Table 2.

Five objectives of public health law (modified from Magnusson et al. [10]) in relation to medicines affordability and financing. Legend: * Economic operators are defined as business entities including but not limited to pharmaceutical manufacturers, distributors, importers, and wholesalers.

Public health infrastructure

These legal rules identify the public entitles (ex. Committees, agencies, authorities, bodies) responsible for actions related to the selection of essential medicines, or the supply/procurement, IP management, pricing, or reimbursement of medicines. This may include the selection criteria for members of these decision-making bodies, their structure and organisation, roles and responsibilities, and other governance aspects [10].

Economic policies and regulation

These legal rules aim to incentivise and regulate the behaviours of government agencies, businesses, professionals and individuals [10]. Economic policies and regulation may include regulations for financing health care and insurance through public budgets (including pooling financing); the criteria for selecting and reviewing pharmaceutical benefits under UHC, and the periodicity of revision; the procurement of pharmaceuticals by public agencies; and policies and formulas for granting patents, data exclusivity, or intellectual property flexibilities, and for identifying prohibited anti-competitive behaviour of economic actors.

Transparency and the provision of information

These legal rules aim to inform and educate third parties regarding a particular behaviour. In the context of medicines financing and affordability, transparency encompasses information disclosure by all actors to empower patients/users (to understand their medicines entitlements and compare prices), health professionals (to provide the best care at the most affordable price), and public authorities (to compare, set, and negotiate prices). Information for users or the public can include entitlements to a UHC benefits package, and how health services are financed and organised.

Health equity

These legal rules aim to recognise the rights of individuals and the duties on States to protect and promote those rights. Health equity may include the explicit recognition of: individuals’ rights to access essential medicines and/or essential medical products/goods; the role of States to respect, protect, and fulfil individual rights; Regulations for the financial coverage of poor people or people in vulnerable situations to protect individuals and households from (catastrophic) out-of-pocket payments.

Remedies and sanctions

These legal rules aim to create mechanisms to hold pharmaceutical sector stakeholders to account for their responsibilities and actions, particularly towards other objectives of public health law (i.e., providing information, governing through committees and bodies, promoting health equity, implementing economic incentives/disincentives and regulation). Remedies and sanctions may include: The availability of recourse for complaints and remedies for users in case of an alleged rights violation in relation to UHC and pharmaceuticals; Sanctioning the behaviour of health providers who are involved in the prescription, dispensing, and/or use of medicines, that is contrary to good pharmaceutical care and/or medical ethics; Sanctioning the behaviour of public authorities (including government officials and employees) that is inconsistent with their legal and ethical obligations regarding pharmaceutical care; Sanctioning the behaviour of economic operators * that is defined in legislation as undesirable.