The groups believe the 2004 Traditional Herbal Medicinal Products Directive (THMPD) is damaging the botanicals sector, particularly Chinese and Indian herbal products that do not possess the kind of scientific backing the legislation requires for authorisation.
At the Brussels meeting they tabled a position paper committing to three measures:
- the initiation of judicial review proceedings with the aim of gaining a reference to the European Court of Justice (ECJ)
- improvement of the food supplements regime governing Chinese and Indian herbal products
- the development of a new herbal product legal framework
The paper can be found here.
The groups have received a legal opinion on challenging the Directive from UK legal firm, 11KBW, and plan to seek an ECJ judicial review via a yet-to-be-selected EU member state. They cite a lack of proportionality and transparency as the main grounds for a potential challenge.
It is also expected the Indian, Chinese and other governments will make a formal complaint about the regulation to the World Trade Organization.
Herb law issues
ANH scientific and executive director, Dr Rob Verkerk, said the treatment of herbal products under the THMPD and 2006 nutrition and health claims regulation (NHCR) was unacceptable.
“While the herbal directive provides an additional framework that is amenable to some, predominantly European herbal products, it simply doesn’t work for the majority of complex, multi-herb products associated with these ancient non-European traditions,” he said.
“We have seen a big increase in classifications by national medicine regulators of herbs as novel foods or unlicensed medicines, and it is clear that regulators intend to narrow the scope of the food supplement regime for herbal products after April next year [when products must comply with THMPD].”
Dr Verkerk said the swathe of negative herbal health claim opinions coming through from the European Food Safety Authority was set to remove hundreds of products from EU store shelves.
“The herbal directive, which should provide a carve out for these products, acts disproportionately against non-European traditions, while also discriminating against those who want to use such products – that have after all stood the test of time – to manage their own health. It is therefore essential that judicial review proceedings are started in advance of the end of the transition period [before April next year].”
The European Benefyt Foundation’s Chris Dhaenens added:
“Amongst our proposals, are revised quality control measures that are both cheaper and more effective than those offered by the existing directive. We are very happy to be collaborating closely with the ANH and are hopeful that a strong, more united effort will bring positive change.”