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

Abstract

Background There are limited studies on the role of efficient regulatory mechanisms in facilitating greater access to Hepatitis C virus (HCV) treatment. Evidence to support the importance of effective pharmaceutical policies and regulations in improving access to oral viral drugs towards the elimination of HCV is needed. This study aims to explore the adequacy of the implemented pharmaceutical policies and regulations in Egypt and their role to improve the availability and affordability of direct-acting antivirals (DAAs) to achieve universal access to the treatment of HCV. Methods The study adopts a qualitative methodology using desk review of regulatory and legislative information, literature review, and semi-structured interviews with key experts from the concerned governmental regulatory agencies, pharmaceutical industries, academic organizations, professional associations, civil society organizations, and clinicians who are working in researching treatments for hepatitis C. Findings The common DAAs available in the market are Daclatasvir, Sofosbuvir, and Sofosbuvir-based direct-acting antiviral combinations. Fast-track medicines registration pathway for marketing authorization of DAAs is used to reduce market access time frames. The pricing policies are supplemented using price negotiation to set up affordable prices that led to a reasonable price for DAAs. Using Trade-Related Aspects of Intellectual Property Rights (TRIPs) flexibility and local production of quality generics DAAs at lower prices. In addition, political will and collaboration between the government, civil society, and pharmaceutical companies improved patients' access to affordable DAAs and succeeding hepatitis C treatment in Egypt. Conclusions The study findings indicated that the implemented pharmaceutical policies and regulations have an immense role in enhancing access to medicines towards the elimination of hepatitis C in Egypt.

Variations in global prices of chemotherapy for childhood cancer: a descriptive analysis

“…5 It has historical precedent as a cost-reduction strategy in the treatment of HIV/AIDS, tuberculosis, and malaria, where pooled procurement was demonstrated to reduce originator and generic prices by 42.4% and 35% respectively, 31 and more recently in the treatment of Hepatitis C, where pooled procurement of direct-acting antivirals reduced prices by up to 99%. 32 Our study observed a potential relationship between increasing purchase volumes and decreasing variance in prices, suggesting that pooled procurement may be beneficial in price stabilization. Pooled procurement has the additional benefits of increasing resiliency of supply chains and reducing quality uncertainty by imposing minimum quality standards.…”