Access to Medicines

Research Paper 190, 24 January 2024

Implementing the Doha Declaration in OAPI Legislation: Do Transition Periods Matter?

By Patrick Juvet Lowé Gnintedem

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provided for a number of transition periods allowing countries to engage in a phased implementation of their TRIPS obligations. More specifically, transition periods targeted the patenting of pharmaceutical products. The original deadlines for transition periods have expired for developed and developing country WTO members. However, based on the Doha Declaration on the TRIPS Agreement and Public Health and subsequent TRIPS Council decisions, least developed countries (LDCs) continue to benefit from extended transition periods. In the African Intellectual Property Organization (OAPI), after an amendment in 1999, the legal framework has evolved with the amendment of the Bangui Agreement, i.e., the Act of Bamako of 14 December 2015. As for the previous text, the newly amended Bangui Agreement consecrates the unification on industrial property amongst its seventeen Member States. The main objective of such an amendment remains to adapt its legal framework to the international environment and to the economic and social development needs of Member States. Yet only five OAPI Member States are developing countries; the twelve others are LDCs. Then the question arises: do transition periods consecrated pursuant to the Doha Declaration still matter for LDCs who have agreed to be subjected to the OAPI legislation? This paper points out that transition periods remain relevant in OAPI countries by application of the more favorable rule between the Bangui Agreement and the WTO TRIPS Council decisions. It is however noted that the OAPI current legal framework is still problematic, while its LDCs members are underutilizing this flexibility.

(more…)

Research Paper 188, 7 December 2023

The Intersection Between Intellectual Property, Public Health and Access to Climate-Related Technologies

By Lívia Regina Batista

On the 20th anniversary of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health adopted by the World Trade Organization, we realize that its impact is beyond issues of public health stricto sensu. The Doha Declaration has inspired discussions at the Council for TRIPS regarding access to climate-related technologies. Climate change is the main and most globalized environmental problem with adverse effects on public health, especially for the vulnerable communities in the Global-South. The main argument of the proponents of the discussion in the TRIPS Council is the need to rebalance public interests (such as public health and environmental/climate issues) with the private/economic interests of the most powerful countries and corporations. This debate addresses both the recognition of intellectual property rights as an important means for the promotion of technological innovation, and the required wider dissemination of technologies – be they medicines or climate-related technologies. This research paper explores the possibilities that the TRIPS Agreement and the Doha Declaration create for international transfer of climate-related technologies. Even though such discussions on climate-related technologies have initially failed in linking climate change and public health, as well as the rhetoric of human rights, the relevance of the topic remains. Besides that, the response to public health issues also must learn from the experience in climate change, such as the case studies evidencing the insufficiency and inefficiency of fast-tracking programs to provide for a wider dissemination of technologies – which have now been widely replicated to address the COVID-19 pandemic. Such comparison can also be an entrance point to discuss the public health implications for the international regime on climate change, highlighting that such issues are deeply intertwined, and need to be addressed jointly as well.

(more…)

Documento de investigación 186, 14 de noviembre de 2023

Patentamiento de anticuerpos monoclonales. El caso de Argentina 

Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini

Este documento de investigación tiene como objeto identificar, describir y analizar las patentes concedidas por el Instituto Nacional de la Propiedad Industrial (INPI) de Argentina, en materia de anticuerpos monoclonales desde el año 2010 al 2020 inclusive. La investigación incluye la materia protegida y el universo de solicitantes, entre otros aspectos. Para ello, se procedió a construir una base de datos de patentes y solicitudes, donde se examinan las características de las patentes solicitadas y concedidas, titularidad y nacionalidad de los solicitantes, estado de las solicitudes, tiempo que demora la resolución de una patente solicitada y patentes divisionales. El documento presenta también recomendaciones de política pública aplicables a las patentes sobre anticuerpos monoclonales.

(more…)

SC Statement – Colombia, Dolutegravir, 3 de octubre de 2023

Colombia declara de interés público el uso de patente sobre Dolutegravir para incrementar el acceso a tratamiento a personas que viven con HIV

3 de octubre de 2023

El South Centre, el organismo intergubernamental de 55 países en desarrollo, celebra la decisión del Gobierno de Colombia de hacer uso gubernamental no comercial de una patente con el objetivo de garantizar que las personas que viven con VIH reciban tratamientos basados en Dolutegravir (DTG). Estos tratamientos son financiadas con recursos públicos asignados a la salud.

(more…)

Research Paper 184, 15 September 2023

Promoting Jordan’s Use of Compulsory Licensing During the Pandemic

By Laila Barqawi  

This paper addresses the difficulties in utilizing Article 31 bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) on compulsory licensing for the export of pharmaceuticals during the pandemic through the case study of Jordan. This paper also recommends that Jordanian officials seek to capitalize on the pandemic whilst the Jordanian Defense Law and Orders are in effect to include Emergency Use Authorization (EUA) as a direct ground for applying compulsory licensing, introduce clauses similar to those introduced by countries who have signed FTAs with the US, as well as deactivate harmful clauses within its national laws that prevent the application and utilization of a compulsory license. Further, Jordanian officials should seek the opportunity, considering the change of stance of the Biden administration towards compulsory licensing, to re-negotiate favourable terms in the Jordanian – US Free Trade Agreement (JUSFTA). Moreover, Jordanian officials should also form a syndicate that calls for the overhauling of TRIPS at Article 31 bis when an EUA is invoked in any country.

(more…)

Research Paper 180, 9 August 2023

Neglected Dimension of the Inventive Step as Applied to Pharmaceutical and Biotechnological Products: The case of Sri Lanka’s patent law

By Ruwan Fernando

Apart from the basic statutory definition in section 65 of the Intellectual Property Act of Sri Lanka, there do not appear to be any detailed statutory guidelines or judicial decisions to provide any framework for the assessment of inventive step in Sri Lanka. The current statutory definition is highly insufficient to evaluate the standard of obviousness in relation to biotechnological and pharmaceutical claims based on a combination or modification of a prior art reference.

The Courts in both developed and developing countries have adopted a variety of tests to evaluate the obviousness standard of a claimed invention based on a combination or modification of a prior art reference. Sri Lanka, as a developing country, should look at the development that has taken place in other jurisdictions and adapt the patent law to local conditions when developing tests or guidelines in a manner that is compatible with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its biotechnology/pharmaceutical policy guidelines.

This approach that is appropriate to Sri Lanka is twofold. First, it is most likely to prevent the issuance of patents on trivial or incremental inventions that do not provide any technical advance to the existing prior art and are a mere extension of what is already known in the prior art. Second, it is most likely to protect genuine technical advances to the existing prior art while at the same time enhancing competition and promoting local innovations so that the local researchers will be able to draw on the existing knowledge for the purpose of follow-on innovations.

(more…)

Informe Sobre Políticas 120, 11 de julio de 2023

Hacia una Agencia Latinoamericana y del Caribe de Medicamentos (AMLAC)

Por Germán Velásquez

El 26 de abril de 2023 en Acapulco, México, las Autoridades Reguladoras de Medicamentos de Colombia (INVIMA), Cuba (CECMED) y México (COFEPRIS) firmaron la “Declaración de Acapulco” para la creación de la Agencia Latinoamericana y del Caribe de Regulación de Medicamentos y Dispositivos Médicos (AMLAC). Esta declaración fué confirmada en Bogotá, Colombia el 16 de junio de 2023 en una reunión titulada “Convergencia regulatoria” por los responsables de las agencias reguladoras de medicamentos de Argentina, Brasil, Chile, Colombia, Cuba y México que acordaron la creación progresiva de una Agencia Latinoamericana y del Caribe de Medicamentos -AMLAC-.

La AMLAC fué creada para contribuir a la integración regional a través de la armonización y convergencia en materia de regulación sanitaria, la creación de un mercado regional de medicamentos en busca del acceso a medicamentos y dispositivos médicos seguros, eficaces y de calidad.

(more…)

Policy Brief 120, 11 July 2023

Towards A Latin American and Caribbean Medicines Agency (AMLAC)

By Germán Velásquez

On 26 April 2023 in Acapulco, Mexico, the Medicines Regulatory Authorities of Colombia (INVIMA), Cuba (CECMED) and Mexico (COFEPRIS) signed the “Declaration of Acapulco” for the creation of the Latin American and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC). This declaration was confirmed in Bogota, Colombia on 16 June 2023 in a meeting called “Regulatory convergence” by the heads of the medicines regulatory agencies of Argentina, Brazil, Chile, Colombia, Cuba and Mexico who agreed on the progressive creation of a Latin American and Caribbean Medicines Agency (AMLAC).

AMLAC was created to contribute to regional integration through harmonisation and convergence in health regulation, the creation of a regional medicines market in pursuit of access to safe, effective and quality medicines and medical devices.

(more…)

SC Statement to Resumed INB5, 12 June 2023

South Centre Statement to the Resumed session of the fifth meeting of the Intergovernmental Negotiating Body (INB) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response

12 June 2023

The South Centre appreciates the opportunity to address this INB. We remain available, here in Geneva or online, to present our views on specific draft provisions.

We recognise the work advanced so far.

In the Bureau text, not all options are yet on the table. All Member State proposals, existing and new ones as they come, should receive proportionate consideration, inclusion and discussion.

The consolidated text of February should remain complementary to the Bureau text.

There must be balance in providing options under various articles and in the approach for legal language under them. The Bureau text as it stands now would not deliver on equity.

The INB is moving towards consensus on principles of equity, solidarity, common but differentiated responsibilities, transparency and respect for human rights. We also support the proposal for a principle on global public goods. The INB needs now to better translate these principles into concrete legal provisions in the text.

The drafting group during this session of the INB could focus discussion on Articles 9 to 13 of the Bureau text, also drawing from the consolidated text.

(more…)

Research Paper 178, 22 May 2023

A Response to COVID-19 and Beyond: Expanding African Capacity in Vaccine Production

By Carlos M. Correa

The unequal global distribution of vaccines against the deadly COVID-19 virus has cast a spotlight on the lack of access to vaccines on the African continent, and the vulnerability that such a lack places on both the economies of African nations and the health of their people. Various initiatives have been launched to overcome the dependence of African nations on vaccines produced elsewhere. If implemented in timely and effective ways, those initiatives will contribute to the diversification of African economies and strengthen the capacity of nations on the continent to address their public health needs during pandemics and at other times. While establishing a viable vaccine industry on the continent presents serious challenges, the African Continental Free Trade Area (AfCFTA) can provide the framework for leveraging economies of scale to stimulate the production of needed vaccines across the region.

(more…)

South Centre Submission to USITC, 17 March 2023

Submission by the South Centre to the USITC hearing on Covid-19 diagnostics and therapeutics

India, South Africa and co-sponsors made a proposal for a waiver to certain provisions of the provisions of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in March 2020. In June 2022, the WTO Ministerial Decision on the TRIPS Agreement provided a partial waiver to obligations in Article 31, namely an exception to the 31.f export restrictions, in relation to patents for Covid-19 vaccines. No decision has yet been made with respect to diagnostics and therapeutics for Covid-19.

In this context, the U.S. Trade Representative (USTR) requested the U.S. International Trade Commission (USITC) to prepare a report on Covid-19 diagnostics and therapeutics.

Read below the submission by the South Centre to the USITC investigation: COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596).

(more…)

SC Opening Statement to WHO INB4, 27 February 2023

Opening Statement of the South Centre to the WHO INB4

February 27, 2023

The South Centre, the international organization and think tank of 55 developing countries, appreciates the opportunity to provide a statement.

We applaud the effort done so far, yet consider that the current Zero Draft is not ambitious enough.

The Zero Draft text should be read against the purported objectives of the international instrument…

(more…)

0

Your Cart