291. Thank you for providing the European Union with this opportunity to follow up on the discussions on our proposal as submitted to the Council in document . The European Union would first like to recall that our proposal is part of a wider comprehensive approach to the COVID-19 crisis, an approach that is based on the use of trade-related measures at the disposal of the WTO to address the real bottlenecks that affect the production and distribution of COVID-19 vaccines and medicines. The European Union set out this approach in the communication on "Urgent Trade Policy Responses to the COVID-19 Crisis", document WT/GC/231 which we submitted to the WTO General Council on 4 June 2021. In that communication the intellectual property component is one element of the solution, as explained in a dedicated communication on "Urgent Trade Policy Responses to the COVID-19 Crisis – Intellectual Property" document , which the European Union submitted to the Council for TRIPS on 4 June 2021.
292. As set out in that communication, the intellectual property component focuses on the clarifications and facilitation of TRIPS Agreement flexibilities relating to compulsory licences. The European Union believes that our discussion in the TRIPS Council should concentrate on how the IP system can contribute towards increasing the manufacturing capacity and equitable access to vaccines around the world.
293. When we discussed the role, that intellectual property plays to solve the COVID-19 crisis, we should not underestimate the role that it has already played and will continue to play. The current system has provided the necessary incentives for vaccine developers to research and invest in the existing vaccines that exist against COVID-19. The world has obtained not only one, but several vaccines against COVID-19 in an unprecedented time. Researchers count on the IP incentives. We still need more effective vaccines, not only for the existing variants but also for the future ones. Therefore, we must make the most of the existing IP system, while maintaining incentives that have proven effective. With our proposal for a General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, the EU would like to find a pragmatic approach on the role of the intellectual property in enhancing access to affordable COVID-19 vaccines and medicines with concrete short- and medium-term solutions that can have quick results on the ground.
294. We agree that intellectual property rights do not and should not stand in the way of deploying existing capacity or creating new capacity or of ensuring that access to COVID-19 vaccines and medicines is equitable. The EU believes that it is possible to achieve this objective while at the same time maintaining the protection required for incentivising technology transfer and investment in innovation so that we can fight against new strains of COVID-19 and any future diseases. In our view, this can be done by using the compulsory licensing system that the TRIPS Agreement provides for and the use of which is supported by the Doha Declaration on the TRIPS Agreement and Public Health. This system provides for an IP solution to a situation when there is a producer having the ability to produce the particular product but does not have a licence from the patent holder to proceed with the production. The system can be used for domestic needs, this is the case where the country grants a compulsory licence to a manufacturer established in its territory, and the product will be predominately sold within the same country, but more importantly, under the current circumstances, it can also be used for exports. In situations where the product cannot be produced domestically at all or in sufficient quantities due to lack of capacity and where the producer having the ability to produce and willing to produce the product is located in a country where a patent is in force on that product and needs a compulsory licence in that country to produce for export.
295. When it comes to the potential IP-related obstacles, this system can work effectively, also in times of a pandemic. It actually has elements inbuilt specifically for the circumstances of an emergency and a pandemic is clearly such a circumstance. In the discussions in the Council we have heard Members assert that this is not the case. These assertions were based on seeing the system as too complex. This is precisely where the EU proposal comes in. We believe that the compulsory licensing system provides for tools that can be used in the times of the pandemic. It also provides enough legislative space to apply the system in a swift manner. The EU proposal is meant to clear any doubts that persist about the use of the system and to indicate ways in which the system can be used in a manner that is full adapted to the challenges of the pandemic. The EU proposal is based on a number of clarifications that have as their objective to facilitate and increase the effectiveness of the use of the system. We have proposed clarifications on the elements that we find most relevant for the situation of the pandemic and these are the fast-track procedure, the support for manufacturers wishing to supply to low and middle-income countries at discounted prices, and a simple single notification of the exporting country.
296. We have provided details on these three elements in our interventions in the informal meetings of this Council. We would like to ask the Secretariat to add all these interventions to the current statement for completeness of the information.
297. In our view, clarifications on the proposed aspects would provide the necessary legal certainty to Members that have the possibility of using the existing capacity or increasing their capacity to produce COVID-19 vaccines and medicines. They would also promote production and supply of those products to low-and middle-income countries at affordable prices including via the COVAX facility and this should be our priority right now.
298. In summary, the declaration to be adopted by the General Council would be based on the following premises:
a. First, it keeps entire necessary incentives that the intellectual property system provides to fight against the current and future variants of the virus that causes COVID-19.
b. Second, it builds upon the existing flexibilities in the TRIPS Agreement and content of the Doha Declaration.
c. Third, it provides legal certainty on those areas related to compulsory licencing that WTO Members have identified as discouraging them from using this possibility due to risk of being in being in breach of their obligations under the TRIPS Agreement.
d. Fourth, it contributes to our global efforts to ensure equitable access to COVID-19 in lowand middle-income countries through the COVAX facility.
e. Fifth, it addresses not only the ongoing COVID-19 crisis, but also future pandemics.
299. Finally, a declaration is a pragmatic solution that can be adopted swiftly. We need to act urgently. As the proposal does not amend Articles 31 and 31bis and the Annex of the TRIPS Agreement, we will not require lengthy procedures. In addition, the clarification that we propose can also be applied in a national legislation swiftly, with none or minimal changes to the current system as it uses the space and the flexibility provided by the system. This means that the declaration could have immediate or almost immediate results on the ground.
300. We would like to recall that our proposal emerges from the discussions that we have had in the Council over the last months. In the course of those discussions, we examined various ways in which intellectual property can help in enhancing access to affordable COVID-19 vaccines and medicines. 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 their use of this tool.
301. We thank all Members for their engagement on our proposal and for their contributions, questions, and thoughts on it so far. We have discussed our proposal in open-ended informal meetings of the TRIPS Council as well as in all small group meetings that the Chair has organised. We have received valuable feedback and we are pleased to see the interest of various delegations in continuing and exploring this approach. We have also heard suggestions from Members on other aspects of the compulsory licensing system that would, in their view, deserve further examination and eventually be included among the elements to be clarified, for example, issues related to labelling and packaging, as well as broader notification issues.
302. We are currently analysing these proposals and are ready to discuss these issues in more detail. We remain also open to discussing which other requirements concerning compulsory licensing can be clarified to facilitate the use of the system. We look forward to our continued discussion on these matters. We are confident that all WTO Members can agree with the clarifications contained in our proposal as well as those that it might be appropriate to add. It is necessary and timely, and it can have immediate impact on the ground and apply also for future situations of a similar kind. Therefore, we believe that, with the commitment of all WTO Members, we should be able to find convergency rapidly on how to clarify and facilitate the use of the compulsory licensing system.
European Union's statement at the informal meeting held on 24 June 2021
303. Chair, thank you for providing us with this opportunity to present our proposal as submitted to this Council in document . We continue to be committed to achieving our common goal: to continue ramping up production, to share COVID-19 vaccines more widely and faster and to ensure equitable access to low- and middle-income countries. Equity for us does not only mean access but also access at affordable prices.
304. We already see incredible progress in the total global production of COVID-19 vaccines with more than 10 billion doses to be produced by the end of 2021. For comparison, the total global output of all vaccines before COVID-19 was only 5 billion doses. However, further ramping up the production and, most importantly, ensuring equitable distribution of COVID-19 vaccines remain essential in the fight against time in this pandemic.
305. 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 within the WTO only either. The World Health Organization, other organizations, institutions and initiatives – such as the COVAX Facility – are working on these solutions. In the WTO, the Members must collectively find ways to address the current delays and shortages in vaccine production to the extent that is possible in the WTO framework.
306. Following the intense discussions in this Council as well as in other fora and events organised by the Director General of the WTO, Dr Ngozi Okonjo-Iweala, it is our assessment 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.
307. 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. This is why, 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.
308. In that communication, the EU proposes that WTO Members agree as soon as possible on a global trade initiative for equitable access to COVID-19 vaccines and therapeutics encompassing the following three components: 1) trade facilitation and disciplines on export restrictions; 2) concrete actions to expand production and ensure supply of vaccines at affordable prices to low and middle income countries during the pandemic and; 3) clarification and facilitation of TRIPS Agreement flexibilities relating to compulsory licences.
309. While the EU considers that the General Council should be the forum to address all three components in a comprehensive manner, the third component on intellectual property is in the remit of the Council for TRIPS. For this reason, on 4 June 2021 the EU also submitted a dedicated communication on "Urgent trade policy responses to the COVID-19 crisis – intellectual property", document , to the Council for TRIPS.
310. Further to that communication, on Monday the EU submitted to the TRIPS Council our proposal for a General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic (document . We are pleased to present this proposal today. The proposal submitted to the TRIPS Council is part of a broad, comprehensive proposal of the EU on the urgent response to the COVID-19 crisis.
311. We believe that our discussion in the TRIPS Council should concentrate on how the IP system can contribute towards increasing the manufacturing capacity and the equitable access to vaccines around the world. When we discuss the role that intellectual property plays to solve the COVID-19 crisis we should not underestimate the role that it has already played and will continue to play. The current system has provided the necessary incentives for vaccine developers to research and invest in the existing vaccines and medicines against COVID-19. The world has obtained and had access to not only one, but several vaccines against COVID-19 in an unprecedented time, less than one year. Researchers count on the IP incentives to continue developing vaccines against COVID-19. We still need more effective vaccines, not only for the existing variants, but also for future ones. Therefore, we must make the most of the existing IP system while maintaining incentives that have proven effective.
312. With this proposal the EU would like to find a way forward in the discussion on the role of intellectual property in enhancing access to affordable COVID-19 vaccines and medicines, with concrete short- and medium-term solutions.
313. Firstly, we would like to recall that in addition to ensuring the uninterrupted flow of raw materials and inputs for the vaccine production, the key issue for increasing access to COVID-19 vaccines is to enhance the transfer of COVID-19 vaccine technology. Contrary to simple chemical medicines that are relatively easy to replicate, COVID-19 vaccines involve a complex biological process which requires the relevant know-how.
314. Voluntary licences are the most effective instrument to facilitate the sharing of know-how. Intellectual property framework provides a platform that incentivises collaboration and transfer of know-how. It is thanks to the intellectual property system that knowledge and technology are disseminated. It is our view that the question as to which measures incentivise transfer of technology and which have the opposite effect, is one of the key questions in this debate.
315. This is why we would like to reiterate our view on this matter: in the context of the novel vaccine production, collaboration and licensing are key for the transfer of know-how. It may be a very different situation for simpler pharmaceutical products. In the current case, the authorisation to use a patent is only one side of the coin, but it is not enough. The patent holder, that is, the inventor of the vaccine, also needs to share its know-how with the manufacturer; and only a voluntary licence provides the ideal framework for this transfer of know-how. This is one of the key premises of our proposal. Setting up the manufacturing infrastructure to produce vaccines not only requires this know-how, but also time and resources. And this is also why Europe committed EUR 1 billion to create, with our African partners and our industrial partners, manufacturing hubs in different regions in Africa. These solutions must go hand in hand.
316. We agree that intellectual property rights should not stand in the way of deploying existing capacity or creating new capacity or of ensuring that access to COVID-19 vaccines and medicines is equitable. The EU believes that it is possible to achieve this objective while at the same time maintaining the protection required for incentivising technology transfer and investment in innovation, so that we can fight against new strains of COVID-19 and any future diseases.
317. The Doha Declaration on the TRIPS Agreement and Public Health affirms that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. It further affirms the flexibilities contained in the TRIPS Agreement, including specific flexibilities related to compulsory licences. The Doha Declaration states that each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. It also states that each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency which includes public health crises.
318. We would like to contribute to the discussion we are having in this Council with a targeted approach. We hope that we will be able to convince Members that our approach, including the key components that will be addressed in the General Council, represents the best way to respond to the crisis in a short term in an effective and pragmatic manner.
319. We would like to recall that our proposal is based on the discussions that we have had in this Council over the last 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 medicines. 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 is a response to these comments.
320. We propose a declaration to be adopted by the General Council that would be based on the following premises:
a. First, it keeps intact the necessary incentives that the intellectual property system provides to researchers on new vaccines and medicines to fight against the current and future variants of the virus that causes COVID-19.
b. Second, it builds upon existing flexibilities under the TRIPS Agreement and reaffirms the content of the Doha Declaration.
c. Third, it provides legal certainty on those areas related to compulsory licensing that WTO Members have identified as discouraging them from using this possibility due to risk of being in breach of their obligations under the TRIPS Agreement.
d. Fourth, it contributes our global efforts to ensure equitable access to COVID-19 vaccines and medicines in low- and middle-income countries thorough the COVAX Facility.
e. Finally, it addresses not only the ongoing COVID-19 crisis but also future pandemics.
321. Consequently, in order to address comments raised in the context of our discussions, provide more legal certainty and enhance the effectiveness of the system, the EU considers that all WTO Members should be ready to agree on the following clarifications of the compulsory licensing system set out in Articles 31 and 31bis and in the Annex of the TRIPS Agreement:
a. the pandemic is a circumstance of national emergency and therefore the requirement to negotiate with the right holder may be waived;
b. to support manufacturers ready to produce vaccines or medicines at affordable prices, especially for low- and middle-income countries, on the basis of a compulsory licence, the remuneration for patent holders should reflect such affordable prices; and
c. the compulsory licence could cover any exports destined to countries that lack manufacturing capacity, including via the COVAX Facility.
322. Clarifications on these aspects would, in our view, provide the necessary legal certainty to Members that have the possibility of using the existing capacity or increasing their capacity to produce COVID-19 vaccines and medicines. They would also promote production and supply of those products to low- and medium-income countries at affordable prices, including via the COVAX Facility. And this should be our priority right now.
323. We would like to recall that an additional value added of our 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.
324. The first element is to clarify that in a circumstance of a pandemic, governments can proceed quickly and they do not have to engage in the negotiations with patent holders, which normally is the longest part of the procedure. Some WTO Members raised doubts as to whether this 'fast-track' procedure can be used only in the case of compulsory licences for domestic use or also with regard to the, crucial now, licences for exports. We want to make it absolutely clear that this possibility applies also to licences for exports. Therefore, we propose to clarify that WTO Members may waive the requirement of making efforts to obtain authorisation from the right holder, provided for in Article 31(b) of the TRIPS Agreement, for the purposes of issuing a compulsory licence not only for domestic use, under Article 31, but also for exports, under Article 31bis.
325. The second element concerns remuneration for patent holders. This is a crucial element of a compulsory licence and we need to promote those manufacturers that are ready to produce at affordable prices for low- and middle-income countries and to provide supplies to COVAX. This means different levels of discounted prices, e.g., supplies at cost or at lower prices to low- and middleincome countries. The clarification would provide legal certainty that in such cases manufacturers will be supported by governments setting the remuneration for patent holders reflecting these discounted prices, in order to ensure that the remuneration does not become a blocking factor in enhancing production. Therefore, we propose to clarify that WTO Members may provide, for the purposes of determining the remuneration to be paid to the right holder under a compulsory licence for domestic use (Article 31.h) or for exports (Article 31bis paragraph 2), that the remuneration reflects the price charged by the manufacturer of the vaccine or medicine produced under the compulsory licence.
326. The third element deals with an often-raised, procedural problem of country-to-country application of compulsory licence. We want to make sure that a willing manufacturer can easily export to all eligible countries, including via COVAX, under a single simple procedure. Therefore, we propose to clarify that the notification procedure in paragraph 2.c) of the Annex to the TRIPS Agreement allows WTO Members to submit a single notification that includes the list of all countries to which the vaccines and medicines are to be supplied. We also propose to clarify that this notification is valid not only when the exporting Member exports the vaccines directly, but also when it does so through the COVAX Facility. COVAX is already supplying vaccines to many countries of the world, many of which are eligible importing Members under the Annex to the TRIPS Agreement. Therefore, we propose that WTO Members agree that, where a WTO Member provides COVAX with vaccines produced under a compulsory licence, it is understood that COVAX distributes those vaccines to the eligible importing Members included in the notification submitted by the exporting Member.
327. We are talking about a substantial reinforcement of the TRIPS flexibilities and of the legal certainty required for their use. It is our objective to bring all sides of the discussion closer together on this approach and find solutions quickly while also fully engaging on other aspects of our comprehensive proposal which are key, in our view, to make a real difference on the ground. We invite all Members to consider our proposal and engage on this approach. We are of course open to discuss which other requirements concerning compulsory licensing can be clarified to facilitate the use of the system.
328. We are confident that all WTO Members can agree that the clarifications contained in our proposal are necessary and timely and can have an immediate impact on the ground and apply also for future situations of the similar kind. Therefore, we believe that, with the commitment of all WTO Members, we should be able to rapidly find convergence on how to clarify and facilitate the use of the compulsory licensing system.
European Union's statement at the informal meeting held on 30 June 2021
329. The European Union much appreciated the possibility provided by the small group meetings 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.
330. 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 discuss all approaches that contribute to enhancing access to affordable COVID-19 vaccines and medicines and can bring results in an urgent manner.
331. The European Union would like to use this opportunity to recall some of the most pertinent, in our view, points that have been raised in the discussion in small groups on the scope of products and provisions covered.
332. 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 have provided explanations on the scope of its proposal.
333. As regards the scope of products covered by the EU proposal, we have explained that:
a. The EU proposal emerges from the discussions that WTO Members have had in the TRIPS Council since the COVID-19 started.
b. Those discussions have focused on how intellectual property can contribute to ensuring global equitable access to COVID-19 vaccines and medicines.
c. We are aware that WTO Members use different terms to refer to the products we aim to cover e.g., pharmaceuticals, medicines, treatments, therapeutics, diagnostics, etc. We also understand that intellectual property law does not usually address definitions of terms such as medicines.
d. It is important to recall that our proposal concerns Articles 31 and 31bis of the TRIPS Agreement and therefore the product scope as applicable to these articles applies also in the context of our proposal. In the case of Article 31 of TRIPS there are no limitations to the scope – all products that are patented are covered. Article 31bis is more specific, as it applies to pharmaceutical products, which are defined as "patented products, or products manufactured through a patented process, of the pharmaceutical sector".
e. Therefore, the EU proposal covers all patented products as far as the application of Article 31 is concerned and all pharmaceutical products as far as Article 31bis is concerned. The pharmaceutical products under Article 31bis cover vaccines, therapeutics, diagnostics and active ingredients and therefore these products, which are key for tackling the COVID19 crisis, are covered by the EU proposal. When we speak about 'medicines' in the EU proposal as regards the facilitation of compulsory licences, diagnostics as well as therapeutics fall under that term.
334. As regards the provisions covered by the EU proposal, the EU has explained that:
a. The EU proposal to the WTO is a comprehensive proposal as it addresses trade issues related to the actual bottlenecks that affect the speed of manufacturing and the fair supply of vaccines and medicines in the current pandemic. The component on compulsory licensing as proposed for discussion at the TRIPS Council is thus only one element of this comprehensive approach. We consider that intellectual property plays an important role as an enabler that contributes to our overall objective of ramping up production of COVID- 19 vaccines and medicines. However, it is not and should not be a barrier to achieve this objective. We have been clear that in a global emergency like this pandemic, if voluntary licensing fails, compulsory licensing is a legitimate tool to scale up production. This is why we propose to clarify and simplify the use of compulsory licensing in times of a pandemic.
b. If we examine how intellectual property can enable the production of vaccines or medicines, the focus is primarily on patents. We believe that a debate on the entire intellectual property system is not necessary and will only delay our urgent action. Moreover, the intellectual property framework is already a system of checks and balances. There are relevant exceptions that can be used with regard to every intellectual property right, be it copyright, design or protection of undisclosed data.
c. For example, as regards trade secrets, it is important to note that the TRIPS Agreement only protects trade secrets against disclosure, acquisition or use in a manner contrary to honest commercial practices. Trade secrets do not have to be protected in situations concerning disclosure, acquisition or use which is consistent with honest commercial practices. This provides for space for governments to provide exceptions e.g. in a health emergency situation. The EU Directive on trade secrets provides for an exception 'for the purpose of protecting a legitimate interest recognised by Union or national law'.
d. As regards regulatory data, we agree that the national provisions on compulsory licensing need to be effective and should therefore allow manufacturers of generics to produce them. Regulatory data protection should not be an obstacle to achieve this objective. Article 39 paragraph 3 of the TRIPS Agreement allows exceptions 'where necessary to protect the public'. The EU uses this exception in its implementation of Article 31bis of the TRIPS Agreement.
e. Moreover, we must be realistic as to what the proposed lifting of the Members' obligations under the TRIPS Agreement can achieve. For example, in the long-discussed case of trade secrets, waiving Article 39 of the TRIPS Agreement does not grant access to companies' confidential information, only removes certain minimum remedies against a misappropriation of that information. There seems to be a misunderstanding about this fact as some Members indicated possibilities of governments to requisition and repurpose trade secrets. We would like to emphasise that such measures which may be provided under national law of some Members fall outside of the realm of intellectual property.
335. Without prejudice to our position on the revised waiver proposal, and in particular the fact that we do not believe that it would have the effect of increasing production and enhancing access to COVID-19 vaccines and medicines, in the course of the small group meetings, we have raised a number of concerns with regard to this proposal:
a. As regards the product scope, it was observed that the link between the accessibility of the broad list of products and intellectual property is not clear. There is no evidence that it is IP that is at the origin of the shortages of these products. The fact that a product is protected by an IP right, such as patent, is not in itself an indication that there is an IP obstacle that limits its accessibility.
b. Moreover, if an IP would stand in the way of accessibility, it is not clear why the existing flexibilities provided in the TRIPS Agreement, and in particular compulsory licensing, could not be used.
c. In addition to the possibility of relying on exceptions which can also be used for public purposes, in accordance with the trilateral study by WHO, WTO and WIPO on Promoting Access to Medical Technologies and Innovation, numerous private sector companies have taken access-oriented actions that include: (i) committing to non-exclusive and royaltyfree licensing or issuing non-enforcement declarations of patent rights in some or all jurisdictions; (ii) publishing scientific data on a free-to-use basis; (iii) publishing technical specifications of vital equipment (e.g. ventilators); and (iv) sharing knowledge to enable others to manufacture and use such technologies. In addition, among other voluntary actions in support of R&D that have been observed are the permission to use text and data mining and machine-learning technologies and to freely access and reuse COVID-19 related scientific literature protected by copyright and the making available of standards protected by copyright. For example, as part of the Open Covid Pledge, a number of private companies and universities are granting free access to patented technologies and protected designs related to diagnosing, preventing, containing and treating COVID-19.
d. There are questions as to the establishment of the link between a product and the prevention, treatment or containment of COVID-19. While certain products, such as vaccines or certain therapies, have been developed and are approved as COVID-19 products, there are also products that have at the same time different uses, this concerns also 'materials and components' covered by the revised waiver proposal.
e. As regards the provisions covered, the EU questions the approach under which the entire sections of the TRIPS Agreement are subject to the waiver. This includes for example provisions on compliance with the Berne Convention, exceptions and limitations to various rights, inventions excluded from patentability, conditions on patent applications or provisions on compulsory licensing. Again, the link between these provisions and the objective of the waiver is not clear. This approach points rather to a suspension of the TRIPS Agreement than a waiver that should be limited to what is justified and necessary in view of its stated objective.
f. We should not lose sight of our common aim, i.e. enhancing global access to affordable COVID-19-related medical products and addressing global production constraints and supply shortages. The EU believes that this objective must inform our discussions. We have previously expressed concerns as to the impact of the proposed waiver on what is the core element for expanding the current production of vaccines, i.e. transfer of technology.
g. As already mentioned, Articles 39 paragraphs 1 and 2 of the TRIPS Agreement provide only for remedies in case of breach of confidence or other dishonest commercial practices. Waiving these paragraphs does not in any way compel the holder of the trade secret, in this case the technology and the know-how, to reveal it. To the contrary, lifting the protection granted by these provisions takes away the platform on which such transfer can occur with full legal certainty.
h. Intellectual property rules provide the legal framework for cooperation between companies by licensing contracts and partnership agreements. Therefore, IP rights do not obstruct production but are an enabler to enhance production. The most efficient way of knowledge sharing is a cooperation on a voluntary basis, that enables a quick exchange of know-how needed besides the patent itself.
i. As regards Article 39 paragraph 3 on regulatory data, it is not clear to us what would prevent Members to use undisclosed data by regulatory agencies where necessary to protect the public as provided by this Article.
j. There are further questions regarding the implementation of the waiver, e.g. its impact on pending patent applications that would need to be discussed and closely analysed. The same concerns medium- and long-term consequences of the waiver. For example it is important to note that health products and technologies developed during the waiver period would, in all likelihood, not be eligible for patent protection even after the termination of the waiver, because they would no longer fulfil the patentability requirement of novelty. Finally, there are also questions as regards effects of the waiver on international obligations of WTO Members under international agreements in the area of intellectual property. We are looking forward to further discussions on these points and will of course present these aspects also in the context of the EU proposal.
336. 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 during the last week's meeting, the EU is also ready to discuss other aspects of the compulsory licensing system that would merit clarification to enhance efforts to scale up the production of COVID-19 vaccines, therapeutics and diagnostics.
337. Finally, we would like to emphasise that the IP-related discussion is only a part of the multifaceted 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
338. For the European Union, the discussions the previous week allowed us to explain in detail the advantages of the EU proposal from the perspective of implementation. We have looked at it from two key angles. First, from a procedural angle, the EU proposal for a General Council Declaration on the TRIPS Agreement and Public Health in the Circumstances of a Pandemic, document can be adopted swiftly. Moreover, the clarifications on the use of the existing flexibilities on compulsory licensing would normally not require implementation by WTO Members to have immediate results - they would remove any legal uncertainty on a number of aspects that WTO Members have identified during the last months as unclear.
339. Second, the other key angle when we discussed implementation is the substantive angle. The EU proposal for a General Council Declaration is targeted and addresses the key aspects of the compulsory licensing system that can be clarified or facilitated to make sure that we make the most of the system during this and future pandemics. Even if the list of these aspects is extended in the course of the negotiations, it will remain targeted and easily applicable. Moreover, if any WTO Member actually needs to incorporate these clarifications into its national regime, the implementation would be simple due to the targeted approach of the proposal.
340. As regards the implementation of the revised waiver proposal:
341. The discussions during the last two meetings showed, in our view, that the implementation of the waiver would be a very complex exercise and would involve important risks. To begin with, a waiver does not have direct application in the national systems of WTO Members. All WTO Members that have implemented the TRIPS Agreement in their national law would need to adopt national law to implement the waiver. This is already an important difference between the waiver and the EU proposal. It is true that, as the proponents have explained, WTO Members having fast-track legislative procedures in place could use them to implement the waiver at national level. However, if we take into account the second implementation angle we have mentioned, i.e. the substantive angle, further hurdles and concerns appear.
342. First, as already mentioned in the previous meeting, the proposed waiver does not contain any indication as regards the measures that can be applied by the Members. In other words – it is not clear what the Members can do on the basis of the waiver and how they can do it.
343. Second, clearly the broader and less targeted the waiver, the more complex implementation is required. This means national rules:
a. to determine which IP rights would fall under the ambit of the waiver, under which conditions and with which effects in the short, mid- and long-term; and
b. to create a legal instrument and procedures to effect the suspensions and circumscribe their scope to the purposes provided in § 1 of the waiver.
344. The proponents have explained that the waiver provides no description of measures to be adopted by Members under the waiver. No measures are indicated or prescribed. These means that, from the substantive angle, there are no set boundaries to the measures that Members can implement. The proponents explain that the 'waiver is permissive' and that 'the choice of measures is left to the Members'.
345. 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. We would like to emphasise here that we are talking about the substance of the measures, not their form – the fact that there can be emergency measures or measures taken in a different procedure does not change the fact that the substance of the measures is unknown.
346. The proponents have explained that they expect that WTO Members will not use the waiver to its full extent, as they should use it in a targeted manner. The waiver is, in their view, a tool that would give freedom to Members to adopt measures in their own way. This does not in any way remove the discussed concerns, including those related to:
a. the invalidation of existing patents, including in the long term, once the waiver ceases to apply;
b. the possibility of rejecting pending patent applications and its effects on the loss of novelty of the products and processes relevant to the manufacture of vaccines, medicines and medical devices;
c. the effects of the waiver on existing and future voluntary licence agreements and open licensing schemes;
d. the effects of the waiver on trade secrets, which, if disclosed due to the waiver, would lose their secret character and therefore any protection, even after the waiver ceases to apply – in that regard we also noted certain comments pointing to using the waiver as a vehicle for forcing rather than enhancing technology transfer – this increases our concerns about this approach;
e. how to ensure that the waiver is used exclusively for the announced intention and not for commercial purposes;
f. how to ensure that a COVID-19 related waiver does not affect IP rights that are related to other purposes or diseases or are relevant for other areas;
g. the application of the waiver to enforcement procedures – it is not at all clear what the waiver would mean for the application of rules such as that the procedures must be fair and equitable, that court decisions must be reasoned and in writing, etc..
347. Chair, the discussions we had last week showed, in our view, that a reply based on mere permissiveness or reliance on Members' freedom to implement the waiver does not provide an answer to these and other questions posed by Members.
348. At the very end of the meeting the previous week, we also started a discussion on regulatory data protection. We did not have much time to discuss this issue, so we look forward to continuing our dialogue on this point in the future. The main area to explore, in our view, is the flexibility provided by Article 39(3). But as the discussion has not really taken place in the small group meeting, we will not comment on these matters at this stage – we have presented our preliminary comments on other occasions.
349. Chair, we, as other WTO Members, remain unconvinced about the benefits and concerned about the effects of the proposed waiver. On implementation, the discussion we have had so far shows 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 also as regards access to COVID-19 vaccines and medicines. On regulatory data protection, subject to further discussions, it seems to us that the existing flexibilities under the TRIPS Agreement do not justify a waiver in the circumstances of a pandemic.
350. We would like to thank again all the delegations that engaged on the EU proposal. We have noted the main two additional angles as regards requirements in Article 31bis – one concerning the labelling requirements and one the statements on the lack of manufacturing capacity. We would like to invite Members to present views on these two issues. We are all aware of the justification of the labelling requirement – which is an anti-diversion measure. It seems to us that in the case of exports to multiple countries there is no need of distinguishing labels depending on the importing country. We would be interested to know whether this is also the understanding of the other Members. It would be important to understand which aspect of the labelling requirement is viewed as cumbersome so that we can advance on our discussion. The same goes for the requirement to indicate the insufficient manufacturing capacity – we would be very interested to hear the views of Members on this requirement. This would also help us present in more detail a case study as suggested by the United Kingdom.
351. We are also discussing bilaterally with various delegations to explain our proposal in more detail and will continue these efforts.
352. Chair, we had important and good exchanges with Members on the EU proposal in the context of the text-based process. In view of these exchanges and the great potential of finding solutions on the basis of the EU approach, we would like to ask you to reflect this fact in the report to the General Council. It is, in our view, vital for the next steps that the General Council has the full view of the discussions that are taking place in the TRIPS Council and all proposals that are on the table.
353. 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. In this context, we invite Members to discussions on the EU proposal. As indicated in the previous meetings, the EU is also ready to discuss all aspects of compulsory licensing system that would merit clarification to enhance efforts to scale up the production of COVID-19 vaccines, therapeutics and diagnostics.
354. Finally, we would like to emphasise that the IP-related discussion is only a part of the multipronged 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.