From translation of indigenous knowledge to innovation for the bio economy: briefing by the International Centre for Innovation Partnership in Science Phytomedicines

Meeting report

The Chairperson introduced Professors Quinton Johnson and Bernard Martin from the University of Western Cape Medical Science and Law Departments, respectively.

From translation of indigenous knowledge to innovation for the bio economy
Dr Quinton Johnson, Director of The International Centre for Innovation Partnerships in Science, University of the Western Cape, stated that people did not understand the way of those with indigenous knowledge. This needed to be corrected. There were 21 000 species of plants, 20 000 medical doctors and over 200 000 traditional health practitioners with unique knowledge about plants and medicines in South Africa. It was a worthwhile scholarly enterprise to try and understand the utility of these kinds of medicines within the context of indigenous knowledge systems. It had been a challenge to persuade the scientific community that it was a worthwhile pursuit. The translation of indigenous knowledge systems to innovation for the bio economy was important. There needed to be a transfer the knowledge systems beyond the custodians of the knowledge. In order to appreciate and understand and appreciate this knowledge better, it needed to be translated.

The International Centre for Innovation Partnerships in Science (TICIPS) started eight years ago when it entered a competition held by the National Institute of Health (NIH) of the United States, the world’s leading medical research innovation agency. On Madiba’s birthday, 18 July 2005, TICIPS won the World Cup of Science competition and was awarded $4.4 million to pursue the research. That was how the centre began.

80% of South Africans consulted traditional health practitioners first, before consulting with medical doctors. The term iSangoma described a traditional health practitioner as a spiritualist working through, and called by the ancestors. The terms iNyanga described a herbalists working with plants in particular. There were 21 000 plants in South Africa, of which 3 000 were documented as medicinal. 300 medical plants were traded annually and an estimated R4 billion generated as a consequence of trade. About 30 million patients were being served annually. The reality was that this health care system existed, but was not a formal part of the healthcare system. The healthcare system was a ‘dual’ system and it was important that the traditional system was increasingly recognized. The use of these plants was widespread and they were used for a variety of conditions such as HIV/AIDS, tuberculosis, malaria, cancer, pain, depression, diabetes, obesity, heart disease, inflammation and infertility. Approximately 20% of the nation used pharmaceutical medicine and 80% used traditional medicines. TICIPS was trying to make sense of the dual system. TICIPS had a variety of scientist, lawyers, psychologists, medical doctors, traditional healthcare practitioners, anthropologists, sociologists and individuals working to understand the system of medicine.

In the bio economy, the number of ‘blockbuster drugs’ in the marketplace was diminishing. Only 21 new molecular entities were approved by the Food and Drug Administration in 2008. The demand from the public for safer drugs was extremely high. Natural and traditional drugs may offer better routes to the discovery, development and delivery of new medicines. Plant derived drugs accounted for $65 billion in sales worldwide. Much of the medicines in the arsenal of oncologists could find their origins in plants used by many people across the world; the science had not been done to understand everything about what was found in the plants. Artemisinin, the #1 anti-malarial drug was derived from a plant. More than 50% of medicines in the market today found their origins in natural products from plants. It was incorrect for the scientific community and others to have scepticism and dismiss indigenous knowledge systems out of ignorance. TICIPS had made it a mission to do research in a fashion that was scientifically world-class but predicated on respect for indigenous knowledge systems and the art of traditional healing. Phytomedicines, or medicines derived from plants, were going to be increasingly important as adaptogens, or medicine that help the body react to a wide variety of challenges and enable the immune system to fight off infections more effectively. 

Interfacing with the South African Medicine Council became important in the process of registering a plant to a medicine. TICIPS had played its part in the institutionalisation of traditional medicine. One such institutionalisation of traditional medicine was the creation of the South African Herbal Science and Medicine Institute at the University of the Western Cape, which Dr Johnson founded in 2003 to study herbal medicines scientifically. It was the only such programme in the country that awarded degrees in this discipline. R100 million was raised from various researches to pursue this kind of science and to support the students and build the infrastructure. Beyond 2010 TICIPS required about R900 million to take the work to the next level. The process had begun to engage sponsors to fund this kind of work. The Department of Science and Technology (DST) requested a proposal, so that TICIPS would be able to source the additional funding. It was simpler to source funding internationally because there were deeper pockets internationally, system were wider than South Africa’s systems, hence response time was faster and international funders were looking for new innovative world class areas to work in. Dr Johnson was concerned that the more the international world invested in the work, the greater the chance that the intellectual property could become compromised.  It was important to have partners, but the work should be led by Africa.  Basic science, clinical science and public health were the three critical pillars that one would need to understand the process of developing a plant to a phytomedicine. The burden of evidence was important to solidify scientific claims. Public-private partnerships were necessary because universities cannot do the work by themselves. African companies in the bio economy needed work in a way that was beneficial.

The translational validation model was a more affordable model in pharmacology for South Africa. It began with the knowledge systems of the healer. Once characterised as safe, trials could begin. Unlike the conventional drug discovery and developmental process, this model did not take 20 years for the process to be completed. In the translational validation model could take under 5 years, for a plant to be registered as a medicine and brought to market at a fraction of the cost. The translational validation model was more economical, more effective and more affordable. Phytomedicines had great molecular diversity and were very advantageous as therapies. They fell within the boundaries of drug-like properties, they had a greater number of chiral centres, an increased molecular rigidity and they follow the ‘Lipinsky rules of five’, which stated the smaller the better.  Indigenous knowledge systems were way ahead of the popular idea that the drugs of the future would be based on our DNA, very personalised and specific to the needs of the individuals.

There were three very important medicinal plants that TICIPS was working on: Tulbaghia alliace was indigenous garlic used in Cancer research, Artemisia afra was commonly used in the Western Cape used to treat Tuberculosis and Lessertia frutescnes is used in HIV research. TICIPS used various cutting edge scientific methods to understand these plants such as high-pressure liquid chromatography, 1D and 2D nuclear magnetic resonance, liquid chromatography- mass spectrometry, X-Ray Chrustallography, Firefly Luciferase Bioluminescence and fluorescence microscopy.  Dr Johnson stated that TICIPS had published some of its work in very laudable journals; however TICIPS had had a problem with the “publish or perish” approach to academia as the Centre would rather protect its intellectual property before publishing. TICIPS was looking for a model to protect IP and then publish. Current research was focused on optimising a Tulbaghia extract, which was extremely powerful in killing Leukemia cells. It was more powerful than standard therapy of care that existed for Leukemia.

TICIPS had characterised a number of molecules in Sutherlandia, which may give treatment to early-stage patients who did not qualify for antiretroviral (ARV) treatment. Important because people may not have access to ARVs and may want to engage with and support traditional medicine. The Phase 2 trial had 150 HIV-positive patients and the results proved that it was safe for healthy volunteer and current research is exploring how effective it was for early stage HIV patients. With the support of the DST, TICIPS had developed an interesting spray-dried extract of Sutherlandia that concentrated the molecules. The process was being kept secret to protect the intellectual property. By the end of the year, the conclusion of the trials would indicate whether the spray-dried formulation of Sutherlandia was safe, effective and possibly delay the onset of HIV/AIDS. Pelergonium sidoles was a phytomedicine that originated in the Eastern Cape in 2005. It was registered as Umcklaloabo and was one of the top sellers in Switzerland to combat Bronchitis and Sinusitis.

TICIPS many partners included the Government of South Africa, The National Research Fund, The European Union, the National Centre for Complementary and Alternative Medicine, the Medical Research Centre, and a number of Universities such as Oxford, Oslo, Kwazulu-Natal, Missouri, Washington-St Louis, Texas-Medical Branch and University of Cape Town.

Intellectual Property Rights and Traditional Knowledge
Professor Bernard Martins, University of Western Cape, began his presentation with the saying “Umuntu Ngumuntu Ngbantu” (A person is person because of other people). This related to the issues surrounding intellectual property rights surrounding traditional knowledge because once information was shared, the community ownership of that information was lost. This was why there was a reluctance to share this knowledge.
In order to effectively work with indigenous knowledge systems, the circumstances in which the systems of intellectual property existed needed to be understood in order to deal with these issues. Conventionally intellectual property existed within the individualist paradigm, whereas traditional knowledge existed in the collectivist paradigm. Even an individual who held traditional knowledge, recognised that as individuals they held that knowledge in trust by the ancestors and for the community. This was what was meant by a ‘communal paradigm’. The environmental cataclysm would force society to move away from an individual, human rights-based paradigm due to a scarcity of resources. Individualism was a relatively new notion, whereas collectivism had existed for centuries. Corporate Social Responsibility was a collectivist paradigm and had changed the way society thought about intellectual property (IP).

The current bill before Parliament that deals with IP did not dovetail with traditional IP rights. There was a possibility of dealing with traditional IP rights through another mechanism called a ‘Sui generis’ mechanism, where a special piece of legislation was set up that incorporated traditional knowledge into conventional intellectual property. The issues that had been identified were who owned the IP, what was it that they owned and how long did they own the IP. In regards to ownership, there was protection for anonymous work, where the author was unknown, but the work enjoyed copy write protection. For example, trademarks did not indicate who owned the trademark, but it was a form of IP that was protected. There was communal ownership of IP, even in conventional IP. There was not a “great canyon” between conventional IP and traditional knowledge. IP can also be owned by a multiplicity of owners.

In regards to protection issues, the question arises of whether traditional knowledge systems should enjoy defensive protection or offensive protection? Defensive protection means to prevent people outside of the traditional context from appropriating the IP and using it for themselves. Offensive protection gave one the right to exploit that which one has and provided ownership in respect of that. Most Sui generis legislation fell into the group of defensive protection. And the drawback was that Sui generis protection did not interact with the ordinary IP so that no benefits were derived from the community.  The reality was that in order to make the money out of traditional knowledge, one had to connect with the standard conventional intellectual property. The main reason why traditional knowledge should not be protected in the same way as conventional IP was that the public domain was being depleted. The Western notion of a public domain was that it was a pool of knowledge, information and ideas available for anybody to use. This denied that the community could own something. This notion was subject to serious challenges, because the community owned traditional knowledge that went back generation upon generation and ownership of traditional knowledge did not take it out of the community, but copywriting or trade marking traditional knowledge could potentially take the benefits of that knowledge away from the community.  

Most important thing was that there was a failure to recognise that traditional knowledge needed to be protected from people who would use it outside of the traditional setting. It was these people who would exploit traditional knowledge for their own personal benefit. It was possible to harmonise IP and traditional knowledge. The identification of communal ownership was not an issues, thus the IP could be protected.

The question of should traditional knowledge systems enjoyed IP protection or Sui generis was one for Parliament to decide. But the answer depended on what were the benefits that would flow directly to the community from the type of protection provided and how would that protection articulate the present understanding of IP. Harmonisation between the individualist and collectivist paradigms to a new paradigm was possible. At that point one could truly say “ex Africa semper aliquid nova” (something new is always coming out of Africa).

Discussion
Ms M Dunjwa (ANC) asked for clarification on the name of the Tulbaghia alliacea plant and where could it be found in the Western Cape. As a Leukemia treatment was Tulbaghia alliacea more powerful than Chemotherapy? How does South Africa be sure that there are no bogus practitioners? She stated that the unfortunate thing was that some traditional practitioners did not want to pass on medicines.

Ms M Shin (DA) stated that the problem was that the traditional knowledge was never written down. How much resource was going into recording and securing the knowledge? What was the attitude from the South African Medicine Council (MCC) in approving the trials? What was the proportion of international funding that TICIPS received?

Ms S Plaatjie (COPE) raised the question about defining traditional healers. Since South Africa was moving to the stage of legalizing traditional medicine, where would it put the healers? At the end of the day they would like to be owners of the knowledge. Where do the traditional healers fit in the trials?

Ms Dunjwa raised the concern that the majority of South Africans were not empowered in understanding the processes. How can South Africa ensure that people did not become vulnerable to exploitation? How many of the African students were interested in this subject?

The Chairperson thanked both professors for their presentation and stated that there needed to be a way to interpret the indigenous knowledge systems, as they were important. There needed to be a link between ancient knowledge and the current applications of that knowledge.

Dr Johnson replied that the utility of Tulbaghia alliacea extended beyond chemotherapy, particularly due to the molecular extracts. Science will be able to separate what is real from what is bogus

The DTS established a national recordal system project called the ’Digital Doorway Project’ created a repository of indigenous knowledge that goes across the country. At the university level the knowledge was somewhat fragmented, because there were 21 universities and not every one was interested in this field.  Important question because if South Africa was able to demonstrate that this was “our knowledge”, South Africa position from and IP perspective would be stronger.

TICIPS business was ‘understanding’ rather than ‘commercial’.  TICIPS received no funding from commercial entities. At a certain point in the development process it would be important to have a public-private partnership in order to go beyond the realm of academia in order to develop the process. All funding comes from government agencies and others in that domain. Last year TICIPS put together a consortium of universities called the Multidisciplinary University Traditional Health Initiative (MUTHI) that won the World Cup of science in Brussels last year and was awarded a grant of 2 million Euros. This grant was to train 25 applicant scholars from eight different African countries in the understanding of traditional medicine. The proportion of international to domestic funding was a ratio of 10-1. There were limitations to internal funding however there were implications of IP with international funding.

The MCC approval took nine months on a trial of healthy volunteers to see if spray dried Sutherlandia was safe. This spoke strongly to the DST’s innovation strategy of the next 10 years to not be solely focused on innovations, but also focused on products.

The question about healers was a very critical one in KZN, TICIPS had a traditional healer’s course with the University of Kwazulu-Natal who worked as equal partners. TICIPS looked for equal partnerships wherever possible. Regarding custodians of indigenous knowledge, indigenous knowledge systems cut across many knowledge holders who would not be classified as traditional health practitioners.

On the question of how many students would be interested in the subject. When he first proposed the degree programme to the University it was not accepted by professors who came from a different era, who believed that nobody would be interested in the scholarly pursuit of traditional medicine that “delved into black magic and witch craft.” Dr Johnson’s response was that science was about veritas and seeking the truth, “no matter where we danced.” It was wrong of those professors to cast doubt on what could be a wonderful scholarly pursuit. In the first year there were 20 students, in the second year there were 40students and in the third year there were 60. University system needed to appreciate indigenous knowledge systems and move towards innovation.

The Chairperson thanked the professors and stated that the South African system needed to work together with indigenous knowledge systems to develop an in-depth understanding of the world around us.

The chairperson closed the meeting.