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.

The ideal way to design clinical trials and establishment of evidence for human cellular and tissue-based products in Japan.

In Japan, the Pharmaceuticals and Medical Devices (PMD) Act established in 2014 included an additional chapter dedicated to frameworks for human cellular and tissue-based products. To further evaluate the product considered to have "likely to predict efficacy" at the time of receiving "conditional and time-limited marketing authorization," a system has been introduced to determine whether the product is eligible for "full marketing authorization" through statistical "confirmation of the efficacy" in a postmarketing surveillance study using a registry. A movement similar to this regulation has been seen among Western nations. For example, in the United States, Regenerative Medicine Advanced Therapy Designation was introduced in 2017 as a provision of the 21st Century Cures Act. This is similar to Japan's conditional and time-limited marketing authorization, which presumes efficacy of a product based on surrogate endpoints in life-threatening diseases. It is true that the current study design has limitations, and study designs that are beyond our imagination should be developed in the future.

Issues on medicine toward realizing Universal Health Coverage / 国際保健医療

  Health service provision is one of the components in Universal Health Coverage (UHC). Medicines are vital for health services, and they should be affordable and accessible for safe and appropriate usage for everyone.  This article is a report on the symposium “Medicines for UHC,” held in the academic meeting of the Japanese Association of International Health in December 2017.  In Lao PDR, a study was conducted in urban and rural hospitals examining lists of available medicines, as well as their usage, distribution, and prices. The study showed that neurological medicines including anesthetics made up 29% of all medicines used in the urban central hospital, as it was one of the few hospitals that provided complex surgeries in Laos, resulting in a high concentration of patients. Anti-tuberculosis, ARV, and anti-Malaria medicines, as well as vaccines, were provided by Global Fund, GAVI, and other organizations, so that their costs were not included in the hospital’s procurement lists. While anti-microbial medicines only accounted for 13% of the medicines used at the urban central hospital, they accounted for 43% of those in rural hospitals, where most patients presented with upper respiratory and digestive infections. While the Ministry of Health sets the standards for evaluating and regulating the quality and cost of medicine, individuals can purchase medicines from private pharmacies without prescriptions, making it difficult to evaluate appropriate usage.  Regarding the quality of medicines, distribution companies, health workers, and patients cannot distinguish between authentic and falsified or substandard medicines. As an example, after a study in Cambodia revealed the existence of inappropriate medicines, the Cambodian government required companies to provide results of dissolution tests.  As the limitations on pharmaceutical regulatory authorities and their staff in developing countries impact their capabilities, we recommend supporting them in establishing effective pharmaceutical regulations internationally.

To sell or not to sell; the differences between regulatory and community demands regarding access to antibiotics in rural Ghana.

BACKGROUND: In Ghana, there is extensive over-the-counter dispensing of antibiotics, resulting in high levels of inappropriate use, and an increase in antibiotic resistance. Regulations prevent Licenced Chemical Sellers (LCS, Over-the-Counter Medicine Sellers) from selling antibiotics other than Cotrimoxazole. In practice, however, these sellers sell a variety of antibiotics. This paper aims to provide insight into the differences between regulatory and community demands on the sale of antibiotics, and to explore how these differences in demand could be resolved to facilitate safe and appropriate use of antibiotics in rural Ghana. METHODS: A total of 32 in-depth interviews were conducted in the Kintampo North and South Districts in Ghana; 16 among antibiotic suppliers, predominantly LCS, and 16 among community members. Six focus group discussions were also conducted among 40 community members. Data were coded using Nvivo 10 and thematically analyzed in line with study objectives. The results are presented as narratives with quotes to illustrate the findings. RESULTS: Generally, antibiotic suppliers were aware that regulations prevent LCS from selling antibiotics except Cotrimoxazole. However, LCS sell all types of antibiotics because of community demand, economic motivations of LCS, and the poor implementation of regulations that are intended to prevent them from selling these medications. Factors that influence community demand for antibiotics include previous knowledge of effectiveness of some antibiotics, delays in seeking care at health facilities, financial constraints, and distance to health facilities. LCS suggested that they should be trained and allowed to sell some types of antibiotics instead of being prevented completely from selling. Community members also suggested that Community-based Health Planning and Services (CHPS) compounds should be equipped to dispense antibiotics. CONCLUSION: The sale of antibiotics by LCS at the community level is influenced by both structural and individual contextual factors. There is a need to educate community members on the appropriate access and use of antibiotics in rural Ghana. In addition, rather than enforcing rules that go against practice, it may be more effective to regulate the sale of antibiotics by LCS and train them to make their dispensing more appropriate. CHPS compound could also be equipped to dispense some antibiotics to improve appropriate antibiotic access at the community level.

Characterization of the evolution of the pharmaceutical regulatory environment.

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. LAY ABSTRACT: The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main mission of public health protection has remained a constant feature over the years; and (iii) since the 1970s other factors such as public health promotion, international harmonization, innovation, and agency modernization are playing more important role in regulatory agency thinking and actions.