On Wednesday morning, 16 October 2024, Brazil delivered the following intervention on patents and health at the 36th session of the WIPO Standing Committee on the Law of Patents (SCP)
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Brazil’s intervention for the SCP Session on Patent Flexibilities and Public Health
Distinguished delegates, Madame Chair,
Thank you very much for allowing my delegation to take the floor and comment on working document SCP/36/6, an agreed updated version of document SCP/26/5 – “Constraints faced by developing countries and least developed countries in making full use of patent flexibilities and their impacts on access to affordable especially essential medicines for public health purposes in those countries.”
The document in front of us, as presented by Secretariat, was based on the information received from MS, in view of their experiences relating to the COVID-19 pandemic and the limitations faced by developing countries and LDCs on implementing TRIPS flexibilities.
Madame Chair,
Indeed, developing countries and LDCs continue to face significant challenges in making full use of the patent flexibilities available under the TRIPS Agreement. These flexibilities, including provisions for compulsory licensing, parallel importation, and regulatory review exceptions, are crucial tools to address public health needs and ensure access to affordable, essential medicines.
However, several constraints hinder their effective use:
Legal and Administrative Challenges
Many countries lack the necessary legal and administrative frameworks to efficiently implement TRIPS flexibilities. As highlighted in document SCP/36/6, the complexity of practical implementation often burdens developing countries. For example, the compulsory licensing mechanism under TRIPS Article 31 is seen as cumbersome, particularly in emergencies like the COVID-19 pandemic, where timely access to medicines is essential.
Institutional Capacity
Another significant constraint is the lack of local expertise and technical capacity. Many countries struggle to effectively navigate the procedural requirements of patent flexibilities, leading to underutilization of critical measures such as compulsory licensing and the exhaustion of rights. This situation, as noted in SCP/36/6, underscores the need for enhanced capacity-building efforts, including training and technical support tailored to the specific needs of each country.
Political and Economic Pressure
Developing countries are often subject to external pressures, including political and economic sanctions, when attempting to use flexibilities like compulsory licensing. As mentioned in the document, countries such as Brazil, South Africa, and India have faced challenges from powerful industry actors or trade partners when invoking TRIPS flexibilities. This creates an environment of uncertainty and discourages the full use of these legal tools.
These constraints not only delay access to essential medicines but also impact broader public health outcomes by restricting the availability of affordable treatments, particularly for conditions such as HIV/AIDS, tuberculosis, and COVID-19.
In light of these challenges and shortcomings, we urge WIPO and Member States to prioritize the following actions in addressing this agenda item:
Strengthening technical assistance programs that support the drafting of clear, accessible, and operational national legislation that fully incorporates TRIPS flexibilities.
Facilitating international cooperation to mitigate the negative impact of political or economic pressure on countries using compulsory licensing or other flexibilities.
Enhancing the scope of capacity-building initiatives to include training for judiciary, patent offices, and health authorities on the practical application of flexibilities.
Finally, Madame Chair, we must acknowledge the global need for equitable access to medicines, vaccines and diagnostics, particularly during health crises. Ensuring that developing countries and LDCs can make full use of TRIPS flexibilities is not just a legal matter but a moral imperative for safeguarding public health and keeping us alive.
Thank you.