229. Though not a co-sponsor, Sri Lanka has been strongly supporting the Waiver Proposal since its inception and spoken at great length on the imperative need for Members to take the proposals presented by the proponents seriously for finding an urgent solution, so that the WTO can deliver one of the most crucial solutions towards addressing the global health crisis of unimaginable magnitude. It is needless to emphasize the imperative need for Sri Lanka to secure the required amount of vaccines on an urgent basis, as the country is undergoing a very complex and challenging pace with the emergence of the third wave which has already created an unimaginable impact on our population. The country is currently on a long lockdown and is trying to stop the spread of the disease desperately. We are thankful to many countries, such as the United States of America, European Union, China, Russian Federation, Australia, India, and other numerous countries, which came forward to support us at this very crucial time in numerous ways.
230. In the same vein, we welcome the revised decision text for the TRIPS Waiver (contained in document IP/C/W/669/Rev.1) submitted by the 63 co-sponsors and focused comments by WTO Members on the revised decision text.
231. We have heard with great interest the explanations provided by the South African Ambassador in presenting the revised decision text for the TRIPS waiver on 31 May and today by the delegate of South Africa. We are of the view that the revised decision text brings greater specificity and clarity as to the objectives, the scope and the duration of the waiver which the proponents and Sri Lanka are seeking for. The preamble text captures well the challenges the international community is facing with respect to the SARSCOV-2 as well as the resulting uncertainties and complexities.
232. With respect to the scope, the range of interventions governments have deployed to control COVID-19 underscores the need for a much broader scope beyond vaccines. It is important for the scope of the revised decision text to include therapeutics, diagnostics and others COVID-19 health products and technologies. These categories of intellectual property are relevant to the production, supply, and access to COVID health products and technologies.
233. The continued surge of COVID-19 highlights the critical importance of meaningful access to personal protective equipment, tests, therapies, vaccines and medical devices to prevent the spread and reduce illness and death in high-risk populations and settings. Accordingly, many countries' national COVID response strategies acknowledge the need to ensure equitable access to critical COVID-19 PPE, tests, therapies, vaccines and essential medical devices. These resources are acutely needed in many communities, with documented shortages and access barriers across the countries.
234. One of the examples, which I wish to highlight here today, is a specific type of a medical device that measures the oxygen saturation of blood, which is in great demand in many countries, including mine, due to the COVID-19 pandemic. We never thought that this device could be in such demand in any of our lives. Since the early months of the pandemic, doctors have been aware of an alarming subgroup of COVID-19 patients who develop "silent hypoxia" – where they show no obvious symptoms of being severely ill, despite having worryingly low oxygen levels. According to information currently available, the phenomenon is difficult to detect without monitoring blood oxygen levels, and it is dangerous because these patients can rapidly deteriorate and require urgent access to machines that can support their breathing.
235. Pulse oximeters cannot diagnose COVID-19, but they can alert patients who are already infected with coronavirus when levels of oxygen in the blood are falling. They are therefore most appropriate for use by those at high risk of developing serious symptoms, such as the older population, and those with medical conditions that put them in a higher risk category, such as serious heart or lung conditions. When we look at the data on the amount of deaths recorded in Sri Lanka, we are sad to state that the aged population constitutes a better portion. This is not unique to Sri Lanka. It is the case in many developing countries. For instance, the UK's National Health Service is currently offering pulse oximeters to COVID-19 patients who are aged 65 years and older and/or are regarded as clinically extremely vulnerable.
236. According to information currently available, the devices work by shining two different wavelengths of light through people's skin to measure how much oxygen is being carried by their blood. Blood containing plenty of oxygen absorbs different ratios of these wavelengths compared to deoxygenated blood. This is a non-invasive device that clips to a fingertip or earlobe and measures how much oxygen is being carried by the blood, as well as heart rate. This information, alongside other health data, can help healthcare workers decide if someone needs extra breathing support and should therefore be transferred to hospital.
237. This prior testing on acute patients will reveal whether those patients should require to be transferred to hospitals for urgent medical treatment, including treatment at ICU rooms, so their lives could be saved. We in Sri Lanka, the hospitals and other medical professionals, are using pulse oximeters to segregate those patients who require urgent medical treatment at hospitals, so the health infrastructure in Sri Lanka will not be overwhelmed and can be well managed during this vigorous third waive, and certain segments of COVID-19 affected population can be easily treated in other care centres established for the same purpose.
238. In view of such benefits, the sales of pulse oximeters are booming in some countries as both individuals and health systems invest in them to monitor the symptoms of discharged COVID-19 patients at home. We also note that there is a scarcity of supplies, not having availability in abundant quantities and at an affordable price, making this essential device not accessible to many developing countries such as mine.
239. When one looks at this medical device alone, it reveals that it entails most of the IP regimes such as, patents, industrial design, possibly trademarks, integrated circuits and trade secrets. Also the data reveals that this medical device has been patented in many countries around the world by many private companies. A commercial prototype of medical grade pulse oximeter as a competitive product on par with other similar products in the local market (which have been imported from foreign countries) has been developed by a team of researchers by a university in Sri Lanka with the financial support under the Technology Grant Scheme.
240. If Sri Lanka wants to produce them locally using the available manufacturing capacity through compulsory licences, there may be a need to issue compulsory licences not only on patents but on an array of related IP regimes. Sri Lanka has also assessed local manufacturing capacity of producing certain vaccines in Sri Lanka which are based on viral vector technology or messenger RNA technology, and have approached many patent holders for securing voluntary licenses assuming that their vaccines have not yet been panted in Sri Lanka. Responses from certain pharmaceutical companies are still being pursued with a view to obtaining know-how transfer programmes to ensure the expeditious commencement of their production in Sri Lanka.
241. Such classical examples demonstrate the scope of intellectual property under the waiver must include aspects that are relevant to the COVID-19 health products and technologies that are patents, copyright, industrial designs and trade secret protection.
242. In relation to the duration contained in the proposal, we have read the justification for the proposed duration provided in the introduction of document IP/C/W/669/Rev.1. Operative paragraph 2 of the revised text adds a paragraph on the proposed duration and the revision states that the Waiver shall be in force for at least three years from the date of this decision. This clearly captures the temporary nature of the Waiver. We agree that the duration has to be flexible and practical in view of the fickle situation we are in. Every day we are learning something new about the pathogen and the new variants and the mutations that emerge, their effectiveness against vaccines, therapeutics and diagnostics. The situation with respect to production is also unreliable. We are looking forward to continue even further in-depth engagement on the text.
243. We call on you Chair to hold a series of informal and formal meetings with the aim to conclude discussions and reach agreement in advance of the General Council to be held in July this year. We also urge you to hold and organise these discussions and consultations with Members in different configurations while preserving the three key principles of openness, transparency and inconclusiveness, so that collectively we will be able to engage in good faith, solution-oriented discussion that will result in a balanced outcome that addresses the concerns of all.
244. Every day counts. We have been discussing this proposal for eight months; we need to accelerate the discussion on the text and reach an agreement that can deliver equitable access. The world is waiting for the WTO to deliver a fair outcome and we must not disappoint. My delegation assures its fullest desire to engage constructively to find a sustainable solution to this pandemic, which requires sharing of new COVID-19 technologies with producers having local manufacturing capacities, such as mine, accompanied by know-how transfer programmes to ensure the rapid uptake of quality high volume production.