98. At the outset, let me clarify that our statement covers both, agenda items 1 and 2.
99. My delegation would like to thank you, Chair for your efforts in this process and for the consultations you held to find consensus on the status report to the General Council. It is important that this report reflects correctly and comprehensively the discussions the Council has held in the various formats on all the proposals made by Members, in an objective and factual manner. This includes, of course, in addition to the waiver request, also the proposal from the EU in document .
100. As you reported to this Council and will to the General Council, Chair, Members have intensified work over past weeks and have held substantive discussions on the proposals on the table. Switzerland remains committed to engage in the Council's discussions and the need to consider all the proposals when we resume that work.
101. My delegation requests the Secretariat to include its statements from the informal meetings since the Council met formally the last time in the minutes of this Council. At last week's meeting, my delegation noted the many questions posed by Members to the proponents and their TRIPS waiver proposal. These concerned in particular questions in relation to the national implementation and the impact and negative effects such a waiver risks to have on the ongoing international efforts to scale up the manufacturing of COVID-19 vaccines. The discussions show that there is still no consensus that a waiver is the adequate approach to achieve our shared goal of making global and equitable access to COVID-19 vaccines and therapeutics happen in the shortest time possible. Nor have we been presented with evidence that the TRIPS Agreement would indeed be a barrier to access. On the contrary, we see, in many examples, that it works as an enabler.
102. My delegation referred previously to the more than 300 voluntary agreements and partnerships that so far have been established internationally and are working currently on scaling up manufacturing of COVID-19 vaccines or work on the development of vaccines adapted to the new variants and respective health technologies. And new ones are announced almost every day. These partnerships are based on the international regulatory framework in place, of which the WTO TRIPS Agreement is a key component.
103. The case example of Lonza illustrates this, a Swiss pharmaceutical and biotech company with considerable experience and existing solutions facility, covering the complete biopharmaceutical lifecycle, ranging from preclinical to commercial stages, from drug substance to the final drug product:
104. The US vaccines developer Moderna and Lonza announced in May 2020 a ten-year agreement to support the manufacturing of Moderna's COVID-19 vaccine. Under this Agreement, Lonza provides drug substance manufacturing capacity for Moderna's mRNA COVID-19 vaccine. On the basis of their cooperation agreement, the two partners established a close collaboration:
a. They exchanged skilled personnel which are the holders of respective experience and knowhow, transferred technology and materials for the manufacturing of the product, handling instructions, protocols of production standards, other documentation necessary to maintain the properties of such materials for the performance of their service.
b. They established a Joint steering committee in charge of overseeing, reviewing, approving and coordinating the activities of the Parties under their cooperation agreement.
c. A joint manufacturing team was set up to oversee the services under each stage of production.
d. Licensing and confidentiality agreements were prepared in relation to trade secrets and manufacturing know-how to be exchanged.
e. Setting up such a complex manufacturing capacity of this scale would normally take up to two years till production is operational. Thanks to their close collaboration, sharing of knowhow and the focus they set to respond to the urgency of the pandemic, the two partners managed to start the first of three production lines after eight months' time. Not of the entire vaccine, of course, but as mentioned of the drug manufacturing substance. Moderna works with many more partners to produce and get the finished and filled vaccines ready for inoculation.
f. At the end April of this year, Moderna and Lonza announced that they intend to double the manufacturing capacity of Lonza, hoping to get three additional production lines going by spring 2022.
g. A major and urgent concern for Lonza remains finding sufficient qualified specialist staff, from vaccines researchers to other expert employees to implement this project and adhere to the set time schedule for establishing and scaling up its manufacturing capacity. This is particularly challenging today, in the time of the pandemic, where in the field of vaccines science the market for qualified research and other experts is almost dried up, and this at the international level. In this state of emergency, the Swiss Federal Government started to dispatch temporarily qualified experts from its own federal and from university staff to support the ramping up of Lonza's manufacturing capacity. Lonza itself contacted other Swiss companies to see whether they could loan specialists to step on a temporary basis.
105. We can take away a few lessons from this case example:
a. The close cooperation between Moderna, the vaccine developers, and Lonza, the qualified manufacturer, was quintessential for the scale-up of manufacturing to succeed. And to succeed within a timeline to matter for the fight against this pandemic.
b. Voluntary collaboration, exchange of expert personnel, transfer of their know-how and technology were key ingredients of their success.
c. Even with partners willing to collaborate, to contribute, exchange and share - it took time to get this up and running. This cannot be done at the push of a button.
d. Many operational challenges need to master: recruitment of the required number of qualified specialists, access to needed raw materials and getting the right supply chains in place to secure the manufacturing process from sourcing raw materials to fill and finish the vaccines.
e. Last but certainly not least: protection of their trade secrets and manufacturing know-how were a given for both partners to enter into a partnership. For this, the two partners relied on the well-established and trusted international regulatory framework, part of which is the TRIPS Agreement. Had there been no international regulatory IP framework or had TRIPS been suspended, this international partnership, just one of many examples, would not have come about.
106. Against this backdrop, my delegation reiterates its concern that the proposed TRIPS waiver would jeopardize the partnerships and collaborations such as the one between Lonza and Moderna currently engaged in the manufacturing of COVID-19 vaccines, adapting them to new virus variants or the development of novel therapeutics against the Sars Cov2 virus. It also risks preventing the establishment of new partnerships and would thus have a counterproductive impact on our achieving, as soon as possible, the goal of broad and equitable access to COVID-19 vaccines.
107. We agree, that, at this juncture, in many countries we still face a severe shortage of vaccines, equitable access to it, and a lack of efficient vaccination strategies to inoculate populations. In this regard, we reiterate that a holistic approach is needed, that notably addresses trade measures and the real bottlenecks affecting access to COVID-19 vaccines and relevant health technologies. The WTO has an important role to play, and we welcome the trade policy actions identified by more than 50 of its Members on 15 July 2021 in the communication "COVID-19 and beyond: Trade and Health".
108. In addition, to ensure more equitable access to vaccines in the immediate term, countries disposing of sufficient doses must now share surplus vaccines quickly. Vaccine's production and sharing in cooperation with WHO's COVAX must be oriented with high priority to the needs of those countries with the most acute shortage.
109. Governments also need to boost local and regional vaccines production to be better prepared for future pandemics, including in Africa. But this is not a goal that can be achieved at once. Nor through a TRIPS waiver. This goal must be pursued in the medium and long term. Cooperation, capacity-building and manufacturing partnerships will be a prerequisite for this to happen successfully - the TRIPS regulatory framework will contribute again as an enabler. We took note with interest of the new initiative of WHO to establish a vaccine technology transfer hub mechanism. Switzerland has already been in touch with the person responsible at WHO to pledge our support.
110. On the further discussions and work of the TRIPS Council after the recess, Switzerland remains committed to contribute actively and constructively with the aim to find adequate solutions that can truly support us in achieving our shared goal that unites this Council.
Switzerland's statement at the informal meeting held on 17 June 2021
111. In order to respond efficiently to the COVID-19 pandemic, many measures are needed. These range from the support and facilitation of partnerships between innovative companies and qualified manufacturers with adequate production capacity, to removing export restrictions and minimizing barriers to trade. This is why a holistic approach is best suited to harness the contribution of trade to an effective response to fight the pandemic. In this regard, Switzerland would like to recall that the "Trade and Health" initiative by the Ottawa Group, and supported by other Members, provides pragmatic proposals on these issues. Switzerland actively supports this initiative and encourages all WTO Members to consider it positively.
112. My delegation reiterates its openness to examine all proposed measures by WTO Members which contribute - effectively - towards the goal of expanding the production of COVID-19 vaccines and health technologies and facilitates prompt and equitable access to them. Regarding the way forward, we would like to thank you Chair for holding small group consultations on this matter on 16 June as well as on 11 June.
113. In light of the various ideas on the table and the different perceptions of the best way forward, Switzerland believes that all the proposals and potential future proposals, which are all working towards the same goal, have to be discussed on an equal footing in this process. This means, irrespective of their current form, at the same time and with equal intensity.
114. Chair, we would like to thank you for your suggested calendar of meetings. This calendar, which contains indicatives dates, is very intensive, but we are ready to engage on this. We understand that in the stocktaking meeting on 30 June, Members will have an opportunity to review this schedule and whether the rhythm and thematic structure of meetings seems appropriate. We also welcome the approach to have dedicated meetings to discuss specific topics. As mentioned by the United Kingdom, which remarks on calendar we fully support, we need a pragmatic, solutionoriented and problem-based approach. To that effect, we need to look at specific topics and how the individual proposals would address them. Effectiveness, short, medium and long-term effects or national implementation are also important elements to discuss.
115. In order to ensure that all proposals can be treated on an equal footing, we would like to express our support to the European Union's suggestion to hold the first small group meeting only after the EU was given an opportunity to present its proposal on the 24 June. We are currently analysing proposals in documents and and would welcome to be able to benefit from sufficient time to allow in-depth study of these proposals. We agree to discuss all proposals that have the objective of ramping-up production and ensuring access, inter alia proposal document , including the draft text. Nevertheless, this is without prejudice to the Swiss position as to the TRIPS waiver proposal as such. Indeed, as we have clearly stated in our previous statements, we have not been convinced and do not believe that IP is a barrier to global access and that the suspension of the TRIPS Agreement would be an effective measure to ensure a global, equitable, affordable and timely access. Doing so could have counterproductive effects for reaching our common goal, fighting this and futures pandemics.
116. Switzerland will continue to actively contribute to the ongoing efforts at the WTO in order to reach our common goal of quickly scaling up global manufacturing capacity for equitable access to COVID-19 vaccines and other medical technologies.
Switzerland's statement at the informal meeting held on 24 June 2021
117. My delegation would like to thank you for organizing this open-ended informal meeting. As this Council is dedicated to proposal document , we will not repeat today our well-known position and refer on that point to our previous statements. We would like to thank the European Union for presenting its new proposal document . As this document was circulated four days ago, we are currently analysing it in capital.
118. Allow us, Chair, to make some preliminary comments and ask the distinguished delegation of the EU a question. Switzerland appreciates that proposal document is part of a broader holistic approach reflected in the EU proposal WT/GC/231 on urgent trade policy responses to the COVID-19 crisis. We fully share the EU's views that the holistic approach is the right way in order to reach our common goal of expanding the production of COVID-19 vaccines and health technologies and facilitates prompt and equitable access to them. This approach is necessary not only to facilitate trade and address export restrictive measures, but also to enhance harmonious and trust-based collaborations as well as mutual exchange of know-how and technology.
119. Thanks to a holistic approach and to efforts based on the tools provided for under the multilateral framework we believe that manufacturing capacity will ramp up. As already stated, Switzerland fully acknowledges that compulsory licences are a flexibility that Members can use under Article 31 of the TRIPS Agreement, as also confirmed in the separate Doha Declaration on the TRIPS Agreement and Public Health. Under Article 31, a compulsory licence can be issued promptly and in the case of an emergency, like the COVID-19 pandemic, even without prior negotiations with the right holder.
120. We encourage Members facing practical challenges when making use of compulsory licences to bring this quickly to the attention of the TRIPS Council. Switzerland remains open to discuss solutions to concrete challenges. In our view, clarifying the application of existing provisions of the TRIPS Agreement concerning certain aspects of compulsory licensing, in the circumstances of a pandemic as suggested in proposal document , is a constructive approach. We believe that solutions should and can be found building on existing multilateral IP rules.
121. We welcome the fact that proposal document underlines the need to provide and preserve appropriate incentives for investments in research and development of COVID-19 vaccines. We also share the view expressed in the communication that legal certainty on the flexibilities provided for in the TRIPS Agreement is essential when making use of compulsory licences in the context of a pandemic. Our delegation would be interested to know if diagnostics are also covered by the proposal since they are not explicitly mentioned. As already stated several times, Switzerland believes that all existing and future proposals on these matters should be discussed on an equal footing. We look forward to discussing in an open-minded and inclusive way all proposals – including the present one – on 28 June at the small group consultation on IP rights.
Switzerland's statement at the informal meeting held on 30 June 2021
122. Our delegation would like to thank you for convening this important meeting, which gives Members the opportunity to take stock of the discussions, review the process's schedule, pace and thematic structure, as well as discuss the next steps. Allow us, Chair, firstly to reiterate that Switzerland is fully convinced that the IP system is part of the solution to fight the pandemic. IP rights are namely key for existing and forthcoming collaborations and partnerships between various stakeholders because they offer safe environment for know-how and technology transfer.
123. In a timesaving manner, we will not repeat our position and refer to all our previous statements made at the TRIPS Council. However, we would like to recall that there is no silver bullet to address the challenges we face in the current pandemic: Only a holistic approach can bring us closer to our common goal of increasing global manufacturing capacity for equitable and affordable access to COVID-19 health technologies. In the context of a holistic approach, we stand ready to discuss IP and in particular possible solutions to practical challenges that Members would face. We believe that Members need to adopt a pragmatic, targeted solution-oriented and problem-based approach, and that solutions can and should be found within the rules-based multilateral IP system.
124. Currently, two proposals – respectively documents and – are on the table, proposing different approaches in order to reach our common goal. There is currently no consensus among Members as to which approach should be pursued. We are convinced that it is therefore necessary to continue discussing all proposals on an equal footing. We appreciated the holding of the two small group consultations related to the scope of products and IP rights. Indeed, they gave Members the opportunity to discuss proposals documents and in a constructive, interactive and inclusive way.
125. In these meetings my delegation was in particular interested to understand better why existing TRIPS flexibilities are not sufficient to adequately address potential problems arising and how the approach suggested in document would achieve the objective of ramping up manufacturing, in particular with regards to the question how a suspension of the protection of trade secrets would encourage technology transfer. We certainly agree with proponents of document on the importance of know-how and technology transfer, but still fail to understand how this would be facilitated with a suspension of the protection of trade secrets.
126. We believe that it is our collective responsibility as Members of the WTO and as Parties to the TRIPS Agreement to search for solutions based on existing multilateral IP rules, rather than simply suspending these rules. In this regard, we reiterate our call to Members facing practical challenges when making use of TRIPS flexibilities such as compulsory licences to bring this quickly to the attention of the TRIPS Council.
127. Considering the number of open questions, Switzerland believes that it would be important to continue these discussions, with the aim to better understand the challenges concretely faced and identify the best way forward to achieve our collective goal. During the last small group meeting, Members touched upon the issue of implementation several times. We would therefore propose that the next small group consultation focuses on how the proposals would be implemented in domestic law, as this is a key aspect which has not been sufficiently addressed.
128. Furthermore, topics such as systemic implications, short, medium and long-term effects also seem very pertinent to us. We also support the suggestion that came up in the meeting on 28 June to have a dedicated small group consultation on technology transfer. Regarding the way forward in July and in order to manage time carefully, we suggest keeping the same rhythm of meetings as described in your communication dated 16 June. We are of the view that one small group consultation per week on a specific topic allows Members to adequately prepare for them and provides predictability. In this regard, we would also appreciate if you could indicate in a communication the dates for the small group consultations to be held in July.
129. As indicated in your communication dated 16 June, Chair, we have noted that you have the intention to convene three TRIPS Councils in the coming month: on 6, 14 and 20 July. These openended meetings would allow Members to take stock of the discussions and to prepare the status report for the General Council meeting of 27 and 28 July. Our delegation would appreciate to get more clarity on the structure on these open-ended TRIPS Councils. As envisaged in your communication Chair, we support the idea of holding one of the three meetings mentioned above as a formal meeting, in order to adopt the status report to the General Council. Let me reiterate, Chair, that Switzerland remains fully committed to engage actively in order to find with all Members a pragmatic solution to reach our common goal.
Switzerland's statement at the informal meeting held on 6 July 2021
130. My delegation would like to thank you for convening this open-ended meeting. We would like to start our statement by making an announcement: we are pleased to inform Members that the Swiss Federal Council decided, on 30 June, to transfer 4 million of vaccines doses to the COVAX Facility. To us, the COVAX facility is a key international initiative to reach the goal of equal and equitable access to COVID-19 vaccines. Indeed, it brings together Members, international organizations and other public and private stakeholders as partners to work together towards the goal of global access to COVID-19 vaccines.
131. Partnerships are key to fight this pandemic, also with regard to ramping up production. The IP system also brings together various stakeholders as partners to continue research and development of COVID-19 health technologies to fight the current pandemic. IP is thus part of the solution and is not a barrier. Therefore, and as mentioned in our previous statements at the TRIPS Council, we are convinced that Members should address the pandemic in a holistic and sustainable manner and within the rules-based multilateral IP system in order to overcome this crisis quickly.
132. As for the small group consultations on 22 and 28 June, we observed on 5 July that the consultation enabled Members to discuss proposals documents and in a constructive, interactive and inclusive way. The day before, we were especially interested to obtain more information on how a waiver would concretely be implemented. Unfortunately, many of our questions remain unanswered. For instance, we still fail to understand how a waiver would be a quick solution for all Members, if Members wishing to implement it would need to amend their domestic legislations. We also do not understand how waiving obligations of the TRIPS Agreement would be consistent with other international obligations. Finally, we also fail to see how predictability and transparency would be ensured with regard to the implementation of the waiver.
133. Regarding the duration of the effects of a waiver, we still do not understand how confidential information, which would be disclosed during the application of a waiver, would be protected after its end. Indeed, the conditions of Article 39 § 2 of the TRIPS Agreement would not been fulfilled anymore; that means that once disclosed, such confidential information would lose protection forever. Related to this, let me add one follow-up question to the discussion on 5 July: If our understanding is correct, safeguards could be built in to ensure confidentiality under the waiver? How would this work and what would then be the reason to suspend the legal certainty and confidentiality we have now with TRIPS Agreement in the first place?
134. While these small group discussions have been helpful in deepening our exchanges also with a view on the status report for the July General Council, Members views on the issues such as scope, duration or implementation are still diverging and it seems that we did not come closer to reaching consensus so far. Switzerland is ready to continue these discussions and will engage constructively.
135. Regarding the schedule, Chair, we understand that your intention is to convene another consultation on 9 July. We reiterate what we have explained at the TRIPS Council on 30 June and hope that you will consider it: namely that to us, one small group consultation per week on a specific topic is appropriate to allow Members to prepare adequately. We believe that having more than one consultation per week would weaken the quality of our discussions and take us away from our common goal.
136. With respect to the meeting on 9 July, we are ready to engage with the understanding that we will continue our discussion on implementation, as we have not had enough time on 5 July to discuss this topic. In order to structure our discussions in line with a pragmatic, targeted solutionoriented and problem-based approach, we propose to discuss topics such as systemic implications and short, medium and long-term effects at the small group consultations. We also reiterate our support to the suggestion made by Brazil to have a dedicated consultation on transfer of technologies and knowhow.
137. We thank the proponents of proposal document for reaching out bilaterally to discuss the way forward. In that meeting, Switzerland indicated its willingness to engage in this text-based process by continuing discussions on all proposals that have the objective of ramping-up production and ensuring access under the Chair-led process. This is without prejudice to the Swiss position as to the TRIPS waiver proposal as such. We also reiterated our view on the importance of voluntary cooperation in particular with a view to enable the crucial transfer of technologies and know-how for the complex production of vaccines. A Swiss manufacturer is producing drug substance. We therefore have first-hand experience on how important the collaboration between IP holder and manufacturer is. In this respect, we fail to understand how this cooperation could still work, not to mention be even better, without the legal certainty granted by the existing multilateral IP framework.
138. Switzerland remains ready to discuss with all Members how we can ensure a global and prompt access to COVID-19 health technologies with the aim to better understand the challenges concretely faced and identify the best way forward based on existing multilateral rules to achieve our common objective.
Switzerland's statement at the open-ended informal meeting held on 14 July 2021
139. My delegation would like to thank you for convening this open-ended informal meeting to inform the Council about your recent consultation and to consider next steps.
140. Switzerland constructively engages in these consultations and the Council's discussion of the proposals made by Members, based on proposed draft texts. We reiterate that this is without prejudice to Switzerland's position - that a waiver such as the one proposed in document is not a useful means to achieve our shared goal of ramping up manufacturing capacity for COVID-19 vaccines to enable global and equitable access as quickly as possible and encourage the development of new health technologies against COVID-19.
141. My delegation would like to thank you, Chair, for allocating time in the most recent small group consultations to discuss questions and concerns raised by Members in relation to the potential implementation of the proposed waiver. Switzerland and other delegations questioned claims that a waiver would – or even could – be swiftly implemented by Members. Members are bound by international IP treaties other than the WTO TRIPS Agreement. These treaties are outside the realm of the WTO and would not be subject to such a TRIPS waiver. Then, there is the national dimension: the domestic regulatory framework would need to be amended which cannot be achieved simply or swiftly.
142. While possible safeguards that could be built in a waiver have been mentioned by proponents of proposal in document , our questions and concerns on this important issue have so far remained unanswered. Why would the legal certainty we now have with TRIPS then be given up in the first place? Members in the consultations reiterated their concerns with respect to the legal uncertainty resulting from the suspension of large parts of the TRIPS Agreement. This would throw into jeopardy more than 300 voluntary agreements and partnerships that engage so far internationally in ramping up manufacturing of COVID-19 vaccines and in developing respective health technologies. It would also have a chilling effect on the establishment of new such partnerships.
143. An implementation of the waiver in a permissive way, such as advocated by the proponents of proposal in document , does not mitigate these concerns. Indeed, a situation where every Member decides whether, how and to what extent it would apply such a waiver would result in even more uncertainty. The various stakeholders would have no idea under what conditions to operate transnationally – as opposed to the current situation where the minimum standards of the TRIPS Agreement provided a safe point of reference and necessary guidance.
144. A number of delegations raised questions and reiterated concerns on the short/mid/longterm effects of the proposed waiver. We disagree with the claim that a waiver would have no negative effects and we believe that the Council should continue its consideration on the potential effects of such a waiver in relation to all three-time dimensions.
145. At the Council's informal meeting the previous week, my delegation mentioned the case of a Swiss manufacturer engaged in the fight against the current pandemic. We would like to provide more detailed information. The Swiss company Lonza provides drug substance manufacturing capacity to the US company Moderna for its COVID-19 vaccine. Lonza and Moderna announced in May 2020 a ten-year strategic collaboration agreement to support the manufacturing of Moderna's COVID-19 vaccine. With this collaboration agreement between them, it took the two companies eight more months of close collaboration, intense cooperation, innumerable contacts and exchange of skilled personnel as well as the sharing of know-how and transfer of technology before production of drug substance could start at Lonza's site in Visp.
146. On the basis of this successful cooperation, Moderna and Lonza announced last April their intention to double production by building three additional production lines. Lonza hopes that with the close support of Moderna to have these new lines in operation in the course of spring of 2022. This target date is only feasible thanks to Lonza's existing solutions facility, which covers the complete biopharmaceutical lifecycle (ranging from preclinical to commercial stages, from drug substance to drug product).
147. A major and urgent concern in this context is to find the necessary qualified specialist staff, from vaccines researchers to other expert employees to implement this project and adhere to the set time schedule. This is particularly challenging today, in times of the pandemic, where in the field of vaccines science the market for qualified research and other experts is close to dry out, and this at an international level. In this state of emergency, the Swiss Federal Government started to dispatch temporarily qualified employees from its own federal and university staff to support the ramping up of Lonza's manufacturing capacity.
148. This example demonstrates how quintessential the close collaboration between vaccine developers and qualified manufacturers is, how the success of their partnership depends on voluntary transfer of technologies and know-how to become operational in a reasonable and useful timeframe in order to be still relevant for fighting this pandemic together. It also highlights that a range of other complex challenges related more to operational matters need to be mastered also successfully. And yes, it also demonstrates that this is still demanding work in progress.
149. Against the backdrop of this case example, my delegation is clearly of the view that the proposed TRIPS waiver would put into jeopardy existing transnational partnerships and collaborations engaged in the manufacturing of new vaccines and the development of novel therapeutics. It also risks to prevent the establishment of new partnerships as the existing international regulatory framework, important part of which is the WTO's TRIPS Agreement, could no longer provide the required regulatory basis.
150. Turning to the status report to the General Council of 27 and 28 July: We agree that the two previous status reports can serve as its basis. We have discussed in various formats how best to achieve our common objective and the role of IP for the past weeks. While we had intensive consultations, including text-based discussions on documents and , Members' views on the best approach to achieve our common goal are still diverging. There is no consensus on the approach to take or on the solutions contained in documents and . Clearly, the status report must refer to all proposals (including document on the table that were subject of the recent consultations and the Council's discussions, and that in the absence of a consensus, the Council will continue its discussions.