Inadequate ethical controls

As the official regulatory authority for medicines, Swissmedic, the Swiss Agency for Therapeutic Products, plays a key role in monitoring compliance with ethical standards in clinical trials conducted in lower-income countries. International ethical standards are only binding if they are explicitly mentioned or implemented in national legislation. However, the law in Switzerland refers to the weakest of these standards, which does not actually protect trial participants, but is merely a list of procedures. However, even the implementation of this minimal regulation in Switzerland by Swissmedic is non-transparent and cannot be verified. Therefore, it is highly likely that medicines sold in Switzerland have been tested in an unethical way.

Key international ethical standards

Over the years, several ethical standards have been devised for conducting clinical trials. They all place the interests of individuals and their protection above the interests of science or society.

• The benchmark for this is the Declaration of Helsinki (DoH), adopted by the World Medical Association in 1964 and revised several times since then. It covers all ethical violations highlighted by Public Eye and partner organizations.

• In 1996, the International Conference on the Harmonization of Technical Requirements for the Authorization of Medicinal Products for Human Use, constituted by the authorities and the pharmaceutical industry in Europe, Japan and the United States, published Guidelines on Good Clinical Practice (ICH-GCP). Its aim is to facilitate the mutual recognition of clinical trial data by the authorities in these three jurisdictions. As far as ethical standards are concerned, however, the ICH-GCP guidelines are less stringent than the Declaration of Helsinki.

• In cooperation with the World Health Organization (WHO), the Council for International Organizations of Medical Science (CIOMS) publishes its own guidelines with the aim of implementing universal ethical principles as set out in the Declaration of Helsinki – especially in lower-income countries. 

• In 2005, the Council of Europe adopted an important additional protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. The Protocol decrees clear principles on ethical questions. In addition, it requires that the 47 member states comply with the same ethical principles where clinical trials are conducted in countries that are not members of the Council of Europe. Switzerland has neither signed nor ratified this additional Protocol even though it adopted the 1997 Convention on which the Protocol is based.

These texts are not binding unless they are explicitly mentioned or implemented in a national law. Countries that have transposed the provisions into national law all refer to the ICH GCP guidelines. They have become a de facto new global standard imposed on all states by rich countries and their pharmaceutical industries – although they are not a code of conduct in themselves, but merely a list of procedures. In Switzerland too, this is the case with the ICH-GCP standards (Guidelines for Good Clinical Practice). However, there is no mention made of the Declaration of Helsinki in Swiss law. In contrast, the EU refers to both the ICH-GCP standards and the Declaration of Helsinki in its legislative texts.

A lax law and a passive regulatory authority in Switzerland

In Switzerland, the Therapeutic Products Act (TPA) regulates the marketing authorization procedures for all medicinal products and the formal approval of clinical trials in Switzerland. The Human Research Act (HRA) regulates the ethical principles of research projects, their monitoring, transparency issues and coordination between various committees for clinical trials conducted in Switzerland.

The HRA and the associated Therapeutic Products Licensing Requirements Ordinance require pharmaceutical companies to submit a self-declaration ensuring that the studies on humans have been carried out in accordance with the recognized rules of “Good Practice in Clinical Trials” (Art. 5) and a risk management plan Art. 5a), and create the legal basis for carrying out inspections abroad (TPA Art. 64a). However, this self-declaration is not published and the risk management plan, the summary of which is available for public access, does not contain any criteria to prove that trial participants are afforded protection and the clinical trials abroad are conduct in an ethical manner. In its annual reports, Swissmedic gives details of inspections carried out abroad and began conducting inspections in 2023 as part of its own internal inspection programme. Although the results are entered in the EMA database, but even these only concern “Good Manufacturing Practice” (“GMP Certificate” and “Non-compliance Report”) and do not include the protection of trial participants during clinical trials, but possible risks with regard to the quality of the product for patients after its authorization.

The investigations, campaigns and political work of Public Eye (Berseticum Forte) have undoubtedly contributed to this legislative progress in the revision of the Therapeutic Products Act as of January 2019. However, both the legal basis and its implementation by Swissmedic are still very limited. Trying to find indications of the ethical conduct of clinical trials and the protection of participants is a waste of time. 

If trials are carried out within a lax regulatory framework, Swissmedic cannot afford to make its judgement solely on the basis of information provided by pharmaceutical companies. Of course, these companies have no interest in investigating ethical deficits in clinical trials. An independent review by the public is certainly not guaranteed due to the lack of transparency.