C2 Federal café : Déclaration de Berne – Globalisation of clinical trials: how to ensure that the same ethical and regulatory standards are applied everywhere? A case study of Switzerland.

C2 Federal café : Déclaration de Berne – Globalisation of clinical trials: how to ensure that the same ethical and regulatory standards are applied everywhere? A case study of Switzerland.

Invited Session
Location: Exhibition Floor Date: April 19, 2016 Time: 12:30 pm - 2:00 pm

Background:

For strategic and economic reasons, major pharmaceutical companies are increasingly conducting clinical drug trials in low and middle-income countries. Recent investigations have however highlighted serious concerns regarding the proper functioning of ethics and regulatory review systems in several low and middle-income countries, resulting in insufficient safeguards for the protection of the trials’ participants, especially with regards to vulnerable populations. The major sponsors of such clinical trials rely heavily on self-regulation (internal monitoring and/or through contract research organisations/CRO) to ensure compliance of globally applicable standards. But some of these clinical drug trials serve for the marketing approval of new medicines in more affluent countries. How can protection of more vulnerable participants – such as those lacking regular access to basic medicine – be safeguarded in the background of commercial interests of the industry-sponsored clinical trials? What can/should drug regulatory authorities in high-income countries such as Switzerland do more internationally in this respect?

 

General objective:

To discuss on how Swiss actors (regulatory authorities, pharmaceutical companies, civil society) could contribute in improving compliance with globally applicable ethical standards no matter where industry-sponsored drug trials take place (no double standards)

 

Specific topic addressed:

• Ethical violations in clinical drug trials conducted in low and middle income countries
• Strengthening research ethics committees, institutional review boards and regulatory authorities in low and middle income countries
• Role of Swissmedic in contributing to ethical compliance of international drug trials serving for marketing approval in Switzerland
• The companies’ responsibility to respect human rights and the need to improve their internal due diligence mechanisms

 

Globalisation of clinical trials: how to ensure that the same ethical and regulatory standards are applied everywhere? A case study of Switzerland.

Samia Hurst, iEH2 (Institut Ethique Histoire Humanités), University of Geneva, Switzerland
Philippe Girard, Swissmedic, Switzerland
Patrick Durisch, Déclaration de Berne – Berne Declaration, Switzerland