28. Thank you for your continued efforts on advancing the discussion on this important topic and on your report from our discussions. We fully support this report, both the factual and objective reflection of the complex situation that we are dealing with in this debate. We are also ready to continue the debate after the summer break in a similar manner as we have organised our exchanges in the last couple of weeks. The EU continues to be committed to achieving our common goal to continue ramping up production to share COVID-19 vaccines and medicines more widely and faster, and to ensure equitable access to these products for low- and middle-income countries. We already see incredible progress in the total global production of COVID-19 vaccines. According to Airfinity, a billion doses were produced by 12 April, another billion were produced by 26 May and the third billion by 22 June. It is clear, that the production is accelerating, and it is therefore realistic to expect that some ten billion doses will be produced by the end of 2021. For comparison, the total global output of all vaccines was only five billion doses.
29. But this is not enough. We need to continue our efforts to further ramp up production and to ensure equitable distribution of COVID-19 vaccines and medicines. In this context, we must focus our efforts where they can deliver best results in the shortest possible time. Setting up and ramping up the production of vaccines is a highly complex process which requires adequate facilities, trained personnel, raw materials and other inputs. It is a complex issue that cannot be solved by one simple solution. The overall strategy is not only within the WTO either. The World Health Organization, other organizations, institutions and initiatives such as the COVAX Facility are working on these solutions. In the WTO, we are collectively looking at possible measures to support the increased production of COVID-19 vaccines and medicines to the extent it is possible in the context of the WTO framework.
30. The intensive discussions in this Council, as well as in other fora have demonstrated that limited manufacturing capacity and restricted access to raw materials and other inputs are the main bottlenecks as regards the production and distribution of COVID-19 vaccines. In addition, having the required know-how is key due to the complexity of the production process of these vaccines. Information collected by the WTO on the bottlenecks regarding critical COVID-19 products indicate that one common theme emerges and that is that essential goods and inputs need to flow efficiently and expeditiously to support the rapid scaling up of COVID-19 production capacity worldwide. The delay of a single component may significantly slow down or even halt vaccine production given the globally integrated supply chains that underpin COVID-19 vaccine manufacturing. This is where we should focus our efforts because these are the real-life problems and in-points when it comes to the production of COVID-19 vaccines and medicines. And this is where trade-related measures, if agreed swiftly, could make a real difference.
31. In order to deal with these bottlenecks with the use of trade-related measures at our disposal at the WTO, the EU believes a multi-pronged approach is needed. We need to look into export restrictions, minimize barriers to trade and put forward trade facilitation measures. The European Union, together with other Members had been at the forefront of these efforts for a number of months in the context of the Trade and Health Initiative by the Ottawa Group. This Initiative provides pragmatic proposals on these issues as well as on enhancing partnerships between innovative companies and manufacturers with adequate production capacity. We would like all WTO Members to join this initiative. In addition, building on the idea also presented in the trade and Health Initiative on 4 June the European Union submitted to the WTO General Council a communication on urgent trade policy responses to the COVID-19 crisis, document WT/GC/231, calling for a multilateral and comprehensive response by trade-related measures to the COVID-19 pandemic.
32. Given the nature of the identified bottlenecks and particularly the fact that they are not related to intellectual property, we do not believe that the full suspension of the TRIPS Agreement is the appropriate and effective measure to increase production and enhance the global, equitable and affordable access to COVID-19 vaccines and medicines. It is a false path, not only it will not increase production of vaccines and medicines as it will not address any of the existing bottlenecks, but also it will have counter-productive effects on our common efforts to enhance access to COVID-19 vaccines and medicines. In addition, it may have harmful effects going forward, when it comes to fighting future pandemics and overall, on the incentives for innovation. Vaccine research and production is generally not profitable and IP incentives are key to maintaining research in this area, in particular for the benefit for many lower-income countries where infectious diseases remain a significant problem. We will not repeat today all the arguments that we have put forward on multiple occasions, and in that regard, we ask the Secretariat to add all the EU statements made in informal TRIPS Council meetings to this statement, so that all these arguments are properly recorded.
33. Today we would like to recall the most important shortcomings of the proposed waiver. First of all, as already mentioned, the waiver focuses on intellectual property while the real bottlenecks lay elsewhere. In other words, the waiver has a wrong target. Second, it would operate against what should be our priority now, that is, to enhance transfer of technology. As mentioned, we are dealing with a highly complex manufacturing process, there is no other way to go about this manufacturing than knowing the exact recipe. This is crucial to be able to produce vaccines that are both effective and safe. The part of the recipe that is revealed in patent applications, which by the way have not even been published yet with regard to the relevant products, is far from sufficient to start a manufacturing process. A real collaboration needs to take place between the vaccine developer and the manufacturer. We have examples of multiple such ongoing collaborations, exceeding anything we know from the past. All these collaborations are based on one and the same framework, the protection provided by intellectual property. This platform provides for guarantees, a safe framework, and in this way helps in building trust between various actors. It is clear what happens when this platform is taken away – the framework falls apart and the relationships built on trust are broken.
34. The waiver proponents never answered the question as to how an action that undermines the existing collaborations, and the transfer of technology can be at all beneficial under the current circumstances. We all agree that we need to enhance transfer of technology to increase the manufacturing capacity for vaccines and medicines, also taking into account the preparedness for future pandemics. But this is a process that needs to be built on voluntary collaboration and trust, it is not by lifting intellectual property and inviting disclosures of information, that would constitute breaches under agreements entered into between vaccine developers and various manufacturers, that such collaboration and trust are built. This is the wrong and very short-sighted approach that will not bring any benefit but introduce confusion and a lack of legal certainty. We need to create conditions that will invite the transfer of technology, strengthening manufacturing capacities and resilience of the health systems of lower- and middle-income countries, creating conditions for investment, including via adequate regulatory frameworks, in order to attract the private sector where their technology is crucial.
35. In that regard we would like to give an example of the Team Europe Initiative, an integrated and comprehensive support package that will tackle barriers to manufacturing and access to health products and technologies in Africa from all angles. This initiative encompasses three dimensions: supply side, demand side and enabling environment of the health system. On the supply side the initiative will incentivise and de-risk investment into local pharmaceutical and biotech companies. The Team Europe Initiative will support technology transfer and develop a number of regional manufacturing hubs in alignment with the African Union and the Africa Centre for Disease Control and Preventions which recently launched the Partnerships for African Vaccine Manufacturing. On the demand side the Initiative will work with African leaders and communities to tackle the fragmentation of local markets and help consolidate demand, facilitate market integration and the use of locally produced goods. The Initiative will substantially strengthen pharmaceutical and health systems, thus creating an enabling environment for sustainability. It will contribute to developing human resources by investing in skills and education, by increasing Africa research capacities and by enhancing scientific cooperation between the two continents. This Initiative will also address the problem of falsified products and boost confidence in local goods by strengthening regulatory frameworks. The European Commission is also willing to support digital solutions, for example, to trading vaccines and medicines across the supply chain. The Team Europe support and funding for vaccine production is also under way in a number of countries in Africa.
36. To improve the vaccine supply we are also working with industry to optimise the use of our existing capacity while building more capability. This will allow us to address the needs of EU citizens as well assist supply to third countries and low-and middle-income economies. We are doing that through the Taskforce for Industrial Scale-up of COVID-19 vaccine production, set up in February 2021. The Taskforce, operating under Commissioner Breton's responsibility, ramps up production capacity for vaccines in Europe and acts as a one-stop-shop for manufacturers in need of support. The Taskforce work includes mapping European vaccine production capacities throughout the supply chain, identifying, addressing and eliminating production bottlenecks in terms of capacity and supply chain issues, and promoting partnerships through matchmaking events for vaccine and therapeutics production.
37. The third shortcoming of the proposed waiver is the fact that it does not in any way specify what measures Members will be permitted to introduce as a result of the waiver. It is the normal practice with waivers that certain provisions are listed in order to allow specified measures. Here we are dealing with a situation where the TRIPS Agreement is lifted almost in its entirety and there is no clarification as to what measures can be taken in what manner. This causes enormous risks that we have pointed to in the previous meetings, ranging from invalidation of existing patents which could result in the impossibility of restoring protection even after the waiver expires, the denial of new patent applications which could result in product and processes losing the possibility of being patented in the future, invalidation of voluntary agreements licensing patents, and therefore a chilling effect on collaborations by removing incentives of the developers of the original products to provide know-how and technology to manufacturers of biosimilars and so on. In short, a great legal uncertainty with potentially long-lasting negative effects as regards production, distribution and access to vaccines and medicines.
38. We are ready to continue to discuss, to present our arguments in more detail, but also given the important shortcomings of the waiver proposal, the EU made an alternative proposal to this Council, the objective of which is to ensure that IP is an enabler for the use of the available and adequate manufacturing capacity as regards COVID-19 vaccines and medicines. We will say more about this proposal under the next agenda point and would like to encourage further engagement of Members. We are looking forward to advancing on this proposal and finding a common ground that would allow us to ensure that IP plays an enabling role in enhancing access to COVID-19 vaccines and medicines.
European Union's statement at the informal meeting held on 17 June 2021
39. The European Union would like to thank you for convening small-group consultations on the manner in which to take the text-based process forward. We have presented our position on the modalities of this process in the course of the small-group consultations. We would like to recall the main points and reiterate our position on the matter.
40. As stated at the previous meeting of the TRIPS Council, the European Union is ready to constructively engage in the text-based substantive process to find a way forward in this discussion on the role of intellectual property in enhancing access to affordable COVID-19 vaccines and therapeutics, and to proceed with concrete and pragmatic short- and medium-term solutions to enhance universal access to COVID-19 vaccines and therapeutics at affordable prices.
41. This discussion is part of a comprehensive approach to the crisis presented by the European Union in a communication on "Urgent trade policy responses to the COVID-19 crisis", document WT/GC/231, calling for a multilateral and comprehensive response by trade-related measures to the COVID-19 pandemic. We would like to emphasise that it is the view of the European Union that only a multi-pronged approach addressing the identified bottlenecks such as limited manufacturing capacity and access to raw materials can bring about a real change.
42. We are ready to immediately start a discussion based on the proposal set out in our communication on "Urgent trade policy responses to the COVID-19 crisis – intellectual property", document , submitted to this Council on 4 June, and intend to follow up in the coming days with a more elaborated text. We would like to thank you, Chair, for planning for a date for presenting our proposal.
43. At the same time, as mentioned at the previous meeting, the EU is ready to continue discussing the revised waiver proposal though we are not convinced that the broad waiver proposed by a number of WTO Members is the right response to the pandemic.
44. This is why the EU wants to include in this discussion our different and more targeted approach. We hope that we will be able to convince Members that our approach, including the components that will be addressed in the General Council, represents the best way to respond to the crisis in the short term in an effective and pragmatic manner.
45. We would like to recall that our proposal is based on the discussions that we have had in this Council over the last couple of months. In the course of these discussions, we have been examining various ways in which intellectual property can help in enhancing access to affordable COVID-19 vaccines and therapeutics. One of the results of these discussions is that a number of WTO Members identified aspects related to the use of compulsory licensing that, in their view, limit the use of this tool. The EU proposal aims to address these aspects, provide more legal certainty and enhance the effectiveness of the compulsory licensing system.
46. We note that our proposal has been welcomed by a number of delegations as a constructive contribution to the ongoing discussion. The revised proposal on the waiver and the EU proposal represent different approaches to the problem of the availability of COVID-19 vaccines and therapeutics and are based on different premises. We are of the opinion that it is key that Members can benefit from having a possibility of discussing these two approaches alongside one another and we request that our proposal is treated and discussed on an equal footing with the revised proposal on the waiver.
47. We also note that in the previous meeting the Chair recognised that there are still divergent views both on the underlying assumptions of the revised waiver proposal and on the specifics. There is no agreement among Members that the waiver can achieve our common goal, i.e. enhancing access to affordable COVID-19 vaccines and therapeutics.
48. In order to take account of all these considerations, to provide for an opportunity to discuss all pertinent issues and to facilitate the examination of both the revised proposal on the waiver and the EU proposal, we request a theme-based approach for our process that we would like to reiterate here for consideration of all Members. This approach would be based around the following themes:
Scope – under which we would examine
a. Provisions of the TRIPS Agreement covered:
i. which provisions are affected and why – this for us is the first priority for setting the basis for our discussion; and
ii. we would also compare waiving entire sections of the TRIPS Agreement to the targeted approach proposed by the EU.
Effects short-, medium- and long-term – under which we would examine effects of each proposal
a. on vaccine/medicine production;
b. on transfer of technology;
c. on legal certainty as to which IP rights continue to apply - effects on the current and future cross-licensing; and
d. on ongoing partnerships and concluded agreements.
Products – under which we would discuss the products covered by each proposal including issues such as
a. How the link with COVID is determined; and
b. Definition of a pharmaceutical product in the Annex to the TRIPS Agreement.
Duration – under which we would examine for each proposal
a. End date
b. Restoration, where applicable, (by type of IP right)
c. Compatibility with the WTO rules
Implementation in national law – under which we would discuss
a. Which measures are needed domestically to implement each of the proposals
b. How will these measures relate to the current legislation on compulsory licensing?
c. Effects on procedures of national IP offices
Links of the proposals with other international obligations
49. Of course, the sub-points are not exhaustive but are meant to indicate the aspects that we find the most pertinent for our discussion.
50. As regards the proposed calendar of meetings, we agree to the proposed schedule of weekly TRIPS Council informal sessions. We are also ready to discuss the use of small groups and will also engage bilaterally with Members to present our proposal.
51. As regards the proposed meetings in a small group starting next week, we would have preferred it to be scheduled after our proposal is presented on 24 June and ask for this request to be considered, but should that not be possible, we request that our proposal is discussed in this small group meeting on an equal footing with the revised proposal on the waiver.
52. We would like to thank you, Chair, for your efforts to find a pragmatic manner in which to organise the process before us and we remain committed to constructively engaging with all Members to find a pragmatic, inclusive and effective way forward.
European Union's statement at the informal meeting held on 6 July 2021
53. Chair, thank you for your efforts in advancing our discussions. We would also like to welcome Deputy-Director General Gonzalez and thank her for devoting her time and attention to this important matter. Enhancing equitable access to COVID-19 vaccines is the priority for the European Union and this is our objective in this discussion.
54. The European Union appreciated the possibility provided by the small group meeting to explain in more detail the EU proposal and to discuss the revised waiver proposal. We would like to thank all the delegations that engaged in the discussions and hope that the input provided by the European Union has been helpful in taking this discussion forward.
55. The European Union remains fully committed to this process and to finding the best way forward to ensure that the intellectual property system plays an enabling role in the context of deploying existing capacity or creating new capacity for the production of COVID-19 vaccines and medicines while keeping intact the necessary incentives that the intellectual property system provides to researchers of new vaccines and medicines to fight against the current and future variants of the virus that causes COVID-19. We will continue to engage constructively and are open to discussing all approaches that contribute to enhancing access to affordable COVID-19 vaccines and medicines and can bring results in an urgent manner.
56. Even though the discussions on the duration and implementation and especially on the implementation have not been finalised in our meeting of yesterday, the European Union would like to use this opportunity to recall some of the most pertinent, in our view, points that have been raised and which, in our view, deserve further discussion at the next small-group meeting.
57. Starting with the EU proposal for a General Council Declaration on the TRIPS Agreement and Public Health in the Circumstances of a Pandemic, document , the EU has provided explanations on the duration and implementation of the EU proposal:
a. As regards the duration, the EU proposal clarifies certain requirements of the compulsory licensing system for the circumstances of a pandemic, therefore these clarifications will apply not only in the times of this pandemic but also in other such cases – as we said previously, this is of course without prejudice to other situations of 'national or extreme urgency' that Members may decide on in accordance with the TRIPS Agreement.
b. As regards the implementation, we would like to recall that we believe that one of the advantages of the EU proposal is that it can be adopted swiftly; the proposal clarifies certain provisions in Articles 31 and 31bis and the Annex of the TRIPS Agreement. As we do not aim to amend these articles, we will not require lengthy debates and procedures. The scope of these provisions will remain the same but agreeing on a declaration will remove legal uncertainty about their application and support those WTO Members who wish to use them. No implementation at national level will be required. This is how we can advance quickly and have immediate results on the ground.
On the duration aspect of the revised proposal on the waiver
58. We believe that any discussion about the duration of a measure needs to be preceded by a reflection on the impacts on the various stakeholders affected by the measure. In that respect, the discussion around the duration of the measures to enhance equitable access to COVID-19 vaccines and medicines also needs to be preceded by a reflection on the impacts in the short-, mid- and longterm, both in terms of benefits and negative impacts.
59. First, we need to make sure that the measure proposed is effective to achieve our common objective. This is a condition to accept any measure that could have negative impacts on various stakeholders or on incentives to innovate and research as well as on public health.
60. Second, only if the measure is effective, we need to make sure that the negative impacts of the measure are as limited as possible, both in terms of scope and duration, and that the benefits offset these negative impacts.
61. In the case of the EU proposal, we remain convinced that the clarification on the use of compulsory licensing under the TRIPS Agreement is effective to enhance equitable access to COVID19 vaccines and medicines, together with other trade-related measures that are part of the comprehensive approach that the EU has proposed. Moreover, the duration is limited to what is necessary ("in the circumstances of a pandemic") in order to reduce the negative impacts of compulsory licensing on patent holders e.g. waiving the requirement to negotiate with the patent holder before issuing a compulsory licensing may result in missing opportunities of agreeing on voluntary licences – however this fast-track procedure is applied in the specific circumstances of a health emergency and not as norm, therefore the negative impacts of our proposal remain limited, as they keep intact the necessary incentives to continue research and innovation on vaccines and medicines against COVID-19 and other diseases.
62. With respect to the waiver proposed in document , we maintain our fundamental concerns about the lack of effectiveness of this measure to achieve our common goal of enhancing equitable access to COVID-19 vaccines and medicines. Moreover, we believe that a discussion on the duration of the potential waiver can only take place once the effects of the proposal in the short-, mid- and long-term are analysed and discussed, in particular:
a. the impacts on transfer of technology required to produce the existing vaccines against COVID-19;
b. the impacts on research and innovation of new vaccines and medicines against the existing and future variants of COVID-19 or against future pandemics; and
c. the impacts on public health (especially in the mid- and long-term if the incentives to innovation are removed).
63. We have had some exchanges on some of these issues yesterday but not in an exhaustive manner and we think it is important that we continue discussing these topics in the next session of the small-group meeting.
64. For example, the proponents of the waiver indicated that the waiver would enhance collaborations among vaccine developers and manufacturers and therefore would also enhance technology transfer. We question how the measure that takes away the platform on which collaboration and technology transfer can occur and introduces legal uncertainty as to the licensing agreements could have this effect. We would like to ask the proponents of the waiver to elaborate on this aspect of their proposal. Transfer of technology, as we know, is absolutely essential in our efforts to ramp up production and therefore understanding how exactly in practice the waiver would affect this transfer is key for assessing the effectiveness of the measure. We understand that this and similar questions will be discussed in the next sessions of the small-group meetings.
65. Without prejudice to the discussion on the effects of the measure and the links with the duration, we also note that the provision on the duration of the waiver is proposed in a manner that does not indicate the date on which the waiver would be terminated. Following three years and subject to exceptional circumstances ceasing to exist, the General Council would determine the date of termination of the waiver. As explained at yesterday's meeting by the waiver proponents, the General Council may or may not decide on the termination in such circumstances. This would indicate that the waiver could stay in force for an undefined period of time after the exceptional circumstances, which are presented as those justifying the waiver, cease to exist.
On the implementation of the revised waiver proposal
66. The proposed waiver does not contain any indications of the mechanisms of implementation at the national level, in contrast with, for instance, the provisions of the Annex to the TRIPS Agreement applying Art. 31bis.
67. The proposed waiver is currently being discussed as though it would be directly applicable to all Members and produce immediate effects. The assumption seems to be that if the waiver is adopted and Members avail themselves of it, the relevant IP rights will be suspended, without any further action being required. But this is not the case. Each waiver of the provisions of the TRIPS Agreement requires national implementation in national systems which are aligned with the TRIPS Agreement requirements – which is the case for most of our systems. The broader and less targeted the waiver, the more complex implementation is required. The discussions we had yesterday confirm that the need for the national implementation would mean that whatever effects the proponents count on, would not materialise in the short term at all.
68. First, a national legal infrastructure would in many cases need to be created by the Members to enact measures permitted under the waiver, and in particular, to:
a. determine which IP rights would be deemed to fall under the ambit of the waiver; and
b. create a legal instrument and procedures to effect the suspensions and circumscribe their scope to the purposes provided in § 1 of the waiver.
69. In that regard we asked the proponents to explain how they see the waiver being implemented and how long this would take. Other delegations indicated that, considering that the corresponding domestic procedures often take time and may be complex, it is questionable how the waiver would provide a quick solution for the Members.
70. Further, the waiver provides no framework to establish clarity and transparency regarding the status of individual IP rights within the respective WTO Members – this creates a risk of additional legal uncertainty and further damage to the incentive function of the patent system as pointed out by a number of delegations in the course of yesterday's meeting.
71. The waiver provides no description of measures to be adopted by Members under the waiver. No measures are indicated or prescribed. There are no set boundaries to the measures which can be taken. The proponents explain that the 'waiver is permissive' and that 'the choice of measures is left to the Members'.
72. The lack of defined measures is, in our view, highly problematic and results in high risk as regards the effects of the waiver. The lack of any boundaries means that Members would be free to take any measures they deem appropriate without any accountability or scrutiny, and regardless of the impact of the waiver on incentives for innovation.
73. While the positive effects of the waiver are not proven and clearly questioned by many delegations, its effect in the short-term is likely impossible due to the need for the national implementation, the lack of defined measures and the permissiveness of the waiver proclaimed by the proponents is creating risks of harmful effects that would continue beyond the time of application of the waiver. It is not only about what procedure is used by Members – based on emergency prerogatives of the state or other – it is, beyond all, about the substance of these measures and their effects.
74. The first one concerns invalidation of existing patents: In the absence of TRIPS obligations to protect patents, Members may choose to invalidate existing patents on COVID-19 related products or processes. This would result in curtailing the patent protection without any compensation or the possibility of restoration of the right. Importantly, this could impact not only inventions that are specific to COVID-19, but also "dual-use" inventions that are relevant to both COVID-19 and other existing and future diseases. This protection would be impossible to restore once the invention would be in the public domain.
75. The second one concerns the possibility of rejecting pending patent applications: In the absence of TRIPS obligations to protect patents, Members may choose to provide that pending applications for new patents for all COVID-19-related technologies or for all products and processes relevant to the manufacture of vaccines, medicines and medical devices can be rejected. This would mean that new inventions related to these products and processes will not have patent protection and can be freely copied. In such a case such products/processes could not be patented going forward as, once known, they would lose their novelty characteristic which is one of the conditions of patent protection. In this respect, the explanations provided yesterday seem to assume that this condition of novelty could be ignored after the expiry of the waiver, but the TRIPS Agreement requires novelty to grant patents, as the novelty requirement is essential for the patent system to work properly.
76. In that regard we would like to discuss how proponents of the waiver suggest to guarantee that no measures may be taken with regard to patents or patent applications (the same goes for other registered rights) which will continue to produce effects once the waiver has terminated?
77. The other set of effects that need to be analysed are the effects on voluntary licence agreements and open licensing schemes: If existing patents are invalidated, this may in consequence also result in invalidation of the voluntary agreements licensing those patents, depending on how the new rules are implemented, under the terms of the contract and the applicable contract law. This would mean that the licensees would be free of licence conditions in their use of the invention. This would clearly undermine the ongoing collaborations and efforts to enhance production of COVID-19 vaccines.
78. As regards the collaborations based on voluntary agreements, compulsory licences or open licensing schemes, the question is – why would a waiver apply to these situations where obviously there is no barrier to access? Generally, where licences have been granted or the willingness to license has been expressed, does this not constitute evidence that the IP right in question is not a barrier to access for health products? Should the consequence be that such an IP right does not fall within the ambit of the waiver?
79. There were a number of other questions raised by various delegations including on safeguards for the holders of undisclosed information – in cases where such information enters the public domain, how exactly the proponents of the waiver suggest to protect the interests of such holders in the time after the waiver expires. It seems that if protection of undisclosed information is once disclosed, such information loses protection permanently, even after the waiver ceases to apply. This is another example of why negative impacts on holders of undisclosed information need to be carefully assessed.
80. We would also have additional questions about the implementation of the waiver that we hope to discuss today or during the meeting on 9 July.
81. We understand that the intention of the proponents of the waiver is to remove intellectual property protection from COVID-19 vaccines, medicines and medical goods for the purposes of making them public goods, so that they can be made accessible more widely to the vulnerable populations. This should entail, in practice, that the use of these inventions has a humanitarian and not a commercial objective. However, whereas the waiver takes away the obligation to remunerate the holders of intellectual property rights, we do not find any mechanism in the proposed waiver to ensure that the access to products covered by the waiver would be ensured in line with the stated objective of the waiver and not for the economic benefit of manufacturers relying on the waiver. In contrast, the EU proposal explicitly provides for a mechanism aiming to keep patent holders' remuneration in line with the non-for-profit manufacture and supply of vaccines and medicines. Therefore, we would like to ask the proponents of the waiver for an explanation: Will it be acceptable that entities benefitting from the waiver reap profits on the manufacture and distribution of health products during the pandemic, when such authorisation to use the invention has been granted under exceptional circumstances in the interest of public health? If not, how do they propose to avoid it in practice?
82. As is clear from the text of the waiver, the suspension of the IP rights should be solely for the purposes set out in § 1. Any further uses unrelated to the prevention, treatment or containment of Covid-19 shall not be covered by the waiver, and IP rights will deploy their full effects in this regard. At the same time, as discussed in the course of previous week, the waiver covers many products which are not limited to treating COVID-19 – how are proponents suggesting to guarantee that the permitted use of the invention under the waiver does not encompass use for other purposes or diseases or simply nullifies patents that are relevant for other areas?
83. The discussions we have had so far, rather than dispelling our concerns about the effects of the proposed waiver, confirm the merit of these concerns. We look forward to further discussions as a number of questions are still unanswered. For instance, the proposed duration, seems to us to be based on a certain assumption rather than evidence and underestimates the negative effects of the waiver on the system that has allowed researchers and innovation to develop various vaccines in an unprecedented time. On implementation, it seems to us that the assumption that the waiver does not require lengthy and complex implementation underestimates the challenges of implementing the waiver proposal in practice. Moreover, the approach according to which the choice of measures to implement the waiver is left entirely to Members, without any boundaries that would take account of necessity and proportionality raises concerns on the long-term effects of the waiver not only on the IP system but on its disruptive effects for access to COVID-19 vaccines and medicines.
84. The EU is looking forward to further discussions on these points and is always ready to respond to any questions on the EU proposal.
85. As was mentioned by a number of delegations, the EU believes that Members should focus on solutions which are targeted, pragmatic and that can bring results in the short-term. We invite Members to discussions on the EU proposal, which in our view fulfils these requirements. As indicated in the previous meetings, the EU is also ready to discuss other aspects of compulsory licensing system that would merit clarification to enhance efforts to scale up the production of COVID-19 vaccines, therapeutics and diagnostics. Finally, we would like to emphasise that the IP-related discussion is only a part of the multi-pronged approach proposed by the EU. We call on all Members to engage in discussions on all elements of this approach as only this way we will be able to adequately respond to the current crisis.
European Union's statement at the informal meeting held on 14 July 2021
86. Chair, we would like to thank you for your continuous efforts in advancing our discussions. Enhancing equitable access to COVID-19 vaccines and medicines is a priority for the European Union and this is our objective in this discussion. The European Union appreciated the possibility provided by the small-group meeting of 9 July to explain in more detail the EU proposal and to discuss the revised waiver proposal.
87. The European Union remains fully committed to this process and to finding the best way forward to ensure that the intellectual property system continues to contribute to enhancing equitable access to COVID-19 vaccines and medicines. We remain convinced that the current intellectual property system can play an enabling role in deploying existing capacity or creating new capacity for the production of COVID-19 vaccines and medicines while keeping intact the necessary incentives for innovation. We will continue to engage constructively and are open to discuss all approaches that contribute to enhancing access to affordable COVID-19 vaccines and medicines and can bring results in an urgent manner. The discussions on implementation during our last two meetings have been helpful to understand the positions of various delegations, in particular of those who have put forward text-based proposals.