Together with a group of local and international IP scholars, experts and pro-access advocates, members of the IP Unit have created and submitted detailed section-by-section comments concerning the dti’s Intellectual Property Consultative Framework, 2016. The submission was signed by dozens of international subject-matter specialist. Among other things, the submission links the dti’s policy effort to the recently released Report of the UN Secretary-General’s High Level Panel on Access to Medicines and emphasises the under-explored tension between overzealous IP protection and human rights. Crucially, the authors of the submission urge the dti in light of the critical public health and public interest issues at stake to move with utmost urgency to finalise an IP policy for South Africa. The submission contains the following overarching recommendations:

• The Government should set strict guidelines and time frames for the finalisation of policy in this area and the drafting of relevant implementing legislation.
• In the meantime, the dti should initiate regulatory and sub-regulatory reforms, including pharmaceutical patent examination guidelines, that would clarify and tighten patentability criteria for pharmaceuticals, and allow for immediate patent examination in this area of vital national interest.
• The implementation of a substantive search and examination system should be prioritised, and the relevant legislation promulgated to facilitate substantive examination beyond mere formalities. Clarifying this issue would, for example, allow the dti to take forward examination of pharmaceutical and other health technology-related patents as a matter of urgency, especially as it has already hired and is training a cadre of patent examiners.
• Legislation should be written incorporating all public health flexibilities, including:

  • The immediate amendment/repeal of Patent Regulations 40 and 41, in order to facilitate substantive examination of patent applications and to fully comply with the intent of section 34 of the Patents Act;

  • The introduction of examination guidelines linked to strict patentability standards with proscription on minor modifications to or variations of known substances, new use and new formulation patents to prevent ever-greening;

  • Full disclosure in patent applications including their foreign status and, when available, the International Non-proprietary name (INN) of pharmaceutical-related patents;

  • Pre- and post-grant opposition procedures, accessible to all interested parties (widely defined);

  • Parallel importation under an explicit international exhaustion regime;

  • Expansive compulsory licensing and government use provisions, including simplified procedures, expanded (including public health) grounds for grant, and remuneration guidelines for low percentage royalties;

  • Compulsory licences to remedy anti-competitive conduct;

  • Extensive early working exceptions, as well as other exceptions for educational, scientific and research purposes; and

  • Exclusion of diagnostic, therapeutic and surgical methods; plants, animals and genetic material.