Accountability means being required to account for one’s conduct and actions, usually to an individual or group but ultimately to the public. Both individuals and organizations may be accountable. There is some overlap between accountability and transparency.

Because the field of medicines is highly commercialized, it is characterized by extreme pressures on the DRA and by intensive lobbying from stakeholders at many levels. A system of accountability is essential in managing these tensions. A DRA is usually accountable to an individual official, such as the Minister for Health, or to a body, such as the parliament.

Mechanisms for ensuring accountability include:

• A requirement to provide public reports on a periodic (e.g. annual) basis;

• Publication of decisions, processes and policies;

• A mechanism for appeals against DRA decisions;

• A procedure for complaints about the actions of the DRA and the conduct of individual staff;

• A code of conduct describing the behaviour expected of DRA staff;

• Regular presentations at government hearings;

• Formalized mechanisms for consulting independent experts;

• Public hearings on new policies, or on applications to register new pharmaceutical products or products containing new APIs. It should be borne in mind that public hearings can be expensive and time-consuming;

• Electronic publication of information about the DRA;

It is not necessary to implement all the mechanisms. The appropriate mechanism(s) will depend on the local context, but should be defined and recognized by the government and the DRA in published documentation.