Allan Malleche (KELIN): +254 708 389 870 | email@example.com
Lotti Rutter (Health GAP): +27 82 065 5842| firstname.lastname@example.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 sent 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 critique of 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 meetings.
“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.”