Regulation of Clinical Trials

This chapter discusses the publication of the European Clinical Trials Directive in 2001 and its incorporation into the law of Member States. It explores the intention of the Directive in harmonising the rules for conducting clinical trials within the EU to facilitate the internal market in medicinal products and to protect the rights, safety, and well-being of participants. It also covers the passing of the new Clinical Trials Regulation (CTR) by the EU in 2014, which was prompted by concern that the system for approving clinical trials was overly bureaucratic and that it was hampering multinational trials. The CTR could not come into force until the Clinical Trial Information System (CTIS), which is intended to provide a single coordinated approval process, became fully functional. This happened too late for the CTR to be automatically incorporated into UK law by the European Union (Withdrawal) Act 2018.

Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

Legacy samples in Finnish biobanks: social and legal issues related to the transfer of old sample collections into biobanks

Biobank operations started officially in Finland in 2013 when the Biobank Act defining and regulating biobank operations came into force. Since then, ten biobanks have been established and they have started to collect new prospective samples with broad consent. The main corpus of biobank samples, however, consists of approximately 10 million “legacy samples”. These are old diagnostic or research samples that were transferred to biobanks in accordance with the Biobank Act. The focus of this article is on ambiguities concerning these legacy samples and their transfer in terms of legality, human rights, autonomy, and social sustainability. We analyse the Finnish biobank operations in the context of international regulation, such as the European Convention of Human Rights, the Oviedo Convention, European Charter of Fundamental Rights, the GDPR, and EU Clinical Trials Regulation, and show that the practice of using legacy samples is at times problematic in relation to this regulatory framework. We argue that the prevailing interpretations of these regulations as translated into the Finnish biobank practices undermine the autonomy of individuals by not giving individuals a right to consent or an actionable right to opt-out of the transfer of these legacy samples to the biobank. This is due to the fact that individuals are not given effective notification of such transfers. Thus, issues regarding the legal status of the biobank samples and the social sustainability of biobank operations remain a challenge for biobanks in Finland despite governmental efforts to create pioneering, comprehensive, and enabling legislation.

EU Clinical Trials Regulation 2014: Fetter or facilitator?

European Union (EU) Clinical Trials Regulation 536/2014, expected to come into force in 2019, provides for a streamlined single EU application for cross-border clinical trials and enhanced transparency of results. The status of the Regulation in post-Brexit UK is uncertain. Matters of regulatory alignment will be covered by agreements on the future EU-UK relationship. In the short term, implementation of the Regulation in the United Kingdom depends on the Brexit model and timing of the Regulation’s implementation. The EU (Withdrawal) Act will convert EU law into UK law, including the vast array of EU life sciences regulation. However, the Regulation is likely to be implemented after the United Kingdom leaves the EU, but within the transition period. If the United Kingdom is not part of the legal framework governing clinical trials in the EU, then the United Kingdom will still need to comply with the global framework set out in the International Council on Harmonisation if it wants to be part of trials of medicinal products for which marketing authorization will be sought for licensing in the European Economic Area. This article extols the virtues of harmonization with the EU and attempts to counter some of the media focus on the advantages of a deregulated bespoke approach.