Concept Note UNDP/OSI meeting on Access to Essential Medicines and Intellectual Property Rights 21-22 September 2009 Kiev, Ukraine Background As of August 2008, an estimated 33 million people were living with HIV and AIDS globally with approximately 7500 new infections occurring every day.1 Yet only three and a half million people living with HIV who need treatment are receiving antiretroviral therapy, leaving 69 percent of those who need treatment without access.2The situation is significantly worse for the more than 2 million children under the age of 15 living with HIV. While 780 000 children living with AIDS need ARVs, only 15% are receiving treatment. Approximately 1.5 million people are living with HIV and AIDS in Eastern Europe and Central Asia, 90 percent of whom live either in the Russian Federation or Ukraine.3 Of the 320 000 people requiring antiretroviral therapy in the region, only 54 000 or approximately 17% are receiving it. 4 This coverage rate is only half of the global rate. In addition, the number of people living with HIV in the region has more than doubled in the space of a mere 7 years. The cost of antiretroviral therapy, particularly regarding those medicines that are under patent, remains a major barrier to universal access. Eastern Europe and Central Asia is likely to be one of the most affected regions in the world5. As the effects of the crisis begin to emerge, the existing ARV coverage rates – which are already insufficient – will be difficult to sustain. National health budgets in the region are expected to face significant cuts beginning in 2010; and the normally reliable support from the Global Fund will be put to the test as well. An across the board 10 percent cut in funding for all Round 8 Global Fund grants may not be the last reduction in funds available treatment of AIDS. Lower prices are essential if governments and donor agencies are to meet the lifelong commitment to keeping patients on antiretroviral therapy, and ensure the sustainability of treatment programmes as the number of people living with HIV in need of treatment grows.6 The utilization of both pre and post-grant TRIPS flexibilities can also play a key role in increasing the supply and availability of more convenient forms of dosing. The obstacles to achieving universal access to the essential medicines for priority diseases are multifaceted and exist at the national, regional and international levels. The most significant barriers include restrictive international and domestic intellectual property laws and the inability of countries to implement manufacturing solutions to address high prices, whether due to a lack of sufficient manufacturing capacity or the correspondingly high prices of raw pharmaceutical materials.
‘UNAIDS Report on the global AIDS epidemic’, August 2008. http://data.unaids.org/pub/GlobalReport/2008/JC1511_GR08_ExecutiveSummary_en.pdf 2 Clinton Foundation HIV/AIDS Initiative, ‘Paediatric Treatment Program 2008 Performance Report’ March 2009. See also WHO, UNAIDS and UNICEF (2008) Towards Universal Access: Scaling up Priority HIV/AIDS Interventions in the Health Sector: Progress Report 2008 WHO, Geneva at: http://www.who.int/hiv/pub/towards_universal_access_report_2008.pdf Since 2002, the expanded provision of antiretroviral therapy in low and middle income countries has resulted in an estimated gain of 3.2 million life years in people living with HIV. 3 Ibid 1. 4 Towards universal access: scaling up priority HIV/AIDS interventions in the health sector: progress report 2008, WHO/UNAIDS/UNICEF, June 2008. 5 IMF World Economic Outlook, April 2009
The number of people who need HIV treatment globally is projected to increase from approximately 11 million in 2007 to over 12 million in 2012 derived using Spectrum package using data in the 2008 Report on the Global AIDS Epidemic UNAIDS, Geneva) at http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp.
The introduction of generic ARV medicines has greatly reduced the cost of treatment from more than US $10,000 per patient per year ten years ago to as little as US $90 per patient per year by the end of 2007.7 However, emerging drug resistance has led to the introduction of more sophisticated, and consequently, more expensive second line ARVs which, cost Least Developed Countries (LDCs) on average more than nine times the price of first line therapies. According to MSF, the first line combination therapy of 3TC/d4T/NVP cost on average $ 99 per patient per year while a second line therapy of TDF/3TC/LPV/r cost LDCs on average $ 926 per patient per year and non LDCs, $ 1 426. 8 The need for second line ARVs (and potentially third line ARVs in future) should provide a strong incentive for developing countries to utilize TRIPS flexibilities as a way of promoting generic competition and keeping the cost of treatment as low as possible. The utilization of TRIPS flexibilities may continue to be important even for access to first line ARVs because it is likely that international treatment guidelines will soon be revised to recommend that treatment begin at higher CD4 counts than is now the norm in developing countries. Depending on the final recommendations to emerge, this could double the number of individuals for whom treatment is indicated, which in turn could lead to serious financial constraints if prices of first-line therapy do not remain low. This development, coupled with the already discussed need for second (and potentially third) line regimens makes it all the more urgent for countries to utilize TRIPS flexibilities as a way of reducing prices and promoting access to treatment. Primarily as a result of setbacks in multilateral trade negotiations, recent years have seen a proliferation of bilateral trading agreements which routinely place intellectual property protection obligations on contracting states that exceed those contained in the TRIPS Agreement. Typically, this has adverse implications on the prices of essential medicine. Table 1 below illustrates which of the Commonwealth of Independent States (CIS) countries are in the process of negotiating Free Trade Agreements (FTAs) that could have an adverse impact on essential medicine prices and those that are involved in negotiations to accede to the WTO, which also could result in intellectual property protection exceeding what is required by the TRIPS Agreement: Table 1 Country Armenia Azerbaijan Belarus Estonia Georgia Kazakhstan Kyrgyzstan Latvia Lithuania Moldova Russia Tajikistan Turkmenistan
WTO member? Y Joining Accession unclear Y Y Accession unclear Y Y Y Y Accession unclear Joining N
Member of EU? N N N Y N N N Y Y N N N N
EUFTA? Being studied Being studied N NA Being studied N N NA NA N N N N
EFTA? N N N N N N N N N N Negotiating N N
This is the lowest price available for a combination of AZT, 3TC & NVP which is recommended by the WHO. Refer to the WHO global Price Reporting Mechanism report of October 2007. http://www.who.int/hiv/amds/GPRMsummaryReportOct07.pdf 8 th Médecins sans Frontières (2007). Untangling the Web 10 version, p 7, available online at: http://www.accessmed-msf.org/fileadmin/user_upload/diseases/hiv-aids/Untangling_the_Web/UTW10_RSep_horizontal.pdf
Source: Sanya Reid Smith, Third World Network Some examples of “TRIPS plus” provisions commonly found in free trade agreements and which have negative consequences on access to medicines include: A limitation on the circumstances under which compulsory licenses on pharmaceutical patents may be issued; Extending the minimum period of patent protection beyond the 20 year minimum requirement of TRIPS, which could delay the introduction of generic pharmaceuticals into a domestic market; Requiring Drug Regulatory Authorities, (DRAs) most of whom have a limited expertise of patents, to consider the patent status of drugs before granting marketing authorization to generic manufacturers, which slows down the introduction of key medicines into domestic markets; and Restrictions on the use of data on pharmaceutical products submitted to drug regulatory authorities which generic companies traditionally rely on to prove the efficacy and safety of their products, which significant slows down the registration of generics in some countries;
Aims, Objectives and Subject Matter of Meeting The meeting will centre on the three following pillars: (i) (ii) (iii) the implications of FTA negotiations on public health and access to essential medicines; the possible ramifications of WTO accession negotiations on intellectual property and access to essential medicines in the CIS; and How the utilization of public health related TRIPS flexibilities can be used as a tool to reduce essential medicine prices in the region.
Modalities To provide a platform for discussions at the meeting, a research document has been commissioned by UNDP. The document, currently being written by an expert in intellectual property and public health, will provide information on the following: The extent to which the CIS countries participating in the meeting have incorporated public health-related TRIPS flexibilities into their intellectual property legislation; What the potential implications of countries in the region signing FTAs (either with the EU or the EFTA countries) which contain TRIPS plus provisions may be; and What the potential public health implications of WTO accession negotiations may be for those CIS countries that are undertaking or considering WTO accession negotiations.
The research paper will be practical in nature and will focus on actual rather than perceived opportunities and threats for access to essential medicines in the region as much as possible. The paper will be translated into Russian and disseminated to the meeting participants in advance of the meeting as a background paper.
The joint UNDP/OSI meeting will be held in September 21-22 in Kiev, Ukraine at the President Hotel and will target participants from Armenia, Azerbaijan, Georgia, Kazakhstan, Russia, Tajikistan and Ukraine. These countries have been identified because according to table 1, they are undertaking or seriously considering either FTA or WTO accession negotiations. From each country, 2-3 civil society representatives (preferably with experience in public health, law or human rights and transparency) and 2-3 government representatives from the Ministry of Health as well as the Ministry responsible for trade negotiations (usually Trade and Industry or Foreign Affairs) will be invited to participate. The meeting will be held over two days. The first day will comprise a plenary format with presentation and discussion focusing on intellectual property and public health, recent international developments on intellectual property and the implications of TRIPS plus negotiations on public health. The second day will comprise 2 parallel sessions, one for government officials and another for civil society groups, during which issues of interest to the two groups will be discussed in detail, and a concluding plenary. One session the second day may bring country teams together to discuss specific national situations and needed domestic next steps. The meeting will be jointly funded by the UNDP Regional HIV/AIDS Practice for Europe and the CIS, OSI and UNDP’s HIV/AIDS Practice in New York. Partnerships The co-organisers of the meeting will approach the WHO Regional Office for Europe and UNAIDS to ascertain their interest in participating in the meeting. WHO (Geneva) and the European Regional Support Team of UNAIDS will also be invited to participate. The Eurasian Harm Reduction Network (EHRN) and the Eastern European and Central Asian Union of PLWH (ECUO) will also be asked to participate in the meeting. Resource people As this will be the first regional meeting of its kind in the CIS, it is important to secure the participation of key international experts in the meeting as resource people. Pedro Roffe, Senior Fellow, International Centre for Trade and Sustainable Development has been approached to facilitate the meeting. In addition to the consultant responsible for writing the paper, other key international experts on intellectual property, free trade agreements and WTO accession that will be invited include: 1. Dr. Germán Velásquez Director, WHO Secretariat on Public Health, Innovation and Intellectual Property, World Health Organization, Geneva 2. Professor Sean Flynn Associate Director, Program on Information Justice and Intellectual Property 3. Juliana Vallini from the Government of Brazil 4. An official from a country that has conducted a bilateral negotiation where intellectual property was a negotiation issue.