Homeopathic medicines : insufficient therapeutic efficacy for reimbursement

Unlike other medicinal products, homeopathic medicines were not scientifically assessed before being listed for reimbursement several decades ago. In this context, the Ministry of Solidarity and Health asked the HAS to assess the validity of their continued reimbursement by the French national health insurance system.

First scientific assessment with a view to reimbursement in France

The HAS Transparency Committee conducted the first French scientific assessment of homeopathic medicines. It concerned some 1,200 homeopathic medicines/products (1,200 stocks, which may each have different dilution ratios and be combined with one another), i.e., a much larger-scale assessment than those usually conducted by the Committee. The Committee based its analysis on more than 1,000 scientific publications, the contributions of stakeholders and the documents and dossiers submitted by the three pharmaceutical companies concerned (Boiron, Weleda and Rocal-Lehning).

At the end of this 9-month scientific assessment, the Transparency Committee issued an unfavourable opinion for the continued reimbursement of homeopathic medicines. This opinion was adopted following a majority decision at the plenary session of 26 June, following the inter partes review. This enabled the three pharmaceutical companies to present (in writing and at the hearing on 12 June) their arguments relative to the draft opinion adopted by the Committee on 15 May.

The Committee’s opinion was transmitted to the pharmaceutical companies and to the Ministry for Solidarity and Health, who is responsible for reaching the final decision concerning maintenance of homeopathic medicine funding in France.

Efficacy not sufficiently demonstrated to justify reimbursement

The Transparency Committee identified scientific data for 24 conditions and symptoms treated with homeopathic medicines, such as anxiety, verrucae, supportive cancer care, acute respiratory infections in children, etc.

For all these conditions and symptoms, the Transparency Committee considered that these medicines had not scientifically demonstrated sufficient efficacy to justify funding. There are several reasons in support of the committee’s conclusion:

• absence of efficacy evidence (insufficient or absence of efficacy data),
• conditions that are not serious and that resolve spontaneously, thus not requiring routine use of medicinal products (conventional or homeopathic),
• absence of robust studies to assess the impact on patient quality of life,
• absence of impact data in comparison to other medicinal products with regards to medication misuse, number of hospitalisations, treatment delays or organisation of care.

Always propose treatment suitable for patient needs

During this assessment, the HAS stressed that the use of homeopathy must not delay the prescribing of treatments known to ensure patient care, particularly for serious and progressive diseases.

It is noteworthy to remind prescribers and their patients that it is not always necessary to prescribe a medicinal treatment. The objective is to move away from a culture of systematic medicine prescribing and use and encourage preventive, non-medicinal treatment approaches with demonstrated health benefits, such as physical exercise.

¹HAS committee tasked with assessing medicinal products with a view to their reimbursement. It is an independent medical committee made up of general practitioners and specialists, pharmacists, epidemiologists and methodologists, as well as patients and users.