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

H.E. Ambassador Dagfinn Sørli
World Trade Organization

82.   Thank you for the opportunity to once again update the Council on trends in licensing and production. Just to recall that this stems from a request from the Council in 2021, and what we have to offer is a simple update of the previous two reports along these lines. As a preliminary, just to observe that there is no single authoritative depository of all data relevant to COVID19, not even on the question of licensing that we are focusing on. At the same time there is very active work under way at the technical level in cooperation with other partners to improve availability and integration of data and we are hopeful that this picture will continue to improve progressively. Members are no doubt aware that on 28 February 2022, in the most recent trilateral technical workshop involving our colleagues in the World Health Organization (WHO) and WIPO, there was direct consideration of the challenges of accessing data and this included work on patent data and information on licensing practices. I would mention that one key aspect of that trilateral workshop was to engage at a technical level with Members, to learn from Members their needs and concerns in relation to improved access to and use of data, and there is plenty of scope to follow-up on the insights from that workshop. 83.   Having said that, the data that we are working with does have shortcomings. It is not necessarily up-to-date or exhaustive, or altogether inclusive. And when we are reliant on second-hand data that is based on public announcements, there is considerable diversity in actual practice as to when licence agreements, for example, are announced, considerable diversity between the announcement of the licensing arrangement and actual production of vaccines – so it is an inherently variable phenomenon at this stage. Therefore, we have to say very clearly that we are only providing this information as general background. It is certainly not data that we can vouch for as a Secretariat for all the reasons I have mentioned. This is an area of active consideration at the technical working level and we are aware that other partners, in particular WIPO and the Medicines Patent Pool, are putting considerable effort and resources into improving the knowledge about the patent landscape in particular with respect to COVID-19 vaccines. There remains ample room for improvement of the precision and completeness of information, so any guidance, requirements or specific needs identified by Members either collectively or individually would be very helpful to us. 84.   To give some broad insights into overall trends, we know that patent activity regarding mRNA vaccines dates back over two decades, but as you would expect, has increased considerably over recent years. I stress this is a very broad-brush picture, but nonetheless one representing two important points. Firstly, the progressive increase of activity globally on mRNA vaccines, one of those critical platforms for vaccine production. Secondly the fact that there are many patent documents that pre-date the identification of the novel coronavirus in late 2019, early 2020. Equally, as you would expect when it comes to specific COVID-related inventions, the general patent procedure is that patent documents are published 18 months after the first filing date. Given that we have only now entered the third year of the pandemic, it is clear that many of the patent documents we are looking at specifically referring to COVID-19 will still be pending, and will not yet have translated into final decisions on patents as such. 85.   One key source for patent information is this database, established by the Medicines Patent Pool and VaxPal, and we have used this as a source for background analysis and information, bearing in mind also that Members will be aware that tomorrow the WIPO DirectorGeneral is due to launch a WIPO report on patenting activity in relation to COVID-19 technologies generally. That, I might say, parenthetically, is completely coincidental. We understand from our WIPO colleagues that this is not timed in any way to coincide with this particular meeting, it is pure coincidence. Nonetheless it is clearly noteworthy in terms of tracking emerging data. Based on our colleagues, and I recognize their excellent work, Alex Chiang and Xiaoping Wu, based on the VaxPal data, these are the trends that have been identified. When it comes to specific vaccine technologies, as you would expect, the more novel platforms, notably mRNA and viral vectors, are the subject of a larger number of patent families identified. This applies when these are broken down according to specific vaccines within each of the four broad categories of technology. Equally, and this reinforces the point I made earlier that quite a number of these patent families do date back prior to the first identification of COVID19 and the pathogen causing it. and this is a factor that clearly has to be born in mind in looking at the patent data in that we are looking at platform technologies that have broader scope – and specific patents that have broader scope – than simply COVID-19 vaccines as such. 86.   Important developments since the last report, and these are not, I suppose, representative of broader trends, but nonetheless are very significant in terms of licensing practices, concern two new developments which are quite emblematic I would say. First is the licence announced by the Medicines Patent Pool (MPP) and Merck Sharp & Dohme for molnupiravir which is an investigational oral antiviral. This is an open and transparent, fully published license that has been concluded to enable access to this COVID-19 treatment for 105 low and middle-income countries. No time to go into details now, but this information is freely available on the MPP website and does represent a significant development in licensing practices. Equally, our colleagues in WHO, together with MPP have announced the first licence concluded under C-TAP, the WHO COVID19 Technology Access Pool, which concerns a diagnostic tool which is the subject of, as the title says "transparent global non-exclusive licence for access" to this diagnostic tool. 87.   Looking at the broader trends and now drawing on the UNICEF COVID19 Vaccine Market Dashboard, in vaccines in particular, the trend here is very clear, based on their data. The green sectors represent production through technology transfer, the blue sectors represent in-house production, production under the direct control of the originator company. And so you will see a variation here. In North America and Europe, essentially production under the control of the originator company, in South America, Africa, in much lower levels of production and in South-East Asia and Oceania the pattern is more production through licensing arrangements, with the exception of North-East Asia. We also see a wide diversity, again based on UNICEF data, of licensing practices between the originator firms, the green bar representing again full technology transfer to separate entities, the blue representing production agreements under the direct control of the originator company. The point here is a relatively simple, but important one, that there is great diversity in licensing practices, at least reported under this system. We now turn to an update of the data we provided earlier, provided by Airfinity and again I stress that this is not WTO data, and this is data based on public announcements of different deals, different agreements for vaccine production, and here the distinction is between in-house production on the left, and contracted technology transfer production on the right. Arrangements range from provision of inputs to source of materials, through to simple fill-and-finish or the provision of inputs such as adjuvants which increase the impact of vaccine doses, so the key point here is that there is both, in terms of in-house arrangements announced and more arms-length technology transfer arrangements, there is a considerable diversity in forms of collaboration. When it comes to supply chains, again, the left concerns contracted production which in these statistics means technology transfer. The bulk of these agreements reported concern production in Asia and Europe, to some extent North Asia, much less so in Latin America, Africa and Oceania, and, again, these cover a wide range of different forms of collaboration. 88.   Looking at overall reported production, again reported production publicly reported and gathered by Airfinity, the overall level of vaccine production is much higher for in-house production, the reported number here is 9.5 billion doses in-house as against 3.3 billion doses for production under tech-transfer arrangements. Again, these are very diverse in character. You will see, for example, the great bulk of the tech transfer type production concerns the Astra Zeneca vaccine, but again there is great diversity in these figures. Similar point are made here that there is considerable diversity by region, and this really reinforces what I mentioned earlier, it ties in with the UNICEF data which is in that form here. One important point concerns the delay between actual production agreements announced, and the start of production. These have varied enormously, I might say that there is some hesitation in using these data because, as I say, the date of announcement can vary considerably, and so cannot be relied on absolutely as a firm figure, but we do see a very considerable difference between announcement of an arms-length or technology transfer licence, much longer delays for production to commence compared to in-house production, and that trend seems to be across the different technology sectors as well as different regions. To reinforce that further point, the majority of production agreements still involves production in Asia and Europe, a point worth bearing in mind in terms of the current conversations about diversification of production capacity, that this is the overall picture we see. The majority of the reported production agreements do concern the transfer of technology, as you can see in the right-hand bar, rather than in-house production. But there is nonetheless a concentration, certainly in Asia, Europe and North America. Supply chain announcements also, we do see an increasing degree of collaboration, and this applies both to contracted production, that is to say that the technology transfer arrangements and the production under the continuing control of the originator firms. Airfinity forecasts at least a tendency for inhouse production to remain predominant, to maintain it is relatively high share, but both in-house and externally contracted production are both growing. 89.   Finally, this chart is perhaps the most interesting from the point of view of the specific question we were put. This shows the evolution over time, up until the current month of reported production of vaccines broken down according to in-house, production under the control of the originator company as against production by external firms through technology transfer. We do see a slow rise in the proportion of the production under technology transfer arrangements, but as is clear from the blue sections of the bar chart, there is still predominant production under the control of the originating company. Once again, the figures mentioned earlier of a total nearly 12.9 billion doses produced, 9.5 billion are in-house production, and the remainder through technology transfer. As I mentioned, the proportion of the technology transfer production has gradually increased, not dramatically, but the absolute numbers are also increasing in line with the overall trend of increased production. 90.   I would stress that this is very much work-in-progress in line with the trilateral cooperation we are working to improve the relevance, the granularity and the timeliness of the information we make available for the benefit of Members, not only on these specific issues that we have been looking at this morning, but on the full range of factors bearing on access to vaccines.

21. The Council took note of the statements made and agreed to revert to this item at its next meeting.
15. The Chair recalled that this agenda item had been discussed in the Council since its informal open-ended meeting in June 2020 and had remained on the Council's agenda at its formal meetings since then. The purpose of this item was to facilitate exchange of views on measures undertaken as the pandemic continued.
16. He referred to the compilation "COVID-19: Measures Regarding Trade-Related Intellectual Property Rights" – 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.
17. 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 October 2021 meeting, the Secretariat had presented an updated set of data from different sources under this agenda item. The Chair invited the Secretariat to provide a further update on the data compilation.
18. The Secretariat took the floor.
19. The representatives of South Africa; the United States; and China and took the floor.
20. The Chair thanked the Secretariat and the Members for their statements. In view of the continued interest on this agenda item, he proposed that the Council revert to the item at its next meeting, so that exchanges could once again take place, including on the basis of the updated Secretariat document of COVID-19-related IP measures.
21. The Council took note of the statements made and agreed to revert to this item at its next meeting.
IP/C/M/104/Add.1, IP/C/M/104/Rev.1, IP/C/M104