United States (US)

Access to medicines: US democrat lawmakers oppose intellectual property rules in the USMCA restraining access to affordable biosimilars

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.

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Policy Brief 65, July 2019

Time for a Collective Response to the United States Special 301 Report on Intellectual Property

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.

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Research Paper 92, March 2019

Notification and Transparency Issues in the WTO and the US’ November 2018 Communication

Various WTO Members submitted a Communication to the WTO in November 2018 which, if accepted, would affect the implementation of Members’ transparency and notification obligations at the WTO. It would strengthen the already burdensome notification obligations and introduce new punitive administrative measures should obligations not be complied with. This paper provides information about WTO Members’ current notification obligations and their level of compliance; looks at the history of discussions on notifications, particularly in the Working Group on Notification Obligations and Procedures which took place in  1995 – 1996; and provides an analysis of the Communication. The analysis focuses on the extent to which the elements are consistent with or go beyond the current WTO disciplines. It concludes that non-compliance with notification obligations is real. However, rather than expanding obligations and introducing punitive measures, constructive and effective solutions should be based on nuancing of obligations in the context of a Special and Differential Treatment approach and through the use of incentives. It also acknowledges that countries with a chronic lack of capacities will continue to struggle with the WTO’s complex notification obligations and requirements until they attain higher levels of development and, thus, improved institutional capacities.

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SC Working Lunch, March 2019

Title:               Working Lunch Meeting on E-Commerce

Date:                Friday, 15th March, 2019, 12:00 – 14:45

Venue:             The South Centre

Organizers:     The South Centre 

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Policy Brief 58, March 2019

Why the US Proposals on Development will Affect all Developing Countries and Undermine WTO

US submitted two highly problematic proposals to the WTO in January and February 2019, undermining the place of Special and Differential Treatment (S&D) for developing countries at the WTO. In the first paper (WT/GC/757), US criticises the practice of self-declared development status by developing countries arguing that the North-South construct no longer makes sense due to “great development strides”. The second paper (WT/GC/764) – a proposed Decision for the General Council – provides a way to operationalise what was in the first paper. It gave criteria that would exclude 34 Members or 53.6 percent of global population from S&D treatment in “current and future WTO negotiations”. This fundamentally changes S&D from an unconditional right for all developing countries to a concession that may or may not be provided. Even for those developing countries that are not part of the 34 excluded Members, the US notes that in sector-specific negotiations, other Members could also be “ineligible for special and differential treatment.” This paper critiques the US approach on Special and Differential Treatment and concludes that these papers by the US cannot be the basis for any further discussions. All developing countries must be able to decide the pace of their adjustment to trade rules.

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