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Source: European Academies Science Advisory Council

Statement date: September 27th, 2017

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 helth and scientific claims made by 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, knlowledge-based regulatory framework to cover 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 appaear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is a robust, reproducible evidence that homeopathy is effective beyond the placebo effect. There are related concerns for patients-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 pratice - 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 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 of 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 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 should not be made without demonstrable and reproducible evidence.

further information: secretariat at easac.eu. EASAC