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

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.

Pharmaceutical policies for diseases related to poverty in Brazil: a review

The "epidemiological transition" has fostered increasing attention to chronic and non-communicable diseases, but neglected diseases are still present and their relationship with the population's socioeconomic inequalities is increasingly evident, so much so that there has been a conceptual conversion to call them “poverty-related diseases”. It is a necessary to review and to discuss the characteristics and challenges of Brazilian pharmaceutical policies for populations affected by diseases related to poverty. This review of the literature was carried out, with works of the last 10 years dealing with the theme and the Brazilian reality. Out of the 272 identified articles, only 43 publications were included in this study. The results were: (i) the difficulties of investing in the research, development and production of new drugs for these diseases; (ii) the characteristics of access policies to medicines already available, their advances and limitations; (iii) and issues related to the right to comprehensive pharmaceutical assistance. Therefore, for the available therapies, national production and federal funding contributed to guarantee the supply. Assisted qualification actions are necessary and little discussed in area studies.

Prospects for COVID-19 in 2021

Significance Having struggled to control the virus as was done in East Asia and the Pacific, many countries are pinning their hopes on ending the pandemic through vaccination. Quantity and quality of vaccines rolled out will determine many of the non-pharmaceutical policies that countries may adopt.