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:

  • A well-developed generics industry.

  • Opportunities for local manufacturing due to improving public- and private-sector focus on generics supply chain management.

  • The largest market in the world (by volume) for HIV drugs.

  • Modern science, local biodiversity, and indigenous knowledge systems could be combined to accelerate product development.

  • World-class clinical sciences researchers and a regulatory framework provide opportunities for globally competitive clinical development.

  • World-class researchers in basic sciences, drug, and diagnostics discovery, and therapeutic delivery systems.

  • Significant investments in vaccine production.

  • Strategic international partnerships with countries and organizations.

 

PROGRAMMES IN SOUTH AFRICA

BIOSIMILARS


Biosimilars are biopharmaceutical medicines that are highly similar, but not necessarily identical, to their corresponding originators. Like their originator counterparts, they are derived from recombinant DNA technology. A guideline which outlines the quality, non-clinical and clinical requirements for the registration of a biosimilar medicine was first published in March 2012. This guideline was amended in August 2014 to include requirements for registering monoclonal antibody biosimilars. The Medicines Control Council is now in the process of approving the registration guideline and is based on international best practices. No biosimilars have been registered in South Africa, yet. Biosimilars, in this context, excludes vaccines, even if these are derived from recombinant DNA technology.




BIOLOGICS


Biological medicines, as the name implies, are complex proteins derived from living organisms – human, animal or microorganisms. They are manufactured using biotechnology processes under controlled conditions, unlike regular medicines which are generally small molecules produced by mixing various chemicals together. In South Africa, like all medicines, biologics are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this Act.




VACCINES and VACCINATION PROGRAMMES


HPV vaccination programme One of the most important recent advances in cervical cancer prevention is the prevention of high risk Human Papilloma Virus (hrHPV) infection through vaccination. In early 2014, the National Department of Health implemented a school-based HPV vaccination program for all girls 9 years and older in grade 4 in public schools, targeting almost half a million girls for the prevention of hrHPV. This followed the approval of two HPV vaccines by US FDA in 2006 and 2007, respectively, and by the MCC in 2008. These vaccines are only effective when used as prophylaxis when administered before exposure. The rationale for this programme is that vaccination should occur before the sexual debut since HPV is mainly sexually transmitted. Both vaccines are then administered to girls from 9 years of age and mainly targeting public schools now. There is, however, still a big gap in the private schools where the HPV vaccine uptake through private health care is very low.




EMERGING TECHNOLOGIES


Tissue engineering and regenerative medicine is one of the emerging areas that is gaining traction in the research and development space in South Africa and the African continent. The recent launch of the Africa Tissue Engineering and Regenerative Medicine International Society has further accelerated this field of health innovation.





PROJECTS

 

REVISION OF THE BIOTECHNOLOGY STRATEGY FOR GAUTENG TO BE ALIGNED WITH THE NATIONAL BIO-ECONOMY STRATEGY


The aim of this project is to review the 2007 Gauteng Biotechnology Strategy to evaluate its impact and relevance; revise and align the strategy with the National Bio-economy Strategy; enhance the competitiveness of Bio-economy sectors through research and innovation; enable the Gauteng Department of Agriculture and Rural Development (GDARD). The further aim is to “strengthen agricultural biosciences innovation to ensure food security, enhance nutrition and improve health, as well as enable job creation through the expansion and intensification of sustainable agricultural production and processing” in alignment with the objective of the National Bio-economy Strategy. This will impact the support of GDARD in achieving its vision of “vibrant, equitable, sustainable rural communities, food security for all, protected and enhanced environmental assets, and natural resources” thereby addressing the South African National Development Plan Mid-Term Strategic Framework (NDP MTSF) outcomes 7 and 1.




FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION


FEASIBILITY STUDY TO EXAMINE EXISTING MARKETS AND POTENTIAL MARKET DEMAND FOR NEW AND UNDERUTILISED CROPS AND VALUE ADDITION
The aim of this project is to conduct a feasibility study to examine the existing markets and potential market demand for new and underutilised crops including their value addition. Results from the market analysis will provide information and recommendations to direct R&D investment in agricultural infrastructure that can facilitate value addition and agro-processing. It is envisaged that this exercise will enable the Department of Science and Technology (DST) to make informed decisions on where to direct funding resources. The feasibility study in this area will assist in fulfilling the Bio-economy Agricultural Implementation Plan targets.





 


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 -:

  1. the diagnosis, treatment, mitigation, modification, or prevention of a disease, abnormal physical or mental state, or the symptoms thereof in humans, or

  2. 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.

 

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