Homeopathic products and practices: regulating medical claims in the EU

Homeopathic products and  practices: assessing the evidence and ensuring consistency in regulating medical claims in the EU 

Summary
EASAC, the European Academies’ Science Advisory Council, is publishing this Statement to build on recent work by its member academies to reinforce criticism of the health and scientific claims made for homeopathic products. The analysis and conclusions are based on the excellent science-based assessments already published by authoritative and impartial bodies. The fundamental importance of allowing and supporting consumer choice requires that consumers and patients are supplied with evidence-based, accurate and clear information. It is, therefore, essential to implement a standardised, knowledge-based regulatory framework to cover product efficacy, safety and quality, and accurate advertising practices, across the European Union (EU). 

Our Statement examines the following issues: 

Scientific mechanisms of action—where we conclude that the claims for homeopathy are implausible and inconsistent with established scientific concepts. 

Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect. There are related concerns for patient-informed consent and for safety, the latter associated with poor quality control in preparing homeopathic remedies. 

Promotion of homeopathy—we note that this may pose significant harm to the patient if incurring delay in seeking evidence-based medical care and that there is a more general risk of undermining public confidence in the nature and value of scientific evidence. 

Veterinary practice—we conclude similarly that there is no rigorous evidence to substantiate the use of homeopathy in veterinary medicine and it is particularly worrying when such products are used in preference to evidence-based medicinal products to treat livestock infections. 

We make the following recommendations. 

1. There should be consistent regulatory requirements to demonstrate efficacy, safety and quality of all products for human and veterinary medicine, to be based on verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of this evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product.
2. Evidence-based public health systems should not reimburse homeopathic products and practices unless they are demonstrated to be efficacious and safe by rigorous testing.
3. The composition of homeopathic remedies should be labelled in a similar way
   to other health products available: that is, there should be an accurate, clear and simple description of the ingredients and their amounts present in the formulation.
4. Advertising and marketing of homeopathic products and services must conform to established standards of accuracy and clarity. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence.

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