[Ip-health] EB134: Statement of South Africa on Access to Essential Medicines (in the wake of Pharmagate)

Thiru Balasubramaniam thiru at keionline.org
Thu Jan 23 15:28:44 PST 2014


On Thursday, 23 January 2014, Malebona Precious Matsoso (Director General
of the South African National Department of
delivered the the following intervention at the 134th session of the World
Health Organization's Executive Board under agenda item 9.7 on Access to
essential medicines<http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_31-en.pdf>
response to the recent Pharmagate <http://keionline.org/node/1908>




Chair, the recent leak by the multinational pharmaceutical industry of the
strategy written by Public Affairs Engagement to undermine South Africa’s
efforts to reform its Intellectual Property policies is unfortunate. One of
the objectives of this policy is to contribute towards the protection and
promotion of public health, and access to medicines in particular.

This is not the first time that South Africa has been under such an attack,
even in the face of the most devastating HIV/AIDS and TB co-morbidities.
The first time was when Nelson Mandela was the first respondent to the
legal challenge.

In 2000, the cost of combination antiretroviral therapy per person per
annum was US$10 000. In 2010, ten years later these costs had been reduced
to USS$1 000 per person per annum. We have further reduced these costs by
50%. This would not have been possible without generic competition. This
explains why today, South Africa has been able to put 2,4 million people on

Today around 4% of South Africans are on second line antiretroviral
therapy. This number must be increased to 14% for those who have been on
ART for more than 5 years. We know the long-term problems of managing a
life-long chronic disease and the challenges of patients who fail first
line therapy, who must be put on second line and salvage therapy. We need
to avoid virological failures and achieve good clinical and immunological
outcomes. This will not be possible at current costs which are 2,5 times
the cost of 1st-line therapy.

Similar arguments can be made regarding XDR-TB which is a killer and can be
aggressively confronted with newer therapies, i.e. only if they are
affordable. We have to put people on treatment that is affordable.

EB134/12 refers to the MDR-TB crisis, having patients put on a waiting
list. This should be avoided - and can be avoided.

Generic competition has been the main driver of affordable medicines
through early generic entry, normally referred to as Bolar Provision. We
have learnt from the experience of Canada on the use of this option and the
US with regard to the anthrax matter. This is one of the safeguards
contained in the TRIPS Agreement that countries can consider.

There are still other barriers to access, that require attention in South
Africa. This new IP Policy that is under discussion will promote
competition and ensure the leveling of the playing field. Patent
examination is amongst these policy reforms, and has been an important
measure as reported in various reports by WIPO and WTO in partnership with

Consistent with practices in developed and developing countries, the IP
reforms include patent examination. It is common practice in Europe, US,
India and Brazil. In all these countries poor quality patents are rejected.
For instance both the US and European Patent Office had 40% rejection of
these applications for which 100% approval was granted by South Africa.

DG, we welcome WHO technical support in providing comments on policy
reforms proposals in defence of public health. The guidance is consistent
with what is provided for in the Global Strategy and Plan of Action on
Public Health, Innovation and Intellectual Property. WHO’s comment to SA on
this draft IP Policy is that, I quote, “WHO encourages and supports IP
policies that maximize health-related innovations and promote access to
medicines for all and commit to provide assistance consistent with GSPOA”.

Various resolutions have been passed in support of the use of the
safeguards in the TRIPS Agreement, e.g. UNGA 65/1. The WHA61.21resolution
came about as a result of collaboration by Member States. This has been a
landmark event termed in IGWG discussions “the spirit of Geneva”.

DG, you have understood the plight of South Africa and WHO Member States
have shown solidarity. We have witnessed this in the fight against HIV/AIDS
and its contribution in increasing life expectancy. We cannot be
side-tracked or derailed in our course of action of defending public health
and the right to life.

I Thank You

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