Quito, Ecuador 22 – 24 April 2010
Organizations of the Latin American and Caribbean (LAC) – Global Alliance for Access to Medicines reaffirm their commitment to work to ensure universal access to medicines, in the belief that medicines are enabling factors for the full exercise of the right to life. The LAC –Global Alliance has identified old and new policies and processes, some of which enable access to medicines, while others sustain commercial privileges that become obstacles to the achievement of public interest outcomes. Access to medicines should not be subordinated to commercial interests.
1. The LAC-Global Alliance welcomes and supports the new initiatives of the governments of Ecuador and Colombia which are aimed at promoting competition and regulating the pharmaceutical market, as effective means to reduce medicine prices. The Ecuadorian government has issued a compulsory license for lopinavir-ritonavir (Kaletra), a medicine for the treatment of HIV that was previously sold under monopoly. The compulsory license offers significant savings that make it possible to expand treatment coverage and use capacity to attend to other health priorities. The Colombian government has issued Decree 1313, which authorizes parallel imports to overcome the high medicine prices being imposed by pharmaceutical companies. Both initiatives are legitimate and the sovereign application of flexibilities enshrined in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). They should be regarded as examples for countries of the region to follow, in order to improve access to medicines in accordance with governments’ efforts to achieve the Millennium Development Goals.
2. The LAC-Global Alliance rejects attempts to enact the so-called Anti Counterfeiting Trade Agreement (ACTA) , which, led by the governments of the United States, Japan, Switzerland and the EU, aims to set new global norms using a biased and malicious interpretation of the concept of counterfeiting. Implementation of ACTA would limit the production and free movement of legitimate generic products. This new agreement has been negotiated in secret since 2008, and only under the pressure of civil society organizations did the parties recently make the draft agreement public. ACTA presents a serious threat to access to medicines that could exceed even the current restrictions countries face under TRIPS and bilateral Free Trade Agreements (FTA’s). This agreement is being negotiated without the participation of countries in the region, even though they will inevitably affect them.
3. The LAC–Global Alliance expresses grave concern about ,and rejects the advancement of, trade agreements that include TRIPS-plus and TRIPS-extra provisions, including trade agreements with the United States and the European Union (EU). The Alliance also rejects pressures related to implementation of these agreements which are intended to impose greater restrictions on national laws and regulations. The Alliance is particularly concerned with the initiation of negotiations on the Trans Pacific Partnership Agreement (TPPA) as well as the EU negotiations with Central American countries. Both risk negative effects on public health and patients’ rights. The LAC-Global Alliance calls on governments, civil society and private companies in Central American countries to be alert to avoid the imposition of new provisions for intellectual property protection such as patent extensions, longer periods of data exclusivity, and enforcement measures, that could affect public health and access to medicines. Similarly, the LAC-Global Alliance calls on all governments in the LAC region not to accept any imposition on their national legislation that could further damage the public interest, particularly the right to health.
4. The failures of the Expert Working Group on Research and Development Financing established by the World Health Organization (WHO) are evident and unfortunate. This is a step backwards in implementing The Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property. We are disappointed and dismayed with the way that WHO has handled this issue. The LAC-Global Alliance is convinced that mechanisms to encourage innovation that de-link the cost of research and development (R&D) from the final price of products should be explored. Monopoly incentives cannot meet the needs for R&D of medicines, particularly for diseases that primarily affect developing countries. Therefore, we call on civil society organizations and governments to engage in a process aimed at setting international norms and standards for innovation, based on the health needs of the majority of the world’s population, including hitherto neglected diseases, to reach a global treaty on biomedical research and development. This should be put on the table for discussion at multilateral agencies such as WHO.
5. The LAC-Global Alliance calls on public and private agencies in countries of the region and multilateral agencies to develop initiatives to measure the impact of intellectual property protection on access to medicines, whether this impact is a result of the TRIPS Agreement, or of bilateral / regional and national laws arising from TRIPS, including the protection of clinical trial data. In particular we call upon the governments of the region to improve their procedures on patenting and protection of clinical trial data, in order to avoid granting undue exclusivity. Moreover, we encourage governments to explore initiatives to avoid any monopoly over medicines that are included in their essential medicines list or formularies.
6. The LAC-Global Alliance welcomes regional and sub-regional initiatives that seek new ways to protect, promote and defend the right to health. These should include innovative solutions that commit countries to put their pharmaceutical production and innovation capacity to work for the needs of regional populations, and provide real impetus to a true pro-innovation and development agenda, founded on and responsive to regional needs.
7. The Alliance notes that in the case of biotechnological health products, there is pressure on our governments to increase exclusivity and monopoly protection, with controversial regulatory requirements and the extension of intellectual property and data protection regimes that will limit market entry of competing medicines. We recommend governments approach any regulatory or intellectual property-related decisions on this matter with the utmost seriousness and independence, including through the participation of civil society to represent the interests of public health.
The LAC-Global Alliance urges governments of the region and political forces in its countries to remain vigilant toward attempts to establish new mechanisms that impede access to medicines. At the same time, the LAC-Global Alliance hereby offers its assistance and puts its technical knowledge at the service of relevant stakeholders toward developing initiatives that contribute to improving the health of populations.
Quito, Ecuador 22 – 24 April 2010
Acción Internacional por la Salud (HAI) Latin America and the Caribbean
Acción Internacional por la Salud (HAI) Bolivia
Acción Internacional por la Salud (HAI) Ecuador
Acción Internacional por la Salud (HAI) Peru
Federación Médica de Colombia – OBSERVAMED
FarmaMundi – Spain
IFARMA Foundation – Colombia
Health Action International (HAI) Europe
Knowledge Ecology International (KEI), United States
Mision Salud, Colombia
Medicines Sans Frontieres(MSF)-Brazil
Public Citizen, United States
Peruvian Network for Fair Globalisation-RedGE
Red Brasilera por la Integración de los Pueblos-REBRIP Brasil