1464. Like others we would like to thank you for the report presented this morning which will go forward to the General Council, as well as all delegation that worked constructively to make sure that this would happen. At the informal meeting of 20 November and 3 December respectively, proponents reverted to questions posed by several delegations. We would like to ask that our responses during those meetings be made part of the record of the present formal meeting. I leave the Secretariat to decide how this should be done.
1465. Taken also that there were issues raised by the proponents of document IP/C/W/671, we will also in our present intervention come back to some crosscutting issues that were raised in that submission, and, as confirmed at the last meeting, we will revert with written responses to the questions that were raised by these particular Members.
1466. We have also seen new Members took the floor in the present meeting that had not previously spoken and so we are heartened at the level of engagement and also would wish to take the opportunity in joining our other co-sponsors to welcome Bolivia to our ranks.
1467. In the present meeting some new issues also arose from interventions including questions from various delegations - specifically, the delegation of Norway and Viet Nam – regarding possible modifications of the scope of this waiver. The co-sponsors stand ready to discuss the scope of the waiver proposal. I think we also have been open to these approaches. We want to note that in our bilateral meetings with many of the Members who may have concerns about the application of the waiver, there has always been any principled objection to look at the language so we welcome this development as a positive one.
1468. We would also like to thank the United Kingdom for the statement that they made and we take good notes of their efforts to explore how products and technologies are quickly made available to the WHO's C-TAP initiative. This is one of the avenues of course that they always say, our waiver supports, and so all efforts are welcomed to scale up reduction and to ensure access to COVID-19 products and technologies.
1469. In the interim, there has also been noteworthy development in policy guidance that would have been issued by some of our Members, including the European Union. So we take note of its IP action plan and its pharmaceutical strategy, which has direct bearing on our discussions in the TRIPS Council, an issue that I will come back to the little bit later on.
1470. We have heard from delegations opposing the waiver proposal have repeatedly suggested that voluntary approaches offer the best solution. We have emphasized, the TRIPS waiver proposal is supportive of any voluntary licenses issued by companies, however the terms of such licenses are often such that they may restrict access or reserve supply only for wealthy nations. Similarly, for vaccines, bilateral deals are being signed by pharmaceutical companies with specific governments, but the details of these deals remain unknown. Usually these agreements are for manufacturing of limited amounts and solely supplying a country's territory or a limited subset of countries. Ad hoc, non-transparent and unaccountable bilateral deals that artificially limit supply and competition cannot reliably deliver access needed during a global pandemic. These bilateral deals do not demonstrate global collaboration but rather reinforces "vaccine apartheid" and enlarges chasms of inequality. Disparity in access is certain to continue unless concrete steps are taken to address intellectual property barriers.
1471. If what the EU, the US and Japan is suggesting is correct, namely that the IP system is responsible for delivery of vaccines in record time, it could fly in the face of the heroic efforts of ordinary people, researchers, scientists and government support and funding to enable this monumental feat. Not companies, but ordinary people have generously donated the skills and efforts to enable global collaboration by participating in vaccine trials - many in developing countries - putting their lives at risk for the greater good of mankind. Yet, the irony does not escape us, these very people a denied priority access despite the enormous sacrifices that they have made.
1472. We also just want to quickly revert to several questions that were posed as to why the scope of the waiver extends not only to patents, but also to trade secrets, copyright and industrial designs and also what the evidence is, that the waiver will address these issues. The co-sponsors presented elaborate answers, and so, if delegations want a reference, they could read the statements that would have been delivered.
1473. Other questions would have also been posed as to how the waiver would resolve issues related to COVID-19 prevention, containment and treatment and what evidence we have to present. Similarly, these would have been addressed during the last meeting, but for consistency and perhaps impact, I would want to come back on to one or two of these issues.
1474. The co-sponsors have been asked which measures would fall within the scope of the waiver and whether measures that are indirectly related would also be included within the scope of the waiver, and who would make those determinations. We clarified, in our last statement, that the issue is not whether a measure is directly related or indirectly related. It is a matter of what is needed to prevent, contain and treat COVID-19. Any measure that is not in relation to the treatment of the COVID-19 would not be covered by the scope of the waiver. For instance, a therapeutic for cancer treatment would not fall within the scope of the waiver. The waiver proposal is very specific to COVID-19, its prevention, containment and treatment; and therefore, is proportionate. Contrary to some of the concerns that we heard in the present meeting. It does not apply to other diseases, although we are aware of severe access challenges in other disease areas as well. It does not apply to other sectors. We have been particular in excluding protection of Performers, Producers of Phonograms and Broadcasting Organizations under Article 14 of the TRIPS Agreement, although it falls within the ambit of copyright, as it would not be relevant to the prevention, containment and treatment of COVID-19.
1475. The waiver proposal does not cover all aspects of the TRIPS Agreement, this should be very clear. So we cannot agree to broad statements that says that the waiver invalidates large parts of the TRIPS Agreement this is not correct and we have cited examples such us the waiver does not include GIs, trademarks, layout of integrated circuits etc.
1476. We have heard in this meeting, just as a further clarification, issues of safety, quality, and counterfeit medicines being raised. I want to clarify once and for all, the waiver request does not extend to trademarks and counterfeit trademark goods as defined in Article 51, was referenced to footnote 14 of the TRIPS Agreement. The TRIPS provisions in relation to these continue to be applicable. I want to emphasize this particular point. The grant of intellectual property or the fact of being an IP holder, does not provide any assurances that the protected subject matter is of a particular quality, efficacy or safety standard. Even originator products of multinational pharmaceutical companies have been recalled in the past for failing quality standards. Therefore, regulatory oversight is required and this shows that the grant of intellectual property has nothing to do with quality, safety or efficacy.
1477. All medical product marketed in a country has to obtain marketing authorization from the national medicines regulating authorities or agency. Which provides authorization after quality checks. And so the issue of quality of a diagnostic therapeutic or vaccine is determined by the national medicine regulatory authority and not by the IP system as such.
1478. At the international level, I want to add that the World Health Organization has a member state mechanism that looks at substandard and falsified medical products. So, to conclude on this point, we urge WTO Members not to confuse and conflate issues of quality of a product with issues of intellectual property of medical products. These are separate issues. In the past such conflation has led to the seizure of quality generic medicines by customs authorities at European ports, hindering inter alia international aid programmes and public health.
1479. We have also heard from some countries that have queried why TRIPS flexibilities and COVAX are insufficient to address the challenges of access posed by COVID. We have addressed this matter extensively at the last TRIPS Council. We reiterate that the targets set by ACT-A, including the COVAX, is to provide 2 billion vaccine doses (for 1 billion people) to the world by the end of 2021, 245 million courses of treatment and 500 million diagnostic tests to LMICs (excluding many developing countries) in 2021 are insufficient to meet global needs of the 7.7 billion people of this world. As we see vaccine roll-outs in the developed world, we cannot but wonder when equitable and timely access will become a reality, with more than 90% of all future production of likely vaccine candidates being reserved for rich developed countries. This cannot be the case.
1480. With respect to TRIPS flexibilities, as mentioned in our previous statement, these flexibilities have played an important role in promoting access but were never designed to address the access challenges of a pandemic. In the present meeting we would like to revert to a few more questions that were raised on 3 December 2020.
1481. The delegations of Brazil, EU and Switzerland have referred to IP/C/W/670 and indicated that the mere existence of patent or patent applications does not amount to a barrier. The EU mentioned that it would be interested to know more about these medicines.
1482. Document IP/C/W/670 presents a preliminary non-exhaustive snapshot of the patent filing and granting status of five selected therapeutic candidates that are under review by the WHO Access to COVID-19 Tools Accelerator (ACT-A), under its therapeutics pillar. Due to the interval between the time of patent filing and publication, which can take up to 18 months, new patent applications that might have been filed this year, may emerge in the coming months.
1483. The first table shows a patent for Regeneron's new monoclonal antibody REGN10993 and REGN10987, granted in the United States in June 2020, and which expire only in 2040. Information on patent applications filed globally should emerge in several months. It is not clear the access strategy of Regeneron on this therapy remains unknown.
1484. Document IP/C/W/670 also reveals high levels of patent filing and granting on other COVID19 candidates. Merck's Molnupiravir (MK-4482) has primary patent applications filed in at least 28 jurisdictions, including two regional patent offices, expiring between 2035 and 2038. Atea's pharmaceutical AT-527 has primary and secondary patents filed or granted in nearly 60 jurisdictions, expiring between 2036 and 2038. There are several other candidates we have also looked into. Document IP/C/W/670 also presents the patent landscape for Pfizer/BioNTech and Moderna vaccines.
1485. Patents confers its holder exclusive rights. With these monopolies the patent holder is able to prevent other competent manufacturers from producing and supplying the patented subject matter, as well as to charge exorbitant prices for these patented medicines, hence hindering the timely access to affordable treatment.
1486. The patent landscape as contained in document IP/C/W/670 is merely a warning shot of the existing and emerging patent barriers to access and the need for the international community to take urgent action to overcome these barriers so that supply may be diversified and scaled-up. Access to this type of information is critical to ensure further transparency and accountability and we have heard, both in the present meeting and in previous meetings, interventions on that point. However, at WIPO we have heard that the United States of America has objected to the update of WIPO's review of the existing research on patents and access to medical products and health technologies to extend the publication period to up to 2020. In light of the destruction brought by COVID-19, one wonders what the United States concerns would be regarding the update of this report by the WIPO Secretariat.
1487. We want to revert to another question which was posed by the EU, regarding the domestic implementation of the waiver, why it would be easier to carry out than introducing fast-track procedures for compulsory licensing on the basis of the existing system?
1488. Under the TRIPS Agreement, the flexibilities are simply insufficient to address the global access challenges that we are facing. In the informal sessions, we have elaborated on this point. With respect to fast-track procedure, under Article 31 of TRIPS Agreement, there is the option to issue a compulsory license on grounds of national emergency or other circumstances of extreme urgency, without engaging in prior negotiations with the patent holder. However, in practice, its use is dependent on requirements contained in national laws and regulations. Importantly, this compulsory license is limited by the condition set in Article 31(f), that it has to be predominantly for the supply of the domestic market, meaning only very limited export is allowed.
1489. To export, the requirements of Article 31bis would have to be followed, and this includes issuing compulsory licences in the importing and exporting countries, and compliance with other procedures. The importing country will have to notify the Council for TRIPS, that:
a. specifies the names and expected quantities of the product(s) needed ;
b. confirms that the eligible importing Member in question, other than a least developed country Member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Appendix to the Annex of the TRIPS Agreement; and
c. confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory licence in accordance with Articles 31 and 31bis of this Agreement and the provisions of the Annex to the TRIPS Agreement.
1490. The exporting Member shall notify the Council for TRIPS of the grant of the licence, including the conditions attached to it. The information provided shall include the name and address of the licensee, the products for which the licence has been granted, the quantities for which it has been granted, the countries to which the products are to be supplied and the duration of the licence. The notification shall also indicate the address of the website whereby before the shipment, the licensee is required to post information about the quantities being supplied to each destination and the distinguishing features of the product(s).
1491. Products produced under the licence have to be clearly identified as being produced under the system through specific labelling or marking and suppliers should distinguish such products through special packaging and/or colouring/shaping of the products themselves.
1492. These are just some requirements of Article 31bis. National laws may include other requirements.
1493. These conditions cannot be referred to as a fast-track process. In fact the process of issuing CLs will have to be repeated again as more effective medical technologies enter the market. They are also not conducive to achieving economies of scale, which are crucial to motivate large scale manufacturing and lower prices of medical products. The current circumstances are especially problematic for countries with insufficient manufacturing capacity.
1494. It is also worth recalling that Article 31 and 31bis only address patent barriers while there are also challenges with respect to protection of undisclosed information, a barrier which remains unaddressed. Our colleagues have addressed problems surrounding Article 39.3 so I will not go into the matter further.
1495. Further if the waiver is adopted, it is a one-time implementation, and may be achieved through executive action. It swiftly addresses all relevant IP barriers. And with its implementation, legal barriers to collaboration, development, production and supply are lifted. A waiver also provides legal certainty as to the freedom to operate, economies of scale can easily be achieved and with supply expanded, substantial price reductions may be expected, which may lead to timely affordable access.
1496. Strangely, developed countries are placing emphasis on use of TRIPS flexibilities, but why is pressure been applied on developing countries for implementing public health safeguards in their intellectual property laws and policies, through EU's annual IP enforcement report and US' annual "Special 301 Report", released in the midst of COVID-19.
Concluding remarks and questions to delegations that have raised opposition to the waiver proposal.
1497. At the 16 October 2020 TRIPS Council meeting, the United States said: "Where intellectual property rights exist, they can be licensed to companies around the world to scale up manufacturing". Other delegations have also argued in the same manner. We have few questions to these delegations:
a. If VL mechanisms work, why do various license agreements concluded by various companies exclude half of the world's population from supply and only license to a few very specific manufacturers. Why is it that no one knows the full terms of the license?
b. If VL mechanisms work, can full details be provided of all voluntary licenses signed with companies all over the world to scale-up manufacturing and for global supply . We would like to know the full terms of the licenses, with whom these licenses have been signed, which countries will be supplied, when will they be supplied etc.
c. If VL mechanisms work why was Oxford/Astra Zeneca license to the COVISHIELD vaccine assigned only to one company in India and a public sector manufacturer in Brazil, when these licenses and technology transfer could have been given to any manufacturer who has technical capacity?
d. If VL works then why are there geographical restrictions in the VL to limit supply to only to low- and middle-income countries (LMICs) under the agreements, excluding supply to other developing countries?
1498. We are taking note that the issue of classification of countries based on singular criteria such as per capita GDP, many times ignores the deep and persistent structural deficits between developed and developing countries.
1499. Some delegations had asked for data regarding how certain obligations have systematically hindered prevention, treatment, and containment of COVID-19 so that a waiver is needed. We consider the discussion of the current proposal an acknowledgement of the limitation of the existing legal options and the need to provide additional flexibility at the international level. We have presented the examples and indications sufficient for Members to consider endorsing the waiver proposal, including illustrative examples as per our previous interventions. We would like to thank Indonesia for sharing its national experiences in this regard. We call on other Members to do the same.
1500. Improving the readiness of law can be done based on due consideration of the probabilities of events. This has been reflected by a few Members who quickly amended domestic laws to get ready based on such probabilities. So, we would like to ask Canada, Germany and Hungary, when they decided to swiftly amend national laws to enable quicker use of compulsory license, what kind of data was relied upon at that time demonstrating the necessity of revising the law? We refer to the Secretariat note and compilation of COVID-19 measures.
1501. TRIPS flexibilities are important to increase access to medicines and other medical product not just in times of pandemics. Why has pressure been applied on developing countries for implementing and supporting public health safety in their intellectual property laws and policies. We have already indicated the impact of this actions by the EU and the US on these particular efforts.
1502. Several delegations highlighted TRIPS flexibilities, particularly compulsory license under Article 31 and Article 31bis, as important and need to be used. We recalled how developing countries have been under pressures and discouraged from using those flexibilities for a long time. The EU and Switzerland both highlight the flexibilities as the key measures for Members to use. Does it mean the EU and Switzerland will from now on commit not to pressure developing countries when they improve their laws on compulsory license and other TRIPS flexibilities or make use of compulsory licenses? Would the European Union from now on exclude compulsory license and other TRIPS flexibilities from its IP enforcement report? Certainly, the same question could be asked to the United States.
1503. We notice the recent IP action plan and pharmaceutical strategy published by the European Commission urges EU Members to use fast track compulsory license and explore coordinated compulsory license in EU. In launching the Pharmaceutical Strategy for Europe, Vice President Schinas underscored the importance of transparency of R&D costs in ensuring access to affordable medicines. In his remarks to the press on 25 November 2020, Vice-president Schinas said,
Equally important, ensuring affordability of medicines will be guaranteed through bolstering transparency on R&D costs and expenditure on medicines in healthcare systems, finding a consensus on costing principles and addressing aspects that impede the competitive functioning of the markets impacting on affordability.
1504. This principle resonates squarely with our submission to the October 2019 TRIPS Council and the WHO Transparency Resolution (WHA72.8). Could the European Union provide more details on how it intends to ensure the "affordability of medicines" through the "bolstering of R&D costs"?
1505. The EU IP Action Plan, released on 25 November 2020, reiterates the exigent need to deploy COVID-19 technologies, "not only in Europe but also on a global basis."
1506. To this end, the EU IP plan calls for "voluntary pooling and licensing of intellectual property related to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health Assembly to promote equitable global access as well as a fair return on investment." Can the European Union elucidate further on how they intend to transform this lofty rhetoric into concrete action? The EU IP Action Plan notes that the Commission is "working on mechanisms that would enable and incentivise the rapid pooling of critical IP in times of crisis". Could the European Union please explicate on these mechanisms that would enable the "rapid pooling of critical IP in times of crisis."
1507. Following on from President Ursula von der Leyen's State of the Union call for the establishment of an EU BARDA, the EU's IP action plan calls for the development of an "effective framework for march-in rights, that should guarantee that publicly funded IP is available in cases of critical shortages". Could the European Union please provide details on the design of these marchin rights?
1508. We would counter the EU's assertion that compulsory licensing should be used as "means of last resort and a safety net when all other efforts to make IP available have failed." Nonetheless, could the European Union please provide further details on the EU IP Action Plan's recommendation to EU Members to "establish fast-track procedures to issue compulsory licences in emergency situations"?
1509. The Commission will explore with member states the possibility of creating an emergency coordination mechanism, to be triggered at short notice when member states consider issuing a compulsory license. What is the rationale behind this policy decision? Further, how reflects many of the concerns that we have put forward in our waiver proposal.
1510. I want to end by thanking all Members who took the floor with very positive interventions. As indicated, we will study these interventions more closely and will revert in writing at the appropriate time in order to further answer questions that would have been posed.