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Traditional Chinese Medicines, based on plants such as ginkgo biloba, face unfair discrimination, claims Alliance for Natural Health International.
The Alliance for Natural Health International has slammed the European Commission’s Traditional Herbal Medicinal Products Directive as “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.
Herbal practitioner
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
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.
8 comments (Comments are now closed)
STALLING FOR MORE RULES
The EU is now trying to stall this for as long as it can to bring in even possibly more regulation, because once we have taken their first medicine the next wont seem so bad so to speak , in other words they will have us where they want us, HUH who are they kidding.
This is a slow destructive process of all that is good and natural and we have to resist , if not we loose everything . I see the same is now happening in the US also and it will decimate the economy there as approx 450,000 jobs will be lost . THIS IS SHEER TYRANNY FROM FORCES THAT HAVE LITTLE RESPECT FOR LIFE . WE HAVE TO STOP PUSSY FOOTING WITH THESE CRAZY PEOPLE AND PROTEST AS MUCH AS POSSIBLE . THE INSTIGATORS OF THESE POLICIES SHOULD ALL BE UP IN COURT FOR CRIMES AGAINST HUMANITY . I AM ASHAMED TO BE ASSOCIATED WITH THESE SO CALLED HUMAN BEINGS . THEY WANT TOTAL DESTRUCTION OF ANYTHING THAT DOES NOT SUIT THEIR AGENDA . WE CAN NOT LET THEM WIN , WE HAVE TO ACT NOW. FREEDOM , FREEDOM , FREEDOM.
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Posted by paul
22 July 2011 | 17h11
Death by Drowning
I applaud Dr Verkerk and all his great work but I fear the total bureaucrats sitting in the cosy EU parliament will drown all of us in a sea of manipulated legislation that many can not understand, in other words rules that do not make sense and try to confuse us in many deceitful ways. Not only do they want to destroy our health but next will be our wealth , and if we go by what's happening in the rest of Europe and the US you will see why. I fear a big storm is coming and they (EU) and british governments will hit us from all angles to dumb us down so we the human race when weak and vulnerable will plead for help, and thats when they have "got you", total control of the population by design. We are in for a hell of a ride but I for one intend to protect myself, family, friends with sanity, health and wealth in whichever way I can, and those who I can help also will be my way of destroying this sheer evil we see happening to the human race. I abhore what is happening to the Natural Health Industry here and in the US and whoever is responsible should be tried in court for crimes against humanity. IF WE DROWN THEY WIN .
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Posted by paul boast
06 July 2011 | 13h17
Destroying Small Businesses
I think most people fail to realise that the high price of THMP registration is not merely European protectionism. In fact it is a form of big business favoritism, which will surely put small herbal supplement brands and health shops out of business. When registration costs €20,000 or more per product, the only companies that can still be reasonably assured of recovering such an outlay are those that sell very large quantities to mass market retailers. Smaller brands, selling to independent shops would be lucky to recover a fraction of that in a year. Only large herbal medicines manufacturers will survive. RIP herbal supplement companies.
How could this have occurred? Consider the differences between small powerless supplement brands and large powerful herbal medicines manufacturers. Early on, the largest herbal medicines manufacturers were afraid of the FSD and THMPD, and most importantly harmonisation across their borders. Previously, they enjoyed a relative monopoly in their respective countries. (For example, in countries, like Germany, garlic powder was regulated as a medicine. Even though it was the same stuff one would sprinkle on pizza, it was a medicine simply because it was sold in capsules.) Harmonisation could have spelled disaster for large manufacturers as smaller, more agile brands would surely have taken considerable market share.
It is not inconceivable that the more powerful interests were able to steer the THMPD to where it is today. Throughout history, luck (regulatory luck) tends to favor the powerful.
The sad part is that without the specialty- and niche-focused approach of small herbal brands, small health shops will be forced to market only the same products available in mass retail outlets. Contrary to historical lore, the David an Goliath scenario rarely works out very well for small businesses.
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Posted by Ralph Leeds
05 July 2011 | 16h56
Challenge the directive and also convert herbals to foods
Since the THMPD came into force, I have had many requests to look into the possible "down regulating" of herbal medicines to foods or food supplements as the costs are much less to get approval (excluding health claims). With a small number of herbal medicine products it is possible to do this. Once they have been "approved" as food supplements, then if the company chooses not to file health claims, it is in general, a much less expensive way of getting products legally on the market. As before, consumers read about the use of these ingredients from third party sources - magazines and research papers, etc., and then buy them if they want to. Ironically this is the situation we had before the THMPD and the health claims directive were put in place. As a famous Buddhist monk once said " If you squeeze mud in your hand it will still seep through the gaps in the fingers”. Squeeze the industry and other avenues will be found – and not necessarily illegal ones. It’s a shame that the THMPD was not more encompassing – i.e., predicting what would happen once the legislation was in place and then accommodating this and making changes before the legislation was passed. As a scientist specialising in the development of botanicals and their regulatory approval for the past 20 years I do feel that the 30 year rule is unscientific - i.e. so what if a product has not been on sale in the past 15 years out of 30 in the EU – that should not mean that the only recourse is a full license costing millions of pounds. The proper way would have been to assess the usage on a case by case basis, most likely in the country of origin (or highest and long standing consumption) and file, properly researched, history of use documents to support safety and efficacy. My company pioneered this approach in the approval of novel foods with great success in 2005 with the African plant Baobab. Does anyone want to give it a try with the THMPD? – i.e., submit a dossier based on a long history of use without the 15 years usage in the EU and couple this with convincing safety / efficacy data to challenge the authorities as a possible “land mark” case. I believe from proven previous experience in this area that the quickest way to modify a directive is to challenge it, not only with lobbying, but with powerful, original, creative submission dossiers. We need inventions and discoveries in regulatory affairs just as we do for example, in music and in science . These landmark “discovery dossiers” should contain convincing “proof of principal” persuasion arguments that test and expand the directive and make it difficult for the authorities to “not approve” the product, even if the dossiers are unconventional (but still highly scientific). Remember the directives are guides and can be challenged – to do this we need to sometimes try new ways of thinking and seeing. To quote the discoverer of Vitamin C “"Discovery consists in seeing what everyone else has seen and thinking what no one else has thought." - Albert Szent-Gyorgi” Nobel Prize winner in Medicine.
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Posted by Dr John Wilkinson, Director, Herbal Sciences International Ltd, UK
05 July 2011 | 15h37
Pure madness
Makes me mad to know I can't use safe and proven herbal medicines, which have been used for thousands of years, for the health care of myself and my family.
This all because some so-called scientist and bureaucrats decide it's time to control us silly citizens. Let's not forget the same scientists were blood-letting only 150 years ago.
In another 150 years nobody will remember orthodox medicine, because we will have learned to concentrate on health and not illness.The law of nature calls for the preservation of life and we all know drugs kill.
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Posted by Jürgen Denzinger
03 July 2011 | 23h24
Clean wealth for Third World countries
Thirld World countries can have their share of clean wealth by exporting medicinal plants and to access the process of registration, etc. It would also benefit millions of people that need treatment of new diseases.
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Posted by Edda Contreras
28 June 2011 | 12h40
Lack of choice
We used to be able to buy more than 350 different herbal medicines now we only have a choice of about 100.
The law was unnecessary. too expensive for the majority of small companies and the net result has been that 99% of the UK herbal market has been given to German companies when all that was needed as the Americans have proven is that all medicines should be made to GMP and a list of all herbs allowed should have been provided by the EMEA
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Posted by Tom Chapman
28 June 2011 | 12h00
Understated costs
Robert Verkerk mentioned the costs of 2000-50000 € only as regulatory fees. He also mentioned that the actual costs of registration (the development of analytical methods and stability studies) accumulate to 100-250,000 € - and even this is a rather accurate estimate for monoproparations only. This is what he meant with the economic disincentive, and he is absolutely right. With good planning, costs can considerably come down below 100,000/product, but only if one accepts a loss in diversity of preparations.
By the way: As far as we know, not a single application for Asian traditional preparations has been filed, so none could be rejected.
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Posted by Mathias Schmidt
27 June 2011 | 16h32
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