25. In respect of the triplets, we note that Paragraph 19 of the Doha Ministerial Declaration instructs the TRIPS Council to pursue its work programme under Article 27.3b, Article 71.1, and paragraph 12 of the Ministerial Declaration, inter alia, "to examine the relationship with the Convention of Biological Diversity and the protection of traditional knowledge..." A large group of developing countries proposed an amendment to the TRIPS Agreement to introduce a mandatory disclosure requirement in patent applications and have sought clear guidance on this matter as part of the modalities decision. The basis of this amendment is contained in TNC/W/59 which requires access and benefit sharing, prior informed consent and disclosure of the source of material when a patent is applied for.
26. South Africa is rich with natural resources, being the 3rd most biologically diverse country after Indonesia and Brazil. It represents 2% of the world's landmass, has 10% of the world's plants, 7% of all mammals, birds and reptiles, and 15% of all known marine species. South Africa is also a Contracting Party to the CBD and has ratified the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilization in 2013 which came into effect in October 2014.
27. The ABS legal regime for South Africa, is contained in Chapter 6 of the National Environmental Management: Biodiversity Act No 3 of 2003 which governs bioprospecting and the use of indigenous biological resources. This Act regulates inter alia: bioprospecting involving indigenous genetic and biological resources; the exportation of indigenous genetic and biological resources for purposes of bioprospecting or any other research purpose; and provides for a fair and equitable sharing by stakeholders in benefits arising from bioprospecting;
28. South Africa also requires disclosure of the use of traditional knowledge or biological resources in patent applications. Section 30 (3A) of the Patents Act No. 37 of 1952 as amended by Act No 20 of 2005 requires that:
"(3A) Every applicant who lodges an application for a patent is accompanied by a complete specification shall, before acceptance of the application, lodge with the registrar a statement in the prescribed manner stating whether or not the invention for which protection is claimed is based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge to this effect."
This amendment to the Patents Act came into force on 14 December 2007 by proclamation and with the publication of Regulations for the Patents Amendment Act. As a result, every applicant for a patent (with the exception of provisional patent applications) filed in South Africa on or after 14 December 2007 is required to lodge a declaration or statement in respect of traditional knowledge or use of indigenous biological resource, irrespective of the nature of the invention sought to be protected. Also in this respect, on 23 March 2016, South Africa issued the second internationally recognized certificate of compliance following a permit made available to the Access and Benefit-sharing (ABS) Clearing-House.
29. Given the extensive (legal) regime that applies in South Africa, we still experience significant instances of bio-piracy and misappropriation. National regimes are therefore necessary, but insufficient steps to protect traditional knowledge or the use of indigenous biological resources. A multilateral system within the context of the TRIPS Agreement that regulates disclosure and access remains the best guarantee against misappropriation of genetic resources and traditional knowledge.
30. While related negotiations can complement the negotiations of TRIPS issues in the WTO, they are not an effective substitute for achieving results in the WTO TRIPS context. Other international fora lack an effective dispute settlement mechanism to ensure compliance with the obligations, and there is no certainty that these negotiations will be successful in these fora.