Around 300 natural products on sale in Malta are being analysed to see whether they can be classified as medicines and left on the shelves, in line with EU legislation that has just come into force.

However, retailers and users of herbal remedies fear the new laws are intended to “ban” such products, which are favoured by many over chemical medicines.

Activists around the world are currently spreading petitions, particularly online, in a bid to reverse the legislation, even though it was agreed upon in 2004. They claim the laws were pushed by the pharmaceutical lobby. The petitions have alarmed consumers, many of whom are currently buying their favourite products in bulk, worried that they will no longer remain available, health shop owners told The Times.

However, the Medicines Authority insists the laws are actually good news for importers, because in order to classify as medicines, they simply have to prove that their active ingredient has been used traditionally for the past 30 years − 15 years of which must be within the EU.

Pharmaceutical companies do not have this luxury, and to place anything on the market they must go through a much lengthier process of clinical trials, including animal and human testing.

The problem is that, while pharmaceutical companies can afford the costs involved in such complicated procedures, even the “simplified” process might prove unsustainable for herbal suppliers financially. It involves bureaucracy and manpower while retailers must also pay a one-time fee of over €550 to get authorisation to sell their product locally.

And since the market for herbal remedies is relatively small, these fees and processes may water down profits for importers to such an extent that it might not be worth selling them.

Retailer Brian Corlett told The Times that many products will stop being imported, because if 20 or 30 bottles of something are sold every year and the registration fee costs hundreds of euro, it becomes unaffordable.

Customers would, therefore, simply resort to buying their products online or bringing them from abroad in their luggage, creating a “black market” unregulated by the government.

He described this as simply an attack on herbal products because people were increasingly opting for healthier options due to the side effects brought about with chemical medication. It was also a threat to people’s “freedom to choose”.

However, another retailer, who preferred to remain anonymous, said this issue was being exaggerated, especially by the euro-sceptic British media. “It’s still too early to say exactly how we will be affected. There will probably be a few products no longer worth importing but this is not a ban.”

According to the Medicines Authority, this system ultimately benefits the consumer. “Our objective is to safeguard public and consumer health, and ensure that only safe, effective medicines that are of good quality are placed on the market... Even though they are natural, a number of these products may be dangerous for patients.”

The authority explained that all medicinal products need a marketing authorisation to be placed on the market. But since traditional herbal medicinal products have a long tradition of use, the EU decided to introduce a “lighter, simpler and less costly registration procedure for them”.

“This directive allows for the industry, including SMEs, to register a herbal medicinal product without the need to carry out pre-clinical tests and clinical trials if they can demonstrate traditional use of 30 years worldwide, out of which 15 years needs to be in the EU.”

To get in line with this legislation, the authority held a seminar with stakeholders last year. Its website, www.medicinesauthority.gov.mt, also has the latest information on the process.

Local importers have submitted around 1,000 products to the authority and 70 per cent of these have already been found to be non-medicinal and can, therefore, continue to be placed on the market. These are classified as food supplements and cosmetics.

However, the other 300 or so products are still being analysed to verify their ingredients.

“This exercise can lead to greater trust by consumers towards herbal medicines, as products will be assessed for quality, safety and efficacy,” the authority added.

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