Sandra GALLINA

What Sandra GALLINA has said (9)

• “The proposal also addresses that, perhaps, you know, I will I will go into detail later. But it's extremely important that when a member state keeps contingency stocks, does not, uh, really create some problems for the other member states. Let's put it very simple, but the idea is that and the verb has a shall and not, uh, it's it's a requirement. It's not an option. Now, I would also like to say that we will produce two types of guidance. We will have a guidance that you know regards these contingency stocks. But we will also produce a guidance for the procurement. So these are things to come. You know the DG comp when we produce this piece this act produced another type of guidance which is for the state aid. So you know this is a very complex piece that requires quite a lot of, uh, props and support. Now, let me finish with the fact that, uh, I think that, uh, in the pharmaceutical reform, you should remember that there are rules that impose EU wide contingency stocks. And I mentioned this because there will be perhaps a discussion on stockpiling. And these can apply to finished products or active pharmaceutical ingredients. And they are imposed on certain actors of the supply chain. This mechanism should allow for support of, I would say, a stock that is rotational in its system, so avoids the problems that stock generally create.”
  State Aid
• “The first thing is the buffer stocks that are intended there. Now, uh, I would like to say that it is important to realize that we also said that the dependency on a single supplier is for a single country, even for certain, um, critical medicines is a problem. So we decided to give the opportunity to have also, um, uh, I would say procurement requirements that favor medicines produced in the EU. Now, uh, favor means it needs to be justified. We are not going to go, um, now completely rogue on our, I would say, principles to be an open I would say a market. But of course, it's important to have, uh, manufactured medicines that are contracted in the, e in, you know, in the in the panoply of the procurement of a member state to create a certain buffer and to create a diversification in the supply. So these are the two, uh, branches. There is a third element, which is extremely important for the member states, which is different collaborative procurement tools. So it's still in the part of the procurement. But here we would like to have cross-border procurement procurement by the Commission on behalf of the Member States and also joint procurement. Now, uh, there is an element I want to stress for all of you. I'm very keen on this element, which is the negative spillover of contingency stocks by member states.”
  Public and private sectors role in healthcare services · "Buy European" provisions
• “Meaning that, first of all, they need to avoid conflict. But they need also to be able to understand whether a project is a project that will be worth of the support. Here comes the whole element of transparency for these projects, which I, I personally welcome. I think it's a it's an issue that will come up in the discussions. The proposal in a sense contains an embryo of that. But, you know, it's for the lawmakers, council and Parliament to see where to go with the with this. But, you know, this group is quite is going to be quite important. I think that I have other questions to reply to. For instance, um, uh, I would say, uh, we have this question constantly. How will the procurement criteria be applied in practice? Um, let me say to you, we I have mentioned it, uh, immediately that we will be producing procurement guidelines. Um, so don't don't expect that this piece of legislation contains also these procurement guidelines. As I mentioned, we have guidelines from state from DG comm for state aid at the beginning, which we felt were quite necessary because, you know, this made an impact on state aid. We are now working on these procurement guidelines. And we will also have guidelines for stockpiling. So let me say this is not the end, The end of the story. Now there is also this issue which is a recurrent issue on the on the stocks. Um, and and and the stockpiling.”
  State Aid
• “Thank you and thank you for the very rich. I would say a series of comments that you have made also in the second round. Again, I will group them under, I would say to two different strands. First of all, let me go into the strand of, I would say, the procurement criteria. Uh, so we say, uh, not just price. Um, by the way, I want to reassure that, uh, and this will be the second strand of my replies. This is fully in the hands of the member States. The competence will remain in the member States. What we are doing now is basically saying you can also not look at simply price, which is, I would say in the smart, uh, rule book, it was not necessarily the most orthodox way to do things. The way to procure was to look, first of all, to the price. Now we are saying you can also look at other criteria. Now it's very important what Honourable Lizzie was saying, because, you know, harmonized procurement criteria, let me say it's very important to have predictability for industry that that we are very well aware of that. But we must balance this with member States competences. Member States competences have competencies for financing their health system, so they are in the best position to decide. I would say what is going to be meaningful, not meaningful important for them, including the fact that they look at perhaps the production facilities rather than the price. You know, it's it's it's all in the, in the hand of the member states. I would like to say that what is important to remember is that in the proposal, there will be a coordination element.”
  Public and private sectors role in healthcare services
• “Um, there is also a floating in the air, an element of the scope, the scope. Uh, let me be very clear. Rare diseases. Yes. They will be covered when we say medicines of common interest or we we go into we did not put a real limitation into what the member states will be wanting to define as as critical medicines. Let me be very frank. It would not have been possible and it would not have been fair, because, you know, we have, um, a different situation in the different member states, as was alluded here. Um, I must say that I would like to, to reassure you that it's not that we're not looking at the research. Research is also taken into consideration in the fact that we are working hand in hand with our colleagues in DG research. So it would be really not useful to focus on the small amount of money as was mentioned by some for me. 80 million is still a good amount of money. Um, because we have the possibilities for member states to be covered through the CMA with their support. We have the possibility to have Step, which is a possibility. What we have, we are offering and then we have the money that comes through the horizon project. So I would not be, um, dismissing dismissing this part. A few other replies that I think are in the order now. Uh, as I mentioned on the procurement, we will have a revamp of the procurement guidelines.”
  Public and private sectors role in healthcare services
• “But, you know, you need to always balance the different needs. So we will need to have more discussions on this point. But let me be reassuring everybody that the competences on reimbursement, procurement, pricing remain competences of the Member States. We are not going to go there. The Critical Medicines Act is definitely not going to, uh, impact on that. Um, I think that I have somehow defended also the point of view of those who want to have more money. Of course, more money is there. But I repeat, we are in discussions for the MFF. So for me, what is on the table is what I can talk about. And the future is in the hands of the legislators. Um, I would like to say that, um, for the procurement to be impactful, we need to remember that there needs to be the will of the Member States. Fundamentally, this is an act of will of the member states. And, um, you will see the words voluntary also in, in many respects in the Critical Medicines Act. We do not want to create a Central Asia. You know, here in Europe, we want to be responding to real needs and to real requests of the member states. And we think that we are trying to balance in the act the two needs, respecting the competences and trying to offer a different path. Thank you.”
  Public and private sectors role in healthcare services
• “So first of all, let me, let me be a bit more disciplined with the, with the wording we have stockpiling, which is a thing which is the competence of the member States. And stockpiling in some respects has undermined. I would say the efforts to keep, I would say everybody afloat, many issues. And the honorable Metz even was quoting the waste that is created with the stockpiles. But let me be clear. We are talking in, in some respects, uh, more about contingency stocks. Contingency stocks are very important because you have I want to draw your attention to the structural nature of of the solutions. Of course you can keep stockpiles, but the stockpile has a cost. It's quite expensive. And, you know, it's not a structural solution. The structural solution. And some member states are very successful. With the companies you can have. I would say the establishment of a clear contingency stock for medicines, even more so for critical medicines, I think. So there what you need to realize is that we have in the pharmaceutical revision an EU wide contingency stock. And this, I think, honorable so-called reply responds to your concern that it cannot be a national and national thing. So let me point to that. It's very important that we are reminded that we have already been working on this issue of stockpile stockpiling and contingency stocks in, in the reform now. Um, I would also like to say that when we are talking about stockpiles and there I would say interconnection between the contingency stocks.”
  Public and private sectors role in healthcare services
• “Also, because one of the defects of the previous instrument that I'm still responsible for is that I don't have a commitment by a member state. It happened to me to do, I would say, for ventilators during Covid, I didn't buy one single ventilator because, you know, in the end, no member state was living up to a sort of Voluntary expression of desire to buy, but it was not binding. So let me say to you here you as legislators, will need to somehow look also at your constituencies because it's it's not it's not possible. Did I reply to all Richie, I don't know, I'm still here. I have I have one element that I want to mention, um, on the rules. Uh, there are many rules. I would not, um, for a minute entertain the thought that we do not have rules for the pharmaceutical industry. We have a formal revision. We have, I would say, the Critical Medicines Act with a few, a few elements. Let me be very clear with you. Um, it's it's it's, uh, certainly important to bear in mind that we need to also, um, consider that the rules are there to protect the public health, and we need to make the most of it at the same time as we keep our competitiveness still flying. So. And and I am very lucid that we have the rules that we need for for pharmaceuticals.”
  Public and private sectors role in healthcare services
• “And this is very important because when we say concepts other than prices, we will need to mention what they are, and we need to offer a modern toolbox to the procurement authorities and not the toolbox that is a bit dated with the cheap, I would say orientation that we had in the past. Now I go a bit into the second area of statements if you allow me, um, which concerned the competences of the member states and what was, uh, labeled as, uh, gizmos. And, you know, uh, may I say to you, um, the collaborative procurement tools that were proposed under the Critical Medicines Act are simply meant to complement the member states usual pathways. And by the way, um, to, uh, we may have to have a bilateral, um, for the issues that were raised by, uh, concerning the procurement in the Czech Republic, um, by Honorable Postel. I must say that, uh, just there is a tweet by Yacoub, a very good friend of mine, who is basically describing that there will be a pathway that may be joining the dots between the Critical Medicines Act already so we can do a bilateral. But let me I would not be too worried. You are in good hands there. Um, uh, the, the the pathways means the national I would say systems of reimbursement, the national I would say abilities that you have to help improve the security of supply within your own country, uh, of critical, uh, medicines. So let me be very clear. This needs to be of common interest. It this is the only, I would say, uh, interesting part that creates this, this bind, um, these voluntary measures may be addressing, in some cases, market failures or in some cases they may be addressing, I would say, other elements.”
  Public and private sectors role in healthcare services