Access To Medicines


Today the Treatment Action Campaign (TAC), Médecins Sans Frontières (MSF), and SECTION27 handed in a submission to the Department of Trade and Industry in Pretoria, in response to the draft National Policy on Intellectual Property, 2013. Having worked for many years to limit the negative impact of intellectual property (IP) on public health, most recently through the Fix the Patent Laws campaign we welcome this opportunity to participate in the policy making process.

Below are our list of recommendations for the DTI. You can access the entire joint submission here.  

Key recommendations:

1. On patentability criteria:

1.1. The Patents Act should be amended to include stricter patentability criteria; and

1.2. In the context of medicines and other health-related products, new uses and methods of treatment should expressly be precluded from being granted patent protection; new forms of known substances should not be patentable to the extent that they fail to demonstrate the required degree of inventive step, strictly construed;

2. On patent searches:

2.1. CIPC online patent search database should be improved to facilitate access to accurate information on patents for ordinary users of the system. This would in turn help stakeholders, such as civil society take action to limit the granting of abusive medicines patents.

3. On substantive patent examination and opposition proceedings:

3.1. Recognising that the Patents Act already requires substantive patent examination, we call for the making of regulations dealing with the establishment and phased implementation

3.2. The Patents Act should provide for meaningful pre- and post-grant opposition mechanisms that recognise broad standing requirements inclusive of civil society and adequate access to information to facilitate such interventions;

4. On the relationship between medicines registration and patent protection:

4.1. Other than what is already contained in section 69A of the Patents Act, no linkage between medicine registration and patent protection should be recognised; and

4.2. Remedies for addressing delays in medicine registration processes should exclude patent extensions;

5. On compulsory licensing and parallel importation:

5.1. The current process in terms of section 56 of the Patents Act should be replaced by a simple, expeditious administrative procedure that is subject only to review proceedings in the High Court or the Court of the Commissioner of Patents. Government use licenses should not require any review proceedings in the High Court;

5.2. Pending any review of the grant of a compulsory licence, interim relief should only be available – upon application – in exceptional circumstances and should not be available for the exercise of government use licenses;

5.3. Default positions regarding licence conditions (including but not limited to royalty rates) and negotiation timelines should expressly be included in sections 4 and 56 of the Patents Act;

5.4. Licensing practices should expressly be regulated, as contemplated by Article 40 of TRIPS; and

5.5. Regulation 7 of the General Regulations made under the Medicines and Related Substances Act 101 of 1965 (“the Medicines Act”) should be amended to give full effect to section 15C(b) dealing with parallel importation;

6. On research and development (“R&D”), public funding, innovation and access:

6.1. The Department of Trade and Industry (“the dti”) should collaborate with relevant departments and statutory councils to ensure that publicly-financed R&D in South Africa is aimed at delivering affordable inventions; and

6.2. In particular, the dti should engage with the Department of Science and Technology (“DST”) regarding the need to consider possible amendments to the Intellectual Property Rights from Publicly Financed Research and Development Act 51 of 2008 (“the IPRs from Publicly Financed R&D Act”);

7. On exceptions to patent infringement:

7.1. The Patents Act should exempt those aspects of scientific research that are not covered by section 69A; and

7.2.  The Patents Act should also include an educational use exception;

8. On data protection and exclusivity:

8.1. Calls for data exclusivity should be rejected on the basis that they are not required by Article 39.3 of TRIPS and they unreasonably and unjustifiably limit access to medicines; and

8.2. The status quo in this regard should be retained, with the Patents Act only making provision for data protection.