Homeopathic products will soon get the definitive green light from the Health Ministry. A ministerial order is being readied to give the seal of approval for thousands of products that are already being sold in pharmacies thanks to a temporary permit that has, in fact, been in place nearly two decades.
According to the draft legislation, in order to obtain a new license, homeopathic products will have to comply with similar conditions as those required of industrially produced medicine. Labs will have to draft a report stating the product's quality, safety and efficiency — although the latter parameter will take into account its homeopathic nature, meaning that clinical trials are not required, just traditional usage, according to the Diario Médico publication. Products that are authorized by the Spanish Drug and Health Products Agency (AEMPS), which answers to the Health Ministry, will be included on a drug registry.
But first they will have to pay a fee of around 390 euros for products with a specific therapeutic goal — such as treating the flu — and around 90 euros for those meant for generic use. Signing up on the register also opens the door to advertising the product, just like any regular over-the-counter drug.
The Health Ministry on Monday declined to discuss the project, but if it goes ahead as planned, it will be one of the few existing regulations in a chaotic market. There is no law on alternative therapies such as homeopathy, which is controversial because of its effectiveness — or lack thereof. A report drafted by the Health Ministry two years ago at the request of Congress concluded that homeopathic products had a questionable effect, similar to that of a placebo.
There is no law on alternative therapies such as homeopathy
Following that report, homeopathy and other practices such as acupuncture remained in a legal limbo, apart from the 19,000 homeopathic products that have been on sale at pharmacies since 1994 thanks to a provisional license that was awarded with the understanding that more permanent legislation would follow. But the legislation never came.
This is not the first time that the health authorities have tried to bring some order to the sector. An attempt by ministers in 2008 got nowhere, meaning that thousands of homeopathic products are still pending analysis. The Health Ministry says in a report that substances are legally being sold that "have little or nothing to do with the homeopathic therapy they claim to be used for, or whose components violate even homeopathic criteria, either because of their nature or their proportions."
This lack of regulation and registration has also made it hard to create a list of existing products for sale, says Susana Díaz, technical director of Boiron, one of the largest homeopathic laboratories. Díaz explains that manufacturers have been demanding a set of rules for years so that the products that are already getting sold can be updated. After that, she says, would come authorization for new substances. Díaz also notes that Spain lags behind other European countries, which sell products that are not on the domestic market.
Boiron, which has a catalogue of around 1,000 substances, is still analyzing the ministry's plan and trying to determine what kind of a cost the fees will mean for them.