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ANH & Benefyt clarify confusion
about EU herbal Campaign
Prepared by Alliance for Natural Health
Europe and the European Benefyt Foundation
We at ANH in Europe and our collaborators in the European Benefyt Foundation have joined forces to deal
with the grave problems facing the availability of particular herbal products
in Europe.
Our detailed and comprehensive joint initiative has
been understood by those closest to the problems. But it is less well
understood by those who are not directly affected. To further confuse things,
many well meaning citizens and even other campaign organisations have got some
of the issues confused and all of this does little to help the cause. The confusion
also causes some to think there isn't really going to be a problem next May,
which couldn't be further from the truth.
We've decided the best way to deal with the confusion
is to provide detailed answers to some of the most commonly asked questions.
Please forward this link as widely
as you can to help people understand why concerted efforts are required to stop
unjustified restriction of our ability to heal and maintain our bodies using
plant products.
QUESTION 1. Given that the THMPD registration scheme
is open to and applied equally to all producers of traditional herbal
medicines, why should the cost of entry to the scheme be a challenge to some
and not to others?
ANSWER: The simplified
medicinal registration scheme for herbal medicines is ideally suited for single
herbs or limited combinations of herbs which have a long history of use in
Europe and are also the subject of Community monographs developed by the
European Medicines Agency (EMA). In contrast, the Directive imposes major
obstacles for herbal producers making multi-herb products that are associated
with non-European traditions, such as Ayurveda, traditional Chinese medicine
(TCM), Amazonian, Kampo (Japan), etc. To-date, only around 200 registrations
have been issued for herbal products across the 27 EU Member States, all of
which are associated with western herbal traditions.
In the case of products where
no monographs exist for constituent herbs, and which contain multiple herbs
that have not necessarily been long-used or well-studied in Europe, there are
major challenges, or even barriers, to registration. The challenges can
generally be divided into two main areas. The first of these relates to
difficulties in meeting the preset eligibility requirements for access to the
medicinal registration scheme. Of these, decisions by national authorities or
the Committee on Herbal Medicinal Products (HMPC) of the European Medicines
Agency (EMA) to prevent use of traditional indications (medicinal claim) are
among the most serious. Equally significant is the difficulty of meeting the
traditional use criteria, where bibliographic or expert evidence is needed to
verify 30 years' safe use, of which at least 15 are within the EU (i.e., the
so-called ’30-year rule’). The second major obstacle to registration under the
simplified medicinal registration scheme of the THMPD is caused by the often
prohibitive costs of meeting the quality control guidelines set by the HMPC.
These are inappropriate for complex, poly-herbal products typical of
non-European traditions and do not necessarily guarantee the safety of
products, which is their main purpose. Where the required data – which include
stability and genotoxicity testing – can be accumulated for registration
dossiers, the costs may rise above €250,000 per product.
Even in cases where eligibility requirements can be met, and where there is a clear ability to validate the safety of products, a high cost for registration of, say, €250,000 per product represents an insurmountable burden for companies whose business model is based on selling a wide variety of products, each with a relatively small sales volume. This kind of model is actually typical of manufacturers and suppliers of Ayurvedic and TCM products. By contrast, manufacturers and suppliers of European herbal products tend to sell a much narrower range of products, with each line generally selling at a much greater volume. Consequently, high product registration costs are much easier to justify economically for typical European herbal suppliers, as compared with those selling products associated with the major Asian and other non-European traditions.
QUESTION 2. How can the THMP registration scheme act
as a barrier to the free movement of food supplements within the EU, since the
Directive is designed for herbal medicinal products only and is not food
supplement legislation?
ANSWER: For the last two or more decades, many products associated with the Asian traditions of Ayurveda and TCM have been sold as food supplements in countries such as the Netherlands, Belgium and the UK. Food law, as opposed to medicinal law, governs food supplements. In itself, medicines regulation should not interfere with products under the jurisdiction of food law. However, certain competent authorities, including those in the three above-mentioned EU Member States, appear to wish to reduce or eliminate dual categorisation – as both food and medicines – of particular herbs or herbal products. Full implementation of the THMPD after April 2011 appears to be seen by these Member States as a suitable occasion to force manufacturers and suppliers to abide by one system or the other. In all three of these Member States, we are aware of instances where products that have long been sold as food supplements are now considered illegal by national authorities, unless they can be successfully registered under the THMPD. In some Member States, it is becoming increasingly difficult to get products notified as food supplements, given that authorities now consider the THMPD to be the appropriate regulatory regime for herbs associated with traditional systems. Such a view is ironic, given the recognition, even by the European Commission, that the THMPD is unsuitable for products associated with Ayurveda, TCM and other ‘holistic’ systems of medicine. Such impacts of the THMPD on free movement of food supplements that have a safe history of use may contravene elements of European law, such as mutual recognition and rules governing the functioning of the single market. The Commission indicated, in this same report, that it may consider development of an entirely new framework for the practice of such traditions. However, our concern is that a framework of this type is likely to take many years to be agreed and implemented.
QUESTION 3. As many herbal products are currently sold
as food supplements in many Member States, are there any impediments to
continued sale of such products?
ANSWER: In at least 5 Member States, regulatory authorities have circulated letters or other communications that unilaterally and arbitrarily classify herbal ingredients as either foods or medicines. On such occasions, relevant and affected sectors representing the Asian herbal industry have not been consulted. In one Member State, the competent authority has even suggested that all positive (food) listed traditional ingredients should be transferred to a negative (medicines) list, in order both to be eligible for medicinal registration under the THMPD, and to protect such ingredients from the Novel Food Regulation (No 258/1997). The Regulation requires burdensome pre-market authorisation of any food or food ingredient that has not been used significantly in the EU prior to the Regulation coming into force on 15 May 1997. Furthermore, at least one Member State has confirmed in writing to a major Ayurvedic supplier that dual status of an equivalent product, as both a food supplement and a medicine, will not be accepted. In principle, forcing such products into a medicinal regime would not present a problem if the THMPD had been created to facilitate registration of the majority of products associated with traditional systems of medicine. However, many products from non-European traditions are effectively ‘locked out’ by their inability to comply with the eligibility requirements of the THMPD. This means that blocking their sale as food supplements effectively bans these products from the market altogether, despite them being manufactured according to traditional specifications and being established as being completely safe to consumers.
QUESTION 4. Does the definition of a medicine under
European law not make it easy for both manufacturers and regulators to
determine which products should be designated as medicines and which can be
sold as food supplements?
ANSWER: The extremely broad
scope of the definition of a medicine in European law (amending Directive
2004/27/EC, Article 1.2) technically makes all foods and food ingredients
medicines by function. However, Recital 7 of the same Directive exempts from
medicinal law those substances that are regarded “clearly” as foods, food
supplements or cosmetics. Should there be any doubt over the categorisation,
Article 2.2 of the Directive gives regulators arbitrary power to apply
medicinal law over any other Community law. While some case law originating
from the European Court of Justice has aimed to clarify the application of medicinal
law to herbal products and ingredients, there are still considerable
differences in how different Member States apply food and medicinal law.
Complicating matters further from the perspective of manufacturers and
suppliers, individual national authorities continue to ‘move the goalposts’ as
the date of full implementation of the THMPD (1 May 2011) approaches.
This lack of coherence between medicinal and food law, as interpreted by various EU Member States, is creating considerable legal uncertainty for many operators. A bizarre situation may arise where an herbal ingredient that may have been sold for decades as a food supplement, given a) its history of use as a food, b) its “physiological effect” (food supplement definition, Directive 2002/46/EC, Article 2) and c) the absence of any therapeutic claim, will now be accepted as a medicine (under the THMPD) yet be banned as a food ingredient for the same alleged physiological function.
QUESTION 5. Why is there confusion among the sector
over the classification of herbal products as foods or medicines, given that
both terms are clearly defined by the EU and that European monographs exist for
many herbs?
ANSWER: Given the great overlap in the respective definitions of food supplements and medicines in European law, as well as the supremacy of medicines law over any other legislation, it is far from certain whether the sale of products long available as food supplements will continue under that regime (see answers to Questions 2–4 above). So far, less than 60 Community monographs for herbal products have been adopted, these all being for herbs common to European, rather than Asian, traditions. There are several hundred individual herb species associated with each of the Ayurvedic and TCM traditions, and their absence from the EC monograph listing makes it much harder to establish quality control standards for use in THMPD registration applications. In addition, meeting the quality control requirements, which are better suited to single or very limited combinations of herbs with well-established analytical markers, is a much greater challenge for Asian herbal medicines than it is for common ones from western traditions.
QUESTION 6. Why is the sector not pressuring the
European Medicines Agency to develop more monographs, with the aim of ensuring
that more herbal products are approved as traditional herbal medicines on the
basis of their mechanisms of action and safety profile?
ANSWER: On 16th November 2010, representatives of various Asian traditions – under the auspices of the Alliance for Natural Health International, the European Herbal & Traditional Medicine Practitioners Association and the European Initiative for Traditional Asian Medicine – initiated a proposal to encourage the HMPC of the EMA to develop more, and more appropriate, monographs, especially those relating to herbs associated with the Asian traditions.
QUESTION 7. Why is there concern amongst sectors of
the herbal medicine community over a ban on polyherbal products after April
2011, as licenses for individual herbal products are increasingly being granted
under the THMPD regime?
ANSWER: While nearly 200
registrations have so far been approved under the THMPD, and considerably more
are likely prior to the end of the transition phase of the THMPD on 30 April
2011, this does not yet include any products associated with the great Asian
traditions of Ayurveda and TCM. Not only is it very difficult, or even
impossible, to register products associated with these non-European traditions
under the THMPD (see answers to Questions 1, 5 and 6 above), it is also
increasingly difficult to ensure the sale of herbal products from these
traditions under the food supplements regime, owing to their arbitrary
classification as either medicines or novel foods (see answers to Questions 2
through to 5 above). As a result, a significant number of products are at risk
of falling between the two ‘stools’ of food and medicines legislation. Products
that are amenable to neither regulatory regime will effectively be banned. Such
bans will disproportionately affect products from non-European traditions. A
medicinal regime is, in principle, entirely appropriate for products being used
directly by consumers for self-care, or that are prescribed by healthcare
professionals. However, the eligibility criteria for the THMPD’s simplified
medicinal registration scheme conspire to exclude a very large number of
products from the scheme. Since the key aspect of simplification offered by the
THMPD involves bypassing the requirement to prove efficacy as required for
conventional medicines, once traditional use is established, the only
additional criterion for registration should be the need to establish safety.
Unfortunately, in its present form, the THMPD focuses on functionality by
considering only minor, self-limiting ailments, and prevents the use of a large
number of products from traditional systems for the indication stipulated in
their indigenous pharmacopoeia. Furthermore, it would be straightforward to
make the technical guidelines set by the HMPC more effective in ensuring the
quality and safety of products, while also being less technically challenging
and costly. It is important to recognise that an enriched extract of an herb of
European origin is likely to meet the quality standards set by the THMPD
considerably more easily than a product made according to the traditional
method given in the relevant Chinese or Indian pharmacopoeia. This gives rise
to the paradox that a product containing a high concentration of a particular,
pharmacologically active constituent, such as a particular alkaloid or
glycoside, will more easily obtain registration under the THMPD than a product
made using a watery decoction of multiple herbs. Ironically, in such cases,
there is a high likelihood that the European product would present a
considerably greater potential public health risk than the Asian product.
QUESTION 8. Given the frequency of major adverse
events among members of the public following the use of herbal products, surely
product registration under the THMPD is vital to safeguard public health?
ANSWER: There has been an
extremely low rate of significant adverse reactions caused by products
associated with traditional systems of Asian medicine that are sold to the
consumer as food supplements. This adverse event rate is far lower than that associated
with conventional foods, implying that such herbal products are, on average,
substantially safer to consumers than conventional foods. There have been a
very small number of well-publicised cases in which practitioners, including
medical doctors, have prescribed herbal products alongside pharmaceutical
drugs, and adverse events have been reported. However, in such cases, there is
uncertainty over the actual role played by the herbal products as against the
pharmaceutical drugs and their respective interactions. While specific and
rather isolated quality problems have been identified with respect to the
manufacture of particular herbal products, the worst of these tend to have been
associated with products legally sold as unlicensed medicines under specific
exemptions in the UK. Such malpractice in the area of unlicensed medicines
manufacture should not be allowed to further constrain registration
requirements for herbal medicinal products or products sold as food
supplements. The former requires pre-market establishment of safety, the latter
places the burden of safety on the manufacturer or supplier with no need to
have safety validated by a national authority prior to a product being put on
the market.
QUESTION 9: Why are companies reluctant to pay for the
quality control requirements of the THMPD, when they are essential to ensure
product quality and consumer safety?
ANSWER: The quality control
requirements for the THMPD are far from the only obstacles to registration (see
answer to Question 1). In many cases, there are other constraints to
registration, such as the inability to meet the requirements for traditional
use, which require bibliographical or expert evidence to verify 30 years' safe
use, at least 15 of which are within the EU. Guidelines imposed on registrants
for the THMPD include the provision of 6 months of stability data, based on
specific marker compounds known to occur within specific herbal ingredients. In
the case of polyherbal products, especially where there are seven, eight or more
herbs represented within the formulation, finding suitable markers can be both
extremely difficult and very expensive (see answer to Question 1 above). There
are other quality control methods, such as those involving the use of
high-performance thin-layer chromatography (HPTLC), that can be used to
qualitatively evaluate the ‘fingerprint’ associated with complex polyherbal
mixtures. Once standards have been established, such methods would not only be
considerably more cost effective than existing methods, they would also
guarantee a higher level of quality.
QUESTION 10. How do the presently disparate approaches
to the regulation of herbal products in EU Member States fit with EU principles
that aim to govern the free movement of goods within the single market of the
EU, while adequately protecting consumers and upholding free choice and human
rights?
ANSWER: It is clear that the situation is disproportionate with respect to the disparate approaches being taken by different EU Member States to the regulation of herbal products associated with non-European healthcare traditions. The current approach will lead to barriers to trade of herbal products that have, until now, been sold safely as food supplements (see answers to Questions 2 through to 5 above). The loss of particular products from the market will dramatically reduce consumer choice. This loss is caused simply because an unsuitable regulatory regime has been created in the form of the THMPD, which excludes both products prescribed by practitioners and a vast array of products from non-European traditions. It thereby infringes human rights, given that these products are central to the holistic healthcare systems with which they are associated. The data requirements for the Directive were subject to a lack of transparency, and this was particularly acute in terms of the quality control requirements, which were not forthcoming until several years after the passage of the Directive into European law. Accordingly, ANH-Intl and the European Benefyt Foundation have seen fit to prepare a case for judicial review of the Directive and its associated impact on herbal products in the EU. The primary aim of such a judicial review is to focus attention on those aspects of medicine and food laws that should be amended, or interpreted differently, to prevent unnecessary distortions of the European market. The legal challenge also aims to ensure that consumer choice and fundamental freedoms are not unjustifiably curtailed.
QUESTION 11. If the THMPD is intended for herbal
products without supervision of a medical practitioner, is there another system
of regulation for traditional medicines that are prescribed by practitioners?
ANSWER: The THMPD was always
intended as a regulatory regime for industrially manufactured products that are
intended for use by consumers for treatment of minor, self-limiting ailments
without the intervention of a healthcare professional. Such products are
sometimes referred to as self-care products. The reality is that a lot of
traditional medicines are designed to be prescribed by a practitioner, this
particularly being the case with Chinese and Indian traditional medicines. At
present there is no adequate regulatory regime for such products, the only
exemption being for “authorised health care professionals” who are able to make
and prescribe unlicensed medicines under the main European medicines code
(Directive 2001/83/EC, Article 5.1). But across the EU, these “authorised
health care professionals” are regarded by national competent authorities as
only doctors and pharmacists. In both cases, these people may have little or no
training in the complexities of herbal medicine or their production. They may
even be unaware of the traditional methods of production for which traditional
indications are made and for which they claim. In the UK, efforts led by the European
Herbal & Traditional Medicine Practitioners Association, are being made to statutorily regulate herbal medicine practitioners.
Statutory regulation in the UK aims to continue to allow registered herbalists,
who are non-medical doctors, to prescribe unlicensed herbal medicines, as per a
long-standing exemption that has uniquely existed under UK medicines law.
Enthusiasm for a similar system in continental Europe is simply not there. But
there is widespread recognition that the THMPD isn’t suitable for Ayurvedic,
TCM and other holistic systems of medicine, even on the part of the European Commission.
The Commission went on to indicate in its experience report of 2008 that it could
evaluate the suitability of a new system. On this basis, the European
Benefyt Foundation (EBF) initiated
work around two years ago to help develop a new framework that would be
specifically applicable to practitioner prescription of traditional medicines.
You can find out more about this initiative in ANH-Intl and EBF’s joint position paper. The problem with any system of new regulation is that it takes time to
develop and this could be years off. The first step is to ensure there is
enough desire from the European Parliament to get the European Commission to
initiate a proposal. That work is already well under way (see answer to
Question 2).
