THMPD Implementation

Germany and France: EU Herbal Directive won’t damage us

By Shane Starling

- Last updated on GMT

Related tags: Herbal medicinal products, Herbal medicines, European union

Herbal medicines must be registered under the EU THMPD from this week
Herbal medicines must be registered under the EU THMPD from this week
The European Union Traditional Herbal Medicinal Products Directive (THMPD) – fully implemented across the bloc after a seven-year transition period over the weekend – has been welcomed by German and French trade groups, even as opposition mounts against it.

While groups in the UK raise funds to mount a legal challenge against a regulation they believe places unfair burdens on the botanical products sector, and 500,000-signature strong petitions are raised by the group Avaaz in other parts of Europe, French and German trade groups say it is business as usual for their sectors.

The German Federation of Pharmaceutical Manufacturers (BAH) said the passing of the deadline for products to achieve THMPD registrations meant little because most of the 2500 or so herbal medicines on the German market had long ago been pre-approved under national botanical medicines rules.

“We do not have the problem that is being felt in the UK where there are so many products on the market without registrations,”​the group’s head of herbal and homeopathic medicinal products, Dr Barbara Steinhoff told NutraIngredients this morning. “We have always supported the regulation because it guarantees safety, quality and efficacy.”

Dr Steinhoff said “only a handful of products” ​had not applied for registration, while about 350 registration applications had been lodged with the German medicines agency for products that required them.

Harald Dittmar, the managing director at the German Association of Food Supplements, Cosmetics and Pharmaceuticals (BDIH), said the deadline altered little, without being as supportive as the BAH because he said its demarcations already existed in most countries.

The secretary general of the French Food Supplements Association, Synadiet, Guillaume de Durat agreed that in France, “there are few companies that are affected. They’ve been preparing for it so there has been no need to panic.”

UK

In countries like the UK and Ireland there is more concern because 1000s of products remain on shelves without registrations that can cost in excess of €50,000, a situation that has provoked the Alliance for Natural Health into a fund-raising campaign to mount a legal action against the directive.

In the UK there have been 211 applications for the likes of St John’s wort and valerian, with 105 registrations and no rejections to date.

The industry has complained the registrations are too costly for small businesses although Michael McIntyre, chairman of the European Herbal and Traditional Medicines Practitioners Association, said the market needed more regulation.

"Products that go on the market now will definitely do what it says on the bottle, while we didn't know how good they were in the past,”​ he told the BBC.

"But registration is expensive so perhaps there may be fewer products on the market and a smaller range. It's difficult to argue that the market should stay as it is, without any regulation, but how many businesses will pack up and walk away? I can't say."

Non-registered products will continue to be available but only via herbal practitioners and products already on shelves will be able to sell through.

Draconian

Avaaz argues against the THMPD on more political grounds. Its website calls on the European Commission to, “amend the THMPD Directive, suspending the draconian measures against herbal medicines and removing all barriers to traditional remedies with a long history of use inside and outside Europe.

“We further call on our governments to refuse to comply with this Directive until it is amended. We have a right to choose among all remedies and medicines that can keep ourselves and our families healthy.”

But EC health commissioner John Dalli said: "We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficacy."

In addition to the claims potential of a product registration, the THMPD dictates that all herbal products not classified as food supplements (like many 'spice rack' herbs such as garlic and sage) or those considered medicines, must have gained THMPD registration by April 30, 2011 to remain on market.

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3 comments

THMPD a dangerous Trojan horse

Posted by Robert Scott,

Although Mr McIntyre is in favour of THMPD, it brings with it the threat of the statutory rgulation of herbal practitioners. Although some might see this as a good thing, the MHRA has stated that this woould open the way to reform section 12.1 of the 1968 medicine act and remove from a vailability not only manufactured products, but herbs in their natural state. Such a move would seriously endanger the future of all traditional medicine, the basic holistic philosophy and approach of which can not be squared with the testing regime of THMPD. There has already been a major attack on Ayurvedic medicine through "Bio-piracy" in India, which the Indian government took steps to block, as a way of maintaining access to traditional medicine for its population. Why is the EU attempting to abandon this human right?

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THMPD registrations

Posted by Shane Starling,

Dear Zee Prime,

Thanks for your comment. You are indeed correct that the actual cost of THMPD registrations with the MHRA in the UK is much less than the €50,000 quoted in the story, but the figure incorporates the costs of compiling data and preparing it in a dossier. Indeed this figure is at the low end of the spectrum, and the costs have been much higher for some companies.
You are also correct in that the THMPD does not require proof of efficacy par se, but it does increase the demands on quality and dosage of products, and demand history of use data, thereby increasing the likelihood of products meeting label claims.

Best regards,

Shane Starling
Editor
NutraIngredients

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Misinformation

Posted by Zee Prime,

There is quite a bit of misinformation in this article. For example, it doesn't cost €50,000 per product (see http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Feesformedicinesbloodestablishmentsandbloodbanks/OtherfeesforTraditionalHerbalMedicinalProducts(THMP)/index.htm) and THMPD products require no evidence of efficacy, so saying they will "do what it says on the bottle" is highly misleading and irresponsible.

I'm surprised that so many are voicing their objections to the public being better protected.

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