The special therapy directions in Germany
The term special therapy direction (German: Besondere Therapierichtungen) is only used in Germany. It refers to the fact that
- Phytotherapy,
- Homeopathy and
- Anthroposophy
were granted a special status in the German Medicines Act (Arzneimittelgesetz) in 1976, in that they were exempted from the requirement to provide scientific proof of efficacy for the approval of their medical drugs. Authorisation as a medicinal product is granted by registration in accordance with defined manufacturing processes, although all the strict rules and requirements for the manufacture of medical drugs apply.
The reason given by the Bundestag committee:
"...In the unanimous opinion of the Committee, it cannot and must not be the task of the legislator to elevate one of the competing therapeutic directions to the status of a generally binding "state of scientific knowledge" and thus to the exclusive standard for the authorisation of a medicinal product by unilaterally determining certain methods for proving the efficacy of a medicinal product. Rather, the Committee was guided by the political objective that the scientific pluralism existing in drug therapy must be clearly reflected in the area of authorisation, particularly in the design of the requirements for proof of efficacy." (German Bundestag, Committee for Youth, Family and Health, 1976; author's transl.)
Furthermore, the Medical Drug Act (Arzneimittelgesetz - AMG) states §25 para. 2:
"...The competent higher federal authority may only refuse authorisation if (...)
the medical drug has not been sufficiently tested in accordance with the current state of scientific knowledge or the other scientific evidence pursuant to Section 22 (3) does not correspond to the current state of scientific knowledge ..." (AMG - Gesetz über den Verkehr mit Arzneimitteln, 2025; author’s transl.)
This so-called "dilution of the concept of science" has been cyclically challenged by strict critics of alternative and complementary healing methods. Representatives of a natural science-oriented perspective across various societal groups — particularly skeptically minded journalists shaped by this worldview — have publicly "raised an outcry" against it.
Underlying this is the paradigmatic struggle for the exclusive dominance of a natural science-based biomedicine. This stance fundamentally and profoundly rejects, out of deep conviction, any conceptual and methodological plurality that cannot be subsumed under a natural scientific concept of science, and therefore seeks to eliminate it.
Such a rigorous approach is set against a constitutional framework which, in a nutshell, reads as follows:
"...Article 5 (3) [of the Basic Law (Grundgesetz GG), author's note] is based on a broad concept of science. It does not permit an exclusive claim to scientific models of thought, but covers everything that can be regarded as a serious attempt to determine truth in terms of content and form; this means that minority opinions are also protected. ... The statistical methods of EBM are therefore contrasted with the centuries of experience of Expirience Based Medicine - in this respect as the best possible evidence... The doctor's freedom of therapy and the patient's right to self-determination show that even at the level of freedom there are different and sometimes contradictory preconditions. ... The principle of the financial stability of statutory health insurance, which has dominated the case law of the Federal Constitutional Court in particular, has led to economic efficiency considerations clearly outweighing the claims of the insured and the protection of the ability of service providers to function. ... The gradual erosion of traditional fundamental rights, as guaranteed in:
- Art. 2 para. 1 GG (freedom of enterprise)
- Art. 3 para. 1 GG (principle of equality)
- Art. 12 para. 1 GG (freedom of occupation)
- Art. 14 para. 1 GG (property guarantee)
must be counteracted by recalling that the Basic Law places the individual and their rights as fundamental principles at the beginning of its constitutional order, and not supply systems or redistribution efforts. " (Zuck, 2004, p. 217 f.; author's transl.)