Pharmaceutical policies and regulations of oral antiviral drugs for treatment of hepatitis C in Egypt—case study (Peer reviewed)

The study delves into the pharmaceutical policies and regulations concerning oral antiviral drugs for the treatment of Hepatitis C virus (HCV) in Egypt. With limited research on the role of regulatory mechanisms in enhancing access to HCV treatment, this research aims to shed light on the effectiveness of these policies in improving access to oral antiviral drugs, especially towards the elimination of HCV.

The research adopts a qualitative approach, encompassing a review of regulatory and legislative information, literature analysis, and semi-structured interviews with key experts from various sectors. The study reveals that common direct-acting antivirals (DAAs) available in the market include Daclatasvir and Sofosbuvir. To expedite the availability of these drugs, Egypt uses a fast-track medicines registration pathway, reducing market access time frames. Pricing policies are enhanced through negotiations to establish affordable prices, resulting in a reasonable cost for DAAs. The study also highlights the use of Trade-Related Aspects of Intellectual Property Rights (TRIPs) flexibility and the local production of quality generic DAAs at reduced prices. A significant factor contributing to the success of HCV treatment in Egypt is the collaboration between the government, civil society, and pharmaceutical companies, ensuring patients have access to affordable DAAs.