[Ip-health] Business Day SA: Draft patent policy a vital step for increasing access to medicines
aprabhala at gmail.com
Thu Aug 17 00:21:23 PDT 2017
Jonathan Berger and I have a piece in Business Day, South Africa on SA's
new draft patent policy, which might be of interest.
Draft patent policy a vital step for increasing access to medicines
Intellectual property law would encourage competition and innovation by
exploiting global flexibility provisions
16 AUGUST 2017 - 06:05JONATHAN BERGER AND ACHAL PRABHALA
The announcement that the Cabinet has approved the Draft Intellectual
Property Policy of the Republic of SA: Phase I — to give the formal
title — was made in a few terse lines embedded within the official
account of its meeting on August 1. On the heels of this announcement,
the detailed draft policy was released by the Department of Trade and
Industry a week later.
At 38 pages and full of arcane technicalities of intellectual property
law, it isn’t exactly light reading. And given that the report was
released on the evening of the no-confidence motion against President
Jacob Zuma, it’s understandable that you may have missed it.
But none of this should confuse you about the significance of what has
just happened. As the first step in the culmination of a 20-year
struggle, this policy offers the potential drastically to transform the
landscape of life itself, in SA and across the continent.
At the heart of the matter is government recognition of patent
protection — a state-sponsored guarantee of market exclusivity for a
defined period of time — which is a non-negotiable requirement for all
members of the World Trade Organisation (WTO) as well as a key
battleground in international trade deals. The purported logic is
simple: as patents are necessary for innovation (and by extension
development), member states should recognise them in their laws.
Yet the protection of patents often comes at an unacceptably high cost:
limited access to new inventions. This is because in the absence of
direct competition, there are few restraints on what may be charged for
In the case of medicines, the mere existence of patent protection may
lead to the high price of lives being lost, as in our recent history,
when millions of South Africans could not afford antiretroviral
treatment for HIV, and as in the present day, when few can afford the
impossible burden of new, life-saving treatments for cancer.
Perversely, even as the patent system strengthens its grip on the
planet, its logic has grown progressively weaker: the system has been
gamed so heavily over the past few decades and the standards so weakened
that a substantial percentage of patents cannot be deemed genuine
innovations by any stretch of the imagination.
Indeed, the existence of patents may actually stifle innovation in key
sectors, for example in software, electronics and medical devices. And
still, despite many obvious contradictions and flaws, the system remains
firmly entrenched in the global imagination.
Hearteningly, protests by developing countries such as SA, India and
Brazil have led to significant changes to patent rules at the
international level. Unfortunately, in SA this has seldom had a direct
domestic effect. Thus, while recognising that the state is
constitutionally required "to increase access to medicines as a
component of its obligation to take reasonable measures towards the
realisation of the right to healthcare services", the draft policy notes
that "the South African government has to date not made full use of the
flexibility within international law through the pursuit of appropriate
policy and legislation".
The flexibility to which reference is made is that provided by the WTO’s
Agreement on Trade-related Aspects of Intellectual Property Rights
(Trips), as subsequently clarified by the Declaration on the Trips
Agreement and Public Health (the Doha Declaration).
Adopted by WTO members in 2001, the Doha Declaration states that "the
Trips agreement does not and should not prevent members from taking
measures to protect public health". Yet most WTO members including SA,
have failed to do precisely that.
Twenty years ago, when countries such as SA first rang alarm bells on
the high cost of medicines and sought to amend their patent laws, there
was no consensus on what WTO members could do to expand access to
medicines. We now have that consensus.
In fact, we have had that consensus for 16 years. The Doha Declaration
unambiguously states "that the [Trips] agreement can and should be
interpreted and implemented in a manner supportive of WTO members’ right
to protect public health and, in particular, to promote access to
medicines for all".
In September 2013, after years of inexplicable inaction, the Department
of Trade and Industry’s consumer and corporate regulation division
published a draft National Policy on Intellectual Property. Not only did
it make particular reference to the Doha Declaration, it also recognised
that there is a direct link between patent protection in SA and the high
cost of medicines, and that an appropriate policy was needed — one that
would take the country’s health and developmental needs into consideration.
After accepting comments on the 2013 draft, the department lapsed into
another long, inexplicable silence. Then, on July 6 2016, the Cabinet
approved the publication of the Intellectual Property Consultative
Framework for public comment. Building on the department’s earlier
draft, the framework – this time prepared by its international trade and
economic development division — included a short-term agenda that
focused on public health concerns. The division has now published the
Cabinet-approved draft policy for comment, thus taking the first
decisive step in delivering on a promise made two decades ago.
Describing itself as "the first phase in what will be a comprehensive IP
[intellectual property] policy to be developed and updated over the
medium-to long-term", the draft policy not only sets out the entire
strategy and identifies issues to be tackled in subsequent phases, but
also describes two sets of issues that are to be dealt with in the short
term: intellectual property and public health and, international
The approach the draft policy appears to have adopted is one that seeks
to strike a careful balance between the appropriate protection of
intellectual property (including, but not limited to, patents) on the
one hand and the use of Trips-compliant flexibilities to ensure access
to medicines on the other. If the proposals in this policy eventually
translate into legislative amendments, they would probably result in
significant benefits to public health in the country and across the
The big change would be that patent applications filed in the country
would be evaluated in a phased manner (as capacity and cost constraints
allow) instead of being accepted without question, as is the current
practice. Other benefits would accrue from provisions for allowing only
genuine innovation to be rewarded with patent protection, a range of
Trips-compliant measures facilitating the early market entry of generic
medicines, and a host of related provisions, such as ensuring that user
rights in the patent system were adjudicated fairly and quickly.
To be sure, the draft policy sets its sights beyond public health to
rationalising the manner in which SA takes advantage of what the
international system offers. For example, it urges the state to sign the
Marrakesh treaty, which — if implemented in domestic copyright law —
would radically expand access to knowledge for visually impaired people
The draft policy would help to increase access to medicines. Moreover,
the policy recognises that direct competition between multiple
manufacturers is the most efficient way to increase the availability and
affordability of medicines, and this is likely to provide a significant
boost to the local production of medicines.
Given SA’s tiny share of the global market for patented medicines, such
changes are unlikely to have any significant effect on manufacturers
whose business model is predicated on patent protection. In contrast,
the domestic generic medicine industry will probably experience
tremendous expansion opportunities, with all the attendant benefits for
economic growth, employment and general socioeconomic development.
Could the draft policy have gone further and tested the limits of the
flexibilities and public health safeguards available under the Trips
agreement? Yes. However, we recognise that the state’s constitutional
obligation is not to adopt a policy that best promotes the right to
health; instead, the state is required only to act reasonably in the
Given the competing interests and rights at stake, the intricate dance
of maintaining stable trade relations with interdependent partner
countries, as well as the human and financial resources at the state’s
disposal, it is arguable that the draft policy — if adopted in its
current form — would constitute the type of reasonable measure
contemplated by the Constitution.
Interested parties were given 60 days to submit comments on the draft
policy. Once finalised, the department will hopefully follow up soon
with the publication of a Patents Amendment Bill for discussion, so the
parliamentary process can begin. With so much at stake, not least of
which is the state’s willingness and ability to discharge a key
constitutional obligation, one can expect the debates to be robust.
Regardless of what follows, we should pause for a moment to consider
what this draft policy represents: nothing less than the state’s first
serious attempt in 20 years to put an end to the unjustifiable support
of multinational commercial interests that compromise the health and
wellbeing of all its people.
/• Berger is a member of the Johannesburg Bar and serves on the Expert
Advisory Group of the Medicines Patent Pool.
//• /Prabhala is a fellow of the Shuttleworth Foundation and works on
innovation and access to medicines in India, Brazil and SA with the
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