By European Coalition on Homeopathic & Anthroposophic Medicinal Products (ECHAMP)
Homeopathic medicinal products have a strong foundation in the EU law.
- Specific EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States.
- Most Member States officially confirm a market in their country, and patients and prescribers use them in all Member States.
- Legislation is based on the EU principles of free trade and freedom of choice.
- The European Pharmacopoeia and other national pharmacopoeias set high-quality standards for the starting materials and manufacture of these products.
An Introduction to the European Union
The European Union (EU) is unique.
It is a political and economic union of 27 member states with a total population of about 450 million. An internal single market has been established through a standardised system of laws that apply in all member states in those matters, and only those matters, where the states have agreed to act as one.
Unlike the United States of America, the EU is not a federal state, because its member countries remain independent sovereign nations. Nor is it a purely intergovernmental organisation like the United Nations. The EU is a hybrid system that combines elements of both federal and intergovernmental systems. The member countries do take some joint decisions by pooling sovereignty, in particular through the European Council, mainly composed of heads of state or government of the EU member states.
EU Pharmaceutical Regulation
EU legislation on human medicines dates back to the 1960s. Its aim is to safeguard public health without hindering the development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is comprehensive, covering the entire lifecycle of a medicine, from manufacture to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution, and pharmacovigilance practice are applied to ensure the quality and safety of the medicines.
A medicinal product must be authorised before it can be placed on the market. In the EU regulatory system, there are several routes for obtaining marketing authorisation: either at European level (the centralised procedure) or at national level (the decentralised and mutual-recognition procedures).
EU Regulation of Homeopathic Medicinal Products
Specific EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States. Even before the introduction of the first EU legislation in 1992, homeopathic medicinal products were prescribed and used in all Member States. Regulation of these products dates back to 1967 in France and 1976 in Germany.
In 1992, European Directive 92/73/EEC created specific provisions for homeopathic medicinal products. The basic values for the legislation were free trade within the Community and freedom of choice for patients and the main motivation behind the legislation was the intention to safeguard quality and safety
Today, most Member States officially confirm a market in their country and patients and prescribers use these products in all Member States. ECHAMP’s timeline charts the milestones in the EU legislation of homeopathic medicinal products since 1992.
Today, Directive 2001/83/EC on medicinal products for human use regulates homeopathic medicinal products at EU level, ensuring the same high level of quality and safety as for other medicines while also recognising the importance of national traditions.
It outlines two procedures for market access of homeopathic medicinal products:
- Special Simplified Registration Procedure (Article 14) (simplified registration);
- Marketing Authorisation (Article 16).
Simplified registration applies to homeopathic medicinal products that comply with the following criteria:
- They are administered orally or externally;
- No specific therapeutic indication appears on their labelling;
- There is a sufficient degree of dilution to guarantee their safety; in particular, they may not contain more than one part per 10,000 of the mother tincture or more than 1:100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription.
Those products which do not comply with these criteria need to be authorised in accordance with Article 16. As a consequence, the general marketing authorisation procedures for allopathic medicinal products are in principle applicable to homeopathic medicinal products which are not eligible for a simplified registration.
However, Member States have the competence under Article 16(2) to retain or introduce specific rules for pre-clinical tests (pharmacological and toxicological tests) and clinical trials in accordance with the principles and characteristics of homeopathy as practised in that particular Member State.
Therefore, the status of implementation of Article 16 of Directive 2001/83/EC varies considerably in the 27 Member States of the EU.
The Highest Level of Quality and Safety
The European legal and regulatory framework guarantees for homeopathic medicinal products, as for all medicinal products, through several mutually reinforcing activities, the quality and safety of these products, and therefore patient safety.
The European Pharmacopoeia and other national pharmacopoeias play a key role in setting the quality standards for the starting materials and manufacture of homeopathic medicinal products.
They are produced according to Good Manufacturing Practice (GMP) and distributed in accordance with Good Distribution Practice (GDP) as in force by European and national pharmaceutical legislation.
In establishing regulations for homeopathic medicinal products, the EU has done a good job in respecting the competence of each Member State to provide comprehensive healthcare best suited to its citizen, while at the same time providing a European-wide regulation. The current regulatory framework for homeopathic products strikes a balance between ensuring their quality and safety, while at the same time giving citizens access to these products.
ECHAMP, the European Coalition on Homeopathic & Anthroposophic Medicinal Products, is the European association of companies that work closely together to ensure that its members can meet the demand from users and prescribers across the EU for these products. It advocates in favour of an appropriate regulatory environment in the EU.
EFTA countries, 2016