Strong support for ANH-Intl/EBF legal action from European herbal interests
Science & Communications Officer, ANH-Intl
The ANH-Intl/EBF judicial review of the THMPD is backed by a broad cross-section of European herbal interests, many of whom have agreed to provide evidence
Judicial review has become necessary largely because of flaws in the Directive's text and implementation, plus failure of diplomacy and lobbying
Disproportionality, transparency and discrimination represent legal grounds for the judicial review
Judicial review seeks to reform, not overturn, the THMPD, with the ultimate goal of a regulatory system inclusive of all traditions and practitioner-prescribed products
A superb legal team will fight the judicial review, giving it every chance of success
On Wednesday 23 March 2011, representatives of herbal medicine drawn from across the European Union (EU) expressed broad support for proposed legal action aimed at reforming the Traditional Herbal Medicinal Products Directive (THMPD), at a meeting convened in Brussels, Belgium by the Alliance for Natural Health International (ANH-Intl) and the European Benefyt Foundation (EBF). ANH-Intl/EBF received many offers to provide evidence for the legal case, underlining the industry's depth of concern at the implications of the legislation.
The clock is ticking
34 days from now, on Sunday 1 May 2011, the THMPD will be fully implemented in all EU Member States. This is a day that many manufacturers and retailers of herbal products, as well as herbal medicine practitioners and consumers, have been dreading. As we have written extensively in the past, many hundreds of herbal remedies, currently sold off-the-shelf for relief of minor, self-limiting ailments, will become illegal from this date unless registered under the THMPD scheme.
The 23 March meeting answered three main questions posed by the attendees, who represented manufacturers, retailers, distributors and practitioners of herbal medicines from many EU Member States. Why is a judicial review of the THMPD necessary? What will such legal action involve? And what are the chances of success?
Why go for a judicial review?
Dr Robert Verkerk, ANH-Intl Executive & Scientific Director, explained that the ANH-Intl/EBF decision to pursue judicial review of the THMPD is a response to various challenges posed by the Directive to herbal medicines in the EU. “The essential problem we’re dealing with,” explained Dr Verkerk, “is products that ‘fall between two stools’ of European medicinal law and European novel food law, and Member State national laws on food and food supplements.” From 1 May 2011, herbal products that fall between these two stools – that is, which are excluded from the THMPD or novel foods regulations, and which are no longer considered food supplements by Member States – will be considered unlicensed medicines, and will become illegal.
A distinctly defective Directive
The ultimate irony of bringing a judicial review against the THMPD is that the Directive may not have been necessary in the first place; at least, not for the reasons given by the EU for its justification. Chris Dhaenens of EBF enthralled and appalled the attendees in equal measure with the story of how the 'aristolochia case' – when 135 Belgian patients treated with a mixture containing the the Chinese herb Aristolochia fangchi suffered irreversible kidney damage – has been wrongly used as the moral basis for the regulation now threatening herbal medicines in the EU. You can read the full shocking story here.
Dr Robert Verkerk, Alliance for Natural Health International
Dr Verkerk went on to describe the five main reasons for initiating a judicial review of the THMPD.
1. The THMPD does not fulfil its original purpose
“If you look at the legislative history, it was apparent that this was intended to be a regulatory framework that would deal with all the major traditions,” explained Dr Verkerk. “Now, we have evidence that it locks some of the biggest ones out.”
Not a single product from any non-European herbal tradition has yet been registered under the THMPD scheme, while only a paltry proportion of the herbal species used by all herbal traditions has been registered. There is clearly something drastically wrong with a licensing regime that threatens to all but wipe out great traditions such as Ayurveda and traditional Chinese medicine (TCM) in the EU.
Unfortunately, as well as excluding the great non-EU herbal traditions, the herbal products being registered under the THMPD regime are not representative of what most herbalists would recognise as ‘herbal’ products, said Dr Verkerk. “If you study carefully the types of herbs that are being registered, you see…that they are nearly all European herbs…most of them are single-herb products…they are nearly all alcoholic or acetone extracts that are then stabilised in a pharmaceutical base, usually consisting of synthetic polymers and synthetic preservatives, in order to meet the key criterion that is supposed to have something to do with safety; which is stability.”
This presents a “big, big problem”, continued Dr Verkerk, because the polyherbal products associated with traditions like Ayurveda or TCM act more like foods than highly purified and stable synthetic drugs. He drew a comparison between herbal medicines and broccoli: “You try and get stability on the broccoli you had for dinner: it changes from the time it was harvested, to the time it comes home, to the time it sits for 4 days in the fridge, and it changes massively when you subject it to steam or heat. We are used to having unstable products with highly complex compositions. [THMPD stability requirements] are unworkable for really natural herbal products.” The result is that more natural forms of herbal medicines are excluded from the THMPD regime.
2. Diplomacy and lobbying have run their course
“There’s no point taking judicial review if you can actually get somewhere with lobbying,” said Dr Verkerk. “But Chinese delegations, Indian delegations, European delegations, consumer action, non-profit organisations such as [ANH-Intl/EBF] have all been doing everything we can to try and get some flexibility in the system, and that flexibility has now run out.”
Legal action, especially against a huge intergovernmental organisation like the EU, is not something to be undertaken lightly. The ANH-Intl/EBF legal challenge could – and should – have been avoided, if the EU had been prepared to negotiate over the Directive’s terms and implementation. Unfortunately, the EU has stuck firmly to its guns, Commissioner John Dalli insisting in February 2011 that the THMPD “does not reduce access for Chinese or Indian Ayurvedic medicinal products or the products of companies with reduced financial means”. Quite how this statement matches the reality, of no registrations for TCM or Ayurvedic products and costs of £80,000–£150,000+ per product for THMPD registration, is something that may be known only to Commissioner Dalli and his henchmen in the European Commission.
3 & 4. Defective implementation by EU Member States & defective text in Directive
Dr Verkerk believes that, “There are such great variations in implementation approaches that we need to [separate] out the elements that are to do with implementation from the fundamental flaws in the Directive itself.”
Space does not permit us to detail every one of the multiple ways in which Member States are interpreting the THMPD in ways that damage herbal traditions, but a few examples will show what a huge problem this is. For example, some Member States have decided that products cannot be sold as foods when they have a medicines license, preventing a so-called ‘dual-use’ classification. Others are classifying products as novel foods if the extracted form is different from the form with recognised food use. Furthermore, food use must be demonstrated and, according to Dr Verkerk, “If you demonstrate [that the recognised food use comes] from India or China, they say “Sorry, Chinese and Indian people are different from people in Europe!”” Another frustrating and illogical approach taken by certain Member States is to consider a product as medicinal if it contains a certain herbal ingredient, regardless of the amount of that ingredient present. As Dr Verkerk put it, “If there’s a tiny amount of Ashwaghanda in a polyherbal product, [the regulators say] “Sorry, Ashwaghanda’s a medicine [and classify the whole product as a medicine]!””
Chris Dhaenens, European Benefyt Foundation
Chris Dhaenens of EBF gave further detail on the problems associated with the THMPD. Describing it as “not eligible for tradition”, he showed that the THMPD has several fundamental flaws:
Prohibitive registration fees for companies wishing to license their products
Exclusion of practitioner-prescribed products from the scheme
Exclusion of herbal products containing minerals from the THMPD regime
No consideration of specific preparation forms of herbal medicines
Analytic costs of stability and genotoxicity testing disproportionate to the safety risks
Inappropriate analytic methodology that relies on single biomarkers to ascertain stability, thereby opening the possibility of fraud by injecting these biomarkers into foreign or inactive materials
Mr Dhaenens highlighted some of the consequences that result from these flaws. “For some ingredients, the THMPD regulation clearly bypasses qualified prescribing herbalists...the first rule in safety in traditional use is that you need a differential diagnosis by a qualified practitioner.” Furthermore, only regulating herbal products only looks at one side of the equation: “Statutory regulation of therapists should automatically be coupled to statutory regulation of products,” said Mr Dhaenens. “If you don't do that, you risk signing a blank cheque.”
Mr Dhaenens is particularly concerned about a paradox inherent in the THMPD regime. “There is a number of traditionally restricted herbs that will be available as self-help remedies, which is not a good thing, [while] on the other hand, a whole lot of traditional food ingredients will be needlessly and expensively medicalised.”
5. Recently available evidence
“It’s all very well saying, “We’re concerned that something might happen in the future, [or] we’re concerned that we won’t be able to get these products registered,”” explained Dr Verkerk. “We now have people who are trying [to register products] who are being locked out. These cases are being put into the evidence for the [judicial review]. A case is only as good as the evidence that supports it. It’s like trying to build a house: if you don’t give the lawyers the foundation bricks to build that house, they can’t build it.”
Grounds for legal challenge
The legal grounds for the judicial review are broadly covered under the terms proportionality, transparency and discrimination/human rights (for further detail, see the ANH-Intl/EBF Position Paper:
Proportionality: the THMPD disproportionately affects products associated with holistic, non-European medical traditions
Transparency: several issues are relevant here: it is not at all clear how EU food law, or novel food law, will be applied; there is no EU positive list of what herbs are allowed, for example, and no clear, harmonised guidance on what extracts are allowed under the THMPD and what constitutes a recorded history of food use. And importantly, as Dr Verkerk explained, “[The industry was meant to have] a 7-year transition period, but...if the guidelines come through from the European Medicines Agency 3 or 4 years too late, do you really have 7 years of transition or do you have 3 or 4?”
Discrimination/human rights: the THMPD discriminates against people choosing to use products associated with certain traditions
The delegates at the meeting, Renaissance Hotel, Brussels
The goal: three distinct regulatory regimes
By bringing the judicial review, ANH-Intl and EBF hope to provide a 'catalyst' to trigger the EU to look again at the terms of the THMPD, rather than seeking to overturn the THMPD – a course of action with very little chance of success. A successfully reformed THMPD will be accessible to all medical traditions, including those from outside the EU, as was originally intended. This could be achieved by adding tradition-specific language to the Directive, argued Dr Verkerk. “What we see now is a system that so badly distorts the traditions that, if you want to use a traditional claim with a traditional product, you can't...[the system is set up to deal] with relief of symptoms, whereas these products actually deal with the cause of disease. It's a different language.”
The legal challenge is also intended to prevent ongoing interference by the THMPD into Member State food-supplement regimes. At present, 1 May 2011 represents what Dr Verkerk called a “regime change” in food supplements, as hundreds of products that have been sold as food supplements become medicines overnight.
As detailed in the ANH-Intl/EBF position paper, the judicial review is one prong of a three-pronged approach that will hopefully result in three distinct and separate regulatory regimes: one, a healthy, realistic and inclusive food-supplements regime; two, the THMPD as it was originally intended, that is, a simplified licensing regime for herbal medicines that is open to all traditions; and three, a regulatory regime for practitioner-prescribed herbal medicines, an area totally neglected by the THMPD in its current form.
Looking to the future
ANH-Intl/EBF have what we believe to be the best legal team available to take on the judicial review. Clive Lewis and Deok Joo Rhee from 11KBW chambers in London represent a formidable team that combines vast experience both of European law and human rights legislation. The judicial review will be a huge case, partly because, as Dr Verkerk pointed out, “We will specifically be going after the definition of a medicine", which goes to the very heart of the entire EU regulatory framework and even its philosophy: “The scope of the definition in European law is so broad that it effectively makes everything a medicine.” But if any legal team can win this case and make these changes that are so desperately needed, we have that team.
And we are building an extremely strong case: high-profile lawyers like Clive Lewis would not even consider getting involved if they did not think we had a chance of winning! ANH-Intl and EBF would like to thank everyone who came on 23 March, not only for their valuable attendance, but for the many offers we received to provide evidence for our case. At this stage, the ANH-Intl/EBF judicial review is the only option around that offers the hope of change, and there is no more valuable contribution to the future of herbal medicine in Europe than to help build this case. So thanks once again, and if you are reading this and would like to provide evidence – please, please get in touch! Your help could quite literally change the world.