Clinical trials: Roche and Novartis neglect their ethical responsibility in emerging countries
Zurich / Lausanne, 20 May 2019
International ethical standards as the Helsinki Declaration clearly state that in the countries where clinical trials take place, the vulnerable members of those societies should be able to benefit from the treatments that they have helped to develop. To check whether this principle is respected by Roche and Novartis, Public Eye studied 22 medicines tested in South Africa, Colombia, Mexico, Thailand and/or Ukraine. The results show progress in terms of bringing them to market: between 86% and 100% of these treatments are officially available in these countries. But they are sold at such exorbitant prices that they are unaffordable and thus inaccessible to most patients.
The investigation reveals serious problems in relation to access to nearly all of the 22 drugs studied, none of which are covered by state healthcare due to their high cost. Roche’s anti-breast cancer drug Perjeta provides a good example of the impact of pharma companies’ irresponsible pricing policies. In Switzerland, the excessively high price of the drug – set after bitter negotiations with the Federal Office of Public Health – threatens the principle of universal coverage of healthcare, as revealed by Public Eye’s campaign for affordable drugs. In emerging countries, Perjeta is almost as expensive: it costs nearly $56,000 a year in Ukraine and Mexico, which would take someone earning the minimum wage in these countries over 30 years to earn.
In contrast to their claims, Roche and Novartis do not respect their responsibilities to provide access to treatment following trials. They must review their pricing policies, factoring in the local economic context. Transparency is another essential part of restraining the unbridled power of pharma companies and guaranteeing access to medicines for all. A resolution introduced by Italy calling for full transparency of research and development costs as well as the true prices charged in each country will provoke heated discussion at the World Health Assembly (WHA), which opens in Geneva today. Responding to the influence of the pharma lobby, numerous EU countries are exerting pressure for the initiative to be buried. If Switzerland, as home country of two of the world’s largest pharmaceutical companies, were to support the resolution it would send a strong political message in favour of defending the public interest.
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Our research into clinical trials
Public Eye has published various investigations highlighting the ethical abuses linked to outsourcing drug testing to low and middle-income countries such as Poland (2015) or Egypt (2016). The main issues include problems obtaining informed consent, controversial testing with placebo drugs, a lack of commitment to provide compensation in the case of adverse effects for the participants and the population.