By Peter O'Donnell
BRUSSELS (Reuters Health) – The European Union has taken a new step towards catching herbal medicines in its net of rules on pharmaceuticals. Today the European Commission proposed a modified authorisation system for traditional herbal products which, it claims, could simultaneously increase consumer protection and boost trade.
The new registration procedure is designed for herbal products with a long-standing traditional use, but which are unable to produce the full range of safety and efficacy data that EU rules normally demand for authorisation of any medicine.
Instead of conducting new tests and trials on the safety and efficacy of the product, manufacturers will be allowed to justify a marketing authorisation application on the basis of information gathered on a product's traditional use over a period of at least 30 years.
The information, in terms of bibliographical data or expert evidence, will have to be "sufficient to draw conclusions on the product's safety and efficacy", according to the text of the proposal. Therapeutic indications and routes of administration will also have to be "limited" and the strength will have to be specified. Quality requirements will remain the same as for all medicinal products.
The Commission says the measure, which now goes for approval to the European Parliament and the EU's Council of Ministers, will improve quality checks and market surveillance.
At present, "The rules governing the placing on the market and surveillance of these products differ from member state to member state", the Commission says, and "This has a detrimental impact on public health protection standards". At present there are national procedures for simplified registration in Austria, Belgium, France and Germany. The potential risks are all the greater since demand for herbal medicines is growing continuously across the European Union, according to the Commission.
At the same time, the Commission argues, manufacturers should benefit too, because creating a clear and reliable regulatory environment for these products will provide a new measure of confidence and give manufacturers, most of which are smaller firms, access to a Europe-wide market for their products. It should also boost investment and employment in the sector, it says.
A new scientific committee of herbal medicine experts will be set up in the London-based European Agency for the Evaluation of Medicinal Products, to establish standard monographs that will harmonise registration applications.
The simplified procedure will not be open to herbal products which can produce the customary evidence required under current EU rules. Nor will it be applicable to homeopathic products containing herbal ingredients.
The Association of the European Self-Medication Industry (AESGP) gave a conditional welcome to the proposal. Professor Jasmina Mircheva, the AESGP director for scientific and regulatory affairs, told Reuters that the proposed new rule should not be seen as a weakening of regulatory controls. She insisted that it would bring a new degree of scientific sophistication to the evaluation of such products.
In a statement, AESGP Director-General Hubertus Cranz said: "This is a missing piece of legislation in the complex regulatory system for medicines", which could "clarify the legal basis for many herbal products in the European Union". But his statement added a condition: it would be successful "assuming that some critical details can be sorted out". Cranz told Reuters that there was likely to be sharp debate in the coming months over the scope of the proposal, the qualifying period of 30 years, and the continuing insistence on quality requirements (which could, he said, negate the overall objective if they are too strictly applied).
There had been internal Commission discussion of a broader proposal covering "traditional" products, but conflicting definitions across the EU member states made agreement impossible, so the proposal covers only "traditional herbal" products.