The Pharmaceutical Market: South Africa

Summary

The Republic of South Africa represents one of the most diverse medical markets in the world. Rich, urban areas retain many of the high-quality facilities developed for the White population under the apartheid regime. Rural areas and Black townships are only now slowly beginning to develop any kind of modernised health service.

Since coming into power in 1994, the ANC government had been determined to redress the years of neglect in the public primary healthcare sector. As a result, the focus of attention has shifted away from the tertiary and medical research sectors towards primary care, leading to severe budget cuts within the public hospital sector. While the latest drugs remain almost exclusive to the high tech hospital sector, rural areas continue to suffer from shortages of the most basic medicines and treatments for infectious diseases such as tuberculosis. The most serious, and certainly the most high profile healthcare concern in South Africa is the HIV/AIDS epidemic; the country has one of the highest infection rates in the world but little money to purchase antiretroviral treatments that are commonly available in the West.

After lengthy debate and many delays, the South African government finally passed its major piece of pharmaceutical legislation in May 2003, the Medicines and Related Substances Amendment Act. The Act was broad ranging and aimed to bring national procedures further in line with international standards. The new regulations should produce a more accessible healthcare system for the country's vast poor population, most notably to HIV/AIDS retrovirals. That said, the sector is still mired in controversy regarding the provision of the antiretroviral nevirapine to pregnant women infected with HIV in order to prevent the transmission of the disease from mother to child. Despite a constitutional Court ruling ordering the government to approve the drug, it has refused to do so, sparking an outcry from drugs companies, notably Boerhinger Ingelheim, as well as HIV/AIDS groups across the country. Although the regulatory authority now appears willing to approve the drug, a decision has still not been reached as there are conflicting reports about its safety following reports of liver toxicity with long-term use.

Pricing and reimbursement procedures are convoluted; there is currently controversy surrounding the pricing of medicines. The industry is challenging new government regulations introducing a Single Exit Price, a figure set by manufacturers for every product and a professional fee for dispensing services which has replaced the system of commercial mark-ups. Mandatory disclosure of information relating to pricing is also in place. In December 2004, the Supreme Court set aside the government's regulations claiming that the regulations did not pass the test of legality and were consequently of "no force and effect." The government has appealed to the Constitutional Court claiming that the Supreme Court had no jurisdiction in the matter and that the decision made was wrong; the current regulations will remain in force until such time as the Constitutional Court makes its decision.

Espicom's in-depth pharmaceutical market reports are ideal for executives wanting to understand the key drivers in pharmaceutical markets and have access to a wealth of statistical data. Each report opens with an outlook section that provides analysis of the market, 5-year market forecasts, national data projections, market outlook and key developments such as regulation, pricing/reimbursement, intellectual property, health facilities and government policy. The report also provides extensive background information, population trends, health status, health expenditure, organisation & administration, hospital services, medical personnel, healthcare development, market access information, trade data for raw materials and finished products and essential industry contacts. Included with the report are 3 free quarterly updated outlook reports, enabling you to keep up to date with market developments for a year.

Content