms of health and safety, as well as job security. I apologise, Mr Bone—I have guests in the Gallery that I have to take round the Chamber in a very short time, but like the character says in the film, “I’ll be back.”

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[Mr Philip Hollobone (Kettering) (Con)]

Natures abhors a vacuum, Mr Bone; it looks as though it falls to me to fill it, albeit briefly. I apologise that I cannot stay for the end of the debate, but I have been encouraged to speak by the excellent contributions that we have had so far, led nobly by my hon. Friend the Member for Bosworth (David Tredinnick), who has an unparalleled reputation for knowledge in this area. I am sure that we all commend him for that.

There is no reason at all why the European Union should interfere in this issue. Why should not the United Kingdom be able to decide for itself whether it wants to regulate herbal medicines? This is another area in which the European Union is unnecessarily interfering in our daily lives and, of course, affecting millions of people. We have already heard that more than 3 million people access Chinese herbal medicine in any two-year period and that 25 million of our citizens buy herbal products over the counter in any two years, so this is a matter of huge interest.

The problem is quite technical, but I think that we could easily overcome it, as indeed the Government said that they would. The European Union has given this country a way around the European Union regulations, and the Government took up the challenge. In February 2011, two months before European directive 2004/24/EC took effect, the then Secretary of State for Health said:

“This Government wish to ensure that the public can continue to have access”

to unlicensed manufactured herbal medicines. That was the clear will of Her Majesty’s Government. The Secretary of State continued:

“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, 16 February 2011; Vol. 523, c. 84WS.]

As the hon. Member for Vauxhall (Kate Hoey) said, millions of people throughout the country—practitioners and users—took great comfort from those words and the clarity of direction laid out by Her Majesty’s Government.

Sadly, although the Government promised that the register would be introduced by the end of 2012, we are now well into 2013 and there is no sign of it. Presumably, the Secretary of State made his clear statement on the advice of officials in his Department. If it is the officials who are now telling the Government that they cannot have the statutory register, we need to hear from the Minister today that that is the case and the reasons for that about-turn, because millions of people in this country, including many of our constituents, took great comfort from those words in 2011.

As my hon. Friend the Member for Bosworth said, it appears that the Department has been thrown into a state of paralysis by the judgment on Poland. Poland was clearly caught out trying to break the rules and, under EU regulations, the Commission took Poland to the Luxembourg Court, which duly found against Poland. The Polish case is not a parallel to the United Kingdom situation. It may be a judgment on the same part of the EU legislation, but Poland was trying to abuse article 5.1; the United Kingdom Government said that they wanted to comply with article 5.1, by coming up with the statutory register. If Her Majesty’s Government believe that that judgment on Poland is the cause of their paralysis, the Minister needs to say so today and explain why that judgment is holding up the United Kingdom setting up a statutory register.

An EU directive has come in; that was in April 2011. The Government said that they would have a statutory register by the end of 2012, to ameliorate the worst effects of the directive, yet more than two years on, the herbal medicine industry, which Her Majesty’s Government said that they wanted to protect, remains exposed to that EU directive. That is simply an unacceptable situation. There will be, in all our constituencies, small and medium-sized herbal practitioners that are finding their livelihoods affected by an EU directive that the Government promised they would ameliorate—two years on, they have failed to do so. The Minister needs to explain to the House today why we are in this sorry state and what he will do to sort it out as quickly as possible.