May 2013

South Africa: Market Access Tracker - 2013

Report Authors
Neil Grubert, M.A.
Nikhil Mehta, M.Eng.
Lulu Pickering, Ph.D.
Andreia Ribeiro, Ph.D.


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 rates, 2011-2014.

Socioeconomic trends of 7 Middle East and Africa countries: Gross domestic product (GDP); gross national income (GNI) per capita.

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 capita (2000-2010).

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 assessment, reimbursement.

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.

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Mentioned in this report:

  • Organizations:
  • - African National Congress (ANC)
  • - Companies and Intellectual Property Commission (CIPC)
  • - Council of Medical Schemes (CMS)
  • - Central Procurement Agency (CPA)
  • - Department of Agriculture, Forestry and Fisheries (Biosafety Directorate) (DAFF)
  • - Department of Trade and Industry (DTI)
  • - Human Resources For Health (HRH)
  • - International Conference on Harmonization (ICH)
  • - International Monetary Fund (IMF)
  • - International Society for Pharmacoeconomics and Outcome Research (ISPOR)
  • - Medicines Control Council (MCC)
  • - Medicines Regulatory Affairs (MRA)
  • - National Association of Boards of Pharmacy (NABP)
  • - National Department of Health (NDOH)
  • - National Essential Medicines List Committee (NEMLC)
  • - Non-Governmental Organization (NGO)
  • - National Health Laboratory Services (NHLS)
  • - National Health Research Ethics Council (NHREC)
  • - African International Property Organization (OAPI)
  • - African Regional Intellectual Property Organization (ARIPO)
  • - President’s Emergency Plan For Aids Relief (PEPFAR)
  • - Pharmaceutical Industry Association of South Africa (PIASA)
  • - Pharmaceutical Manufacturers Association (PMA)
  • - South African Clinical Research Association (SACRA)
  • - South African Health Products Regulatory Authority (SAHPRA)
  • - Trade-Related Aspects of Intellectual Property Rights (TRIPS)
  • - United Nations Population Division (NHPD)
  • - World Bank
  • - World Health Organization (WHO)
  • - World Trade Organization (WTO)
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