European Herbal Health Products Summit - Which way forward?
The invitation from the German Society for Medicinal Plants and Natural Product Research (GA) came as a complete surprise, so I travelled to the summit in Brussels full of anticipation. The two German federal associations of the pharmaceutical industry (BPI) and pharmaceutical manufacturers (BAH) supported this event. Recent political developments such as the new EU pharmaceutical strategy, including the revision of the Medicines Directive and the planned new regulation on health claims, had inspired the organizers to hold this event.
In addition to the four thematic panels on:
1) "Future and relevance of herbal medicinal products in the EU outlook and challenges from competent authority perspective",
2) "Revision of EU pharmaceutical legislation - Impact on herbal medicinal products",
3) "Quo vadis “Health Claims Regulation” – Implementation report of the EU Parliament" and
4) "Regulatory challenges for herbal medicinal products", the summit was intended to serve as a platform for lively discussions with key stakeholders.
The room was well filled and the President of the event, Prof Dr Michael Heinrich, opened the event on behalf of the GA, which was founded in 1953 - and set the tone: Botanicals (food supplements) have a much easier barrier getting to market! Sales of food supplements are rising, while sales of herbal medicinal products are falling. The health claims for food supplements are without evidence - which raises the question, especially for the EU bodies: What evidence is needed for the food supplements that use health claims?
The presentations that followed had an academic, specialized level. The time-honored professors and doctors presented various versions of the status quo of current legislation. They also set the tone in the four panel groups. In total, I only heard three interventions from the audience. Unfortunately, no one from official EU politics was present. Two members of the EU Parliament had joined as members of the panel-groups: A German doctor from the Renew-Europe and a German doctor from the EVP.
In general, all speakers made two basic demands: a) the Health Claims Regulation must be tightened up urgently - and b) this means finally establishing consumer-related product safety and proof of efficacy for health claims!
These demands were justified in different presentations.
I was struck by the fact that only three EU countries have a strong herbal medicines market: Germany, France and Italy. In the other EU countries, the majority of the market is dominated by food supplements. The price difference, the difference between mono-drug and combination product, the extremely complex and cost-intensive bureaucracy of drug authorization and the time-consuming research work to provide evidence were mentioned here.
However, it is also surprising that the situation of health claims for food supplements, which was first created by the Europe-wide new regulatory requirements from 1978 on until today, now poses a problem for the representatives of rational phytotherapy in pharmaceutical law. It is precisely these professional associations that are in favor of herbal mono-products with indications for use in accordance with the guideline system within mainstream medicine. It is precisely for this reason that the scientifically orientated phytotherapy representatives have been demanding ever stricter evidence criteria and laboratory test procedures for years. This long-standing development is reflected in an increasingly bureaucratic and cost-intensive ideology to supposedly strengthen safety in accordance with the precautionary principle.
At this summit, representatives of food supplements, patients and even non-physician therapists and users did not get a chance to speak. The longer the event went on, the more the impression was reinforced that rational phytotherapy and its professional stakeholders have long since moved away from a natural way of thinking and the development of medicinal products for the healing systems of traditional medicine.
In contrast, food supplements appear to be returning to the situation prior to post-authorization due to easier market access. In a positive sense, food supplements and their users are responding to the need for natural health promotion. The current trend within the population towards self-optimization and saving money and competent professional support through Internet use is certainly present. However, the telematics, e-health and digital health spheres of the EU and state healthcare systems are heavily involved.
The pharmaceutical legislation led to the exclusion of non-European herbal products due to the explosive increase in costs and bureaucracy. As a result, it still represents an obstacle to innovation today. The Europe-wide collection of signatures from over 2 million citizens to revise the THMPD in favor of traditional healing systems and their remedies was ignored in 2012 - both by the EU and by rational phytotherapy and its professional associations.
Which path will lead to the future of rational phytotherapy and herbal health products?
One suggestion for improvement was that herbal products should no longer be included in food supplements: Product information of food supplements should list what is contained in the product and not what is NOT contained; also for food supplements should apply: Quality, efficacy, effectiveness and safety based on clinical evidence; the EU agencies EMA and EFSA should speak the same language; the EU should finally act and revise the Food Supplements Directive of 2002; misinformation should disappear.
For my point of view the gap between EU food legislation (EFSA) and EU pharma legislation (EMA) is huge. The speakers saw no reason to change their own views and approach. Instead, they called for this to continue and for even more far-reaching measures to be taken to ensure that herbal medicinal products, with their 169 HMPC-monographs, are included in all mainstream medicine guidelines and university training programmes. Conference President Prof Dr Michael Heinrich thanked all participants for a successful day and held out the prospect of further events.