Non-transparent research and development of drugs

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Clinical trials on humans are a key step in the research and development process for new treatments. But there is a lack of transparency about their ethical conduct, about study results and the actual costs – which only serves to benefit the pharmaceutical companies. Serious ethical violations are taking place, negative study results are often not published and the industry can continue to perpetuate the myth that the high costs justify the exorbitant prices charged for new drugs.

A vital aspect of the research and development of new drugs takes place in public institutions. However, it is the pharmaceutical companies that have the capacity to conduct large-scale clinical trials. They must prove the safety and efficacy of drugs before marketing authorization can be applied for.

These trials are expensive and account for about 60–70% of total research and development costs. This is one of the main reasons why they are outsourced to lower-income countries. In addition to the lower costs and often less stringent regulation, these companies benefit in particular from the fact that more people in these countries participate in clinical trials because they simply have no other way of accessing treatment due to a lack of social insurance and high prices. This increases the risk that trial subjects will be exploited, as borne out by Public Eye’s investigations.

If medicines are tested on volunteers, the results must be made available to the general public. However, the results of half of all clinical trials conducted worldwide are never published – especially if they are negative. The pharmaceutical industry opposes this demand for transparency, under the pretext of commercial confidentiality and protecting patients. However, the anonymized results do not reveal industry secrets or allow individual patients to be identified. 

In Switzerland, tighter regulations are needed to ensure the ethical conduct and publication of the complete results of clinical trials when a new treatment is approved by Swissmedic (national authorization and supervisory authority for drugs and medical products). Through their inadequate efforts to strengthen these, the authority is complicit in this situation, but is also structurally limited in its power, as it is financially dependent on the pharmaceutical companies due to the registration fees charged. 

Furthermore, transparency is finally needed about the pharmaceutical companies’ own and public investments in research and development (R&D) so that the Federal Office of Public Health (FOPH) can negotiate an appropriate price that compulsory health insurance pays for a drug. The pharmaceutical industry defends its high prices by arguing that they have to cover the risky research and development of drugs, but refuses to be transparent about the investments actually made and the public money received.