Access to required medicines is considered part of the Right to Health, which was declared a social right in the World Health Organization Constitution (1946) and the United Nations’ Universal Declaration of Human Rights (1948). Within the realm of access lies the question: is regulatory approval enough for access? With the growing trend towards specialised medicines, therapies are becoming increasingly complex to develop but also more expensive to commercialise to the point of unaffordability for individual patients. This makes coverage under a universal healthcare offering ever more difficult, with delays to reimbursement often occurring to ensure cost-effectiveness. Hence, although a medication may be available after regulatory approval, it is not necessarily accessible to patients.

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