ABSTRACT
BACKGROUND: Access to quality-assured, safe and efficacious medical products is fundamental for Universal Health Coverage and attaining Sustainable Development Goal 3: Ensure Healthy Lives and Well-being for All. To guarantee this right, there is a need for robust and efficiently performing national regulatory systems for the regulation of medical products. Well-functioning regulatory systems apply globally accepted standards which ensure that the level of control is proportionate to the level of public health risk. OBJECTIVE OF THE STUDY: The study aimed at analysing the regulatory systems for medical products in the 16 Member States of the Southern African Development Community (SADC). It provides an overview of the national regulatory systems for medical products in the region in 2017 and outlines the institutional frameworks, which enable the implementation of regulatory functions. METHODOLOGY: A survey was conducted in March-December 2017 in English, French and Portuguese. National Regulatory Authorities for medical products (NMRAs) of the 16 Member States within SADC responded to the questions asked and sent in their answers. The survey was constructed around five themes instrumental for implementation of the Universal Health Coverage actions framework. Three of the themes are discussed in this article. RESULTS: The outcome of the survey demonstrates that within SADC, NMRAs vary in terms of organisational set-up and modalities of medical product regulation. The majority are within the Ministries of Health, and a few are either semi-autonomous or autonomous. Legal frameworks for medical products are in place for some of the SADC NMRAs, although they vary in the scope of products subject to regulation. Traditional medicines, biologicals and medical devices are regulated, however not uniformly across the region. CONCLUSION: Despite major progress over the years, the survey demonstrates variable levels of governance and regulatory framework among NMRAs in SADC. The survey supports the need for shifting from the broad strengthening of the regulatory systems which exist and are underpinned by the mandates, to more product-type focused approaches. This shift will ensure that medical products are quality-assured, safe and effective for a performant Health Systems attainment of the Universal Health Coverage and Sustainable Development Goals.
ABSTRACT
The objective was to model the HIV/AIDS epidemic among the adult population (15-54 years) in Uganda; taking into account the sexual mixing and variability of infectiousness of an individual infected with HIV. The HIV/AIDS epidemic in Uganda is modeled using a computer simulation; based on a mathematical model; over a period of 30 years from the period the virus is anticipated to have been introduced in the population. The model examines transmission via sexual contact; blood transfusion; and intensive surgery. The results showed that HIV prevalence rates are found to be higher for uniform infectivity compared to variable infectivity; as well as for number of new partners based on a distribution compared to mean number of new sex partners. Blood transfusion was responsible for 0.09- 0.30of the HIV infection; while none were obtained from the projections for invasive surgery. It was concluded that use of uniform infectivity as well as use of categorical mean number of new sex partners may over estimate and underestimate the epidemic; respectively. Before blood was screened; it accounted for a small but significant portion of the epidemic
Subject(s)
Acquired Immunodeficiency Syndrome/epidemiology , HIV SeroprevalenceABSTRACT
The objectives was to model the HIV/AIDS epidemic among the adult population (15-54 years) in Uganda; taking into account the sexual mixing and variability of infectiousness of an individual infected with HIV. The HIV/AIDS epidemic in Uganda is modeled using a computer simulation; based on a mathematical model; over a period of 30 years from the period the virus is anticipated to have been introduced in the population. The model examines transmission via sexual contact; blood transfusion; and intensive surgery. The results showed that HIV prevalence rates are found to be higher for uniform infectivity compared to variable infectivity; as well as for number of new partners based on a distribution compared to mean number of new sex partners. Blood transfusion was responsible for 0.09- 0.30of the HIV infection; while none were obtained from the projections for invasive surgery. It was concluded that use of uniform infectivity as well as use of categorical mean number of new sex partners may over estimate and underestimate the epidemic; respectively. Before blood was screened; it accounted for a small but significant portion of the epidemic
