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 51 responses were received (34 practitioners, 13 consumers and 4 manufacturers).

Apologies for the inconvenience caused.

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

However, I think firm but fair regulation is required nad the EU has gone OTT. Regulation must require that products are made under GMP conditions and assayed so that they are what they say they are. Claims on health benfits (including “can help with” which means nothing) should be regulated so that they are fair and clear.

Herbal medicines that interact with allopathic medicines or have demonstrable harms should be restricted to pharmacies

Actually in the medical literature St John’s Wort hasn’t ’caused problems for many patients’. The meta-analysis by Jonathon Treasure (2000) is rather revealing for example.

Ereshefsky, Gewertz et al. 1999) determined that St John’s Wort is a significantly weaker inhibitor of
CYP3A4 than grapefruit juice.” Should we issue health warnings of potential drug interactions from grapefruit? Or Brussels sprouts whose glucosilinate compounds induce CYP1A2?

I do concur that safety is vital – first do no harm – we clearly need to establish risk from good evidence, for example in vivo research in which hepatic detoxification status is determined in all participants before, during and after, and that in the case of herbal medicines fresh whole herbs preparations are used, rather than standardized extracts or isolated ingredients which can in some cases offer misleading results.

If credible risk is indicated then appropriate steps should be taken – practitioner only for example – patient information sheets etc but the problem is that with an unrestricted internet consumers can freely purchase materials irrespective.

Most people who are taking two or three more allopathic drugs are mere rattling the pills of unknown sideeffects.
Go and test the greatest gamble going on, the gambling of mixing drugs whiich have never been tested being given out daily by doctors all over the world, this has become normal, when did doing insane things become normal.