Agenda – Peter Maybarduk and Brook Baker
Item One: Positive Agenda Campaigns: (1 1/2 hours)
Opposing FTAs and the enforcement agenda are primarily defensive strategies. At a Congress devoted to a public-interest approach to IP, and to the ecology of innovation and access more broadly, it is important to think about positive, pro-access-to-medicines strategies as well. Fortunately, there are a large range of active and planned “positive” campaigns to report on and strategize about.
One of the most promising A2M campaigns in the HIV/AIDS context is the establishment of the Medicines Patent Pool and the announcement of licenses from NIH and Gilead. The NIH license for one of the darunavir patents was essentially unrestricted an set a powerful positive example, but will be impossible to operationalize unless Johnson & Johnson/Tibotec license in the remaining duanavir patents. The Gilead license, though positive in terms of licensing both existing and pipeline medicines and preserving rights for compulsory licenses and delinking of API licenses, had troubling restrictions on geographical scope (excluding many middle-income countries in Latin America, North Africa, and Asia), on API sourcing, and on country of manufacture (among others). A robust debate has emerged among civil society about the imperfections in the licenses and some aspects of transparency and participation at the MPP, which remain to be addressed. However, it is strategically important to focus on how to convince/force Gilead to improve its licenses and to provoke plunging into the pool by other Big Pharma companies.
The Medicines Patent Pool cannot go it alone, so there are also needs for complementary compulsory licensing strategies in excluded middle-income countries. Although there have been select CLs issued and performed in a small number of countries, especially Thailand, there has not been a concerted campaign to date to coordinate and prioritize CLs . Fortunately, Public Citizen has been working behind the scenes with respect to such and campaign, and other activists are promoting CLs within their countries.
It is nearly ten-year post-Doha and remarkably little has been done to enact TRIPS-compliant flexibilities into national law in most developing countries. It will be hard to argue for extensions to TRIPS waivers for least developed countries (2013/2016) unless countries begin to enact and use the flexibilities that they have clearly had for ten years. Belatedly, UNAIDS, UNDP, and WHO have urged all developing countries to enact TRIPS flexibilities and there is an imminent activist campaign in at least one country that is likely to be announced on the ten-year anniversary – November 14. However, there are other proposed IP reform activities afoot, most of which are shielded from participation by CS activists and experts.
All the IP reform in the world won’t work if there’s no money to buy generic medicines. Global funding for HIV/AIDS, TB, and malaria is under attack just as additional illusory commitments are being made about access to family planning and medicines/diagnostics for chronic non-infectious diseases. AIDS activists are organizing a major mobilization at the International AIDS Conference in Washington DC next summer and will be highlighting IPRs as one of their key demands.
The UNDP has heightened its activity in providing technical assistance to developing countries on a wide range of IP, trade, and competition issues. It is supporting the Commission on HIV and the Law, which is investigating IP as one of its key areas of inquiry. It is advising countries and providing technical guidance on IP reform, trade negotiations, IP/competition policy, and even an anti-anti-counterfeiting agenda. We need to strategize on how to leverage this assistance into national campaigns that go beyond mere consultations.
KEI, MSF and others have for many years championed an innovation agenda for medicines that challenges reliance on IP and monopoly pricing as the sole system for incentivizing translational R&D for medicines. Although the full scope of this campaign at WHO, in WIPO, and in many other settings, is beyond the scope of this meeting, it is highly useful to identify key developments and advocacy opportunities and to enlist the broader engagement of health activists in the innovation side of the medicines equation.
The issue of unsafe substandard and falsified medicines is troubling indeed, but IP enforcement is the wrong tool to address it. However, in order to put this wrong tool aside, it will be important to mount a more positive campaign that builds regulatory capacity in developing countries to register medicines, to supervise the supply chain, and to regulate retail outlets. Some efforts are underway in sub-Saharan Africa and elsewhere to harmonize registration standards and build capacity for pharmacovigilance, but greater input and participation by civil society is greatly needed. IP experts have a particular role to play – both to expose the demerits of an IP-focused anti-counterfeiting approach and the dangers of data exclusivity and linkage regimes.
Finally, US activists in particular are working on a campaign to convince the National Institutes of Health to adopt more pro-innovation and pro-access policies and systems.
In preparation for this session, participants should think strategically about how to prioritize these disparate efforts and how to create greater synergies between them under a coherent umbrella of public interest-public health alternatives to IP fundamentalism.
Item Two: Declaration and further strategy (1/2 hour)