By Adam Smith,

Science & Communications Officer, ANH-Intl

KEY POINTS

1. Natural healthcare in the EU is threatened by regulation of herbal medicines, maximum permitted levels (MPLs) of vitamins and minerals, definition of ‘novel foods’ and health claims
2. Judicial review of the Traditional Herbal Medicinal Products Directive (THMPD) appears the only hope for real change in the Directive
3. MEPs can veto MPLs during its one-month window of European Parliamentary scrutiny (‘comitology’)
4. The Nutrition and Health Claims Regulation must be amended to safeguard freedom of speech about healthy foods, including acceptance of realistic scientific evidence by the European Food Safety Authority (EFSA)
5. Cases of kidney damage attributed to the Chinese herb Aristolochia fangchi were wrongly used to justify the THMPD regime
6. EU citizens can now urge their MEPs to take concrete, positive action on behalf of natural healthcare in Europe

Citizens of the European Union (EU) have been voicing their concerns, frustration and anger over the current unprecedented regulatory threats to natural healthcare for some months now.  A broad coalition of Members of the European Parliament (MEPs) is necessary if a more appropriate regulatory framework is to be adopted.  Wednesday 2 March saw a significant step being taken along this road when, at the invitation of Marian Harkin MEP, ANH-Intl and the European Benefyt Foundation (EBF) led a briefing session for MEPs on the various aspects of the regulatory threat.

We urge you to read this entire article, as Dr Robert Verkerk of ANH-Intl captured the key issues that need immediate democratic action and Chris Dhaenens of EBF gave an explosive presentation on the Chinese herb Aristolochia, and its relations to the origins of our current regulatory troubles.

Democracy in action!

You can now ask your MEPs to do something concrete that will help the cause of natural healthcare in Europe!  The MEPs and their assistants who attended the meeting represent a growing group of European Parliamentarians who are keen to do what they can to help bring about a regulatory regime for natural health that is workable and proportionate – and that doesn’t strangle the very sector it is set to regulate.  The group effectively represents a ‘natural healthcare action group’ committed to implementing certain action points, in collaboration with ANH-Intl/EBF.  As you will see, each set of action points is specific to a strand of regulation that affects natural healthcare.  So, not only can you ask your MEPs to sign up to the action group, you can also find out whether they intend to work proactively in favour of natural healthcare.

If you don’t know who your MEP for each relevant political group here. 

MEPs troubled by implications of regulation

Signs have been apparent for a while that the wider issue of threats to natural healthcare, and by extension, to the rights of self-determination of EU citizens by caring for their own health as they choose, is rising steadily higher on the agendas of MEPs.  At the end of last year, pressure from worried EU citizens led directly to a unique meeting between industry stakeholders and MEPs.  That ANH-Intl and EBF are now being invited to educate MEPs on the intricacies of the regulatory threat is a powerful indicator of widespread concern among EU legislators.

Two identical briefing sessions were held in order to accommodate as many MEPs as possible, bearing in mind their busy schedules.  Turnout was good, with more than 30 MEPs coming personally or being represented at the briefings, representing a broad cross-section of different Member States.  It is wonderful to know that the word is spreading so far and so fast, and we sincerely thank all attendees for their time and commitment.

Dr Verkerk: the lowdown on EU regulation of natural healthcare

After an introduction from Marian Harkin MEP, Dr Rob Verkerk, ANH-Intl Executive & Scientific Director, gave a presentation that crystallised, in 20 minutes, the implications for natural healthcare of various strands of EU law.

Dr Verkerk began by putting ANH-Intl into context for the audience.  “We want to ensure that you recognise [ANH-Intl] as…one of the key sources EU-wide for information in this sector”, he said.  “We have no vested interests: we are a passionate group of professional people – scientists, doctors, lawyers and others – who are working together to ensure a fair and proportionate regulatory framework to ensure people can manage their health naturally.”

The biggest threats to natural healthcare are found in five pieces of legislation:

1. The Food Supplements Directive (Directive 2002/46/EC), which will set maximum permitted levels of vitamins and minerals
2. The Traditional Herbal Medicinal Products Directive (THMPD; Directive 2004/24/EC)
3. The Novel Food Regulation (258/97), under which foods classified as ‘novel’ may be banned and which particularly threatens botanical ingredients in food supplements
4. The Nutrition & Health Claims Regulation (1924/2006), which defines what claims manufacturers will be allowed to make about their products

Dr Verkerk presenting at the European Parliament

These threats realise in a concrete manner the perspective of a prior Commissioner of DG SANCO, Mr Markos Kyprianou, who stated in 2007 that “Food supplements are regulated as food and are intended for supplementing the normal diet rather than having therapeutic effects…claims as to treatment, cure or prevention of disease…would place the product under the legal framework of medicines.”

Most affected by these various strands of legislation will be the consumer, stressed Dr Verkerk: “There are 500 million people in Europe, and most surveys say that as many as 25% of the population use these sorts of products regularly.  That is why there is such interest in it!”

Gradualism and the Imminent menace to herbal medicine

Under a process of ‘gradualism’, these regulations are being brought in over time, in order that their full, devastating effects are not immediately apparent.  A pertinent example of this creeping threat can be seen with the THMPD, which has been operating in a 7-year ‘transitional’ phase since 2004 and which comes into full force on 1 May 2011.  From this date, any manufactured herbal products destined for self-care of minor conditions will become illegal if they are not registered under the THMPD scheme.  Because the legislation has been on the statute books for some considerable time, relatively few people are aware of its implications and the regulators are able to brush off criticism by saying “Well, you’ve had 7 years to prepare for the THMPD, so what’s the problem?”

Never mind that thousands of herbal products are set to become illegal, and that entire herbal medicinal traditions are threatened with extinction in the EU.  Not a single authentic herbal product associated with traditional Chinese medicine (TCM) or Ayurveda, from the Indian sub-continent – nor, indeed, from any tradition originating outside the EU – has yet been registered under the THMPD scheme.  In addition, explained Dr Verkerk, “All of the products that have so far been registered – and only about 40 botanical species out of the more than 1500 that are regularly used medicinally have got through the door – are alcoholic extracts put into a pharmaceutical base that includes synthetic polymers, synthetic preservatives or, in some cases, artificial sweeteners.  For many people, they are not the sort of traditional herbal products they were expecting to be registered.  The real problem is that the products they were expecting to be registered are likely to ‘fall between the two stools’ [of food and medicines regulation], and will be banned.”

Dr Verkerk pointed out that the ANH-Intl/EBF ‘three-pronged strategy’ offers the best hope for a rational and fair system of regulation for herbal medicine in the EU.  Under this system, the food-supplement regime would be kept as inclusive as possible for herbal medicines, along with an EU-wide regulatory system that would replace and expand upon the THMPD by also regulating herbal products prescribed by practitioners.  The third prong will be the judicial review of the THMPD being brought by ANH-Intl/EBF, funding for the first stage of which is now in the bag.  “All other forms of negotiation, debate and appeal to the Commission and Member States have been given very little latitude, so we feel that there is no option but to go to court,” explained Dr Verkerk.

Dr Verkerk urged MEPs to maintain the pressure around the THMPD by raising further questions in the European Parliament and pushing for its amendment, while monitoring progress of the judicial review and making the first steps toward adoption of an EU-wide practitioner framework.  Providing accurate information to consumers would also be key, he said.

Minimal maximum levels and hopeless health claims

Of course, threats to herbal medicine are only one side of the EU regulatory coin.  Rational maximum permitted levels (MPLs) of vitamins and minerals in food supplements look unlikely under the terms of the EU’s Food Supplements Directive (2002/46/EC), given the shortcomings of the science underpinning the relevant assessments by the European Food Safety Authority (EFSA).  “It could be that the levels are set so low that we are not likely to see products out there with dosages that are likely to be beneficial for health management purposes”, said Dr Verkerk.  He drew the audience’s attention to his two papers on the subject, published in the respected, international academic journal Toxicology, which clearly demonstrate the faulty basis upon which MPLs are being calculated: “The proposed MPLs clearly fall into the range of deficiency”, he concluded.

Importantly, MEPs have the power to veto these MPLs if they are as inadequate upon release as seems likely.  In this regard, scrutiny of the so-called ‘comitology’ process will be vital, and Dr Verkerk urged the MEPs present to be on their guard.

EFSA has also been hard at work refusing the vast majority of health claims for natural products under the terms of Nutrition and Health Claims Regulation (No.  1924/2006), said Dr Verkerk.  He observed that “Napoleonic law will be used to effectively remove, from any commercial environment, any claim unless it has been approved by EFSA,” thereby hugely restricting freedom of speech and the ability of companies to accurately describe their products.  The main problem, according to Dr Verkerk, is that “The scientific criteria have been set so high.  They require clinical trials in healthy people, and in many cases, those data are not available…Consumers again lose out.”  Cruelly, EFSA’s requirement that clinical studies in support of health claims be performed in healthy subjects was added after many companies had spent thousands of pounds developing dossiers of evidence!  Claims for antioxidant properties of berries and for the beneficial effects of glucosamine on joint health have been two of the higher-profile victims. 

But even that is not the whole story.  “It is of great concern to us that so many health claims are being dismissed because of the scientific substantiation”, said Dr Verkerk.  “But at the same time, it’s interesting that the very same body that’s doing the evaluations, EFSA, is ‘green-lighting’ or approving so many products that have been genetically modified.  We say it’s not a level playing field scientifically.”

The key message for MEPs here was that the NHCR must be amended to ensure freedom of speech, and that “plausible and qualified” scientific evidence must be accepted by EFSA in its deliberations, rather than its present reliance on causal relationships.

Chris Dhaenens: the truth about Aristolochia

Chris Dhaenens of the EBF then spoke on the technical aspects of the THMPD.  He detailed for MEPs many of the ways in which the Directive is unsuitable for its purpose of regulating all forms of herbal medicine, regardless of tradition.  With no products designed for use in Ayurveda or traditional Chinese medicine (TCM) yet registered under the scheme, something has clearly gone terribly wrong.

Chris Dhaenens presenting at the European Parliament

The key part of Mr Dhaenens’ presentation concerned the Chinese herb Aristolochia fangchi and the origins of the current regulatory problems.  Many readers will be familiar with the story: back in 1990 in Brussels, Belgium, the very seat of the EU, 135 of around 15,000 people given a preparation containing Aristolochia as a slimming aid suffered irreversible kidney damage.  The problems were attributed solely to Aristolochia, and a new condition was named in honour of the case, so-called “Chinese herb nephropathy” or CHN.  We can see the direct results of the Belgian cases in the threat to herbal medicine posed by the THMPD, which was originally designed to ensure that similar cases did not occur again.

Mr Dhaenens and his colleagues have spent 20 years looking closely into the Aristolochia case.  As trained TCM practitioners and scientists, they were shocked that Aristolochia was implicated for CHN, given that they had prescribed it to thousands of patients in that time without a single episode of kidney failure.  As it turns out, the ‘Aristolochia cases’ are nothing of the sort, and CHN has been entirely mischaracterised.  As time has elapsed and more evidence has emerged over what went on in the clinic, it seems there may have been a cover-up and malicious intent to damage the reputation of herbal medicine and allow the doctors to walk away unscathed.  The story looks more and more like the plot of the latest bestselling thriller!

The dangers of orthodox medical arrogance – not of herbal medicine

Mr Dhaenens told the audience that all 135 cases came from a single clinic in Brussels over a period of 5 months.  Closer inspection revealed that the cocktail in question was prescribed, not by herbal practitioners trained in TCM and use of the Chinese pharmacopoeia, but by orthodox medics entirely unskilled in the herbal tradition with which they were dabbling.  In Belgium and throughout the EU, “authorised health-care professionals” – usually doctors and pharmacists – can prescribe unlicensed medicines, including herbal medicines.  This gives medical doctors the ability to prescribe any herbs they wish, despite often not knowing their radix from their stamen!

The doctors prescribed Aristolochia as a slimming aid, an indication not found in any Chinese pharmacopoeia.  As Mr Dhaenens stated, “The Aristolochia case is the best example we can find that herbs should not be used out of their context.”  Not only that, but the cocktail they prescribed contained several amphetamine-like substances – many of which have since been legally restricted for their danger to human health.  Mr Dhaenens emphasised that Aristolochia can be toxic under normal circumstances, but that this toxicity is both acute and reversible and never leads to irreparable kidney damage.  As an added bonus for their patients, the doctors gave them a big dose of intravenous serotonin.  Given such a potent brew of circumstances – doctors prescribing outside their competence a mixture of substances that included amphetamine-like ingredients, many of which are now banned, along with serotonin – it is quite amazing that the investigators managed to blame the kidney failure entirely on Aristolochia fangchi.

Aristolochia not to blame

But the real bombshell was to follow.  Three court cases have occurred since 1993, the findings of which have never been publicised.  All three judgements in these cases were unequivocal in stating, in Mr Dhaenens’ words, “There is no connection between the pathology of the victims and the herb Aristolochia, and that other scenarios should be investigated.  That’s what we did for 20 years, and now scientific research establishes that…probably ochratoxin is at the root of this problem.”

Regulation built on a fallacy

Think about that for a moment.  The cases of irreversible kidney damage attributed to a single Chinese herb, Aristolochia, had nothing to do with Aristolochia.  Yet these cases were used to justify the regulatory framework represented by the THMPD, a framework that has since been skewed in such a way that it now threatens entire herbal traditions with extinction in the EU as well as EU citizens’ freedom of choice and self-determination.  The skewing is such that the Directive does not even provide a suitable regime for the very traditions it was supposed to regulate!  The root of the Belgian ‘Aristolochia problem’, as it happens, had everything to do with orthodox medical doctors working outside their competence, prescribing herbs in a cavalier manner with no respect for the traditions from which they came. 

This is probably the biggest untold story in herbal medicine – ever!  Please do all you can to spread this news far and wide: to your friends, family, newspapers, TV, whoever will listen. 

Safety of herbal medicines is all very well – but how is it measured?

Another crucial point made by Mr Dhaenens was the methods used by the EU for safety assessment of herbs are inadequate and inappropriate.  They rely on measuring levels of biomarkers, single molecules among the thousands found in every plant that are deemed to hold a special significance as a ‘signature’ of that plant.  If a biomarker representing a certain plant is present in a mixture or compound below a pre-specified ‘safe’ level, EU regulators consider that herb to be present at a safe level. 

However, the herbalists represented by Mr Dhaenens and EBF see biomarkers as a crude and inadequate method of assessing safety.  They are proposing the adoption of methods such as high-performance thin-layer chromatography (HPTLC), which are capable of producing a signature that encompasses the whole chemistry of the plant, rather than focusing on a single-molecular biomarker.  “The bottom line is that we are offering a control system that is more adequate, that is more cost effective, and that is more descriptive of what we are doing; whereas the THMPD imposes a very expensive system that has a lot of loopholes and flaws.”

Mr Dhaenens made clear that the use of single biomarkers opened the way for the production and registration of fraudulent herbal products.  He said such products could just be spiked with a biomarker and not have any proper biological or therapeutic activity, something that requires a very specific profile of chemistries, often derived from the whole plant. 

Finally, Mr Dhaenens criticised the THMPD for its ‘removal’ of the practitioner.  The THMPD is a directive that is specifically intended for products sold off-the-shelf for minor, self-limiting ailments that do not require the supervision of a practitioner.  He emphasised the important contribution made by herbal practitioners, saying “The first safety filter is the advice given by a qualified person.” Mr Dhaenens added, “But this is not considered by THMPD.  This is very sad, because it means that some botanicals will be available over the counter [off the shelf] without any prior advice, while they are restricted within their own tradition.  At the same time, some food ingredients will be unnecessarily and expensively medicalised.”

In its experience report of 2008 [COM(2008) 584 final], the European Commission acknowledged the inadequacy of the THMPD in terms of regulating holistic medical traditions, such as Ayurveda or TCM.  That report has since been ignored, but now that many MEPs are aware of the issues and willing to get involved, we are hopeful that things are about to change.

(From L to R) Back row: Adam Smith (ANH-Intl), Harrie Sandhovel (EBF), Meleni Aldridge (ANH-Intl), Chris Dhaenens (EBF). Front row: Marian Harkin MEP, Dr Robert Verkerk (ANH-Intl)

LINKS

Dr Verkerk's blog about the Aristolochia case and the THMPD

ANH-Intl herb challenge page

ANH-Intl press release on herbs threatened by the THMPD (16 Feb 2011)

ANH-Intl Health Choice campaign page

ANH-Intl Good Science campaign page

ANH-Intl briefing paper on the EU Food Supplements Directive and MPLs

ANH-Intl briefing paper on the EU Nutrition and Health Claims Regulation