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.
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.
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.
The Use of TRIPS Flexibilities for the Access to Hepatitis C Treatment
By Dr. Germán Velásquez
In late 2013, a new Hepatitis C treatment called direct-acting antivirals (DAAs) was introduced in the market at unaffordable prices. The eradication of the disease is possible if medicines can be purchased at AFFORDABLE prices within health budgets. IF THIS IS NOT THE CASE, governments should consider the use of the TRIPS flexibilities to facilitate access to the treatment.
Statement by the South Centre to the Third High-Level Meeting on the Prevention and Control of Non-Communicable Diseases
Below is the statement by the South Centre to the Third High-Level Meeting on the Prevention and Control of Non-Communicable Diseases (NCDs) during the 73rd session of the United Nations (UN) General Assembly held on 27 September 2018 at the UN headquarters in New York.
Statement by the South Centre at the High Level Meeting on the Fight to End Tuberculosis
Below is the South Centre statement at the High Level Meeting on the Fight to End Tuberculosis during the 73rd session of the United Nations (UN) General Assembly held on 26 September 2018 at the UN headquarters in New York.
The South Centre is pleased to announce that it is scaling up its services to developing country governments in the area of intellectual property rights and public health, thanks to the support of Unitaid. The project “Expanding the use of TRIPS flexibilities to promote affordable access to medicines” will allow the South Centre to roll out a number of training activities at regional and national level and a global advisory service on the use of TRIPS flexibilities for public health.
