The INH to MEPs on homeopathy in the EU Medicines Directive

In the meantime, the Spanish government has initiated a wide outreach against pseudomedicine. For example, it no longer wants to accept the medicinal status of homeopathy, wants to ban homeopathy from pharmacies and has already “discontinued” the first batch of homoeopathics which could not present a valid proof of efficacy upon request. England is currently performing a complete “blacklisting”, i.e. a process that means the end of any registration for homeopathic medication with a drug authority.

The EU Medicines Directive does not regulate in detail how exactly the member states deal with homeopathy in health care. However, it does fix two key points: It includes homeopathy in its definition of a medical drug and obliges the states to regulate a simplified registration procedure for homeopathy instead of the usual drug approval. If one seriously wants to dispute the status of homeopathic medicinal products (and thus their privileges), one cannot completely ignore EU law.

Spain knows that. At various levels (including that of the government), there are efforts to achieve a revision of the EU directive on medicinal products in the field of homeopathy. These efforts need support. The INH has therefore addressed the following letter to German MEPs, which is initially intended to provide basic information on the facts of the case and support Spain’s position in the expected discussion. This seems all the more necessary as the European homeopathic manufacturers and associations have for a long time maintained a lobby organisation directly in Brussels, which apparently has quite good material and personnel resources and whose task is to exert direct influence “on the spot”. We do not have such resources, but we do have the facts. And who knows – perhaps one or the other national government will even join Spain and become active in the EU?

______________

Mr. Mrs. …
MEP

by e-mail                                            7 August 2019

Homeopathy in the EU Medicines Directive

Dear Madam / Sir,

The European Medicines Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,  Official Journal of the European Community L 311, 28.11.2001) classifies homeopathic preparations as medicinal products and requires national governments to establish a simplified registration procedure outside the otherwise prescribed rules for marketing authorisation for pharmaceutical remedies.

However, the consensus of the worldwide scientific community has long since classified homeopathy as a specifically ineffective sham therapy, the spread and “popularity” of which have completely different bases than those of medical relevance (evidence). In many countries, this insight is now gaining acceptance. It will be in the well-understood interest of the public’s health to take consequences of this. The misguiding of the public that homeopathy is a form of therapy expressly recognised by the legislator and therefore endowed with the credit of efficacy and harmlessness may not be continued.

In this respect, the Kingdom of Spain is already campaigning for an amendment to European pharmaceutical law, which not only grants homeopathic preparations the status of medicinal products by definition, but also grants them the additional privilege of registration (see also http://www.europarl.europa.eu/doceo/document/E-8-2018-004948-ASW_EN.html). This special legal framework has no objective justification, as the EASAC – as official advisor to the EU institutions – clearly stated in its statement of 20.09.2017 (https://easac.eu/publications/details/homeopathic-products-and-practices/).

In the interest of a science-based, honest and patient-oriented health policy, also on behalf of the German Consumer Association e.V. and its regional associations, we ask you to support a revision of the Medicines Directive in the sense described, in order to clear the way for appropriate national regulations under Community law.

You can inform yourself about the scientific status of homeopathy on the (multilingual) website of our association: www.network-homeopathy.info .

Yours sincerely

For the  Information Network Homeopathy

Dr. Natalie Grams – Dr. Ing. Norbert Aust – Dr. Christian Lübbers