The Irish market for herbal medicines has evolved dynamically over the past number of decades, with herbal remedies being used widely as a form of complementary medicine and often used in addition to orthodox treatment.
This development has resulted in a growing demand for better regulation of herbal medicines and for the medical establishment to have confidence in their efficacy and safety, with greater protection for consumers. This recommendation for better regulation has included the regulation of herbal products that are manufactured and sold over the counter as pills, capsules, lotions, creams and tinctures – a market estimated to be worth around €200m (£133.1m) a year.
Medicines are strictly regulated in the EU and elsewhere for obvious reasons. In effect, any product stated to have a therapeutic effect – for example by making a claim on its label – needs a licence, which is known as a ‘marketing authorisation’. To get one, all prescription drugs and many over-the-counter drugs must undergo rigorous testing, including extensive clinical trials to ensure that they meet very strict safety, quality and efficacy criteria.
For herbal medicines, the legal situation has been quite different. Many countries have little or no regulation in place and herbal medicines are generally more likely to be regarded as ‘foods’ than ‘medicines’. This means that they do not undergo any licensing procedure. Manufacturers of herbal medicines do not have to prove safety and efficacy. The manufacturers are responsible for the truthfulness of the claims but are effectively unregulated.
Herbal medicines can make claims about effects on the structure or function of the body. They cannot make claims about disease or prevention of disease. If the manufacturer of a herbal medicine wants to make such a claim, the product will have to be regulated as a drug. The Irish Medicines Board (IMB) will generally become involved with herbal medicines when issues of public concern are raised.
In order to deal with such issues, the EU has moved towards the statutory regulation of herbal medicines and has adopted the Directive on Traditional Herbal Medicinal Products (the directive) legislation.
The European Parliament and the European Commission requested the creation of a working group on herbal medicinal products. Subsequently, the European Agency for the Evaluation of Medicinal Products (EMEA) set up an ad hoc working group to address the issues of quality, safety and efficacy of these products. The working group liaises with learned societies interested in the field of herbal medicinal products and draws upon available expertise in the development and manufacturing of such products. The main thrust of the working party is to provide guidance for the assessment of herbal products, both to individual member states and those applicants now applying for marketing authorisations.
The purpose of the directive is to create a ‘soft’ licensing system for herbal medicines, which will allow evidence of quality and safety, but not evidence of efficacy in the way required for pharmaceuticals.
Herbal manufacturers will have to demonstrate that products have been safely used for 30 years in the EU, or for a combination of 15 years within the EU and 15 years outside it. The manufacturers will be required to register unlicensed products and produce them according to “good manufacturing practice” (principally sterile conditions) with a guarantee that herbal remedies conform to a certain minimum standard. This is particularly important, as the active ingredients of the herbs will be clearly tested for safety and proof of quality to restrict the level of potentially hazardous ingredients and warnings about safe and correct use will thus be provided.
There has been a great deal of anxiety expressed by many manufacturers with regard to the directive regarding the licensing procedure: many say it will be so costly that many small businesses in the herbal sector will be forced to remove their products from the market and have their practice restricted to untenable levels.
However, the benefits that will emerge from the proposed new directive will be significant and there will be greater protection offered to consumers.
The directive was adopted formally at a Council of Ministers meeting on 11 March 2004 and it is expected that the text will soon be published in the Official Journal of the European Communities. Under the terms of the directive, measures to implement the directive must be taken within 18 months of it coming into force. This could lead to the introduction of a simplified registration scheme for manufactured, over-the-counter traditional herbal remedies in the second half of 2005. There would then be a further “transitional” period of five years to allow all existing herbal medicines to gain a “traditional registration”.
Any herbal manufacturer now wishing to obtain product registration for its herbal product must make an application to the IMB and provide a bibliographic review of the safety data. In the absence of clinical or toxicological data, the safety of a product may be determined primarily by reference to bibliographic data. Such data will include post-marketing surveillance data and periodic safety update reports. All such data will be verified by an expert.
A product registration may be refused or later revoked if the herbal manufacturer fails to provide the necessary information, or if new safety data emerges that highlights a potential threat to public health. The herbal manufacturer will be provided with an opportunity to appeal the decision for any application that is refused. When an application is refused, the herbal manufacturer must remove the product from the market.
The IMB is the competent authority responsible for the licensing of all drugs on the Irish market. It has set up a database of traditional and herbal medicinal products, providing essential information on the potential size of the market, and to date there are 2,246 products on this database. The total number is expected to increase once the directive is in place.
Marcella Clarke is a legal executive, and David Cullen a partner, in William Fry’s biotechnology and healthcare department