Traditional herbal medicine

In the European Union, traditional herbal medicines are medicines for self-medication that have been used medicinally for at least 30 years and contain exclusively herbal substances or preparations as active ingredient (s).

history

There are numerous testimonies to the use of medicinal plants from the early advanced civilizations , many of which have been or have been used for centuries. The knowledge about these healing methods was passed on orally in folk medicine and recorded very early on, for example in medical papyri . In later centuries scholars such as Hildegard von Bingen compiled the knowledge of folk medicine in medical treatises.

With the introduction of strict approval requirements for drugs in the second half of the 20th century, including in the wake of the Contergan scandal , proof of effectiveness in the form of clinical studies became a prerequisite for any drug approval.

Traditional herbal medicines have e.g. Sometimes not through the latest clinical studies, but their effectiveness has often been proven through decades of experience, including medical prescriptions. In order to ensure the continued existence of traditional herbal medicinal products without the implementation of new clinical studies, the European Parliament created a legal framework with Directive 2004/24 / EC on Traditional Herbal Medicinal Products (THMPD), which enables their simplified registration in all member states of the European Union should. In Germany, the guideline was implemented by Sections 39a-d of the German Medicines Act, in Austria by Sections 12 and 12a of the Austrian Medicines Act (traditional herbal medicinal specialty) . A key element of this European regulation is the establishment of a scientific committee made up of experts from all member states to evaluate the knowledge material of as many medicinal plants as possible and their preparations ( Herbal Medicinal Products Committee (HMPC), London), which has been producing more than 150 monographs since 2005 with a focus on traditional ones Herbal Medicinal Products ( Traditional Herbal Medicinal Products ).

Admission / registration

Medicines may only be brought onto the market in the EU with official approval . There is a simplified procedure for traditional herbal medicinal products in which, in particular, no clinical data on efficacy have to be submitted: the medical efficacy is considered plausible due to the many years of use and experience, sometimes over centuries. However, the applicant must prove that the drug in question or a corresponding drug has actually been used medically or veterinary for at least 30 years, at least 15 years of which in the European Union, and is harmless under the specified conditions of use . With regard to the pharmaceutical quality and the safety of the drug, the registration procedure does not provide for any simplifications, the same standards apply as for other drugs. With the registration, the competent approval authority certifies that the drug meets the statutory quality and safety requirements.

In countries outside the EU, this is done by national authorities, e.g. by the Food and Drug Administration in the USA or the China Food and Drug Administration in China.

Alleged ban on medicinal plants in the EU

In the course of the implementation of Directive 2004/24 / EC, conspiracy theories increased towards the end of the transition period . In 2010, more than 100,000 citizens signed a petition to the German Bundestag to prevent an allegedly threatened ban on medicinal plants in the EU. In April 2011, the alleged ban was again widely spread on the Internet. The Federal Association of Drug Manufacturers pointed out in a press release that it was a false report. In the following years, an alleged ban on medicinal plants was repeatedly used for propaganda purposes in the summer months, in some cases underpinned by arguments with the short-term ban on the use of plant manure from the great nettle in 2006 in France.

application areas

The permissible field of application of a drug must be expressly approved by the competent regulatory authority. For traditional herbal medicinal products, the indication text is in each case: "Traditional herbal medicinal product for use for ... exclusively due to long-term use".

Classic areas of application include:

• Heart problems (e.g. hawthorn )
• Liver problems (e.g. milk thistle )
• nervous restlessness, nervous sleep disorders (e.g. passion flower , valerian root )
• Prostate problems (e.g. nettle )
• Menstrual symptoms, premenstrual syndrome (e.g. chaste tree )
• Pain, rheumatic complaints (e.g. feverfew , devil's claw , incense )
• Digestive problems (e.g. artichoke , licorice root )
• Moods and depression (e.g. St. John's wort )
• Menopausal symptoms (e.g. black cohosh )

Traditional herbal medicinal products are expressly suitable for self-medication due to their low risk potential when used as intended . As a rule, the costs for these funds are not reimbursed by the statutory health insurance companies.

Web links

• Directive 2004/24 / EC of March 31, 2004

Individual evidence

1. ↑ Directive 2001/83 / EC , Article 16a (1) e) - ( Directive 2001/83 / EC ).
2. ↑ Nina Weber: Petition on medicinal plants: Absurd fear of the chamomile. In: Spiegel Online. November 11, 2010, accessed February 18, 2017 . 
3. ↑ Peter Ditzel: Phytos and natural remedies can also be marketed after April 30th. In: Deutsche Apotheker Zeitung . April 28, 2011, accessed February 18, 2017 . 
4. ^ Catching votes for dubious interests. To the petition “Basic right to health”. Hufelandgesellschaft e. V. , archived from the original on September 1, 2013 ; accessed on February 18, 2017 . 
5. ^ Opinion on the fundamental right to health petition. True interest of the unknown authors unclear. Karl and Veronica Carstens Foundation , August 30, 2013, archived from the original on March 30, 2016 ; accessed on February 18, 2017 . 
6. ↑ Committee on Herbal Medicinal Products ( Committee for Herbal Medicinal Products , HMPC) of the European Medicines Agency : List of monographs of herbal medicines

This article is about a health issue. It is not used for self-diagnosis and does not replace a diagnosis by a doctor. Please note the information on health issues !