Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Dagfinn Sørli (Norway)
2 DRAFT GENERAL COUNCIL DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH IN THE CIRCUMSTANCES OF A PANDEMIC
373.   I also thank the European Union delegation for introducing their proposal. I take this opportunity to raise certain questions and seek clarifications and explanations from the EU on their proposal. It is indeed heartening to see that the proponents recognise the pandemic to be a global and economic crisis that calls for urgent multilateral action which is key to respond to this crisis swiftly. It would be useful if EU could clarify what it envisages as the urgent multilateral action and what would be the timeline for such an action. We are glad to see that the main objective of this proposal as reflected in the preamble is to ensure fair and equitable distribution of vaccines and medicines to fight against the COVID-19 pandemic and that requires concerted efforts to increase manufacturing capacity and investment as well as supplies at an affordable cost. 374.   It also mentions in a number of places the need for accelerating the production of vaccines and medicines and their equitable global distribution. We wish to know and understand how this is envisaged in the proposal to achieve equitable distribution of this accelerated production of vaccines and medicines, especially with the concern over rampant pre-ordering of vaccines by developed country Members, how will this increased output be equitably distributed. 375.   The proposal stresses the need for legal certainty on the flexibilities provided by the TRIPS Agreement and that the established procedures to use compulsory licences for those purposes be as efficient and streamlined as possible. It proposes to facilitate the determination of the renumeration to be paid under compulsory licences in the circumstances of the pandemic in order to support manufacturers ready to produce pharmaceutical products including vaccines or medicines at affordable prices for low- and middle-income countries. It is reassuring that at this critical time the proposal then delivers to reaffirm existing rights emanating from the Doha Declaration on the TRIPS Agreement and Public Health and the TRIPS provisions itself. It would be helpful if the EU could share some experiences in this regard. The proposal desires to facilitate the use of WTO notification procedures on compulsory licensing and I would like to state here that it is these cumbersome preconditions that render the mechanism impractical in a pandemic situation and these need to be revisited. 376.   We have heard from a delegation in this meeting itself regarding their first-hand account of the difficulties being faced in utilising the compulsory licensing system, especially in the context of a pandemic, and we hear that the proponents still continue to support their proposal. However, while the majority of Members of the waiver proposal are calling for a waiver, it has not been given a chance to prove itself. 377.   Another pertinent question here would be whether, since its proposal deals with explanation on the compulsory licensing, the EU is monitoring existing requests on compulsory licensing being filed by Members. 378.   Now let me touch upon the three points mentioned in the operative part of the proposal. Point A clarifies that a pandemic is a national emergency or other circumstance of extreme urgency, that is the meaning of Article 31.b. We are not clear what elicited such clarification from the EU, since this was never in dispute and a pandemic by its definition is a global emergency and that does qualify as a national emergency. Additionally, Article 5.c of the Doha Declaration on the TRIPS Agreement and Public Health clearly states that each Member can determine as to what constitutes a national emergency. Further the second point reads that a Member can set a remuneration that reflects the price charged by the manufacturer of the vaccine for medicine produced under the compulsory licence. However, Article 31.h already provides for Members' freedom to set the level of adequate remuneration. Point C of the proposal says that the exporting Member may provide in one single notification a list of all countries to which vaccines and medicines are to be supplied. What these points covered is a reiteration of existing provisions of the TRIPS Agreement. Importantly the proposal contains only 'may' obligations which makes these proposals even more redundant in addressing the current COVID-19 pandemic. Would the EU elucidate how these reiterations of the existing provisions result in ensuring production of vaccines, therapeutics and diagnostics for the treatment, prevention and containment of the pandemic and how they will secure access to vaccines for the developing countries and the LDCs? 379.   Finally, we also want to know and understand what the legal enforceability of this declaration will be since it does not bring in any change to the existing agreement. How will Members use this declaration to procure more vaccines, therapeutics, PPE kits, masks etc. for their population? The proponents of the waiver proposal have argued on many occasions how flexibilities provided in the TRIPS Agreement are inadequate in responding to a pandemic of this magnitude. The limited policy space provided by the TRIPS Agreement flexibilities to address monopoly actions through issue of compulsory licences would not be a feasible option in a pandemic. Invoking compulsory licences across a wide range of medical products, on a case-by-case or product-by-product basis is a cumbersome and time-consuming process, severely limiting its effectiveness in the context of products and technologies required for fighting the virus. Beyond patents, other IP rights including trade secrets, industrial designs, copyrights etc. also pose barriers, and the current proposal is silent on those issues. Compulsory licence does not address these barriers posed by these rights. 380.   What is pertinent to note here is that the discussion on improving on existing TRIPS flexibilities as well as the 2001 Doha Declaration on TRIPS and Public Health is crucial and relevant. However, we would also only be deceiving ourselves by believing that a mere reiteration of existing flexibilities, with more stringent interpretations, would make them practical, less cumbersome and effective, and provide a timely solution to the pandemic. India's statement at the informal meeting held on 24 June 2021 381.   I thank you Chair for organising this meeting and I also thank the EU for introducing their proposal. 382.   I take this opportunity to raise some questions and seek clarifications and explanations from the proponents. It is indeed heartening to note that the proponents recognise the pandemic to be a global health and economic crisis that calls for urgent multilateral action which is key to respond to this crisis swiftly. It would be useful if European Union could clarify what it envisages as urgent multilateral action and what would be the timeline for such action? 383.   Further it reads that pandemic affects all countries and therefore requires concerted global efforts to ensure that all people in all countries have access to safe and effective vaccines and medicines as soon as possible. Here again would want to know what is meant by concerted effort and what is the understanding of the term 'as soon as possible' as it lacks specificity. 384.   We are glad to see that the main objective of this proposal as reflected in the text is to ensure fair and equitable distribution of vaccines and medicines to fight against COVID-19 and that requires concerted efforts to increase manufacturing capacity and investment, as well as supplies at an affordable cost. The text does mention in a number of places the need for accelerating the production of vaccines and medicines and their equitable global distribution. 385.   So while the proposal aims for fair and equitable distribution of vaccines and medicines it does not recognize that access to diagnostics and therapeutics is equally critical to save lives. Does the proposal aim to increase existing manufacturing capacity of the few players and, if so, could they provide evidence as to how increased manufacturing capacity will yield affordable supplies? And especially, with rampant pre-ordering of vaccines by developed country Members, how will the increased output be equitably distributed? 386.   The proposal also talks of the need to provide and preserve appropriate incentives for investments in research and development of COVID-19 vaccines and medicines, particularly in view of the continuing emergence of new variants of the virus. What would be an appropriate incentive for R&D? Will it not be prudent to prioritise vaccination of people across the globe, as more unvaccinated people would only help the virus incubate and mutate into new variants defeating the purpose of these concerted efforts? 387.   The proposal stresses the need for legal certainty on the flexibilities provided by the TRIPS Agreement and that the established procedures to use compulsory licences for those purposes be as efficient and streamlined as possible. to facilitate the determination of the remuneration to be paid under a compulsory licence in the circumstances of a pandemic, in order to support manufacturers ready to produce pharmaceutical products, including vaccines or medicines, at affordable prices for low- and middle-income countries. It is reassuring that at this critical time EU proposal endeavours to reaffirm our existing rights emanating from the Doha Declaration on the TRIPS Agreement and Public Health and the TRIPS provisions itself. The proposal desires to facilitate the use of WTO notification procedures on compulsory licensing, let me state here that it is these cumbersome preconditions that render the compulsory licensing mechanism impractical in a pandemic situation and these need to be revisited. 388.   Now let me touch upon the three points mentioned in the operative part of the proposal point a clarifies that pandemic is a national emergency or other circumstances of extreme urgency withing the meaning of Article 31.b. We don't know what elicited such clarification from E.U since this was never in dispute and pandemic by its definition is global so a global emergency does qualify as a national emergency. Additionally, Article 5.c of the Doha Declaration on TRIPS Agreement and Public Health clearly states that each Member can determine as to what constitutes a national emergency. 389.   Further, the second point reads that Members can set a remuneration that reflects the price charged by the manufacturer of the vaccine or medicine produced under the compulsory licence. However, Article 31.h of TRIPS already provides Members freedom to set the level of adequate remuneration. 390.   Point c of the proposal says that the exporting Member may provide in one single notification a list of all countries to which vaccines and medicines are to be supplied. What these points covered is a reiteration of existing provisions of TRIPS Agreement. Could the EU elucidate how these reiterations of existing provisions result in ensuring augmentation of production of vaccines, therapeutics and diagnostics for the treatment, prevention and containment of the pandemic, how will these secure access to vaccines for developing countries and the LDCs. 391.   Finally, we would like to hear as to what will be the legal enforceability of this declaration, since it does not change the existing Agreement, how will Members use this declaration to procure more vaccines, therapeutics, PPEs, masks etc. for their population? 392.   The proponents of the Waiver proposal have argued previously on many occasions how flexibilities provided in the TRIPS Agreement are inadequate in responding to a pandemic of this magnitude. The limited policy space provided by the TRIPS Agreement flexibilities to address monopoly actions through issue of compulsory licences would not be a feasible option in a pandemic. Invoking compulsory licences across a wide range of medical products, that too on a "case by case" or "product by product" basis is a cumbersome and time-consuming process, severely limiting their effectiveness, in the context of products and technologies required for fighting the virus. Beyond patents, other IP rights, including trade secrets, industrial designs, copyrights, etc. also pose barriers. Compulsory licence does not address the barriers posed by these rights. In fact these limitations posed by the compulsory licensing can be easily addressed by the Waiver. The waiver once approved and applied would provide countries with an effective and expeditious way to remove key IP barriers that scuttle the use of existing idle capacities. 393.   What is pertinent to note, Chair, is that this discussion on improving upon the existing TRIPS flexibilities as well as the 2001 Doha Declaration on TRIPS and Public Health is crucial and relevant, however, we would only be deceiving ourselves by believing that a mere reiteration of existing flexibilities would make them practical, less cumbersome and effective and provide a timely solution to the pandemic.
19. The Chair said this item had been put on the agenda at the request of the European Union. Two communications had also been received from the European Union and had been circulated as documents IP/C/W/680 and IP/C/W/681. He invited the European Union to introduce the topic and the submissions.
20. The delegations of the European Union, Chad, on behalf of the LDC Group, South Africa, Switzerland, Paraguay, Singapore and India, took the floor.
21. The Council took note of the statements made.
IP/C/M/101, IP/C/M/101/Add.1