HOMEOPATHY TODAY

What regulations exist for homeopathy throughout the world ?

Every year, more and more countries are granting homeopathic drugs an official status. Overview of the regulations throughout the world.

Homeopathy recognised by the European Union

In Europe, the harmonisation of the legislation on homeopathic medicine marked a turning point: it constitutes official recognition of homeopathic medicine in all EU countries.

Although the first “medicine” directive adopted by the European Union dates back to 1965, the status of homeopathic medicine was only officially recognised in 1992 with the adoption of two directives concerning homeopathic medicine for human and veterinary use.

This Community recognition demonstrates homeopathic medicine’s integration into the European medical and pharmaceutical world.

A medicine just like the other

Since these two directives came into effect, specific registration rules have been set for homeopathic medicine. However, as regards good practices in terms of manufacturing, control and stability studies, they are subject to the same rules as other medicine:

      • The chemical, pharmaceutical and biological documentation demonstrates the quality of the homeopathic medicine according to the same provisions applicable to other medicine.
      • The harmlessness, justification of the homeopathic use and therapeutic indications are based on the bibliography, the homeopathic materia medica and clinical data.

What are the concrete effects for the member countries?

The European directives on homeopathic medicine are aimed at harmonising the regulations and allowing the free circulation of homeopathic medicine in EU countries.

The majority of countries, including France have now transposed them into their own regulations.

Mutual recognition

In 2004, the European pharmaceutical legislation was amended: now, the mutual recognition procedure, which enables a Member State to recognise a medicine as soon as it has obtained its registration from another Member State, also applies to homeopathic medicine with a common name.

World overview of the status of homeopathy

Used in over 80 countries by approximately 100,000 doctors, homeopathy is continuing to become more widespread in North America and is achieving breakthroughs worldwide. At present, a large number of countries’ health systems recognise homeopathic medicine..

A regulatory context is being established

In America, the FDA (Food and Drug Administration) has recognised the Homeopathic Pharmacopœia of the United States (HPUS) since 1983. As an official reference on the subject, it enables homeopathic stocks to be registered. In order to be placed on the American market, the homeopathic medicine must meet the conditions established by the FDA in 1998.

For its part, the National Centre of Complementary and Alternative Therapies of the NIH (National Institute of Health) is circulating information to patients and the medical community on the scientific evaluations of homeopathic medicine.

In Canada, the regulatory context of homeopathic medicine has evolved since 2003. Whilst the use of a (DIN-HM) registration number has been kept, since 1 January 2004 homeopathic medicine has been included in the natural health products category.

In Brazil, homeopathy is a medical specialisation that has been recognised by the Conselho Federal de Medicina since 1980.

In the United Arab Emirates, the Ministry of Health implemented a homeopathic regulation in 2001, constituting a sphere of influence for several countries in the region.

In India, over 250,000 homeopathic practitioners and 75,000 medical assistants prescribe homeopathy. This specialisation is part of the Indian national health system beside western medicine and the two traditional Indian systems of medicine: Ayurveda and Unani.

Pharmacopoeias recognised worldwide

While a number of countries may not have their own homeopathic pharmacopoeia, they do recognise the French German (HAB), American (HPUS) and European pharmacopoeias.
This is notably the case in Australia, Tunisia, Morocco, Lebanon and Ukraine.

Russia also recognises these pharmacopoeias, in addition to its own.

Price and reimbursement

At the heart of the debate on health expenditure control, the issues of the price and reimbursement of homeopathic medicine raise different questions.

In the European Union, the price of medicine and its reimbursement rate are very different from one Member State to the next due to their individual national policies. In fact, in this domain, subsidarity is still the rule: with the decisions of the Member States remaining pre-eminent to those of the Union.

In France homeopathic medicine has a 35% reimbursement rate

In France, due to the price freeze in place since May 1988, the average retail price of reimbursable homeopathic medicine is 5 times lower than that of other reimbursable medicine (1.86 euros compared to 9.33euros ).

Despite this, since January 2004, the reimbursement rate of homeopathic medicine has fallen from 65 to 35%, the difference being payable by the mutual insurance companies.

Therefore, while reimbursable homeopathic medicine equate to 7% of the units sold in France, it represents only 0.4% of the reimbursed price.

A “homeopathy progress contract”

Following this decision, nearly a million patients and health professionals joined forces to ask for this project to be quashed.

Beside the other homeopathic players, Boiron is continuing its undertaking and has put forward a “homeopathy progress contract” to the public authorities asking them to:

      • Recognise that homeopathy represents a source of medicine with consideration of its specificity, without favouring or penalising it in relation to the other branches of therapeutics.
      • Accept a 65% reimbursement of certain homeopathic medicine that has undergone individual or collective evaluation during clinical or medico-economic studies..
      • Authorise the prescription of homeopathic medicine in hospitals..
      • Help contribute to research development in homeopathy by increasing the prices of medicine that have been frozen since 1988..

How are the prices and reimbursement rate set?

In the European Union the decisions of the Member States concerning price and reimbursement remain pre-eminent to those of the Union, in accordance with the principle of subsidarity.

In France, homeopathic medicine has been reimbursable by health insurance since 1945.

Due to the price freeze in place since May 1988, the average retail price of reimbursable homeopathic medicine is 5 times lower than that of other reimbursable medicine.

Despite this, since January 2004, the reimbursement rate of homeopathic medicine has fallen from 65 to 35%, the difference being payable by the mutual insurance companies.

Progressive world officialisation

Source : OMHI 2003