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Pharmaceutical policies and regulations of oral antiviral drugs for treatment of hepatitis C in Egypt—case study
Article Number: SIS208417AI170123
17th January, 2023
Author(s):
Mahmoud H. Teaima, Adi Al-Nuseirat, Dalia Abouhussein, Osama A. Badary & Mohamed A. El-Nabaraw
Abstract:
Background: There are limited studies on the role of efcient regulatory mechanisms in facilitating greater access to
Hepatitis C virus (HCV) treatment. Evidence to support the importance of efective pharmaceutical policies and regu‑
lations 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 avail‑
ability and afordability 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 aford‑
able prices that led to a reasonable price for DAAs. Using Trade-Related Aspects of Intellectual Property Rights (TRIPs)
fexibility 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 afordable DAAs
and succeeding hepatitis C treatment in Egypt.
Conclusions: The study fndings 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.