Herbals directive enters into force
Europe this weekend are likely to push up prices over coming years
as manufacturers meet high costs for registering their products.
Europe's Traditional Herbal Medicinal Products Directive (THMPD) aims to establish higher levels of safety and quality for traditional herbal remedies and improve public confidence in the products.
While most herbal suppliers recognise the merits of the law in the long-term, many are worried about the high costs of complying with all elements of the new law.
"The overriding concern about this directive is the cost," confirms Penny Viner, chairwoman of the Herbal Forum, a group of industry and practitioner associations.
"A lot of companies in the herbal industry are SMEs," she added.
To register a product as a traditional medicinal herbal, allowing the company to make a low-level claim on it across all member state markets, involves compiling data to prove a plant's traditional use as a medicine for at least 15 years in the European Union.
Manufacturers must then meet ongoing quality standards and have data on the safety of the production process, a level similar to that required by medicines manufacturers.
They must also issue consumer information on the product and directions for its safe use, in braille as well as standard print, adding to initial costs.
"If a firm does not already have a medicines manufacturing licence they are required to invest significantly in quality control," noted Viner.
She added that the UK market is likely to see higher costs than others because of the great number of combination products on offer.
"Doing traceability on herbs back to the field, for the number of different raw materials in some traditional herbal products will be nigh on impossible," she said.
Raw material suppliers will be impacted too as the more evidence they can provide of good agricultural practice, the better equipped their customers will be for registration of their products.
"Because of the costs, there will be some product losses," said Viner. "And I think it is probable that there will be price rises."
"But to a degree, some of the increased costs are inescapable and it really is about planning ahead," she concluded.
The new directive must be written into the national laws of all member states by 30 October, however most states will permit a transitional phase, giving companies until April 2011 to adapt to new arrangements.
Companies serious about gaining a THMPD registration are already holding meetings with their national medicines authorities, says Viner. Others should be looking at the alternative options under food law.
With the planned introduction of health claims on foods, this option could allow some herbal product makers to make claims even though they are not registered as traditional medicines.
"Of course the industry is concerned that there will still be a large market that goes underground or sells over the Internet," Viner noted.
