Dr Tsung-ling Lee1
1Research Fellow, Centre for Biomedical Ethics, National University of Singapore
One key challenge in the regulation of regenerative medicines and cell-based therapies is balancing the demands for early access to innovative treatments with the need for robust scientific evidence of that demonstrates safety and efficacy. In March 2014, the European Medicines Agency (EMA) launched a pilot program under the “adaptive pathways” scheme designed to expedite market approvals for novel therapeutics in the European Union. Under the adaptive pathways, this has seen the EMA granting a conditional market approval to Holoclar, a stem-cell treatment used to treat damaged eyes of adult burnt patients, despite of limited clinical data supporting its efficacy and safety. Proponents of the adaptive pathways applaud the scheme as an example of regulatory innovation which legitimizes state power in the risk society. In contrast, opponents argue that the scheme undermines the existing legislative framework on advanced therapies and at risk of favoring vested interests of the pharmaceutical industry.
The paper makes two contributions. First, the paper provides an overview of the adaptive pathway, identifying the features of adaptive pathways that facilitate clinical translation of advanced therapies.
Second, focusing on Holoclar, the paper critically examines whether the adaptive pathways genuinely facilitate clinical translation of advanced therapies and the extent to which the process balances the competing demands of the stakeholders.
Tsung-Ling is a research fellow with Center for Biomedical Ethics, National University of Singapore. Her research investigates the role of law in promoting public health interests, with a focus on regulatory issues in global health.