South Africa: The Great Pharmaceutical Patent Debate

Last Updated: 18 November 2011
Article by Joanne Van Harmelen

In recent news, the TAC (Treatment Action Campaign) has called on government to revise the Patents Act to reduce the patent protection available to pharmaceutical inventions, which the organisation believes is responsible for the high cost of medicines and a delay in the availability of generic medicines.

The organisation refers to the Doha Declaration, which has been signed by South Africa as a member of the World Trade Organisation, to support its call. 

There is no denying that the impact of diseases such as  HIV/AIDS, tuberculosis and malaria on developing countries, including South Africa has been devastating.  However, amendment of the Patents Act is not necessarily the best or more efficient way forward to deal with this health crisis.  In fact, there are already mechanisms in place in both the Patents Act and the Medicines and Related Substances Control Act which address the very concerns raised in the Doha Declaration and provide mechanisms for government to step in and ensure affordable medicines.  The problem is that government has not yet been proactive in utilising these mechanisms.

The Doha Declaration, which was signed in 2001 provides that member countries are not prevented by membership of the TRIPS Agreement from taking measures to protect public health and that the TRIPS Agreement can be interpreted to protect public health and to promote access to medicines for all.  Certain mechanisms for doing so are set out in the Doha Declaration including: the right of member countries to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted; and the right to determine what constitutes a national emergency in order for the government to exercise its "walk-in" rights and an affirmation that HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency.

The South African Patents Act has a number of sections which may be used by government (or other parties) to give effect to the measures described in the Doha Declaration in relation to the public health issues and access to medicines.

Section 4 of the Patents Act sets out that a Minister of State can use an invention for public purposes on agreed upon conditions, or if there is no agreement, on conditions as are determined by the Commissioner of Patents on application by the Minister and after hearing the patentee.  There are no grounds stipulated here, merely that the invention must be used for public purposes.   However, this section has not to date been utilised by the State.

Section 78 of the Patents Act sets out that a Minister may on behalf of the State, acquire any invention or patent on agreed upon terms and conditions.  No grounds are stipulated, only that conditions must be agreed upon between the parties.  Again, the State has to date not pursued such an acquisition of a patent or invention.  

Section 56 of the Patents Act sets out the grounds for an applicant to be able to apply for a compulsory licence from the Commissioner of Patents in regard to a patented invention where there has been an abuse of rights by the patentee.  This section in particular, pertains to the compulsory licence provisions provided for in the Doha Declaration.

Of particular relevance to the issue of access to affordable medicines are subsections (1)(c) and (e).  In specific, subsection (c) provides that a compulsory licence can be applied for in a case where the demand for the patented article in South Africa is not being met to an adequate extent and on reasonable terms.  Our courts have indicated that "adequate extent" means sufficient for the needs of South Africa and that a lack of "reasonable terms" may be evidenced by public dissatisfaction with the prices.  Although the decisions are made by the Commissioner of Patents on a case-by-case basis to award a compulsory licence, it seems that a lack of access to affordable medicine would meet the requirements for such a compulsory licence application.

Although more limited in application, subsection (e) provides that an applicant for a compulsory licence may do so on the ground that the price of the patented article is excessive compared to country of manufacture where the demand for the patented article in South Africa is being met by importation but where the price charged in the South Africa is excessive in comparison to countries where the patented article is manufactured and there is no good reason for the substantially higher price.

Despite these provisions, very few applications for compulsory licences have been brought to the Commissioner of Patents.

Furthermore, the  Medicines and Related Substances Control Act in section 15C sets out measures which can be applied by the Minister of Health to ensure supply of more affordable medicines.  Firstly, the Minister can, despite the provisions of the Patents Act, prescribe that certain rights of an owner of a medicine registered in South Africa are limited and do not extend to acts in respect of the medicine.  In other words, acts of infringement by a third party when pertaining to provision of access to affordable medicines can be allowed by the Minister of Health in terms of this section. 

Secondly, in a more limited provision, the Act also sets out that the Minister can prescribe conditions on which a generic medicine can be imported by a person who is not the holder of the registration certificate for a registered medicine.  However, the medicine must have originated from the site of manufacture of the original manufacturer.

The reality is that amendment of legislation tends to be a lengthy process and depending on the quality of the drafting can often have unintended or unforeseen consequences.  As indicated, there are a number of existing mechanisms that can already be used and I believe that government should be lobbied to be more proactive in putting these mechanisms to use to provide more affordable access to medicines, which would in turn be in keeping with our undertaking as a signatory to the Doha Declaration.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions