Indigenous Knowledge Systems Bill [B6-2016]: Departments of Environmental Affairs & Health on comparative legislation

Meeting report

Election of Acting Chairperson
Ms Shireen Isaacs, Committee Secretary, asked Members to elect an Acting Chairperson, and Members unanimously agreed that Ms L Maseko (ANC) should take the Chair.

Protection, Promotion, Development & Management of Indigenous Knowledge Systems Bill (IKS Bill)
Department of Environmental Affairs (DEA) briefing on comparative / complementary legislation
Ms Natalie Feltman, Director: Bioprospecting and Diversity, Department of Environmental Affairs, said that the main piece of legislation falling under the control of the Department of Environmental Affairs (DEA) that covered similar ground to the IKS Bill was the National Environmental Management: Biodiversity Act, No 10 of 2004. South Africa is the third most biodiverse country in the world, occupying about 2% of the world’s land area, and is home to nearly 10% of the world’s plants, 15% of known coastal marine species as well as 7% of reptiles, birds and mammals. Historically, bioprospecting was  free for all, which led to an unregulated space leading to biopiracy with unfair, inequitable and no sharing of benefits rising from the bioprospecting. It had also led to the unsustainable use of indigenous biological resources (IBRs) from which the country did not benefit. In order to address those concerns, DEA developed international and national legislation and frameworks.

The overall objectives of the policy behind the NEMBA are to redress the injustice of the past so as to achieve socio-economic development goals with fair and equitable sharing benefits. It provides a regulatory framework for bioprospecting biotrade activities and attains conservation and sustainable utilisation of indigenous biological or genetic resources. The Bill introduced a permitting system that could regulate what is being utilised in the country.

Another objective is to make it obligatory for the regulated sectors to recognise existing traditional knowledge on the usefulness of the indigenous biological/ genetic resources, and to provide for Benefit Sharing Agreements (BSAs). In terms of the legislation, the regulated sectors have to seek permission from the land owners to access or collect indigenous biological resources. If that is agreed then there has to be a Material Transfer Agreement, as well as a Benefit Sharing Agreement, between the two parties. The last obligation is to implement international regulatory obligations adopted by South Africa.

South Africa became a party to the Convention on Biological Diversity in 1995. The protocol that stems from the Convention is called the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from the Utilization (the Nagoya Protocol). This was ratified by South Africa in 2013 and came into action in October 2014. The other pieces of legislation within the framework include:
- The White Paper on Conservation and Sustainable Use of South Africa’s Biodiversity of 1997
- The National Environmental Management Act,1998 (NEMA)
- National Environmental Management: Biodiversity Act, 2004 (NEMBA)/ NEMLA 2009/ NEMLA 2013
- Bioprospecting Access and Benefit Sharing Regulation of 2008/BABS Amendment Regulations of 2015.

The purpose of NEMBA is to provide for the management and conservation of biological diversity and its components, within South Africa. NEMBA also provides for the use of indigenous resources in a sustainable manner. It covers the fair and equitable sharing of benefits arising from the use of indigenous biological resources, and associated traditional/indigenous knowledge.

The key provisions in NEMBA are in Chapter 6, headed ‘Bioprospecting, Access and Benefit Sharing which provides a framework for the following:
- The regulation of export from the Republic of indigenous biological resources for purposes of bioprospecting.
- The regulation of bioprospecting involving indigenous biological resources.
- A fair and equitable sharing of benefits arising from bioprospecting involving commercial utilization and biological resources and associated traditional knowledge.
- Ensuring that the nation’s indigenous biological resources are developed and used in an ecologically sustainable manner, while promoting social and economic development, in particular in the areas where the indigenous biological resources and associated traditional knowledge are based.

She expanded on Chapter 6 requirements. Section 81 related to the permit requirement. Other relevant sections were notification requirements (section 81A), Protection of interests of Access Provisions and/or Tradition/ Indigenous Knowledge Holders (section 82), Bioprospecting Trust Fund (section 85) and Exemptions (section 86).

Ms Feltman gave a definition of bioprospecting as “the scientific search and exploration of indigenous genetic and biological resources for commercial exploitation, to produce commercial or industrial products”. The top five plant species that are being exploited and traded are Rooibos, Buchu, Aloe Ferox, Pelargonium sidoides and Honeybush.

Bioprospecting also includes trading in indigenous genetic and biological resources in order to develop and produce products such as enzymes, drugs, perfumes, colorants and extracts. The “indigenous biological resources” refers to animals, plants or microorganisms of indigenous species, living or dead, but excludes genetic material of human origin and all other exotic species.

The key points of bioprospecting are categorized into two phases. The first phase is Discovery, which means any research on indigenous biological resources where the nature and extent of actual or potential commercial exploitation in relation to the project is not sufficiently clear or known to begin the process of commercialisation. The second phase is the commercialisation phase meaning any research on, or development or application of indigenous biological resources where the nature and extent of any actual or potential commercial exploitation in relation to the project is sufficiently established to begin the process of commercialisation. Biotrade is another term used in NEMBA, and that means the buying and selling of milled, powdered, dried, sliced or an extract of indigenous biological resources for further commercial exploitation. Commercial exploitation means engaging in any bioprospecting activity with the intention of making a profit.

Ms Feltman mentioned that the “Traditional Use” term in NEMBA may overlap with the IKS Bill. Traditional use or traditional knowledge refers to customary utilisation or knowledge of indigenous biological resources by an indigenous community or specific individuals, in accordance with written or unwritten rules, usages, customs or practices traditionally observed, accepted and recognised by them. It may include discoveries about the relevant indigenous biological resource by that community. A Material Transfer Agreement refers to an agreement between the applicant and any person or organ of state or community providing access to indigenous biological resources to which the application relates. The Benefits Sharing Agreement refers to an agreement that provides for sharing of any future benefits that nay be derived from bioprospecting between:
1, the applicant and any person or organ of state or community providing access to indigenous biological resources to which the application relates: and
2, the applicant and an indigenous community or specific individual whose traditional uses/ knowledge/discoveries on indigenous biological resources to which the application relates have initiated or are to be used in the proposed bioprospecting.

NEMBA Chapter 6 calls for the protection of certain interests of stakeholders before a permit is issued. The enabling provisions of Chapter 6 require the permit applicant to fulfill certain requirements in order to ensure protection of the rights of the indigenous communities. These include obligations on the applicant for the permit to:
- Disclose all material or important information about the bioprospecting or biotrade project to the identified access provider or traditional knowledge holder
- Obtain prior consent for access to indigenous biological resources and or use of traditional knowledge
- Enter into Material Transfer Agreements
- Enter into Benefit Sharing Agreements. The benefit sharing agreement as well as the Material Sharing Agreement must be approved by the Minister before a permit is issued.

A permit may only be applied for by a juristic person registered in terms of South African law, a natural person who is a South African citizen or a permanent resident of South Africa and a non-juristic or natural person, jointly with a juristic or natural person, in terms of South African Law.

The amended  regulations apply to commercial and industrial sectors that use indigenous biological resources for biotrade, or for any research, application or development of drugs, complementary medicines, neutraceuticals, industry enzymes, food flavors, fragrances, cosmetic, colours, extracts and essential oils. They also apply to the use of traditional knowledge associated with any indigenous biological resources and also to non-commercial sectors that export industrial biological resources from the Republic for research to generate scientific data.

The major challenge in implementation of the bio-prospective access and sharing regulations is the identification and verification of indigenous communities who are the holders of indigenous or traditional knowledge associated with indigenous biological or genetic resources.

She concluded that section 82 of NEMBA does complement the IKS Bill, as it protects the interests of indigenous communities whose traditional uses, knowledge or discoveries of the indigenous biological resources are used as a basis for bioprospecting. There is also a requirement that a Benefit Sharing Agreement must be entered into between the permit applicant and the identified indigenous community.

There are potential legislative overlaps. The permit system under NEMBA and the IKS Bill's licensing requirements and industrial knowledge protection will have to be discussed and agreement reached as to how government will implement, to avoid duplication or conflict. The proposed way forward is that  the DEA and DST will be meeting on 2 September 2016 to identify and resolve the overlaps.

Department of Health briefing on comparative / complementary legislation
Mr Bruce Mbedzi, Acting Director, National Department of Health, noted that the main piece of legislation falling under the National Department of Health (DOH) that dealt with similar matters was the Traditional Health Practitioners Act No. 22 of 2007 (THP Act) to them. 31 August is African Traditional Medicine Day and is commemorated in the whole of Africa, having been declared by the World Health Organization African Regional Committee in 2000. The purpose of the THP Act is to establish the Interim Traditional Health Practitioners Council of South Africa; to provide for the registration , training and practices of traditional health practitioners in the Republic: and to serve and protect the interests of members of the public who use the services of traditional health practitioners. The Interim Council must, in the interests of the public, promote and regulate and liaise between traditional health practitioners and other health professionals registered under any law, as well as implement health policies determined by the Minister concerning traditional health practice.

The Council was set up in 2013. It comprises 20 members, of whom 13 members are traditional health professionals themselves, including  he Chairperson and the Deputy Chairperson. Section 16(1) of the Act provides that the funds of the Council must consist of money appropriated by Parliament and fees raised by the Registrar in the performance of his or her functions under this Act. The funds of the Council also are boosted by penalties such as a fine for misconduct as well as any other fees contemplated in the Act.

Mr Mbedzi said that the main relevant provision with links to the IKS Bill is the application for registration to practice. No person may practice as a traditional health practitioner within the Republic unless he or she is registered in terms of the THP Act. In order to do this, the registrar to whom the application is made must be satisfied that the information and documentation submitted in support of the application meet the requirements of this Act. Two regulations had been published under the Act; the first was in 2011, and provided details for the nominations of members to be appointed by Minister to serve in the Interim Traditional Health Practitioners Council. The second regulations were published in 2015, to provide details and processes for the registration of traditional health practitioners with the Interim Traditional Health Professions Council of South Africa. The processes in line with the regulations have not yet been finalised because the Council is currently not fully functional and the office of the Registrar still needs to be established.

There are similarities across the THP Act and the IKS Bill. They both promote public awareness of indigenous knowledge, both promote the use of commercial utilisation, although the IKS Bill promotes use of indigenous knowledge and the THP Act promotes use of traditional medicine knowledge.

The problem identified in the IKS Bill relates to the definition of the “indigenous knowledge practitioner”- for it includes all the community of practice including the traditional health practitioners. Clause 14(1) of the IKS Bill still requires all traditional health practitioners to register. Sections 21 (1) and (2) of the Traditional Health Practitioners Act also require traditional health practitioners to register. The IKS Bill seems therefore to be providing an alternative for traditional health practitioners to register with other councils, other than the Traditional Health Practitioners Council. The general understanding is that the IKS Bill will accredit, to put value to indigenous knowledge holders, and place their skills within the national qualification framework or quality assurance. Therefore traditional health practitioners and their institutions which are to be accredited in terms of the IKS Bill, should be registered with the Indigenous Traditional Health Practitioners Council of South Africa (ITHPCSA).

The draft regulations and guidelines for registration and accreditation of institutions provide for registration of practitioner. It is estimated that there are over 300 000 traditional health practitioners in South Africa. The THP Act requires that all traditional health practitioners have to register with the Council. To be accredited in terms of the IKS Bill, traditional health practitioners have to apply and meet certain requirements. It is also recommended that the Advisory Panel in terms of the Bill should establish a permanent relationship with the ITHPCSA.

Advocate Ezra Letjoalo, Legal Technical Officer, DOH, noted that the Medicines Amendment Act 14 of 2015 created the South African Health Product Regulatory Authority (SAHPRA) which is intended to replace the current regulatory medicines authority of the Medicines Control Council (MCC). The scope of SAHPRA will be wider and more comprehensive. The MCC only regulates and control medicines, but the SAHPRA will regulate medical devices including complementary medicines. The new National Medicines Regulatory Authority will have a mandate that will include the management, registration and control of medicines, complementary medicines, including the conduct of clinical trials, to ensure that public interest is protected. The overarching intention of the Act is to strengthen the drug regulatory capacity, especially for the inspection, quality control and laboratory work.

The amendments provide for the functioning of SAHPRA under the Board, define the functions and responsibilities of the Board and enable recognition of work done by other regulatory agencies in order to reduce duplication of effort.

SAHPRA will be a Schedule 3A public entity with operational autonomy, accountability and with responsibility for regulation of all medicines, medical devices and in-vitro diagnostics and radiation control. The functions of SAHPRA would include inspections and compliance functions, so it will be very different, in size and function, from the MCC.  SAHPRA will be accountable to the Minister of Health through a Board. Statutory Advisory Committees will be expert committees that oversee the overall function of SAHPRA, with the Chief Executive Officer managing the Authority. SAHPRA, as a public entity, will be at an arm’s length from its parent ministry, but will in effect be an extension of the Department of Health with the mandate to fulfill a special responsibility of Government to regulate medicines and medical devices.

Currently, there is already an extensive framework of regulations that looks into issues of registration and packaging of medicines, how medical devices must be registered and other issues. The regulations will also look into scheduling of medicines in accordance with the substance contained in the medicines. Section 22A of the Act empowers the Minister to make scheduling arrangements in consultation with the Medicines Control Council. The Department is now in the process of reviewing its regulations as the Act is somewhat unrelated to the IKS Bill.

The Chairperson noted that the Department of Science and Technology (DST) officials did not wish to make any comment.

Discussion
Dr A Lotriet (DA) asked for clarity on the SAHPRA Act. She asked for clarity in that it referred to complementary medicines and it does not exclude traditional medicine but it does not specifically specify it.

Dr Lotriet also thought that there was a high degree of overlap between the IKS Bill and the NEMGA. The definitions in the IKS Bill are wide but it actually encompasses everything that is in the NEMBA. She asked which department would need to be asked for accreditation and to be registered, and where a person would go to for the product that they intended to commercialise.

Mr N Koornhof (ANC) said legislatures should not make legislation more difficult for the public to understand. Departments are very jealous when it comes to their legislation, but he asked what amendments could be made to ensure that the IKS Bill aims would actually be achieved. If this was possible, then he asked why departments had not volunteered to look at this before now, and why this had taken so long.

Mr C Mothale (ANC) mentioned that he agreed with his colleagues that the legislation mentioned was interrelated.  He asked what the possibility was of having the IKS legislation speaking directly to what the NEMBA Act was trying to achieve, in order to complicate the applications of those who had to interact with the legislation.

Mr N Paulsen (EFF) noted that the Traditional Health Practitioners Act of 2007 was promulgated in 2007. This was eight years ago. The DST had been allocated R300 million rand for the project of registering traditional knowledge practitioners. He asked how this came about, whereas the real custodians of this knowledge did not have any stake in the matter. Effectively, any commercialisation of traditional knowledge was allowing something to be taken from people who relied upon it for their livelihood, without getting anything in return. Huge multinationals are being allowed to benefit from traditional knowledge, and he thought the IKS Bill was merely going to “legitimise this theft”. African people have been robbed of land, minerals and now robbed of traditional medicines. He thought that the Bill was evil and that it must never see the light of day. He asked if the DST would actually be speaking to the people who were going to be affected by the Bill, or if they would be discovering that people, who should never be allowed into the country and should be “shot on sight”, had bought their traditional knowledge.

The Acting Chairperson interrupted Mr Paulsen, and told him that in this Committee he should not be suggesting shooting.

Mr Paulsen retorted that since he came from the Cape Flats, perhaps mentioning using a knife would be more apposite.

Mr Paulsen continued that the Bill creates a fertile battle ground between ethnic communities over who owns what. This would be evil. He maintained his concern that the indigenous people would be disempowered by the law. He pleaded with the Committee not to allow this theft of knowledge, saying it would affect more than 800 000 people. 

Mr Mothale said that the officials had not created the Bill and had merely been asked to present on what it contained.

Mr Paulsen asked what academic recognition was to be afforded to the traditional healthcare practitioners. Traditional healers had been bio-prospecting for a very long time.

The Acting Chairperson asked what would happen in the case of any conflict between the IKS Bill and the THP Act and which might prevail. She then asked if section 82 of NEMBA fell under Chapter 6. It was important to make it as easy as possible for people to be able to practise as traditional health practitioners.

Ms L Mulomow, Deputy Director, Department of Environmental Affairs, said that the Department had a mandate  to look at issues of conservation and sustainable use of South Africa's biodiversity. However, when it came to issues of bioprospecting, the Department had realised that biodiversity included knowledge that is held by the indigenous community. When the regulations were drafted the community aspects could not be sidelined, and the emphasis is more on benefit sharing. Clause 32(2) of the IKS Bill states that whatever the Bill seeks to achieve will not change what NEMBA seeks to achieve. The challenge is on all departments in the government to talk together and find a way to reach a system with an internal process to deal with all aspects, without confusion, perhaps a system that shows different entry points.

Mr Mothale (ANC) interrupted and asked why she had mentioned that government departments should be forced to talk together? This implied that the Department of Environmental Affairs thought that this was something new? The initial question raised was why there should be two laws instead of just one.

Ms Mulomow replied that the DEA and others were in the process of discussing that possibility, which could result in just one entry point. That was not certain at the moment. The IKS Bill contributes to existing processes, through verification and identification of the knowledge holder, and the advantage is that it will provide assistance, as there are currently challenges in  identification of the knowledge holders. The IKS Bill should help in documenting the knowledge holders.

Mr Mothale asked if it was creating any efficiency in the system, to speak of  amending the NEMBA to deal with the challenges that the IKS Bill is trying to address.

Ms Molomow responded that the DEA was discusing the possibility of amending the Act where needed. Some of the areas that will be addressed properly in the IKS could also be amended in the NEMBA.

Ms Feltman added that the perhaps the Department of Science and Technology could explain that the IKS Bill will not just look at indigenous knowledge associated with plants and other species, but also would look at cultural expressions and other forms of traditional knowledge. By way of contrast the NEMBA only looks at indigenous knowledge associated with indigenous biological resources. Therefore the IKS Bill has a much broader objective and scope.

Mr Mothale said his main question was whether the NEMBA could be amended to deal with what the IKS is raising? The presenters should feel free to provide more honest and unapologetic insight so that the Committee can decide whether to pass the law or not.

The Acting Chairperson mentioned that NEMBA had been on the statute books for a long time. Perhaps the IKS Bill would be “their saviour”.

Ms Molomow replied that the IKS Bill scope is broad in comparison to NEMBA, repeating that NEMBA is focused only on biological resources and associated traditional knowledge. The Bill assists NEMBA by bringing information on legitimate indigenous knowledge holders who will  have been taken through the national recording system. Once the applicant comes to NEMBA, it would make it easier for the DEA to identify which are the legitimate communities that hold the knowledge.

Mr Mbedzi provided comments on behalf of the DOH, firstly speaking to the question whether the prescribed requirements for registration under the IKS Bill and the THP Act are the same. IKS has a wide scope. It speaks to a community of practice. Within that practice there is traditional medicine knowledge. Under the THP Act, registration must be in line with what DOH does by licensing practitioners to practice. No one is South Africa is allowed to practice traditional medicine without being licensed by the Interim Traditional Medicines Council.

The IKS Bill also concentrates in that community of practice, but it will not license. Instead it will sort of accredit traditional health practitioners, in terms of quality assurance or setting standards that are mentioned under the IKS Bill. There is no confusion. The only question that the DOH wanted to raise was whether a traditional practitioner should be accredited as an indigenous knowledge system holder, or have a practice number. Such requirements are not specifically raised in the Bill. The DOH wanted to know if they should be.

Advocate Letjoalo addressed the question of the differentiation between African traditional medicines and complementary medicines. There was a difference at the point of commercialisation. When that happened, the Medicines and Related Substances Act takes effect because the medicine or medicine compounds will be regarded as “medicine” in the broader definition. Complementary medicine definitions speak about a mixture of substances used to assist innate healing powers of humans.

In relation to the MCC and when it will transit into SAHPRA, he said that in order for the current Amendment Act to become effective, there must first be an amendment of Act 72/2008. When that happened, the MCC would be obsolete. The transitional arrangement would take over.

Insofar as the THP Act was concerned, there would be some room for amendment. There were some challenges on how to work around the registration of traditional health practitioners because there was some confusion between what the THP Act said and what the IKS Bill said, although the IKS Bill recognised that they must also be registered. The formalisation of the profession of THP is a new effort, and there is some uncertainty with the DOH on that, which had caused some of the delays. He thought that the THP Act did interface with the IKS Bill quite well already. However, if the DST could modify the process around the appeals and the existing framework, then that should obviate some of the uncertainties.

Ms Carol van Wyk, Director: Knowledge Management, Department of Science and Technology, said that the IKS was a holistic body of knowledge and cannot be dissected into different pieces. In relation to the standards of accreditation if you lo, she pointed out that the DOH accreditation focused on registration of the educational qualifications of IKS practitioners. The accreditation and certification system was trying to dissect these. The standards for practice are practice based and evidence based. Registration is not just linked to the competences within the National Qualifications Framework, but must also take into account that a prime purpose is to register indigenous knowledge in communities, for the sake of its promotion, protection and management. She suggested that there should be another discussion session between the Department of Health and the Interim Health Council, as to where they are on the process, and how best to bring the two streams together .

Mr Tom Suchanandan, Director: Advocacy and Policy Development, Representative, Department of Science and Technology, mentioned that the mandate of the DST  is not about the conservation and sustainable use of the resource. That mandate belonged to the DEA. The IKS had identified 16 aspects of indigenous knowledge, and those included music, culture and science. The NEMBA only dealt with one aspect. If it was being suggested that an amendment of NEMBA would be sufficient, he disagreed because that would exclude the other 15 aspects not covered by NEMBA.

Mr Mothale said that he understood that, but his question was related to whether what was already in NEMBA needed to be dealt with also in the IKS Bill.

Mr Suchanandar replied that NEMBA is essentially about access to resources, research and development, clinical trials and the commercial phase. Each department is responsible for one aspect. The Bill would focus on protection, management, development and promotion of IKS. It was not the mandate of DST to conserve and preserve the resource. The IKS Bill is about knowledge behind using a biological resource, not specifically about the biological resource itself.

The Acting Chairperson mentioned that whether there is an amendment or a merger of concepts, there needs to be an understanding about serving the traditional health practitioner and protecting the indigenous knowledge, and also recognising the people who discovered and hold the knowledge.  It is important that the departments must work together. At this stage, as much information as possible was being gathered. After the public hearings there would be more guidance from those making submissions to strengthen the Bill and help Parliament to ensure that it achieved what it aimed to do.

The meeting was adjourned.