[Ip-health] South Africa: Stop Blindly Handing Out Drug Patents!

Lotti Rutter lotti.rutter at mail.tac.org.za
Wed Oct 16 21:35:23 PDT 2013

(With apologies for cross-posting)


*Health activists hand-over comments on Draft Policy to Dept. of Trade &
Industry, supporting patent law reform*

*PRETORIA, 17 October – *Marching in support of government-proposed patent
law reforms, Doctors Without Borders (MSF), the Treatment Action Campaign
(TAC), and SECTION27 today handed their submission commenting on the*Draft
National Policy on Intellectual Property, 2013 *to the Department of Trade
and Industry (DTI)*.*

*“This policy is not just about legal technicalities. It will directly
affect the health and lives of many millions of people. By fixing the
patent laws, South Africa can  lower prices of existing medicines, and also
create incentives for the development of new and improved treatments to
tackle the diseases people live with every day,”* says Andrew Mosane, TAC
Provincial Secretary in Gauteng.

The joint MSF-TAC-SECTION27 submission notes that South Africa pays
artificially inflated prices for medicines because it blindly hands out
patents, without examining applications to see if they meet criteria
defined in the country’s Patents Act.  This allows pharmaceutical companies
to get multiple patents on the same medicine by making small changes, even
when such changes have no benefit for patients. This can block more
affordable generic competitors from bringing products to market beyond the
20 years required by international trade agreements.

*“In South Africa, competition is not as robust as it is in many other
countries.  As a result, we don’t have more affordable generic versions of
oral contraceptives, medicines to treat bi-polar disorder, cancer medicines
and other vital drugs that are available elsewhere. When desperately needed
drugs are too expensive, people pay both from their wallets and with their
lives,”* Julia Hill, MSF Access Campaign Officer, explains.

MSF, TAC and SECTION27 are pleased that in the draft policy, the DTI also
called for rigorous criteria for granting a patent, and recognised the need
for a patent examination system, alongside procedures that allow for
opposition to frivolous patents.

*“Complementary systems like these will reduce abuse of the system by
pharmaceutical companies, and help to increase access to medicines.
However, the policy requires more detail about the practicalities of
implementing these reforms,”* Umunyana Rugege of SECTION27 says. “*The
DTI’s policy must also be more specific about how it will overcome
legitimate patent barriers when pharmaceutical companies charge exorbitant

The cumbersome process for using legal flexibilities such as compulsory
licensing has never been applied to gain access to more affordable versions
of these drugs. Consequently, medical aid schemes opt to exclude expensive
treatments for breast cancer or leukemia from their prescribed minimum
benefits, as paying for these drugs would hike up premiums for all members.

The public sector is also unable to purchase some patented drugs like
linezolid for the treatment of drug-resistant tuberculosis (DR-TB) because
one pill in South Africa costs R676 – even though far more affordable
generic versions are available from India.

South Africa’s current patent laws offer little incentive for companies to
research and develop new or improved treatments. Phumeza Tisile from
Khayelitsha knows this all too well. Recently she was cured of extreme
drug-resistant tuberculosis (XDR-TB), in part because MSF was able to
provide her with linezolid in a treatment pilot project.

*“I had to take thousands of pills, for more than two years, and I was
lucky enough to be cured,” *she says. *“Many people do not survive TB, and
I saw friends die because the treatment was not good enough. I became
permanently deaf as a side effect of one of the drugs. South Africa needs
to do more to make sure new drugs and new regimens are available to fight
TB more effectively.”*

Phumeza echoed the demands contained in the MSF-TAC-SECTION27 submission to
the DTI that its revised policy include a broad research exception and new
approaches to research and development that will better meet the health
needs of South Africans.

* “Today if you are trying to test new combinations of patented drugs to
treat HIV or TB, you have to negotiate with the rights holder, just to
conduct research in South Africa,”* says Julia Hill, MSF’s Access
Officer. *“This
is impractical, and delays the development of better treatments for
neglected groups, like children with HIV, who are not considered a
profitable enough market for big pharmaceutical companies.”*

South Africa is not alone in the process of undertaking patent law reform
to improve access to medicines. Its BRICS partners, such as India, as well
as Argentina have already implemented a number of reforms similar to those
proposed by the South African DTI.

In Brazil a patent law reform bill currently before parliament has received
widespread support, in a similar fashion to global backing for South
African reforms. Over 100 organisations and experts have signed on to an
open letter to the DTI in the past week alone – supporting the changes
called for by MSF, TAC, and SECTION27.

*“We have waited too long for the system to change so that life-saving
medicines can be made available and affordable,”* says Mosane. *“The South
African public and the world are calling for it—the DTI’s proposed reforms
cannot be implemented soon enough.”*


*Note to Editors:*

TAC, MSF and SECTION27 are calling for the following recommendations to be
expressly included by the DTI in the final policy on intellectual property:
 1)    *Curtail evergreening and abusive patenting through stricter
patentability criteria.* The Patents Act does not explicitly exclude from
patentability new uses and new properties of known compounds, and obvious
new forms of already-existing medicines.  South Africa should amend
patentability criteria to make full use of public health flexibilities
available under international trade rules, and prevent the patenting of
trivial changes to existing medicines.

2)    *Implement a substantive patent examination system for pharmaceutical
patents* to enforce patentability criteria and limit the number of patents
granted in South Africa.  Excessive patenting keeps prices artificially
high far beyond the twenty year patent term and medicines remain
unaffordable for patients.  Section 34 of the South African Patents Act
requires that all patent applications are substantively examined, but to
date, the DTI has failed to take any of the necessary steps needed to
implement this provision.

3)    *Enhance public transparency of the Patents Office**. *In South
Africa, the specifics of patent applications are not available in an online
database, and the claims of granted patents are only accessible through
time-consuming, in-person searches at the Patents Office. The lack of
information available online or through easily accessible publications
makes it difficult to know when patents have been applied for or granted,
or to oppose abusive patents.

4)    *Allow for pre-grant and post-grant patent opposition** by a broad
range of third parties. *Greater transparency from the Patents Office
should be accompanied by changes to the law that allow patent applications
and granted patents to be opposed by a broad range of third parties,
including generic manufacturers, researchers, civil society, and other
interested persons.  Patent oppositions provide patent offices with
additional input to identify prior art, examine claims, and curb abusive
patenting of pharmaceuticals.

5)    *Broaden the grounds and facilitate procedures for issuing a
compulsory license. *South Africa can issue compulsory licenses for the
production of generic versions of medicines that are rendered inaccessible
due to high cost or limited supply—but South Africa has never issued a
compulsory license for a pharmaceutical.  At present, it would cost an
estimated R1million in legal fees and take up to three years of court
proceedings to obtain a compulsory license— thus, amended and easier
procedures are needed.

6)  *Include a research exception: *Countries can establish “limited
exceptions” to the exclusive rights conferred by a patent. One of these is
a general research or educational use exception, which does not currently
exist in the South African Patents Act. A research exception allows the use
of patented material, for research or educational purposes, while a patent
is still in force. Such an exception would permit clinical trials,
operational research, or development on and of new combinations that
include a patented pharmaceutical—this could pave the way for new treatment
regimens in the fields of HIV or TB, where multiple drugs are required to
effectively combat different strains of the disease.

You can access the entire TAC-MSF-S27 joint submission online here:

You can access the open letter from over 130 international organisations
and experts to the DTI here: http://www.fixthepatentlaws.org/?p=773

* *

*For more information and to arrange interviews:*

Kate Ribet, Media Liaison Officer, MSF SA

kate.ribet at joburg.msf.org | 079 872 2950 | www.msf.org.za

More information about the Ip-health mailing list