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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. Robert Verkerk PhD on April 12, 2012 at 2:41 pm said:

   The following comments are made on behalf of the Alliance for Natural Health Europe (www.anh-europe.org) and are supported by a questionnaire [see summary at: http://www.anh-europe.org/sites/default/files/120412-ANH-Red-Tape-Questionnaire_summary.pdf] we prepared associated with the medicines/traditional herbal medicines themes, to which 41 responses were received (28 practitioners, 11 consumers and 2 manufacturers).

   In terms of products that may be regarded as traditional herbal products or medicines, we uphold that:
   1. The requirement for registered products to be able to demonstrate 15 years EU use is arbitrary and inappropriate. While it is reasonable to require a 30-year period of safe use in place of safety studies, the requirement to prove 15 years usage in the EU has no scientific rationale and could be regarded as a protectionist measure.
   2. Significant amounts of non-herbal ingredients should be allowed in products on the condition that the products is both safe and ethically-sourced. The restriction of active ingredients to herbal ones unfairly excludes a large number of traditional medicines from the registration scheme. Minerals, in particular, should be allowed where these are used in traditional medicines.
   3. The high cost of data compilation, stability tests and ongoing compliance is a barrier to smaller companies. Simplified data requirements would greatly increase the possibility of herbal products being registered and would avoid the proportionately greater burden on smaller operators that characterise UK herbal suppliers and manufacturers.
   4. The THR scheme’s restriction to minor ailments unfairly limits its applicability.We are not aware of a specific rationale to support the view either a) that herbal products intended to support minor ailments are intrinsically safer than those intended for use in those with major ailments, or b) that persons suffering major ailments who are using herbal products will avoid medical support and will so endanger their health
   5. Food supplements containing the same botanicals sources as those present in products with traditional herbal registrations (THRs) should be allowed to remain on the market if they have a history of safe food or food supplement usage.
   6. Traditional medicines have typically had traditional indications, some of which are not relevant to Western medicine (e.g. because they refer to energetic states or body types, doshas, etc.). The inability to use traditional indications (e.g. for Asian medicines) for products registered as traditional medicines is a problem and could mean that products were not used for the appropriate purpose.
   7. The proposed statutory regulation of herbalists is viewed by many practitioners as being unlikely to adequately safeguard the practice of herbal medicine. Many practitioners are concerned that the rights that have enabled them in the UK to prescribe unregistered herbal medicines under the terms of the Section 12(1) of the Medicines Act 1968 will not be fully carried through to statutory regulation, and/or that significant numbers of practitioners currently practicing herbal medicine may not be able to gain access to the statutory register of herbalists.
   8. Many herbalists are of the view that the Section 12(1) Medicines Act 1968 exemption for herbalists has not exposed patients to unnecessary risk, and therefore does not warrant being repealed.
   Additional comments (9 in total) supplied by respondents to our questionnaire [see http://www.anh-europe.org/sites/default/files/120412-ANH-Red-Tape-Questionnaire_summary.pdf] were as follows:
   1. Regulators should look at the figures for deaths and injuries caused by prescription medication – difficult to find in UK as disguised in with other statistics. Compare even a rough estimate to the number of deaths/injuries from herbs and food supplements
   2. We have removed the relevant products from our range as the stock has diminished, however, we have noted that others have not. We feel this creates confusion for consumers and unfair competition, particularly when other companies have launched entirely new, unlicensed, retracted herbal formulas.
   3. If people cant get what they need in the UK (customers) they will source it from elsewhere. This may encourage the black market sale of sub-standard contaminated herbs from elsewhere. What scientific evidence have the MHRA et al got to prove that unlicensed medicines are dangerous when taken as directed on the packet? Shouldn’t they publish proof of their actions too?
   4. There is an unfair bias towards pharmaceuticals. Pharmaceutical companies have large budgets to test all products, at the detriment to patient choice and increased costs to the health care system. There are more deaths and side effects per annum from prescribed drugs than from things that grow naturally. Natural products cannot be controlled in the same way as pharmaceuticals, they by their nature are variable. Chemicals are controllable by manufacturers and therefore should be regulated.
   5. Something that grows wild cannot and should not be controlled. I personally feel that legislation aimed at Traditional Herbal medicines is flawed and is an unnecessary waste of time, money and effort. It also deprives people of choice, not only a choice of medication, but a choice of choosing natural versus chemical.
   6. I have successfully used European and Maharishi Ayurveda products for 35 years. Such use has saved me pain and disability and the NHS many tens of thousands of pounds. There must be freedom to prescribe, use and buy products proven in traditional use.
   7. Herbal practitioners have been safely and conscientiously treating their patients for many years. I know of no herbalist that would even consider using a medicine if they were not sure of its safety, effectiveness or possible interactions with other medicines etc.
   8. Consumers should be allowed to make their own informed choices on what health products or herbs they take. Individual responsibility for ones own health should be encouraged and celebrated. Pharmaceutical drugs are by no means safer or even more effective than herbal remedies. Who gains really from these types of legislative decisions, the public or Big Pharma???????”
   9. Western medicine should get its facts clear about alternative therapies – that they are ‘alternatives’ to the medical format not something that is trying to replace visiting a doctor to help with a broken arm etc. Vitamins, herbs, Ayurveda and traditional Chinese medicine provide an alternative therapy to people where western drugs or treatment pose too many side effects, are too costly, not specific enough for their treatment, or as I mentioned HAVE TOO MANY SIDE EFFECTS. Its about choice. About finding what works for YOU as an individual not as a statistic. Its about using herbs that have been successfully helping people for thousands of years and been ‘tested’ on countless people through time. Western medical ‘trials’ have proven again and again how unsuccessful their model can be (thanks western medicine for your trials with thalidomide), and most drugs are on the market without even having been tested at all. How can western medicine then say that alternative models such as the use of herbs, Ayurveda or traditional Chinese medicine are “untested” when they have been around for much longer that the western model and in some cases have even contributed to treatment methods/drugs now being offered within the western medical system? It is sad that in the end we have to entertain a debate that is all about big companies and the financial threat they feel from ‘alternatives’ to their model. And it is seriously worrying that legislation could take away peoples freedom to make their own informed choices where health is concerned. I know certain western medically minded readers will say “but reaching for vitamin c or a garlic capsule or a cup of raspberry leaf tea isn’t making an informed choice!”, and I guess they’re right, if reaching for Zoloft, Benzodiazepines, Risperdal, Visine or countless other “safe” drugs with serious side effects is a better way to go. Taking away people’s freedom is a worrying and dangerous game to play.Comment Tags: ANH, Asian, Ayurveda, practitioner, TCM, THR
2. Sara Dickens on April 11, 2012 at 8:36 am said:

   There is a very important issue regarding the proposed conversion of herbal licenced products (PLs) to Traditional Herbal Registrations (THRs). The MHRA should allow PLs to continue as they are, they don’t require assessment as they are up to date and transfer to THR is costly and unnecessary and is an extra level of red tape which is national and not EU. The extra cost of converting the PLs to THRs is so onerous that PLs currently sold will be priced out of the market. Why should the UK suffer when the rest of Europe are not.
   For years we have maintained the PLs to a very high standard and we are now being penalised.
   Let PLs remain unchanged.Comment Tags: PL, PL conversion to THR, THR
3. Patricia Gallagher on April 9, 2012 at 1:44 pm said:

   I had assumed this Red Tape Challenge was designed to hear comments about the THMPD and how it could be improved (made easier) therefore I am surprised to read the unhelpful comments about scrapping the legislation.
   The THMPD legislation is crutial for herbs and for consumers and practitioners as it allows sale of herbal products whose safety and quality has been reviewed and a Patient Information Leaflet included.
   My reply to those who are asking for the THMPD to be scrapped is ” when are you going to wake up and realise that this is law and EU law, it is not going to go away? Companies had 7 years to get products registered but some have chosen not to, one might ask why they don’t want their products scrutinised. ”

   What we need:-

   1. The MHRA to publish a list of herbs which can only be sold as medicines (such as St John’s Wort, Echinacea, Milk Thistle and Black Cohosh) and can not be allowed in food supplements at any strength/quantity. This would avoid the huge confusion in the market place.

   2. The MHRA to enforce the law by prossecuting those producing medicinal herbs without a registration.

   3. Reduction or scrapping of pharmacovigilance where use of a herb is well documented.

   4. Allow several extract suppliers to be added to THR registrations, even if the source is not used often, as the European extract suppliers for THRs have a stranglehold on supply and are charging artificially inflated prices. We need ease for adding new extract suppliers.Comment Tags: extract supply, medicinal herb list, pharmacovigilance, THMPD, THR
4. 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