On 30 July 2020, the World Trade Organization (WTO) convened a formal meeting of the TRIPS Council. The TRIPS Council held discussions on two COVID-19 related topics: agenda item 3 on IP Measures in the Context of COVID-19 and agenda item 14 on Intellectual Property and the public interest: Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach To TRIPS Flexibilities.
South Africa delivered this general statement on COVID-19.
ITEM 3
General Statement on COVID-19
“Madam Chair,
More than 16.5 million cases and 650 thousand deaths of COVID-19 have been confirmed globally. The global community is facing an extraordinary challenge. No country has been spared the devastating effects of Covid-19. Health and human toll are substantial and expected to continue to grow.
In this context we recall Resolution WHA73.1 of 19 May 2020, which recognises that COVID-19 pandemic has a disproportionately heavy impact on the poor and the most vulnerable, with repercussions on health and development gains, in particular in low-income countries. It further calls on cooperation between multilateral organisations and other stakeholders and the WHO Director General to identify and provide options that respect the provisions of relevant international treaties, including the provisions of the TRIPS Agreement and the flexibilities within the Doha Declaration on the TRIPS Agreement and Public Health, to be used in scaling up development, manufacturing and distribution capacities needed for transparent equitable and timely access to quality, safe, affordable and efficacious diagnostics, therapeutics, medicines, and vaccines for the COVID-19 response. South Africa welcomes the launch of the Trilateral Study on Access to Medical Technologies and Innovation, but notes with disappointment that it does not cover issues related to COVID-19.
Madam Chair,
The list of verified measures prepared by the Secretariat already indicate some steps taken by Members and supplemented by views Members will express during this TRIPS Council meeting and further meetings. A further step in concretizing this commitment is to hold a workshop as requested by the ACP Group which will give Members and other participants an opportunity to further discuss IP challenges with respect to access and to explore approaches to deal with COVID-19 in the context of intellectual property rights.
Curbing the pandemic and limiting the social and economic fallout is dependent on an unprecedented timely roll out of sufficient quantities of medical supplies to all countries in need including masks, personal protective equipment, ventilators, diagnostic kits as well as therapeutics and vaccines as they are identified. This requires global solidarity to transfer of technology and massively scale-up manufacturing globally. At present there are vast shortages of medical products within a country as well as between developed and developing countries. In light of possible second waves of the coronavirus, countries must take measures to ensure that they are able to restock medical products that will be needed to fight the virus.
On the subject of vaccines, there are already news reports of intellectual property disputes that could hinder the development and production of COVID-19 vaccines. We observe with great apprehension the rush by developed countries to sign deals to gain preferential access to vaccines, leaving many countries behind. Vaccine nationalism may address short term political demands of a country but drastically falls short of what is required to contain this pandemic. World leaders from the north and south have referred to vaccine as a global public good, that should be fairly and equitably available globally, leaving no one behind. Now is the time to put it into action.
The challenge before us is to produce an effective vaccine to meet the needs of the world population of 7.8 billion in as short a time frame as possible. This will require the sharing of knowledge and technology of successful vaccines so that the widest distribution at lowest cost can be achieved. Even the European Parliament Resolution entitled “The EU’s public health strategy post-COVID-19” which was adopted on 10 July 2020 acknowledges its importance as it calls for “maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data to the benefit of all countries in the context of WHO’s Technology Access Pool (C-TAP). It also calls for strong support for the WHO’S Technical Access Pool (C-TAP), while incorporating collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for exploitation of final products, in all current and future calls for funding and investment. It further calls for enhanced dialogue with third countries and the issuance of compulsory licences in the event that such countries do not share their vaccines or therapeutic knowledge.
On the subject of vaccines, there are already news reports of intellectual property disputes that could hinder the development and production of COVID-19 vaccines. We observe with great apprehension the rush by developed countries to sign deals to gain preferential access to vaccines, leaving many countries behind. Vaccine nationalism may address short term political demands of a country but drastically falls short of what is required to contain this pandemic. World leaders from the north and south have referred to vaccine as a global public good, that should be fairly and equitably available globally, leaving no one behind. Now is the time to put it into action.
The challenge before us is to produce an effective vaccine to meet the needs of the world population of 7.8 billion in as short a time frame as possible. This will require the sharing of knowledge and technology of successful vaccines so that the widest distribution at lowest cost can be achieved. Even the European Parliament Resolution entitled “The EU’s public health strategy post-COVID-19” which was adopted on 10 July 2020 acknowledges its importance as it calls for “maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data to the benefit of all countries in the context of WHO’s Technology Access Pool (C-TAP). It also calls for strong support for the WHO’S Technical Access Pool (C-TAP), while incorporating collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for exploitation of final products, in all current and future calls for funding and investment. It further calls for enhanced dialogue with third countries and the issuance of compulsory licences in the event that such countries do not share their vaccines or therapeutic knowledge.
In short, we are of the view that the WTO should be cognizant of IP obstacles across essential medical products needed to contain the pandemic and take urgent steps to address these barriers in a comprehensive manner. The WTO-TRIPS Agreement does provide a number of flexibilities that may be utilized by member states to overcome IP obstacles. In anticipation of such barriers, some WTO members have undertaken urgent changes to national patent legislation to make it easier to issue compulsory licenses. However, there are a number of challenges:
Firstly, IP barriers go beyond patents, and often flexibilities in other intellectual property such as industrial designs, copyright and trade secrets is often less understood and implemented nationally.
Secondly, developing country Members may face legal, technical and institutional challenges in using TRIPS flexibilities. This is especially true for countries that have never utilized flexibilities such as compulsory licenses.
Thirdly, when an exporting country is producing under a compulsory license mainly for export, the mechanism established by the 30 August 2003 decision, and later translated into an amendment of the TRIPS Agreement as Article 31bis, would be applicable. This mechanism waives the condition in Article 31(f) that a compulsory license should be predominantly for the supply of the domestic market. However, experience in using this mechanism is largely non-existent. In 2006, Medecins Sans Frontieres (Doctors without Borders) attempted to use the procedures to export HIV medicines from Canada to Rwanda but it concluded that the mechanism is neither expeditious nor workable. We also note that implementation of the Article 31bis mechanism at a national level is rather limited or may not achieve its intended objectives. Further some countries have opted out of using this system as importers, which may pose a challenge to access.
Several voluntary initiatives have emerged since the outbreak of COVID-19 including pledges and voluntary licenses. Some of these are commendable, but these are ad hoc initiatives, simply inadequate to systematically and comprehensively address IP barriers. IP holders of essential technologies may also decide not to participate in such initiatives.
The World Health Organization has launched the COVID-19 Technology Access Pool (C-TAP) calling IP holders to voluntarily issue global non-exclusive licenses or to voluntarily surrender intellectual property rights, to facilitate the widescale production, distribution, sale and use of such health technologies throughout the world. However, to date no company has committed to doing so. Instead limited, exclusive and often non-transparent voluntary licensing seems to be the preferred approached and these are insufficient to address the needs of the current COVID-19 pandemic.
“Business as usual” approaches are simply inadequate to tackle COVID-19. We need to consider new bold measures that will comprehensively and expeditiously address IP challenges. The following approaches can be considered:
Members must explore international collaborations and binding commitments to facilitate the open sharing and right to use technologies, know-how, data and global non-exclusive rights to use and produce COVID-19 medical products.
Members must take policy and legislative measures to ensure that patents and other intellectual property do not erect barriers to access to medicines, diagnostics, vaccines and medical supplies and devices. This includes addressing evergreening of patents by restricting the grant of secondary patents on known medicines and excluding from patentability second medical uses as being mere methods of treatment in terms of Article 27 of the TRIPs Agreement. Members are encouraged to take measures to facilitate the local manufacturing or import of essential medical supplies, devices or technologies including diagnostics, medicines and vaccines.”
South Africa provided the following riposte to the United States who stated that intellectual property did not pose a barrier to access to COVID-19 technologies.
“Earlier this month, it was reported that Gilead had agreed to supply the US its projected production for the next three months, raising concern about supply of Remdesivir to other countries. Gilead has entered into 9 licensing agreements with generic manufacturers from 3 countries for the supply to 127 countries. These limited, non-transparent exclusive licenses seem to be an attempt to contain competition by creating an oligopoly. Generic manufacturers globally that can contribute to expanding global supply have been excluded. The lack of transparency, and accountability in the present dire times is extremely worrying and dangerous. It is an indicator of the IP and access challenges ahead of us, that the WTO Members need to address effectively and swiftly.”
On a separate agenda item on Member notifications under provisions of the TRIPS Agreement, South Africa posed the following questions to Canada and Hungary.
Chair,
We thank the Secretariat for the overview of notifications received under this item. As rightly pointed out some of the notifications overlap with the list of verified measures which was published by the Secretariat. South Africa wishes to raise some questions on COVID related notifications under item two. We look forward to study Australia’s notification and for the short explanation of the amendment. Also, we the intervention from Canada has been well noted. We have some further questions of clarification regarding Canada’s notification. The EU also discussed the notification of Hungary about which we also have some questions. For brevity I will focus only on a few questions and submit the remainder in writing.
Canada: IP/N/1/CAN/30 (Canada: Laws and Regulations)
Does the scope of the amendment allow compulsory licenses to be sought by the Minister of Health for purposes of importing generic versions of patented medical products to respond to public health emergencies?
The amendment limits the duration of the CL to a maximum of one year. As is now apparent, pandemics and other public health emergencies can go on for much longer, how will Canada address this gap? Can the CL be renewed or can the Minister of Health reapply for a new CL to cover the same products. Would this not disrupt access during an emergency?
Do patent holders have the right to apply for an injunction or any other relief that may halt implementation of the CL sought by the Minister of Health?
Why has Canada limited the right of a Minister of Health to apply for and be granted a CL only in situations of public health emergencies. How will the Minister of Health address patent challenges in other situations of public health need in Canada?
Hungary: IP/N/1/HUN/3 (Hungary: Laws and Regulations
The TRIPS Agreement reaffirmed by the Doha Declaration on TRIPS and public health recognize that each WTO Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. The right to issue compulsory license be it to address public health or any other national concern should be a common feature in national patent legislation.
Why has the Government of Hungary decided to rely on its emergency powers to issue a Government decree for public health compulsory licenses.
Section 1(4) of the Decree states the period for which a public health compulsory licence is granted shall not last longer than until 31 March 2021. Given that the Covid-19 challenge is expected to continue for a number of years, and shortages are likely, what other provisions exist in Hungary’s patent law that will allow Hungary to issue compulsory or government use license to import or manufacture patented medical products.
The public health CL decree allows exploitation of patented inventions presumably including importing from other countries. How will the opt-out of Hungary as an eligible importing country in connection with the 30th August 2003 and Article 31bis mechanism impact the utility of Hungary’s public health compulsory license decree.
What circumstances informed the government’s decision to terminate the special legal order (State of Danger) on 18 June 2020?