The levels of enforcement of intellectual property rights (patents) may have critical impact in fostering or hindering access to medicines. The UNAIDS vision of “zero new infections, zero AIDS-related deaths, and zero stigma and discrimination” is based on the recognition that medicines are public goods and, therefore, the proprietary/private right must not prevail over the public interest
Managing Intellectual Property Rights to Ensure Access to HIV Medicines
by Carlos Passarelli*
Senior Expert Treatment, UNAIDS
The impact of intellectual property rights on access to health
Since the establishment of World Trade Organization in 1994, being the Trade Related Intellectual Property Rights (TRIPS) agreement one of its founding documents, WTO members must grant patent protection to commodities, including pharmaceutical products and processes, for a minimum period of 20 years, once they fulfil patentability criteria, such as novelty, inventive step and industrial application. Assuming that countries present different levels of development, the TRIPS agreement also foresaw some flexibilities in order to ensure an appropriate balance between the (private) right of the inventor and the social welfare, a public good. This paper will discuss the importance of using those flexibilities by developing countries to implement and/or sustain public policies in the realm of public health and to achieve international agreed targets on access to essential medicines to treat HIV infection.
The first AIDS cases were reported in 1981, and since then the epidemic rapidly became a public health concern for both developed and developing nations. From a period of fear and lack of alternatives for those affected by the HIV infection to the appearance of several preventive and therapeutic approaches, the international community has been suffering losses, but also sharing hopes. In 1996, almost 13 years after the isolation of the virus which causes AIDS - the HIV, new scientific evidences have proven that the HIV infection could be controlled, and that AIDS was not the same of a death sentence. Nevertheless, in the year 2001, when UNAIDS estimated that almost 30 million people were living with HIV worldwide, less than 200 thousand people were accessing antiretroviral (ARV) treatment. In 2013, 9.7 million people were enrolled on ARV programs, against 28 million people who would be eligible, according to the most recent (2013) WHO guidelines for HIV treatment. Thus, even if there is a huge gap to be filled, much have been achieved and it is important to identify the pathways that may assist countries in further reducing the AIDS-related deaths by scaling-up access to ARV treatment. This paper will focus on those public health opportunities that could be enhanced (or challenged) by trade issues.
The year 2001 constitutes a landmark towards more determined efforts to curb the AIDS epidemic. In September of that year, during the United Nations General Assembly Special Session on HIV AIDS (UNGASS 2001), member states agreed on concrete actions to face the global crisis posed by the epidemic, by issuing the UN Declaration of Commitment on HIV/AIDS. It created a favourable political environment to the establishment, in the same year, of the Global Fund to Fight AIDS, Tuberculosis and Malaria, mobilizing financial resources to address the major threats to the public health of developing countries.
Still in 2001, in November, the WTO conference in Doha discussed the impact of the intellectual property rights on access to essential medicines, being the HIV epidemic one of the major topics that served as a background for WTO members to sign the inter-ministerial declaration on TRIPS and Public Health, known as the Doha Declaration.
“(§1) We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. (§4) We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the 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 this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose” (Doha Declaration)
The great majority of flexibilities provided within the TRIPS agreement, highlighted by the Doha Declaration, are in direct relation to the ability of governments to protect public health and ensuring the right to access to medicines1, such as: exhaustion of rights (parallel importation; article 6), patentable subject matter (article 27); research and experimental use and bolar exceptions (article 30); compulsory license and government use (article 31), data protection (article 39.3), competition law (article 40), transition periods (articles 65.2, 65.4, and 66.1)2;3.
Despite the great importance of the Doha Declaration in supporting developing countries to further utilize the flexibilities within TRIPS, they are also challenged to not make use of them, by the threat of trade barriers posed by industrialized countries or by the so-called TRIPS-plus measures contained in Free Trade Agreements (FTAs)4. In the realm of public health, those agreements may imply concrete barriers in ensuring access to health products and services5, since they reduce the possibility of developing countries to benefit from the application of the above mentioned flexibilities. For instance, some TRIPS-plus provisions might eliminate and/or reduce the transitional periods for developing countries provided in TRIPS, preventing them to lessen the negative effects that intellectual property enforcement might originate for local development. Furthermore, those provisions may also extend the lifespan of a given license beyond the 20 years established by TRIPS, by pushing health authorities to comply with more restrictive data exclusivity protection and therefore making difficult the marketing approval of generic products. There are also TRIPS-plus provisions that will address directly the extension of patent protection term. Additionally, TRIPS-plus measures will seek for reducing, and even excluding the possibility of developing countries to undertake parallel importations, to issue compulsory licenses, to explore use exceptions and also to enlarge patentability criteria.
New paradigms for managing intellectual property rights within the public health arena
Generic competition has proven to be an effective tool for pushing prices down and therefore scaling-up treatment. From 2000 to 2010, prices for first line anti-retroviral drugs (ARV) of originators decreased from U$ 10,000 to U$ 300 per patient per year (pppy), while generic prices varied from U$ 2,700 to U$ 70 pppy. In this regard, since the Doha Declaration, international health negotiations have been undertaken aiming at supporting developing countries to preserve the political space to use TRIPS flexibilities and, in doing so, to enhance affordable prices for assured-quality products.
Following on a 2003 World Health Assembly resolution, WHO has established the Commission on Intellectual Property Rights, Innovation and Public Health6 in 2004, to “collect data and proposals from the different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries” (WHA56.27). In its report, the Commission concludes that the current intellectual property system is not properly addressing the health needs of developing countries, since it doesn’t foster research and development (R&D) of health products that don’t represent an attractive market for the pharmaceutical industry. The report puts a set of recommendations forward to enhance innovation within the health sector taking into consideration the health gaps in the R&D landscape.
Based on the recommendations of the Commission, WHO established the Intergovernmental Working Group (IGWG). This body was mandated to elaborate a global strategy and plan of action to support countries to address innovation and management of intellectual property rights in relation to their health needs. The document was endorsed by the World Health Assembly in 20087 and it paved the way for the formation of the Consultative Expert Working Group on Research and Development (R&D): Financing and Coordination (CEWG). The main recommendations in their final report8, launched in 2012, were based on the assumption that new financing models for R&D are needed to ensure that innovation should be funded by other mechanisms than granting patents (delinking).
Specifically in the realm of the HIV epidemic, an independent body of eminent persons expressed their concerns regarding the potential failure of the current patent system to address the health needs of people living with HIV in the developing world, especially the access to ARV treatment: “while intellectual property protection is supposed to provide an incentive for innovation, experience has shown that the current laws are failing to promote innovation that serves the health needs of the poor”9. In its report, the Global Commission on HIV and the Law included a chapter on the impact of intellectual property rights on access to HIV medicines, recommending that the management of the intellectual property system should be undertaken through the lens of human rights protection and principles.
Some concrete mechanisms were developed to explore alternative and public health-oriented models to manage intellectual property rights. In 2010, the UNITAID executive board, a WHO-hosted initiative to purchase drugs for HIV, Malaria and Tuberculosis, channelled resources for the creation of the Medicines Patent Pool, an independent foundation that negotiates voluntary license agreements with patent holders to foster generic production of second-line and paediatric ARVs and drugs to treat opportunistic infections in people living with HIV. Through the patent pool, “patent holders voluntarily offer, under certain conditions, the intellectual property related to their inventions to the patent pool. Any company that wishes to use the intellectual property to develop medicines can seek a license from the pool against the payment of royalties and may then produce the medicines for use in developing countries”10.
Platforms for action
In 2010, UNAIDS and WHO have launched the Treatment 2.011platform, a framework designed to support countries in achieving and sustaining universal access and, at the same time, maximizing the preventive benefits of antiretroviral therapy. The main components of this programmatic approach are: treatment optimization, simplification of treatment monitoring tools, cost reduction, adaptation of service delivery, and community mobilization. Against this background, it was possible to further mobilize and coordinate technical and financial resources, at global and local levels, helping countries to identify the bottlenecks and opportunities towards scaling-up access to ARV treatment. On the price reduction pillar, much discussion is still being undertaken, especially around availability and affordability of optimized drugs (fixed dose combinations) and entry into market (with affordable prices) of newer/innovative (second- and third-line) ARVs.
The levels of enforcement of intellectual property rights (patents) may have critical impact in fostering or hindering access to those products. As stated before, the Medicines Patent Pool plays an important role in facilitating licensing agreements with a public health-oriented (access) perspective. But other mechanisms must be put in place by individual countries, intergovernmental bodies, and even pharmaceutical companies (both originators and generics) to explore political options for scaling-up access to medicines. Some mechanisms are directly related to the use of the above mentioned TRIPS flexibilities, and the Doha Declaration offers directions12that could be taken by concerned stakeholders to protect public health. Moreover, other measures, which are not necessarily in close relation with intellectual property matters, such as, strengthening regulatory (quality assurance) capacity of local and regional agencies in developing countries, ensuring drug security, coordinating procurement supply management procedures and adapting services to more efficient care provision and drug delivery, should also be under the focus of policy makers and health providers, within the public, private and community sectors.
Current initiatives are on the lookout for synergizing these different driving aspects of access to HIV-related medicines. For instance, the African Union roadmap on Shared Responsibility and Global Solidarity for AIDS, Tuberculosis and Malaria, through its second pillar - “ensure accelerated access to affordable and quality assured medicines and health-related commodities as enshrined in the Pharmaceutical Manufacture Plan for Africa (PMPA)” - convene several stakeholders, including UNAIDS, around common objectives, such as: to promote investing in medicines manufacturers; to strengthen regional regulatory capacities and lay foundations for a continental regulatory agency; to develop essential skills on drug production and foster technological transfer, mainly through South to South cooperation; and create a legislative environment that incorporates the TRIPS flexibilities and avoid TRIPS-plus measures. With African Union Commission, NEPAD agency, UNIDO, UNDP, WHO, and other, UNAIDS is advocating for sustained political leadership to ensure the full implementation of the PMPA and the sovereignty of African countries to address their access to health needs.
More recently, UNAIDS, WHO, The Global Fund, and PEPFAR joined efforts to assist countries in achieving the 2011 United Nations Political Declaration on HIV/AIDS treatment targets, i.e., enrolling 15 million people under treatment until 2015. Recognizing the progresses made by countries in expanding ART coverage, but, at the same time, focusing on the existing bottlenecks in relation to key geographic settings and populations where rates of HIV transmission and unmet access needs are still high, the “Treatment 2015″13 initiative intends providing countries with a comprehensive framework to greatly scale-up ARV treatment.
The HIV epidemic has been the ground on which the global community is continuously advocating access to life-saving drugs, and, broader, access to health, as a fundamental human right. Every single person in this world, regardless his/her place of birth, must be offered the existing assured-quality treatment options, and governments, agencies, companies have to provide people with the conditions to make drugs available and affordable. All these initiatives converge to this same ultimate goal: no one will be left behind. The UNAIDS vision of “zero new infections, zero AIDS-related deaths, and zero stigma and discrimination” is led by the principle that the AIDS response cannot be dissociated from the Human Rights agenda, and, in this regard, it is based on the recognition that medicines are public goods and, therefore, the proprietary/private right must not prevail over the public interest.
1 UNAIDS. DOHA+10 - TRIPS flexibilities and access to antiretroviral therapy: lessons from the past, opportunities for the future. Geneva, 2011 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRIPS_en.pdf)
2 UNAIDS. Implementation of TRIPS and access to HIV medicines after January 2016: strategies and options for Least Developed Countries. Geneva, 2011 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2258_techbrief_TRIPS-access-medicines-LDC_en.pdf)
3 UNAIDS, UNDP. TRIPS transition period extensions for least-developed countries. Geneva,2013 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2013/JC2474_TRIPS-transition-period-extensions_en.pdf)
4 UNAIDS, UNDP. Issue brief: The potential impact of Free Trade Agreements on public health. Geneva, 2012. (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2012/JC2349_Issue_Brief_Free-Trade-Agreements_en.pdf)
5 Mohamed K. El Said. Public health related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and implementers in the Eastern Mediterranean Region. WHO and International Centre for Trade and Sustainable Development, Cairo, 2010
6 WHO; Commission on Intellectual Property Rights, Innovation and Public Health. Public health, innovation and intellectual property rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva, 2006
7 WHO. Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. Geneva, 2011
8 WHO. Research and Development to meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination. Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination. Geneva, April 2012
9 UNDP. Risks, Rights and Health. Report of the Global Commission on HIV and the Law. New York, July 2012
10 ‘t Hoen, E. Passarelli, C. The role of intellectual property rights in treatment access: challenges and solutions. Current Opinion on HIV/AIDS. 2013, 8:70â74
11 WHO, UNAIDS. The treatment 2.0 framework for action: catalysing the next phase of treatment, care, and support. Geneva. WHO, 2011. (http://whqlibdoc.who.int/publications/2011/9789241501934_eng.pdf)
12 Doha Declaration, Paragraph 6 and 7: (§) We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002. (§) We reaffirm the commitment of developed-country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66.2. We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.
13 Treatment 2015. Geneva, UNAIDS, 2013 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2013/JC2484_treatment-2015_en.pdf)
*Carlos Passarelli is Senior Expert Treatment at UNAIDS in Geneva. Prior to this, he was the Chief of the International Relations Advisory at the Oswaldo Cruz Foundation (FIOCRUZ) office in Brasilia. Dr Passarelli has a long career in HIV/AIDS programming, research and policy. He served as Chief of the International Cooperation Advisory of the National STD/AIDS/VH Department within the Brazilian Ministry of Health (MoH); Executive Director of the International Centre for Technical Cooperation on HIV/AIDS (ICTC); Deputy Executive Director of the National SDT/AIDS Programme within the MoH; and Project Officer at the Brazilian Interdisciplinary AIDS Association (ABIA).
He received a BA from the Institute of Psychology at the University of Sao Paulo, a Masters in Social Psychology from Catholic University of Sao Paulo, and a PhD in Clinical Psychology form Catholic University in Rio de Janeiro. He has published several articles on HIV/AIDS policy and access to ARVs in Brazil.