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

H.E. Ambassador Xolelwa Mlumbi-Peter
European Union
1 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19

139.   Madame Chair, we would like to thank you, the Secretariat and all the delegations for the constructive engagement on the status report, which we fully support. 140.   We would like to recall our statements made in the formal and informal meetings of the TRIPS Council, including the answers we provided to the questions that have been posed to us. 141.   There is no doubt that all WTO Members agree on the objective in this global fight against the COVID pandemic: to rapidly develop and manufacture safe and effective therapeutics and vaccines and to distribute them equitably across the world as soon as possible. However, our extensive discussions have shown that our views as to the best way of achieving this objective are far apart. 142.   I would like to emphasise that achieving the objective of equitable access to vaccines is a top priority of the EU. We believe that the main global mechanism to achieve such equitable access is the COVAX Facility. It just has received a major financial boost following the G7 meeting the previous week. We very much welcome the important financial contribution to the COVAX Facility made by the United States as well as additional contributions made by Japan and Canada. 143.   The European Union has also announced an additional EUR 500 million for the COVAX Facility, doubling its contribution to date. These new pledges bring us closer to achieving COVAX's target to deliver 1.3 billion doses for 92 low and middle income countries by the end of 2021. Team Europe is one of the lead contributors to COVAX with over EUR 2.2 billion, including EUR 900 million pledged by Germany last week. 144.   It is clear that this is only the start and that we will need to mobilise additional support as we move forward. It is not the time to find flaws in the COVAX Facility, the only viable solution we have to deliver the vaccines globally, it is time to support it and encourage the industry to step up and make their vaccines available and affordable to COVAX, so that there can be a timely global rollout. 145.   Novavax, for example, announced last week that it signed a Memorandum of Understanding with Gavi, The Vaccine Alliance, to provide COVAX with 1.1 billion cumulative doses of its vaccine candidate. COVAX continues to actively negotiate with various suppliers to reserve three billion doses in 2021-2022, seeking to diversify the vaccine portfolio and to ensure the minimum coverage in all participating countries. 146.   However, we see clearly that having a vaccine developed and reserved is not enough. The actual delivery of vaccines will depend on a number of factors which include timely regulatory approvals, country readiness, logistics and other factors. In the last few weeks, several emergency or conditional regulatory approvals of different COVID vaccines in the EU and across the world were granted. 147.   Since our last meeting, two versions of the AstraZeneca/Oxford COVID-19 vaccine have been given WHO Emergency Use Listing (EUL). This follows the Emergency Use Listing for Pfizer/BioNTech vaccine. This announcement means that two versions of the AstraZeneca/Oxford vaccine, produced by AstraZeneca-SK Bioscience (AZ-SKBio) and the Serum Institute of India (AZ-SII), are now available for global rollout through the COVAX Facility. This is crucial for the functioning of its COVAX's distribution mechanism and we hope to see more vaccines approved for emergency use soon. 148.   Other challenges related to actually delivering the vaccine to the people remain enormous and depend a lot on country readiness, including for example creating priority lists for vaccination, organising vaccination centres, with conditions such as storage at very low temperatures. Despite the efforts of everyone involved, this is not easy for any country. 149.   At the moment, however, we are all still facing one major challenge – ensuring rapid and predictable production of the new vaccines, while simultaneously increasing levels of that production and maintaining the supply of all other medicines and vaccines. 150.   We all agree that the ramping up of manufacturing capacity is a clear priority now. Any available manufacturing capacity anywhere in the world should be used to the full extent. Any indication of where underused capacity exists as indicated by some Members would be very welcome. 151.   As set out in the Communication Towards HERA: making Europe's bio-defence capacities fit to deal with SARS-CoV-2 variants, the EU is taking action to facilitate the production of COVID-19 vaccines and to allow for a ramping up of production in the shortest possible time. The European Commission will continue to address potential bottlenecks in production and supply of raw materials and other essential input required for vaccines manufacturing. It will build on the ongoing mapping of existing industrial capacities for vaccine production in Europe, as well as facilities which can be potentially repurposed to produce vaccines. 152.   Where such capacity exists and can be deployed quickly, the best way of using it to the fullest is by disseminating the technology and know-how of those who developed the vaccines through a collaboration with other companies that can contribute to the developers' manufacturing capacity. Intellectual property is a key factor in providing a framework that enables this collaboration. 153.   This is because the IP system is crucial in providing a legal framework for the collaboration and dissemination of any new technology. The objective of an IP system is not merely to create exclusivity for the owner of intellectual property, but also to ensure the publication and dissemination of research results when otherwise they would remain secret. And this dissemination is precisely what we need now. The IP system enables commercialisation of the research results and their transfer through licensing agreements. Developers of vaccines can enter into manufacturing agreements, transfer technology and expand production with their licensees. 154.   The increase of production capacity is happening, as developers of vaccines are entering into manufacturing agreements with producers, and are expanding global production by transferring their technology to licensees. We see this being done by AstraZeneca, Johnson & Johnson and we hope to see these collaborations grow and intensify. 155.   No doubt more needs to be done in the weeks and months ahead, but, as we have already mentioned previously, there are many examples of collaboration and licensing to producers in the developing countries. 156.   As was said before, we fully agree that all adequate manufacturing capacity must be used where possible. However, in this forum we have disagreed on the best way to tap into that potential manufacturing capacity. The proponents of the Waiver suggested that the Waiver would in fact achieve that objective. We do not think that this is the case. It is through collaboration and the rapid transfer of technology and know-how that we can get there. 157.   We consider that the TRIPS Agreement and the principles of the Doha Declaration can play a role in addressing this crisis, as they reflect a careful balance between protecting intellectual property on one hand, which is a crucial incentive to innovation, and promoting widespread access to medicines and health care, on the other hand. 158.   As indicated in previous meetings, we believe that the concerns that have been raised in the current discussion can be addressed through the combination of, on the one hand, licensing and expanding manufacturing capacity via manufacturing agreements and, on the other hand, the framework of the TRIPS Agreement and the flexibilities it offers. These flexibilities are absolutely legitimate tools for Members in need as many are in the midst of this pandemic. 159.   We have noted carefully the difficulties conveyed by some Members with regard to the implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. Administrative burdens should not stand in the way of manufacturing and delivering vaccines to where they are needed. It is important to note that the TRIPS Agreement also provides for flexibilities and exceptions in relation to other relevant IP rights, not only patents. This includes copyright, industrial design and regulatory data protection. The principles of the Doha Declaration on the TRIPS Agreement and public health that direct countries to interpret the TRIPS Agreement in a manner supportive of their right to protect public health and to promote access to medicines for all are equally applicable to all types of IP rights. 160.   Since questions have been posed to us on this matter, we would like to emphasise that the TRIPS Agreement does not stand in the way of the consistent application of the patent and regulatory data protection provisions to enable the application of compulsory licences. The EU, just as any other Member of the WTO, has the possibility of framing its legislation in this manner. 161.   One of the main concerns with the suspension of intellectual property rights like the proposed TRIPS Waiver is that it will not enhance the ongoing voluntary collaboration and the needed transfer of technology and know-how. To the contrary, the lack of a framework that guarantees protection can effectively block such transfer, to the detriment of all at a time when we need it most. 162.   In this forum, our focus is on intellectual property. However, as we have highlighted, intellectual property is only a small part of a broader massive financial, manufacturing and logistical response to COVID-19. The EU and its Members have been in the forefront of this response. 163.   I would like to recall what we have already said on the role of public financing and its impact on the need to protect IP. Public financing does not mean that there is no financing or risk carried by private investors. In some cases, private financing may significantly exceed public support. IP makes possible licensing agreements in the pharmaceutical sector (which requires multiple partners) and the creation of partnerships. Pharmaceutical development requires trials, manufacturing developments and deployment-related logistics that are not necessarily publicly funded (or public funding is not enough), in this context IP does not only make licensing activities possible, but it is a critical loan collateral to obtain private financing. 164.   We have also already said that, as part of their national or regional health and research policy, every Member has the right to attach certain conditions to the public funding it provides to pharmaceutical companies. 165.   As a last remark, I would like to mention the agreements that the EU has entered into for purchasing of vaccines and I would underline again that we have invested in manufacturing capacity not only to guarantee vaccines for the EU citizens but also so that vaccines are more rapidly available to everyone, everywhere. 166.   We are all facing significant difficulties during these first weeks of 2021. However, we are also hopeful that the situation will gradually improve with more vaccines coming to the market and more production of the already approved vaccines materialising. On 19 January, the European Commission announced that –- we are ready to set up an EU vaccine sharing mechanism, based on the "Team Europe" approach. This would allow the sharing of access to some of the vaccine doses secured by the EU. Special attention would be given to the Western Balkans, our Eastern and Southern neighbourhood and Africa. This could primarily benefit health workers, as well as humanitarian needs. Details of that mechanism are currently being worked out. 167.   As we have already said before, the EU is committed to an open and comprehensive dialogue with all WTO Members to explore how the multilateral rules-based trading system can best support universal and equitable access to COVID-19 vaccines and treatments as we seek to provide for a robust, rapid and universal response to the pandemic. 168.   In that regard, and in order to facilitate a consensual, constructive and evidence-based discussion, we fully support document IP/C/W/671 submitted by the delegations of Australia, Canada, Chile and Mexico and the approach to the current discussion presented in this communication. We are ready to work together with the sponsors of this communication and all other Members to contribute to such an evidence-based discussion. 169.   We have already indicated our willingness to discuss problems with the implementation and the use of the TRIPS flexibilities, in particular how the use of the flexibilities such as compulsory licensing can be facilitated. It is important that these flexibilities can be used when the need arises and are not hampered by administrative hurdles. 170.   We are committed to cooperation mobilising the global manufacturing, trade, and delivery response that will end this crisis and help build a more resilient system for the future. We would also like to ask the Secretariat to add our previous statements to the minutes of this meeting. European Union's statement at the informal meeting held on 4 February 2021 171.   During the last four months, we had an intense schedule of exchanges in various formats of the TRIPS Council as well as the December General Council of the WTO. There is no doubt that all WTO Members agree on the objective in this global fight against the COVID pandemic: to rapidly develop and manufacture safe and effective therapeutics and vaccines and to distribute them equitably across the world as soon as possible. However, our extensive discussions have shown that our views as to the best way of achieving this objective are far apart. 172.   I would like to repeat once again that achieving the objective of equitable access to vaccines is a top priority of the EU. We believe that the main global mechanism to achieve such equitable access is the COVAX Facility. The EU so far has been the COVAX's biggest donor with more than EUR 850 million provided by the EU and its Members. The larger Coronavirus Global Response beyond vaccines also remains crucial. For this purpose, a global recovery package of EUR 38.5 billion delivered under a common "Team Europe" approach has been supporting partner countries with emergency response to humanitarian needs, strengthening health systems and crucial health services, and assisting economic recovery and social support. 173.   It is clear that this is only the start and that we will need to mobilise additional support as we move forward. We welcome the United States' recent decision to join COVAX and strongly encourage other WTO Members to help address the remaining financing needs. 174.   The COVAX Facility is now well placed with nearly two billion doses of COVID-19 vaccine candidates reserved for 2021. COVAX continues to actively negotiate with various suppliers to reserve three billion doses in 2021-2022, seeking to diversify the vaccine portfolio and to ensure the minimum coverage in all participating countries. 175.   However, we see clearly that having a vaccine developed and reserved is not enough. The actual delivery of vaccines will depend on a number of factors which include timely regulatory approvals, country readiness, logistics and other factors. In the last few weeks, several emergency or conditional regulatory approvals of different COVID vaccines in the EU and across the world were granted. However, only one vaccine – Pfizer/BioNTech – has so far completed the World Health Organisation Emergency Use Listing Procedure (EUL). The procedures for other vaccines are still pending, including those reserved by COVAX. This is crucial for the functioning of its COVAX's distribution mechanism. 176.   Other challenges related to actually delivering the vaccine to the people remain enormous and depend a lot on country readiness, including for example creating priority lists for vaccination, organising vaccination centres, with conditions such as storage at very low temperatures. Despite the efforts of everyone involved, this is not easy for any country. 177.   At the moment, however, we are all still facing one major challenge – ensuring rapid and predictable production of the new vaccines, while simultaneously increasing levels of that production and maintaining the supply of all other medicines and vaccines. 178.   We all agree that the ramping up of manufacturing capacity is a clear priority now. Any available manufacturing capacity anywhere in the world should be used to the full extent. Any indication of where underused capacity exists as indicated by some Members would be very welcome. 179.   However, the EU still considers that if such capacity exists and can be deployed quickly, the best way of using it to the fullest is by disseminating the technology and know-how of those who developed the vaccines through a collaboration with other companies that can contribute to the developers' manufacturing capacity. Intellectual property is a key factor in providing a framework that enables this collaboration. 180.   This is because the IP system is crucial in providing a legal framework for the collaboration and dissemination of any new technology. The objective of an IP system is not merely to create exclusivity for the owner of intellectual property, but also to ensure the publication and dissemination of research results when otherwise they would remain secret. And this dissemination is precisely what we need now. The IP system enables commercialisation of the research results and their transfer through licensing agreements. Developers of vaccines can enter into manufacturing agreements, transfer technology and expand production with their licensees. 181.   The increase of production capacity is happening, as developers of vaccines are entering into manufacturing agreements with producers, and are expanding global production by transferring their technology to licensees. No doubt more needs to be done in the weeks and months ahead, but, as we have already mentioned previously, there are many examples of collaboration and licensing to producers in the developing countries. 182.   As was said before, we fully agree that all adequate manufacturing capacity must be used where possible. However, in this forum we have disagreed on the best way to tap into that potential manufacturing capacity. The proponents of the Waiver of the TRIPS Agreement suggested that the Waiver would in fact achieve that objective. We do not think that this is the case. 183.   We consider that the TRIPS Agreement and the principles of the Doha Declaration can play a role in addressing this crisis, as they reflect a careful balance between protecting intellectual property on one hand, which is a crucial incentive to innovation, and promoting widespread access to medicines and health care, on the other hand. 184.   As indicated in previous meetings, we believe that the concerns that have been raised in the current discussion can be addressed through the combination of, on the one hand, licensing and expanding manufacturing capacity via manufacturing agreements and, on the other hand, the framework of the TRIPS Agreement and the flexibilities it offers. These flexibilities are absolutely legitimate tools for Members in need as many are in the midst of this pandemic. 185.   We have noted carefully the difficulties conveyed by some Members with regard to the implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. Administrative burdens should not stand in the way of manufacturing and delivering vaccines to where they are needed. It is important to note that the TRIPS Agreement also provides for flexibilities and exceptions in relation to other relevant IP rights, not only patents. This includes copyright, industrial design and regulatory data protection. The principles of the Doha Declaration on the TRIPS Agreement and public health that direct countries to interpret the TRIPS Agreement in a manner supportive of their right to protect public health and to promote access to medicines for all are equally applicable to all types of IP rights. 186.   Since questions have been posed to us on this matter, we would like to emphasise that the TRIPS Agreement does not stand in the way of the consistent application of the patent and regulatory data protection provisions to enable the application of compulsory licences. The EU, just as any other Member of the WTO, has the possibility of framing its legislation in this manner. 187.   One of the main concerns with the suspension of intellectual property rights like the proposed TRIPS Waiver is that it will not enhance the ongoing voluntary collaboration and the needed transfer of technology and know-how. To the contrary, the lack of a framework that guarantees protection can effectively block such transfer, to the detriment of all at a time when we need it most. 188.   In this forum, our focus is on intellectual property. However, as we have highlighted, intellectual property is only a small part of a broader massive financial, manufacturing and logistical response to COVID-19. The EU and its Members have been in the forefront of this response. 189.   I would like to recall what we have already said on the role of public financing and its impact on the need to protect IP. Public financing does not mean that there is no financing or risk carried by private investors. In some cases, private financing may significantly exceed public support. IP makes possible licensing agreements in the pharmaceutical sector (which requires multiple partners) and the creation of partnerships. Pharmaceutical development requires trials, manufacturing developments and deployment-related logistics that are not necessarily publicly funded (or public funding is not enough), in this context IP does not only make licensing activities possible, but it is a critical loan collateral to obtain private financing. 190.   We have also already said that, as part of their national or regional health and research policy, every Member has the right to attach certain conditions to the public funding it provides to pharmaceutical companies. Beyond the financing, it is also clear that without the researchers and the industry we would not have the vaccines that we have at the moment. 191.   As a last remark, I would like to mention the agreements that the EU has entered into for purchasing of vaccines and I would underline again that we have invested in manufacturing capacity not only to guarantee vaccines for the EU citizens but also so that vaccines are more rapidly available to everyone, everywhere. 192.   We are all facing significant difficulties during these first weeks of 2021. However, we are also hopeful that the situation will gradually improve with more vaccines coming to the market and more production of the already approved vaccines materialising. On 19 January, the Commission announced that – in addition to our contribution to COVAX - we are ready to set up an EU vaccine sharing mechanism, based on the "Team Europe" approach. This would allow the sharing of access to some of the vaccine doses secured by the EU. Special attention would be given to the Western Balkans, our Eastern and Southern neighbourhood and Africa. This could primarily benefit health workers, as well as humanitarian needs. Details of that mechanism are currently being worked out. 193.   As we have already said before, the EU is committed to an open and comprehensive dialogue with all WTO Members to explore how the multilateral rules-based trading system can best support universal and equitable access to COVID-19 vaccines and treatments as we seek to provide for a robust, rapid and universal response to the pandemic. 194.   We have already indicated our willingness to discuss problems with the implementation and the use of the TRIPS flexibilities, in particular how the use of the flexibilities such as compulsory licensing can be facilitated. It is important that these flexibilities can be used when the need arises and are not hampered by administrative hurdles. 195.   We are committed to cooperation mobilising the global manufacturing, trade, and delivery response that will end this crisis and help build a more resilient system for the future. European Union's statement at the informal meeting held on 4 February 2021. 196.   I refer to the statements made by this delegation in the discussion under this ad hoc agenda item in the TRIPS Council's past five formal and informal meetings. On procedure and the follow up: a. We are flexible on the presentation of the status report of the TRIPS Council to the General Council, as long as the report presents the state of discussions in a factual and succinct manner; and b. The EU is ready to engage in the discussions following the suggested format of small group consultations. EU Vaccine export authorisation 197.   This decision is a reaction to a possible breach of contracts signed with the EU, as doses that were initially targeted for the EU may have been exported to third countries. This would be a clear and unacceptable violation of legal obligations by the companies in question, while delaying the vaccination of EU citizens. 198.   In order to prevent such violation, the Commission has decided that all vaccine manufacturers should declare exports to third countries. From 30 January, the customs authorities are checking all vaccine export declarations. They may also control the products and trace their origin to ensure that they do correspond to third countries purchase contracts. These checks and controls will ensure transparency in a sensitive market, and avoid reselling, litigations and traffics. They will be conducted in a speedy manner to avoid unnecessary additional delays. 199.   These obligations are strictly targeted to vaccine manufacturers and are applicable until end of March 2021. They will be proportionate and will not slow down the vaccine trade between the EU and third countries. 200.   These measures have been designed in a targeted manner to limit the impact on our trade partners and on the most-vulnerable countries. The legal decision adopted today explicitly rules out exports: a. to the EEA countries, the Western Balkans, the Neighbourhood countries; b. the 92 low- and middle-income countries covered by the COVAX facility, as well as those delivered through COVAX, UNICEF and PAHO to any COVAX participating country, as well as; c. in the context of a humanitarian emergency response. 201.   With these provisions, the EU stands to its commitments towards its partners. European Union's statement at the informal meeting held on 19 January 2021 202.   It is very clear, following the earlier discussions in the TRIPS Council and the exchanges in the General Council of the WTO, that in this global fight against the COVID pandemic, we all share one objective: to rapidly develop safe and effective therapeutics and vaccines, to manufacture them in required quantities as soon as possible and to distribute them equitably across the world. What we are discussing is the best way of achieving this objective. 203.   We thank the delegations of from the Plurinational State of Bolivia, Eswatini, India, Kenya, Mozambique, Mongolia, Pakistan, South Africa, the Bolivarian Republic of Venezuela and Zimbabwe for their contributions to the debate presented in documents IP/C/W/672, IP/C/W/673 and IP/C/W/674. We are still studying the provided information and may come back with questions at a later stage. A number of questions have been posed in these documents to the European Union and we will do our best to respond to all of them. 204.   I would like to repeat that delivering on the objective of equitable access to vaccines is a top priority of the EU. Out of the EUR 16 billion provided to the Coronavirus Global Response, nearly EUR 12 billion was pledged by the Members of the European Union, the European Commission and the European Investment Bank. 205.   The EU and its Members have so far provided more than EUR 800 million to the COVAX Facility - which makes the European Union COVAX's biggest donor. 206.   In the second half of December we received a good news from COVAX which confirmed that it had arrangements in place to access nearly two billion doses of COVID-19 vaccine candidates, on behalf of 190 participating economies. These arrangements will enable all participating economies to have access to doses in the first half of 2021, with first deliveries anticipated to begin in the first quarter of 2021. 207.   This is a very good news but, to answer one of the questions, it is not enough. We are aware that this is only the start and that we will need to mobilise additional support as we move forward. We are working hard with our partners to procure the needed funding. We strongly encourage other WTO Members to help address the remaining financing needs, as underlined in the G20 Riyadh Leaders Declaration. 208.   Over the last weeks, we received some good news on the regulatory approvals of several COVID vaccines in the EU and across the world. Particularly optimistic is the fact that the AstraZeneca vaccine enters the market, including in India, as this vaccine can be stored in a normal fridge temperature making it much more accessible to the developing countries. Importantly, a significant share of the AstraZeneca vaccine actually goes to the developing countries and the COVAX Facility. 209.   The Novavax vaccine, the lion's share of which, we understand, is designated for the developing countries (according to reports Novavax reached an agreement with the Serum Institute of India that could enable them to produce as many as two billion doses a year) has not been approved yet but it began a last phase trials in December in the United States. The results from the last phase trials of the Johnson & Johnson vaccine are expected later this month. At the same time, it is clear that we will have to wait for a number of vaccines before they are ready to enter the market. 210.   As we know, having a vaccine developed and approved is not enough. The challenges related to actually delivering the vaccine to the people remain enormous, in particular producing the vaccines at an unprecedented scale and then distributing them, organising vaccination centres, with conditions such as storage at very low temperatures. 211.   Many countries face systemic and financial challenges such as fragile and underfunded healthcare and procurement systems, a limited number of health workers or inadequate cold chain equipment. These are, in addition to manufacturing, the main hurdles in the access to and the rollout of the vaccines. 212.   The TRIPS Agreement and the principles of the Doha Declaration can play a role in addressing this crisis, as they reflect a careful balance between protecting intellectual property on one hand, which is a crucial incentive to innovation, and promoting widespread access to medicines and health care, on the other hand. 213.   A question has been asked about the role of public financing and its impact on the need to protect IP. We believe that we have answered this question in our previous statements. Just to recall that public financing does not mean that there is no financing or risk carried by private investors. It is the researchers and the industry with their know-how, previous and current investment that are delivering the new vaccines, including the running of clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of a successful vaccine. 214.   We have already provided the example of the vaccines based on the mRNA technology which would not reach the market so quickly were it not for decades of work and investment in this novel technology undertaken at high risk of failure by researchers and companies. Finally, as part of their national or regional health and research policy, every Member has the right to attach certain conditions to public funding it provides to pharmaceutical companies. 215.   As indicated in the previous meetings, we believe that the concerns that have been raised in the current discussion can be addressed through the combination of licensing, expanding manufacturing capacity via manufacturing agreements with the TRIPS Agreement and the flexibilities it offers. These flexibilities are absolutely legitimate tools for Members in need as many are in the midst of this pandemic. I want to be very clear on the fact that the European Union never questioned the use of compulsory licences in the times of need. 216.   We have noted carefully the difficulties conveyed by some Members with regard to the implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. Administrative burdens should not stand in the way of manufacturing and delivering vaccines to where they are needed. We note a question in this regard addressed to some of our Members as to what data they relied upon when they decided to amend national laws to enable quicker use of compulsory licence. 217.   We have in the past explained the nature of the amendments introduced in Hungary so will not repeat these details but would like to make certain clarifications regarding the changes in the law of the Federal Republic of Germany as the question posed is reflecting a factual misunderstanding. Last year, Germany did not modify the conditions for the granting of compulsory licences. The Patent Law was only amended to change the competence for the issuance of a government order (and again not the conditions for the issuance of a government order). Previously, a government order for the use of medicinal/pharmaceutical inventions required a decision by the Federal Cabinet (Kabinett-Beschluss). This has been changed. It is now the Ministry for Health which can issue such an order, provided that the (unchanged) requirements have been met. 218.   More generally, we would like to clarify that the TRIPS Agreement requires no data or special justification to introduce rules on compulsory licensing, including fast track procedures in Member's legislation. Each Member has the right to have these rules. 219.   It is important to note that the TRIPS Agreement also provides for flexibilities and exceptions in relation to other relevant IP rights, not only patents. This includes copyright, industrial design and regulatory data protection. The principles of the Doha Declaration on the TRIPS Agreement and public health that direct countries to interpret the TRIPS Agreement in a manner supportive of their right to protect public health and to promote access to medicines for all are equally applicable to all types of IP rights. Since questions have been posed to us on this matter, we would like to emphasise that the TRIPS Agreement does not stand in the way of the consistent application of the patent and regulatory data protection provisions to enable the application of compulsory licences. The EU, just as any other Member of the WTO, has the possibility of framing its legislation in this manner. 220.   It seems that we all agree that what is most needed now, beyond developing vaccines, is the ramping up of manufacturing capacity, and a seamless follow through by the transport and distribution sectors. The best way of achieving that is by disseminating the technology and know-how of those who developed the vaccines through a collaboration with other companies that can contribute to the developers' manufacturing capacity. Intellectual property is a key factor in providing a framework that enables this collaboration. 221.   This is because the IP system is crucial in providing a legal framework for the collaboration and dissemination of any new technology. The objective of an IP system is not merely to create exclusivity for the owner of intellectual property, but also to ensure the publication and dissemination of research results when otherwise they would remain secret. And this dissemination is precisely what we need now. The IP system enables commercialisation of the research results and their transfer through licensing agreements. Developers of vaccines can enter into manufacturing agreements, transfer technology and expand production with their licensees. 222.   The increase of production capacity is already happening, as developers of vaccines are entering into manufacturing agreements with producers, and are expanding global production by transferring their technology to licensees. No doubt more needs to be done in the weeks and months ahead, but I would note that we have many examples of companies that have either accepted to produce at cost for citizens in developing countries or licensed production to producers in the developing countries. And then there are other examples of collaboration among different players. 223.   A number of questions regarding the terms of licensing or manufacturing agreements have been posed by the proponents of the Waiver. We do not know the details of the terms of these agreements so cannot answer but can share our understanding of the situation. On the concern related to the choice of manufacturers – it is our understanding that the production of a vaccine is a very complex process and not all pharmaceutical manufacturers can step up to such production. This is why in the EU, new production facilities are being set up and efforts are being made to use the facilities that can be used for the production of vaccines to the maximum. 224.   We believe that constant close coordination between governments and the pharmaceutical industry is required to ensure that all the adequate manufacturing capacity is used where possible. The potential use of compulsory licensing is of course also a leverage that governments have in that regard. 225.   One of the main concerns with the suspension of intellectual property rights like the proposed TRIPS Waiver is that it will not enhance such collaboration, that it will not enhance the needed transfer of technology and know-how. To the contrary, the lack of a framework that guarantees protection can effectively block such transfer, to the detriment of all. In this forum, our focus is on intellectual property. However, intellectual property is only a small part of a broader massive financial, manufacturing and logistical response to COVID-19. 226.   This response includes close coordination with pharmaceutical companies, creating and maintaining complex, international supply chains to import crucial raw materials and equipment (in parallel to the production of vaccines, supplies of vials, syringes, and other ancillary materials must remain adequate). There may be a need for pharmaceutical companies globally to reallocate critical materials among themselves. Where some vaccines development projects fail, as they are bound to do, successful vaccines producers should be able to use the manufacturing capacity, glass vials, and other ancillary materials that had originally been reserved for failed projects. Where surplus of vaccines may occur, it would be important to set up arrangements allowing the reallocation of doses. The flows of the required raw materials and vaccines cannot be hampered by export restrictions and other impediments affecting supply chains. 227.   In that regard I would like to recall again the work undertaken by the EU in the WTO to safeguard global supply chains. Under our "Trade and Health Initiative" WTO Members would jointly agree on a number of actions in response to the current crisis that would ensure free flow of essential goods which would facilitate an effective response to this and any future crisis. 228.   A lot has been said in this forum about the agreements that the EU has entered into for purchasing of vaccines. We have invested in manufacturing capacity not only to guarantee vaccines for the EU citizens but also so that vaccines are more rapidly available to everyone, everywhere. Today in the European Parliament, the Commission informed on the ongoing work to propose a mechanism to share vaccines with other countries. We hope to be able to provide more detail soon. 229.   We would also like to thank South Africa, India, Mozambique and Pakistan for their detailed questions and interest in the EU's policy developments, in particular two recent strategy documents: the Pharmaceutical Strategy for Europe and the IP Action Plan (both published very recently, on 25 November 2020). Both strategy documents are ambitious roadmaps covering a wide variety of issues and objectives to be attained in the short and mid-term. A number of concrete actions must be still agreed upon and their details worked out. But, to the extent possible, we are happy to provide more detail on the intentions and the objectives of the Commission. 230.   Among its objectives, the Pharmaceutical Strategy indeed has a goal of ensuring access to affordable medicines – this goal is shared globally. It also focuses on addressing the unmet medical needs of patients, strengthening of the EU pharmaceutical industry, and enhancing EU's crisis preparedness. This strategy document sets out the priorities of the EU's future action in this area. Concrete steps will follow with all the necessary details, including on the creation of the new EU Health Emergency Response Authority which would be responsible for strategic investments for research, development, manufacturing, deployment, distribution and use of medicines. Details on any march-in rights or other conditions for receiving support from the new agency are also still to be worked out. 231.   The Pharmaceutical Strategy proposes actions at EU level to promote the affordability of medicines and the sustainability of health systems. The Commission will support cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and health system's sustainability. The Commission will also help improving transparency on methods used for establishing the R&D costs of medicines. Over the next years, this will help national public authorities to improve their capacities and take better decisions. But it will also help the producers of high valued products to better make their case, and the EU patients to access cost-effective medicines in a timely, equitable and affordable way. 232.   Closely linked and in complete synergy with the Pharmaceutical Strategy, the IP Action Plan outlines concrete areas of priority in the field of intellectual property for the EU. It highlights that intellectual property is a key driver for economic growth as it helps companies to valorise their intangible assets. 233.   The IP Action Plan also highlights that the IP system must be balanced, meaning that access to critical technologies, where and when necessary, while ensuring an adequate return on investment for innovators, must be ensured. Therefore, the IP Action Plan fully supports all avenues of voluntary licensing in relation to COVID technologies, as endorsed in the World Health Assembly's Resolution of May last year. We believe that existing and effective patent pooling initiatives should be supported in the face of this crisis. 234.   The Commission has recently signed a Memorandum of Understanding with the Medicines Patent Pool – the most known, experienced and effective public health organisation delivering medicines to low and middle income countries through licensing contracts. We will explore all ways to help the Medicines Patent Pool to continue delivering in the COVID crisis as well. Many pharma companies are supporting the Medicines Patent Pool with free or cost-based licensing. Medicines Patent Pool is one of the actors mentioned in the C-TAP initiative that calls upon holders of knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines to voluntary license and provide access to their proprietary assets. We note that MPP is an organisation with the working history and experience in pooling IP and concluding licensing agreements with pharma companies and a one that can deliver results, gather support. 235.   In the EU, compulsory licences are regulated and granted by the EU Members. With the IP Action Plan, the Commission encouraged the EU Members to assess their domestic legislation and to make sure that the all the tools are indeed available. 236.   Since the competence for compulsory licences remains national, the Commission considers that early coordination and information among the Members would secure maximum benefits whilst at the same time avoiding excessive distortions. This is a specific issue in the EU which other WTO Members may not face. As concerns the EU's status under Article 31bis of the TRIPS Agreement (i.e. the procedure set up for cases of insufficient manufacturing capacity), it must be noted that the EU possesses very extensive manufacturing capacity for pharmaceutical products. Nevertheless, we closely and constantly monitor the situation, together with our Members, to be able to address any issues that may arise. 237.   The EU is committed to an open and comprehensive dialogue with all WTO Members to explore how the multilateral rules-based trading system can best support universal and equitable access to COVID-19 vaccines and treatments as we seek to provide for a robust, rapid and universal response to the pandemic. 238.   We have already indicated our willingness to discuss problems with the implementation and the use of the TRIPS flexibilities, in particular how the use of the flexibilities such as compulsory licensing can be facilitated. It is important that these flexibilities can be used when the need arises and are not hampered by administrative hurdles. 239.   Only international cooperation can mobilise the global manufacturing, trade, and delivery response that will end this crisis and help build a more resilient system for the future. We are committed to such cooperation.

The Council so agreed.
1. The Chair said that the "Proposal for A Waiver from Certain Provisions of The TRIPS Agreement for the Prevention, Containment and Treatment of Covid-19" had been circulated in document IP/C/W/669 by India and South Africa on 2 October 2020 and had since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt and – most recently – the African Group and the LDC Group.
2. At the Council's last formal meeting on 10 December 2020, the Council had agreed to provide a 'Status Report on the consideration by the TRIPS Council of the waiver proposal' to the General Council meeting of 16-17 December 2020. That Status Report provided a factual overview of the waiver discussions in this Council and highlighted Members' common goal of providing access to high-quality, safe, efficacious and affordable vaccines and medicines for all. It reported that Members had exchanged views, had provided information and sought clarifications, but had not been able to reach consensus. It concluded that,
"[T]herefore, the TRIPS Council will continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement."
3. Since then, the Council had continued its consideration of the waiver request at informal open-ended meetings on 19 January and 4 February 2021, including on the basis of three new submissions circulated by the co-sponsors on 15 January 2021, and which bear the document numbers IP/C/W/672, IP/C/W/673 and IP/C/W/674.
4. She said that, after the informal open-ended meeting on 19 January, she had held consultations with a number of delegations on 27 January 2021 to encourage more solution-oriented discussions and to explore in concrete terms whether a possible landing zone could exist – in terms of concrete elements and outcomes – and to hear views on our report to the General Council. In preparation of that meeting, she had requested delegations consider three questions, namely (1) which elements of the Waiver were critical to deliver a multilateral solution on the common objective of ensuring swift, timely, affordable and equitable access to the vaccines and therapeutics to combat the COVID19 pandemic, (2) whether the discussion had provided clarifications about core elements of the TRIPS Agreement in relation to public health and how these can be captured to establish a common understanding; and (3) what were delegations' views on the timing and format of deliberations towards a report to the GC as communicated by the TRIPS Council in December 2020.
5. While delegations' responses to these questions did not indicate any significant shifts in positions, a number of delegations signalled openness to hearing concrete evidence of any IP-related challenges that would be related to or arising from the TRIPS Agreement, and to seek consensual, proportionate and commensurate solutions to any such problems where necessary. The co-sponsors also indicated that they were ready to consider the contours, the scope and the time frame of the waiver proposal, and indicated that they would once again reach out to delegations individually for further discussions.
6. At the informal open-ended meeting on 4 February 2021, Members had continued their consideration of the waiver request. She said that, from the discussions at these meetings, it seemed that there remained differences in Members' approaches to the waiver proposal. A number of delegations had indicated a need for more evidence-based discussions in the TRIPS Council to understand the issues underlying the waiver request, as well as clarifying the impact and operation of the waiver in practise. The co-sponsors had made numerous interventions – and circulated a number of new documents – in response to questions and concerns raised by delegations and had indicated that they would wish to advance to text-based negotiations.
7. She said that, as regards the question about the Council's report to the General Council, most delegations indicated a preference for a factual report that would once again reflect the state of play of discussions among Members, following the same lines as the status report delivered in December 2020.
8. As foreshadowed at the informal open-ended meeting on 4 February, she had circulated draft language for such a report on 9 February, with an invitation for Members to comment on this language by 12 February 2021. On the basis of the comments that were received by the deadline, she had held further consultations on 16 February, and circulated a revised draft status report in document JOB/IP/42 on 17 February, which she hoped could be adopted today. The item had also been placed on the agenda of the General Council meeting scheduled for 1 March. This concluded the summary of the Council's activities since its last formal meeting.
9. Turning to the revised language for the oral status report to the General Council which had been circulated in document JOB/IP/42 on 17 February 2021, she noted that the African Group and the LDC Group had now been listed as co-sponsors of the waiver proposal, and she suggested that this be also reflected in the first paragraph of the status report for the purposes of accuracy. She therefore proposed the Council agree that she would deliver an oral status report to the General Council as follows:
At the meeting of the TRIPS Council on 15-16 October 2020, India and South Africa introduced document IP/C/W/669, requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19, which had been circulated on 2 October 2020 and has since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group and the LDC Group. The Council continued its discussions under that agenda item at informal meetings on 20 November and 3 December, as well as at its resumed meeting on 10 December 2020. Following the status report to the General Council on 16-17 December 2020, the Council continued its consideration of the waiver request at informal meetings on 19 January and 4 February 2021, and at its formal meeting on 23 February 2021.
At those meetings, delegations highlighted the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through documents IP/C/W/670, IP/C/W/671, IP/C/W/672, IP/C/W/673 and IP/C/W/674, on the waiver request but could not reach consensus, including on whether it is appropriate to move to text-based negotiations. Delegations indicated a need for further discussions on the waiver request and views exchanged by delegations.
This means that the TRIPS Council has not yet completed its consideration of the waiver request. The TRIPS Council will therefore continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.
10. The Council so agreed.
11. The Chair thanked all delegations, particularly those involved in the consultations, for the constructive spirit in which they had engaged in the discussions on this report. As regards the TRIPS Council's next steps in this regard, this item would now be on the agenda of the next regular meeting, scheduled for 10-11 March 2021. After that, the next regular meeting of the TRIPS Council was scheduled for 8-9 June 2021. She said delegations might wish to consider how to organize the Council's consideration of this issue going forward, would be invited to also share their views in this regard, so that the Secretariat and the Chair could make any appropriate arrangements.
12. In her view, the single most important priority of the global community was to stop the COVID19 pandemic, halt its rapid transmission, reduce the risks of variants and reverse the trend of consequential global distress. This goal is only achievable when everyone, everywhere can access the health technologies they need for COVID-19 detection, prevention, treatment and response. This was a goal that Members of the WTO have consistently repeated in their statements. Now more than ever, international cooperation and solidarity were vital to restore global health security, now and in future.
13. The business community is calling for a coordinated approach to vaccine access in view of the risks to the global economy inherent in an uncoordinated approach. The WTO's four DDGs have also issued a statement calling for heightened international cooperation, including ensuring the global availability of vaccines. Importantly, that the war against the pandemic can only be won when universal coverage in vaccination is achieved. The new WTO DG had stated that for the global economy to return to sustained growth, the global community would need to get a tight grip on the pandemic by intensifying cooperation to make equitable and affordable access to vaccines, therapeutics, and diagnostics a key plank of the recovery.
14. In the informal meeting of 4 February 2021, many Members had recognized the challenge arising from limited manufacturing capacity of vaccines and the inability of existing manufacturers to meet global demand. She urged Members to engage in a candid and good-faith discussion on what is required to scale up global production in these unprecedented times of a public health crisis. She expressed her hope that Members would engage in a solution-oriented process that will provide an effective solution to boosting productive capacity for products that are essential to deal with COVID-19 across the world. The WTO membership should demonstrate its commitment to the overarching goals of universal and equitable access to COVID-19 medical products not only in words, but through action. She also reminded Members of the heightened public interest and concern in this regard.
15. The Chair invited Members to take the floor.
16. The representatives of Chile; Tanzania; South Africa; Egypt; Colombia; Chad; Pakistan; Bangladesh; Mozambique; India; Indonesia; El Salvador; Venezuela; Sri Lanka; Namibia; Nepal; Nigeria; China; the European Union; the United States; Norway; Switzerland; Mali; Singapore; Canada; the United Kingdom; Australia; Japan; and the Holy See took the floor.
17. The Chair said that it seemed from delegations' statements that there was still no consensus on this waiver request at this point. She noted that the proponents had made further efforts to address a number of questions on the functioning and the impact of the requested waiver, which delegations have raised in the last meetings and in a recent submission. In light of this, she encouraged delegations to continue to engage with each other, and to seek common ground in regard to the subject matter of the waiver request, including in relation to scope and substance – as indicated by proponents in order to achieve the common objective shared by all.
18. She emphasized that the detailed exchanges and discussions that Members had had in the context of the waiver proposal were extremely useful and valuable. While Members were still discussing the waiver proposal before them, it was her impression that these discussions had highlighted a number of shared understandings with respect to TRIPS flexibilities which Members might wish to reflect on and explore further. COVID-19 may not be the only pandemic. Therefore, the TRIPS Council might wish to highlight and communicate such shared understandings on the role of IP in the context of a pandemic, as these could provide valuable elements and could help prepare for future pandemics.
19. She said that she herself, and the Secretariat, were always available to help facilitate any path forward that Members might wish to explore in this regard
IP/C/M/97, IP/C/M/97/Add.1