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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