ABSTRACT

The definition of 'access' is enhanced by the four principles of the right to health: availability, accessibility, acceptability, and quality. These four elements constitute the broader possessory concept of 'use' of which access is a component. Access, in the sense of physical property, implies the value to which the property-holder has the opportunity to deny to others. Incorporating both physical and mental well-being, the definition of health relies upon attention to cultural diversity in its very interpretation and realisation, as explained in the Committee on Economic, Social and Cultural Rights General Comment and the element of 'acceptability'. Indeed, regulatory laws will influence not only the immediate availability of the medicine, but also the pricing. While regulatory authorities determine the actual legality of the drug with respect to the market, the infrastructure for pricing impacts directly upon accessibility in both developing and developed countries. In the United States, the key regulatory authority is the Food and Drug Administration.