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18th Sep 2018

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EU alternative-medicine safety rules will slim down access

  • Traditional herbal medicinal firms have had seven years since the passage of an EU law governing the sector in 2004 to register their products with national authorities (Photo: Jean-Francois Chenier)

Measures forcing the purveyors of alternative medicines to prove they are safe and that they have a long track-record of people believing they work will cut the number of herbal remedies and traditional Chinese medical products on the European market from 1 May.

Firms providing such products with medicinal claims, from echinacea to peppermint oil, have had seven years since the passage of an EU law governing the sector in 2004 to register their wares with national authorities, and the deadline for the sector - after an unusually long transitional period for the implementation of a directive - arrives on Sunday.

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Alternative medicine producers must now prove to national authorities that their wares are both safe to use and ‘effective'.

"We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficacy," said John Dalli, European health commissioner said on Friday ahead of the deadline.

"Patients can now be confident about the traditional herbal medicinal products they buy in the EU."

The rules still remain far laxer than the stringent procedures most countries enforce with respect to normal medicine, with products not required to undergo safety tests or clinical trials.

The law's definition of proof of safe usage is limited to documentation that "indicates that the product is not harmful in specified conditions of use," according to the commission.

Meanwhile, proof that a product works does not have to be evidence-based, but can instead be furnished by literature describing "efficacy is plausible on the basis of long-standing use and experience."

Such documentation is defined as sufficient evidence of the medicinal use of the product for at least 30 years, 15 of which must have been in the EU itself. Long-term use of a product is equated with evidence that it works.

"This should be decades of use in a region, involving testimonies from doctors, pharmacists and the people who have been using a product," Frederic Vincent, commission health spokesman told EUobserver.

Pressed whether efficacy can be proved without clinical trials or safety tests, Vincent said that clinical trials for regular medicine often do not prove whether something works.

"It's the same with regular medicine. Often for years, you do not know whether it is going to work or not. And it takes years to know whether something is safe, and frequently we find even after clinical trials that products are dangerous."

Nevertheless, despite the leniency of the new rules, supporters of alternative therapies have kicked off campaigns warning that the EU is out to ban the sector, with left-wing online pressure group Avaaz on Thursday launched a petition against the rules with over 200,000 signatories at the time of writing.

The group claims the EU in two days is to "ban much of herbal medicine", including "virtually all Chinese, Ayurvedic and African traditional medicine" in order to "drive the profits of Big Pharma".

Another group, Slow Food, a group normally focused on the promotion of local produce and traditional cuisine, says on its website that Brussels is to criminalise herbal medicine and the growing or use of herbs in teas.

According to the commission's spokesman, there will be a restriction in the number of medicines on the market as a result of the rules, but there is no ban on any "specific substance, practitioners, books or plants as such."

The commission says that the law does not reduce access for Chinese or Indian medical products per se, but, according to Vincent, "The issue is they say: ‘We can't prove it, but it works.' And we're saying: ‘Do your best to prove it. Otherwise you won't be able to sell it as a medicine."

One EU official, on condition of anonymity told this website that the accusation of criminalising herbal remedies or teas is "Nonsense. This is coming from companies that cannot even produce the simplified evidence demanded. They are trying to sell things that really may not be safe."

For decades alternative medicines have been sold with very little in the way of safeguards and in recent years, stories have abounded in the press of life-threatening incidents and even deaths resulting from the consumption of products that contain microbial contaminants, heavy metals, chemical toxins or that have been adulterated by pharmaceutical drugs.

In the last two years, UK authorities for example have issued over a dozen safety alerts, including over a plant that contained a banned toxic plant derivative that caused kidney failure in two individuals.

Attempts to garner comment on the development from the UK-based European Federation for Complementary and Alternative Medicine did not meet with success.

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