A Call For Regulation of the Herbal Medicines Industry in Uganda
Many herbalists still use rudimentary and crude methods of production and care not about sophistication in processing and packaging. They still vend their products in poorly or barely branded packaging materials. As a result, the herbal medicines commercial potential has not been exploited.
That notwithstanding, there is a new tide of rising, learned and commercially driven herbalists who want to and are taking the herbal products business seriously. They have invested heavily in advanced technology and scientific research and are coming up with commercially viable products that fairly compete with other products on the market. Kazire, Vintage Herbals, Dr. Nambatya, and Dr. Ssali are some of the few that have recognized and harnessed the opportunities in this industry and are smiling all the way to the bank.
However, for some of these progressive herbalists there is a ceiling on their potential resulting from lack of a robust regulatory framework. There are sales that will never be made due to the lack of trust from consumers. One herbalist I spoke to shared that she quit her job as a banker and went abroad to study a course in herbal medicines. Upon return to Uganda, she set up a commercial production unit and also a shop in Kampala for her stylishly packaged herbal products. However, her business stagnated due to lack of a standards regulator for herbal products. She observed that although she registered her intellectual property with the Uganda Registration Services Bureau, upon going to Uganda National Bureau of Standards to get her products certified, UNBS informed her that such products were beyond its mandate and referred her to the Uganda National Drugs Authority which also turned her down citing the same reasons. This left her frustrated and she still struggles to convince her some people that her products are safe.
Gaps in the law
There are gaps relating to licensing, production, standardization, and marketing of these herbal products. As a result, this has allowed quarks who have defrauded their victims and also some of these products have led to several adverse health effects. This has further caused a lack of trust and confidence for many potential customers and thus led to a slow growth of this industry.
The lack of a robust regulatory framework has also allowed imported herbal products to steal a lion’s share of the Ugandan market. Moreover, for these importers, herbal medicines business is treated like any other mainstream business. Their products are well packaged and attract a great appeal to all. Companies like GNLD, Forever Living, and Alliance in Motion have taken it a notch higher by using the pyramid scheme as their main distribution strategy. They have been able to attract young corporates who would ordinarily never vend herbal products. The main beneficiaries for these imports though are the countries of origin.
Regulatory situation in Uganda for Herbal Medicines
At a policy level, The Uganda National Health Policy 2000 recognizes the role of traditional medicine in the healthcare delivery system as a step towards improving health service delivery in Uganda. There is also under the Ministry of Health, the Natural Chemotherapeutics Research Laboratory which studies the therapeutic potential of natural products.
Further, The Medical Practitioners and Dental Surgeons Act prohibits unlicensed persons from practicing medicine, dentistry, or surgery. However, Section 36 allows the practise of any system of therapeutics by persons recognized to be duly trained in such practice by the community to which they belong, provided the practice is limited to that person and that community.
This year, the Parliament of Uganda passed the Traditional Medicine and Complementary Medicines Act. The objective of the Act is to define and standardize the concept and provide acceptable standards of traditional and complementary medicine practice in collaboration with modern medicine sectors. The Act seeks to establish a council responsible for the regulation of traditional and complementary medicine practitioners, defining their roles registering and issuing them with licenses, with sufficient representation from the practitioners.
This Act is pending the President’s assent and therefore until then, it is not law.
Although the Act once law will go a long way in boasting the industry, there is need to ensure that a balance is struck between ensuring disclosure of necessary information for standardization and protection of intellectual property.
There have been concerns expressed by some herbalists about the Traditional and Complementary Medicines Act in so far as it requires them to disclose information regarding the contents of their products. Their fear is that it will cause them to lose their trade secrets which form the basis of many players in the industry. It is important that a balance is struck between keeping trade secrets and creating/enforcing standards. Standardization cannot be done without certain disclosures otherwise, the potential of the industry shall not be fully exploited. Herbalists in Uganda should see the bigger picture and advantage that comes from certain disclosures. The reason Ayurveda, and Chinese Traditional medicines that date way back into the 8th and 10th Centuries BC have stood the test is of time is the disclosures and documentation done by the generations of herbalists that came before. As a result, China and India have greatly benefitted economically from improving on this traditional knowledge.
At the same time, the regulators must not require disclosures that are beyond what is necessary for the process of standardization. The Trade Secrets Protection Act of Uganda empowers one to withhold certain information that gives an edge and competitive advantage to the owner of such information.
Relatedly, it must be recognized that for herbal medicines, there are limitations from the Industrial Property Act, 2014 which puts restrictions on the registrability of medicine and therefore may prevent a herbalist from registering a patent to enjoy the exclusive right to exploit his/her patent. In that case therefore, the most feasible form of protection left for the herbalists is that under the Trade Secrets Protection Act.
Why does it matter for Uganda to have a strong regulatory framework?
Acting to the World Health Organisation in its report on the ‘Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review’ 2001,
‘‘National policies are the basis for defining the role of traditional and complementary/alternative medicine in national health care programmes, ensuring that the necessary regulatory and legal mechanisms are created for promoting and maintaining good practice; assuring authenticity, safety and efficacy of traditional and complementary/alternative therapies; and providing equitable access to health care resources and information about those resources.’’
According to the National Medicine Policy 2015, nearly 80% of the population in developing countries use traditional medicine as a first call for treatment before visiting a health facility. In Uganda the PPP for Health Policy (2012) states that 60% of the population use Traditional and Complimentary medicine (TCM) for primary healthcare. It is therefore a matter of national importance in the context of national health and safety.
From a business perspective, it also matters because there is a growing global preference for herbal products. Specifically, the demand for herbal pharmaceuticals which form the biggest percentage of herbal products is growing exponentially. It is reported by Market Research Future [MRF] that the Herbal Medicine Market Value is going to surpass USD 129 Billion Revenue Mark by 2023. The same report indicates that hospital, and retail pharmacies account for 55.82% of the global market followed by Ecommerce. It is also reported that Europe continues to provide the biggest market for these products. The growing trend stems from the fact that although western medicine has for long been the most consumed and perceptively the most effective medicine, many consumers have acquired a general dislike for it especially due to the increased synthetic chemicals in it. As a result consumers now prefer complementary and alternative medicine.
The question for the herbalists in Uganda is, can their products pass the standards or even compete favorable at a global scale? For government, what revenue benefits are being lost from the absence of an effective regulatory framework?
Uganda should emulate governments in other places like Europe which have recognized this growing trend and have resorted to investing in significant research and development of herbal products. The aim for these governments is to promote the creation of equally sophisticated herbal products that give the consumer the best of both worlds.
In conclusion, there is need to change our perspective on herbal medicine. As a country gifted by nature, we need to recognize and harness the benefits that come from our biodiversity. We need to switch from looking at herbal medicines at a subsistence level and we see how to scale up its commercial potential. This will not only boast our economic growth but will also promote good health. I therefore implore the President to assent to the Traditional and Complementary Medicines Act and to empower the relevant organs to implement and enforce the law.
DAMALIE TIBUGWISA is a commercial lawyer and founder of M/s Tibugwisa and Co. Advocates.