Adam Smith

Science and Communications Officer, ANH-Intl

KEY POINTS

1. ANH-Intl worked with Marian Harkin MEP on a list for the European Commission concerning the herbal Directive (text) (pdf)
2. The Commission replied to our questions on 8th September 2011
3. We are running our response to the Commission’s answers in two parts, one published today and Part Two in a few days
4. Part One looks at the way the herbal Directive excludes non-European systems of traditional medicine, regulation of holistic traditions and the Directive’s implications for public safety
5. The Commission’s evasive and incomplete answers represent a democratic travesty, and further confirm that a legal challenge is the only option for change
6. Get involved with our Calls to Action, and help to keep up the pressure on the lawmakers in Brussels!

Before the European Commission (EC) and European Parliament (EP) left for their summer recess in August, ANH-Intl worked with Marian Harkin, Member of the European Parliament (MEP), to produce a parting gift. Down in the bowels of ANH-Intl, under cover of dark and utmost secrecy, a crack team of writers toiled away feverishly for days before finally emerging, shakily, into the light. There, clutched in the bedraggled scribes’ hands, were 23 of the finest written questions for the Commission on the subject of how the EU and Member States were proposing to regulate herbal products within the EU.  Perfectly formed, with phrasing as tight as a drum, clearly referencing the relevant European Union legislation, these were questions leaving little ‘wiggle room’ for the Commission and its officials: spotlights aimed at focusing the Commission and the European Medicines Agency's full attention on the many problems we and others had identified with the legislation.

Now, we thought, we’ll get some useful answers.

You can read the full list of questions here and the ones dealt with in Part 1 of this feature at the foot of this page. The answers from the EC are reproduced here.  As you can see, Commissioner John Dalli answered most of the questions at once on 8th September 2011, instead of presenting each question and its answer separately. For purposes of easy understanding, we would have preferred to provide a document in that format, but unfortunately many paragraphs in the EC’s long answer apply to more than one question. What follows, therefore, is a general commentary on the EC’s replies as they pertain to various aspects of the THMPD, but we have numbered each question on the consolidated list and cross-referenced them with the Commission’s answers.

It’s always worth remembering when you read the following, dear reader, that the Commission isn’t replying to an impertinent non-governmental organisation, such as ANH-Intl: it’s replying to the elected representatives of the people of Europe. The implications for openness, transparency and democracy are there for all to see, and they are not good.

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Non-European traditional medical systems left out in the cold

Questions 1–4 concerned various aspects of the THMPD’s failings as regards non-European, specifically Asian, systems of medicine, such as Indian Ayurveda or traditional Chinese medicine. As of today, 14th September 2011, a grand total of zero registrations has been granted under the THMPD for products exclusively associated with these medical systems. Since the Human Medicinal Products Directive (HMPD; 2001/83/EC) effectively defines these products as medicinal by function, we wondered in Question 1 whether TCM and Ayurvedic products have actually been illegal, unlicensed medicines for a long time?

This is where we got the first taste of what was in store from the EC’s answers: “Patients should have access to the medicinal products of their choice...herbal medicinal products that are not registered or authorised...may not be placed in the EU market”. Elsewhere, the Commission referred to a recent report from the European Medicines Agency, pointing out that, “The percentage of applications rejected is very limited and in several Member States no applications have been rejected”. Nothing about the lack of registrations, the HMPD’s overly wide definition of a medicine or whether TCM and Ayurveda products have been illegal for years. Nothing, in fact, that addressed either the letter or the spirit of our question!

Question 2 queried the apparent advantage given to herbal products from the German phytopharmaceutical ‘tradition’ under the THMPD. Here, the Commission pointed out that, “Manufacturing and quality requirements...are not specific for herbal medicinal products, and in fact apply to all medicinal products” and that a public consultation was performed on the terms of the proposed THMPD before it became law. This answer is actually highly revealing, since it appears to be an admission that the THMPD’s technical requirements were written without any kind of realisation that herbal medicines are not the same as other medicinal products, i.e. purified, synthetic pharmaceuticals.  Surely, that means the THMPD was fundamentally flawed from the start – and confirms many of the points we have been making about the herbal Directive for some time.

Interestingly, the Commission’s answer to Question 3 revealed that THMPD applications may be made in the absence of approved EU monographs on the herbal ingredient(s), “Provided that the criteria set by [the THMPD] are fulfilled for this product”.

As to the issue of herbal medicines “falling between two stools” of regulation, when they are unable to access the THMPD and are neither covered by food/food supplement or novel food legislation, the Commission’s reply to Question 4 simply pointed applicants toward full marketing authorisation.  This is an absolute impossibility for anyone but the largest corporations, requiring multiple clinical trials in humans and millions of pounds in funding. The Commission may as well have answered, “Like it or lump it!”

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Regulation for practitioners and holistic traditions

In Questions 5–7, we tried to prise some information from the EC on their intention to develop specific legislation for practitioners of holistic traditions, and for those traditions themselves. The latter requirement was clearly noted in the Commission’s own experience report of 2008, COM(2008)0584. Once again, however, we got short shrift!

First of all, in its answer to Question 5, the Commission washed its hand of any responsibility for, “A regulatory regime for non-medically qualified practitioners of long-standing traditions of medicine”, passing it squarely on to the Member States. Thanks to the THMPD, this is a recipe for chaos as it relates to herbalists, as regulation of herbal products is undertaken at an EU level, while regulation of practitioners who might use those products is devolved to Member States. At present, only the UK appears to be planning on recognising herbalism as a state-approved profession, thereby hopefully allowing them to prescribe unlicensed herbal medicines. Elsewhere, it looks like THMPD-approved products or nothing.

As for the EC’s experience report, the answer to Question 6 agreed that EU legislation, “Follows a product-specific approach and does not provide a framework for the regulation of traditions of medical practice”. Furthermore, “The Commission does not envisage extending the scope of the [THMPD] to cover traditional medical systems as such.” Apart from wondering what the EC means by “as such”, we are struck by the doublespeak here: the experience report’s final words were, “Nevertheless, independently of this report, the suitability of a separate legal framework for products of certain traditions should be assessed” – but the Commission completely avoided any mention of a separate framework, which was the clear subject of our question.

We wonder whether the Commission understands the concepts that underpin Question 7, as they failed to address it anywhere in their answer. Maybe next time – but our breath remains resolutely unheld.

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Quality control and public safety

Questions 8–14 took on various aspects of the THMPD’s quality-control requirements and its effects on public safety. 

Perhaps most interesting is the Commission’s response to Question 14, since this concerned the notorious ‘aristolochia case’ that goes to the very heart of the THMPD. Indeed, without the impetus provided by this case, the THMPD may never have existed. In its answer, the EC declined to educate us on how consumers are protected by a Directive that has, so far, registered no Chinese herbal medicines at all, despite its supposed aim of protecting a repeat of the ‘aristolochia case’. It preferred to split hairs over the provisions of Article 5(1) of the HMPD, when the results – that medical doctors prescribe unlicensed medicines – can be in no doubt. The EC’s answer also told us plenty we already knew about several strands of legislation affecting herbal products in the EU!

Apparently, it’s OK that manufacturers of herbal products wishing to apply for a THMPD license weren’t given full guidance by the European Medicines Agency (EMA) until well into the 7-year transition phase built into the legislation. The result of this delay meant that companies had far less than 7 years to prepare for the THMPD era, which the EC justifies in its answer to Question 8 by saying that, “Development and publication of guidelines before adoption of legislation would pre-empt the results of the legislative procedure”. What the EC fails to mention is that EMA guidance was premature when the 7-year clock of the Directive's transitional phase began ticking and was significantly revised 3 or 4 years into it.  

We have serious concerns over the implications of the EC’s answer to Question 9, concerning bioequivalence – the degree of similarity between herbal products in terms of their chemical composition and their effects on human biochemistry. Many THMPD-approved products are extracted from their herbal ingredients using substances such as acetone or alcohol, whereas the herbs have traditionally been used in the form of watery decoctions, such as teas. The two extraction methods result in chemically distinct products, or at least very different ratios of plant chemicals, yet the THMPD-approved products carry indications for use in the same medical conditions as the traditional watery decoctions. Effectively, the THMPD products are claiming to treat conditions for which there is no or little evidence – that is, traditional use – for their effectiveness.

The EC seems a bit confused over this issue. On the one hand, “The concept of a ‘corresponding [i.e. bioequivalent] product’...does not allow to consider that equal aqueous extracts and hydroethanolic extracts are equals [sic]”. Fair enough. However, “It has to be shown that each product with its specific active substance and a specified quality, strength and posology has been safely used in this indication” – which assumes that the entirety of the medicinal properties of an herbal product can be isolated in a single active substance! Once more, the EC is demonstrating both its ignorance of how herbal medicine actually works and its dogmatic acceptance of the pharmaceutical worldview.

The Commission’s response to Question 10 shed no light on why manufacturers of herbal products associated with Asian medical traditions were not consulted on the quality-control guidelines for complex, polyherbal products. Also addressing Questions 11 and 12, the answer revealed that full-spectrum analytical methods – so-called ‘fingerprinting’ of herbs – are already employed for quality and stability testing of herbal products. Interestingly, “Applicants may replace conventional methods with own validated methods if justification/data are provided to demonstrate identity, purity and content”.  But they fail to tell us that you'd get little change out of 1 million euros if you wanted to develop and validate a new method.  Worse than that, you'd take a huge risk and might have it rejected in any event.  That's a risk far too great for any small business.

The EC also wondered about the suitability of newer analytical methods that, “May involve more recent, expensive equipment...an advantage over conventional chromatographic methods, especially for small manufacturers, might be questionable”. Good of it to concern itself over the cost burden to smaller companies, if rather inconsistent with its own approach (see below). It also ignores the fact that the analytical methods preferred by ANH-Intl and the European Benefyt Foundation are not only more suitable for characterising herbal medicines than the approach currently favoured by the THMPD – they are also considerably less expensive. Finally on the topic of polyherbal products, the EC pointed out that, “If it is not possible to determine the stability of each active substance, the stability of the medicinal product should be determined by appropriate fingerprint chromatograms, appropriate overall methods of assay and physical and sensory tests or other appropriate tests.”

The Commission disagreed that the quality and stability testing requirements of the THMPD open the possibility for unscrupulous manufacturers to ‘top up’ with biomarkers, thereby making inactive or unstable products appear active and stable. “As regards addition of biomarkers...since the herbal substance or herbal preparation in its entirety is regarded as the active substance, a mere determination of the stability of the constituents with known therapeutic activity will not be sufficient.”

Unless the EC’s comments on the application of manufacturing and quality requirements to all medicinal products, noted above, can be taken as its answer, it had nothing to say on the presence in ‘traditional’ herbal medicines of artificial polymers, preservatives, colours and flavours that was the topic of Question 13.

As you can see, the EC is simply not answering the questions put before it, or at best offering incomplete responses that display no willingness to compromise or be flexible in any way. After its dismissive response to our open letter to Commissioner Dalli, we aren’t entirely surprised – but consistency is no virtue in this case! Be sure to tune in for Part Two in a few days, when we’ll look at the Commission’s attitude to the crucial issue of herbs as medicines, among others.

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Call to action

• Help us to keep the pressure on the European Commission by thinking of some more questions to ask them! Send your ideas to [email protected]
• We always need your donations of money, time, experience, ideas, food, chocolate, jokes and energy – so please keep them coming!
• Spread the word about the threats to herbal products and medicines in the EU as a result of the THMPD and related laws, and about our campaign – we need as many people as possible on board!

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The questions

1.     Commissioner Dalli stated in a letter to Giles Chichester MEP on 13 April 2011 that ‘herbal products falling under the definition of a medicinal product have to be authorised in accordance with the above mentioned rules (full marketing authorisation under Directive 2001/83/EC) until the adoption of Directive 2004/24/EC’. Given that no TCM or Ayurvedic products have yet to be registered under the traditional use registration scheme and that most are medicinal by function (Article 1.2(b), amending Directive 2004/27/EC), does this mean that such products may have been illegal in the EU prior to full implementation of Directive 2004/24/EC on 1 May 2011, and are most certainly illegal after this date?

2.    When considering the 359 registrations granted EU-wide by the end of December 2010, the majority are for products which do not contain any whole-plant material and are based on alcohol- or acetone-extracted European single herbs, coming from the relatively recent (20th century) Germanic phytopharmaceutical tradition.

Prior to 2004, many of the German products had already received national medicinal licences without undergoing the same quality-control systems as required for registration under Directive 2004/24/EC. It appears that the Traditional Herbal Medicines Products Directive (THMPD) was built around these German products, so they were THMPD-ready when the Directive was enacted. How can this be proportionate, from the perspective of Asian traditional medicines, when the latter undergo such different preparation and manufacturing methods that were not taken into account when the Directive’s eligibility and technical criteria were developed?

3.    Why has the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) reviewed so few herbal species associated with Chinese, Tibetan, Ayurvedic, Amazonian, African or other very long-established, non-European, healthcare traditions?

4.     In some Member States, more and more products containing herbal ingredients that have in the past been sold as botanical food supplements are being deemed to be either unregistered medicinal products or unauthorised novel foods. This trend is primarily caused by competent authorities for medicines applying more scrutiny to botanical products, now that Directive 2004/24/EC is fully implemented.

Where these products are based on long-standing, non-European traditions, they are generally incapable of accessing the THMPD registration system owing to eligibility, technical or cost challenges. Being unable to be sold any longer as food supplements, and effectively being ‘locked out’ of the THMPD regime, means they fall between regulatory regimes.

Does the Commission agree that such products are now illegal, and will it take steps to address this ‘falling between two stools’ problem?

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5.    Can the Commission envisage the establishment of a regulatory regime appropriate for non-medically qualified practitioners of holistic, long-standing traditions of medicine, who prescribe authentic traditional products?

If so, when?

6.     The Commission states in its experience report of 2008 (COM(2008)0584) that the registration procedure under Directive 2004/24/EC is ‘not appropriate’ for holistic traditions, such as those associated with Ayurveda and TCM, and that it might consider assessing the ‘suitability of a separate legal framework for products of certain traditions.’ Is the Commission prepared to progress its assessment of feasibility of such a framework?

7.     Many multi-herbal, authentic traditional products from long-standing, non-European systems of medicine deal with multiple systems in the body. To date, the indications that have been accepted in those products that have been granted registration are generally limited to symptomatic relief of a single, minor condition.

Will the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) accept authentic claims that involve multiple systems in the body, such as liver, lungs and spleen?

Also, will claims be allowed that relate to metaphysical concepts that are fundamental to these traditions, such as ‘chi’ energy in traditional Chinese medicine or the three ‘doshas’ of Ayurveda?

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8.     Directive 2004/24/EC was intended to contain a full 7-year transition phase to allow sufficient time for companies to register products.

Why was the EMA’s guidance on quality control requirements not prepared in advance of this transition period, rather than being altered during the course of it?

9.     Consumer safety is cited as one of the major justifications for Directive 2002/24/EC. Many of the herbal products successfully gaining registrations are based on enriched extracts, produced by modern, non-traditional systems of extraction (e.g. alcohol, acetone, hydro-alcoholic, supercritical); however, the products themselves carry indications (medicinal claims) based on traditional preparations that are biochemically distinct or ‘non-bioequivalent’, such as watery decoctions.

How can such a high degree of non-bioequivalence between herbal products and therapeutic indications guarantee public safety?

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10.     In a letter of 13 April 2004 to Giles Chichester MEP, Commissioner Dalli states: ‘….the simplified procedure does not reduce access to Chinese or Indian ayurveda medicinal products or of products of companies with reduced financial capacity…’ The fact that so many traditional herbal medicines are comprised of decoctions of whole-plant material often derived from multiple herbal species – often more than 8 and sometimes more than 20 – creates a severe technical hurdle with regard to the EMA quality control guidelines. This is evidenced by the lack of applications from manufacturers of Chinese and Indian traditional medicines. Based on the EMA’s figures up to December 2010, only 5% of the registrations granted involved products containing 5 or more herbal ingredients, and only 1% included products with more than 10 herbal ingredients. None of these were traditional Asian herbal medicines.

Why has the Commission and the EMA not consulted with key manufacturers in the TCM, Tibetan and Ayurvedic sectors, all of which have long expressed grave concerns over the lack of suitability of the quality control procedures for complex polyherbal products based on traditional manufacturing methods?

Also, why are so few of the herbs associated with these Asian systems of medicine subject to HMPC (Committee on Herbal Medicinal Products) monographs?

11.     One of the primary ways in which Directive 2004/24/EC is intended to ensure that safe herbal medicinal products are placed on the market is by requiring pre-market authorisation of products that have undergone appropriate quality control testing. Among the most important tests are those that determine stability over a period of several months via an identified biomarker.

How does the EMA ensure that sub-standard products have not been ‘topped up’ with, or adulterated by, the addition of a biomarker following the extraction phase?

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12.    The European Medicines Agency (EMA) guidelines on quality control continues to focus on tests that require identification of single biomarkers related to active constituents of individual herbs. This is in contrast with newer, more comprehensive analytical methods that characterise (‘fingerprint’) the full spectrum of chemical constituents, methods which are far more appropriate for polyherbal products based on comminuted herbs or watery decoctions that are associated with many of the major, non-European traditions.

Why is the EMA so slow to recognise these full-spectrum analytical methods?

13.     Many consumers have assumed that the ‘Traditional Herbal Medicinal Products Directive’ 2004/24/EC, as that title implies, provides a regulatory regime for products from the longest-standing traditions in herbal medicine, especially those associated with the great Asian traditions of Chinese and Ayurvedic medicine.

Does the fact that a great many of the products registered to date contain synthetic polymers, synthetic preservatives and, in some cases, artificial colours and flavours, not suggest there is a problem with the eligibility requirements, given that such products cannot properly be regarded as ‘traditional’?

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14.     It is clear from the legislative history of Directive 2004/24/EC that a major stimulus for the Directive’s development came from the poisonings associated with a Brussels-based slimming clinic, operated by medical doctors, in 1990. Of the 135 patients who contracted moderate- to late-stage kidney disease, which predisposed them to urothelial cancer, all were prescribed slimming pills including both synthetic drugs and herbal products within a three-month period. The case is widely considered the worst known case of herbal poisoning and has been attributed to aristolochic acids derived from a Chinese herb, aristolochia fangchi. However, three court cases brought by victims who consumed the slimming pills have failed to establish causation by aristolochic acids. Nonetheless, the Directive was presented as a means to ensure consumers were protected from unsafe herbal medicines, with the aim of ensuring that such an event would not be repeated.

Given that not a single Chinese herbal product has yet been registered under the Directive, how are consumers being adequately protected? And is it not the case that medical doctors are exempted anyway under Article 5(1) of Directive 2001/83/EC and so are allowed to prescribe unregistered medicines, meaning there is still no additional safeguard protecting consumers from a repeat of the 1990 event?

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