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Background: Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization's (WHO's) minimum PV requirements for a Functional National PV System. Methods: A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO's minimum requirements. Results: All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion: A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in regulating the market ensuring the safety and effectiveness of medications. National PV systems in the study countries needed strengthening. Greater attention to funding is needed to coordinate and sustain PV activities. Our study highlights a need for developing more systematic approaches to regularly monitoring and evaluating PV policy and practices. [ABSTRACT FROM AUTHOR]

Objective. To investigate equity in the geographical distribution of community pharmacies in South Africa and assess whether regulatory reforms have furthered such equity. Methods. Data on community pharmacies from the national department of health and the South African pharmacy council were used to analyse the change in community pharmacy ownership and density (number per 10 000 residents) between 1994 and 2012 in all nine provinces and 15 selected districts. In addition, the density of public clinics, alone and with community pharmacies, was calculated and compared with a national benchmark of one clinic per 10 000 residents. Interviews were conducted with nine national experts from the pharmacy sector. Findings. Community pharmacies increased in number by 13% between 1994 and 2012 – less than the 25% population growth. In 2012, community pharmacy density was higher in urban provinces and was eight times higher in the least deprived districts than in the most deprived ones. Maldistribution persisted despite the growth of corporate community pharmacies. In 2012, only two provinces met the 1 per 10 000 benchmark, although all provinces achieved it when community pharmacies and clinics were combined. Experts expressed concerns that a lack of rural incentives, inappropriate licensing criteria and a shortage of pharmacy workers could undermine access to pharmaceutical services, especially in rural areas. Conclusion. To reduce inequity in the distribution of pharmaceutical services, new policies and legislation are needed to increase the staffing and presence of pharmacies. [ABSTRACT FROM AUTHOR]

The fast-track registration policy of the South African National Department of Health allows for rapid registration of new medicines of public health importance and of all medicines on the Essential Medicines List, most of which are generics. No limit is placed on the number of generic brands of a medicine that can be submitted for fast-track registration. This, together with resource constraints at the regulator, may delay access to important new medicines, new fixed-dose combinations of critical medicines or affordable versions of biological medicines (biosimilars). One reason for not limiting the number of fast-track generic applications was to promote price competition among generic brands. We found this not to be valid, since market share correlated poorly with price. Generic brands with high market share were, mostly, those that were registered first. We propose that the number of generic brands accepted for fast-tracking be limited to not more than seven per medicine.