Homeopathy: AIFA recognizes new products

After hearing the Italian Drug Agency gave the go-ahead to the recognition of homeopathic preparations and starting from January 2019 the homeopathic medicines on the market must have obtained the marketing authorization.

But is this really a positive news?

Let us try to understand better what is happening in this scenario of great transformation, perhaps more economic than cultural.

Recognition of homeopathic preparations

As we all know, in Italy the homeopathic medicine is not recognized, consequently not even the homeopathic remedies that we can in any case find in the pharmacy, but which lack the so-called "leaflet", without information on indications and dosage. The costs of the preparations are quite high, which makes homeopathy a practice for the few.

The recognition of homeopathic remedies in Italy allows a regulation of the practice, of the doctors who practice it and of the indications concerning the use of the preparations.

Also the costs could be reduced in the face of a greater diffusion on the market and perhaps their introduction in the national pharmaceutical handbook with a prescription charged to the National Health System.

This is a great step forward that also serves to protect the end user from incorrect indications on the properties of homeopathic remedies.

The costs of recognition

However, this goal is not painless. In reality it costs, it costs a lot, very much indeed. The bureaucratic procedure applied to the manufacturing companies is the same applied to the drug multinationals and without being great experts in the field we can understand that the debacle will be fierce and not everyone will be able to survive economically in this recognition.

Until some time ago on the Italian market there were about 6000 homeopathic preparations that have drastically decreased to around 3000 since the process of accrediting the dossiers on the remedies in question started in 2016, because the initial cost of each individual dossier is around a thousand euro per drug, destined to increase up to 20 times.

The renewal of the AIC will then be at five-year intervals with relative payment and also changes to the composition of the preparation will have an additional cost.

The consequence is that many companies in the sector will be in difficulty and many remedies will not be produced to contain the registration costs. On our market, however, there are many foreign brands, extremely widespread those in France, which could represent an alternative where there was a lack of Italian production and even this aspect could represent a further difficulty for national companies.

We hope that the Ministry evaluates all the aspects related to the procedures of recognition of the homeopathic remedy, and that if there must be a selection, it is a qualitative selection !!!!