Regulation of stem cell therapies under attack in Europe: for whom the bell tolls
At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations.
Unproven and unauthorized ‘stem cell therapies’ are not new (Enserink, 2006; Hyun et al, 2008; Regenberg et al, 2009). What is new is the government’s support for unproven therapies in countries, where rules set out by regulatory bodies (FDA, EMA) have so far been effective in protecting patients from serious risks associated with their indiscriminate use. This may be rapidly changing.
The Italian case (Box 1; (Abbott, 2013; Nature Editorial, 2013b)) follows two similar cases in the United States, and one in Germany (in which one patient died) that were effectively halted by relevant regulatory bodies (Nature Editorial, 2013a). In one case, the proponent was arrested. However, the Italian case is the first in which unproven ‘stem cell therapies’ may be de facto made legal, rather than being stopped by regulatory bodies and the government. Thus, this is the first case in which unproven stem cell treatments are officially recognized as a bona fide treatment, without having been tested in rigorous clinical trials, and based on flimsy and highly debated preclinical evidence, to be made part of a publicly funded, public health care system (Box 2 and Box 3).
This makes the Italian case unique and of global concern.
Journal: The EMBO Journal (2013), 1–7