ANH: Herbal Medicinal Products Directive is “a protectionist tool”
In an open letter to European commissioner John Dalli, Robert Verkerk, the alliance’s founder and scientific director wrote: “It seems that the criticism you now face in some quarters is down to the creation by the EU of what is effectively a protectionist tool; one which favours certain products of the European phytopharmaceutical system and discriminates against those of non-European traditional systems of medicine.”
Verkerk’s letter follows a forum in the European Parliament on 21 June to consider the challenges posed by the Traditional Herbal Medicinal Products Directive (THMPD Directive 2004/24/EC) to traditional systems of medicine; particularly those of non-European origin.
The new legislation requires that traditional herbal medicinal products, many of which have been used in Europe for decades, must be licensed or prescribed by a registered herbal practitioner in order to comply with a directive passed in 2004 and implement on May 1 2004.
In the UK, for example, over-the-counter herbal medicine products require either a Traditional Herbal Medicines Registration (THR) or a full marketing authorisation. To be eligible for a licence, products must have been on the market for 30 years, including 15 within the EU.
So far, only about 100 herbal products have been registered under the THR scheme, which is run by the Medicines and Healthcare Products Regulatory Agency (MHRA). This could mean that thousands of products may eventually be banned.
But in a letter to Giles Chichester MEP on 13 April 2011, Dalli said that there were no additional barriers to the registration of Ayurvedic and traditional Chinese medicine (TCM) compared with products from other European traditions.
Verkerk responded by writing: “By contrast not a single product authentic to the Ayurvedic, Unani, TCM, Tibetan, Thai, southern African or Amazonian – or, indeed any other non European – system has yet been registered.”
The open letter goes on to list four barriers allegedly preventing the uptake of registrations among the non-European traditions. Those are claimed to be: Eligibility limitations, technical limitations, excessive cost, and lack of incentive.
The eligibility barrier refers to traditional use requirement specifying at least 15 years useage within the EU. “This locks out many products which that may have been used for decades or even centuries, or even millennia outside the EU,” wrote Verkerk.
Technical limitations refer to the pharmaceutical and stability standards set out in the European Medicines Agency (EMA) guidelines. These are more straightforward for single-herb products or limited combinations than for most authentic traditional herbal medicinal products which are often whole herb or aqueous extractions.
Registration fees varying from €2,000 to €50,000 per product are “…unquestionably out of reach of the small-to-medium sized enterprises (SME) supplying products associated with non-European traditional systems,” wrote Verkerk.
Finally, a lack of financial incentive to register non-European medicines is said to be a powerful disincentive to take up registrations.
Verkerk ends his open letter with a plea for Dalli to comment on his concerns and for the Commission to consider the feasibility of a new regulatory framework more appropriate for holistic systems of medicine.
No one from the Commission was available to respond to Verkerk’s criticisms. But an EC spokeswoman promised a response by the end of next month.
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