Goals to achieve
Our deepest concerns
The European Union’s respective legislations ask for a full implementation of THMPD by 2011.
Although registration of products is already possible now, the procedures cause many problems because of the many issues that are still unclear. For instance; which herbs are allowed in the registration of THMP? Can a registered product still be sold parallel as a food supplement? In short, many questions arise for which the European legislation offers no clear answers.
This situation is rapidly becoming a serious concern for companies, doctors, researchers and citizens. Doing nothing, would certainly cause a serious decline in business. And it will considerably limit the choice of doctors and citizens in looking for proven alternative medicine.
For this reason we have decided to create Benefyt, a Netherlands based foundation which will represent and defend the interests of those companies and operators in Europe involved in working with traditional medicinal products and ingredients in a highly professional and tested fashion.
To this purpose we like to invite you to our first conference, which will take place at the Hotel Hilton in Brussels, November 21st 2009. All additional information can be found here under the "Conference" section. Our first conference is designed in such a way, that we are not addressing the issue to the greater public. We like to work with you to identify the right way forward. It will be relevant to find effective avenues for representing and defending our interest. At the same time we like to build an effective strategy. In addition, we like to discuss the structure of the board and the management committee of the foundation for Benefyt with you. Finally we like to discuss our financial possibilities - funding will be crucial to make progress fast and to become effective.
Goals to achieve
Work with the European Parliament, Council, Member States, Commission and Agencies to find a solution to change the path of the existing legislations – ideally through amending existing legislation.
Promote traditional medicine in the European-Market; we will not accept discrimination of traditional medicine which is based on purely rigorous legislation without respecting cultural differences.
Protect traditional medicine against laws, which would limit or reduce the opportunities to manufacture and practice traditional medicine.
In creating Benefyt, we wish to become an effective operator in promoting traditional medicine.
Our deepest concerns
The European legislative framework will negatively affect Ayurvedic and all TCM medicinal products, more then it will harm Western herbal medicine.
EMEA, the responsible agency is already implanting the relevant legislation and is preparing regulation for market authorization of herbal medicine. THMPD shall be fully implemented in 2011. Many traditional formulas will be wiped out from the market without scientific arguments given.
The European legislation poses a great threat to health because it limits international options. The WHO (WHO - Fact sheet N°134 - Revised December 2008 - Traditional medicine) rightly argues that “in some Asian and African countries, 80% of the population depend on traditional medicine for primary health care. Herbal treatments are the most popular form of traditional medicine, and are massively present in the international marketplace. Annual revenues in Western Europe reached US$ 5 billion in 2003-2004. In China, sales of products totaled US$ 14 billion in 2005. Herbal medicine revenue in Brazil was US$ 160 million in 2007.
We fully understand and support that European legislation wants to ensure high standards in the import and use of traditional medicine but we will not tolerate that formulas of traditional medicinal formulas will be forbidden. The WHO described the challenges for Legislators in the following way (source mentioned above).
“International diversity: Traditional medicine practices have been adopted in different cultures and regions without the parallel advance of international standards and methods for evaluation.
National policy and regulation: Not many countries have national policies for traditional medicine. Regulating traditional medicine products, practices and practitioners is difficult due to variations in definitions and categorizations of traditional medicine therapies. A single herbal product could be defined as either a food, a dietary supplement or an herbal medicine, depending on the country. This disparity in regulations at the national level has implications for international access and distribution of products.
We are looking forward to work with you to identify an effective and timely strategy in building support for traditional medicine in the European Union. We fully respect European lawmakers' desire to protect citizens from harmful ingredients. We share the same goal but we are convinced that the world health future rests on the richness of traditional medicinal systems originating from various cultures, as well as on modern medicine.
We sincerely believe that through an intensive international academic collaboration and through a coordinated governmental approach a solution can be found which will not mutilate the richness of traditional medicine but will concentrate on eliminating the abuses and misrepresentations, which are, by the way, not specific for our sector.
We are hopeful that a positive approach, like signing a "Memorandum of Understanding" between the European Union and respective countries, like India and China will bring positive result to both sides.
"The two systems of traditional and Western medicine need not clash. Within the context of primary health care, they can blend together in a beneficial harmony, using the best features of each system, and compensating for certain weakness in each. This is not something that will happen all by itself. Deliberate policy deciisions have to be made. But it can be done successfully."
(Beijing. People's Republic of China/ November 2008/ Address at the WHO Congress on Traditional Medicine/Dr. Margaret Chan/Director-General of the World Health Organization)
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