HERBAL MEDICINE: REGULATORY CHALLENGES AND OPPORTUNITIES

The race to a COVID-19 has re-awakened a decades-long discussion on the safety and efficacy of herbal medicine. These are also known as traditional and complementary medicines (TCM). The controversy stems from the absence of verifiable data regarding the claimed benefits, as is the case with conventional medicine.

 The world health organization (WHO) estimates 80% of the world population relies on herbal medication as the first line of care. In Uganda, the Ministry of Health estimates 60% of the population use herbs as their first line of care. Herbs are widely available, easy to access, and command higher consumer confidence. 

 Contrary to popular belief, herbal medicines or herbal products are considered essential aspects of most healthcare settings. WHO encouraged member states to establish comprehensive national pharmacovigilance systems to include coverage of herbal medicines. WHO has since released regulatory-operational guidelines to which member countries could refer.  

 While Uganda has since developed a policy and a TCM Act, bringing herbal medicine/products into the regulatory fold is not without implementation challenges around safety, efficacy, and quality control.

 A single plant contains over a hundred substances. In conventional medicine, regulators examine an extract, but in TCM, one must evaluate an entire plant. Now imagine a mixture of more than 10-plants and the resources required to identify the contents of a given concoction and ensure the medicine is free of toxins. Medicine interaction with other products is usually a crucial aspect of concern by a regulator. If taken in combination with conventional medicine, it is hard to trace the effects of such interactions. 

 In the absence of accurate data, it is hard to evaluate the effectiveness of the medicine to support the “cure” claims by the innovators. Almost all conventional medicine gets into the market as prescription drugs, and with proper monitoring of the safety and efficacy much later, drugs are re-classified as non-prescription. Herbal products are entirely non-prescription as the owners claim they have no side effects. Partly explain why regulators across the world hesitate to endorse TCM as having curative factors. 

 Quality control is yet another problem, especially adulteration. Standards are non-existent. Practitioners seem to be operating in a free-fall mode.

 On September 14, 2020, the President assented to the Traditional and Complementary Medicine Act 2019, opening unlimited opportunities for the herbal industry. The new legal regime has the vast task of organizing the seemingly uncoordinated industry. Investing in research and quality assurance will be much easier. Practitioners can, for example, be encouraged to form and register associations. Organized communities ease stakeholder consultations and engagement. Developing universally acceptable standards will be easier and improve consumer safety. 

Investing in the production of herbal drugs is much cheaper than conventional medicine. Conventional drug discovery requires a minimum of 15-years and a substantial financial investment. Such products are pricey and therefore not affordable to majority of those that may require such a product. Many will still hesitate to consume such conventional medicine even at a lower cost. 

 Through phytomedicine, Mali developed an effective anti-malarial drug. Mali invested in improving an already existing traditional product at a cheaper cost within six years. The product was affordable, and patients were readily willing to take it. We can easily emulate Mali’s herbal regulatory system.

 With an organized industry, traditional practitioners can acquire essential skills in the efficient and sustainable utilization of natural resources. Rural communities can also earn a decent living as suppliers of raw materials. Farmers can be taught how to sustainably use natural resources to conserve the environment.

 Emphasis should be on sensitizing the herbalists, dialogue, and form partnerships. Enforcement should not be a priority now or in the immediate future. Let us nurture, build confidence and help the industry grow.