Challenges in public policy for the implementation of pharmacogenetic tests in Europe

Abstract

Pharmacogenetics innovation in biomedicine has fostered new hope in pharmacotherapeutics and in the prevention and management of adverse drug reactions. Proponents argue that pharmacogenetics will improve drug safety and efficacy while also revolutionising marketing. Integral to this survey is the recognition that pharmacogenetics has been hailed as a revolutionary frontier within biomedicine. This expectation amplifies the anticipation and promise associated with the emergence of new biotechnologies. This progress, however, raises several policy concerns with the need to balance the creation of a unified legal framework. We outline the European regulatory framework, and discuss the current challenges and opportunities related to licensing, the development of innovative medicines, cost-effectiveness, resource allocation, and stratification. There is the need to substantiate the value of a regulatory framework and vigilant monitoring to ensure equitable access and just distribution of the benefits of pharmacogenetics in Europe.