Right to Health and Drug Regulation

Abstract

Access to essential medicines is part of the right to the highest attainable standard of health, founded in international law. The contribution focuses on global drug regulation, devising from an ethical and regulatory point of view main issues related to the right to health; namely, the entry discusses the issues of international trials for safe and effective drugs, early access to drugs, drug promotion, drug price, sustainability of pharmaceutical expenditure, and orphan drugs. The ethical principle of equitable and universal care should always prevail over profits of individual pharmaceutical companies, particularly in key issues, for example, drug pricing; the recognition of this ethical principle should enforce the right of patients to have free access to necessary medicines, as recognized in the panorama of constitutional rights. Finally, some conclusions on constitutional recognition of the right to access to essential medicines as an important sign of national values and commitment, but neither a guarantee nor an essential step, as shown by those countries that have failing health systems despite constitutional recognition, and by those that have good access without it.

Laura Palazzani wrote paragraphs 1, 4–7, and the conclusions. Margherita Daverio wrote paragraphs 1 (section on US, EU, and Japan regulatory authorities), 2, and 3.