[Ip-health] Over 60 health organisations demand ARIPO reform to increase access to more affordable medicines in Eastern & Southern Africa

Lotti Rutter lotti at healthgap.org
Thu Jun 20 08:20:44 PDT 2019

June 20, 2019 | Access to Medicines
Over 60 health organisations demand ARIPO reform to increase access to more
affordable medicines in Eastern & Southern Africa


Allan Malleche (KELIN): +254 708 389 870 | amaleche at kelinkenya.org

Lotti Rutter (Health GAP): +27 82 065 5842| lotti at healthgap.org

(Harare, Zimbabwe) — More than 60 health organisations are calling for
rapid reform of the Harare Protocol of the African Regional Intellectual
Property Organization (ARIPO) in order to protect public health across its
18 Eastern and Southern African member states. Representing people living
with cancer, tuberculosis, HIV, and many other diseases and conditions—the
organisations are demanding that ARIPO takes urgent steps to amend the
Harare Protocol and introduce public health safeguards that will
significantly improve access to medicines in the region.

In a joint submission
to the ARIPO Secretariat and its members, the organisations outline major
concerns over the excessive price of medicines and other health
technologies in the region—where governments are forced to use
under-resourced health budgets to pay artificially inflated prices because
of overly permissive patent rules, or more often, their citizens are forced
to go without. These high prices and embargoed access are a direct result
of excessive patenting in the region, allowed under Harare Protocol rules.

The Harare Protocol established a regional mechanism that administers the
filing, examination and grant of pharmaceutical patents applicable to 18
countries in the region. As such it has a direct impact on whether the
population in the region have access to affordable medicines. However,
instead of utilising public health safeguards allowed under international
trade law (the World Trade Organization Agreement on Trade Related Aspects
of Intellectual Property Rights—“TRIPS Agreement”), ARIPO continues to
grant undeserved pharmaceutical patents, applicable even to countries where
the national patent law does not recognise such patents.

One major concern is that ARIPO fails to rigorously examine patent
applications to ensure they meet certain standards for what deserves a
patent. This allows pharmaceutical companies to get multiple patents on the
same medicine by making small changes, even when such changes are obvious
and lacking inventiveness. This strategy commonly known as “patent
evergreening”, aims to extend patent monopoly beyond the 20 years allowed
by the TRIPS Agreement and block early entry of generic competitors that
can bring more affordable products to market.

Furthermore, ARIPO grants these frivolous patents in the 12 least developed
countries in the region where the TRIPS Agreement does not require
pharmaceutical patents to be upheld at all. Whilst global patent rules
recognise the need for an exemption for resource-poor countries from
granting patents on medicines, ARIPO continues to undermine this right. Not
only does the exemption promote access to medicines, it also provides an
opportunity to boost local generic manufacturing capacity in the region—an
area of development encouraged by various pharmaceutical business plans in
the region. By failing to implement this exemption, ARIPO is not only
undermining regional development strategies but also “kicking away the
ladder” for countries in the region.

The submission goes on to outline a number of recommendations to prevent
excessive patenting and other barriers to generic entry in order to allow
competitive price reductions on medicines and medical technologies
(including diagnostic tools). These recommendations include (but are not
limited to): The exclusion of all least developed country (LDC) members
from the requirement to grant or enforce pharmaceutical patents until 2033;
the adoption of more stringent standards of patentability and examination
practices that exclude patents on new uses, new formulations and new forms
of known medicines and other health technologies; and a regional patent
opposition mechanism.

“These reforms are not just about legal technicalities. They will directly
benefit the health and lives of many millions of people in ARIPO member
countries. We must follow the lead of countries like India, Egypt and
Argentina who have been actively using these safeguards—such as rigorous
patent examination standards and practices—to make sure their citizens have
the medicines they need,” says Maud Mwaka from the Women’s Coalition
Against Cancer in Malawi.

“Despite numerous attempts to formally engage in ARIPO processes and with
the Secretariat and gain access to reports, as well as earlier promises to
include civil society and intellectual property experts in ARIPO’s relevant
stakeholder meetings, to date we have been entirely left out of
discussions,” said Mulumba Moses, from the Centre for Health, Human Rights
and Development (CEHURD) in Uganda.

A smaller group of regional civil society representatives sent an earlier
an ARIPO commissioned report on industrial property laws in the region and
has heard nothing in response thus far. The report’s description of the
state of national laws in the region and under-inclusive set of policy
recommendations reveals a serious lack of competency and understanding of
patents and TRIPS flexibilities. The civil society submission described and
recommended that all ARIPO member states incorporate a much broader set of
TRIPS-compliant public health safeguards into their national industrial
property law.

“Currently the Secretariat is relying almost exclusively on the advice
being given by the World Intellectual Property Organization (WIPO)—a
well-known proponent for the multinational pharmaceutical industry and
whose technical assistance in the area of patents and use of TRIPS
flexibilities is often critiqued for its bias, and lack of public interest
and development consideration,” says Allan Malleche, from the Kenya Legal
and Ethical Issues Network on HIV and AIDS (KELIN). “Instead the
Secretariat must leverage on existing expertise and capacity in its member
countries, including through fully including civil society and patient
groups in these processes.”

At this point civil society activists are most concerned about attending
upcoming ARIPO meetings where the Secretariat and member states will begin
discussing and deciding on Harare Protocol reforms and possibly setting an
agenda for national reforms as well. Activists are informed that there are
relevant meetings in August and November, but despite multiple requests,
have not yet received responses to these submissions or invitations to the

“We are not going to let these opportunities slip through our hands,” said
Lotti Rutter from Health GAP, working across several countries in the
region. “Too many lives are at stake to allow drug companies to continue to
get away with unwarranted patenting and monopoly pricing.”


*Lotti Rutter*
Associate Director
International Policy & Advocacy
Health GAP

Cell: +27 82 065 5842 (South Africa)
Phone: +1 347 263 8438 x104 (US)
Twitter: @HealthGAP @lottirutter
Skype: lotti.rutter

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