268. The pandemic continues and so must our efforts to ensure equitable distribution of COVID-19 vaccines. The immediate goal is to continue to ramp up production, to share vaccines wider and faster and to ensure equitable access to low - and middle-income countries. Equity does not only mean access but also access at affordable prices. We believe that this is a common goal for all of us. The European Union is doing its utmost to achieve this objective. With over 300 million doses exported, the EU continues to remain the largest COVID-19 vaccine exporter in the world. The EU and its member States also remain the biggest donor to COVAX Facility, a global effort to distribute vaccines equitably, with EUR 2.8 billion worth of funding. In addition, the EU has committed to donate 100 million doses of vaccines to those in need by the end of 2021.
269. Certain important advances in the effort to ramp up production have been made - in less than a year, the global production of COVID-19 vaccines has gone from 0 to 2 billion doses produced by end of May 2021. It is estimated that more than ten billion doses of COVID-19 vaccines will be produced by the end of 2021. However, the urgency of the public health crisis requires not only the acceleration of the production of vaccines but also of their global distribution. We believe 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. We are willing to discuss any proposal that aims at effectively achieving those goals. And we have tabled a proposal going in that direction.
270. But before presenting our proposal let me start by thanking the proponents for their revised proposal which we have been considering carefully. We note that the proposal waives obligations of Members to implement or apply Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement with regard to a wide range of health products, technologies, devices, personal protective equipment and components for the prevention, treatment or containment of COVID-19. This means that all the relevant intellectual property rights (except for trademarks) that concern these products could be potentially waived as the result of this proposal with regard to a very broad range of products, technologies and components.
271. 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. 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.
272. We would like to engage in a thorough discussion of this text to examine how the revised proposal addresses the identified bottlenecks for the production and distribution of COVID-19 vaccines, including its expected impact on the transfer of COVID-19 vaccines technology. Indeed, following the intense discussions in this Council as well in other fora and events organised by the Director-General of the WTO, it is our assessment that limited manufacturing capacity, access to raw materials and other inputs are the main bottlenecks as regards the production and distribution of COVID-19 vaccines. In addition, know-how is key due to the complexity of the production process of these vaccines.
273. In order to deal with these bottlenecks, 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. 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: first, trade facilitation and disciplines on export restrictions; second, concrete actions to expand production and ensure supply of vaccines at affordable prices to low and middle income countries during the pandemic and; third, clarification and facilitation of TRIPS Agreement flexibilities relating to compulsory licences.
274. 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 IP/C/W/680, to the Council for TRIPS. 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 therapeutics and proceed with concrete short and medium term solutions to enhance universal access to COVID-19 vaccines and therapeutics at affordable prices.
275. The EU is ready to continue discussing the revised proposal on the waiver but is not convinced that the broad waiver proposed by a number of WTO Members is the right response to the pandemic. 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.
276. 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. 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 therapeutics 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.
277. We would therefore want to include in this discussion a different and more 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.
278. 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.
279. The discussions in the Council for TRIPS since the start of the COVID-19 pandemic have identified aspects related to the use of compulsory licensing that, in the view of a number of WTO Members, limit the use of this tool. In order to address these aspects, 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: first, the pandemic is a circumstance of national emergency and therefore the requirement to negotiate with the right holder may be waived; second, to support manufacturers ready to produce vaccines or therapeutics 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 third, the compulsory licence could cover any exports destined to countries that lack manufacturing capacity, including via the COVAX Facility.
280. 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 its capacity to produce COVID-19 vaccines and therapeutics. 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.
281. 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. Doubts were raised 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.
282. 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 medium-income countries and to provide supplies to COVAX. This means different levels of discounted prices, for example supplies at cost or at lower prices to low- and middle-income 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.
283. 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. 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.
284. We are ready to immediately start a discussion based on the proposal set out in our communication and intend to follow up with a more elaborated text. At the same time, as mentioned, the EU is ready to continue discussing the revised Waiver Proposal. We are ready to continue this discussion in the course of additional meetings of this Council that the Chair may decide to convene to advance the discussion.