In 2013, Public Eye had already shed light on the inadequate monitoring by Swissmedic through its compaign “Berseticum Forte”. To further highlight these inadequacies we organised an international conference jointly with the NGO Health Action International in 2016 in Geneva, in the presence of internationally renowned experts. Public Eye also closely followed debates in the Swiss parliament on this question, in particular by taking position on the postulate “For the commercialisation in Switzerland of drugs tested in an irreproachable manner” which was submitted to the National Council by Marina Carobbio in 2013. We also took position in relation to the consultation on the revision of prescriptions of the new law on therapeutic products in 2017.
Swissmedic – a too-passive approach
Swissmedic – the Swiss Institute for Therapeutic Products – does not fulfil adequately the double requirement of verifying that the drug has been tested irreproachably in both scientific and ethical conditions. While efforts at an international level have enabled rigorous regulation of the manner in which data is gathered and recorded, nothing similar exists to guarantee the respect of ethical standards. Where tests are performed in a context of lax regulations, the institute cannot be satisfied with issuing a judgment based on the conclusions of local ethical bodies or – as it says itself – on statements by those promoting the drug. Evidently, the pharmaceutical companies themselves have no interest in investigating possible gaps in ethical regulations that arise during their clinical trials.
The lack of transparency surrounding the approval of drugs does not allow checks by third parties. On the basis of information published by Swissmedic, it is not even possible to determine which trials form the basis of an authorisation decision. In this respect, Switzerland is lagging behind the European Union, as the European Medicines Agency (EMA) already envisaged in 2014 the publication of the entire set of reports of clinical trials used for approval, and lists the main trials having presided over the certification decision.
A new law with significant omissions
In 2014, Switzerland introduced a new law relating to research on human beings. This text complements the law on medicinal products and medical devices (TPA) dating from 2001, which is currently being revised. This law will continue to regulate procedures for the authorisation of marketing the product, as well as the formal authorisation of clinical trials, while the HRA details the ethical principles connected to research projects, their supervision, and questions of transparency, as well as the coordination between the various authorities.
Although the standards of protection are reinforced by the HRA, its provisions only concern research undertaken in Switzerland. The HRA has enabled the creation of a public register (www.kofam.ch), but this only covers clinical trials performed in Switzerland, and only contains minimal information. Delocalised tests are not included. With this new law, Switzerland has clearly missed an opportunity with regard to the globalisation of clinical trials.
A revised version of the TPA
A new TPA was adopted by Parliament in 2017. It will come into force once the prescriptions concerned have been adapted – normally in 2019.
The new TPA is intended to include two new articles concerning the publication of the results of clinical trials (Art 67b), as well as a new legal basis allowing Swissmedic to perform inspections outside of Switzerland (Art 64a). Public Eye was consulted during the revision of the prescriptions (see our position statement in French).
In the framework of the revision of the prescription on the requirements relating to drugs (OEMéd in French), Swissmedic intends to request from pharmaceuticals companies an additional justification (self-declaration) of respect of recognised regulations of good clinical practice. However, no sanctions are foreseen if the declaration is subsequently found to be incorrect (contrary to similar practices adopted in the EU).
Public Eye’s campaign, in addition to the dialogue that followed with the Swiss authorities, has certainly contributed to these legislative developments relating to clinical trials. However, there still remains much to be done even to reach the level of the EU in terms of transparency and ethical monitoring, let alone to surpass it. The Swiss legislation is only in its infancy.