Last Updated 31 May 2013
With its relatively small population of 50 million and rank
as the world’s 29th largest economy, South Africa is nonetheless
considered to be a gateway to the African continent, especially for sub-Saharan
Africa. South Africa’s designation stems, in part, from the strength and
stability of the country’s financial markets, regulatory systems, and economy,
which is buoyed by large gold, diamond, and platinum resources. The South
African government is spearheading major reforms to restructure the country’s
healthcare and health financing systems in order to address the growing levels
of health, social, and economic inequity in the country. Despite a relatively
high spend on healthcare for a middle-income country and progress in treating
HIV/AIDS since the early 2000s, South Africa is still plagued by high rates of
infectious and chronic non-communicable diseases--5.6 million people in South
Africa live with HIV/AIDS, representing 17% of the global burden of the
disease. Providing universal health coverage by means of a national health
insurance (NHI) program and improving primary healthcare services are at the
heart of the reforms.
Market profile: Market access drivers; key opportunities
and challenges; analysis of more than 40 market parameters.
Economic outlook: Global, regional, and country growth
Socioeconomic trends of 7 Middle East and Africa
countries: Gross domestic product (GDP); gross national income (GNI) per
Demographics of 7 Middle East and Africa countries
projected to 2030: Population size; population growth rate; life expectancy
at birth; median age; percentage of population aged 65 or more; percentage of
population that is urban.
Healthcare investments of 7 Middle East and Africa
countries: Healthcare spending as percentage of GDP (2000-2010), healthcare
spending by government and private entities (2010); healthcare spending per
Pharmaceutical markets (3 regions and 15 countries): Ranking
by size; market sizes; market growth.
Healthcare system: Organization and financing of
public and private sectors; hospital-based services, providers, and facilities;
essential drugs program; donor funding and PEPFAR; healthcare reform plans;
national health insurance.
Regulatory affairs: Key decision makers; reform
of the regulatory agency; South African Health Products Regulatory Authority
(SAHPRA); clinical trials in South Africa; registration process; Bolar-type
amendment for generics registration; biosimilars regulations.
Pricing and reimbursement: Key decision
makers; public sector pricing, procurement, formularies, and state tender;
private sector single exit prices, annual price adjustments, international
price benchmarking, price setting for new medicines, health technology
Cost-containment measures: Generic substitution;
internal reference pricing; rational drug use; copayments and coinsurance.
Intellectual property protection: Key decision makers;
patent protection; patent reform; data exclusivity; patent linkage; compulsory
licensing; voluntary licensing; counterfeit drugs.
Outlook and implications for the pharmaceutical industry: 10
key factors to appreciate when doing business in South Africa.
Exhibits: 21 data-rich tables and figures.