Pressure from European Union (EU) citizens forced a recent meeting between Members of the European Parliament (MEPs) and the European Commission (EC) to discuss the impact of the EC’s directive on herbal medicines which will be fully implemented EU-wide as of 1 May 2011. Unfortunately, the meeting, held at the European Parliament on the 29th November 2010, showed how unwilling the EC is to follow through on a pledge it made back in 2008. The pledge was made in the Commission’s report (COM(2008) 584 final) on its first four years of experience with the herbal directive, known as the Traditional Herbal Medicinal Products Directive. In the report, the Commission specifically recognised that the directive was not suitable for holistic traditions, such as Ayurveda and traditional Chinese medicine (TCM). Crucially, it also indicated it would consider the feasibility of an entirely new regulatory framework for such traditions.
Members of the European Parliament got the opportunity to seek answers on the THMPD from Andrzej Jan Rys, Director of Public Health and Risk Assessment at the Directorate General for Health & Consumer Policy. The meeting was called as a result of concerns voiced through many hundreds of communications sent to MEPs, whose constituents are worried that thousands of herbal products will become illegal from 1 May 2011.
You could well have been one of those people who contacted their MEP about this flawed Directive – and if you were, congratulations on your efforts that are now forcing the European Commission to answer some difficult questions! If we keep up the pressure, we are hoping to force the Commission to reconsider its view. If the Commission refuses to budge, it will have to be answerable to its actions in court.
While it’s great to see there’s life left in the European democratic process, we can’t pretend that we’re not somewhat disheartened to hear the Commission’s response. Green Party MEP, Bas Eickhout, when questioning the Commission over the possibility of an extension of the transition phase and hence a delay to the full implementtion of the Directive, was told simply, and unequivocally, by Mr Rys of the European Commission: “We do not plan any postponement of the deadline”.
In a bid to help the Commission maintain a previously made commitment, Mr Eickhout also asked the European Commission if it was going to consider the feasibility of a new regulatory framework, as alluded to in its experience report of 2008. In response, Mr Rys simply declared that no separate regulatory framework was planned for TCM or Ayurveda, and he did not mention any other traditions.
Mr Eickhout went on to question the Commission over the controversial 30-year rule, which requires that 15 years’ safe usage within the EU is demonstrated out of a total of 30 years, as a means of establishing the safety of traditional medicines under the THMPD. Mr Rys indicated that he understood that the EC was not assessing the 15-year requirement in any way; in fact, the Commission’s priorities were to revise the clinical trials directive and veterinary medicinal product legislation!
It’s worth remembering that the THMPD was never intended as a regulatory framework for practitioners of herbal medicine. The directive clearly states its intent to be a framework for manufactured products sold directly to the end consumer, for minor ailments, without the supervision of a medical practitioner. So what about practitioners? Since August 2008, when the Commission’s experience report was published, practitioners of herbal medicine all over Europe have seen the concluding statement in that report as a ray of light among the regulatory bleakness being foisted upon them. However, without this framework, which has been one of the three main prongs of the joint ANH/Benefyt strategy, that hope has been dashed for the time being.
This recent meeting of MEPs and the European Commission could be likened to a curate’s egg. While it is undoubtedly great news that EU citizens’ voices are being heard on the THMPD, and that serious questions are being asked by MEPs on their behalf, the outcome of the encounter with Mr Rys can be summed up in two words: no change. But change never comes overnight, so keep up the pressure – you are being heard! Persistence is the name of the game.
The Commission’s response also vindicates our decision to go to the courts to achieve a more proportionate, transparent and non-discriminatory legal framework for herbal products within the EU.
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Comments
your voice counts
22 December 2010 at 12:46 pm
"It’s worth remembering that the THMPD was never intended as a regulatory framework for practitioners of herbal medicine. The directive clearly states its intent to be a framework for manufactured products sold directly to the end consumer, for minor ailments, without the supervision of a medical practitioner."
You have the solution to the problem right here. Since the THMPD was not intended as a regulatory framework for herbal practitioners, it will not touch herbal practitioners. It establishes a registration process for over-the-counter herbal medicines. Full stop.
What happens in the world of practitioners is outside the scope of the directive and any national implementation of it.
The Italians have understood this. We have, in Italy, a thriving economy of herbal practitioners and herb shops, called "erboristerie" (that's plural of erboristeria). Herbalists have a three-year university training, and many of the shopkeepers are trained herbalists. No one expects them to pack up and go home just because the EU made a law to register herbal medicines.
I believe that we are confusing two things here. Herbal traditions including practitioners are very much alive. Herbal medicines as registered products are in trouble. The bar has been set too high, and very few have been registered. But that does not mean we should think that herbal traditions can or will be wiped out by an initiative of the EU bureaucracy to permit registration of herbal medicines under certain conditions.
23 December 2010 at 8:41 pm
The passage of this EU regulation concerning herbal products should be contested in the Courts. This is the thin end of a very large wedge no doubt fostered by 'Big Pharma'who unfortunately have a bottomless pit of money to sustain their desire to ban all naturaL Herbs and Supplements. Since a growing number of people have realised that natural substances do not have the inevitable sometimes fatal side effects on our bodies which manufactured drugs always have.
If democratic means are to be effective it requires that our MEPS are left in no doubt by their constituents that this legislation and any future moves to ban natural supplemenmts by undemocratic, unelected organisations such as the EU are anathema.
26 December 2010 at 12:30 pm
Following the comment from Sepp, herbal practitioners should be able to continue to sell all available herbal products to their patients, and when they are brought to court by the national authorities they should be able to defend themselves all the way up to the ECJ. Which makes it even more important to have a large war chest of money at the ANH for the legal battle over the THMPD.
The problem is countries such as Sweden that don't have any formal recognition of herbal practitioners (or any alternative practitioners whatsoever outside of the medical establishment).
31 December 2010 at 11:11 pm
There should only be one consideration when looking at the need for legislation. Does a herb vitamin, or mineral have any kind of record for killing people? Any other consideration is hypocrisy.
In England and Wales alone, alcohol is responsible for 6000+ deaths a year, tobacco related to 86,000 deaths. Both have a long record of killing people. So that's OK, as they produce huge revenues?
Moral considerations and protection of the public from herbs and other nutrients is a deliberate lie and an insult to the people.
I can't find any figures for deaths caused by any nutrients or herbs in Europe, probably because there aren't any There are figures for the US. Not one death in more than 5 years !! Any deaths from Pharma drugs? [Latrogenics] Latest figures put them at 723,000 in the US pa, but these only include deaths occurring in Hospital.
It is estimated that the real total is in excess of 2 million annually.
This is what the ANH should be concentrating on. Is there any other aspect of our lives where Legislation is forced on us, denying us access to any pastime,pleasure,or indulgence which causes no deaths amongst 300 million Americans and probably 500 million Europeans? Breathing and sex are probably next in line?
Abstaining from breathing and sex will probably be declared mandatory.
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