Antivirales de acción directa para la Hepatitis C: evolución de los criterios de patentabilidad y su impacto en la salud pública en Colombia
Por Francisco A. Rossi B. y Claudia M. Vargas P.
La hepatitis C en el siglo XXI y el VIH en el final del siglo XX han representado los más relevantes retos de salud pública para la comunidad internacional. No solamente por ser enfermedades infecciosas y transmisibles (razón de ser de la salud pública) sino por su carácter mortal si no se recibe tratamiento de manera oportuna. En Octubre de 2015, la fundación IFARMA solicitó que todos los medicamentos antivirales para la hepatitis C, utilizables para curar una infección crónica transmisible potencialmente mortal, fueran declarados de interés público, dado que su precio amenazaba la sostenibilidad financiera del sistema de salud. Una declaración de interés público para estos medicamentos sería el primer paso para la emisión de licencias obligatorias. Este trabajo se ha llevado a cabo para identificar las patentes existentes en Colombia para estos productos, su alcance y sus consecuencias, en el marco de una discusión sobre la transparencia del sistema de patentes y la evolución del rigor con que se evalúan las solicitudes y se conceden las patentes.
Inequality is one of the greatest challenges that the world needs to face. Inequality is intimately linked with poverty. Although there has been progress in reducing poverty, a large part of the global population (overwhelmingly living in developing countries) is still denied access to a dignified life. While no poverty and reduced inequality are two of the outstanding Sustainable Development Goals, these and other goals are unlikely to be achieved by 2030. In fact, inequality is on the rise. Changing this situation will certainly require significant efforts at the national and regional level. But it also requires an international architecture that supports those efforts by respecting the policy space that countries need and coordinating constructive actions within the multilateral system. The current initiatives to ‘reform’ this system will only be legitimate if they recognize the gaps in the levels of development and contribute to effectively address them under a fair, pro-development system of rules. Please see last month’s SouthViews on “Understanding global inequality in the 21st century” by Jayati Ghosh, development economist and Professor of Economics at Jawaharlal Nehru University.
Access to medicines: US democrat lawmakers oppose intellectual property rules in the USMCA restraining access to affordable biosimilars
On July 11, 2019, US democrat lawmakers signed a letter addressed to US Trade Representative Robert E. Lighthizer, expressing strong opposition to provisions that limit access to medicines in the United States-Mexico-Canada Agreement (USMCA). They are requesting to amend the USMCA to increase competition and enhance patient access to more affordable prescription drugs, particularly biosimilars. The current USMCA text would limit Congress’ ability to adjust the biologics exclusivity period, locking the US into policies that keep drug prices high while exporting this model to Mexico and Canada. Below is a link to the letter.
Le 11 juillet 2019, représentants démocrates du Congrès américain ont signé une lettre adressée à Robert E. Lighthizer, le représentant américain au commerce, exprimant leur forte opposition aux dispositions de l’Accord conclu entre les États-Unis, le Mexique et le Canada, qui limitent l’accès aux médicaments. Ils demandent que les dispositions de l’Accord soient modifiées afin de favoriser davantage la concurrence et de faire en sorte que les patients puissent accéder à des médicaments sur ordonnance à un coût abordable, en particulier les médicaments biosimilaires. Le texte actuel de l’Accord a pour conséquence de limiter la capacité du Congrès à ajuster la durée de la période d’exclusivité pour les médicaments biologiques, enfermant les États-Unis dans une politique tendant à maintenir le prix des médicaments à un niveau élevé tout en exportant le modèle au Mexique et au Canada. Vous trouverez ci-dessous le lien sous lequel la lettre peut être consultée.
El 11 de julio de 2019, legisladores demócratas de los Estados Unidos firmaron una carta dirigida al representante de Comercio de los Estados Unidos, Robert E. Lighthizer, expresando su firme oposición a las disposiciones que limitan el acceso a medicamentos en el Tratado entre México, los Estados Unidos y el Canadá (T-MEC). Solicitan modificar el T-MEC para aumentar la competencia y mejorar el acceso de los pacientes a medicamentos con receta más asequibles, especialmente a los biosimilares. El texto actual del T-MEC limitaría la capacidad del Congreso para adaptar el período de exclusividad de los medicamentos biológicos, lo que obligaría a los Estados Unidos a establecer políticas que mantengan altos los precios de los medicamentos mientras se exporta este modelo a México y al Canadá. A continuación, se encuentra un enlace a la carta.
Mainstreaming or Dilution? Intellectual Property and Development in WIPO
By Nirmalya Syam
In 2007 Member States of the World Intellectual Property Organization (WIPO) unanimously adopted a set of 45 recommendations which constitute the WIPO Development Agenda. Developing countries sought to give new direction to WIPO through the Development Agenda, away from the pursuit of facilitating and strengthening protection, acquisition and enforcement of intellectual property (IP) rights as an end in itself towards an approach that would be sensitive to the impact of IP on development, both in terms of opportunities as well as costs. This paper explores whether development considerations have been adequately addressed by WIPO since its creation as the United International Bureau for the Protection of Intellectual Property (BIRPI) in the nineteenth century. The paper also analyses whether the implementation of the WIPO Development Agenda adopted in 2007 has shaped the current vision of the WIPO Secretariat and its Member States to address the impact of IP on development; and whether implementation of the Development Agenda has facilitated the use of IP law and policy as a tool that responds to advancing innovation, industrial, health, agricultural, education and other development policies in developing countries. The paper finds that the approach towards IP in WIPO continues to be dominated by a perspective that pursues acquisition, protection, management and enforcement of IP rights as an end in itself. Conflicting interpretations of development orientation have adversely impacted the implementation of the Development Agenda in the spirit in which the developing countries had proposed the Development Agenda. The paper recommends developing countries to undertake cross regional coordination to enhance their level of engagement on IP and development, advance specific suggestions for achieving greater impact on addressing development challenges through specific activities including projects in the areas of technical assistance as well as norm-setting, pursue governance reforms in WIPO to ensure greater representation of developing countries in the decision making bodies of WIPO and in the staff composition of the WIPO Secretariat, amend the WIPO Convention to align its mandate on IP promotion to the development needs and challenges of its Member States and the development goals of the United Nations (UN), and also pursue a review of the relationship between the UN and WIPO as a UN specialized agency in the UN Economic and Social Council.
Time for a Collective Response to the United States Special 301 Report on Intellectual Property
By Viviana Muñoz-Tellez, Nirmalya Syam and Thamara Romero
This policy brief discusses the annual Special 301 report issued by the Office of the United States Trade Representative (USTR). The report is a unilateral tool of the US to pursue its foreign intellectual property (IP) policy by exerting pressure on countries to reform their IP laws and practices. Developing countries are particularly susceptible to this threat. The report identifies countries that are considered by the US as not providing adequate and effective protection of IP of rights holders from the US. The selection of countries is biased to the concerns raised by segments of the US industry. The report targets balanced provisions in countries’ legislations to ensure that IP rights do not hinder the ability of the government to adopt measures for promoting development priorities, particularly in the area of public health. A uniform and collective international response by the affected countries is long overdue. The way forward is to continue dialogue in appropriate multilateral fora, recognizing the need for all countries to maintain policy space to use IP as a domestic policy tool.
The USMCA must be amended to ensure access to affordable drugs in Mexico
By Maria Fabiana Jorge
The intellectual property rights (IPRs) chapter of the U.S.-Mexico-Canada-Agreement (USMCA) grants longer and broader monopolies to originator pharmaceutical companies than those currently in force in Mexico, at the expense of patients and taxpayers. Among other things, Mexico would be required to provide patent term extensions both for delays in the granting of patents and for those incurred in the regulatory approval process, broader and longer exclusivity periods, including for expensive biologic drugs, as well as to adopt broader patentability standards, for example by requiring the granting of patents for new uses. Mexico is, without doubt, the country in the USMCA that will be most negatively impacted, but if the Democratic Members of the US House of Representatives are able to renegotiate some of these provisions to restore some balance between the need to foster innovation and competition, the Administration of President López Obrador and the Mexican Congress can still make a difference.
Title: Regional training for patent office representatives
Date: 4 June, 2019
Venue: Kyiv, Ukraine
Organizers: The South Centre, International Treatment Preparedness Coalition (ITPC Global), Scientific Research Institute of Intellectual Property (National Academy of Law Sciences of Ukraine) and All-Ukrainian Network of People Living with HIV
The US-Mexico-Canada Agreement: Putting Profits Before Patients
By Maria Fabiana Jorge
In the US-Mexico-Canada Agreement (USMCA, NAFTA 2.0), the U.S. Trade Representative negotiated intellectual property provisions related to pharmaceuticals that would enshrine long and broad monopolies. This policy brief focuses primarily on the negative effects of the USMCA intellectual property provisions on access to medicines in the U.S. Such effects may be even worse for Canada and Mexico. The impact of this trade agreement goes well beyond the three countries involved as this is the first one negotiated by the Trump Administration and is likely to set a precedent for future trade agreements. A careful review of the USMCA text raises very serious concerns about the impact that this agreement would have on the generic/biosimilar industry and therefore on access to more affordable drugs throughout the world.
Access to Medicines: Experiences with Compulsory Licenses and Government Use – The case of Hepatitis C
By Dr. Carlos M. Correa and Dr. Germán Velásquez
This South Centre research paper discusses first, the limitations of the current research and development (R&D) model and its implications for access to medicines. Second, it considers the tension between intellectual property rights applied to medicines and States’ observance of the fundamental right to health. Third, it examines the case of access to medicines for the treatment of Hepatitis C, illustrating the barriers to access created by intellectual property and the high prices normally associated with its exercise. Fourth, it presents the background, main aspects and obstacles to the achievement of the objectives of the Doha Declaration on the TRIPS Agreement and Public Health (2001). To conclude, this paper examines the experiences of compulsory licensing and government use of patents in Latin America (particularly in Ecuador, Peru and Colombia).
The ‘obvious to try’ method of addressing strategic patenting: How developing countries can utilise patent law to facilitate access to medicines
By Olga Gurgula
The current patentability standards for pharmaceutical inventions, as well as strategic patenting used by pharmaceutical companies, have substantially impacted access to affordable medicines. This has been especially detrimental for developing countries, which are under significant pressure to remain compliant with their international and bilateral obligations, while also providing their people with essential drugs. In order to improve access to medicines, developing countries may choose from a range of various mechanisms that may help to facilitate such access, while also allowing them to remain compliant with their international and bilateral obligations. This policy brief suggests that one of such mechanisms is to strengthen the obviousness requirement by applying the ‘obvious to try with a reasonable expectation of success’ test to pharmaceutical follow-on inventions. It is argued that the application of this test may be an effective tool in addressing the negative effect of strategic patenting. It may help to prevent the extension of patent protection and market exclusivity of existing drugs by pharmaceutical companies and, as a result, may open such medicines up to generic competition.
