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

H.E. Ambassador Dagfinn Sørli (Norway)
World Trade Organization
25.   Thank you for the opportunity to provide an update on the data that was presented the formal session of the Council in June. I would start with a number of caveats about this data, and I guess about data in general in this area. 26.   Firstly, I think we are all aware that there is no single authoritative repository of data, no single source for data, even on the specific question of licensing and production that we have been asked to look at. The target is a moving target but the methodology and ways of gathering data are also developing over time, and we do expect a progressively clearer picture to evolve. Particularly when it comes to data on licensing and production there are important caveats, this is based on publicly available information, announcements for example by the firms concerned and other reports, it cannot be fully comprehensive or up-to-date by its very nature. Sometimes when we look at dates the timing is determined by the date of an announcement rather than by the date of an actual development or change in the world. And as you would see from some of the coming slides, that can affect the picture given. 27.   We are offering this as a general background, as requested, but we are certainly not vouching for any particular data, this is not WTO data, not our own material but rather an attempt to provide an overview. I would say too that while this a general review of the situation if any particular delegation or group of delegations wanted any more granular data or more focused information could make that available, because there are indeed powerful tools available despite the limitations I have mentioned. As background, we have to bear in mind looking at patenting activity this is of course not the only area of licencing or the only IP right that is licenced in relation to vaccine production but the data is more readily available I would say, and an important point to bear in mind is that there are two broad categories of rights that are licenced. 28.   The platform data and this concerns the well-known MRNA platform for vaccines and the point here is of course there has been a large increase in recent years but the platform technology has been around for some time. This is important to bear in mind in the context of licencing because as we know from broader discussions licensing of platform technology even before the identification of COVID can be as significant as more specific COVID technology. 29.   When we look at specific COVID-related inventions which by definition the patent application must have been filed since roughly January last year, these are overwhelmingly pending because of the natural time lag in patent processing, so bear in mind the data which itself is being licenced is quite dynamic and it is difficult to get an immediate snapshot as to the rights that are being specifically licenced or need to be specifically licenced. 30.   An important initiative being taken by Medicines Patent Pool which is developing a vaccinefocused landscape alongside its well-established VaxPal on certain essential medicines and while this data is quite preliminary, an early review shows that there are a number of patent families directly relevant to the specific four areas of vaccine technology and as you may imagine while MRNA being understood as being the most disruptive there are a large number of patent families with bearing on that technology and here it is broken down by the leading approved vaccines showing that there is a very diverse picture even in terms of the different vaccine technologies and I would like to acknowledge colleagues in the IP Division who have put this work together, likewise as before there is a certain time-lag and it is not as if all activity and therefore all relevant material for licensing emerged since the coronavirus was identified and this is important to bear in mind in terms of the overall licensing picture. 31.   Our colleagues in UNICEF have a very useful tool, a vaccine market dashboard and this is well delegates' attention as it does have a large amount of material on licensing and production. 32.   Here is a general picture from that source which illustrates the extent of production of vaccines across the globe and essentially the blue represents production directly controlled by the originator, sometimes called in-house production but where the originating company is running the production and the green is where there is a degree of technology transfer, and that is very interesting from the licensing point of view. North America and Europe predominantly in-house, Asia a varying trend and South Asia, South-East Asia typically there is a technology transfer, North Asia, North-East Asia a different picture and relatively low levels, but mainly through technology transfer in Latin America, Africa and Australia, a mixed picture of course. 33.   We see this also when we look at the different vaccines and we see this also when we look at different vaccines, this is only the most widely reported, there is also other candidates that are reported in this database, but as you see for the best-known or leading vaccines again a differing picture, the green representing technology transfer arrangements announced or at least reported and the blue representing more in-house arrangements so you would see amounts varying enormously according to the vaccine technology. I should mention for every slide but this based on publicly announced information, and should not be regarded as definitive, rather illustrates a broad, diverse picture. The character of licensing agreements and other arrangements can vary enormously we focus on the full production of vaccine as such, but there is a wide variety of commercial technology sharing and other production sharing arrangements and without going into details these range from sourcing critical materials to other materials such as adjuvants which improve the impact of vaccines and of course ranging from full production to fill-and-finish, simply filling vials with already produced vaccine. The important point here is the diversity of arrangements and this applies to both to inhouse production and more diverse production involving technology transfer of the key technologies. 34.   This slide says the same thing in a different ways, illustrating the breadth of diversity of arrangements across the different regions. 35.   Concerning the projected production, of course this is a much-debated question, what is the overall likely production and to what extent are licensing agreements keeping track with production. This represents the growth of reported production and supply chain agreements and you see it is essentially a linear line and one that roughly keeps pace with the growth in production but the reported rate of production is increasing significantly more than the growth of specific agreements that are counted and looking at the link between production and the nature of technology transfer. This is Airfinity data, not our data, one private sector supplier who relies on publicly reported information, according to their analyses, again in-house production is still predominant – the estimate here by end of 2021 is 9.4 billion doses in-house as against 3.2 billion doses contracted or technology transferred at arms-length to another producer, so this is the broad trend and you would see that, as expected, it varies enormously depending on the specific technology. Again, as this chart has illustrated, the situation is quite different across the regions and as the UNICEF dashboard data illustrates this better, about the diversity of arrangements across the regions. One point that has come up consistently is the time lag between the announcement of production arrangements whether it is in-house or involving technology transfer and we have extracted this data but it should be viewed with some caution because it is based on the announcement. So this looks like it takes longer for in-house production to go from the establishment of the arrangement to actual production, it looks like it is actually quicker to transfer technology to another producer, but as with the detailed notes here, always read the fine print and this is probably more likely because the in-house production would be announced much earlier and a technology transfer agreement would be announced much closer to the production. I put this here for interest, but in effect it also illustrates the difficulty of getting a really firm grasp of the actual trends. Production agreements are still predominantly in Asia and Europe and we know from the broader discussions going on and further initiatives that the production agreements diversifying production particularly to Africa and Latin America have so far been lagging behind and certainly these data demonstrate that. 36.   Finally, on actual production and projected production of vaccines, again these are Airfinity projections, the smooth line represents forecasts, the less smooth lines represent the actual observed reported levels of production so at least according to these analysts the forecasts are relatively in tune with the observed production and again you see so-called in-house production as I have mentioned is still predominant and is forecast to increase beyond a linear increase and the same applies to contracted production, although starting from a significantly lower base - again contracted production, the technology transferred licences, the arms-length production that we have been talking about. Finally, was also shown in June, it has been updated and really establishes the same pattern. Overall, the blue here represents in-house production, still the predominant source of production of vaccines, the violet element of the bar represents production through technology transfer agreements. Finally, just as a final remark, one factor with bearing on technology transfer agreements in particular for production it is interesting to note that for example for an innovative platform such as MRNA, WHO approval with a regulatory dimension has a significant effect on enabling technology transfer and production agreements. Again this represents the situation especially for the MRNA vaccines which you might say presented novel regulatory challenges which made a significant difference in the ability and willingness of technology originators to licence their technology. I hope this has been of interest to delegates. If there is specific interest on any of these data and desire for more granular information on a more practical level we are certainly on hand and can help in this area, again with the continuing reminder that there are limitation on these data. They are certainly not absolute or complete, but I hope can give an overview of the really important trends.
20. The Council took note of the statements made and agreed to revert to this item at its next meeting.
14. The Chair recalled that this agenda item had been discussed in the Council since its informal open-ended meeting in June 2020 and had been on the Council's agenda at its formal meetings since then. In light of broad support – in principle – for a continuation of these exchanges at the Council's last meetings, the item was on the agenda to facilitate exchange of views on measures undertaken as the pandemic persists.
15. He referred to the compilation "COVID-19: Measures Regarding Trade-Related Intellectual Property Rights" that was available from the WTO website, which 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 the attention of the Secretariat was slowing down. He thanked those Members that had informed the Secretariat of measures that should be included in this list, as well as any update or information on the expiry – or end of application – of such measures, and encouraged others to do the same.
16. The Chair recalled that in earlier meetings of the Council and at 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. At the Council's June 2021 meeting, the Secretariat had presented an initial set of data from different sources under this agenda item. The Chair invited the Secretariat to provide an update on the data compilation.
17. The Secretariat took the floor to present document RD/IP/45.
18. The representatives of the European Union; the United States; Switzerland and South Africa took the floor.
19. The Chair thanked the Secretariat. In view of the continued interest on this agenda item, he proposed that 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.
20. The Council took note of the statements made and agreed to revert to this item at its next meeting.
IP/C/M/103, IP/C/M/103/Add.1, IP/C/M/Rev.1