Spain wants medicines that are not proven as such to stop being called “medicines.”

A recent backlash against homeopathy is sweeping the European countries that are its biggest users — and that may give Spain's efforts extra momentum.

The Spanish health ministry has been campaigning for a change in a 2001 EU law that classifies homeopathic products as medicines. The European Commission is cool to that idea, amid resistance by the French, Germans and even Spaniards themselves. But with France deciding to stop paying for the products and German doctors calling for the same in their country, the tide could turn in Spain's favor.

At present, the EU has different requirements for homeopathic products, Spanish Health Minister María Luisa Carcedo said recently in El País. But it would be "sensible" if the same standard applied to them as the tougher one that's applied to conventional medicines, she added.

The backlash in Spain seems to have been triggered by reports of people refusing or abandoning regular treatment in favor of homeopathic products to treat serious diseases like cancer. One of them was Rosa Morillo, who died of breast cancer in 2017, after she refused chemotherapy and sought homeopathic treatments instead, according to El País.

"What we can do is keep up the pressure, because the change in the directive must be done at a European level." — María Luisa Carcedo, Spanish Health Minister

“The problem is the damage that can be done by opting for an alternative therapy that has not demonstrated scientific evidence,” Carcedo said.

In a national plan against pseudotherapies, Spain's health ministry cites studies showing that alternative medicines increase the risk of death in patients with serious diseases, either because standard treatment is rejected or delayed, or because using alternative medicines together with regular treatments can increase the latter’s side effects.

This argument has been challenged by the Spanish Association of Integrative Doctors, which includes homeopaths. “We don’t have proof that the person existed,” said Luis de Miguel Ortega, the association’s lawyer, referring to Morillo.

The association, which goes by the Spanish acronym AESMI, asked the health ministry for a document, presented at an informal EU health ministers’ meeting last September, that called homeopathic products a risk to citizens’ health. The Spanish government refused, saying it is an internal document meant for an international meeting.

Carcedo raised the issue again in bilateral talks at the most recent EU health ministers’ meeting in Luxembourg in June, according to one person with knowledge of the talks.

"What we can do is keep up the pressure, because the change in the directive must be done at a European level," she told El País.

The backlash in France, Germany and even Belgium — and the potential reopening of the EU pharmaceutical legislation by the next Commission — may be what Spain needs.

While EU countries have yet to formally discuss the issue, “homeopathy will be moved more and more towards wonderland,” said one health attaché.

Turning up heat on EU directive

The Spanish government has taken aim at the 2001 EU directive on the code for human medicines. It states that “homeopathic medicinal products” are eligible for a simplified registration procedure if they are administered orally or externally, have no specific therapeutic indication on their packaging; and are sufficiently diluted to guarantee their safety.

Homeopathic products with a specific therapeutic indication, meanwhile, have to get a marketing authorization following the same rules as regular medicines, including providing proof that they work.

“The average consumer ... knows what they need and they can’t be fooled” — Luis de Miguel Ortega, AESMI’s lawyer

At issue is that many homeopathic remedies are based on natural substances that have been diluted many times in water until there's little, or none, of the original substance left, according to the U.K. National Health Service. They're used for conditions ranging from asthma to depression.

But many studies and national authorities have concluded in recent years that there is no scientific proof that these purported cures work. At best, homeopathy works as a placebo, they said.

AESMI’s de Miguel Ortega, however, cited studies that show homeopathy works, and pointed to a 2013 scientific review by two Spanish doctors based on animal studies. As an unwitting test subject, the animal cannot experience a placebo effect, he argued.

Spanish rebellion

Spain has also been reluctant to implement the part of the 2001 directive that refers to homeopathic products as medicines.

That stance prompted the European Commission to take the first step toward an infringement procedure against Madrid in 2017, arguing that its policies "make it impossible in practice to introduce homeopathic medicines that are lawfully marketed" elsewhere in the EU.

The Spanish health minister at the time, Dolors Montserrat, passed an order asking homeopathy producers to renew their products’ authorization with the national drug regulator. Homeopathic medicines claiming a therapeutic indication would have to submit proof of evidence, like regular medicines. Those without an indication would have to go for a homeopathic registration, which means they can't claim on product labeling that they can combat a particular ailment, such as colds.

The Spanish medicines agency later published a list of homeopathic products that should be taken off the market, because their manufacturers had not submitted an authorization request. The products covered by the request were allowed to stay on the market until a decision on the authorization was taken.

AESMI lodged a complaint with the Commission as a result, claiming that the government was harassing homeopathic producers and intervening in the market, leaving consumers without access to some of the products. The medicines agency was trying to push out complementary products, said AESMI’s lawyer de Miguel Ortega.

The association also conducted a survey to respond to a Commission request for more information about the impact of the Spanish medicines’ agency’s move on the homeopathic market. Almost 40 percent of the 2,500 respondents said they occasionally can’t find their products in pharmacies anymore, while almost 15 percent said there are products they can’t find anymore.

A majority of the respondents said they were homeopathy users for more than 10 years.

“The average consumer ... knows what they need and they can’t be fooled,” de Miguel Ortega said.

Meanwhile, figures from the Spanish Foundation for Science and Technology released in 2018 show that homeopathy remains popular. Almost 22 percent of Spaniards think that homeopathy has a scientific basis, and one in four of them believe in its benefits. Some 5 percent said they had used either homeopathy or acupuncture instead of standard medicines.

That support is the reason why the Commission has been reluctant to give in to Spain’s request to change the 2001 law. It noted in a statement that such products remain "very popular" in many EU countries, including Spain.

The current law “strikes a balance between ensuring their quality and safety whilst giving citizens access to these products,” it said, adding that the labeling of homeopathic medicines can only mention a therapeutic indication when there is evidence to back it.

“The more diluted the evidence for homeopathy becomes, the greater seems its popularity,” the medical journal The Lancet wrote in a 2005 editorial. It explained this paradox as a search by patients for “a holistic alternative to a disease-focused, technology-driven medical model.”

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