Can the EU traditional herbal medicines directive be amended?
Come 2011, any herbal products seeking to make non-medicinal claims in any of the EU’s 27 Member States will require registration under the Traditional Herbal Medicinal Products Directive (THMPD).
Marian Harkin, Irish Member of the European Parliament, met with European Commission representatives to discuss the THMPD recently, along with European food law reform group, the Alliance for Natural Heath (ANH) and the Irish Association of Health Stores (IAHS).
After the meeting, Harkin and the two bodies issued a joint statement that said the EC had recognised some parts of the Directive “fell short of its intended purpose of providing an effective simplified registration system for traditional herbal medicines”, and was therefore a candidate for amendment.
However after EC spokesperson, TonVan Lierop, told NutraIngredients.com the EC was not of this view, Harkin contacted us to clarify the situation and said the joint statement may have been slightly over zealous.
In the statement, Harkin said she was, “glad to see that the European Commission is prepared to rethink its current approach, which is otherwise scheduled for full implementation in 2011.”
Van Lierop said the ANH’s imputation that amendments might take place before the directive’s full implementation in 2011 was off the mark, as “any possible amendments in the legislation would take several years.”
Harkin agreed the statement’s timeframes may have been ambitious but said the momentum for reforming the THMPD remained strong as were her ties with ANH and IAHS. She was encouraged by the open tone of the Commissioners at the meeting and was confident it would be possible to work with the Commission on taking the matter forward.
Less confident are campaigners in the UK who recently met with the Medicines and Healthcare Products Regulatory Agency (MHRA), and were told there was little scope for flexibility in the regulation.
Paul Chamberlain, supplement maker Solgar UK’s technical director and a member of the Herba Sacra group formed recently to lobby for botanical law change, said the MHRA had listened to complaints about smaller businesses being harshly hit by the registration process and other concerns about market devastation, but suggested no path of change.
“They listened but we are not sure they see much room for manoeuvre,” he said.
Harkin has begun rallying support in the European Parliament for amendments that may include drawing up of a separate piece of legislation to cater for botanicals such as Traditional Chinese and Ayurvedic medicines, Harkin told this publication.
This “other” legislation was hinted at by the EC in September when it issued a document that stated, “the suitability of a separate legal framework for products of certain traditions should be assessed."
But there exists no timetable for this process, and given typical EU lawmaking timeframes, therefore little chance it would enter the legislature before 2011. Harkin said companies, in the meantime, should work within the legislation as it stood, as “timescales were very tight”.
ANH executive and scientific director, Robert Verkerk, said despite any misunderstandings between his group and the EC, the push for amendment was growing in strength, and would see it head to India soon to collect data that may influence EU lawmakers.
“Whether it happens before the 2011 or not is hard to say, but there is room for negotiation,” he said, adding he was under no illusion about how much work needed to be done.
“The process will be helped greatly if there is an acceptance by the European institutions that evaluation systems will need to be based on those already in use by premium suppliers in countries like India and China,” Verkerk said.
"If the THMPD is not amended 1000s of jobs will be lost," said vice president of sales and marketing at Unigen Europe, Doug Lynch.
EC representatives at the meeting with ANH and co. were Georgette Lalis, director of consumer goods, Martin Terberger, the head of pharmaceuticals unit and Per Thomas Thomassen, advisor on traditional herbal medicines.
After 2011, it is feared thousands of products will fail to achieve registration for scientific, financial or other reasons, resulting in a mass homogenisation of the EU botanicals market.
It is felt botanicals such as arthroscopic, Ayurvedic and Chinese medicines are particularly under threat because the requisite science is often not in place, nor do they have the 30 years of safe use, including at least 15-years inside the EU.
The THMPD is often criticised for favouring bigger companies that can afford to pay the registration fees and build scientific dossiers to back claims – a process that can cost €100,000+.
It is also seen to have a pharma slant as it demands toxicology and other data that often doesn’t exist for many traditional herbs and especially those that fall into the arthroposphic, Ayurvedic and Chinese medicines.
So far it is estimated about 100 registrations have been approved, mostly in the UK and Germany.