Abstract
Many herbal ingredients from indigenous cultures and traditional paradigms of
medicine have made a successful career in developed countries’ markets as foods,
cosmetics, or medicines. Historically, the exploration and exploitation of paradigms of
traditional medicine was driven and supported by pure chance, entrepreneurship,
colonialism, greed and, finally, the absence of regulatory barriers and the Nagoya Protocol.
This made it possible for several traditional southern African herbal medicines to
establish themselves in the European and/or the US marketplaces. Spirited individuals
introduced traditional remedies primarily into the European markets, and subsequently
others. These remedies, over time, were eventually transformed into well-researched
phytopharmaceuticals. More recently, this trend has slowed down, primarily due to
increasingly stringent regulations affecting developed countries’ markets. From a
commercial point of view, the higher the barrier of entry, the greater are the investment
needs. However, while Access-Benefit-Sharing agreements protect traditional knowledge
at its source, it has become increasingly difficult to protect proprietary (manufacturing)
knowledge in the marketplace. As a result, manufacturers shy away from product
development with new ingredients, because economic opportunity does not justify the
investment. This dilemma is exaggerated by regulatory barriers as well as regulatory
‘loopholes’, which form a highly heterogeneous landscape of opportunity, ranging from
relatively open to almost entirely closed systems. Here I present several case studies
which follow the life cycles of southern African herbal ingredients from traditional use to
established natural product in a variety of regulatory environments and categories. It can
be concluded that market access was most successful when markets were largely
unregulated, while modern regulatory systems oftentimes lack suitable categories for
herbal products from different traditional medicinal paradigms.
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The case studies presented in the following each have a unique twist to their
commercialization, all of which are linked to the same set of impacting factor clusters,
namely:
• identity and quality,
• resources and supply chain management,
• efficacy and safety,
• regulations affecting innovation at the country of origin as well as product
categories in the target market,
• intellectual property, traditional knowledge, and access-benefit-sharing.
The case of Umckaloabo1 (Pelargonium sidoides) may well be the only ever unquestionably
successful transformation of a patent remedy into a modern phytopharmaceutical.
The case of hoodia (Hoodia gordonii) drastically shows all the pitfalls that could lead to
failure in ethical product development and at the same time the outcome of a less
scrupulous approach.
The case of devil’s claw (Harpagophytum spp.) shows how supply chain constraints and
substitution can cast a shadow of doubt over a large body of otherwise legitimate clinical
efficacy data.
The case of sceletium (Mesembryanthemum tortuosum) demonstrates how regulations
determine access or barriers to market.
The case of buchu (Agathosma spp.) reflects on opportunities hampered by the lack of
clinical research and of a clear product development strategy.
The case of Cape aloe (Aloe ferox) shows how availability of alternatives along with
evolving safety concerns can impact a solid market share. The cases of rooibos (Aspalathus linearis) and honeybush (Cyclopia spp.) demonstrate how
extrinsic factors linked to category placement and supply chain can affect a market
presence.
The cases of hypoxis (Hypoxis hemerocallidea) and uzara (Xysmalobium undulatum) are
similarly unique, as for both only a single product emerged that showed commercial
success. Both products apparently outmanoeuvred regulatory constraints. They are
shrouded in secrecy, published contemporary research is scarce, and supply chains are
not transparent.
The introductions of southern African (functional) botanicals to primarily European and
secondarily northern American marketplaces occurred over approximately 300 years.
Case studies can be grouped chronologically into
• Early (17th to 19th century): aloe, buchu, honeybush
• Recent (early 20th century): devil’s claw, rooibos, uzara, and Umckaloabo
• Current (late 20th and early 21st century): hypoxis, hoodia and sceletium
Some forces that drove commercialization are common to all groups, such as
entrepreneurship and supply chain, others gain importance as they evolve over time,
such as regulations governing market access in terms of quality, efficacy, and safety, as
well as regulations affecting the protection of traditional knowledge.
Taken together, from today’s perspective, innovation, product development and
commercialization must follow a simple mantra
Know your ingredient.
Respect traditional knowledge.
Secure your supply chain.
Comply with regulations.
Understand your market.
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Too many setbacks and outright failures have resulted from ignoring a mere facet of any
single one of these aspects.