The Pharmaceutical System and Its Component: Regulation and Management and Associated Challenges

Abstract

Equitable access to health products is a key condition and an indicator for countries’ progress towards Universal Health Coverage (UHC). Access to healthcare, including essential medicines, is a fundamental human right. Realization of this right involves various combinations of public and private financing and service provision arrangements. The pharmaceutical system is an integral subset of the health system which requires mature regulatory structures and robust supply systems to ensure that health goals are achieved and support country efforts to effectively advance UHC. The landscape of pharmaceutical systems is rapidly changing with increasingly complex technologies, often without clear regulatory approaches or mechanisms to achieve equitable access, especially in low and middle-income countries (L&MICs). Medicines are life-enhancing and lifesaving commodities. For a health system to achieve public health goals, medicines should be available in sufficient quantities and be affordable to the population. Health products must also be safe, quality assured, efficacious and used appropriately to achieve desired health outcomes.