Remarks by UNAIDS Secretariat and on behalf of UNDP: Capacity building on the Paragraph 6 System and related TRIPS flexibilities

World Trade Organization
Council for TRIPS – Regular Session
Annual Review of Paragraph 6
Doha Declaration on the TRIPS Agreement and Public Health
Agenda item 4 – Capacity building on the Paragraph 6 System and related TRIPS flexibilities
Remarks by UNAIDS Secretariat and on behalf of UNDP
27 October 2010

Mr Chair, Distinguished Delegates

Allow me, at the outset, to express UNAIDS’ appreciation to the Council for the opportunity to observe today’s important meeting and to make this statement. At least two of the ten UNAIDS Cosponsoring agencies – WHO and UNDP – provide important technical expertise and action within our Joint United Nations Programme in the area of intellectual property and access to HIV medicines, and you have heard directly from WHO. I am here today representing the UNAIDS Secretariat and also on behalf of our Cosponsor, the United Nations Development Programme (UNDP).

Mr Chair, the work of UNAIDS and its co-sponsoring agencies is guided by the health related Millennium Development Goals (MDGs) with special attention to MDG 6 which is “to halt and reverse the spread and HIV, Malaria and other epidemics by 2015”. With AIDS the leading cause of death worldwide among women of reproductive age, and with the possibility of virtually eliminating mother-to-child transmission of HIV, an integrated approach to the AIDS response is also central to improving maternal and child health.

• We believe that this discussion by the Council for TRIPS is timely for a number of reasons:
• Treatment of HIV infection – antiretroviral treatment – is significantly reducing mortality for people living with HIV. At the end of 2009, 5.2 million people were on HIV treatment, a twelve-fold increase from 2003 when WHO and UNAIDS first launched the historic 3-by-5 Initiative. According to estimates, the total number of people for whom antiretroviral treatment is needed is approximately 15 million.
• The global economic crisis has begun to adversely affect prospective commitments to AIDS from both donors and low- and middle-income countries. For the first time in a decade, disbursements from donors for HIV/AIDS actually fell in 2009 from a high of US$7.7 billion one year earlier.
• The 2009 report of the inquiry of the United Kingdom’s All-Party Parliamentary Group on AIDS into long-term access to HIV medicines reports that we are sitting on “a treatment time bomb.” The cost of the least expensive first generation regimen has now dropped to less than $70 per patient, per year. But as increasing numbers of people move towards more efficacious and tolerable first line treatment regimens, some experts project drug prices to double compared to first generation regimens. As patients develop drug resistance and require more expensive and more highly patent-protected second- and third-line antiretroviral medicines, some projections see treatment costs escalating as much as twenty-fold.

In addition to the important work being undertaken by WHO, under the UNAIDS division of Labor UNDP is mandated to serve as the lead Cosponsor in providing support to governments to incorporate public health related TRIPS flexibilities into appropriate domestic legislation. In cooperation with WHO and on behalf of UNAIDS, UNDP has provided policy and technical support to countries reforming domestic intellectual
property legislation to incorporate public health related TRIPS.

The most recent example of UNDP’s work in technical cooperation on the Paragraph 6 system has been to provide assistance to civil society organizations advocating for a revised Access to Medicines Regime in Canada. As the Council has heard, Canada was the first country to amend its law to give effect to the August 30 2003 Decision. Bill C 393 has been proposed to streamline the practicability of the August 30 2003 Decision. Together with the Canadian HIV/AIDS Legal Network, in February 2010 UNDP coorganized consultations to explore opportunities to strengthen the CAMR. The focus of the discussions was on ensuring compliance of Bill C-393 with the TRIPS Agreement and on giving more flexible and rapid effect to the 30 August 2003 Decision. In addition, a UNDP staff member was invited by and appeared before the Canadian House of Parliament to provide technical information.

In 2003, UNAIDS welcomed the multilateral consensus among WTO Member States regarding access to affordable medicines for countries without sufficient manufacturing capacity in the pharmaceutical sector. We appreciated that the consensus covered public health problems in addition to AIDS, since people living with HIV are prone to a host of opportunistic infections – TB, cancers, fungal infections and others – and these
diseases are important health problems in themselves. UNAIDS urged that the arrangements under the 30 August Decision of the Council for TRIPS be implemented in the most flexible manner possible, so that countries could utilize the system easily and efficiently in their efforts to ensure greater access to HIV medicines for their peoples.

In reality very few importing countries have introduced provisions that would facilitate the use of the August 30, 2003 Mechanism. In 2007, UNDP provided assistance for the introduction of such provisions to legislators in Zanzibar, United Republic of Tanzania. The Industrial Property Act 4 of 2008 came into operation in the second half of that year and contains a number of important TRIPS flexibilities including the exclusion of
pharmaceutical patents until 2016 or such other time as might be agreed by WTO Member States. Similar technical assistance was provided by UNDP to other sub- Saharan African countries in the process of amending legislation.

UNDP has provided technical and policy support on the utilization of non-voluntary licenses under Article 31 of TRIPS. In partnership with the Intellectual Property Institute of Ecuador, UNDP held stakeholder consultations on compulsory licensing in Quito in March 2010. Similar assistance has also been provided to the government of Thailand through a WHO mission in 2008 in which resource persons from UNDP, UNCTAD and WTO participated to provide technical information with regard to the TRIPS Agreement.

Again on behalf of our Joint UNAIDS Programme, UNDP has provided capacity development activities to assist States to implement their intellectual property commitments made either through the process of acceding to the WTO or during free trade agreement negotiations (FTAs) obligations. Examples of such technical cooperation include a regional conference on access to essential medicines, HIV and intellectual property, held in Kiev in September 2009 organised by UNDP and the Open Society Institute.

UNDP has supported capacity development trainings for patents examiners focusing on the examination of pharmaceutical patents. Capacity development trainings have so far been carried out in Africa, the Arab States and Latin America.

In order to support our colleagues in the field in this complex technical area of work, UNDP, WHO and UNAIDS will be issuing in the coming days a joint briefing paper on the use of TRIPS flexibilities to improve access to HIV treatment.

Finally, Mr Chair, UNAIDS and UNDP have also provided technical and policy support to recipients of Global Fund Grants in using public health related TRIPS Flexibilities to increase the availability of affordable antiretroviral medicines. The procurement policy of the Global Fund, dating back to 2002, calls for Global Fund beneficiaries to obtain quality medicines at the lowest possible price and encourages grantees to utilize the TRIPS flexibilities to this end.

As donors face a period of extended financial uncertainty and understandably heighten their focus on accountability and value for money, UNAIDS expects continuing and even heightened interest in TRIPS flexibilities including the Paragraph 6 system.

On behalf of my Executive Director, Mr Michel Sidibé, who is following your deliberations closely, we would like to reiterate our appreciation to this distinguished Council for its strong engagement in public health issues including the response to AIDS, and of course to the WTO Secretariat for its close and always supportive collaboration.