Herbal medicines banned from sale Local doctors don't know
March 31, 2004, the European Union promulgated the "Traditional Plant Medicines Registration Procedures Directive". The directive stipulates that all botanical medicines sold in the EU market must be registered under this new legislation and receive marketing authorization before they can continue to be sold.
At the same time, the directive provides for a seven-year transition period, allowing the sale of herbal products until April 30, 2011, in a variety of capacities, such as food, to be sold in EU countries. Now the door to herbal medicines in the EU is about to close all the way.
Yesterday, the reporter contacted some doctors who run local TCM clinics in Europe, but they invariably said they didn't know there was a ban on sales. Many of the interviewees also lamented after hearing the news: "If we really don't allow the sale, it will be more difficult to dispense Chinese medicine in the future."
"Clinics like ours don't have the right to sell Chinese medicine, so we have to go to a pharmacy and buy natural herbs that are recognized by the German health authorities." Mr. Zhang, who runs a clinic in Munich, Germany, said that no proprietary Chinese medicines produced by Chinese pharmaceutical companies are allowed to be sold because they do not have marketing authorization.
Sun Jie, who runs a Chinese medicine clinic in Switzerland, also said that her clinic now only writes prescriptions and does not sell medicines, and that patients have to go to Swiss-owned pharmacies to buy them themselves. This way many domestic Chinese medicines can not be bought, like hippocampus, a common domestic Chinese medicine, in Switzerland can not find the shadow.
Sun Jie said, this is mainly because Europe is generally universal health insurance, Switzerland is a high welfare state. No matter what the problem, as long as the Western medical treatment, all are reimbursed. But Chinese medicine is not this treatment, although acupuncture and massage has been included in the health insurance system, but the core of Chinese medicine has never been in their "eyes".
The Chinese medicine has a reputation for being underground and has to be sold
But even so, Chinese medicine still has a certain number of followers in Switzerland, and Sun Jie believes that the future of Chinese medicine is not all dark. She said, like in Britain and France, Chinese medicine has been emerging for two to three decades, consumer base and reputation are good. In Switzerland, although Chinese medicine is just emerging, but also has three to four hundred clinics.
"As far as I know, all the clinics are profitable." She said that the Chinese medicine market in the EU is mainly two big pieces: one is the major difficult and complicated diseases, Western medicine there is no way to think of Chinese medicine here to try their luck. The second is the need for long-term health care, such as pregnant women, high blood pressure patients.
These two types of patients need to take a lot of Chinese medicine for a long time. But because the varieties of Chinese medicines are regulated, they may not be dispensed in full, and in addition, long-term conditioning costs a lot of money, and without the backing of health insurance, patients are under a lot of financial pressure. So she believes a proper solution should eventually be put in place.
Wang Yafeng, program director of the World Federation of Societies of Traditional Chinese Medicine, expressed similar views in an interview, saying that even after the April 30 deadline, traditional Chinese medicine can still be sold in Europe as health care products, and will never be banned completely.
"Chinese medicine is still recognized among ordinary consumers in European countries, only the identity can still only be underground, there is no way to 'convert', so that the inclusion of the health care system is very difficult, which is a big hold on the development of Chinese medicine." He said.
Application under normal procedures takes five to 10 years
For domestic companies worried about the high cost of registration, Dominic, head of media at the British Pharmaceutical Council, said the cost of registering a drug in Britain is under 3,000 pounds, and the registration fees in other countries are not so high that they would not reach the millions of dollars that the country is worried about.
He believes that the registration fees claimed by domestic companies may be adding in expenses such as upgrading business equipment and technology.
As for the requirement of "30 years of medicinal history" and "at least 15 years of use in the European Union" for registration, Monica, head of media at the European Medicines Agency, said that according to the "Directive on the Registration Procedure for Traditional Plant Medicines" procedure, there is no requirement for Chinese herbal medicines to be registered. procedure, there is no requirement for herbal products to have special safety details and documentation, while 30 and 15 years of use history can prove the safety of medicines, so the procedure can not be less.
However, Wang Yafeng, program director of the World Federation of Societies of Traditional Chinese Medicine, said it is not easy for Chinese pharmaceutical companies to obtain this proof of safety, he said, adding that Chinese companies have been accumulating evidence of relevant trade since 2004, and it will only be 15 years in 2019, a condition that is clearly not met now.
So Wang Yafeng believes that, for now, China's drug companies can only apply in accordance with internationally accepted drug management. This includes applying for clinical trials, applying for marketing and sales and other procedures.
As far as he knows, the European Union does not yet have specific regulations for the registration of Chinese herbal medicines. If they were to be registered under the Western drug program, the hurdles would be considerable. Because if a drug has 100 ingredients, it would take time to test them separately.
If a 30- or 15-year period is difficult to meet, he said, then the normal application process is characterized by long lead times and high costs. Successful registrations can take five to 10 years at the shortest.