Table 3 Summary of the mechanisms that contributed to improve access to DAA in Egypt

Market authorization

Fast track registration of DAAs generics has been granted to the interested companies

The DAAs have been exempted from the condition that they should be registered and distributed in the country of origin or the reference country for at least 1 year to accelerate the registration of DAAs

Egypt enabled early market entry of DAAs generics

The local pharmaceutical manufacturers have been allowed to register an unlimited number of DAAs (formerly, Egypt used the “Box” system in the authorization of Pharmaceuticals that limits the number of registered products to 12, in which the maximum number of registered generics for each brand product must not exceed 11 items)

Pricing

Multiple pricing policies were used to achieve low prices of DAAs that included external reference pricing in conjunction with price negotiation, and policies to promote the use of quality‑assured generics

Regular price revisions are undertaken at a pre‑specified frequency

DAAs medicines and their active ingredients were exempted from taxations

Intellectual property and patent protection

Law 82/2002 on intellectual property protection offers a wide range of flexibilities with the aim of protecting public access to medicines from drug monopolies and anti-competitive practices by patent holders

The Egyptian Patent Office applies rigorous patent examination practices in the form of high patentability standards, only allowing medicines with ‘strong’ patent applications to be protected

The DAAs didn’t get patent protection by the Egyptian Patent Office, this gave the local pharmaceutical manufacturers to produce generic versions of DAAs without IP-related restrictions

Local production

The government promotes and facilitates local production of HCV treatment

Competition between producers of the generic versions of the DAAs reduced the price of these medicines, making it available and accessible to Egyptian patients at affordable prices

Other factors

Political will: The government established national guidelines for the treatment of chronic HCV, worked closely with several local and international companies to ensure adequate supply of DAAs, financially sponsored the treatment for all patients who are not covered by health insurance and provide free treatment to poor patients

Community-based participation: Several civil societies contributed to HCV screening efforts, community-based education, and supporting the treatment costs for uninsured patients. The local media played a key role in raising awareness about HCV and promoting screening and treatment efforts