New European rules require all herbal medicines to be registeredBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d2815 (Published 06 May 2011) Cite this as: BMJ 2011;342:d2815
All rapid responses
The legislative issues surrounding herbal medicine registration
within the EU is complex and may take 10 to 20 years to resolve.
Certainly, it is will encompass court cases between companies who register
(= invest money) essentially the same product but for diverse usages or at
different levels of registration.
Although originally intended as a "1 Europe" concept, registration of a
herbal medicine is required in each country of sale. Registration occurs
within a cultural framework resulting in a "Many Europes" reality. For
example, since September 2008 (and updated 30th April 2011) (1) the
Swedish Medical Products Agency has restricted sales of ginkgo, griffonia,
hawthorn, milk thistle and St John's Wort. However, these products are
freely available in Italy and the United Kingdom while, boldo is
restricted in Italy but not Sweden or the UK.
The key significance of the new legislation is that it allows companies to
make claims based on traditional usage. These can be printed on labels and
used in advertising. To register a traditional-use product initially costs
?10 - 20,000, including document preparation, for the first country and ?1
- 4,000 for subsequent countries. On top of this there is an annual fee
per country of sale of ?1 - 4,000. These fees are determined individually
by each country. Due to the impact of colonial trade, a large number of
Asian, African and American have been freely available in local
communities within Europe for over 100 years and so it is unlikely that
many non-European plants will be excluded from the traditional usage
The new legislation also allows for plants to be registered as regular
medicines that will be available on prescription only. Candidates for this
group include hawthorn, kava, milk thistle and St John's Wort. This
registration is expensive and the investment can only be recouped if
doctors prescribe these products. Furthermore the classification of a
plant as a medical entity may lead to restrictions on the sale of the
plant in other products as has occurred in Sweden with Echinacea purpurea.
Most plant products will continue to be sold as foods and will not be
registered. Even if a plant product is registered as a "traditional
herbal medicine", such as fennel and sage in Sweden (2), it does not
preclude the sale of these plants in other products. The European Court of
Justice was very specific in its 2007 ruling C-319/05: GARLIC EXTRACT
POWDER CAPSULES ARE NOT MEDICINAL PRODUCTS: ""garlic extract powder
capsules" do not contain any substance other than natural garlic and have
no additional effects, either positive or negative, as derived from the
consumption of garlic in its natural state". (3) Garlic extract powder
capsules "do not correspond to the definition of a medicinal product by
presentation ... or function. Therefore they cannot be classified as a
medicinal product". Consequently galenical preparations of plants may be
freely traded as long as they are sold without any medical claims. For
example, Traditional Chinese Medicine which uses herbal teas is outside
Registered herbal medicines may be more expensive than similar plant
products. As well as registration costs, product sales need to be reported
and so there are additional bookkeeping costs. Registered herbal medicines
may be subject to higher VAT. In Sweden plant products are subject to 12%
VAT while traditional-use herbal medicines are subject to 25% VAT.
The likely scenario for the next 10 to 20 years is as follows:
1. Plants registered as regular medicines will be available in countries
where herbal medicines are culturally acceptable, such as Germany, but
will not be available in countries lacking herbal traditions such as
Sweden and Finland. This could lead to medical tourism, e.g. hepatitis
patients seeking milk thistle extracts.
2. Plants used for traditional-use herbal medicines will number 10 to 30
in each country. Numerous products made from the same plants will be
available and extensive advertising can be expected as companies compete
for the market share. As there is no specification of dosage in the
legislation, it is to be expected that dosage will differ between products
while standardisation substances are likely to differ between companies.
Notably, as stated it the original article "it is not necessary for
applicants to demonstrate their product's effectiveness". The overall
situation will not be much different from today. Subsequently I am
sceptical that there will be a meaningful improvement in knowledge about
interactions as suggested by the representative of the British Medical
3. Plant products, including galenical preparations, will continue to be
widely available. In some cases the quality may drop. For example, St
John's Wort can be "washed" in acetone to remove hypericin. The hypericin
is then used to produce standardised extract tablets while the "washed" St
John's Wort is sold off as a full-value dried herb. While vigilance by
food authorities is required to maintain standards for plant products as
for other food products, it is expected that the more-informed consumers
will prefer to purchase products that are quality-tested following
production in Europe.
4. The internet purchasing of both traditional-use herbal medicines and
plant products is likely to boom as exasperated individuals buy products
that are available in EU countries other than their own.
Conclusion: The present legislation deters the free movement of goods and
is likely to be the subject of litigation. It is a political solution
attempting to control sales of herbal medicines without addressing
pharmacological issues. Although patients can be confident that medicines
are safe, they cannot be confident that the registered herbal medicines
PS Despite the assurances of the European Commission that nutritional
agents will not be restricted the supplement glucosamine is classified as
a medicine in Sweden (1) but freely available in most European countries.
1. Lakemedelsverket - Medical Products Agency, Sweden. Frequently
asked questions and answers about product classification.
http://www.lakemedelsverket.se. [Online] 29 April 2011. [Cited: 14 May
2. --. Vaxtbaserade lakemedel (VBL). http://www.lakemedelsverket.se.
[Online] 18 November 2010. [Cited: 14 May 2011.]
3. European Court of Justice. GARLIC EXTRACT POWDER CAPSULES ARE NOT
MEDICINAL PRODUCTS. www.curia.europa.eu. [Online] 15 November 2007.
[Cited: 14 May 2011.] cp07084en.pdf.
Competing interests: Herbal practioner and retailer of herbal and nutritional products in Sweden