Yesterday, while the Supreme Court of Appeal heard the arguments between Aventis, Cipla and TAC regarding whether to grant an interim interdict to prevent Cipla from producing generic docetaxel, an interesting debate on South Africa’s use of the TRIPS flexibilities was published on Druginfo Digest. The debate was ignited by the case and Anso’s article posted below.

The letter below is in response to the published article by Anso Thom published on Health-E and posted below. The response is written by Val Beaumont, Executive Director of Innovative Medicines South Africa. The response is addressed to Andy Gray and was published on Druginfo Digest on 15 May 2012.

Dear Andy,

I refer to the paragraph in the article below re: South Africa currently provides patent protection beyond what is required by the TRIPS agreement.

As I am sure you must be aware, this is not a full or totally accurate reflection of the current IP regime in South Africa.  South Africa has already adopted arguably the most critical TRIPS Flexibilities into legislation to promote public health.  These include:

*       a Bolar provision that provides for a generic to be registered during the period when the originator medicine is still patent protected,  and

*       provisions to allow parallel importation

These TRIPS flexibilities have been incorporated into our law exclusively for the benefit of the generics industry in an effort to improve access to medicines in a developing country.

We also have Section 56 of the Patents Act 57 of 1958 which provides for a compulsory licence to be granted when an abuse by the patent holder of their rights is proven

There is currently no legislation in South Africa to ensure data exclusivity, a minimum standard of IP protection offered by the TRIPS agreement.

In addition, there are pricing regulations for medicines aimed to address medicine pricing in the private sector.

South Africa clearly has incorporated several legislative provisions to promote public health.  We seek your support in encourage balanced reporting on this technically complex and emotive issue.

Regards

Val

 

Andy Gray, Senior Lecturer at UKZN’s School of Health Sciences and Consultant Pharmacist to CAPRISA, wrote a response to Val’s letter which was also published on Druginfo Digest on 15 May 2012.

Hi all

Val wrote : “I refer to the paragraph in the article below re: South Africa currently provides patent protection beyond what is required by the TRIPS agreement. As I am sure you must be aware, this is not a full or totally accurate reflection of the current IP regime in South Africa.  South Africa has already adopted arguably the most critical TRIPS Flexibilities into legislation to promote public health.”

I’m not sure I agree – so, let’s take each of the examples Val has cited. However, first, it needs to be pointed out that South Africa’s patent law has not been amended AFTER the 2001 Doha Declaration (or the August 2003 decision).

*  “a Bolar provision that provides for a generic to be registered during the period when the originator medicine is still patent protected” – that’s true, in relation to the ability to prepare batches for registration purposes, ahead of patent expiry. However, what is more important is the lack of linkage between patent and medicines regulatory systems.

*  “provisions to allow parallel importation” – while the issue of exhaustion of rights is excluded from action under TRIPS by Article 6, and this is one area where the 1997 Medicines Amendment Act did make a change, no parallel traded medicines have yet reached the market since 2003.

* “We also have Section 56 of the Patents Act 57 of 1958 which provides for a compulsory licence to be granted when an abuse by the patent holder of their rights is proven” – true, but the process is a judicial one, which exceeds the minimum (an administrative procedure) stipulated in TRIPS. There has, to date, been no successful application for a compulsory licence for a medicine. Where voluntary licences have been issued, this has largely occurred under duress, linked to actions taken in terms of Competition law. More recently, a more pro-active licensing picture has emerged, but this has nothing to do with the extent to which the Patents Act facilitates access to compulsory of government use licences in order to address pubic health challenges.

* “There is currently no legislation in South Africa to ensure data exclusivity, a minimum standard of IP protection offered by the TRIPS agreement.” – this is an area of contention, with differing interpretations of what the minimum required by Article 39(3) should be. The standard advocated by the research-based pharmaceutical industry, and which applies in many developed countries, and the linkage between patent and medicines regulatory systems, is considered by many to represent a TRIPS+ stance.

Val does mention that, in addition, “there are pricing regulations for medicines aimed to address medicine pricing in the private sector”. That is true, but in the absence of a reference pricing system, the impact on the cost of newly-launched medicines is minimal.

So, while it is true that South Africa has “incorporated several legislative provisions to promote public health”, there are a number of outstanding issues, including:
* the standards for patentability; and
* the absence of rigorous pre- and post-award examination and opposition procedures.

South Africa’s patenting authorities are perceived to be slow, but also to award patents without clear evidence of these having met a reasonable standard. It seems that if the paperwork is submitted, and the fee paid, the patent applied for will be granted. We still have a way to go before we can really be said to have implemented all of the flexibilities that exist in TRIPS, and the Doha Declaration.

regards

Andy