Remove Red Tape

Medicines: Traditional Herbal Medicine

These regulations affect companies who wish to manufacture over-the counter traditional herbal medicines. The purpose of the regulations is to allow consumers to make an informed choice of over-the-counter medicines made to assured standards of quality, safety and patient information.

The new European Traditional Herbal Medicinal Product Directive 2004/24/EC came into effect on 30 April 2004. The aim of this Directive is to remove the differences which create obstacles to the free movement of medicinal products in the European Union, while ensuring protection for public health. This has been done through requiring each EU country to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision.

We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections.

You can find the regulations that relate to Traditional Herbal Medicines to the left below.

Please note that some regulations in the medicines section also apply to herbal medicines.

Tell us what you think should happen to these regulations and why, being specific where possible:

• Should we scrap them altogether?
• Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
• Could they be reformed, simplified or merged? How?
• Can we reduce their bureaucracy through better implementation? How?
• Can we make their enforcement less burdensome? How?
• Should they be left as they are?

206 comments on “Medicines: Traditional Herbal Medicine”

1. Amarjeet-singh Bhamra on March 15, 2012 at 2:46 pm said:

   The EU directive has now banned much of herbal medicine, pressing more of us to take pharmaceutical drugs that drive the profits of big Pharma.

   The EU Directive erects high barriers to any herbal remedy that hasn’t been on the market for 30 years — including virtually all Chinese, Ayurvedic, and African traditional medicine. It’s a draconian move that helps drug companies and ignores thousands of years of medical knowledge.
   There are arguments for better regulation of natural medicine, but this draconian directive harms the ability of Europeans to make safe and healthy choices. Let’s stand up for our health, and our right to choose safe herbal medicines.
   (www.saveherbalmedicine.com)Comment Tags: Ayurveda, Save Herbal Medicine
2. Chris on March 15, 2012 at 2:26 pm said:

   The THMPD is apparently about safety however the dangers of herbal medicine compared to modern drugs is miniscule, if patient safety is to be protected better to spend money on stopping drug companies falsifying research and lok at how to stopp the thousands of iatrogenic deaths every year.

   Furthermore the tHMPD takes away the consumer’s right to chose their own healthcare and take responsibility for their own health. I believe is has done nothing to help modern health care or protect consumer safety.Comment Tags: THMPD
3. Scottish Health Food shop worker on March 15, 2012 at 11:56 am said:

   Scrap the legislation.
4. Victoria Chanin on March 15, 2012 at 11:16 am said:

   please scrap this legislation, it cripples small businesses like mine and infringes my right to practice my profession and earn a living for my family. These laws do not protect the public from charlatans, but belittle the knowlege and research carried out by professionals who have one, and sometimes two degrees in herbal medicine. Instead of insuring that all herbal products that are available are of the highest quality it allows large corporations with the money to finance licensing to produce cheap products making the best profit. Please show our profession some respect.Comment Tags: Scrap it.
5. Claire MacKay on March 15, 2012 at 10:39 am said:

   THMPD should be scrapped altogether.

   The regulation impinges on consumer rights and freedom of healthcare choices, and is based on speculative safety concerns that are unreasonable at the least and indemonstrable.

   The DoH announced previously that no evidence is documented on file showing that herbal medicines are a safety concern. The concerns of this nature have come through the media and the opinions of those with a corporate incentive.

   While I welcome this opportunity to speak out, and am happy to see that all prior comments have articulated my own thoughts- I feel that this is not the way for the Government to handle regulation- to implement and than ask in retrospect for expert and public opinion.

   With the subject of Statutory Regulation and the uncertainty among Herbalists on if/how Schedule 12:1 of The Medicines Act 1968 could be affected by the proposal, It concerns me that this issue is not given attention on this forum.

   I hope the Government learns from this debacle of regulation enough to realise the even bigger debacle of the proposals regarding SR. Another unnecessary, corporate-incentive driven proposal to limit the freedom of healthcare choice among the free public and criminalise a tradition that has been part of human heritage and culture for 5000 years as documented in this country- but most likely since the beginning of humankind.Comment Tags: Freedom of choice, SCRAP SR, THMPD, Traditional Herbal medicine
6. John on March 15, 2012 at 10:28 am said:

   This THMPD should be scrapped.
   2004/24/EC is yet another piece of draconian legislation passed by the faceless eurocrats, and has more to do with big pharmaceutical business than public safety.
   Just like the proposed Fiscal compact treaty, most countries just roll over [Deleted Text]
7. Philip Evans on March 15, 2012 at 8:40 am said:

   It was interesting to read the following in the preamble to this consultation: “With the help of comments made to the website, the MHRA will go through and decide what action it needs to take on each and every regulation. Its proposals are then reviewed by a ministerial ‘Star Chamber’ who again meticulously go through the regulations with the presumption that they will go unless they can be strongly justified.”
   I understand that the Dept of Health has a policy that surveys should underpin – or justify – any proposed regulation, yet that it has stated that no surveys have been carried out on any harm caused by herbal medicines: since the guiding principle for all medicines regulation is public safety, it is difficult to see how the implementation of the THMPD can in fact be justified.Comment Tags: justification, justified, justify, THMPD
8. Ann George on March 14, 2012 at 7:06 pm said:

   I also would scrap this draconian legislation for the following reasons:

   1) Compared with allopathic medicines, traditional herbal medicines have an excellent safety record. This legislation is completely over the top and gives yet more power to the pharmaceutical giants.

   2) Many of my patients are disappointed that I am now unable to obtain practitioner-only tablets because the small companies who make them cannot afford the prohibitive cost of licensing. Since these tablets are only available to properly qualified medical herbalists, who know and trust their suppliers, there is no danger to the public.

   3) The legislation has reduced patient choice and may make some patients switch to more expensive pharmaceutical drugs with unwanted side effects.

   4) I am extremely dismayed that we in the UK have to slavishly follow European legislation when many other European countries do not. For example, good quality herbal tablets no longer available here because of licensing can easily be purchased in Germany.

   6) If the legislation cannot be scrapped then the the licensing process should be more of a level playing field allowing small ethical companies to compete. There cannot be any justification for the current enormous cost of licensing which could put many small firms out of business.Comment Tags: THMPD, Traditional Herbal medicine
9. tim lane on March 14, 2012 at 6:39 pm said:

   2004/24/EC should never have been impemented. It impacts on all producers but especial;ly the small businesses. Pre-existing UK legislation regarding quality was more than adequate to deal with any problems with regard to quality and product description. It is yet another example of the top heavy bureaucracy seeking to justify their reason for being, and well paid positions of employment, with scant regard to the impact of their decisions upon those who have to bear the brunt of them.Comment Tags: THMPD
10. Stephen Church, Herbalist on March 14, 2012 at 4:49 pm said:

    I should scrap it!

    The THMPD is a prime example of bad law-making arising for over-bureaucratisation – favouring corporate interests over those of small businesses, whilst being too ill-conceived to be workable. There is no substantive evidence that herbal medicines present a significant risk to public safety, and even less evidence that this sort of regulation could possibly reduce it. The THMPD is largely ignored elsewhere in Europe, whilst in the UK it would force many dedicated and highly motivated small producers, manufacturers, traders and practitioners to ‘go underground’ or simply flaunt the law, as many certainly would in order to keep making what was hitherto a perfectly legitimate living. Of critical interest, in terms of cost/benefit ratio, this is very poor value for the taxpayer!
11. D Paul Bremner on March 14, 2012 at 1:55 pm said:

    The EU Directive was supported by the UK and through it’s development. It has created a rigour to common, commercially produced Herbal Drug products. All in a thrust to protect public safety througout the EU. If people are proposing scraping it – what is the alternative? Products produced on a mass scale are now assured to be safe, except for interactions we currently know of or are yet to identify, and of a desired quality. This has been more the seven years in the development. The MHRA are the responsible body, they should be the ones to enfore the leglislation they supported. Not use this red tape process to use as an excuse to scrap it. I am not sure it is possible under EU leglislation anyway. But would certainly welcome an annual review to understand how it is and is NOT working. The debate clearly identifies the need for regulatory bodies to identify what is a Herbal Drug and waht is a Food Supplement. Danny O’Rawe said on March 14, 2012 at 11:09 am below has some interesting comments to make on a way forward.Comment Tags: THMPD Herbal Drug Quality
    • Danny O'Rawe on March 14, 2012 at 4:35 pm said:

      My comments are largely from the Alliance for Natural Health website – the anh have a very good take on the flaws in the current process but are also offering a viable alternative.Comment Tags: THMPD
12. Belfast herbalist on March 14, 2012 at 1:30 pm said:

    Let’s be clear – THMPD is designed to benefit corporate interests at the expense of consumer choice and traditional cottage industry. The licensing process is prohibitively expensive. Why is it it is financially prohibitive for the very companies active in this specific sector?

    THMPD, strikingly appears to ignore ancient herbal traditions which have origins beyond the UK. Does that make it institutionally racist? This needs serious consideration.

    THMPD has and will cause products to be withdrawn, not because those products can be considered unsafe, but because they don’t meet with the unnecessarily restrictive licensing criteria that are the hallmark of this draconian legislation.

    THMPD has and will force small companies to close for the same reason, creating unnecessary redundancies, and creating a gaping hole in traditional British culture as a consequence.

    THMPD has and will limit the consumer’s right to choose how they govern their own health – the opening salvo in the introduction to this page above which states this legislation allows consumers to make ‘informed decisions’ couldn’t be further from the truth. By limiting choice within blinkered parameters one actually ‘misinforms’ the public.

    THMPD has and will limit innovation particularly in the use of polyherbal products – the so-called evidence-based model thought to be the gold-standard of modern science reduces herbal products to ‘active-ingredients’ and fails miserably to take account of whole-herb theory which has been the benchmark of western herbalism for centuries and will only stifle investigation and true scientific pursuit intend to benefit humanity.

    THMPD needs to be amended considerably or ideally scrapped. If it is based on the interests of public safety it is and will be a categorical failure as it will actually increase the safety risks and multiply inadequate and inappropriate use of traditional plants.

    As to an alternative – we might ask what was so wrong with what was in place beforehand under the Medicines Act 1968?Comment Tags: Beurocracy, Corporate interests, THMPD Disaster
13. C Henderson on March 14, 2012 at 11:31 am said:

    This piece of legislation is prohibitive and stiffles innovation for new combinations. When one reads the word ‘traditional’ one thinks it means traditional use of single herbs and combinations for various conditions,documentation of which covers the past 1000 years, but in reality it means traditional market use for 30 years (15 of which in the EU), many companies do not have records going back to 1980, or simply do not have products that have been on the market that long. I work with many non EU clients who simply cannot even apply for a THR because of these stipulations. It also stiffles innovation and new combinations in herbal products. The cottage industry element of herbal medicines has been decimated by the THMPD. The UK has a massive immigrant population from around the globe, they should be able to access chinese and ayurvedic medicines. Also the borderline element of so many of these products, slows down day to day business massively, consultants like myself spend days trying to ascertain the status of single substances and the information focus is on western herbs. The system of clarifying borderline products, does not marry with the pace of normal business activity. Many many companies are making their products comply with food supplement legislation in order to avoid the expense and time consuming nature of THRs, this is the reality. This directive was brought about with safety in mind and the much referenced case of the Belgium slimming clinic, but it was not just the herbal substance they were using that effected these poor Belgian female slimmers, they were given amphetamines and all sorts. The argument of safety is a good one, a blanket one, but it is not based on the statistics of reality, because statistically homeopathic and herbal products actually very very rarely create adverse events. Are we using a sledgehammer to hang a nail here? I am all for monitoring such things, but in my opinion the THR is europe centric, prohibitive to non EU products, time consuming, expensive and complex for UK based herbal smaller companies.
14. Mrs. Deborah Syrett on March 14, 2012 at 11:24 am said:

    the only effect of these regulations so far is to block my access to one of the high quality tablets and capsules from the most reputable, professional herbal medicine supplier (MediHerb) in the market (who only supply to professionals, not members of the public) because of the prohibitive cost of licensing safe western herbal remedies (that have an exemplary safety record in comparison to pharmaceutical preparations) – these products are not suitable to test using the current ‘scientific’ double-blind clinical trials – they are too complex and there is no will to do the clinical trials using whole herbs (the only way they should be tested). However, if our authorities cared to look beyond the english-speaking world to Russia, China, India, France and Germany they would discover thousands of well-designed clinical trials that have verified the efficacy of these medicines – my suggestion – stop allowing yourselves to be blinded by the power and prejudice of the pharmaceutial lobby. These regulations are a blow to freedom of choice – Thomas Jefferson said “If we allow Governments to decide what foods we eat and what medicines we use our bodies will soon be in as sorry a state as the souls of those who live under tyranny”Comment Tags: Insidious misleading influence of the pharmaceutical lobby
15. Danny O'Rawe on March 14, 2012 at 11:09 am said:

    The key issues for scrapping this legislation are:

    Erosion of consumer choice
    Negative Effect on small business
    Negative Effect on ethnic systems of medicine such as TCM and Ayurveda
    Negative effect on polyherbal products
    Negative effect on culture and tradition

    Full implementation of the Traditional Herbal Medicinal Products Directive
    (THMPD) (EC Directive 2004/24/EC) as of 1st April 2011 is likely to force from
    the European market thousands of products associated with traditional
    systems of medicine. The end of the 7 year transition phase of the directive
    will be interpreted by many Member States as a fundamental regime change
    whereby many herbs included in products that have been sold safely as food
    supplements, often for decades, will need to be registered under the THMPD
    if they are to continue to be available beyond 31st March 2011.

    While, in theory, national food supplement regimes for botanicals are
    maintained following this date, a number of factors suggest that it will be
    increasingly difficult to use this route to continue to sell or dispense finished
    polyherbal botanical products that have long been associated with traditional
    systems of medicine, particularly non-European ones. These challenges
    include:

    • the application of positive lists
    • classification as ‘novel’ under the terms of the Novel Food Regulation
    (No. 258/97)
    classification as one or more constituents (or their dosage) within the
    product as medicinal (under the terms of amending Directive
    2004/27/EC)
    • imposition of onerous and disproportionate quality control
    requirements
    • gradual implementation of the Nutrition and Health Claims Regulation
    (No. 1924/2006).

    The simplified medicinal product registration scheme offered by the THMPD
    provides an additional regulatory route, specifically intended for botanicals
    associated with traditional systems of medicine. However, a series of
    eligibility and technical challenges, as well as prohibitive costs, prevent a
    very large number of traditional medicines, especially from non-European
    traditions such as Ayurveda and traditional Chinese medicine (TCM), from
    being registered under the scheme.

    Weaknesses of the existing regulatory framework include:

    • disproportionate regulation, especially on products from non-
    European traditional medicinal systems
    • lack of transparency over legal requirements
    • threat to the free movement of food supplements between Member
    States
    • Infringement of human rights

    Ways forward

    a. Improvement of the food supplements regime EU-wide

    b. Judicial review of the THMPD

    c. Facilitation of a new regulatory framework for traditional medicinal
    products

    Principle grounds for challenging this legislation:

    a. Proportionality combined with a restriction of freedom of movement of
    goods argument (under Article 28 EC of the Treaty of the European
    Community). This argument will expose the manner in which the
    Directive, and associated European laws and guidelines,
    disproportionately impacts stakeholders associated with non-
    European and minor traditional systems of medicine in Europe.
    Amongst other things, the monographs developed by the Committee
    on Herbal Medicinal Products will be challenged, the unnecessarily
    onerous nature of the technical requirements for the scheme will be
    exposed in terms of the intended purpose of the Directive, and,
    deficiencies in the technical requirements will be revealed,
    demonstrating that they do not adequately guarantee the safety of
    products

    b. Transparency, an argument focusing mainly on the lack of
    transparency as to the nature of the technical (including quality
    control) requirements at the time the THMPD was passing through the
    legislative process, prior to 31st March 2004.

    c. A human rights/cultural discrimination argument, which will delineate
    the social and cultural impacts of the planned restriction of access to
    products associated with traditional medicinal systems.

    An Alternative

    The need to facilitate a new regulatory framework was the justification for the
    establishment of the EBF. Work on a draft regulatory model was commenced
    in early 2010, and has received considerable inputs from Peter Bogaert, a
    leading European lawyer specialising in EU medicinal law, pharmacognosists,
    analytical chemists, phytotherapists, practitioners of Chinese and Indian
    medicine systems and a diverse range of stakeholders in the sector. The
    model has become known as the Benefyt model and is now near-complete.

    The purpose of the model is to act as the basis for a new regulatory
    framework that not only replaces the THMPD, but also expands on its
    present scope. The model, therefore, aims not only to cater for OTC herbal
    medicines, but deals with practitioner prescribed and pharmacy-dispensed
    traditional herbal products, as well as those that are currently sold in some
    Member States as food supplements. It is intended that the Benefyt model
    will provide the basis for a future legislative proposal.

    A major ‘selling point’ of the Benefyt model to legislators and politicians alike
    will be that it offers a higher level of safety for products than the THMPD,
    while at the same time considerably cheaper. Additionally, the quality control
    elements of the Benefyt model could also readily be applied to an amended
    version of the THMPD.Comment Tags: THMPD
16. Drew Durning on March 14, 2012 at 11:04 am said:

    The simplest way to deal with the THMPD would be to scrap it altogether. The only people positive about this legislation are large foreign companies, that can easily afford the huge costs of licenses and are keen to take market share from UK companies being forced out of business.
    If it is not possible to scrap altogether, I would suggest the MHRA provides a list of herbs that it deems to be Botanical Food Supplements and it has no further involvement with those. It could then provide a list of herbs that it deems to be Traditional Herbal Remedies with recommended strengths, doses, contraindications, warnings and permitted claims. The industry could then self regulate in line with that guidance. If the MHRA felt it still needed to be able enforce this legislation it could ask manufacturers to provide evidence of GMP for a licence fee of a few pounds per year. All stability tests should be scrapped allowing minor variations in strength due to natural varying harvest conditions. Manufacturers should be allowed to revert to 5 year best before dates for tinctures (phytochemicals preserved in alcohol) which never caused any problems before this hugely bureaucratic and unnecessary legislation came into force.
    The MHRA should also drop its ridiculous interpretation of the word “organic” as promotional. Wording linked to organic production should be approved by an organic certifying body such as the Soil Association and the MHRA should have no involvement in product names.
    This Red Tape Challenge could be the best news for the Herbal Medicines industry since it became apparent the pharmacists at the MHRA were going to take a heavily bureaucratic approach to implementing the THMPD. Please don’t waste this opportunity to scrap this legislation.Comment Tags: Herbal. Licences, MHRA, Organic, Red Tape, THMPD, THR
17. Maria Charlton on March 14, 2012 at 10:28 am said:

    The legislation should be scraped. Centuries worth of data on the safety of herbal remedies have been ignored in favour of companies that produce them and can afford to spend thousands of pounds on licenses. It ties up government resources in terms of enforcement which could be better used in conventional medicines research where there is potentially less data available on their safety and efficacy when compared to herbal remedies which have in effect been used by millions of people for centuries.
    There was already legislation in place that could have perhaps been updated to include herbal remedies specifically, why create more? Let common sense prevail please!
18. Paul on March 9, 2012 at 2:33 pm said:

    This piece of legislation is terribly written, confusing and unreasonably enforced by the MHRA.

    Removal of products and destruction of legally obtained products is the current over-reaction of the MHRA in order to appease lobbyists within the EU for large corporations. In reality expecting small companies to pay exhorbitant fees to license individual herbs which have been in use in the EU for decades is effectively closing down the entire market – with a concurrent loss of jobs and confidence. Only a few corporations are able to afford the measures and despite their well paid lobbyists they primarily represent companies operating out of Germany.

    The regulations are patently unfair and seek to criminalise a large portion of honest retailers with MHRA over-reach, seizures and prosecution of entirely safe and legal herbal products. A similar level of quality assurance could be made through the GMP or ISO accreditation for manufacturing facilities – or a voluntary code of conduct (which most retailers are more than happy to abide by and already do). Existing legislation on medicines covers products which are tainted or mislabeled and these can continue to police the industry.

    Removing all public choice except for a handful of large corporations over-priced compounds which still makes no guarantee of manufacturing quality – only to penalize organic and traditional farming methods – and then to further ensure that retailers are the subject of criminal prosecution and seizure orders has already caused a public outcry and will continue to do so as the pharmaceutical aligned MHRA continues to crack down on an industry it neither understands nor wishes to.

    Legislation should be used to ensure public safety, not to stifle free enterprise, not to ensure large corporate interests and not to criminalize a large portion of retailers and consumers for supplying botanical products that have been used safely for tens if not hundreds of years.

    Given the MHRA’s utter disregard for medical device management and it’s regular embarrassment in the media for both the breast implant failings and the artificial hip replacement fiasco, not to mention the refusal of senior staff to report to parliamentary committees where said staff have previously worked for Pharmaceutical companies – it seems ridiculous that the MHRA wishes to focus it’s time and resources on cracking down on health food shops for selling herbs you can legally grow in your garden or find growing wild without penalty.

    I would not expect the industry to remain utterly unregulated – food standards regulations already adequately cover the consumption of food stuffs and herbal extracts. Medicines regulation adequately covers the sale of unlicensed medications. To try and ‘muddy the waters’ and ensure that any herbal extract is counted as a pharmaceutical of synthetic origin is both bizarre and discriminatory.Comment Tags: Traditional Herbal Medicinal Legislation faults
19. Roger Barsby on March 9, 2012 at 2:22 pm said:

    Homeopathic medicines are intrinsically safe due to the dilution factor of the medicines. Their use is based on over 100 years of practical application and is detailed in materia medica. If homeopathic medicines are manufactured to a controlled quality level then they should be allowed to be sold for ailments as detailed in materia medica without further evidence. In this way they could be removed altogether from medicinal regulations and instead just be regulated on manufacturing quality.
20. Roger Barsby on March 9, 2012 at 2:19 pm said:

    Traditional herbal medicines have been around for a very long time, with a time proven safety record. Their action is gentle, unlike normal prescription drugs. As a result the control of these medicines should only rely on a) the use of traditionally recognised materials and b) on the manufacturing quality. It should then be possible to remove all other regulatory requirements of proof and much simplify the process.