Publications Pharmaceuticals
Up one levelProtection of clinical trial subjects in countries outside the EU
As medicines intended for the European market are increasingly tested on clinical trial participants outside the EU in low and middle income countries, European institutions have a moral and legal responsibility to protect their rights. Many cases of violations of ethical principles and guidelines have been reported. Therefore, in this briefing paper, Wemos and SOMO call upon the European Parliament, the European Commission and the European Medicines Agency to take measures at the following three levels: 1) Vigorously pursue the integration of ethical principles into EMA procedures, 2) Increase transparency in clinical trials outside the EU and 3) Strengthen capacity in low and middle income countries.
Putting Contract Research Organisations on the Radar
An exploratory study on outsourcing of clinical trials by pharmaceutical companies to contract research organisations
Ethical concerns in clinical trials in India
This report is the product of a journalistic investigation on clinical trials. It set out to identify ethical concerns in clinical trials that were conducted in India and used for approval of new drugs in the European Union (EU).
Clinical Trials in Developing Countries
European legislation regulating the marketing authorisation of medical products states that results from clinical trials that do not meet the ethical requirements of Good Clinical Practice, cannot legally be used by an applicant to justify its application, irrespective of whether the trial was done inside or outside the EU. However, earlier studies indicate that this legislation is not always properly observed: these studies identified trials with an unethical design that were part of approved EU marketing applications.
Examples of unethical trials
This briefing paper provides an overview of known examples of unethical clinical trials. It was prepared by SOMO, in collaboration with Wemos, and is based on secondary sources.
Ethics for Drugs Testing in Low and Middle Income Countries
In this report SOMO links clinical trials carried out on people in low and middle income countries to medicines that are currently available on the European market. The number of clinical trials off-shored to countries like China, India, Russia and Argentina has experienced enormous growth in the last five years. However, trial subjects in these countries are more vulnerable and their rights are less secured than in high income countries.
Clinical trials in Kenya
The report describes relevant regulations, procedures, and actors in Kenya with regard to ethical standards in clinical trials involving human beings.
Roll Back Malaria Partnership
This report forms part of a broader research project on the role of companies in public-private partnerships (PPPs). Such collaborations have become an increasingly important way to stimulate sustainable development. The research project aims to contribute to a better understanding of the rationale, functioning and effectiveness of these partnerships.
Global Alliance to Eliminate Lymphatic Filariasis
This report describes and analyses the Global Alliance to Eliminate Lymphatic Filariasis (GAELF), a Global Public-Private Initiative (GPPIs) for health.
