Swiss Group Finds Patent-Related Ethical Violations By Pharma Overseas

The Berne Declaration, a Swiss non-profit, has released results of investigations that found industry-sponsored offshore clinical drug trials in developing countries involve “multiple ethical violations,” a problem increased by the patent-based industry business model.

“Researches carried out in Ukraine, Russia, Argentina and India have shown multiple ethical violations due to weak regulatory environments and inadequate ethics monitoring,” the group said in a release. “Another enquiry conducted in Switzerland highlighted the current flaws at the Swiss medicines agency level in terms of ethical controls as well as the total lack of transparency prevailing during the marketing authorisation process.”

“Ethical violations such as improper informed consent process, abusive use of placebo, absence of post-trial treatment access and lack of compensation in case of serious adverse events have been documented in 4 the different country reports, which have just been published in English,” it said.

The findings echo concerns raised in debates at the European Union level with regard to regulation of clinical trials and access to research data, it added.

“The business model of pharmaceutical companies revolving around patent protection acts as an incentive to reduce the duration of the R&D phase of a medicine, thereby increasing the risk of ethical violations during clinical trials, in particular those offshored in weak regulatory environments,” Berne Declaration said.

It highlighted a “special publication” entitled “Clinical trials: human guinea-pigs on the cheap,” which it said gives an overview of the situation and summarises the results of its investigations and demands to the Swiss health authorities for increased transparency and ethical control.

All of the reports are available at www.ladb.ch/clinicaltrials.