Joerg Gruenwald06.01.02
The Future Of Herbal Medicines In Europe
The impact of legislation on the herbal market.
By Joerg Gruenwald
It is well accepted internationally that the growth of herbal medicinal products around the world during the last two decades was built on a consumer need, but also on increasing science about the effects of herbal medicines. Europe is leading with regards to sales of herbal medicines per inhabitants but also regarding the performance of pharmacological and clinical trials. The key market is Germany followed by France as these countries have the highest sales, but also the most rigid requirements regarding quality, safety and efficacy.
When looking at the legislation of herbal products in Europe it is characterized by a great variety. In the main markets, herbal products are regulated predominantly as medicines as is the situation in Germany with full medical registration. In other countries, however, some products are marketed as drugs but with a simplified registration procedure as is the case in France. In other countries herbs are regarded as food and need notification or even registration like in Belgium, or they are completely under food status like in the Netherlands. Due to the European harmonization, an overall framework has to be established.
Over 35 years ago, the directive 65/65 from the European community indicated that herbal medicinal products, which are used for treatment or prevention of diseases, have to be regulated as drugs. More recently, however, a European draft for the regulation of supplements is under development. The first part does not cover herbs but it is likely they will be addressed in the future.
Harmonizing herbal medicines as traditionally used drugs is another possibility, which would permit the free sale of herbal products.
Uniform regulation for Europe is essential because at the moment, it is practically impossible to bring the majority of the American combination products in the same formulation to European markets. There are some creative ways to modify formulations and to be flexible with regard to the status of the product and the claims they can make, but it is a time consuming process.
The American way has its limitations considering the problems it has faced in the market over the last couple of years. These problems occurring in the U.S. do not exist in the same way in the major European markets. For example, in the German and French market the quality of the products is defined in monographs so that an effective dose is delivered to the consumer. The medical community is very open to those products and are prescribed by physicians and even reimbursed by the health insurance system.
An opening of the market, which will happen sooner or later, will allow new herbal products to be introduced. For the future, therapeutic doses with medical claims may require drug registration, probably with a simplified procedure. In addition there are the traditional products, which have a good market history and are safe.
Discussions continue between the industry, researchers and regulators describing a separate supplement category with lower non-therapeutic dosages and milder claims, which could open up new, interesting segments all over Europe.
The acceptance of herbal products in Europe is very broad in several markets. Although the medical communities strongly support products, we see new growth in this category as Europe-wide regulations open new opportunities to the industry.NW