WHAT IS
A number of government strategies and policies to support further growth of the health industry have been developed and adopted. The key to the future growth of this industry is the Bio-economy Strategy of the Department of Science & Technology. This strategy puts health Biotechnology as one of the key pillars. The Bio-Economy Strategy identifies several strengths of the local Health Biotech sector that will drive the bio-economy. These include:
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A well-developed generics industry.
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Opportunities for local manufacturing due to improving public- and private-sector focus on generics supply chain management.
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The largest market in the world (by volume) for HIV drugs.
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Modern science, local biodiversity, and indigenous knowledge systems could be combined to accelerate product development.
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World-class clinical sciences researchers and a regulatory framework provide opportunities for globally competitive clinical development.
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World-class researchers in basic sciences, drug, and diagnostics discovery, and therapeutic delivery systems.
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Significant investments in vaccine production.
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Strategic international partnerships with countries and organizations.
PROGRAMMES IN SOUTH AFRICA
PROJECTS
REGULATORY MATTERS
The biotech sector is one of the most carefully regulated industries in the world. Biotech products have to meet an exhaustive series of regulatory requirements to ensure environmental and human safety before they are released into the market.
The regulation of health innovations derived from genetically modified organisms also follows the route of approval by the Executive Council on GMO Act, as it is with agricultural biotech innovation. This is in addition to the approval and registration that is regulated by the Medicines Control Council.
The MCC, in considering whether a medicine is suitable for use for its intended purpose, assesses its relative risk against the benefits. The Medicines and Related Substances Act, 1965 (Act 101 of 1965), defines a medicine as any substance or mixtures of substances used or purporting to be suitable for use or manufacture or sold for use in -:
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the diagnosis, treatment, mitigation, modification, or prevention of a disease, abnormal physical or mental state, or the symptoms thereof in humans, or
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restoring, correcting, or modifying any somatic or psychic or organic function in humans, and includes any veterinary medicine.
All medicines for human use are subject to this law, including complementary and complementary biological medicines. Further, all veterinary medicines must be registered in terms of the Act, excluding stock remedies registered in terms of Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act No. 36 of 1947.
