H.E. Ambassador Dr Pimchanok PITFIELD

United Kingdom

11 PARAGRAPH 8 OF THE MINISTERIAL DECISION ON THE TRIPS AGREEMENT ADOPTED ON 17 JUNE 2022

274.  The MC12 Decision on COVID-19 vaccines was brokered in a particular context of the pandemic and was clear in its scope and applicability. The landscape for COVID-19 vaccines is very different to that for therapeutics and diagnostics, both in terms of supply and demand dynamics, and the scope of products covered. At present, the United Kingdom has not formed a conclusion on an extension and we are still considering our position. The United Kingdom supports discussions, led by evidence and facts, as a necessary step to determine whether an extension is required, taking into account other factors, including unintended consequences that a broader scope may bring. 275.  We welcomed the discussion papers circulated last year, by Mexico and Switzerland, and Chinese Taipei, as important contributions to the discussion. We understand that pertinent questions raised by these submissions are yet to be addressed. These relate to, among other things, identifying if any barriers to accessing COVID-19 therapeutics and diagnostics are caused by IP, how product scope could be defined, the current supply and demand dynamics for these products, as well as concerns over the broad scope of a possible extension. 276.  Chinese Taipei's paper raised two fundamental questions: whether IP rights are the cause of insufficient accessibility, and whether an extension of the Decision will help? Their paper also notes the role of patents in incentivizing innovation and how weakening patent protection could adversely affect collective efforts to fight the pandemic. 277.  The United Kingdom shares the view that more patent applications do not equal restricting access to products and instead are proof that the current IP framework provides confidence to innovators to develop new products. It is important to note that businesses of various sizes, including micro, small, and medium-sized enterprises (MSMEs), are involved in the development and manufacture of therapeutics and diagnostics. Patent protection is a way to help these businesses, particularly the MSMEs, attract investment. We would therefore be interested to better understand the concerns expressed by some Members that a growing number of patent applications should be interpreted as the patent system blocking access to therapeutics and diagnostics. 278.  The paper also helpfully notes that a key factor to increasing production and enhancing access to therapeutics is closer industrial cooperation between originators and generic producers. 279.  The number of voluntary licensing agreements in place for COVID-19 therapeutics is noted by Mexico and Switzerland in their submission. They say that, as of 11 October 2022, 138 bilateral or Medicines Patents Pool-based voluntary licensing agreements comprising some of the most highly demanded treatments have been signed all over the world. These agreements cover more than 127 countries. The United Kingdom recognizes the essential role of generic manufacturing and has reiterated that it should be enabled by voluntary licensing agreements which include technology and know-how transfer. It is positive to see these partnerships formed in the COVID-19 therapeutic space. We believe that discussions on how to promote technology transfer and voluntary partnerships can be fruitful, and the United Kingdom stands ready to engage constructively with Members on this topic. 280.  We remain of the view that TRIPS strikes the right balance between incentivizing innovation and ensuring access through the flexibilities enshrined in the Doha Declaration. Therefore, decisions on TRIPS should be underpinned by evidence-based policymaking as businesses, of various sizes and all around the world, rely on certainty in the international intellectual property (IP) framework to seek effective protection for their inventions. Changes that could potentially weaken the ability of this framework to incentivize investment and innovation risks impacting our ability to tackle health emergencies both now and in the future. 281.  Moving forward, we would welcome constructive sessions that bring valuable evidence to the conversation from a range of relevant stakeholders.

The Council agreed to hold an Informal Thematic Session for Stakeholder Input as suggested by the Chair.
The Council took note of the statements made and agreed to revert to the item at its next meeting.

53. The Chair recalled that under paragraph 8 of the Ministerial Decision on the TRIPS Agreement, adopted on 17 June 2022, Members agreed to make a decision within six months from adoption, on whether to extend this Decision to cover the production and supply of COVID-19 diagnostics and therapeutics. The General Council had decided to extend this deadline and had kept the question of the duration of the deadline extension on its agenda, while substantive discussions should continue in the Council for TRIPS.
54. With respect to these substantive discussions, she said that Members' interventions during the March meeting of the TRIPS Council had illustrated that a wide variety of views persisted in regard to this issue. In her recent consultations on this question, delegations had largely recognized that substantive engagement will be more constructive once all Members have completed their domestic consultation processes but that, in the meantime, fact- and evidence-based discussions should continue. Some had explicitly pointed to the questions posed in papers circulated by Members as a good starting point.
55. In response to these views, she said she had held an informal open-ended meeting of the Council on 8 June 2023, where Members had continued their exchanges on the substance of the matter, including with reference to Members' various submissions in this regard.
56. She said she also explored with delegations the possibility to gather facts and take stock of developments relevant to the COVID-19 pandemic with outside stakeholders, such as international organizations, civil society organizations, business representatives and academia. Delegations were generally supportive of this idea to gather such input and experiences from within the competence of stakeholders, that was relevant to the COVID-19 pandemic. She said she had pointed out that this event could help inform not only the narrow question under paragraph 8 of the MC12 Decision, but also the broader mandate under paragraph 24 of the Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics ().
57. The Chair said that, if Members so decided, such a one-day thematic session could be organized after the summer break in late September or early October. Her suggestion would be that she would develop a draft program together with the Secretariat which would then be circulated to Members for comments. In this context, she had well taken note of Members' preference for a balanced composition of participating stakeholders from diverse geographical and organizational backgrounds. It was also clear that external stakeholder participation would be limited to the thematic session itself, and that negotiations and substantive deliberations would remain reserved for Members.
58. She invited Members to continue their substantive discussions and to also share any further thoughts with regard to such an "Informal Thematic Session for Stakeholder Input on IP and COVID-19 and the MC12 Decision".
59. The representatives of South Africa; China; Djibouti, on behalf of the LDC Group; Bangladesh; Indonesia; Nepal; El Salvador; Peru; Tanzania, on behalf of the African Group; the United States of America; India; Switzerland; the European Union; Japan; Thailand; the United Kingdom; Brazil; Korea, Republic of; Cambodia; Singapore; and Hong Kong, China took the floor.
60. The Chair assured Members that the envisaged thematic session was not an attempt to delay a decision, but rather an effort to continue a fact- and evidence-based discussion that could support a decision when all Members would be ready to engage. She also said that, while there had already been a number of substantive submissions on this topic, more written submissions from Members on their experiences or on pertinent questions would be useful to support a robust discussion of the questions before Members.
61. As work at the WTO was expected to accelerate after the summer, she pointed out that a decision under paragraph 8 of the Ministerial Decision did not have to wait until MC13 and could be taken by the General Council at any time, even before the end of the year. Finally, she recalled that paragraph 8 of the Ministerial Decision and paragraphs 23 and 24 of the Ministerial Declaration on Pandemic Response were two separate mandates for Members to discuss. While the thematic session could provide inputs for both, and she did not exclude that Members would discuss both mandates together, she wished to highlight that the mandates had separate objectives and would have to be looked at separately. Paragraph 8 of the Ministerial Decision was aiming for an eventual decision by Members, while paragraph 24 of the Ministerial Declaration mandated general reflection on experiences during COVID-19, and reporting to the General Council.
62. The Council agreed to hold an Informal Thematic Session for Stakeholder Input as suggested by the Chair.
63. The Council took note of the statements made and agreed to revert to the item at its next meeting.

IP/C/M/108, IP/C/M/108/Add.1