EU draft legislation on clinical drugs trials

imagesEuropean Union is expected to finalise and give formal approval to the draft legislation on clinical drugs trials on 02 April 2014. The draft legislation inter alia requires all trial data to be placed in an accessible database. It also specifies that study protocols and full clinical study reports should be made public after approval. As members deliberate on the legislation, European Court of Justice (“ECJ“) will emerge as the legal battle field between drug companies and European Medicines Agency (“EMA“), the European Union agency responsible for regulation of medicines in Europe. In this context, I intend to introduce our readers to the article in NewScientist titled “Europe faces up to big pharma over clinical data” by Barbara Mintzes. As I intend to explore the Indian regulatory regime on clinical trials in later post(s), this report will set the background for the discusssion.  As you know, the Indian regulatory regime witnessed quite a few significant legal developments in the year 2013.     

The report links release of clinical drug trials data to the safety of medicines. According to the article, “disclosure also serves the true interests of advancing collective knowledge, allowing the science underpinning drug development to flourish.” Presently, drug companies release data selectively on the grounds of commercial confidentiality. This does cause “a systematic misrepresentation of medicines, making them seem more effective and safer than they actually are.”


Until as recently as 2010, EMA was not forthcoming in releasing the data. In 2010, the European Ombudsman ruled against the EMA after it refused to provide trial reports on anti-obesity medicines to researchers from the Nordic Cochrane Centre, part of the global, independent Cochrane Collaboration network, which aims to promote and facilitate evidence-based healthcare. The Cochrane research group, which was carrying out a systematic review of these medicines, appealed to the Ombudsman, arguing that they needed all the relevant scientific evidence, including the full clinical study reports submitted to the EMA.

The Ombudsman ruled against the EMA holding that public access to information “empowers citizens to monitor and scrutinise effectively the exercise of the powers vested in the EU institutions”. Further, “not only should the EMA provide access in these cases and in response to requests, but it should proactively release information.”

Since this ruling, the EMA has made available full clinical study reports and anonymised individual patient data. This was, however, challenged by the pharmaceutical companies, AbbVie and InterMune in ECJ. The companies argue that such release of data will provide competitors with an unfair advantage.

Concluding remarks

The concluding remarks of the author are quite prophetic which we can afford to overlook only at our own peril: “These provisions underline the fact that transparency is no panacea by itself. Trials need to be designed to address the right questions, and ideally there should be a firewall between testing drugs for effectiveness and safety, and commercial interests, with no direct company involvement in the design or conduct of trials. Transparency in clinical trials is a crucial first step, however. The European Court of Justice’s ruling on these two legal cases, expected in 2015, is likely to be pivotal. We can only hope that science and the public interest prevails.”




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