On 4-5 October 2011, UNITAID held its third Consultative Forum giving stakeholders the opportunity to view UNITAID’s achievements to date as well as provide input on UNITAID’s activities moving forward. Attendees at the forum included civil society, NGOs, implementing partners, representatives from the pharmaceutical industry and private foundations, and governmental officials. Several of the presentations from the IP workshop as well as the recommendations from the IP workshop are attached below.
The plenary sessions on both mornings included several excellent presentations, including on treatment needs and strategy generally, the overall strategy of UNITAID, the need to ensure the validity of UNITAID projects, the future of paediatric treatment in the medium and long term, mechanisms to ensure access to medicines, and value for money to ensure sustainability.
The afternoon of 4 October 2011, gave participants the opportunity to break into four workshops on different topics. These four sessions included HIV/AIDS, tuberculosis, malaria, and intellectual property related access issues. Participants in each session explored challenges and opportunities in the topic area, with the aim of drawing up recommendations for UNITAID going forward. The remainder of this blog focuses on the IP workshop and the recommendations that emerged from that session.
The IP workshop focused on three objectives: discussing IP related access issues, the role of the Medicines Patnet Pool and other strategies that could be supported or developed by UNITAID (as well as others), and exploring the different IP options available to ensure access to medicines. Although the IP workshop was designed to include discussions on HIV/AIDS, TB and malaria, the session ultimately focused on HIV. This workshop included two panels, with four speakers on the first panel and six presenting on the second panel.
Panel 1: Challenges in ensuring access to HIV medicines through IP rights
Carmen Perez from the Global Fund presented on the necessity of providing value for money and identifying problems early in the grant cycle. She noted that individual countries often need guidance and technical assistance in order to manage IP issues at the country level. She further noted the role of Indian generic manufacturers with 93% of ARVs procured by Global Fund recipients coming from Indian manufacturers.
Michelle Childs from MSF spoke from a treatment provide background and also acknowledged the importance of Indian generics as 80% of MSF’s medicines are sourced from India. However, she cautioned, this statistic is changing due to changes in Indian law. She noted also that IP is not a static scenario and the landscape is evolving. The high costs of medicines, particularly for second-and third-line treatments, often present a barrier to scaling up treatment and called for UNITAID to work with other institutions to use TRIPS flexibilities and push back against threats to these flexibilities.
Dr. Peter Beyer from WHO presented on country experiences and approaches to overcoming challenges. He noted the importance of the use of TRIPS flexibilities and gave an overview of how the flexibilities have been used in both developed and developing countries. He raised several areas for consideration or studies, including parallel importation, the impact of pre- and post-grant opposition on patent quality, an assessment of voluntary licensing practices, and intra-country tiered pricing in emerging economies.
Jorge Bermudez, the Brazil member of the UNITAID Board, gave the final presentation on the first panel and discussed the national experiences of his country. He presented relevant landmarks in Brazil’s quest to provide free access to ARVs and the strategies Brazil has used. He noted that Brazil formally complained regarding the Medicines Patent Pool license with Gilead on the issues of non-exclusivity, non-discrimination and transparency. Additionally, he noted that President Dilma defends access to medicines as a human right. He stated that while Brazil respects the IP commitments it has made, the procedures Brazil has used to promote access to medicines have been completely legal under both domestic and international law. He stated that the flexibilities on the TRIPS agreement, the Doha Declaration and the Global Strategy and Plan of Action on Public Health are indispensible to ensure the right to health.
Following these four presentations, participants in the workshop discussed the issues raised. One common theme that emerged was that individual governments have the power to move forward and should not sit back and wait, that there is no place for complacency regarding ARV pricing because the IP landscape is a dynamic one that is changing.
Panel 2: Exploring IP options available to ensure access to medicines
First, Ellen ‘t Hoen, Executive Director of the Medicines Patent Pool presented on the status of negotiations between the Medicines Patent Pool and ten targeted pharmaceutical companies. She then gave an overview of the Medicines Patent Pool license with Gilead and highlighted several key concerns and shortcomings of the license that was announced in July. She stated that the Gilead license is not a template and that the Medicines Patent Pool strives to improve the existing licenses. Finally, she emphasized that intellectual property goes beyond access and that UNITAID has a place in shaping an innovation agenda in addition to its access agenda.
Next, Brook Baker, Professor of Law at Northeastern University and Health GAP Board Member compared MPP and Pharma to David and Goliath. He stated that an access to medicines strategy depends on expanding resources, expanding tactics, and putting pressure on governments, with specific examples for each. Baker emphasized the need to use all tools available, such as a coordinated and strategic compulsory license and patent opposition campaign. He noted that governments need to enact all TRIPS-compliant flexibilities and take strategic actions so that these flexibilities are not diminished. He called for individual countries to take immediate action and to reject TRIPS-plus measures.
Antony Taubman of the WTO gave the next presentation on the Doha Declaration and implementation of TRIPS flexibilities. He noted that compulsory licenses are very clearly within the bounds of the rules on trade, and that countries have not only the right to grant compulsory licenses, but the very clear freedom to determine the grounds upon which they are granted. He suggested that UNITAID engage in a more direct, technical cooperation with those engaged in actual procurement activities and to strengthen empirical basis for this work.
Sisule Musungu from IQ Sensato, also covering the Doha Declaration, stated that while Doha was an extraordinary achievement, other factors have since come into play. He noted that the world is rapidly changing, that stakeholders in developing countries are also changing, and the IP landscape is evolving which requires new strategies. He called for UNITAID to look at anti-counterfieting initiatives and IP enforcement issues. He also suggested that countries should not focus on one flexibility (such as Kenya’s use of parallel importation) to the exclusion of other flexibilities. Finally, he suggested that the WIPO Development Agenda presents a space for the public health community to shape the debate.
Nelson Otwoma from the UNITAID Board looked at the community perspective and noted that we are still far from universal access for ARVs. He stated that HIV/AIDS still presents a disaster and communities need intellectual property norms that consider public health obligations and allow a supply of affordable medicines. He also pointed out the need for second-line treatments and the creation of pediatric formulations. In discussing the Medicines Patent Pool, Otwoma stated that more dialogue and debate is a positive and suggested that communities should petition pharma and join the negotiations to get the best outcome out of the pool.
Sarah Zaidi from ITPC gave the final presentation emphasizing the need to scale-up treatment. She stated that costs are a concern given the difficult financial environment. Additionally, she highlighted the need for better, more forgiving treatment regimens including access to second-line therapies and development of pediatric formulations. She suggested that studies be done to determine what is an acceptable profit on essential life-saving medicines which necessarily involves an evaluation of the cost of research and development. In terms of civil society responses, Zaidi suggested that advocates push back against restrictive IP laws and policies, strengthen partnerships at all levels (local, national, regional and global), to file patent oppositions, and advocate for compulsory licensing.
The ten speakers on the two panels provided an excellent basis for discussion and debate. Much of the follow-up commentary and discussion covered the expansion and spread of free trade agreements, with a call to ensure that human rights trump trade rights and to stand against new IP protections for rightholders. Many participants raised specific concerns regarding challenges faced by middle-income countries and also highlighted the need for more innovation, including for fixed-dose combinations and pediatric formulations. Additionally, the discussions, criticisms and recommendations regarding the patent pool were diverse. Although all groups agreed that the Medicines Patent Pool licenses have room for improvement, the strategies proposed for achieving that goal varied; four consensus recommendations regarding the Medicines Patent Pool were made.
Recommendations
Ultimately, nineteen consensus recommendations emerged from the workshop and were reported back in the afternoon plenary session on 5 October 2011. The recommendations that emerged were largely focused on specific items that UNITAID could focus on or where it could take action. They are as follows:
1. IP challenges that remain barriers to access to medicines for all, and must be overcome
- Consider that IP is not a static scenario and presents a changing landscape and UNITAID should therefore monitor the IP landscape on an ongoing basis.
- Look at IP barriers and competition issues. In doing so, UNITAID should identify the barriers and the countries that would be affected, and determine how to overcome those barriers.
- Address the challenges faced by middle-income countries, including through active participation on these discussions.
2. “Within IP framework” opportunities that needs more attention to ensure access to medicines in a context of severe resource constraints
- Monitor impact of IP on new formulations, technologies or other tools that come to market and identify what the IP obstacles.
- Explore impact of parallel importation on pricing and public health.
- Determine the actual cost of R&D and evaluate what is an acceptable profit on essential life-saving medicines.
- Actively encourage countries to use the full range of flexibilities, in particular, the strategic and coordinated use of compulsory licenses for medicines. UNITAID should support government actions and reject complacency regarding HIV/AIDS pricing because of the growing need for second and third line treatments.
3. IP opportunities that UNITAID is well placed to further maximize/explore
- Technical support regarding IP provisions in domestic legislation as well as those that are introduced through other mechanisms (such as FTAs).
- Counterfeit legislation should not undermine access to legitimate generic medicines.
- UNITAID’s work should foster generic production, including outside of India. Explore feasibility of and ways to support local production.
- Continue to advocate for pro-health IP provisions. UNITAID is in a good position to add a strong voice to the agenda and use its market intelligence to influence debates at WHO and WTO using its on-the-ground data. Examples: WHO discussion on an R&D treaty framework; WTO 2016 deadline extension for LDCs. Additionally, WIPO’s Development Agenda offers a good space for the public health community and UNITAID should shape discussions there.
- Work with other institutions to encourage full use of TRIPS flexibilities.
- UNITAID should continue to add its voice to those that warn against the inherent risks in many trade agreements, such as through issuing statements that draw attention to the public health effect of specific FTA provisions.
- Examine tax incentives and research and development subsidies to encourage voluntary licensing mechanisms.
- The IP issues do not center solely around access, but also include innovation. UNITAID needs to encourage mechanisms that would not only increase access to existing drugs, but also find ways to promote innovation—in particular with regard to ensuring uptake of the opportunities that are created by the Medicines Patent Pool.
4. Basic principles that must guide the patent pool as a tool for making public health oriented IPs available to improve access to affordable medicines and sharing the benefits of innovation “within IP framework”
- Continue and expand the dialogue with civil society and communities.
- Conduct a study of all possible options that would expand geographic scope and increase product coverage for the Medicines Patent Pool including, but not limited to, the Bangladesh, Barbados, Bolivia and Suriname donor prize fund proposal, a submission being considered by the WHO CEWG and WIPO’s Development Agenda project on open collaborative models. UNITAID should evaluate and identify ways to incentivize participation in the Medicines Patent Pool.
- Develop best practice guidelines for voluntary licenses, including the need for greater transparency with regard to terms and conditions of voluntary licenses reached outside the scope of the patent pool.
- Make efforts to improve licenses (such as geographic scope and sourcing of API outside of India) in the future.
The attachments below include the presentations by 1) Carmen Perez, 2) Jorge Bermudez, 3) Ellen ‘t Hoen, 4) Brook Baker, 5) Nelson Otwama, and 6) Sarah Zaidi. Additional presentations will be attached here if we receive copies of them.