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.
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.
Positions
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.""A new, more appropriate and affordable system of quality control is urgently required to prevent discrimination against the long-standing traditions, and this is something we aim to push for through our planned judicial review," Verkerk said.
A spokesman for the Association of the European Self Medication Industry, which represents the manufacturers of non-prescription medicines, said: "We have heard that among some of the smaller companies that manufacture these remedies there may be some difficulties with the new rules. However there has been a very long transitional period pending the introduction of the full directive and we do not disagree fundamentally with the directive itself."
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."
Czech Socialists & Democrats MEP Pavel Poc said: "It is not acceptable that a directive which originally aimed at safe use of traditional Asian medicines doesn't allow registration of even a single Ajurveda or Traditional Chinese medicinal product. Yet, this is exactly the situation in the Czech Republic and according to our information also the case in other countries of the EU. If the product doesn't fit into a food supplement category its sale becomes illegal. I'm now considering further options how to prevent such a scenario."
Background
The Traditional Herbal Medicinal Products Directive, 2004/24/EC, was established to provide a regulatory approval process for herbal medicines in the EU, and came into force on 30 April 2004. Under the regulation, all herbal medicinal products are required to obtain an authorisation to market within the EU.Those products marketed before this legislation came into force can continue to market their product until 30 April 2011, under the transitional measures defined in the directive. Once this time limit has expired, all herbal medicinal products must have prior authorisation before they can be marketed in the EU.
Under the directive, a company needs to demonstrate the safety and efficacy of its herbal medicine through traditional use within the EU for at least 30 years, or 15 years within the EU and 30 years outside the EU.
The intended use of a herbal medicine will only be authorised on the basis of its traditional history and/or the recognised pharmacological properties of the herbal ingredients.
Next Steps
- 1 May 2011: Full implementation of the directive comes into force.
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