An EU ban on unregistered herbal medicine will be difficult to implement fairly and is set to be challenged in the courts, campaigners have claimed in advance of an impending deadline for the sector.
On 1 May the EU’s Traditional Herbal Medicinal Products Directive – first passed in 2004 – will come into full effect, compelling herbalists to conform to new registered standards.
The initiative affects manufactured products sold online or in shops without the supervision of a practitioner. From May onwards the distribution and purchase of such unregistered medicinal herbal remedies will become illegal.
Campaigners for the industry are set to challenge the full introduction of the directive and claim that member states are adopting varying standards to its implementation.
Dr. Robert Verkerk, executive and scientific director of the UK-based Alliance for Natural Health – an NGO promoting natural remedies – said: “At the end of April we plan to challenge the directive first of all in the High Court in London, on the grounds that it is disproportionate, non-transparent and discriminatory. We then hope to have the case referred to the European Court of Justice in Luxembourg.”
Verkerk said that countries such as the Czech Republic and the Netherlands were adopting a liberal approach to implementation which meant that many herbal remedies could be construed as ordinary foodstuffs and thus escape regulation.
He added that other states, notably the UK and Belgium, were approaching the directive more vigorously, outlawing many more unregistered herbal remedies.
In defence of natural medicine
Meanwhile in France a petition against the directive has been launched by a group of natural remedy stakeholders calling itself ‘Le Collectif pour la Défense de la Médecine Naturelle’.
It also complains of the variety of different approaches taken in member states and claims the directive imposes a disproportionately costly administrative burden on numerous natural remedies which have existed in Europe for centuries and are not dangerous. A statement from the campaign said: “We simply want the right to treat ourselves using alternative methods.”
Examples of remedies threatened following the expiry of the deadline include traditional European herbal cures using hawthorn and meadowsweet in addition to a swathe of herbs used in traditional Indian Ayurvedic, Chinese and Amazonian remedies.
Exact data on the use of herbal medicines is scarce. However, an influential US-based medical journal, the New England Journal of Medicine, estimated that in 2003 European countries spent almost €3.5 billion (at manufacturers’ prices to wholesalers) on over-the-counter herbal medicines.
Dr Robert Verkerk, executive and scientific director of the UK-based Alliance for Natural Health, said: “The problem is that [synthetic chemical ingredients] are deemed necessary by formulators in order to meet the pharmaceutical stability standards set by the EU directive. Forcing non-European herbal traditions into a European straitjacket would effectively corrupt these great traditions.”
Irish liberal MEP Marian Harkin, who is a member of the NGO Health First Europe, said: “There are real concerns that many of these herbal remedies will not be available to the public anymore. Many have been in use for thousands of years. There are issues about how they are to be assessed: can you use pharmaceutical techniques to assess something that is not a pharmaceutical product? A lot of these remedies will disappear.”
A spokesperson for Le Collectif pour la Défense de la Médecine Naturelle said: “If charlatans exist within the sector, that does not justify the persecution of those who rely on numerous producers of plant-based alternative therapies. This type of vigilance will only benefit those who are able to verify that their medicaments are manufactured using certain petrochemical compounds, from which the side effects are incontestably worse.”