Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Dagfinn Sørli (Norway)
World Trade Organization
34.   I would like to express our appreciation to Members for their close engagement on this issue and for the interest expressed in gathering together these important data. Indeed, in the light of the interest expressed by Members in this Council and in the General Council subsequently, and as part of the WTO Secretariat's ongoing efforts to gather and compile data on the full array of trade and policy issues with a bearing on COVID-19 vaccines production and distribution, we had to put together what is, I have to say, a preliminary report on licensing activity relating to vaccine production over time and on the projected and observed volume of resulted production under those agreements. It is worth bearing in mind that there is no single authoritative source for all such information. And we have taken some trouble to survey the range of currently available resources. 35.   As a first step, at least, the report that we are sharing with you in the present discussion is, mostly, but not exclusively, based on the work of Airfinity. This is a private firm which maintains a database of information on science, production, and distribution of COVID-19 vaccines and therapeutics, on the basis of publicly available information, announced development. A particular strength of this source, or one of its uses, in particular, is that it enables us to break down activity over time, as this is one of the specific areas of interest that was flagged in the discussion. It is also valuable in its approach to forecasting expected future production based on continuing the recursive attention to matching the predictions with subsequently observed data. We also, however, consulted other sources which do pay close attention to vaccine licensing, and these include UNICEF and the Medicines Patent Pool, and we will, as part of our own efforts, continue to broaden this approach, in the interest of completeness and inclusiveness, so that we can be sure that any future updates are ever more precise and timely. 36.   I should stress that we cannot guarantee the accuracy or completeness of any particular source of data, or any particular report. These are not WTO data. It is material that we have sought to collect, and we are providing it in the interest of background information and transparency, rather than presenting it as an official finding of any sort. We are simply not in a position to do that at this stage. Considering the sources available, it is important to bear in mind that there is currently no single authoritative or definitive repository of licensing and production data – and what data we have available are based on information culled from a very wide range of public sources. Moreover, there is active work underway on several fronts to strengthen the gathering and compilation of data, to improve its accuracy, and to complete its coverage. So, this is very much a preliminary report (RD/IP/44), and it should be understood that there is a continuously dynamic picture which is progressively improving over time in terms of completeness, accuracy and timeliness. 37.   Further, I would stress that there is no absolute distinction between some of the categories mentioned here, in particular between in-house production, which may be distributed geographically quite considerably, 'in-house' not being literally in a single location - and various forms of contracted production or 'production under contract', and licensed production, or 'production under license'. So, a range of different forms of technology transfer and diffusion can be identified across a spectrum. Accordingly, these data should be considered as a general overview rather than a water-tight or exhaustive analysis. I hope, at least, that this sets the following data in a realistic but, nonetheless, useful framework. 38.   One valuable source is the UNICEF COVID Dashboard. This material, looking at manufacturing agreements, demonstrates the very diversity and the complexity of the data. It is important to bear in mind that these are necessarily, inevitably, complex, multifaceted arrangements, that do not necessarily slot into any well-defined categories. This chart illustrates, on the left, the originator or the original vaccine developer and, on the right, the licensees or contracted manufacturers – and gives you some idea, top-down, of the complexity of the situation. This chart, also from the UNICEF Dashboard gives quite a useful picture of the different approaches taken for some, or all, of the lead vaccines. The blue bar represents contracted manufacturing and the green bar shows technology transfer arrangements. 39.   While once again stressing that these are not absolute categories, this gives you an overview of the different approaches taken. In terms of delivery, the UNICEF Dashboard also gives you an overview of the range of doses delivered. In this case, distinguishing between different categories of agreements, bilateral and multilateral in the blue spheres here; COVAX supplies, in the dark green colours; donations as the light green, and others. Once again, we cannot be absolutely precise as to these categories, but just to issue a sense of the different patterns of distribution of the doses, according to the distribution agreements. 40.   Another source, at least at the moment relevant for treatments is the Medicines Patent Pool (MPP). The MPP has for years maintained a very useful database on patenting and licensing in the medicine space, but only recently has it turned to COVID matters. Nonetheless, Remdesevir, which is one of the candidate treatments, is on their database, and it is possible to pull out this picture of Remdesivir's licensing arrangements, those that are reported. Once again, nobody is viewing any of these as complete, but it is useful as the general picture of the situation. 41.   I now would like to turn to the report that has been distributed to Members in RD/IP/43. This is the material that is contained in the Room Document, and which is prepared by a private firm, Airfinity. As I mentioned, there are two particular strengths of these data focussing on vaccines, which are of the immediate interest. It has been possible to break down activity over time, together with a sense of the evolving situation. In addition, and I will mention this shortly, there is close attention to the forecasting of production based on announcements of agreements, licensing arrangements, and this makes it a particularly useful tool. However, as I stress, it is one tool, one source, and we do not mean to endorse or guarantee this, but once again we hope that it provides a valuable general overview. 42.   This slide contrasts the different forms of agreements that had been reached. What people are most interested in in this context concerns the blue part, which represents agreements that involve a transfer of technology, transferring the use of the technology, rather than fill and finish, the final stage of preparing vaccines for distribution. The production of adjuvants, which are a vital ingredient for vaccines, and the other categories, are self-explanatory: distribution, storage, and the source of materials. The blue columns here are of most interest in the current context. The left-hand column, the large column, concerns in-house arrangements, and the right-hand column concerns those that are contracted out. So clearly, from this top-down approach, there is a greater proportion of inhouse arrangements. 43.   This chart brings us more or less up to date from March 2020, and it shows the growth over time of production and supply chain agreements. Without getting too technical, it shows a regular, a linear increase in the number of those agreements. This is a head count of announced agreements, I should stress. It does not relate to volume of production, but represents a simple head count of the agreements which responds to the query about the developments over time. Turning to the question of the forecasting, this is not official in any sense, and it is not endorsed by the firms themselves or anybody else. It is Airfinity's own forecasting. The left-hand column, again, is in-house production; the right-hand column is contracted production, and it is broken down according to the different vaccines. Just by way of illustration or contrast, on the left-hand column the largest block concerns the BioNTech vaccine, in partnership with Pfizer – still very much in the in-house category. By contrast, the dark green colour on the right is the AstraZeneca vaccine, demonstrating that it has been produced more through contracts. 44.   Regarding the regional contrasts, the tendency in Europe, North America and Asia is towards in-house production, whereas in Latin America, Oceania and Africa it is the reverse, a greater tendency towards contract production. Here is a description of the forecasting methodology I mentioned before. I will not go through the details, but some key points: there are obviously and inevitably going to be differences between announced licensing deals and production level, and what is actually delivered, both in terms of numbers and in terms of time. This is one of the approaches that makes Airfinity data quite interesting, because they do work with great precision on both of those points. They are adjusting their predictions according to likely actual production, not just basing it on the announced production, but basing it on feedback from actual production and on the time lag involved between the announcement and the actual commencement of production or supply. 45.   The working model has typically fixed a three to four months period for production facility to reach capacity after an agreement is struck, but that is adjusted according to subsequently available data. Without going into further detail, this is why the forecast figures here, while not authoritative in any way, are nonetheless quite interesting and give us some potential insights. This slide takes their forecast figures from February this year through to the present date. As you can see the observed production tracks quite closely the forecast figures. So from that point of view, while not definitive in any way, it makes it interesting at least to look at their forecasts until the end of this year, for each of the currently available vaccines. Again, we could go into individual detail, but the overarching finding is that, if the current trends continue in terms of approval and production, then these data lead to an estimate of total production by the end of this year of around ten point seven billion doses overall. Of the sites of manufacture, by their estimate, China, followed by the European Union, the United States, and India, are expected to be the lead producers over this time. 46.   This slide contrasts in-house production with contracted production, providing again another forecast until the end of this year. You will see that, overall, the expected trend is for both in-house production and contract production to increase, but while the in-house production remains the greater proportion, the share of contracted production or arm's length production is increasing over time. That becomes even clearer in this chart, which takes us up to the end of this year, leading to the total figure of ten point seven billion produced. Looking at the numbers underneath, you can see that the share of contract production is forecast to rise from 20%, in January this year, to 36% at the end of this year. That reinforces the point that the share of such contracted production is expected to increase progressively over time. Again, this is according to this one set of predictions and numbers that, as I keep stressing, are not endorsed or guaranteed in any way, but are at least one valuable source of insight. 47.   To conclude, I would say that, as the various sources of data improve and expand, and our capacity as the Secretariat to navigate and integrate the diverse sources of data improves, we will be increasingly able to provide more granular and precise information on the situation relating to vaccine production and distribution, and draw from a wider range of data sources. So, if there is a continuing interest, we can continue to provide successive updates in the coming months. Finally, I would stress that these are general, top-down data. It is possible to mine the data in a more precise and granular analysis, so if there is a very specific interest on the part of any Member or group of Members, we can certainly sit down and go through it in a more an informal and, I might say, more interactive arrangement. I hope that, at least, this provides some idea of the possibilities and the data available.
14. The Chair recalled that this agenda item had been discussed in the Council since its informal open-ended meeting on 19 June 2020 and had been on the Council's agenda at its formal meetings since then. In light of the broad support for a continuation of these exchanges at the preceding meetings, the item was once again on the agenda to facilitate exchange of views on measures undertaken as the pandemic persists.
15. As one basis for the Council's exchange, he referred to the compilation "COVID-19: Measures regarding trade-related intellectual property rights" that was available from the WTO website and contained a non-exhaustive list of IP-related measures taken in the context of COVID-19, compiled by the Secretariat from official sources and verified by the Members concerned. This list was updated continuously, even if the rate at which new measures are brought to our attention had slowed considerably since the last meeting. He encouraged Members to inform the Secretariat of any measures that should be included on this list, as well as any update or information on the expiry, or end of application, of such measures. He invited Members to inform the Council on their measures.
16. He suggested that, on this occasion, this item also be used to hear from the Secretariat regarding other information it had been asked to compile. He recalled that in earlier meetings of the Council, and in the General Council, a number of Members had asked the Secretariat to provide and compile data on the number of voluntary license agreements regarding COVID-19 vaccine production over time, and on the projected and observed volume of vaccine dose production under these agreements. Given that this request also related to information compiled by the Secretariat the Chair suggested that this be dealt with under this item. It was his understanding that the Secretariat had circulated an initial set of data in a room document RD/IP/43 and would be ready to provide a short introduction to this document.
17. The representatives of Chile; the United States; and China took the floor.
18. The Secretariat took the floor to present documents RD/IP/43 and RD/IP/44.
19. The representatives of Sri Lanka and South Africa took the floor.
20. The Chair thanked the Secretariat for the information presented and said that an update of such information would be appreciated and would contribute to the deliberations of the Council.
21. The Chair proposed that, in view of the continued interest on this agenda item, the Council agree to revert to the item at its next meeting, so that the exchanges can once again take place, including on the basis of the updated Secretariat document of COVID-19 related IP measures.
22. The Council took note of the statements made and agreed to revert to this item at its next meeting.
IP/C/M/100, IP/C/M/100/Add.1