European herbal remedies ban 2011
January 11, 2011
You’ve probably seen alot of news and petitions floating around about the ban of herbal medicines in 2011. This legislation is nothing new, it was first put into motion on 30th April 2004! I’ve been scouting around for reputable information on the subject and found it very hard.
Most of the articles I’ve found so far are a bit ‘grey’. I can’t find a definitive list as to what this new legislation will actually cover…in plain English.
Here are the facts I’ve managed to find so far:
- This directive is formally known as, ‘Traditional Herbal Medicinal Products Directive, 2004/24/EC’ and was put in place by European Parliament and Council.
- “Directive 2001/83/EC(4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.” (Eur-Lex)
- 200 products from 27 plant species have been licensed.
- 300 plant species are in use in the UK alone.
- The Directive also demands that a traditional herbal medicinal product must be shown to have been in use for 30 years in the EU (or at least 15 years in the EU and 15 years elsewhere) for it to be licensed and obtainable over the counter.
What will this mean for consumers?
The ban would work for and against consumers in equal measures.
- Under the new law, those who receive herbal treatments will be able to do so from a qualified practitioner. This will ensure that they will be receiving treatment from someone who knows how to do so safely.
- Remedies will meet certain safety and quality criteria.
- It will be harder for consumers to obtain certain products.
What will this mean for practitioners?
- Coalition Government and the previous Labour administration have delayed plans to introduce a statutory herbal practitioner register.
- Practitioners will not be able to prescribe or use unlicensed herbs for therapy.
- Practitioners who are statutorily regulated (already legally qualified) will be able to continue prescribing unlicensed products.
What will this mean for manufacturers?
- Manufacturers will have to apply for a licence for each plant used.
- The ANH has estimated the cost to license herbs at £80,000 – £120,000 per herb (cost dependant on herb).
- Countries outside of Europe will need to formulate their products to comply with the new UK law.
- The directive could have a positive impact on the quality of the herbs available to consumers and practitioners.
- Products will be certified safe for use
- It may no longer be commercially viable for manufacturers to licence the variety of herbs currently in use.
- Practitioners may have access to fewer herbs making it harder to obtain remedies and treatments for certain conditions.
- It could lead to a greater amount of ‘black market’ herbs. If manufacturers don’t or can’t license a particular herbs, consumers may seek it out from elsewhere.
- Herbs in use for under 30 years could be withdrawn. The directive states that herbs must have been in use for a total of 30 years in order to be licensed.
- Consumers will probably pay more for products in order to cover licensing costs.
- It could be harder for ‘new’ herbs to appear on the market.
- The Independent: Europe to ban hundreds of herbal remedies
- EUR-Lex: Access to European Law
Image Source: imcomkorea on Flickr.