Natural medicines under threat

By Sula Changuion

The government is doing its utmost to restrict access to functional foods, African Traditional Medicines, homeopathic and nutritional products. Complementary Medicine regulations were first gazetted in November 2013, and broader regulations to regulate ‘health supplements’ were gazetted in August 2017. These steps appear to aim at crushing the traditional and natural health sector of our economy. This industry contributes about R20 billion to the economy and creates around 120 000 income opportunities. Extreme legislative measures seem designed to throttle this potential. Natural products save the country millions through disease prevention. Perhaps a hidden hand wishes to steer us from prevention and natural cures. The natural health industry is being confronted with a circus-worthy course presenting higher obstacles to clear and more flaming hoops to jump through. One may imagine that certain role players do not like the fact that 70-85% of South Africans choose to use traditional and natural therapies. Access to services, products, education, and accurate information is being increasingly restricted. Effective and cost-effective solutions may be a spanner in the cogs of the synthetic pharmaceutical industry. TNHA (Traditional & Natural Health Alliance) has been fighting the regulations since 2013. They are currently launching legal cases to have the Complementary Medicine and Food Supplement regulations scrapped. They also want to have traditional & natural health products placed under the jurisdiction of a new Traditional & Natural HealthProducts Regulatory Authority under new legislation outside of the Medicines Act. This will be facilitated through tabling a Traditional & Natural Health Products Bill which is being drafted by their expert legal team and will be tabled by supportive MPs in Parliament. It appears the SAHPRA is either unable to assess traditional & natural health products under its current drug assessment framework, or they are deliberately obstructing and eliminating the entire traditional & natural health product sector by making it impossible for manufacturers and importers to comply financially and technically with procedures and standards which are only appropriate for pharmaceutical drugs. The previous Medicines Control Council failed to fulfill its mandate in this regard by issuing blanket registrations to over 9,600 ‘old medicines’ or ‘grandfathered medicines’ between 1965 and mid-1987. These drugs have been allowed to be sold on the market for decades in various schedules without any modern assessment of their safety or effectiveness. This means that one in every three drugs currently sold in pharmacies today may not have been tested for their safety, or may have labels claiming cures and benefits which have never been scientifically validated. Further to this, there are reportedly over 16,000 drugs that drug companies have applied for and are still awaiting assessment since 2011. In 2017 the MCC only could assess and register 150 drugs in that year. At their current bench-marking of assessing and registering 150 products a year, it will take an estimated 170 years to clear the existing backlog of a combined 25,600 drugs. It will take another 800 years to assess the 120,000 traditional and natural health products which require the same CTD documentation and rigor to be assessed as drugs. It is patently absurd to expect the traditional and natural health products industry to have their products registered by 2019 for discipline-specific complementary medicines and 2022 for health supplements. Before anything else can work, natural health product regulations must be right. To protect the consumer and enable practitioners and businesses to carry out their proper function without monopoly control from competitors. Change has to occur at the political and regulatory level to ensure all businesses can operate fairly and reasonably without double standards or pharmaceutical bias. Large companies must not achieve monopolies by regulation. We also need a system that encourages innovation and demands accountability. Being responsible for looking after our own health is the most fundamental of human rights. We cannot afford to allow this right to be ruthlessly stripped from us.