Science and Communications Officer, ANH-Intl
Last week, we brought you the first part of our response to answers given by the European Commission (EC) to a tranche of 23 Parliamentary questions developed by ANH-Intl and Marian Harkin MEP. We told you how the EC managed to almost completely avoid giving full or direct answers to any of our questions. It’s not like we made it easy for the EC, either: the way the questions were drafted, it must have been more work for the EC to avoid the issues than to address them!
Today, we bring you Part Two, which include questions on how European Union (EU) law and regulators treat herbs as medicines, among other issues. So, without further ado...
The thorny topic of EU legislation effectively making all herbal products – all foods and food-related substances known to humankind, in fact, and even cosmetics – medicines was tackled by Questions 15–19.
In its answer to Question 15, the Commission sensibly deferred to the European Court of Justice ruling which found that, “[The definition of a medicinal product by function] does not serve to include substances which, while having an effect on the human body, do not significantly affect the metabolism and this do not strictly modify the way in which it functions...a product which does not have any additional effects compared to those of a foodstuff consumed in a reasonable quantity may not be classified as a medicinal product as established in Directive 2001/83/EC [the HMPD].” This appears to be an acceptance by the Commission that, in the words of Question 15, “It is possible for an herbal ingredient or substance to trigger a significant metabolic or immunological response, indirectly, rather than directly”, with the caveat that the definition of “significant” metabolic effects is open to interpretation.
Continuing on that topic, the EC stated that the reason the words “immunological or metabolic action” were included in the 2004 amendment of the European medicinal code, as per Question 16, was because it, “Made it possible to cover medicinal products such as gene therapy, radiopharmaceutical products as well as certain medicinal products for topical use”. If this is the case, we find it absolutely astonishing that no-one responsible for drafting the legislation understood that the wording actually defines as medicines all foodstuffs on the planet, since any substance when taken internally will have either physiological, metabolic or immunological effects. Neither does the EC’s bland response reflect the dodgy backroom deals that saw this wording included in the originally proposed legislation, then amended to better distinguish medicines from non-medicines at the first reading in the EP, and finally reinstated at second reading. At the same time, wording that would have legally protected substances that are “clearly” foods, food supplements, cosmetics or medical devices was shunted off into Recital 7, where it has far less legal weight than if it were included in an Article. Someone certainly wanted that form of words in the final legislation, we suspect for reasons above and beyond simply wishing to ensure gene therapy, radiopharmaceuticals and topical medicines were appropriately regulated.
A partial solution to the problem could see the EMA developing a categorisation system for individual herbal species and preparations, aimed at more clearly delineating the food/medicine borderline. On this, the topic of Question 17, the Commission simply declared, “EU pharmaceutical legislation does not foresee a responsibility of the [EMA] in the classification of medicinal products”.
In Question 18, we asked why the THMPD is limited to herbal products designed for mild, self-limiting conditions, when traditional systems of medicine offer some of the most effective solutions for more serious conditions, such as type 2 diabetes and osteoporosis. With no legislative harbour, such products are now effectively banned, making this a question of prime importance to millions of EU citizens. But direct answer came there none. One could possibly discern the EC’s attitude from its suggestion that manufacturers apply for full marketing authorizations for products that fall outside the THMPD – which obviously includes these products.
Neither could the Commission find time in its hectic schedule to give a straight answer to Question 19, as to whether herbal products registered under the THMPD may ever be sold as food supplements, rather than herbal medicines. The EC referred to a previous written answer in its response to our list of questions, and answer E-008614/10 stated that, “Herbal products may be classified and placed on the market as foods provided that they do not fulfil the definition of medicinal products; and that they comply with EU food law.” Sounds like a “no” to us!
The cost burdens placed by the legislation on small- and medium-sized enterprises (SMEs) wishing to apply for THMPD product licenses were the subject of Question 20 – and were completely disregarded by the Commission in their answers. This is a particularly cavalier evasion, given how severely the registration costs are distorting the market in favour of larger, phytopharmaceutical firms and against manufacturers typically making traditional herbal products – especially those representing the non-European traditons of Asia, Africa or South America.
Asked why the THMPD excludes herbal products that contain non-herbal ingredients, such as minerals, in Question 21, the Commission replied: “The rationale behind the current simplified registration procedure is to enable products that have been in long-standing traditional medicinal use to be registered...because their safety and efficacy can be deduced from their long-standing use under the specified conditions of use. The vast majority of medicinal products with a sufficiently long tradition are based on herbal substances. It therefore seemed appropriate to limit the scope of the simplified registration to traditional herbal medicinal products.” Once more, this reply ignores without foundation the long traditions of use of herbal products containing, for example, minerals, in both the Ayurvedic and Chinese traditions.
The last two questions looked at the so-called ’15-year rule’, whereby only herbal products that have been on sale in the EU for at least 15 years, out of a total of 30 years’ use or more worldwide, can gain access to the THMPD registration process. The 15-year requirement is there, according to the Commission, to allow the necessary side-effect monitoring; but, “Where 15 years of use in the EU cannot be demonstrated...[the THMPD] allows to prove the safety of the product by other means which are to be assessed by the Committee for Herbal Medicinal Products of the [EMA].” Still no answer as to why evidence from outside the EU, in the same form as would be acceptable if originating from within the EU, is not acceptable. However, we would be interested to know more about the “other means” of proving safety.
Even minor adjustments to herbal formulations can mean that the revised product falls foul of the 15-year rule, and we asked in Question 23 whether the Commission foresees a more flexible regime in future. The answer was blunt: “The corresponding product has to be sufficiently similar to the product under registration to allow use of the evidence on the corresponding product.” As flexible as a brick, in other words.
The European Commission is a bureaucracy; we recognise and acknowledge that, and expect a certain degree of ‘official-ese’ and opaque language in its answers to MEPs’ questions. It is, however, supposedly obliged to answer the questions laid before it, not simply to develop a convenient case of word blindness and answer only what it wants to answer. Depressingly, in its responses to a comprehensive set of questions on a single topic, the THMPD and the regulation of herbal products more generally, the EC has given us a masterclass in avoidance that would do a squirming banker proud.
Over and over again, the EC told us things we already knew, answered questions partially at best, gave replies that bore little resemblance to the subject of the query – or simply ignored the question entirely! Is this the sign of a guilty conscience, if ‘conscience’ is the right word? Does the EC know the THMPD is a gigantic cock-up, a legislative nightmare that cannot be genuinely defended? Or does it care so little about the THMPD’s effects on EU citizens, whether manufacturers, suppliers, users or practitioners of herbal medicines, that it feels it appropriate to dismiss their concerns with a sneer?
Either way, we didn’t learn very much, other than the fact that the European Commission and European Medicines Agency are unlikely to change course unless they get forced to do so by the courts.
The good thing is that a growing group of MEPs, such as Michelle Rivasi and Marian Harkin, are waking up to the senselessness of what the EC is trying to mastermind. As we have said before, a legal challenge to the THMPD represents the only possibility for change. We can’t thank you enough for your support so far in this direction, but things will get really interesting in the next few months and we need you to stick with us!
15. Does the Commission and the EMA recognise that it is possible for an herbal ingredient or substance to trigger a significant metabolic or immunological response, indirectly, rather than directly? (This is generally because the product provides a factor or substrate that is in inadequate supply in the diet and so enhances specific metabolic pathways.) In such cases, is it fitting that such products should be deemed medicinal by function, according to the definition in Article 1.2(b) of amending Directive 2004/27/EC, when effectively these products are simply enhancing homeostatic mechanisms? (It should be recognized that many ‘healthy foods’, such as broccoli, berry fruits and oily fish, operate in exactly this way.)
16. What was the justification for including the words ‘immunological or metabolic action’ in the 2004 amendment of the European medicinal code (Article 1(1) of Directive 2004/27/EC), as this amendment effectively makes all beneficial herbal products medicinal by function? (The amendment was not supported by the European Parliament at second reading.)
17. At present, some Member States’ competent authorities are unnecessarily medicalising herbs, and products containing herbs, that have an excellent safety profile and history of safe use.
Would the European Medicines Agency consider a categorisation system for individual herbal species and preparations to allow more equitable delineation of the food/medicine borderline by Member States’ competent authorities?
18. The claimed indications currently allowed for products registered under Directive 2004/24/EC (amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use) are restricted to minor and self-limiting conditions.
What is the legal basis of the decision to exclude indications for more serious conditions, such as Type 2 diabetes and osteoporosis, which have become a scourge in modern, western societies and for which Asian systems of traditional medicine have particularly effective solutions?
Is it assumed that serious diseases need to be treated with more hazardous products? Is this territory reserved for conventional pharmaceuticals that have undergone full marketing authorisation procedures? Or are there other reasons?
19. What is the Commission’s policy on the use of herbs that have a history of medicinal use in botanical food supplements? If an herb is successfully registered under the THMPD scheme, may it still, under specific conditions, be sold within a food supplement?
20. The typical cost for registration for the above medicines, including fees and quality control testing is in the order of EUR 200 000 per product. Given that a typical supplier of traditional, non-European herbal medicines is generally required to carry a line of a least 100 products, the cost of registering these would amount to around EUR 20 million. If these products each generated an annual revenue of EUR 5000, it would take 40 years to recover the initial costs of registration.
What impact assessment has the European Commission undertaken to evaluate these kinds of potential cost burden on typical SMEs engaged in the supply of products associated with non-European systems of medicine?
21. Many products associated with long-standing, non-European systems of medicine contain non-herbal active ingredients, such as minerals.
Why have such products been excluded from Directive 2004/24/EC?
Also, considering the views expressed by the Commission in its experience report COM(2008)0584, will the Commission be addressing this issue and supporting amendment of the directive to make products containing non-herbal ingredients potentially eligible?
22. Why does Directive 2004/24/EC require 15 years usage of herbal products within the EU as a component of the 30 years traditional use requirement? Why is it unsatisfactory to provide evidence only from outside the EU where, in some cases, there are hundreds of years of verified usage for particular classical formulae?
23. The traditional use requirement in Directive 2004/24/EC appears to have no flexibility with regard to the specific combination and ratio of herbs. If there is a minor adjustment to a formulation of a product that met the 15/30 year use requirement to cater for different target groups or more recent science, the product would presently not be deemed eligible to the scheme.
Will the Commission consider the possibility of allowing more flexibility in ‘corresponding products’ eligible to the traditional use requirement in the future?
Updated: 27 Sep 2011
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