Revision of the designation of homeopathic substances as medicinal products under Directive 2001/83/EC

26.4.2018

Question for written answer E-002348-18
to the Commission
Rule 130
Soledad Cabezón Ruiz (S&D)

There is growing concern in Europe about the lack of scientific evidence to support the effectiveness of homeopathy. In addition, there are cases where homeopathy is used instead of medical treatment, which puts patients’ health at risk, for example in the case of serious diseases, such as cancer.

Under Article 1(2) of Directive 2001/83/EC on medicinal products for human use, a ‘medicinal product’ means any substance, or a combination of substances, presented for treating or preventing diseases, and substances administered with a view to modifying physiological functions.

The same Directive also refers to homeopathic substances, for which the authorisation process requires only that they do not include therapeutic indications and that they demonstrate a sufficient degree of dilution, without being required to demonstrate their effectiveness, as ‘medicinal products’. Consequently, their treatment will vary from Member State to Member State.

1. Does the Commission consider it appropriate to revise the directive to remove the reference to homeopathic substances as ‘medicinal products’?

2. Does the Commission consider their inclusion in a directive on medicinal products to be consistent with the principles of quality, safety and efficacy of medicinal products advocated by the EU?

3. Does the Commission agree that European consumers would be better informed if the designation ‘homeopathic substances’ were used in all cases instead?