What does the German “internal consensus” mean?

This text describes the topic “Homoeopathy in German Pharmaceutical Law”.

In 1976, consultations began on a fundamental reorganisation of German pharmaceutical law. By and large, the state’s involvement in the pharmaceutical industry previously consisted of little more than a “registration” of drugs placed on the market under the responsibility of pharmaceutical manufacturers.

It had taken a long time for the legislature to consider its own responsibility in the field of drug supply. A trigger for this was the thalidomide scandal of the 1960s. This terrible process, in which neither the manufacturer nor the state authorities presented a particularly happy picture, gradually led to a growing awareness of the need for action – yet it still took 17 years before a fundamental reorganisation took place.

The basic approach of the new Medicines Act was to replace the mere registration with an “approval procedure” for pharmaceutical medicinal products and to link this to scientifically substantiated evidence of efficacy and side effects. The parliamentary and extra-parliamentary discussion dragged on for more than two years – in the end, the “Medicines Act 1978” (Arzneimittelgesetz) was passed. This marked a move away from a largely individual-empirical based therapy towards a drug therapy on as objective a basis as possible. All old remedies already registered at that time were subjected to a subsequent approval procedure, and many were no longer approved – often to the chagrin of doctors who had been using these remedies for a long time for “empirical medicine”. Even the pharmaceuticals marketed in the former GDR at the time of reunification were subject to such a subsequent approval procedure.

So far, so remarkable. So are all available medicines based on scientifically proven efficacy?

Not at all.

A very active parliamentary and also extra-parliamentary lobby succeeded in obtaining special rights for the “Erfahrungsheilkunde” ( experience medicine), to which apart from homeopathy anthroposophy and herbal medicine were added (how these three are connected is a story in itself). At that time it could be suggested to the parliamentarians in the context of the upcoming “innovations” that the “empirical medicine” of these directions pursues a completely different “approach” and that the principle of scientific proof, so to speak, bypasses the “peculiarities” of these directions. The parlamentary paper at that time speaks volumes and is quite interesting to read. [1]

Many parliamentarians may have been aware that the demand for proven effective drugs has nothing to do with “pluralism in science” and “a fundamentally different approach”, but represents nothing more than a self-evident basic consensus for health care. On the other hand, the representatives of the homeopathic and anthroposophical lobby will have been fully aware that the demand for a scientific proof of efficacy would have meant the end for their remedies on the pharmaceutical market. Which, incidentally, was basically an admission that the homeopaths’ claims about the efficacy of their remedies and their great benefit to the patient were not substantiable. So it was about something.

And so it came to the inclusion of paragraph 38 in the German Medicines Act – a complete break with what had actually been the intention of the new law. Paragraph 38 established homeopathy, anthroposophy and phytotherapy (herbal medicine) as “special therapeutic directions” and granted them special rights. The old instrument of “registration” was retained for the medicinal products of these “directions”, with the privilege of not having to provide proof of efficacy as for all other pharmaceutical medicinal products. In order to maintain the appearance of state regulation, it was determined that special commissions were to be set up at the Federal Institute for Drugs and Medical Devices (which at the time was still called differently) for the “special therapeutic directions” remedies.

For homeopathy, this is still Commission D today. Its task is not to evaluate the scientific evidence of efficacy presented according to objective scientific criteria, as is the case with normal pharmaceuticals. No, there the internal circle of “experts” who have the “medical expertise of the therapy direction” is responsible for the registration and thus the free market access of homeopathic remedies. Internal. By consensus. According to personal perception, opinion or “experience”, to “internal evidence” rather than intersubjective, universal criteria. Commission D is assisted by Division 4 of the BfArM, whose homepage still mentions the relic of “scientific pluralism in the field of drug therapy”, which is expressly provided for by legislation. [2]

This is the so often invoked “internal consensus” which still privileges homeopathy (and the other “special therapeutic directions”) in an unacceptable way, even erecting a real protective fence around it. While the rules and methods for proof of efficacy and side effects have improved and refined more and more since the Medical Law Act came into force in 1978 (in the field of scientific methodology as well as in the legal framework – e.g. through the Good Practice Directive for studies), Commission D continues to meet unperturbed and decides on the market access of remedies according to the personal views of a few personalities who are declared to belong to the lobby of the ” therapeutic direction “. From the legal point of view – and in the general public’s perception – of means that are just as ” medicines ” as any pharmaceutical product that has undergone a testing and approval process that often lasts for years (only about eight percent of all new developments in the pharmaceutical industry make it to approval at all). Homeopathy – and anthroposophy – are obviously doing their utmost to preserve this special legal regulation. This is because its integration into the health care system and social security law depends directly on it.

There is nothing in German pharmaceutical law that is more in need of reform.