By Timo Minssen
Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC. As described in a press-release, the new law:
“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”
Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.
These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).
The benefits of more transparency and sharing of clinical trials data are vast. The new rules enhance cross-border cooperation and increase operational efficiencies in conducting larger clinical trials with more viable and more reliable results. By optimizing the surveillance of drug safety and effectiveness, as well as boosting the accuracy of research reports on the benefits and risks of drugs, the regulation accelerates innovation and renders the EU area more competitive and attractive for clinical studies. It also provides a suitable framework for further inquiries into already existing data in order to examine new scientific opportunities and find new applications. This should e.g. support the development of special treatments and orphan drugs against rare and neglected diseases and provide a better platform for reaching strategic decisions about potential avenues of research and development. In addition, such data bases might allow individual patients and advocacy groups to gain more information about their specific medical problem. Last but not least, if combined with effective safeguards for the research participants’ safety, the new regulation may fundamentally increase public confidence in medical research and pharmaceuticals.
However, the increased transparency and sharing could also result in unintended negative consequences. Compulsory disclosure of clinical trial data may e.g. collide with the patentability of products, processes and 2nd uses. This could have adverse effects on incentives to invest in research and to develop new drugs. Other concerns relate to the risks for the privacy-protection of research participants, and to the problem that the new transparency might encourage market competitors, unskilled analysts, or other actors with particular agendas to independently publish poorly conducted analyses. This indicates that a proper operation and responsible administration of the new clinical trials data sharing system is complex and will involve considerable costs. All of the above issues are certainly aggravated by the still ongoing discussions in the US and Europe about even more far-reaching disclosures of complete depersonified patient files.
These potential risks and serious fall-backs have inspired Petrie Flom fellow Nicholson Price and me to collaborate on two papers analyzing these problems and potential solutions with a special focus on the patentability of 2nd medical indications and a more flexible use of regulatory exclusivities. We will keep you updated.