South African Pharmaceutical

Before the introduction of the SEP regulations, the South African pharmaceutical market was dominated by innovator brands, with very little generic penetration. Medicines were promoted directly to doctors and pharmacists, who often received samples, bonuses and many other incentives to drive the prescription or dispensing of particular drugs. These practices led to doctors often prescribing more expensive drugs. 

Yokes, S. (2007) Trade dynamics affecting the face of retail pharmacy in South Africa, South African Pharmaceutical Journal, 74 (7), 6-9. 

These regulations are a major development in our effort to ensure that South Africans have access to affordable, good quality medicine. You will recall that when this Act was passed in 1997, it was strongly opposed by pharmaceutical companies. It took these companies almost four years to withdraw their court action in 2001 and finally accept the legitimacy of our efforts and genuineness of our respect for the international trade treaties that we are party to. 

The pharmaceutical industry was very pleased with the actions of the ustr, but decided to pursue the matter further. In February 1998, the consortium of 40 drug companies, led by the Pharmaceutical Manufacturers Association of South Africa, filed a suit. Its key legal claim was that the statute, the Medicines Amendment Act of 1997, was in violation of South African obligations under trips. It was also claimed that the statute was unconstitutional because it gave sweeping power to South Africa s health minister to override the country s patent laws (Kongolo, 2001). For its part, the South African government promised to defend the Medicines Act, which could not be implemented because of the lawsuit. 

The deliberate addition of a biologically active substance to a plant preparation (known as adulteration) has become a major issue in the United States and elsewhere 48). Adulteration may be both purposeful and accidental. It is a cotmnon type of misconduct used to enhance the efficacy of the herbal products 43). Adulteration of herbal remedies by synthetic therapeutic substances is well documented 49-51). Until recently there had been no reports of deliberate adulteration of traditional African herbal remedies (52). The first such study reports two separate incidences in which South African traditional remedies were adulterated with western pharmaceuticals causing severe toxicity 52). 

LEGALLY AUTHORISED PERSON A person who has successfully completed the Pharmaceutical Manufacturers Association s Advanced Technologist Course Part II and subsequently the examination set by the South African Pharmacy Council and is registered by the Pharmacy Council as a Pharmacist s Assistant (Industry). 

South African law lays down certain requirements for pharmaceutical companies, the managing director and pharmacists e.g. ... 

Mozambique s particular industrial environment was recognized as another factor hampering the development of the pharmaceutical factory. In comparison to other African countries with a more established industry, Mozambique seems to be lacking a critical mass of suppliers, products and services needed for the development of a competitive pharmaceutical business. All the primary products needed for Maputo factory s manufacturing are, up to now, imported from Brazil all the basic maintenance and technical services are contracted to South African firms, and resorting to lower cost Indian and Chinese equipment has not been an option, given the limited equipment maintenance services provided by such suppliers in Mozambique. 

African governments are all grappling with the issue of high medicine prices. Coupled with the increasing momentum for developing local pharmaceutical industries, the issue of medicine prices and how to contain them will come into sharp focus for policy makers. African policy makers are also acutely aware of measures employed by other countries around the world to contain runaway health care costs, and specifically pharmaceutical expenditure. Although price controls are important policy instruments, they are very controversial. The South African experience with pharmaceutical price controls may therefore be a useful case study to inform other African coimtries interventions. 

In total, 19 interviews were conducted, involving 4 industry associations Innovative Pharmaceutical Industry Association (IPASA), National Association of Pharmaceutical Manufacturers (NAPM), South African Chambers of Commerce (SACCI) and South African Medical Device Industry Association (SAMED). 

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