Authorization

Summary Authorization
Underneath we have described the history of the development of the Hahnemann Apotheek bv. It all began in an accelerated pace because of the authorization law for homeopathica in the Netherlands that was passed in 2002. The numerous changes for everyone involved since that time are described briefly.In the book ‘Homeopathica’, in the first chapter (I-2), published in 2015, you can find an extensive description. In itself the authorization of homeopathica can be considered a positive step towards recognition, but because of the increasing demands and costs involved it is a hindrance in the freedom of choice for the patient.

The situation concerning homeopathic remedies in the Netherlands since June 1, 2002
Based on a European ruling, homeopathic remedies must be authorised before they can be put on the market, in the whole of Europe. Towards this end international rules were issued that were then adopted by the legislatures of each member state.

The Netherlands decided, contrary to the other European countries, to enforce these rules rather rigidly and in a short period of time, without taking the characteristic properties of homeopathy into account

First some figures
There are about 3000 base materials that are used in classical homeopathy. Of these, 600 are used quite regularly and the rest to a much lesser extent. Even so, it is very important for homeopathic prescribers to have access to the whole arsenal for his/her patients. The single homeopathic remedies come under a simplified authorisation regime.

In 2003 the most important 600 raw materials were authorised at the CBG (Authorisation Office) by VSM Geneesmiddelen bv. Of those initial ones, 500 remained in the following years. The requirements became more and more stringent. Eventually, by October 1, 2011, VSM had an active authorisation of 400 base materials. In 2015 this number was lowered to 350. It is not probable that more authorisations will follow. Because of the high costs involved, it is often not worthwhile to authorise remedies that are prescribed less, even though they can be important for the individual patient.

(The figures used by the Authorisation Office (CBG) greatly differ, because they do not count per base material, but per pharmaceutical shape: drops, tablets, granules etc.)

Till June 1, 2002 there were about 10.000 homeopathic complex remedies, ampoules etc. on the market that are now being judged by the much more extensive authorisation regime. So far, about 500 products have been authorised; mainly the frequently used self-medication remedies.

The consequences
On June 1, 2002, a homeopathic remedy that had not been authorised (or not given for authorisation) had to be taken off the market immediately, without any transitional measures. The producers and pharmacies were prohibited to sell these remedies instantaneously.

Unauthorised homeopathic remedies are allowed to be supplied by a pharmacy on doctor’s orders (thus, with a prescription), if the pharmacy prepares the remedies itself. In fact, this is the ‘raison d’être’ of the Hahnemann pharmacy.

There are only a few pharmacies in the Netherlands that prepare homeopathic remedies like the Hahnemann pharmacy does. Authorised remedies can be looked up and the information leaflet can be read on the Internet website of the CBG.

Except for the odd one out (see under reimbursement), insurance companies actually only want to reimburse authorised homeopathic remedies.

What does this mean for the patient?
If the patient only uses single homeopathic remedies, the consequences for the patient will be better than expected. That is to say, that in conjunction with VSM, the Hahnemann pharmacy has arranged that everything that could be delivered by VSM before June 1, 2002, could be delivered by the Hahnemann pharmacy after that date too. The only difference is that for the non-authorised homeopathic remedies a prescription by a professional is always needed. If the Hahnemann pharmacy, unexpectedly, cannot prepare a single homeopathic remedy itself, the prescription is sent on to a colleague pharmacy in Europe. This means that the prescriber and the patient don’t have to figure everything out themselves. This work is done for them by the Hahnemann pharmacy.

If the patient is prescribed ampoules or a complex homeopathic remedy, a replacement will be needed in 80% of the cases. The Hahnemann pharmacy will advise the prescribers where possible. As a last resort the Hahnemann pharmacy can make a complex remedy itself, if asked. As a result, however, the costs will be much higher, because of the work involved. An alternative could be that the patient sends his/her prescription to a pharmacy abroad, e.g. Germany or Belgium, where some remedies are still available. As mentioned above, the Hahnemann pharmacy can take care of this for the patient. Because insurers, like the government, are mainly cost oriented and have little understanding of alternative medicine, reimbursement for homeopathic remedies is very limited. Only authorised homeopathic remedies qualify for reimbursement. The preparations by our own pharmacy are not reimbursed. 

Consequences for the homeopathic prescriber
He/she is not allowed to have unauthorised homeopathic remedies available for the patient in his/her practice anymore. More than ever, the prescriber will have to give a prescription, especially for non-authorised homeopathic remedies.