188. At the outset my delegation would like to thank you for your endeavours in taking this process forward. We would also thank Members who have unequivocally supported the waiver proposal. The past year-and-a-half has been unprecedented in the history of this Organization with regards to where we have reached on the wavier and our continuous engagement on the proposal, and more so because of the waning enthusiasm to finalise it. Since the previous formal TRIPS Council meeting on 8 and 9 June 2021, we have had several rounds of small-group meetings and informal TRIPS Council meetings to take stock of the progress made. These meetings gave the opportunity to Members to discuss in detail key elements of the waiver proposal like the scope of products as well as the scope of IP, implementation issues, the duration for which the waiver would be in place and other relevant elements.
189. I also take this opportunity to inform Members on the outreach undertaken by the proponents of the waiver proposal. In continuation of our outreach to Members on this proposal in the previous two weeks, proponents have engaged bilaterally with several Members and have explained in detail the reason and rationale behind the proposal, with an aim to respond to all their concerns. In these discussions we have proposed to a few Members to engage bilaterally on the text and iron out the differences in a focused manner. However, there seems to be little enthusiasm among these Members to engage bilaterally on detailed text negotiation. Generally, we have seen Members have been receptive of such bilaterals during fisheries negotiations. The lack of enthusiasm substantiates our fear that a few Members have agreed for the text-based negotiations, but not with an intent of concluding it. Most of the questions and concerns raised by these Members with regards to the waiver text were repetitive and had already been answered in detail, and those responses are contained in the documents , , and . The cosponsors have engaged positively and responded to these questions at the small-group meetings. However, such beating around the bush has only led to losing precious time that also means losing lives. Clearly, and sadly indeed, the delaying tactics of these few Members has worked, and that entails that we will not be able to deliver the outcome by end of July.
190. For the sake of time, my delegation will not repeat the detailed responses and statements made in the small group and open-ended meetings, and provide these as my written statement to the Secretariat to be incorporated in the minutes of the present formal meeting.
191. As the challenges posed by the pandemic are still unfolding, we would still need to work towards collaborative efforts to combat COVID-19. In this regard, while discussions are moving forward on various proposals seeking to combat the crisis and enhance preparedness for future pandemics, it is our firm belief that the TRIPS waiver proposal remains at the core of our response and preparedness. It is also important that we agree on the waiver as it aims at relieving the supply side constraints. The waiver entails enhancing the production and the supply of vaccines and other COVID-related products. This is addressing the root cause of most problems with respect to distribution, access and affordability. The past ten months have been spent discussing the waiver, we have lost three million more people with new variants adding to the uncertainties surmounting us.
192. Only 2% of the least developed countries that represent 14% of the world population and 23% of developing countries that represent 70% of the world population have received at least a single shot as of June 2021, compared to 46% of the developed world. With less than 1% of vaccines administered in low-income nations, increasingly we see that a two-track pandemic is developing, with richer countries having access, while poorer nations being left behind. Each nation's fate is entwined with that of the other, while developed country Members have outpaced developing and LDCs in vaccinations, and have also secured supplies for future doses, such a differential approach will not help us in ending the pandemic, as the virus does not differentiate and discriminate in affecting people.
193. Despite Members agreeing to the collective goal of saving lives and the consequent need of augmenting production of vaccines, therapeutics and diagnostics needed to combat COVID-19, we see a lack of urgency and enthusiasm by a few Members to reach a conclusive decision on the waiver. Time is of the essence. We should not miss the opportunity of finalising the waiver. The extraordinary circumstances of the pandemic demand more than a moderate collective response, and everyone in a position to contribute must do so. Members have agreed to pursue different approaches simultaneously in this regard, and without prejudice to each other. The co-sponsors of the waiver proposal have reiterated that they welcome all proposals. However, this understanding from the cosponsors have been construed differently. What we intend to say is that each proposal should be considered on its own merit and follow its own course, and agreeing on the waiver does not mean that we cannot agree on anything else or vice versa.
194. We have also clearly stated in several meetings earlier that the two proposals cannot be clubbed together as they follow different procedures and legal approaches and with this understanding, we have engaged in discussions on the European Union proposal in good faith, but this has not been reciprocated. We have never said that there could only be one approach which could deliver. No single mechanism will be able to provide a perfect solution for this crisis.
195. There have been questions with regards to the uncertainty that the waiver may bring. On the contrary, we understand that in fact the waiver would provide more companies with the freedom to operate and to produce more without the fear of infringing on other parties' rights and the threat of litigation. From what has been reiterated often by a few Members, that they do not see the waiver as a response to the crisis, this argument compels us to think that perhaps we do not share the urgency, severity and need for quick solutions to put an end to the pandemic. The waiver is necessary at this time as the existing flexibilities in the TRIPS Agreement have not proved to be sufficient in the context of the pandemic. Additionally, the insufficient voluntary mechanism and engagement by pharmaceutical companies to scale up manufacturing makes the waiver an important policy response for radically increasing manufacturing capacity and thus ensuring sufficient supplies and facilitating pathways to achieve equitable access.
196. The waiver will be a critical ingredient of the multi-pronged approach to combat the pandemic. The proponents have argued previously on many occasions how flexibilities provided in the TRIPS Agreement are inadequate in responding to the pandemic of this magnitude. The limited policy space provided by the TRIPS Agreement flexibility to address monopoly actions through the issuing of compulsory licences would not be a feasible option in a pandemic. Beyond patents, other IP rights including trade secrets, industrial designs, copyrights etc. also pose barriers. Compulsory licensing does not address the barriers posed by these rights. In fact, these limitations posed by compulsory licensing can be addressed by the waiver. The waiver, once approved and applied, would provide countries with an effective and expeditious way to remove IP barriers that scuttle the use of latent capacities.
197. Lastly, it is imperative of us that we logically and meaningfully conclude what we started. It is important that the waiver proposal is taken forward constructively and finalised expeditiously. The discussions that were held in the small-group meetings on the draft of the oral report of the Chair to the General Council do not reflect our position. Such a report to the General Council by a subsidiary body, mandated by Article 9.3 should contain only deliberations with respect to the waiver and other discussions on the TRIPS Council on other proposals could be reflected separately. However, in the spirit of compromise this was agreed to have a report to the General Council and also to help move the process forward. It is our view that any other discussions on other proposals should be looked at separately and are not mutually exclusive or clubbed together with the waiver proposal.
198. While we have been painstakingly creating this rules-based system, it is to our dismay that the rules here get selectively interpreted and run contrary to our understanding of the rule of law. These derogations would not help in our efforts of restoring the credibility of this Organization in the midst of the pandemic. This cannot be achieved without delivering on the solutions that would help scale up production of life-saving vaccines, therapeutics and diagnostics and ensure access for all.
India's statement at the small-group meeting held on 22 June 2021
199. Let me begin by thanking Members for their continuous engagement on this critical issue, I also thank the Chair for his tireless efforts and guidance in bringing this together to this point where today we begin substantive discussions on the text, we have come a long way in these nine months, wherein we have engaged and discussed the waiver proposal thoroughly and have now achieved concurrence on a range of crucial issues that are pertinent in formulating the solutions to the pandemic. We have acknowledged the existence of supply side problems and therefore the need for expanding manufacturing, we have recognised that there is idle and latent capacity that needs to be harnessed, we agree that different aspects of IP and IP-related barriers are impeding the availability and accessibility of vaccines and other products required for prevention, treatment and containment of COVID-19, we are also looking at the limitations of existing TRIPS flexibilities in a pandemic situation especially the need to improve upon compulsory licences. This summarises our work so far and would be the basis to continue discussions on the text with a view to finalise it before the next General Council.
200. Chair as the proponents of the proposal and as suggested by you Chair in the previous informal meeting, we will begin by discussing the scope. The scope comprises of two elements i.e. the scope of products covered by the waiver and the scope of different aspects of IP, it would be prudent to focus the discussions today on scope of the products.
201. Let me take this opportunity to briefly reiterate and explain the rationale behind the proposed Scope. The operative paragraph 1 of revised waiver text in document 1. has been revised to add specificity to the decision text in response to the concern that the original decision text was too broad. Hence the revised text addresses this concern by focusing the language in the paragraph on "health products and technologies" as the prevention, treatment or containment of COVID-19 involves a range of products, their materials or components, as well as their methods and means of manufacture.
202. The TRIPS waiver proposal is motivated by the need for swift ramping up of manufacturing, to address alleviate the supply side concerns for timely availability, accessibility and affordability of the required products to prevent, treat and contain COVID-19.
203. Hence, the starting point in determining the scope of health products and technologies to be covered by the text is to determine what is needed to prevent, treat, or contain COVID-19. Any strategy that does not address these three elements simultaneously would fall short of yielding any positive results.
204. We have learnt from experiences of the past year and a half that it is critical to scale up production and access to personal protective equipment (PPE), masks, testing kits, ventilators, diagnostics, therapeutics apart from vaccines to prevent the spread and to treat the disease and prevent deaths. These resources have been in acute shortage in many countries leading to limited accessibility. It became clear that the prevention, containment and treatment of COVID-19 involves a range of health products and technologies. It is clear that vaccines are necessary but not sufficient to respond to the pandemic in the short term
205. The scope of products is also reflected in the national COVID-19 response strategies, of many countries that acknowledge the need to ensure equitable access to critical COVID-19 PPE, tests, therapeutics, and vaccines. For example, one of the therapeutic strategy states "vaccines will not eliminate the disease overnight and therapeutics will still be needed for patients in hospitals and at home, including people suffering from 'long COVID' (the long-term effects of COVID-19 infection). For these reasons, therapeutics will continue to play a significant role in the response to COVID-19.
206. In a similar vein another Member recognizes antiviral medicines as part of the wholeofgovernment strategy. What these statements reveal is that therapeutics are expected to play a role in addressing the response gaps in the pandemic. WHO's consultations on COVID-19 therapeutics reveals that a range of therapeutics will be required including "drug combinations targeting specific aspects of infection, as well as suites of treatments targeting different disease processes (such as antivirals, immunomodulators and anti-coagulants)". Thus, one cannot ignore therapeutics, diagnostics or other health technologies relevant and required to combat COVID-19.
207. Equally critical are diagnostics, as the ACT-A strategy recognizes that "Testing is a critical element in the armoury of tools needed to defeat COVID-19. Without it, the spread of the virus cannot be tracked or contained, patients cannot access the care they need, the efficacy of vaccines cannot be assessed, nor the emergence of new variants detected. Major gaps in testing are still putting lives at risk and threatening progress to end the pandemic. There is an urgent need to scale up testing and ensure immediate, equitable access to diagnostic tools in every country across the world. In high-income countries there are 603 tests per 100 thousand of population compared to about 100 tests in middle income countries and about five tests in low-income countries. We stress that the disparity in testing is hindering efforts to control the pandemic. No country can afford to adopt only one intervention in this pandemic. Vaccination and test and treat strategies are needed alongside other interventions.
208. In this context, it is justified that the revised text extends to "health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19." Having said that Chair, we would like to hear from delegations their views on the scope of products proposed by the co-sponsors in the revised decision text.
India's statement at the small-group meeting held on 28 June 2021
209. On 22 June, discussions were held on the scope of products and the co-sponsors provided justification for the scope of products proposed in the revised decision text. Today the discussion would be focussed on the scope of IP with regards to these products. Therefore, the proposal calls for a waiver of the application, implementation, and enforcement of TRIPS provisions on copyright (Section 1), industrial designs (Section 4), patents (Section 5) and protection of undisclosed information (Section 7).
210. These categories of intellectual property are relevant to the production, supply, and access to COVID-19 health products and technologies. We also point out that Paragraph 3 of the revised text makes explicit that the waiver will not apply to the protection of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations under Article 14 of the TRIPS Agreement.
211. The proponents have made several submissions highlighting the relevance of addressing existing and potential IP issues in copyright, industrial designs, patents, and protection of undisclosed information.
212. Let me also reiterate here that the proponents at no point have argued against the Intellectual Property rights in fact most of us have robust domestic frameworks protecting Intellectual property rights. We must bear in mind that the proposal calls for a limited period waiver from these four sections and is an exceptional measure for exceptional circumstances like these.
213. The patent landscape usually varies from product to product and country by country. In the case of COVID-19, the patent landscape remains quite uncertain as many patent applications are yet to be published.
214. In the case of mRNA vaccines there is a complex web of patent holdings. While larger companies involved in product development may have a patent portfolio, the patents portfolio to the underlying technology is held by numerous other academic labs or small biotech companies. This reveals the complex patent landscape that exists with respect to mRNA technology.
215. In the case of therapeutics, in document the co-sponsors have presented a preliminary patent landscape that offers a non-exhaustive snapshot of the patent filing and granting status on five selected therapeutics candidates. However, many more therapeutics are being investigated and evaluated for efficacy against COVID-19. Some of the therapeutics under investigation are presently off-patent but as its use is explored for COVID-19 treatment, the filing of new patent applications extending to secondary uses of these therapeutics is expected. A similar situation exists with respect to other health products and technologies as well.
Trade Secret Protection
216. In addition to patents trade secret protection is another hurdle to access various health products and technologies. With respect to vaccines and bio-therapeutics, the manufacturing methods and techniques (know-how) tend to be protected by trade secrets. This includes dossiers to obtain regulatory approval that will usually include robust information regarding the manufacturing process, formulation and dosage, method of delivery, storage conditions, indicated uses along with safety and efficacy information. Hence the importance of addressing protection of undisclosed information under Article 39 of TRIPS.
217. Lifting trade secret protection is essential to expanding and diversifying global production. For instance, by waiving trade secret protection, and as a start facilitating the sharing of regulatory dossiers especially with potential manufacturers, existing production capacity especially in developing countries can be mobilised. And as demonstrated sufficiently now most recently by the event hosted on the 14 April where interaction with several pharmaceutical companies did show that several unused capacities do exist in several developing countries.
218. The slow roll out of vaccination in developing countries is testament to the fact that the current system of production and supply is not working to deliver equitable access. Numerous examples have been reported of the industry turning down offers of help from other drug makers, including those from developing countries, to boost global manufacturing and supply. There have been and continue to be similar experiences in developing countries and least developed countries. We have also provided other examples in paragraph 43 of document and paragraph 65 in document .
219. These numerous examples show how in a pandemic we cannot rely solely on ad hoc, nontransparent and unaccountable voluntary mechanisms. The existing mechanisms are not delivering and artificially constraining supply, at the expense of prolonging the pandemic, lives and live hoods around the world. A pandemic by nature of its spread, severity and uncertainty needs global collaboration and extraordinary measures.
220. We need supply now and at least in the near future and we need supply at affordable prices. With developed country Members prebooking future supply for boosters and additional rounds of vaccination, we urgently need to ramp up manufacturing and this requires the lifting of trade secret protection. Expanding manufacturing of health products is crucial not only for this pandemic but also for future pandemics. The waiver, if granted, would provide potential manufacturers the freedom to operate and achieve economies of scale, thereby incentivizing production and supply of therapeutics and vaccines.
Copyright and Industrial Designs
221. Copyright and Industrial Designs are also categories of IP that may hinder production and supply. Copyright issues may also arise in other situations such as with respect to software in medical devices, compilation of data and algorithms, product information documents or product labelling, diagnostic kits, and digital technologies, etc.
222. In document , the co-sponsors responded in detail from paragraph 54 to 63 on the industrial design and copyright challenges faced by Members in procurement or of seeking local manufacture or production of COVID-19 diagnostics, equipment, therapeutics or vaccines. In the same document the co-sponsors illustrated the case where a hospital ran out of ventilator valves and had 3D-printed replacement valves at a much lower cost, but it was stymied by threats of IP infringement.
223. These instances elucidate that complex intellectual property issues are involved in the manufacture and supply of needed health technologies and their parts, and these issues go beyond patents.
224. The proponents and the co-sponsors of the waiver have these four elements in scope of IP as we believe that rather than entering discussions on the nitty-gritties of the relevance of each section we must work towards the final objective that is to ramp up production and save lives. We must list out all possible elements of IP that may be a barrier in achieving our final goal.
225. Finally, would like to draw attention to the fact that we often tend to overlook the lessons learned from the HIV/AIDS crisis where an absence of IP landscape did enable augmenting production of life saving generic drugs, thereby enhancing both accessibility and affordability of ARVs and FDCs which helped saved millions of lives. The current pandemic is far worse, severe and unprecedented, the waiver would be an enabler to boost the production of vaccines, therapeutics and other health products needed to combat the virus. Increased production coupled with robust competition; we see a substantial reduction in prices. Here would give an example of a study that shows that for products with a single generic producer, the generic Average Manufacture Price is 39% lower than the brand AMP before generic competition, with two competitors, that generic prices are 54% lower with four competitors the generic prices are 79% less than the brand drug price before generic entry and with six or more competitors, generic prices show price reductions of more than 95% compared to brand prices.
226. Thus, the waiver would aid in ramping up production, fill the supply side gaps, and this augmented supply would ensure both accessibility and affordability. We are of the view that a waiver once implemented will provide greater certainty to manufacturers by providing them freedom to operate, and for governments to collaborate to increase supply options. Waiver being sought for a limited period and that too only from some specific TRIPS provisions in such testing times does not increase uncertainty for the IP system. This is not an ideological debate on the IP regime per say. Instead, it shows that in exceptional circumstances, the IP system can be flexible and accommodating and one that can be manoeuvred to suitably address the unprecedented challenges posed by the pandemic. We have heard from some Members in the recent meetings that they do not see waiver as a part of the solution, and do not see how IP is a barrier even for vaccines production. Had that been the case why have these Members agreed to engage in the text-based negotiations on the waiver proposal which was clear from the previous formal meeting held on 89 June 2021. Was this the case such Members should be more forthcoming during the discussions on whether to start the text-based negotiations or not. Or is it an attempt to filibuster the entire process? And hopefully if that is not the case, we would urge Members to engage constructively and in good faith on the waiver text under consideration with an aim to finalise it.
227. It will be presumptuous to think that the co-proponents do not believe in IPR, some Members have argued that they do not see waiver of IP resulting in augmenting manufacturing or as a measure easing supply side constraints, or having impact outside voluntary licensing mechanisms , on the other hand they firmly believe and argue that this proposal will cause significant damage to commercial interests of IP rights holders so both arguments cannot be true at the same time, we cannot have the cake and eat it too. And if the proposal seriously damages the commercial interests of a few private entities by ramping up production then we are on our way to achieve our objective. And if the waiver fails to succeed as some Members say there will be no harm to commercial interests and this could be another tool in the WTO policy toolkit.
228. We have agreed to work on a multipronged approach to tackle the crisis and finalising the waiver is a step forward towards our end goal of saving lives. Thus, discussions must be continued in a constructive and focussed manner on the waiver text towards achieving this. Other proposals will be considered separately and not in tandem with the waiver proposal.
229. These elaborate explanations provide the basis of including in the revised decision text the relevant parts of the TRIPS Agreement within the scope of IP, that should be waived to ramp up production and supply.
India's statement at the informal meeting held on 30 June 2021
230. Chair, I thank you for your summary of the discussions that took place in the small group meetings held on 22 and 28 June 2021. There were several questions posed and answers provided both on the scope of products as well as on the scope of IP. While all Members have committed to engage in text-based negotiations it is disappointing to note that some Members are not willing to contribute to the waiver text with an aim to finalize it.
231. In the past nine months we all have invested our time and energy in discussing the waiver proposal in various formats formal informal at the TRIPS Council, in small group meetings as well as in bilateral engagements. All Members have concurred that there is a dire need to enhance the production of health products including vaccines, diagnostics, and therapeutics to ensure timely and equitable access. All Members have further agreed that various ways can be pursued simultaneously and without prejudice to each other. Furthermore, Members including the proponents and cosponsors of the waiver proposal have said that they welcome all proposals, and it is only fair to say that each proposal should be considered on its own merit and as to what it brings on the table as a part of the solution. The waiver has been a standalone agenda item and cannot be clubbed together with any other proposal, the waiver proposal will follow a different procedural course under Article IX.3 of the Marrakesh Agreement. Its therefore not clear as to how the waiver and the European Union proposal stand on equal footing.
232. From what has been reiterated often by some Members that they do not see waiver as a response to the crisis, well more than half of the membership does see waiver as a legitimate policy option that could be used to offset the supply side constraints. This argument compels us to think that perhaps we are not on the same boat and the urgency, severity, and the need for quick solution in the form of waiver would depend on the vantage point of the Member, whether you are the one who has secured access to vaccines, therapeutics medicines or you are part of the scramble.
233. On the EU proposal, notwithstanding the fact that compulsory licences and other TRIPS flexibilities are important, but the limited policy space provided by the TRIPS Agreement flexibilities to address egregious monopoly actions through issue of compulsory licences has not until now proved to be a feasible and expeditious option in a pandemic of this scale and magnitude.
234. 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 Licensing does not address the barriers posed by these rights. The understanding and implementation of TRIPS flexibilities in IPRs other than patents are limited making their use to address the supply side constraints for products required for dealing with ongoing pandemic not a viable option.
235. Additionally, the medical technologies required for COVID-19 response are surrounded by a thicket of patents and other intellectual property rights. Practically, operating within the current system means that each country is obligated to use its stretched human resources to identify which of the patents and other IPRs are relevant and thus should become the object of a compulsory licence. The accompanying delays in such a process are unacceptable in an emergency like this.
236. Furthermore, Article 31bis which allows export to countries with insufficient or no manufacturing capacity, is subject to extremely cumbersome and lengthy procedures, rendering it meaningless and impractical to use especially in a pandemic where each delay costs several lives. Simply put, there are currently no provisions in TRIPS Agreement to allow countries to act more expeditiously in a global crisis to use Article 31 compulsory licensing to export without limitation on quantity and other additional procedural requirements. In fact, these limitations posed by the compulsory licences can be easily addressed by the waiver. Moreover, the EU proposal does not bring any value add to the existing flexibilities rather a fundamental flexibility enjoyed by WTO Members to determine any grounds for compulsory licensing as explicitly affirmed by Doha Declaration, the proposal however as an unintended consequence asks for an agreement to be reached to allow WTO Members to use the pandemic as a ground for issuing compulsory licensing thereby reducing the existing flexibility enjoyed by all WTO Members.
237. I stated in an earlier discussion Chair, that if a particular prescription is not effective in treating a disease then, it is only logical and prudent to find a new prescription, we do not continue following the old prescription.
238. Chair, lastly, it is imperative upon us that we logically and meaningfully conclude what we started, it is important that the waiver proposal is taken forward constructively and finalized expeditiously. We look forward to intensive discussions on other elements of the waiver text including the implementation issues and duration in the upcoming TRIPS Council meetings.
239. The credibility of this organization will not be successfully reinstated if it overlooks vital policy options like the waiver that acts as an enabler, a policy option among the many options being discussed, for Members to use as per their own needs and circumstances. We owe this not just to ourselves but to our future generations as well.
240. Members have often said this crisis is unprecedented, we need extraordinary measures, we need concerted multilateral efforts, saving lives is a priority, no one is safe until everyone is safe well the time to act on this is now. Now is the time Chair for us to walk the talk.
India's statement at the small-group meeting held on 5 July 2021
241. The WHO COVID-19 dashboard of 4 July 2021 shows that there have been over 184 million confirmed cases of COVID-19, including 3.9 million deaths, reported to WHO. As of 1 July 2021, a total of 2.95 billion vaccine doses have been administered. 75% of these doses, however, have been administered in the developed country Members. Only about 1% of people in low-income countries have received at least one dose. Until June not more than 3 billion vaccines have been produced, it is difficult to fathom how without taking exceptional measures, like agreeing to the waiver proposal, will we be able to reach an output of even 10 billion doses by the end of the current year. Again, we often forget that it's not just the availability of supply but also the vast inequity both in accessibility and affordability of these supplies.
242. Previously as well, in several discussions the proponents of the waiver proposal have presented their understanding and rationale behind the proposed implementation and duration of the waiver. We are grappling with a novel pathogen, and this novelty brings with it many uncertainties. There are emerging variants and mutations and while we are better off in our understanding of the virus than the previous year still many unknowns remain with respect to the duration of immunity provided by the vaccines, effectiveness of these vaccines against new variants, whether or not there will be a need for a booster dose, or the requirement for an annual vaccination.
243. All these elements such as the duration of immunity conferred, need for booster doses, effectiveness of vaccines against new variants, and the need of vaccines for children will determine the scale of manufacturing needed and supply that will be needed to control the pandemic, and this is just for the vaccines. Production for therapeutics, diagnostics and other COVID 19 related health products will also need to be ramped up in order to diagnose and treat people as subsequent waves continue infecting people across the globe.
244. Therefore, with regards the time or duration of the waiver the revision text states that the waiver shall be in force for at least three years from the date of this decision. And the uncertainties and reasons that we just cited along with the concerns raised by Members in earlier meetings on the original text, the proponents have proposed this, this also clearly captures the temporary nature of the waiver. Furthermore, the General Council shall determine the date of termination of the waiver, once the exceptional circumstances justifying the waiver cease to exist.
245. What needs to be guiding us while deciding on the timeline therefore is that the duration also has to be practical for manufacturing to be feasible and viable. The complexities and uncertainties related to the pandemic suggest the need for a practical and flexible duration. Hence it is proposed that the General Council assesses the existence of the exceptional circumstances justifying the waiver after a minimum period to determine the date of termination. The proposed language is based on Article IX (4) of the WTO Agreement. Importantly, in accordance with the provisions of paragraph 4 of Article IX of the WTO Agreement, the waiver shall be reviewed by the General Council not later than one year after it is granted, and thereafter annually until the waiver terminates.
246. Now coming to the implementation of the waiver, we have reiterated that the waiver is not a prescriptive tool, it's an enabler. National implementation of the waiver depends on a country's political and/or constitutional arrangement. There is no one size fits all approach to national implementation. However, once the waiver proposal is approved, emergency, disaster management legislations or any other relevant legislative methodology may be relied upon to provide for executive action to operationalise the waiver at the national level. Many governments have/are already using executive action to put in place lockdowns, quarantine, and other measures to curb the spread of present pandemic.
247. As we have mentioned, at several meetings earlier on this issue the national implementation should be left to national governments as each operates within its own legal system. We also believe that in many cases implementation may be done through executive action, relying on existing national legislation or through use of emergency legislative provisions.
India's statement at the informal meeting held on 6 July 2021
248. Chair let me thank you for your efforts in taking this process forward, the past few meetings in the small group format were quite helpful in taking these discussions forward and inputs from Members does help in improving the text and arriving at a landing zone.
249. Chair before coming to the substantive part of the intervention, as suggested by you yesterday Chair, I take this opportunity to inform Members on the outreach undertaken by the proponents of the waiver Proposal. In continuation of our outreach to Members on this proposal in the last two weeks proponents have engaged bilaterally with several Members and have explained in detail the reason, rationale behind the proposal, with an aim to respond to all concerns raised. In these discussions we proposed to some Members to engage bilaterally on the text and iron out the differences in a focused manner, however, there seems to be little enthusiasm among these Members to engage bilaterally to discuss the text. Generally, Members have been receptive of such bilateral during fisheries negotiations, chair this lack of enthusiasm substantiates our fear that some Members have agreed for TBN but not with an intent of concluding it.
250. Chair in the short time span when we have begun 13 million people have got further infected, and 430 thousand more lives have been lost. In total so far there have been over 184 million confirmed cases of COVID-19, including 3.9 million deaths, reported to WHO as per the WHO COVID19 dashboard of 4th July 2021. Chair, time is of the essence we do not want to miss the opportunity of finalizing the waiver in July and get going on finding modalities for ramping up production for COVID-19 related health products.
251. As of 1 July 2021, a total of 2.95 billion vaccine doses have been administered. 75% of these doses, however, have been administered in the developed country Members. Only about 1% of people in low-income countries have received at least one dose. Until June not more than 3 billion vaccines have been produced, it is difficult to fathom how without taking exceptional measures, like agreeing to the waiver proposal, will we be able to reach an output of even 10 billion doses by the end of the current year. Again, we often forget that it is not just the availability of supply but also the vast inequity both in accessibility and affordability of these supplies.
252. Previously as well, in several discussions the proponents of the waiver proposal have presented their understanding and rationale behind the proposed implementation and duration of the waiver. We are grappling with a novel pathogen, still many unknowns remain with respect to the duration of immunity provided by the vaccines, whether there will be a need for a booster dose, or the requirement for an annual vaccination also there are varying reports on how long it will take to roll out vaccination globally to ensure immunity. Demand in developed country Members for booster doses and vaccines for teens and children will further impact supply in developing countries. And even more importantly, vaccines will not only be needed in 2021 but also beyond. Some developed country Members have already reserved vaccines right up to 2025.
253. Among all these uncertainties one thing is certain and clear to us that wherever vaccination rates are higher the severity of the disease in the form of hospitalization and mortality is lower. Augmenting the manufacturing of vaccines as of now seems to be the only way to save lives and therefore we should aim for producing 14 billion doses by the end of 2021.
254. Chair, apart from vaccines production for therapeutics, diagnostics and other COVID-19 related health products will also need to be ramped up to diagnose and treat people as subsequent waves continue infecting people across the globe. The pandemic has already gone on for 1.5 years and right now no end in sight with infections rising in most countries. While the pandemic continues unabated it would be unwise for us to have a short time frame for a TRIPS waiver.
255. What needs to be guiding us while deciding on the timeline therefore is that the duration of the waiver must be practical to scale up manufacturing a noticeably short time might not be feasible and viable for the intended purpose of ramping up manufacturing.
256. With these reasons in mind the proponents in the revision text have proposed that the waiver shall be in force for at least three years from the date of this decision. This also was in response to concerns raised by Members in earlier meetings on the original text, this duration also clearly captures the temporary nature of the waiver. The duration of three years is also reflective of the fact that co proponents at no point in time have intended for the waiver to be of an indefinite nature.
257. Further it is proposed that the General Council assesses the existence of the exceptional circumstances justifying the waiver after a minimum period to determine the date of termination. The proposed language is based on Article IX (4) of the WTO Agreement. Importantly, in accordance with the provisions of paragraph 4 of Article IX of the WTO Agreement, the waiver shall be reviewed by the General Council not later than one year after it is granted, and thereafter annually until the waiver terminates. And as was discussed in the small group meeting yesterday we are open to deliberate on these aspects further based on any suggestions.
258. Now coming to the implementation part of the waiver and responding to the concerns raised by Members with respect to lack of guidance or mechanism in the text on the domestic implementation of the waiver, we have reiterated that the waiver is not a prescriptive tool, it is an enabler and therefore national implementation of the waiver depends on a country's political and/or constitutional arrangement. There is no one size fits all approach to national implementation. However, once the waiver proposal is approved, emergency, disaster management legislations or any other relevant legislative methodology may be relied upon to provide for executive action to operationalise the waiver at the national level. Many governments have/are already using executive action to put in place lockdowns, quarantine, and other measures to curb the spread of present pandemic.
259. TRIPS flexibilities have played a crucial role in promoting access to medicines. The use of such flexibilities and the waiver are not mutually exclusive. However, the global pandemic presents exceptional circumstances for the international community that demands an exceptional global solution. After all, countries all over the world have had to put in place extraordinary measures to contain COVID-19.
260. Compulsory licences are issued on a country by country, case by case and product by product basis, where every jurisdiction with patents would have to issue compulsory licence, practically making collaboration among countries for the development and manufacturing of medical products (where different components are sourced from different countries) onerous.
261. Further Article 31bis mechanism (that waives the condition in Article 31(f) that a compulsory licence should be predominantly for the supply of the domestic market) established to support countries with insufficient pharmaceutical manufacturing capacity has been found to be cumbersome like the mechanism includes procedures such specific labelling or marking of products; special packaging and/or special colouring/shaping of products. Moreover, the E.U proposal does not bring any value add to the existing flexibilities, it seeks to clarify something that is not in dispute on the contrary could limit existing flexibility.
262. Much has been said about "business as usual voluntary licensing" as the way out of this pandemic and yet more than a year on, this "business as usual" approach premised on voluntary, secretive, limited and restrictive licensing has failed to leverage global expertise and capacity to scale-up manufacturing and deliver equitable access. Instead, this approach has limited competition, and is artificially constraining global supply.
263. These "business as usual" approaches championed by some Members is not the global solution but really the root cause of why to date we have less than 1% of people in low-income countries that have received at least one dose.
264. The global needs are massive and can only be addressed with global sharing of technology, knowledge and related IP, which is what our waiver proposal seeks to achieve. We believe it would be naïve for any country to think that it can win over a virus, which knows no boundaries, by securing vaccinating their own population. By putting boundaries to and limit Members policy options in combating the virus that knows no boundary seems to be counterintuitive.
265. A recurring concern against the waiver proposal is the impact on the incentives for the development of diagnostics, therapeutics and vaccines. Generally, R&D in emerging infectious diseases (EIDs) has been driven by public investment. The narrow emphasis on maintaining intellectual property to increase resources for private pharmaceutical R&D, disregards the fact that rapid development of COVID-19 diagnostics, therapeutics and vaccines is the sum of public funding and global collaboration. The waiver is more than just a legal mechanism, it is a statement of intent by all countries that they accord highest value to protecting human lives rather than protecting private profits.
266. The TRIPS waiver is a necessary, proportionate, and temporary legal measure for clearing IP barriers paving the way for more companies to produce COVID-19 vaccines and other health products and technologies by providing them freedom to operate without the fear of infringement of IP rights or the threat of litigation.
267. Chair, to conclude we would say we all need to rise to the demands of this crisis and show to the world that WTO is still relevant and very much capable of responding to the global need of saving lives and livelihoods, at least during a health crisis like COVID-19. We have been open to the suggestions from Members on the text of the Proposal and look forward to subsequent discussions in small group meetings or other formats including further discussion on elements like undisclosed information, duration or any other aspects and look forward to a constructive discussion in small group meetings.
India's statement at the small-group meeting held on 9 July 2021
268. Chair let me begin by some comments on the implementation aspect of the waiver. Among WTO Members there is a diversity of legal systems, hence national implementation of waiver depends on a country's political and/or constitutional arrangement. Similarly, the parameters and conditions of implementation should be a national decision. Each country will need to decide what is needed nationally to curb COVID-19 and the parameters of implementation. One size does not fit all as the legal systems, needs and conditions varies from country to country. In fact, the IP systems instituted in Member countries differ from each other. Therefore, the proponents of the waiver have not prescribed definite set of rules or methods as far as national implementation of the waiver is concerned.
269. In order to expeditiously implement the TRIPS waiver each Member should decide what is the best approach in the context of their legal system and this need not involve an amendment of the intellectual property laws.
270. Some countries have invoked emergency provisions or enacted legislation to implement the wide range of measures required for effective response to the COVID19. Such legislation may also provide governments the discretion to implement measures with respect to existing laws or privileges and such provisions could be used for the implementation of the TRIPS waiver. In some country's emergency legislations has been utilised to make changes to intellectual property legislation.
271. Apart from the emergency powers the executive may also have certain powers under the Constitution to issue orders suspending or amending the legal provisions. For instance, I can give an example for India where if both houses of the parliament are not in session, to avoid delay in passing a legislation the executive can give effect to the waiver decision through an ordinance. Under Article 123 of the Constitution "the President is satisfied that circumstances exist which render it necessary for him to take immediate action, he may promulgate such Ordinances as the circumstances appear to him to require". The ordinance can then be tabled for the approval of both house of parliament within six months from the date of its promulgation and becomes law after the obtainment of the assent of the parliament. WTO Members may also have disaster management laws to organise an effective response to disasters including a pandemic. These laws may also contain provisions providing powers to the government to suspend the operation of legislations to take effective measures. There is also the option of amending national intellectual property legislations. Such an amendment need not be a time-consuming exercise. In this pandemic we have seen governments fast tracking enactment of legislation and taking extraordinary measures for controlling the pandemic.
272. Since the outbreak of the pandemic, almost every country has implemented or is still implementing lockdown in some form or other to contain the spread of COVID-19. That does not mean that authorities of these countries were against the fundamental rights of "freedom of movement" of their citizens. Governments worldwide have also introduced fiscal packages to the tune of trillions of US dollars to help the recovery of ailing economies. That does not mean that they have deviated from their stated objective of fiscal consolidation towards fiscal profligacy. In the same light, the temporary waiver from certain provisions of TRIPS Agreement does not mean that the co-sponsors are against the Intellectual Property Rights but are arguing only for a temporary departure therefrom to ensure enhanced manufacture, timely supply and enhanced accessibility as well as affordability of health products essential for prevention, treatment and control of COVID-19. The global community has resorted to exceptional measures in the exceptional circumstances of pandemic, and the waiver should be seen in a similar vein. The proposed waiver requires a one-time implementation and, for the duration of the waiver, will remove legal barriers, create freedom to operate facilitating collaboration at the regional and global levels, allow economies of scale to be achieved, motivating further manufacturing, and consequently lower prices. With a waiver, the administrative and procedural delays and conditions linked to Article 31 and 31bis will be avoided, meaning that countries will have full freedom to collaborate, manufacture and supply the required products.
273. Some arguments from Members portray that it is the IP system and the incentives that accrue from this system that has driven all innovation and R&D. However, it cannot be denied that it was public funding, the institutional support in terms of research contributions by public universities, the global collaboration in sharing of genome sequencing data and public health information that has led to the development of successful vaccines in record time. We respect the intellectual property rights and their value as incentives for innovation, but for the COVID-19 pandemic research and innovation has mostly been spearheaded by massive public funding, expedited regulatory approvals, and global collaboration. While millions of lives have already been lost, and no respite is in sight, where the only thing certain is the uncertainty, we cannot just rely on endeavours and voluntary mechanisms of a handful of private companies to secure an end to this pandemic. The proponents have always argued that the waiver is not standing in the way of any other solution or way that we could pursue, it is one of the many ammunitions in the policy arsenal of Members that can be deployed to fight the virus. The waiver is a collective response to a collective crisis; this should not be viewed as a zero-sum game.
274. Let me quickly reiterate our understanding and rationale behind the proposed duration of the waiver. We are combating a novel virus. There are emerging variants and mutations that lead to uncertainty with respect to the duration of immunity provided by the vaccines, the effectiveness of these vaccines against these new variants, whether or not there will be a need for a booster dose, or the requirement for an annual vaccination, the need and efficacy of vaccines for children and teens, and the duration of immunity conferred by them. All these factors determine the scale of manufacturing needed and supply that will be needed to control the pandemic, and this is just for the vaccines. Production for therapeutics, diagnostics and other COVID 19 related health products will also need to be ramped up in order to diagnose and treat people as subsequent waves continue infecting people across the globe.
275. Therefore, with regards to the time or duration of the waiver the revision text states that the waiver shall be in force for at least three years from the date of this decision.
276. While deciding on the timeline or the duration one has to keep in sight that this duration is practical, feasible and viable for scaling up manufacturing, however, as said in last small group meeting as well proponents are open to constructive suggestions on the duration and would rather have Members provide an alternative to this formulation than raising similar question on the duration.
India's statement at the informal meeting held on 14 July 2021
277. Chair, thank you for your opening remarks summarizing the discussions that took place in the small group meetings. Also Chair I take this opportunity to thank you for your efforts in organizing and taking forward these discussions. Since the previous formal TRIPS Council meeting on the 8-9th June 2021 we have had several rounds of small group meetings and informal Council meetings to take stock of the progress made. These meetings gave further opportunity to Members to discuss in details key elements of the waiver proposal like the scope of products as well as on the scope of IP, implementation issues, the duration for which the waiver would be in place and other elements.
278. I thank South Africa for their comprehensive summary on these discussions that were held in these small group meetings. It is helpful for the information of the larger membership participating today.
279. Chair, briefly, as you suggested we would inform on our outreach with Members. Chair, in the last few weeks the proponents have continued their outreach to Members and have engaged bilaterally with several Members explaining in detail the reason, rationale, and our understanding behind the proposal, and have responded to the many concerns raised. In these discussions we proposed to some Members to engage bilaterally on the text and iron out the differences in a focused manner, however, there seems to be little enthusiasm among these Members to engage bilaterally to discuss the text. Generally, Members have been receptive of such bilaterals during fisheries negotiations. Chair, this lack of enthusiasm substantiates our fear that some Members while agreeing for text-based negotiations in 8-9 June TRIPS Council meeting, have shown lack of interest when the actual process started thus not allowing a text-based negotiation.
280. The Pandemic will not wait for MC12. Its spread will continue unabated negatively impacting lives and livelihoods. Also the virus will not take a break or pause while we go for our summer break and come back to the issue of scaling up manufacturing and ensuring equitable access in September after whiling away our time in July and taking a break in August. As responsible Members we have responsibility to conclude this if we all agreed to start it and reach a minimal understanding on the text by July end.
281. Chair, in the past nine months that we spent discussing the waiver we have lost 3 million more people, with new variants adding to the uncertainties surmounting us, only 2% of least developed countries (that represent 14% of the world population) and 23% of developing countries (that represent 70% of the world population) have received at least one shot as of 23 June 2021 compared to 46% of developed world receiving a shot. This huge disparity and gap in accessibility and affordability of vaccines must be a driving force for us to deliver an outcome in the form of waiver.
282. Despite Members agreeing to the collective goal of saving lives and the consequent need for augmenting production of vaccines, therapeutics and diagnostics needed to combat COVID-19 we see lack of urgency and enthusiasm in some Members to reach a conclusive decision on the waiver. Chair, time is of the essence we should not miss the opportunity of finalizing the waiver in July and get going on finding modalities for ramping up production for COVID-19 related health products.
283. Each nations' interests are entwined with that of the other, while developed country Members have outpaced developing and LDCs in vaccinations and have also secured supplies for future doses such differential approach will not yield results of ending the pandemic, as the virus will not differentiate and discriminate in affecting people.
284. The extraordinary circumstances of the pandemic demand more than a minimal or even moderate collective response and everyone in a position to contribute must do so. Members have agreed to pursue different approaches simultaneously in this regard and without prejudice to each other. The co-sponsors of the waiver proposal have reiterated that they welcome all proposals, and that each proposal should be considered on its own merit and follow its own course. And we have engaged in discussions on the E.U proposal as well in good faith. We have never said that there could be only one approach which could deliver, no single mechanism will be able to provide a perfect solution for this crisis. There have been questions with regards the uncertainty that waiver may bring on the contrary Chair we understand that in fact the waiver would provide more companies with freedom to operate to produce more without the fear of infringing another party's rights and the threat of litigation.
285. While Members have been undertaking extraordinary measures domestically in the form of lockdowns, quarantine and restricting movement of its people thereby essentially curtailing their fundamental human rights, for the larger and greater good. We have seen there has been no problem in the implementation of such extreme measures. Similarly, the economic stimulus packages that many Members have provided to their domestic industries without a prerequisite of this stimulus not being used to target exports which can potentially distort global trade. All these extraordinary measures were taken, and no questions were raised as to their compatibility with WTO agreements or Members' international obligations. The waiver should also be viewed in a similar vein as a temporary and extraordinary measure.
286. From what has been reiterated often by some Members that they do not see the waiver as a response to the crisis. This argument compels us to think that perhaps we do not share the urgency, severity, and the need for quick solution to put an end to the pandemic. The waiver is necessary at this time as the existing flexibilities in the TRIPS Agreement have not proved to be sufficient in the context of the pandemic. Additionally, the insufficient voluntary mechanisms and engagements by pharmaceutical companies to scale up manufacturing makes the waiver much needed for radically increasing manufacturing capacity and thus ensuring sufficient supplies and facilitating pathways to achieve equitable access. The waiver will be a critical ingredient of the multi-pronged approach to combat the pandemic.
287. The EU proposal talks only about compulsory licence under Article 31 and Article 31bis of the TRIPS Agreement. These Articles are confined to the issue of patents. Hence, the proposal by the EU attempts to address only patent barriers and not intellectual property barriers in general in responding to the pandemic. Issues such as trade secret, copyright, industrial designs, etc which are equally important barriers are out of the purview of this proposal. The proposals by the EU are confusing and repeat what is already addressed under Article 31, Article 31bis and the Doha declaration on public health. Importantly, the proposal by the EU contains only 'may obligations' which makes these proposals even more redundant in addressing the COVID-19 pandemic. The EU proposal even fails to address the problems with current Compulsory Licensing procedures under the TRIPS Agreement such as requirement under Article 31bis for mandatory differential packaging and colouring of products under the compulsory licences. Also, requirements of notification of quantities and other details under Annex of the TRIPS Agreement which delays the process of exporting compulsory licences products instead of simplifying it are important. What the proposal covers is a reiteration of existing provisions of TRIPS Agreement. We wish to know 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. Additionally, we would like to know 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.
288. 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. Beyond patents, other IP rights, including trade secrets, industrial designs, copyrights, etc. also pose barriers. Compulsory Licensing does not address the barriers posed by these rights. In fact, these limitations posed by the compulsory licences 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.
289. Chair, lastly, it's imperative upon us that we logically and meaningfully conclude what we started, it is important that the waiver proposal is taken forward constructively and finalized expeditiously. The report to the General Council should convey both the importance and urgency to conclude the discussions and finalize the waiver. Any other discussions on other proposals should be looked at parallelly and not as mutually exclusive to the waiver proposal.
290. We talk of restoring the credibility of this organization, but this cannot be achieved without delivering on the solutions that would help scale up production of life saving vaccines, therapeutics and diagnostics and ensure access for all.