The main intention behind the EU Traditional Herbal Medicinal Products Directive (THMPD) has been to ensure the consumer has access to safe products that have a history of traditional use, while also ensuring there is adequate consumer choice. It is well recognised that there have been particular issues with some herbal products containing heavy metals, pesticides and some have been spiked with synthetic pharmaceuticals. However, whilst the intention for this simplified medicinal licensing system may have been good, it has backfired. Its main problem is that there are too many obstacles to successful registration of authentic traditional herbal medicinal products, especially from the non-European traditions. Even the European Commission admitted in 2008 that the scheme provided by the Directive was not appropriate for traditions such as Ayurveda and Traditional Chinese Medicine (TCM), which include two of the most well established herbal traditions in the world. The reliance on western style pharmaceutical standards to ensure compliance with the Directive has resulted, by and large, with registered products being single herbs that have been extracted in alcohol and stabilised within a chemical base similar to that used for conventional drugs. For many consumers, this is not what they expect of ‘traditional herbal medicinal products’.
The widespread negative publicity about the risk of kidney failure or disease is generally linked to evidence that high concentrations of aristolochic acids, which are derived from a number of species of plant, including those of the genus Aristolochia, when present in high concentrations. The case of medical doctors in a slimming clinic in Belgium, prescribing drugs alongside aristolochic acid containing herbs, was widely publicised in 1998 after cases of kidney disease and cancer were noted. Over the last 12 years, while there have been continuing question marks over the precise role of aristolochic acids in the victims of the Belgian clinic, as well as suggestions that it was interactions between the various drugs being prescribed that were responsible, European authorities (including the UK MHRA) applied a complete ban on Aristolochia and other aristolochic acid containing herbs between 1999 and 2001. Since Aristolochia and its related herbs are already banned, the EU herbal directive will have no effect on any continuing illegal sales of aristolochic acid containing products. Such problems will only be dealt with by more effective enforcement of the existing ban.
The majority of evidence for risk with herbal products has been caused by:
Interestingly, extraction with alcohol is associated with only one specific strand of European phyto-pharmaceutical medicine, which evolved during the 20th Century in countries such as Germany, Switzerland and the UK. The major non-European traditions such as Ayurveda, TCM, Tibetan, Southern African traditions, Amazonian medicine, etc. have tended not to use alcoholic extracts traditionally, being generally more reliant on the use of dried whole plant material or watery decoctions. It has been the more recent adoption of hydro-alcoholic and alcoholic extraction systems by the Asian traditions, as a result of influence by western pharmacological methods, that have given rise to some safety concerns. Of particular relevance, ANH-Intl along with its collaborators at the European Benefyt Foundation, argue that quality control methods could be instigated that ensured higher quality and safety standards than those provided by the THMPD, while at the same time being much more affordable to smaller companies. It is a major concern that, to date, not a single authentic herbal product from the Ayurvedic, TCM, Tibetan, Southern African or South American traditions has yet to be registered.
While registrations have been slow to be issued, since the passage of the herbal directive into Member State laws in 2005, about 200 licenses have now been issued EU-wide. The largest number of these (90) has been in the UK. Important reasons for the slow uptake include the lack of clarity over registration requirements and technical difficulties in providing the necessary data. While more herbal products are likely to be licensed before the full implementation date of 1st May 2011, it is expected that these will not greatly expand the number of botanical species included (currently 34 in the UK). It is also expected that very few, if any, authentic Ayurvedic, TCM, Amazonian or other products from non-European traditions will be registered by this date.
If you are buying products on the web via a European retailer, you are subject to European law. While it is likely that online retailers will flout the rules to a greater extent than those selling via health stores, pharmacies and supermarkets, enforcement by regulatory authorities will in time reduce the supply of unregistered herbal products for all routes. If you are buying products from outside of the EU, you may still be able to purchase an herbal product for personal use (but not for resale) under what is informally known as a ‘personal use exemption’. But this is only the case if the authorities in your country do not regard the product you are buying as illegal. One of the dangers of buying products from unknown sources on the internet, is that they are likely to be completely unregulated and therefore may be adulterated or contaminated. From the perspective of trying to maintain maximum choice of safe, effective products, we at the ANH-Intl believe the THMPD needs to be fixed. It needs to do what it originally set out to do; which is to provide a simplified registration system suitable to all authentic healthcare traditions involving the use of herbal products. This is why ANH-Intl along with the European Benefyt Foundation is preparing to challenge the THMPD in the courts.
Different Member States will police and enforce the laws in different ways. Some, like Italy, appear to not want to adopt the Directive to the letter of the law. Others, like the UK, Belgium, Germany and Sweden, appear to want to follow the law to the letter. Most believe by the full implementation date of 1st May 2011, there will still be significant numbers of products on the EU market that may be deemed ‘traditional herbal medicinal products’ by regulatory authorities. Some of these products, in some Member States, may be able to remain on sale as food supplements, on the condition that no claims for treatment of any ailments are included in labelling or marketing. In other Member States, such as the UK, authorities have been clear that they are not going to tolerate the continued sale of herbal products as food supplements, if any of the ingredients within the products are deemed by the UK medicines controller, the Medicines and Healthcare products Regulatory Agency (MHRA), as medicines. A further challenge to the continued sale of herbal products as food supplements is the 1997 Novel Food Regulation, which required pre-market authorisation of any food or food ingredient that has not been consumed to a significant degree within the EU prior to 15th May 1997, when the Regulation came into force. The MHRA has indicated it will allow sell through of products already stocked by retailers, and Richard Woodfield of the MHRA has indicated that policing will initially be “light, but accurate”. Enforcement is likely to be assisted by ‘dobbing in’ by players who have already received registrations, who then report unregistered products to the authorities where these compete with their registered products. The implication is that, in time, for a number of reasons, effective enforcement will be ramped up.
There is no doubt that batch testing requirements under the registration system will generally ensure that excessive levels of contaminants like pesticides and heavy metals will not find their way into registered products. However, most of the responsible and well established players currently selling herbal products as food supplements already operate such procedures, some to higher standards that those required under the THMPD. If consumer choice is dramatically reduced by obstacles in the registration process, consumers may be more likely to purchase products online, from completely unregulated markets, where risks of contamination or adulteration are increased, rather than reduced.
These products are very popular with consumers and as a result the market size for these products is more able to fund the high costs of registration, which are typically between £80,000 to £150,000 for a single herb product. But not all consumers will find that their favoured formulation containing these, or other herbs found in registered products, have been registered.
There is no doubt that some consumers may be happy with the range of licensed products available, and there will be more registered products available in the coming 75 days before the full implementation date of the Directive on 1st May 2011. Inevitably, market forces dictate that those products that have been commercially successful either as unlicensed medicines or as herbal remedies selling as food supplements, are more likely to have been able to be registered, on the condition they are single herb products, and are alcoholic extracts. But some people may, for example, not wish to consume products with excipients more typical of pharmaceutical drugs, which are found in the majority of registered products. Others may not be able to find any products that they consider to be suitable among the list of registered products, given they don’t perceive them to be ‘traditional’ or sufficiently natural (i.e. they may contain extracts with high concentrations of certain plant compounds rather than whole plant material). Still others may only want to buy products if they are both organically certified and have been guaranteed to not have been irradiated.
The THMPD only affects herbal practitioners who are reliant on prescribing manufactured products, particularly if these are recommended for purchase by their patients or clients, who may in turn buy them from a conventional retail channel. Herbal practitioners in the UK are still uniquely able to use unlicensed herbal medicines made up for individualised treatment following one-to-one consultation, under an exemption in UK medicines law (Section 12(1) of the Medicines Act 1968). However this exemption is likely to be repealed imminently to be replaced by an exemption in European medicines law (Article 5(1), Directive 2001/83/EC), that allows 'authorised health care professionals' to use unregistered medicines. Only the UK government appears to be willing to apply this exemption to practitioners who are neither medical doctors or pharmacists. But in order to apply this exemption in European law, a functioning system of ‘statutory regulation’ will need to be operational, this having been a major target of particular groups of medical herbalist in the UK for a number of years. The fact that other EU Member States seem unwilling to apply this exemption to non-medically qualified practitioners requires that a new regulatory framework specific to practitioners is developed; this has been a major focus of ANH-Intl’s collaborators at the European Benefyt Foundation.
Technically the ban on unregistered ‘traditional herbal medicinal products’ applies, at the latest, to the date of full implementation i.e. 1st May 2011. This is specified in Article 2(2) of the THMPD, which states that member States “shall apply the provisions of this Directive within seven years after its entry into force” (i.e. 30th April 2004). However, some Member States have started applying certain provisions of the law earlier.
ANH-Intl, via its expert external lawyers, is hoping to demonstrate to the High Court in London that there are elements of the THMPD and its implementation that contravene European law. We will be arguing in court that the law, and its implementation, is disproportionate, non-transparent and discriminatory. We are then hopeful of getting a reference to the European Court of Justice in Luxembourg. If successful, we hope to be able to show the European Court that the Directive is fatally flawed and we aim to help the court, with support from expert evidence, to propose ways in which the THMPD, and its implementation, can be resolved so that it does not act disproportionately, nor does it act to discriminate against non-European traditions which utilise herbal products. We have raised nearly 70% of the £90,000 estimated to be needed for legal fees for the initial phase of the action in the High Court, but if successful there, we will need to continue to fund raise to meet the costs of the case in the European Court. We have brought a challenge against the Food Supplements Directive between 2003 and 2005, which also involved this two stage process, and the challenge resulted in important clarification and simplification of the Directive’s scope and effect.
We have met with both the Chinese and Indian authorities and we have detected frustration by both these governments in the lack of flexibility being shown by the European Commission, the European Medicines Agency and some of the European Member States over the registration process stipulated by the THMPD. Both the Indian and Chinese governments have made several representations to European authorities in recent years and months and it seems very little benefit has materialised. ANH-Intl has met with senior Chinese government officials on this issue in Beijing and the problems for authentic TCM products was well recognised on the Chinese side. Similarly, meetings with officials from the Indian government Department of AYUSH has revealed the Indian government’s frustration over the unnecessary obstacles in the registration process being proposed under the THMPD. Given that diplomacy has achieved little in making the registration system more appropriate for non-European traditions, legal challenge is seen as a last resort.
It is likely that different Member States will ban different herbs and different products containing different herbs. European law ascribes a very broad definition of a medicine to any substance used for healthcare purposes and there is a risk that any herb or herbal product containing herbs that are used medicinally that are: a) not registered under the THMPD, b) do not have a history of food use, or c) have a history of food use but are neither dried, comminuted herbs nor aqueous (water) extracts or decoctions. ANH-Intl has provided partial lists TCM (Chinese), Ayurvedic (Indian) and western herbs that are endangered by European medicinal law and could be subject to bans as of 1st May 2011. Download ANH-Intl's list of 'endangered herbs'.
Back to related press release: EU herb directive keeps consumers in the dark.
Updated: 15 Feb 2011
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