Germany’s statutory health insurance spent millions on homeopathic and anthroposophical remedies, even as the evidence base remained weak. This study asks what happened to the costs, the claims, and the legal standards over time. The prescription of homeopathic remedies at the expense of Germany’s statutory health insurance system has been criticized for years due to a lack of evidence, and the planned abolition of reimbursement reignited the debate.

The analysis examined costs and their development from 1985 to 2021, using selected homeopathic medicines and comparing their defined daily dose, or DDD, development with rational pharmacological alternatives. The study also analyzed clinical studies and the presentation of remedies on company websites, online pharmacies, specialist information, and package leaflets, including side effects, interactions, indications, and alleged proof of efficacy.

The reported overall pattern was higher average costs, rising DDD costs, incomplete information, non-compliance with the Therapeutic Product Advertising Act, and clinical evidence that was generally poor. Homeopathy is based on the simile principle, or “like cures like”: diseases are treated with substances that would cause similar symptoms in a healthy person.

Homeopathic teaching gives a decisive role to potentization, in which the starting substance is diluted and shaken in a certain way, with the claimed effect becoming stronger as the process is repeated. Many remedies are diluted so extensively that they do not contain a single molecule of the starting substance, while large meta-analyses have found no reliable evidence beyond the placebo effect.

That evidence gap leads to the central German policy question: can SHI funds continue financing treatments that contradict the principles of evidence-based medicine? In 2021, the statutory health insurance system spent twenty-two million euros on homeopathic and anthroposophical remedies.

In Germany, homeopathic remedies generated around six hundred seven million euros in sales in 2022, with self-medication accounting for five hundred thirty-four million euros. Around seventy-four million euros were attributable to prescriptions, and those prescriptions can be submitted to statutory health insurers and partially reimbursed.

Since the SHI Modernization Act of 2003, prescribing homeopathic remedies has no longer been part of the SHI benefits catalogue. However, homeopathic remedies can still be reimbursed through statutory benefits, which are voluntary additional benefits provided by individual health insurance funds competing with one another.

The analysis was designed to bring scientific data to that discussion by examining the German homeopathic medicines market with stringent pharmacoeconomic and pharmacological criteria. Using data from the Scientific Institute of the General Local Health Insurance Fund, the analysis examined defined daily doses, DDD costs, and total sales of sixteen homeopathic medicines from 1985 to 2021.

The preparations were selected from the drug prescription report, which presents the three thousand leading drugs on the German pharmaceutical market, and the analysis excluded anthroposophic and phytotherapeutic medicines. The data covered medicines prescribed by registered doctors in outpatient care, dispensed through public pharmacies at the expense of SHI, and regularly prescribed through an SHI prescription.

Private prescriptions, which probably provide a large share of the market, could not be recorded. The next step identified rational pharmacological alternatives and compared them with the homeopathic medicines using DDD costs from 2021.

The comparison also used the pharmacy retail price of the smallest pack in each case, while homeopathic remedies were assessed by the smallest pack for each application and dosage form. Clinical evidence came from representative studies on PubMed and from studies listed by manufacturers on their company websites, and the studies were analyzed by evidence class.

The findings were then compared with manufacturers’ information about efficacy or proof of efficacy. An important qualification is that the analysis concerned the evidence class a study was intended to achieve, not necessarily the class it actually achieved.

The study examined how preparations were presented on company websites, two selected online pharmacies, specialist information, and package leaflets, looking for indications, adverse drug reactions, and interactions. It also recorded whether an effect was claimed and whether that claim was substantiated by studies, then extended the analysis to compliance with the Therapeutic Product Advertising Act.

For company websites, all pages operated by the manufacturer of the preparation were included. In 1995, accumulated sales of the analyzed preparations reached their maximum at forty-four million three hundred seventy-nine thousand six hundred euros.

The maximum DDD was seventy-seven million seven hundred seventy-one thousand one hundred in 2001, mainly because prescriptions of HR1 increased sharply. Starting in 2004, sales and DDD decreased significantly for the homeopathic remedies providing consistent data.

In 2021, the most recent sales were three million eight hundred nine thousand euros, while the DDD was four million forty-seven thousand four hundred. Figure 3 shows that overall sales of homeopathic medicines remained fairly stable between 2012 and 2021.

Average DDD costs for homeopathic remedies rose from zero euros and forty-three cents in 1985 to one euro and forty-nine cents in 2021. The remedies with consistent data confirmed this upward trend, although slight deviations appeared because the graph for all analyzed remedies contained data gaps.

In 2021, the average DDD cost of the analyzed homeopathic medicines was one euro and forty-two cents, around fourteen percent higher than the rational alternatives. The rational pharmacological alternatives had an average DDD cost of one euro and thirty cents, while the average pharmacy price of the smallest homeopathic pack was approximately thirty percent higher.

There was no DDD-cost data for HR15 in 2021, so the analysis used 2019 DDD costs for HR15 and its rational pharmacological alternative as a proxy. Because WIdO could not provide DDD costs for HR9 after 2011, HR9 was excluded from the DDD-cost analysis of sales shown in Figure 6.

Table 4 evaluates manufacturer websites against the Therapeutic Products Advertising Act, with green indicating compliance, red noncompliance, and yellow ambiguous or subjectively determined cases. Company name and product name appear at one hundred percent under “Yes,” while discount promotions show zero percent “Yes” and one hundred percent “No.” Several information requirements are incomplete: presentation of ADRs and exact composition are each thirty-seven point five percent “Yes,” and price specification is twelve point five percent.

This matters because it maps where legally relevant advertising information is present, missing, or unclear. Company websites always stated that the preparation was effective, but only fifty-six point two five percent of those claims were also “substantiated” with studies.

Studies were cited much less often in other media, including only six point two five percent of cases in online pharmacies. Adverse drug reactions were least frequently reported on company websites, at twenty-five percent, and the same applied to interactions.

Online pharmacies reported these details more often: adverse drug reactions appeared in seventy-five percent of cases at OP1 and fifty-six point two five percent at OP2. For registered homeopathic medicinal products, indications were not always stated because, legally, registered products do not have an indication.

The evidence analysis included studies listed on manufacturers’ official websites and representative PubMed studies for the relevant preparation and indication, while one example indication was analyzed for registered remedies. Studies were limited by indication, application form, and single-remedy design, and in vitro studies were excluded.

After those criteria were applied, nine studies were found for company websites and eleven for PubMed. The distributions favored studies aiming for a higher evidence level on PubMed; manufacturers mainly advertised studies with a low evidence level, usually observational studies in evidence class three.

Figure seven summarizes the evidence levels of clinical studies reported on manufacturers’ company websites. The pie chart divides the reported studies among evidence categories labeled three, two-a, and one-b, with the largest segment corresponding to category three.

This matters because the authors assessed whether manufacturers’ clinical claims were supported by studies at different levels of evidence, providing context for evaluating the information presented on these websites. Figure eight summarizes the evidence levels of clinical trials reported on PubMed, using three categories shown in the legend: three, two-a, and one-b.

The authors determined these levels for representative PubMed studies associated with each preparation and its selected indication, providing a snapshot of the evidentiary basis available for the homeopathic remedies examined. Among the clinical studies, eleven had accessible full texts and were included for closer analysis.

Those studies were examined for randomization, a placebo group, masking, ethical standards, primary outcome measures, possible bias, competing interests, and the journal of publication. A closer inspection of the study comparing HR2 ointment and gel with diclofenac gel raises methodological questions.

HR2 ointment and diclofenac gel had different colors, and the study did not use double-blinding. It was also possible that the one-percent diclofenac concentration was not high enough to produce a therapeutic effect. An additional placebo arm would have remedied this methodological problem.

The studies manufacturers listed on their websites were usually classified as evidence class three, mostly observational studies, and were not sufficient to prove clinical efficacy beyond doubt. These studies also often contained methodological flaws. The uneven evidence-level distribution suggests that manufacturers tended to refer to lower-level studies because those studies were more often in their favor, a pattern also congruent with publication bias known in homeopathy.

Another explanation is that high-quality studies cost more, and manufacturers may refrain from conducting them because they already assume the result would not favor the homeopathic remedy. Registered homeopathic remedies such as HR2 or HR7 do not have to provide proof of efficacy for registration, but they are also not allowed to state an indication.

The advertising of HR2 was therefore described as more than questionable because it clearly targeted musculoskeletal complaints without directly stating the indication, despite the legal restriction on advertising registered or exempt homeopathic products with indications for use.

Following a legal dispute between Verbraucherzentrale NRW and the manufacturer of HR1, the Landesgericht Dortmund ruled in 2022 that the advertising constituted misleading advertising under the Therapeutic Product Advertising Act. The analysis found that homeopathic medicines remain important to the German drug market, with a clear shift from SHI prescriptions toward non-SHI prescriptions and over-the-counter use, for which the available data are very limited.

DDD costs substantially increased over the years, and homeopathic medicines were often more expensive than rational, pharmacologically effective alternatives. The study also found multiple deficiencies in product presentation, substantial non-compliance with the Therapeutic Product Advertising Act, and suggestive product naming.

Most importantly, the overall quality of clinical studies dealing with homeopathic medicines was poor. Taken together, the data provide pharmacoeconomic, legal, and pharmacological arguments for excluding reimbursement of homeopathic remedies from Germany’s SHI system.

Across the study’s economic, scientific, and legal analyses, homeopathic remedies were more expensive on average, costs rose over time, and manufacturers’ evidence and product information showed major weaknesses. The authors argue that SHI reimbursement should be excluded.