A Room with a View (and with a Gene Therapy Drug): Gene Therapy Medicinal Products and Genetic Tourism in Europe

European countries have traditionally had a very cautionary approach towards gene editing when it operates as a medical procedure,1 not only because it is an innovative therapy,2 but also, et pour cause, there are many unknowns in these therapies.3 There is some acceptance of genetic interventions if they meet two criteria: i) that they are somatic (i.e., they do not affect any offspring) and ii) that they are therapeutic (even though the exact contour of the concept ‘therapeutic’ is unclear).4 Such genetic procedures are allowed by Article 13 of the Oviedo Convention5 and therefore by several European national laws.6 Still, several restrictions are in place and medical procedures involving gene editing somatic therapies are highly regulated.7

However, gene therapy can also operate through medication rather than a medical procedure, and when that is the case the legal regime becomes much looser due to various loopholes on European pharma regulations. This chapter will address how the loopholes in pharma laws are allowing unproven genetic therapies to reach the market, exploiting the fragilities of vulnerable patients. Moreover, this scenario is harmful to the steady development of genetic technologies, jeopardizes funding and social credibility of legitimate gene editing drugs.8