241.   We thank you for the schedule of meetings to engage on this important issue. The World Health Organization has been abundantly clear about the need to deal with the COVID-19 pandemic comprehensively. Dr Ghebreysus, Director-General of the WHO, has said, "Vaccines alone will not end the pandemic." "Many countries need diagnostics, lifesaving therapeutics — including oxygen and support for vaccine rollout". 242.   The COVID-19 pandemic is ongoing. Health experts have warned that while Omicron subvariants BA.4/5 have dominated in Europe over the summer, newer Omicron subvariants are gaining ground. WHO data released last Wednesday showed that cases in the European Union reached 1.5 million last week, up 8% from the prior week while hospitalization rates in Europe have increased significantly over the past few weeks. It is reasonably foreseeable that this trend will be replicated in other regions heading into the winter months.⁶ 243.   As we witnessed in the initial waves of the pandemic, the interconnectedness of the global economy rendered the spread and mutation of new variants inevitable. Let us learn from the lessons of the past few years and develop a comprehensive response to the pandemic as health experts have urged. 244.   The Ministerial mandate in paragraph 8 of the WTO Decision on the TRIPS Agreement is a matter of utmost priority. The 17 December deadline is fast approaching and necessitates that we act decisively on this important item that affects people's lives. The Decision reached at MC12 demonstrated what we can achieve as the Membership when we work together and adopt a solutionoriented approach to issues that affect humanity. The said Decision was a step in the right direction, but we must conclude our unfinished business. 245.   The waiver proponents have provided sufficient evidence in the documents that have been submitted before on the intellectual property barriers applicable to therapeutics and diagnostics, including concerns regarding accessibility and affordability. Therefore, we urge all Members to move beyond circular Q&A sessions and expeditiously proceed with the decision entailed in paragraph 8. 246.   As we stated in the General Council last week, the paragraph 8 mandate is clear: the task before us is to decide within 6 months on the extension of the WTO Ministerial Decision on the TRIPS Agreement to cover therapeutics and diagnostics. It is not an agreement to renegotiate the text. 247.   Some delegations have expressed concern about therapeutics with multiple uses and have thus called for the products covered by the decision to be limited. However, the WTO Ministerial Decision contains safeguards to ensure that products produced and supplied under the authorization are for COVID-19. This is reflected, for instance, in paragraph 1 which provides that authorizations under the Decision may only be granted, "to the extent necessary to address the COVID-19 pandemic". My friend Sherif spent many hours in the green room negotiating those wordings. 248.   In addition, the treatment options to be availed to patients depend on many factors, such as the disease severity, the availability of drugs, routes of administration (only intravenous for remdesivir and the monoclonal antibodies), and duration of treatment, among others. Some of these treatments can be used in combination (i.e. as for severe or critical COVID-19) while others are to be used as alternatives. The evolution of the virus and patterns of vaccination affect the efficacy of therapeutics thus raising the importance of adapting the treatments to local contexts. We caution against an approach that ties the hands of health authorities on the ground and therefore defeats the very purpose of the waiver Decision. 249.   At the TRIPS Council meeting of 19 September, a number of questions were posed to the cosponsors and we thank delegations for these questions. They are, however, similar to the questions that have been repeatedly asked and answered since October 2020. We suggest that delegations go back to the submissions that we have already made. However, as we did at the informal meeting on 3 October and in the spirit of constructive engagement, we offer some reflections on some of the most pertinent of these recent questions. So I have selected some of them and will read them out and give some responses. Two of them read as follows: a. In which countries and for which products have the prices been prohibitively high so that they have posed a barrier to access? b. Do these prices reflect the lower prices that many pharmaceutical companies offer via their tiered pricing systems? 250.   In response we would posit the following: equitable access means that therapeutics and tests are available and affordable for all who need them at the same time everywhere. Currently, many therapeutics and diagnostics, which are widely available in high-income countries (HICs) are not so in low- and middle-income countries (LMICs). Developing countries are kept waiting for donations or for companies' decisions on whether: a. to enter into a voluntary licence and the conditionalities that companies impose on their voluntary actions, e.g. geographic limitation; b. to donate some products to countries or populations of the company's choice; c. to lower the price to a level and for countries of the company's choice. 251.   Clearly this is not a sound public health policy to leave LMICs subject to the largesse of companies' decisions. 252.   There are two important issues related to access to COVID-19 therapeutics and diagnostics: a. supply in terms of the quantity of the product available for LMICs to procure; and b. the price. Like vaccines, pharmaceutical companies prefer to supply the high-income market where they can sell for higher prices and maximize their profit than in LMICs where profit will be less. 253.   That is why access to therapeutics and diagnostics is repeating the inequitable situation seen in vaccines. For example, as of April 2022, 66% of Merck's anti-viral medicine (Molnupiravir) was sold in high-income countries. 254.   Other medicines such as monoclonal antibodies are not available in many LMICs. When available, the price is prohibitive. For example, Roche's price of a 600 mg dose of tocilizumab is USD 646. The main patent on tocilizumab expired in 2017, yet several secondary patents remain on the medicine in a number of LMICs that cause uncertainties about the potential of production of biosimilars. Shortages of tocilizumab have been observed in many countries that have already started using it for COVID-19 treatment. It has been documented by Médicins Sans Frontières that during the second wave, in one developing country⁷, the distributor ran out of the medicine and not a single vial was available in that country for critical patients. 255.   WHO recommended the monoclonal antibodies (mAbs) casirivimab and imdevimab for people at high risk of developing serious COVID-19 diseases and defined these groups as: a) older age b) have immunodeficiency or chronic disease or c) are unvaccinated.⁸ The medicine is the subject of patent applications filed in at least 11 LMICs. 256.   These medicines are examples where the producing companies dictate supply, allocation, and price. Supply is not adequate, and the prices are too high in LMICs. Since the real cost of R&D and manufacturing are not known due to a total lack of transparency, it is difficult to assess the prices offered except in terms of countries' affordability to purchase. In the case of repurposed drugs it is particularly difficult to justify monopoly prices as an incentive for research and development. Many LMICs would not consider the current prices of most COVID-19 therapeutics and diagnostics to be affordable. 257.   Turning to the next question, it is more of a statement than a question: there are many therapeutics for which patent rights do not exist, or which are royalty-free. In response, we would posit that there are medicines such as dexamethasone that have been produced by generic companies in several countries. Generic competition of this medicine has led to lower prices and wider availability. This is precisely the situation that we would like to create for newer therapeutics and hence extending the WTO Decision of June to therapeutics would be helpful in this regard. There are not many royalty-free therapeutics for COVID-19 and, as we pointed out before, treatments that are suitable for patients differ and are based on a number of factors. 258.   Patent barriers affect accessibility and affordability. For example, tocilizumab, which was mentioned before, is strongly recommended for treating patients with severe and critical COVID-19. It is a biological medicine manufactured by a Swiss-headquartered company.⁹ Tocilizumab is in fact a repurposed drug, having been used for inter alia rheumatoid arthritis since it was first marketed. Its main patents expired in 2017. However, subsequent patent applications for other features have been filed leading to the extension of tocilizumab's patent thicket up until 2028 for some jurisdictions in the world.¹⁰ These are known as "evergreening" patents. Although Roche voluntarily said that it would not enforce its patents in some developing countries and least developed countries, it leaves out key manufacturing countries.¹¹ In South Africa, for example, despite an expert panel finding that tocilizumab reduced deaths, the recommendation was for the medicine to not be used because it is "not affordable at the current offered price". The life-saving therapy is largely out of reach for African populations at a cost of around 2,000 dollars per patient.¹² The cost to manufacture tocilizumab is estimated to be as low as 40 dollars per dose of 400 mg.¹³ Further, the demand for tocilizumab far outstrips its limited supply, jeopardising the treatment not only of COVID-19 patients but also those who use the drug for the other indications available.¹⁴ 259.   Two further questions state as follows: first, there are some COVID-19 therapeutics available to developing countries at low prices through voluntary licences including via the Medicines Patent Pool (MPP), or tiered pricing. Considering these facts, patent rights are unlikely to be the cause of rising prices or restricted access to therapeutics in developing countries. 260.   The second one reads as follows: we need comprehensive information about existing collaborations and in particular voluntary licences. For instance, are there countries that would have been interested in applying for a sublicence for molnupiravir and Paxlovid but were not able to do so because they fall outside the scope of the MPP licence agreements? Which companies from those countries, that are eligible for applying for a sublicence, have been rejected in WHO's prequalification phase? Have applications been turned down for other reasons? And in which cases has it been possible for low- and middle-income countries to conclude voluntary licensing agreements? 261.   In response we would say the following: there are only two anti-viral products that have been recently licensed to the MPP, molnupiravir produced by Merck and a combination drug produced by Pfizer. One generic equivalent of molnupiravir received WHO prequalification approval and several more versions of both medicines are awaiting approval. However, these licences have limitations, for example, as to the geographical scope. Although the licences allow for manufacturing worldwide, they limit where the licensees can supply these products. 262.   The licences exclude most of Latin America and many Asian countries from benefiting from these arrangements directly. The extension of the June Decision would streamline the process for compulsory licensing to allow excluded countries to access lifesaving treatments at affordable prices. 263.   Outside the MPP, bilateral voluntary licences between producing companies and generic companies lack transparency and have several conditionalities on supplies and geographic allocation. For example, a bilateral licensing agreement for remdesivir excluded nearly half of the world's population from benefitting from price-lowering generic competition.¹⁵ 264.   Other medicines, especially monoclonal antibodies, colloquially knows as mAbs, such as baricitinib, are not available due to exclusive rights held by the originator.¹⁶ The originator holds patents in more than 50 developing countries, e.g. Latin America, Asia and Africa, which are hit hard by the pandemic. 265.   Problems with access to mAbs are not limited to LMICs. For example, the drug bebtelovimab is recommended for immunosuppressed patients with COVID-19. It is not available in Europe because the company that holds the IP rights refuses to register and market the product for patients in Europe.¹⁷ This is discussed extensively in an open letter by Michel Goldman, President of the Institute for Interdisciplinary Innovation in Healthcare, Université libre de Bruxelles, Belgium. This open letter dated is 5 August 2022.¹⁸ 266.   Many of these details that we provided today are available in our written submissions document IP/C/W/670-674. We urge delegations to consult these submissions.