360. At the outset I want to thank the European Union for its introduction. I think we are on record in many of the meetings indicating that we believe that the response proposed by the European Union is essentially insufficient. We also note that the proposal is underpinned by an assumption that the laudable and unprecedented progress made in developing COVID-19 vaccines was incentivised by IPRs. While recognizing the role of IP to research and development, we also have to recognize other factors incentivising the rapid development of COVID-19 vaccines would also apply in this case. We believe that a common desire to ameliorate and eliminate an existential threat to the human race in terms of its health and economic wellbeing is part of that driving force. Also, large-scale public investment in research and development amounting to billions of dollars have also contributed.
361. We would be the first country to acknowledge and appreciate the role that intellectual property can play in stimulating innovation and as we have said in previous statements our IP Policy of 2018 is testament to this particular aspect. However, we believe that it is important to focus on the facts of the matter. In our view, an urgent multilateral response to the pandemic requires acceleration and diversification of production of health products and technologies, especially in low and mediumincome countries. We see that Africa lags far behind in the global distribution and access. A continent of 1.2 billion people imports 99% of its vaccines. This is unsustainable and something that would have to change. It is therefore critical that we use all the policy tools available to us to achieve this stated purpose to address barriers to production and diversification of production across the world. From this perspective we believe that the TRIPS waiver is a credible response by Members that should engage in good faith to achieve this objective, and that objective would be to save lives.
362. Substantively, we have raised various issues, and I will quickly go through some of these points. We believe that the proposal which envisages a declaration by the General Council provides clarification in relation to the rights of Members that are already clear. Where Members have to use compulsory licences, in reality, all the clarifications that have been advanced by the European Union are already abundantly clear and this can be ascertained by a simple reading of the text of TRIPS Article 31bis, and the Doha Declaration on TRIPS and Public Health has already given us a very clear picture of the right of Members to use compulsory licences. So from that perspective the EU proposal seeks to provide a clarification at the level of the General Council to essentially seek clarification on so-called national emergency and other circumstances of extreme urgency within the meaning of Article 31.b of the TRIPS Agreement.
363. This was never in question. We believe that in addition, the highest decision-making body of the WTO clarified in 2001 that for the purposes of Article 31.b, "Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency". Another concern that we have raised in the deliberations that we have had relates to the clarification that the EU is advancing, which seems to limit the flexibilities provided to WTO Members under Article 31 and 31bis of TRIPS. During a pandemic, compulsory licences can be issued for purposes of public non-commercial use as well as to remedy anti-competitive practices, in which event there is also no need to obtain authorization from the right holder.
364. A serious concern with EU's proposal is that it implies that an authoritative interpretation by the WTO is required before an event can qualify as a "national emergency or other circumstances of extreme urgency". But this is not the case as - clearly - paragraph 5.c of the Doha Declaration has already provided this particular clarification.
365. In relation to remuneration, we have also raised the issue that Article 31.h of TRIPS allocates and states that "the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization". The TRIPS Agreement already provides full freedom in terms of the level of "adequate remuneration" to be paid to the patent holder under a compulsory licence. From that perspective, under Article 31.j of the TRIPS Agreement, the right holder has the right to appeal such a decision concerning remuneration, if the holder is not satisfied. This has also been clarified by work conducted by the Secretariat that the decision to set the level of remuneration is that of the national authorities that are competent to make such a decision.
366. The EU's text also implies that remuneration reflecting the generic price is only allowed in situations of "addressing the pandemic at affordable prices for low- and middle-income countries" and for "vaccine or medicine" although the flexibility to determine adequate remuneration in Article 31 is applicable to all WTO Members in all circumstances even beyond pandemics.
367. Furthermore, we would want to say, in short, it is unclear what the EU proposal adds to the status quo from a substantive perspective. If anything, it appears that the EU proposal seeks to limit the existing TRIPS flexibilities. Another point that we would very quickly like to raise is that the EU proposal treats compulsory licensing of products as a panacea for all IP-related barriers. In reality, this is not the case. As proponents of the TRIPS waiver, we have outlined in detail why compulsory licensing of patented products are inappropriate to comprehensively and expeditiously deal with COVID-19 in our documents and , so I will not repeat those particular aspects but merely indicate that compulsory licences as a response to the pandemic may not be able to deliver the results that we are seeking.
368. We do believe there is a need to simplify the compulsory licensing system, however we do not see how the EU proposal achieves this objective, other than maintaining the status quo. We take good note of the intervention by Brazil that looks at issues such as packaging as a further simplification, and we believe that this could be useful as an addition to our discussions. From that perspective we think that the EU proposal does not go far enough and certainly, as we have stressed, the EU proposal in its current form cannot be seen as an alternative to the waiver proposal, since it addresses only very limited issues and so from that perspective, we think that a further discussion could unlock an expansion of the ideas that have been introduced by the European Union.
369. I guess, as we have reiterated, the proposal is certainly limited to compulsory licensing of patents. As the waiver proponents have said, it does not address intellectual property beyond these concerns and so we think that issues around the protection of undisclosed information, copyright, industrial designs and so forth are also important responses to deal with the situation that we face with COVID-19. On the other hand, as we have reiterated, the waiver proposal comprehensively deals in a holistic manner with all the matters in relation to COVID-19 technologies and intellectual property. It is also not clear how the EU proposal will facilitate the transfer of technology and knowhow. We also note the call by several Members, including the delegation of Brazil, to have a further discussion on this particular issue. The communication also fails to address the major underlying concern with respect to compulsory licensing-that is the "case-by-case" or "productbyproduct" approach which is limiting during the pandemic, and that this approach means that additional tools are needed to overcome IP barriers.
370. At the start of this discussion on the TRIPS waiver in October 2020, we heard some developed country Members referring to C-TAP and COVAX as tools that will deliver equitable access in due course. We have always been open to alternative approaches and we have welcomed these as alternatives to what we are proposing, but to date these tools have not delivered as much as they had promised. We have seen many pharmaceutical companies rejecting CTAP and we have witnessed a growing inequality and insufficient supply to COVAX which as of 19 July 2021 had only shipped 129 million doses, 6.5% of the 2 billion doses which will be due by the end of 2021. From that perspective it is very clear that we need additional capacity, we need more producers to come online to produce vaccines for everyone including for the developing world. We have heard voluntary licences is the way to go, but the experience during this time has indicated that these are extremely limiting. We have heard various delegations including the delegation of Indonesia indicating that many producers in the developing world requesting licences have been rebuffed and clearly under these circumstances compulsory licences are not delivering the results that we need.