Committee on Public Health Ordinary meeting
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SANT European Parliament
Follow its sittingsAdam Jarubas
Abstain? Adopted. Compromise amendment six, who's in favor? Against? Abstain?
Adopted. Compromise amendment seven, who is in favor? Against? Abstain? Adopted.
Compromise amendment eight, who is in favor? Against? Abstain? Adopted. Compromise amendment nine, who is in favor?
Against? Abstain? Adopted. Compromise amendment ten, who is in favor? Against?
Abstain? Adopted. We're going to the final vote by roll call. I open the vote. I close the vote.
Adopted. Congratulations to the rapporteur. Thank you so much. Dear colleagues, let's move on to the next point, reporting back from the negotiations of the pathogen access and benefit sharing annex of the WHO pandemic agreement. Please stay in the room because we have one point yet.
We're honored by the presence of Mr. Americo Beviglia Zampetti, Minister Counselor for Global Health at the Delegation of the European Union to the United Nations, who came to us from Geneva today. So please stay with us. Dear colleagues, the pathogen access and benefit sharing annex is a central component of the WHO pandemic agreement. Following the adoption of the pandemic agreement in May 2025, WHO member states engaged in negotiations for its annex, which aims at developing a system that enables the rapid sharing of pathogens with pandemic potential while ensuring the fair and equitable sharing of benefits arising from their use, including pandemic vaccines, diagnostics, and therapeutics. I welcome today Americo Beviglia Zampetti, Minister Counselor for Global Health at the Delegation of the European Union to the United Nations, who came to us from Geneva today.
Mr. Zampetti will bring us the progress of the negotiations on the annex of the pandemic agreement. I will give the floor to Mr. Zampetti for his introductory speech and after to the members for Q and A session. As usual, our discussion is based on catch-the-eye and I ask you to indicate us if you want to take the floor. Mr. Zampetti, you have the floor for eight minutes, please.
Americo Beviglia Zampetti
Thank you very much, Chair, and many thanks for the invitation. It's always a pleasure for us to come and brief the committee. As you noted, the negotiations are ongoing. In May 2025, the World Health Assembly adopted the new pandemic agreement after three years of difficult negotiation. At the same time, the Assembly established an intergovernmental working group to continue the negotiation on the annex to the pandemic agreement aimed at operationalizing the pathogen access and benefit sharing system, a multilateral scheme established under Article 12 of the pandemic agreement.
The objectives for the EU, very much driven by public health concerns, are to establish a PABS system that, on the access side, facilitates and enhances access of researchers and pharmaceutical companies to biological materials of pathogens with pandemic potential and their sequence information, thereby improving disease surveillance and enabling the rapid start of research and development and innovation activities for the development of vaccines, therapeutics, and diagnostics needed in case of a pandemic emergency. And the system, on the benefit-sharing side, a system that contributes to more equitable access to medical countermeasures during pandemic emergencies by improving the capacity of the WHO and of the parties to the pandemic agreement to respond equitably and efficiently to pandemic emergencies, including through the voluntary conclusion of contracts for benefit-sharing between pharmaceutical companies and the WHO, first and foremost covering the donation of vaccines, therapeutics, and diagnostics. This, of course, should also be considered in the context of the many initiatives and funding that the EU and more broadly Team Europe have undertaken already during and after the COVID-19 pandemic to support, to assist partner countries on many public health priorities, from regional health security to the support of local manufacturing capacity and diversification of health products production. Negotiations in Geneva have so far proven difficult, marked by deep-seated divisions between developing and developed countries, especially on how access to pathogens with pandemic potential can be improved and how private companies can be bound by benefit-sharing obligations. After more than one year of negotiation, positions remain quite apart on many issues.
This led the working group to recommend to this year's World Health Assembly to extend the negotiation with the objective of presenting their outcome for consideration at either the May 2025 World Health Assembly or, if possible, at an earlier special session. As a result of this decision, the entry into force of the pandemic agreement is unfortunately further delayed since the agreement can be open for signature and ratification only once the PABS annex negotiations are concluded and the annex itself is adopted by the assembly. While the objectives noted above remain unchanged, in the run-up to the May 2025 assembly, the EU fully reassessed its previous proposals and identified areas for further flexibility with a view to facilitating an agreement at the assembly. This was in line with many discussions we have had in Council. At the March 2025 working group meeting, the EU put on the table several potential landing zones representing a significant effort by the EU and its member states to find middle-ground solutions that could be acceptable to all partners.
Now, in light in in terms of prospects for the extended negotiations, we believe that at this juncture it is particularly important to pursue realistic, straightforward solutions that focus on the core elements of the annex and aim to secure tangible results on the ground in terms of first and foremost, but not exclusively, more affordable and predictable access to vaccines, therapeutics, and diagnostics. The EU the EU needs to remain firm on the approach developed so far, which is to establish a reasonable, useful, implementable, and ratifiable PABS system that offers good prospects for private sector uptake and can make a real difference for global public health. This, of course, while remaining constructive and open to improvements and adjustments to the solution we have put on the table and to the consideration of alternative approaches that negotiating partners may wish to offer. Thank you.
Adam Jarubas
Thank you, Mr. Zampetti. Now I open the floor to MEPs if someone... Sorry. Mr. Andriukaitis, do you want to take the floor, please?
Vytenis Povilas Andriukaitis
Thank you so much. Thank you, Mr. Zampetti, for your for your information and update of of situation. We know very well the situation is very difficult one and still till now we are in in very difficult circumstances because if annex would not adopted, it means that treaty is not in in in the power. And this creates globally a lot of discussions. My question is, what do you see how do you think about possibilities to mobilize partners at G20 level and of course mobilize partners between EU and Africa, you know, countries, African Union countries?
Why? We need once again we need now to have a lot of diplomatic efforts, otherwise we will be in delays for sure. And but but situation is very dangerous now, nobody knows, especially keeping in mind pathogens which are artificially produced, nobody knows about biological weapons and so on. Situation in in conflict zones and in in wartime is very much more complicated once again. It would be good now to know how can be build global coalition together with with G20 partners, with G7 partners, with with maybe with with in a bilaterally between between EU and African Union, bilaterally between EU and and Mercosur countries.
Now, as never before, we need to do much more diplomatic efforts. I am not touching situation concretely point by point, but but globally for me it's I see lack of leadership in this situation.
Stine Bosse
Thank you very much. I share the the points from from colleague Vytenis here on on that this is this is really serious. If anything, is there something that from your position we can do as the SANT Committee? Is there any pressure, any commitments that we could that we could undertake? And I also see that I mean we need to get this done for many reasons and and I also think that the history around the COVID crisis and the relationships to African countries is not a beauty for for for the EU.
And how do you see that we can actually not only repair but actually also get back into a different relationship in this area?
And finally, do you see any way that we could hinder a delay? We are living in very turbulent times and we don't need this area to be not solved. So are there any sort of tangible things that you say this could actually happen from this committee, from the Parliament, then please let us know.
Tilly Metz
Yeah, thank you very much for the update. It's indeed an important topic, especially for those of us who have been more than once now in Geneva to discuss with the WHO. So we are very much aware here in the Parliament of the necessity to have this pandemic treaty. So again, maybe I did not hear it regarding the timeline, what do you think, when will we advance finally that we can have the ratification? And then a point that was always important for me, but I think my question is, is it debated again?
It's the waiving of the intellectual property rights during a pandemic, or is that completely out of the discussion, or is it maybe coming back? And then a third point I wanted to know a little bit more, I know that there was another discussion regarding the contracts with the pharma industry, if you could just explain a little bit more on the content of these contracts that are also I think discussed here in the framework of this annex, if you... Thank you very much in advance.
Ondřej Dostál
Thank you, Chairman. As I was also twice at WHO with our colleagues, I would like to say several things. Generally, the public funding of WHO from mandatory state contribution is pitifully small and this can be very easily strengthened also from our MFF. This being said, I strongly disagree with WHO taking money from private donors and foundations behind which are also supranational big pharma companies, often American. This in my opinion may cause conflicts of interest and undue influence on the work of WHO.
A high-level UN agency such as WHO should never be at mercy of private funders, which is connected to the pathogen access and benefit sharing concept. I think that the states of Global South which share the pathogen info through the WHO system correctly claim the right to affordable treatments and vaccines in return. Pandemic response should be an exercise in solidarity, not in greed, and especially now when USA is essentially out of WHO and does not contribute, I cannot see a reason to bow to commercial interests of big pharma, mostly American. I am a lawyer and I understand perfectly the purpose of intellectual property, but I cannot see a justification for commercializing an emergency response. So I would like EU to push in this direction.
Thank you very much.
Adam Jarubas
Sorry, this is not for a minute, this is a big topic. Sorry. Okay, thank you. And I have a question as well. It has been seen that some countries withheld sharing samples during outbreaks to retain the leverage needed for benefit sharing, and that low-income and middle-income countries that promptly detected outbreaks and shared pathogen samples were frequently the last to access medical countermeasures despite their urgent need to deploy them.
My first question is how can the agreement ensure in practice a fairer approach to pathogen access and benefit sharing so that low-income and middle-income countries are less vulnerable when it comes to benefit sharing? And the second question, how can the agreement provide for better local research and development capacity, expertise and invest in building more resilient health systems that would address inequities among the nations and better curb disease outbreaks at the source? Thank you. And I'd like to ask Mr. Zampetti to comment the question posed by MEPs. Please.
Americo Beviglia Zampetti
Thank you very much, all of you, for the important question that you raised. I would like to start by stressing that the template for access and benefit sharing is a template that comes from the world of biodiversity conservation, from the Convention of Biological Diversity adopted back in 1992, which, you know, made the case for a system whereby companies and private operators that take advantage of biodiversity should in some way contribute back to the conservation of biodiversity. So this is the template which is very much unsuited for pathogen. Pathogen is not something that you want to conserve and surely not something that you want to, you know, provide resources to to preserve. So it's a concept, it's a template that is really unsuited for the purpose that we are at hand, which unfortunately was in a sense forced on us by a general sentiment in many developing countries that that is something that needs to be used across the board and also in in the area of health.
So creating coalition of like-minded is difficult because we come from a very polarized sort of approach. We believe that that we should try to do as much as we can to ensure that pathogen are fought, right, and that we can support these these efforts and that there is no in a sense an entitlement to to benefit sharing. The two needs to go in parallel, but there is no linkage between making available pathogen, which should be in a sense the responsibility to all, to humankind, and improving the access and the availability of countermeasures. Those are two in and of themselves very important elements that need to be pursued, but not because there is a causality between them. So we are in a world which is very polarized across this particular issue and any constellation in geopolitics, be that G20 or or African Union or whatever, suffers from this polarization that we see in the negotiation where we really do not see eye to eye in terms of what is the best approach for the purpose of be prepared and respond effectively to future pandemics.
We don't think we need to be hung up on who gave the pathogen to whom. It's a common shared responsibility that everybody should take very seriously to ensure that innovation starts very early and more lives are saved. And at the same time, it is a shared responsibility also to promote a much more equitable access to the countermeasures. So the polarization is there and unfortunately, I don't think it is solvable in the next few months. We just need to try to bring it to conclusion on something that is reasonable that both sides, you know, may see some use for, right?
And so try to be modest and say, look, we disagree on the grand scheme, but at least we can agree that making WHO better equipped is in the interest of all. We don't have to agree on the, you know, the concept of access and benefit sharing linked to biodiversity conservation and how it applies to health, but at least we can all agree that if WHO would have had at its disposal a much larger stock of countermeasures during the pandemic that we experienced a few years back, many lives would have been saved. So making WHO better equipped should be a priority for all, should be a no-brainer as people say, right? But that is not entirely recognized. So there is a lot of, how can I say, a lot of ideology on these elements.
And the Parliament can certainly try to make the reasonable case that, you know, when there are very deep sort of differences and divisions, nonetheless, you can cooperate somehow on a common denominator. And the common denominator we see is that WHO needs to be better equipped in case of a future pandemic. And if people don't recognize that, then we have a big problem because then nothing will be agreed, because that seems to us to be a minimum common denominator that should be under no discussion. And that is something that we hope, you know, would prevail in the next few months. And coming to the timeline, the idea is to conclude by the next assembly or earlier, which seems a little bit optimistic, but at least no later than the next World Health Assembly.
So that is the timeline that we see. This particular annex tries to stay away from the debate on intellectual property rights, which is a very divisive debate again and one that would prevent making, you know, any meaningful improvement in the area of helping WHO to be better equipped. That would polarize even further. It's already polarized as it is. If you inject the debate, which is decades old, on intellectual property rights, we would certainly conclude nothing.
So, that is basically trying to be modest, see what is the common denominator and try to get agreement on that. Because by doing so, the annex would be adopted and it would unlock the opening for signature and eventual entry into force of the full agreement, which includes a very important set of provisions, be that in the area of prevention, be that in the area of preparedness and response. So, the whole agreement, let's say the mother agreement is kept hostage by this annex, which is very, for lack of a better word, ideologically driven by different views on how you do things in the area of health, which, you know, really risks having the whole project collapse. Final point on the contracts. The contracts are meant to be private law contracts between pharmaceutical companies and WHO that would provide, not exclusively but first and foremost, for in-kind donation of vaccines, therapeutics and diagnostics from the pharmaceutical companies which have received market authorization for the particular disease that has caused the pandemic and the WHO.
So it's not, the way we see it, not the way everybody sees it, but the way we see it, there is no financial contribution to WHO. It's an in-kind contribution. Again, think about if there were such a commitment back during COVID-19. It would have meant that, you know, the rush to the countermeasure would have been tempered by a firm obligation of the company producing the particular countermeasure to provide X amount, let's say 10 to 20 percent, to the WHO for use in the countries most in need and for the population most vulnerable. That is a huge improvement that we fail to see how many negotiating partners cannot come around to recognize.
That would be a huge improvement over the status quo. We understand that people always see the famous glass half full and half empty. But this is really, the half full is a very important one because you don't want to repeat the experience, let's say of COVAX, that needed to be created on the fly and with a lot of difficulties. You would have had a much more orderly approach where a significant amount of countermeasure would have gone to WHO for equitable sharing right away. So, we think that is very important.
Maybe it's not all what people would want to see, which is now branching into extremely complex areas of database management of, you know, what I'm sure you are very familiar, issues similar to the European Health Data Space, which is a highly complex endeavor. All interesting things, but surely not useful to realize important improvement on the ground, which is what we are really after at this juncture. Thanks.
Adam Jarubas
Thank you. Is there anyone who wants to take the floor? Stine, please, once again.
Stine Bosse
No, I just want to thank you for taking that position. I guess that's very practical. And again, just perhaps, and you can come back to us if there is anything practical in that sense that we can do as a commission. Because what I fail to see mirrored in the positions that you're talking about is that if we do not find a solution to this, that's not only a problem for countries in Africa.
That's definitely also a problem for us. And we were warned with the COVID-19. Now we have seen what can happen next time. There will be one. It can be worse.
And if we don't have the countermeasures done on forehand, I really fear that, you know, and the question is, do people see this, one? And second, on this question of, you know, the role of the pharmaceutical sector, and perhaps it's not a question for you but rather for our colleague Gestal. I mean, who on earth should make the vaccines if not the pharmaceutical sector? I mean, we can't sit there in our backyards making vaccines. So, I mean, that's the only real solution as I see it.
But yeah.
Vytenis Povilas Andriukaitis
But if I may, if I may, you know, now we have more or less two months in our hands. But of course also controversies are on the table. Polarization also very difficult one. I am not optimistic that we will overcome polarization without possibility to actively involved into dialogues, into possibility to build coalitions, keeping in mind some reasonable grounds, keeping in mind finding small areas where possibilities to accept, to find common views is possible. If we are not doing this, we can lost situation after two months.
We will be once again in challenging issue. Now keeping in mind how is difficult to find compromised agreements. AMR, we can't, we fail, you know, if you look into many, many our obligations, we're always failing. We are not ready to fulfill our obligation globally. And of course as partners.
It means now as never before, we need, maybe we can organize some sectoral debates with like-minded groups and countries, but we need to activate. Otherwise, believe me, forget in two months to move forward with some progress. Knowing that some are deliberately playing game, deliberately playing game against. You know, I was part of debates for many, many years and now I am very worried about situation, keeping in mind, you know, global crisis, climate change and so on and so on. And of course also artificially made pathogens which can now raise, now we are speaking about biosafety, about biosecurity issues.
And it's also part of biosecurity.
Americo Beviglia Zampetti
Yes, thank you very much. Indeed, we, to be candid with you, we are very concerned that we will, we seem unable to move past these kind of ideological debates on the notion that, you know, I'm sitting on a particularly valuable asset, the pathogen, and I will, you know, do whatever I want with it unless I am content that, you know, enough benefits are being shared. This transactional approach seems to us very unsuited to get to good results. And we need to get to something that is pragmatic.
We need to have common sense prevail. We have difference of views. And we respect them, of course. There are policy differences and they are not likely to go away. But we need to get down to that minimum common denominator, which is ensure that if there is a new pandemic emergency, God forbid, the response that the international community can offer is much enhanced with respect to what happened during COVID.
And that means making WHO, which is the main organization in this space, much better equipped to respond. That is something that should not be a matter of contention. And that is something that everybody should agree is worth having, even if perhaps doesn't fit our view of the world, how things should go and what normatively should be done. This is something very concrete, very important, that would help all regions of the world because we don't know how a new pandemic may develop. It may develop in a developed country, in a developing country, in east, west, we don't know.
So everybody would stand to benefit from an international community better prepared to respond. And we see a lot of unhelpful rhetoric also within civil society on these matters, where the issue is clearly misunderstood and where, you know, civil society is very important. In some cases is very helpful. In some cases it makes the thing a little bit more complicated than it should be because, again, we really fail to see how this could be in contention, that having a WHO better prepared would be a great benefit for us all.
Ondřej Dostál
Thank you, Chairman. So please respond to me very clearly. The whole pandemic agreement is basically hanging on a disagreement about a commercial financial issue, that the private companies are unwilling in case of emergency to share some small parts of their product with the whole world. And if it is so, why we cannot access further? Because obviously these companies are receiving the benefit from the information gathered through the public and publicly financed WHO.
If they want to get these informations about pathogens from other areas, they can. But if they received it from the WHO, they should share, right? So can you answer these two questions for me? Thank you.
Tilly, please.
Tilly Metz
Yes. I mean, just to react on what you have been saying. I mean, behind the companies, if we speak about Moderna or another vaccine from China, there stand countries behind. And I think it's also, if I understand, it's also the countries that oppose then to this pathogen sharing and benefit sharing. So I think it's not only the company, for once defending the industry, but I think that is also maybe something to acknowledge.
But then I think you made a very important point that I have a lot to struggle sometimes with people that are critical to this pandemic treaty.
It's about the misinformation or mistrust that we have there. And is the WHO not I know you have less financial and human resources, but should we not together also organize like campaigning what is the pandemic treaty, what is really the use of the pandemic treaty or what can we really achieve? I think it would be already great to have common rules in order to prevent a pandemic and how to deal with a pandemic and then also to have one unit at the European level, the ECDC in this case, monitoring and then also that we have one model of sample of contracts to work with the companies. And I think already these three points could show why it is important to have this pandemic agreement. Yeah, so my question was also more about the campaigning that we maybe also need to do together, WHO together with Commission and Parliament, and how do you see that that we fight this mistrust that a lot of people have?
Americo Beviglia Zampetti
Yes, starting with the question about WHO and how to make a better case for moving ahead with this agreement. WHO is in a very difficult situation, as you know, because of the lack of funding, the cut of funding that they have and now the renewal of the Director General that is coming up. But more generally, WHO is very concerned not to appear to take sides on things, you know, because of course it receives a lot of criticism from different quarters and so they are very attentive to preserve a role of impartial support, almost secretarial support to the negotiation and leave it to the members to discuss and to decide. So WHO is there is as much as you can do, but of course, you know, we believe that they are clearly seeing the advantage of an approach which is, again, pragmatic to say, look, you know, we need to move to a situation where companies that produce vaccine, therapeutics and diagnostic are bound by private law contract with WHO so that a fraction of their production will be assigned to WHO for use in the country most in need. In kind.
These are in kind. So it would be let's say 10 plus percent of their real-time production. So whatever they, you know, get out of the factory, 10 percent would be available to WHO to use, 10 plus, 10 is the floor. And that is something that the pharmaceutical companies have in a sense agreed to do. You know, they after the COVID experience, we believe that most of the pharmaceutical company understand that they have to play a more active role and they have to be more sort of present in the response and they are on record on this.
So we would expect that they would honor this commitment to conclude contracts so that in case they are the producer, the manufacturer of the vaccine, therapeutic or diagnostic, will make available to WHO a very significant fraction of their production.
And that would make a huge difference on the ground. No financial flows of money within to WHO, but the goods that would be necessary to fight the pandemic were it to come back to us in the future. I hope I have answered the question to the honorable member, but if not, I'm happy to, you know, to come back.
Adam Jarubas
Thank you so much. Thank you all for this exchange, especially to our guests who came to us from Geneva. It was a very good discussion. We know we should be better prepared for the next future health crisis, so it's important to shape international collaboration, strengthening the WHO as well. Thank you for your presence, thank you for this discussion.
Okay, dear colleagues, any other business? None foreseen. Dear colleagues, I close today's meeting. Our next ENVI meeting will take place on 28th September. Thank you all.