International ethical standards

© Mark Henley/Panos
The massive delocalisation of clinical trials in regions where access to care is not guaranteed, and where the regulations are less strict, poses serious ethical problems. Although they deny the existence of a “double standard”, pharmaceuticals companies exploit the vulnerability of patients in the poorer countries. Ethical standards have, however, been established by several international texts.

The Declaration of Helsinki (DoH)

The Declaration of Helsinki (DoH), adopted by the World Medical Association in 1964, is the reference text for this field.

Guidelines for good clinical practice (ICH-GCP)

In 1996, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, which brings together the authorities and the pharmaceutical industries of Europe, Japan and the United States, published guidelines on good clinical practice.

Inspired by the guidelines published by the World Health Organisation in 1995, and subsequently harmonised for the requirements of the regulatory authorities, they contain little information on the questions of the controversial use of placebos or the post-trial continuation of treatment. The ICH-GCP guidelines were updated in 2016, but this revision concentrated on the questions of traceability and the reliability of data.

Therefore, although thus amended, the new ICH-GCP guidelines E6(R2) are essentially a catalogue of procedures designed to guarantee the validity of data produced by clinical trials, and the harmonisation of their format, that are aimed at satisfying the needs of regulatory authorities in wealthy countries, rather than a genuine ethical code designed to protect participants in the various areas where the tests take place.

The additional protocol to the Convention on Human Rights and Biomedicine

The Council of Europe enacted, in 2005, an important additional Protocol to the Convention on Human Rights and Biomedicine, relating to biomedical research. The Protocol decrees clear principles on ethical questions linked to consent, the use of placebos, access to trial results, protection of dignity, and the management of conflicts of interest. In addition, it requires that the 47 member states respect the same ethical principles where clinical trials are conducted in countries that are not members of the Council of Europe. Switzerland has neither signed or ratified this additional Protocol – for no apparent reason – even though it adopted the 1997 Convention on which the Protocol is based.

© Roger Anis
Despite several international agreements meant to protect participants in clinical trials, pharmaceutical companies continue to profit from lax minimum standards.

Guidelines of the Council for International Organisations of Medical Sciences (CIOMS)

In 2016, the Council for International Organisations of Medical Sciences, an inter-governmental organisation established jointly by the WHO and UNESCO, published the fourth version of its guidelines. These specify how universal ethical principles should be implemented, with a particular emphasis on countries with low or modest revenues. This last revision specifies the pertinence of the research in countries where the resources are limited, the obligations in terms of continuation of treatment after the trial has ended, the commitment of the communities to which the participants belong, an evaluation of their vulnerability, and specific protection measures to be put in place.

None of these texts are binding in nature as long as they are neither transposed nor explicitly referred to in the laws of the respective nations. In Switzerland, this concerns the ICH-GCP standards, but not the Declaration of Helsinki. The European Union, for its part, makes reference to these two texts. Those countries that have integrated such texts in their national legislation all refer to the ICH-GCP guidelines, which have become de facto a new global standard, imposed by high-revenue countries and their pharmaceuticals industries on to the rest of the world, even though they do not constitute an ethical code per se but rather a catalogue of procedures.