fact finder
The effect of homeopathic remedies is considered unproven in science. Nevertheless, several hundred million euros are spent on globules and the like in Germany every year – but only a fraction of this comes from health insurance companies.
“Services that have no medically proven benefit may not be financed from contributions,” says a letter from the Ministry of Health led by Karl Lauterbach to the other ministries. “For this reason, we will delete the option for health insurance companies to provide for homeopathic and anthroposophical services in their statutes and thus avoid unnecessary expenditure by health insurance companies.”
But what is actually known about the effectiveness of homeopathy and how much money can statutory health insurance companies save through his initiative?
What is homeopathy?
Homeopathy is based on the assumption that “like can be cured by like”. This means that diseases should be cured by substances that cause “similar” symptoms in healthy people. To do this, the active ingredient is serially diluted and ritually shaken (so-called potentization). Homeopathy assumes that when regularly diluted and shaken, the individual substances develop “dormant powers to the point of incredible”.
A distinction is made between high potencies and low potencies. At low potencies, chemical components of the starting material can still be detected in the end product; at high potencies, it is very likely that no molecule of the starting substance is still present.
Do homeopathic remedies have an effect?
Homeopathic remedies have not been proven to have an effect beyond the placebo effect. The quality of many studies is criticized in larger meta-studies that summarize the results of several investigations. Serious studies have shown no reliable evidence of the effectiveness of homeopathic remedies, although individual studies have suggested a positive effect.
However, it is controversial whether studies on the effects of homeopathic remedies are useful at all. Since there is no longer any active ingredient in the high-potency drugs, testing their effectiveness is obsolete in the opinion of Christian Weymayr, a member of the German Evidence-Based Medicine Network.
“If the so-called a priori probability is zero, the result of a study is irrelevant.” In clinical trials, the a priori probability indicates the probability that the treatment being tested will be effective before the results of the trial are available. The more studies are carried out, the higher the probability that a certain proportion of the studies will produce falsely positive results, says Weymayr.
For a study in science to support a hypothesis, the so-called p-value must be 0.05 or less. Roughly simplified, this means that the probability that the study result can be explained by chance is a maximum of five percent. Conversely, according to Weymayr, it is possible that a large number of studies carried out could produce a result by chance that, from a scientific perspective, meets the quality criteria, but would still not be reliable evidence of an effect.
How are homeopathic remedies approved?
The German Medicines Act counts homeopathy as one of the “special therapeutic areas”, which is why different rules apply to homeopathic remedies than to the approval of pharmaceutical medicines. There are two different ways to bring homeopathic remedies onto the market. Homeopathic medicines that are based on a single active ingredient that is diluted by a factor of at least 1:10,000, just need to be registered. All that needs to be proven is that it is harmless to health.
In order to be approved, applicants must object according to the Federal Institute for Drugs and Medical Devices (BfArM) “Submit documents on the quality, safety and effectiveness of the drug”.
However, this is not a scientific proof of effectiveness, says Nikil Mukerji from the Science Council of the Society for the Scientific Investigation of Parasciences (GWUP). The approval process cannot be compared with the usual approval studies for drugs. All that is necessary is a decision from Commission D of the BfArM. “According to the principle of internal consensus, it is only determined that the evidence based on homeopathic knowledge is sufficient,” says Mukerji.
How big is it? Homeopathy industry in Germany?
In the country of origin of homeopathy, there are various global manufacturers of these products. For example, the German Homeopathy Union (DHU), Heel or Pflüger. The DHU says its founder, Willmar Schwabe, entered large-scale industrial production at the end of the 19th century. However, the market share of homeopathic products is low compared to conventional medicines. According to data from the medical research company IQVIA, the share of homeopathic medicines in the total pharmaceutical market is in the range of 1.3 to 1.5 percent.
The Federal Association of Drug Manufacturers does not know the number of employees in the industry. According to its own information, DHU, one of the largest companies on the market, currently employs 300 people, while competitor Heel reports on its website that it has 1,300 employees. For comparison: Germany’s largest pharmaceutical company, Bayer AG, employs around 22,000 people in Germany alone.
How has demand developed?
The demand for homeopathic products has been declining in recent years. According to preliminary projections by the IQVIA Pharmascope, around 41 million packs were delivered in 2023, compared to around 56 million in 2019. In contrast, overall drug sales are increasing. According to IQVIA, the entire pharmaceutical industry recorded a sales increase of 2.3 percent in 2022. Homeopathic products did not benefit from this increased demand for medication.
How much money is made with the products?
In a preliminary projection, the IQVIA Pharmascope expects sales of 710 million euros in German pharmacies for homeopathic remedies last year. However, there are very different data here. They depend, among other things, on which products are considered homeopathic remedies. The Federal Association of German Pharmacists Associations expects sales of 300 million euros for 2022.
How much do statutory health insurance companies give for homeopathic products? Services out of?
According to the National Association of Statutory Health Insurance Funds, health insurance companies spent around 22 million euros on homeopathic and anthroposophic medicines in 2021. The Federal Association of Drug Manufacturers counters this by saying that spending on homeopathic products by statutory health insurance accounts amounts to less than 0.1 percent of total spending on medicines. In addition to the costs of medication, there are also fees for homeopathic doctors. However, it is difficult to find out the total costs here because the health insurance landscape in Germany is very fragmented.
How serious are the planned changes for pharmacies and manufacturers?
Most homeopathic products are paid for by customers themselves. According to IQVIA Pharmascope, only around two percent of all products were recently purchased in pharmacies with a prescription. A spokeswoman for the DHU said tagesschau.de-Inquiry about the possible consequences of Lauterbach’s reform on the company that the “sales share of homeopathic medicines reimbursed by the GKV as part of the statutory benefits is very low”.
Nevertheless, the DHU rejects the Health Minister’s proposal “because it arbitrarily restricts patient autonomy and free competition between health insurance companies.” The Federal Association of Drug Manufacturers, in which homeopathic companies are also represented, warned of negative effects for small and medium-sized manufacturers in Germany, despite the low savings for the health insurance companies.
Hans-Werner Bertelsen, a member of the recently dissolved Münster Circle, says Lauterbach’s plans do not go far enough. The draft stipulates that statutory health insurance companies can offer private supplementary insurance for homeopathic services. “This puts homeopathy on an equal footing with other evidence-based services, for example from supplementary dental insurance,” says Bertelsen. “But homeopathy is a pseudoscience and health insurance companies should not support sick people taking money out of their pockets.”
Dietrich Karl Mäurer, ARD Berlin, tagesschau, January 11, 2024 4:42 p.m