[Ip-health] IP Watch: Health Advocates Eye Proposed Changes To Patent Law In South Africa
joanna.l.keenan at gmail.com
Mon Aug 20 10:01:43 PDT 2012
Health Advocates Eye Proposed Changes To Patent Law In South Africa
Published on 20 August 2012 @ 4:41 pm
By William New, Intellectual Property Watch
CAPE TOWN – South African health activists and pharmaceutical industry
stakeholders are keeping close watch over the government’s attempts to
amend patent laws, which activists claim compromise the ability of the
country’s poor majority to access cheaper generic medicines.
Activists are hopeful that the still-to-be-released draft policy on
intellectual property, which includes recommendations on current patent
laws, will help South Africa catch up to some developing countries’
decision to allow cheaper life-saving generics into the market through the
issuing of compulsory licences.
A draft policy document on IP has been in the works for some time and
according to Macdonald Netshitenzhe, who is in charge of policy and
legislation in the Department of Trade and Industry, a refined version will
be submitted to cabinet soon.
Once it is presented to cabinet, the policy will be forwarded to
Parliament, followed by a period of public participation to further inform
the policy. Netshitenzhe said that the public participation process could
happen as soon as “the next few months.”
The draft policy on IP, which is driven by the Department of Trade and
Industry, is an attempt at developing a single, over-arching legal
framework on IP that would inform and harness a coordinated approach on IP
matters by various government departments.
The draft policy discusses all types of IP, including trademarks,
copyright, patents and designs, and makes recommendations on each of these
within the context of South Africa as a developing country.
It is against the backdrop of South Africa as a developing nation that
health activists have placed a magnifying glass on the country’s patent
laws, saying it protects big pharmaceutical companies and doesn’t make it
easy for the introduction of cheaper generic medicines onto the market.
In a bid to galvanise support for a change in the patent laws, the
Treatment Action Campaign (TAC), a public health-focused NGO, has initiated
the “Fix the Patent Laws” campaign.
The campaign demands that patents be given only for real improvements. At
present, South Africa grants patents for new uses or new formulations of
existing medicines. Low patent standards lengthen the term of the patent
monopoly by allowing companies to get new patents for making only small
changes to existing medicines, which is termed “evergreening.”
The TAC believes that the public has a right to challenge patents and
demands that the South Africa’s Patents Act be changed to allow for pre-
and post-grant opposition to the issuing of patents.
Also included in the “Fix the Patent Laws” demands is the allowance of
compulsory licences by government where prices are unaffordably expensive
and in cases of public health and national emergencies when medicines are
The TAC’s senior researcher on patent law, Catherine Tomlinson, believes
that South Africa provides intellectual property protection beyond what is
required in international law and that patents keep prices of medicines
high and out of reach of the poor.
She gave the example of the cost of a first-line regimen of medication for
an HIV positive person costing US$10,000 per patient a year in the early
2000s. Today, that cost has been driven down by the generic equivalent of
the drug to a cost of about US$178 (R 1,500).
Mara Kardas-Nelson, access and innovation officer for Médecins Sans
Frontières (MSF, Doctors without Borders), is a supporter of the TAC’s
She said that drug companies make significant profits on patented medicines
and that countries face enormous pressure not to use compulsory licences.
“The US has a watch list and threatens trade sanctions,” she said. “We saw
it happen in Thailand where a company removed its products from the country
after the government enforced a compulsory licence on a certain drug. We
need to have the political will to stand up to this. Other countries such
as India have flexibilities in their 20-year patent. South Africa has not
done that, which makes medicines here significantly more expensive than
“It’s simple economics that as more firms compete on the same product, the
price of that product will lower,” Kardas-Nelson continued. “We would
certainly not have been able to see a massive increase in the number of
people in the developing world access first line ARVs [antiretrovirals]
within generic competition and the resulting price drop.”
Activists campaigning for a change in South Africa’s patent laws refer to
the World Trade Organization Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) as a stumbling block to allowing for
more cheap generic medicines to be sold in the country, especially to treat
persons with HIV, tuberculosis and patients with cancer.
It is under this agreement that signatory countries had to grant patents
for periods of 20 years. The TAC and their supporters say that the
protected long patent period results in the high cost of medicines without
the option of cheaper generic drug competition during that time period.
Furthering their argument that South African patent laws are out of step
with international declarations on the issue, activists point to the 2001
Doha Declaration on TRIPS and Public Health agreed to by WTO member states.
It made clear that countries have the right to decide when to grant
compulsory licences and that they can do so, amongst other reasons, in
response to emergencies like the HIV pandemic.
While intellectual property law remains a technical subject for most,
Kardas-Nelson said that practically, it is not such a complicated issue.
“In a way, intellectual property is very complicated in practice, but it’s
actually not so complicated at all,” she said. “You put more generics on
the market and the price of medicines drops. People do understand the issue
of access to medicines since almost every family has struggled with that.
When you say that this medicine is less expensive in India than here,
people understand that,” she said.
The TAC’s campaign has attracted some support from pharmaceutical industry
stakeholders such as the National Association of Pharmaceutical
NAPM is a voluntary. non-profit organisation made up of South African
generics-based pharmaceutical manufacturers and distributors.
The NAPM, like the TAC, has made a submission to the draft IP policy. The
group believes amongst other things that the patent laws as they currently
stand are problematic and lead to the abuse of the patenting privilege.
In response to a query from Intellectual Property Watch as to whether it
supports the TAC’s campaign, the body responded in part: “Evergreening of
patents, whereby patents are granted (for often small or non-inventive
steps) is a greater issue in South Africa as there is presently no
investigative process in the South African patent office. For this reason,
patents are granted as a matter of procedure, even if they are obviously
invalid. The onus is left to generic companies to apply to the courts to
revoke the patents.”
The statement continued: “With the courts experiencing major backlogs, this
further adds to the significant delays generic companies face in having
their applications heard. This in turn delays and impacts the entry of
generics onto the South African market.”
But the campaign to fix the country’s patent laws does have its detractors
who have expressed some caution in the attempt to revamp the laws.
The Pharmaceutical Industry Association of South Africa (PIASA), a trade
association of companies involved in the manufacture and marketing of
prescription medicines in South Africa, also made a submission to the draft
PIASA Chief Operating Officer Vicki St. Quintin said that while PIASA
supports the ideal that the population should have access to efficient
healthcare services and quality medicines, “it is essential that any
intervention does not result in a trade-off of short-term gains for the
loss of sustainability, access to innovation and loss of investment. The
local registration of innovative medicines feeds the generic pipeline of
St. Quintin added that South Africa’s history of intellectual property law
has encouraged widespread foreign investment and ensured access to the
newest and best treatments in South Africa.
“There is no consensus that intellectual property rights prevent access to
medicines,” she said. “In addition, price is not the only factor in
determining access to medicines and a number of other factors should also
be considered, including political will, lack of resources and
infrastructure, regulatory issues such as tariff barriers and most
important, funding issues.”
St. Quintin added that South Africa is a high-level user of generic
medicines, with more than 60 per cent by volume in the private sector being
generic medicines and at least a similar level in the state sector.
“The long-term results of weakening intellectual property laws should be
carefully evaluated against the existing and long-term benefits of having
access to new and more effective medicines, which eventually become the
generics of the future. The industry is committed to working with other
stakeholders to overcome the barriers to access where they exist and to
finding creative solutions to ensure the best patient care,” she said.
The draft policy on IP indicates that it is attempting to remedy the
reality that South Africa does not have an IP policy and the subsequent
result that the country’s approach to IP matters is fragmented and is not
informed by national policies. The draft policy recognises that the
concluded IP policy must be “fused” with all relevant national policies, be
it on trade, public health, indigenous knowledge, innovation and
It will now be up to cabinet to approve the draft policy ahead of its
release to the public for further comment.
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