ANH scientific and executive director Robert Verkerk, PhD, wrote an open letter to EC commissioner John Dalli in June highlighting his group’s concerns about how the Traditional Herbal Medicinal Products Directive (THMPD) will damage sectors such as Ayurvedic or Chinese herbal products.
This week’s response from an EC official was a whitewash, the ANH said.
“Unfortunately, the response letter provides no answers to the very serious issues ANH-Intl had raised,” it said.
“The EC letter was signed off by Mrs Joanna Darmanin, and it contains no indication as to whether there was any direct input from Commissioner Dalli himself.”
Indeed the letter scolds the ANH for its coverage of a European Parliament (EP) forum where such issues were debated, and its references to particular individuals within the EC. It advised the ANH to seek EP routes to air its concerns.
Frustrating
“It is frustrating to get the cold shoulder from the Commission in this manner,” Dr Verkerk said.
“ANH-Intl and other organisations have in the past, and continue to, raise numerous questions in the European Parliament, only to meet with the same whitewashed responses on each occasion. It seems that the Commission is intent on maintaining a monolithic institutional stance, devoid of any individual responsibility.”
“What this amounts to is a particular blend of controlled democracy, where individuals and organisations are only permitted to voice concerns in a way that ensures no one person or group of individuals are answerable.”
In his open letter to commissioner Dalli dated June 21, Dr Verkerk expressed his frustration at the result of the EP forum three days earlier where he felt debates about herbal food supplements would be treated by the THMPD gained short shrift.
“…rather than trying to force non-European products into a European phytopharmaceutical model, would it not have been better to build a regulatory system around the great, long-standing, non-European traditions?” Dr Verkerk wrote.
“But we understand neither the European Commission nor the EMA was ever serious about getting the necessary technical support from China, India or elsewhere, so perhaps we should not be surprised.”
While the UK and German medicine agencies take the same position that all non-prescription botanical supplements must be registered, all but a few hundred of the estimated 2500 products on the German market have had previous national registrations accepted under the THMPD.
The opposite is true in the UK, and, as of May 1 this year, the UK Medicine and Healthcare products Regulatory Agency (MHRA) has issued only 105 THMPD registrations, out of 211 applications. Dossiers backing individual products can cost more than €50,000 to prepare and process. The registration focuses on safety and tradition of use and demonstration of efficacy is not required.
Dr Vrekerk’s full letter can be found here.
The EC’s response can be found here.