Written for CANCERactive by Dr Rob Verkerk, ANH
Freedom of information vs. freedom of choice
Two of our fundamental rights may be tested in 2011: freedom of information and freedom of choice in healthcare. Julian Assange’s arrest and its possible impact on the whistle-blowing website WikiLeaks could represent a blow to freedom of information. We need to ask: how far will governments go to prevent further revelations?
How does this relate to the treatment or prevention of cancer from an holistic standpoint? Our freedom to choose what natural products we put into our bodies is under threat, courtesy of a raft of legislation coming from national governments in Europe, including the UK, and directly from Brussels.
Thousands of herbal products soon to be illegal
The EU’s Traditional Herbal Medicinal Products Directive (THMPD) was originally designed with a positive aim: to provide a simplified registration scheme for herbal medicinal products. It was meant to include herbal medicines from all traditional medical systems, albeit restricted to medicines sold over the counter for minor, self-limiting conditions without practitioner supervision. The Directive came into force in the UK and other EU Member States in 2005, in a 7-year transitional phase, during which producers and suppliers could apply for product registrations. After the transitional phase ends on 30 April 2011, all unregistered, over-the-counter herbal medicines become illegal. However, because of very tough eligibility and technical requirements, less than 200 THMPD license applications have so far been received across the entire EU only 80 of these being from the UK!
Importantly, to be eligible for registration under the Directive, herbal medicinal products have to have been safely sold in the particular formulation within the EU for at least 15 years, out of a total of 30 years. This, plus the high or often prohibitive costs of complying with the quality-control regime, has meant that not a single registration has yet been issued for any herbal products associated with non-European traditions. These include the great, holistic systems of traditional Chinese medicine (TCM), Ayurveda from the Indian subcontinent, Japanese Kampo, Amazonian, and many others.
The European Commission (EC)’s own experience report recognised the unsuitability of the THMPD for these traditions, saying, the suitability of a separate legal framework for products of certain traditions should be assessed. The authorities have since ignored the report.
Falling between two stools of legislation
Many herbal products are presently sold as food supplements, rather than as medicines. Theoretically, this can continue under the THMPD, but practically, it is becoming extremely difficult. Member States can adopt their own national rules for herbal products in food supplements, a situation the EC has no intention of changing. Another EU law, the Novel Foods Regulation, classifies many herbal products as ’novel’ foods. These also become illegal, unless they are authorised after a tortuous and very expensive application process.
Herbal medicines that are not registered under the THMPD and cannot be sold legally as foodstuffs or food supplements will fall between two ’stools’ of EU law, and may be lost forever.
The position of practitioners
UK herbalists can prescribe unlicensed herbal medicines those likely to be used in serious conditions, such as cancer under an exemption to the Medicines Act 1968. This exemption is incompatible with EU law while there is no government recognition (statutory regulation) of practitioners. This is because EU medicines law only allows authorised healthcare professionals (typically only medical doctors and pharmacists) to prescribe unlicensed medicines. To comply, the government will need to recognise herbal practitioners, hence the campaign for statutory regulation of medical herbalists. But statutory regulation will only apply to UK herbalists. An EU-wide regulatory framework is badly needed that deals rationally with all herbal medicines, from all traditions and for all conditions. As it stands, many herbs used in cancer protocols will be lost, such as herbs used in immunosuppressed patients and herbs used to reduce the effects of chemotherapy.
What can we do?
The Alliance for Natural Health International (ANH-Intl) and its partners in the European Benefit Foundation have developed a three-pronged strategy to address these problems, as follows:
- Judicial review of the THMPD to force the EU to look again at the provisions of the Directive, and make it work as originally intended
- Improve the EU food-supplement regime to allow herbal products with a history of food usage to remain on sale as food supplements
- Develop and implement a new regulatory regime for European herbal medicine practitioners. Much of the work for this has already been done, but implementation will require pressure on European authorities from European citizens and Members of the European Parliament.
The most urgent of these actions is the judicial review, to be initiated in the Royal Courts of Justice in London. ANH-Intl requires 90,000 for the first part of the campaign, of which nearly half has already been raised. ANH-Intl would be deeply grateful for any donations that you can provide and emphasises that all funds received are placed directly in the legal fund and will not be used for general administration costs of the campaign. For more information, see their website at www.anh-europe.org and the specific legal challenge page at http://www.anh-europe.org/node/3113.