Rainer BECKER

Policy topics Rainer BECKER is active on

What Rainer BECKER has said (8)

• “So, simultaneous with the proposal, the Commission issued a guidance on specifically how state aid can be granted. Legal stated in in the um in the area of of of of of of curriculum medicines. At EU level. Strategic projects may also be supported by EU funding if they fulfil the conditions and the requirements of the programmes at EU level that may apply, for example, Horizon Europe and all the the different other programmes that that you're well aware of, strategic projects that address a vulnerability in the supply chains of critical medicines, will be deemed as another important measure in the act. There will be deemed to contribute to the objectives of Step as the Strategic Technologies for Europe platform, and once a project has the Step seal, that project can then benefit from preferential consideration when applying for existing EU funds like cohesion Funds. We know that in some instances in some member states, some of these funds are not being fully used that actually is being made. Such and As such funds are being made available if there is a strategic project that addresses a vulnerability for critical medicines. It opens the door through the step seal if once obtained, to to other sorts of EU funds. Second, and that's another big chapter. The act proposes several different ways in which member states public procurement can be used to make supply chains more resilient. This is what I like to call the smart procurement criteria. You can in procurement just say the cheapest price wins and that's the medicine I buy.”
  State Aid
• “So really in the union, procures will also be able to apply this requirement for other medicines of common interest when that is justified, and requiring that at least part of the contracted medicines is manufactured in the EU will help to reduce the dependencies of, and also the in the supply chains and also diversify supply. Asking that 100% of the medicine in Europe is produced in Europe, it may not always be required. Maybe a certain percentage gives us enough to give us that breathing space to have this alternative local, domestic, EU source to really deal with a shortage. If something goes wrong with a longer supply chain somewhere leading somewhere else to the world. Um, so that's why the act is talking about a proportion. It can be, of course, a very high proportion, but it can also be that a smaller proportion, because of course, production in Europe may have a different cost than producing elsewhere in the world. So I think there the act is trying to be really measured by talking about the proportion and only where supported by a vulnerability analysis that that that points to the fact that we only have one supplier elsewhere in the world, that this is really the problem of of shortages here in Europe. Third, the act outlines how member states can request support from the Commission in using, um, collaborative procurement tools. So this discovers the facilitation of cross-border procurements of several member states getting together their their years. The commission would help in the back office if don't um if one one could say so would support and facilitate such regional cooperation in procurement, but they can also be procurement by the Commission on behalf of the Member States.”
  "Buy European" provisions
• “I would just like to invite you to, to consider having the possibility to deal with something at a European level is just so much more effective and efficient. And finally, we have proposed that the commission can further. And that's the last chapter of the Medicines Act. A small chapter can can explore international partnerships with like minded countries or regions. If something can be done there to help us diversifying our supply chains for critical medicines. Honourable members, I hope you agree with me that the proposed act is part of a comprehensive approach to address shortages and to improve the availability of critical medicines. It builds on a number of actions that we already are taking at EU level, and they include the European Medicines Agency extended mandate. So that's this. This the steering group I referred to earlier, and also the ongoing pharmaceutical reform with important obligations on companies really to have their supply in, in order and reliable. And I think all together will um, will will create a rulebook that will be effective to prevent and mitigate the shortages. I really welcome your ambition, um, as an opinion giving committee in examining the commission proposal. And I look forward to hearing your initial views today. And of course, very happy to answer any questions that you may have. And I do want to reiterate also that we're fully committed to working with the European Parliament and the Council to bring forward these discussions and make sure that this important, proposal. Thank you. Achieved quickly.”
  Sourcing of critical raw materials
• “Thank you very much, chair. Yes, I'd like to answer some of the questions, but first of all, I have heard a lot of support for the objective of the act to really strengthen supply chain resilience, diversification. Ultimately, in the interest of the the patients also broad support a sense we can discuss a lot about the details. I'm very happy to work on the details. Um, our our doors open there really to to discuss. But on the the range of measures um put forward picking up on a few points. Um, yes. We have put forward an incentive based system. I think there have been if you think look at what was discussed in the Curriculum Medicines Alliance, there were alternative ideas out there which, which which were much more digitised. This is and I really do take pride to say that in the Internal Market Committee, it is a market base. So it is trying to correct where the markets are not functioning, setting incentives, but with flexibility. And by retaining this industrial policy measures to make markets function better to address issues there, but not to replace it by any planned economy or so very much an incentive based system that has been put forward and not more flexibility.”
  Public and private sectors role in healthcare services
• “Again, there were many options. You could have a complicated platform run by the commission for approving any strategic project. It's decentralized. Any authority in the member states can do that. There are strict criteria, so there are strict boundaries. But it is something we one of our top priorities was to have something flexible and avoiding bureaucracy. So when I heard that you're speaking for my from my heart, um, that is very important that we're not creating any bureaucratic monster here. This is about making markets more efficient. Making sure that supply chains are strengthened but in the most effective and also efficient way twice. I think there were strong points made on the contingency stocks and on the buffer stocks. What you see in the proposal for the act is actually, um, something already very ambitious. It is in a regulation, a directly applicable EU supreme obligation on overriding potentially national law and really channeling to insist on the transparency, proportionality so that we don't have the situation, that we have something one member state, because actually it's prevented from going to another member state if there's more to be done. Um, Mr. Chairman, shadow rapporteur. Happy to look into that. And if that can be improved, I think it is important to have a European dimension when it comes to the supply of medicines, access and fair access to medicines.”
  Public and private sectors role in healthcare services
• “Or one could insist and design the the tender specifications in a way that supply chain diversification and resilience is, is is supported. So the Commission will develop guidance on on such smart criteria that procures in the member States can use in the national procurement procedures in relation to critical medicines, Procurers will have to apply requirements some other than price in the procurement procedures. If we're talking about a critical medicine and such criteria could be, for example, criteria requiring a backup supplier of input material. So not just one supplier of the active ingredients from one country elsewhere in the world. Or it could require they could require to keep a minimum amount of a buffer stock stock stock, stock. So if there is a problem in the supply chain that we're not immediately running dry, but actually gain some time and try to then find maybe an alternative solution, or simply it could require a state of the art monitoring of the supply chains. Because after all, I mean, those who offer medicines for sale to our health systems on a commercial basis, it's not asking too much, I suppose, to to to insist on having a really, um, a really good system for monitoring the supply chains and to detect any risks that there may be for critical medicines, which have proven high dependency on a single or limited number of third countries, public procurers will have to apply procurement requirements that favour critical medicines being produced in the EU.”
  "Buy European" provisions
• “Remember the Covid vaccines the Commission negotiated and it can be joint procurement, where the Commission negotiates on behalf and for the Member States, but also purchases itself. So different forms, new tools again being made available to be used where appropriate, used in the right way. These tools can create economies of scale and reduce disparities in access and availability. The proposal for Critical Medicines Act also addresses the potential negative spillover effects of national laws, obliging companies to keep contingency stocks in a balanced way. So these are national legal requirements. You, if you are supplying a medicine, must always keep a three month off stock, um, for oncology products for example just And if one member said it's requiring this, it can have immediate effects on the supply in the neighbouring member states. So a measure that is intended to prevent shortages can actually lead to shortages in the pharmacies in neighbouring member states. So these things are not benign, but they can be very useful. So the act is proposing um, measures to, to, to really make sure that there are no negative effects coming from that they really can deliver the full potential. So the provision what we propose in the act is the is an obligation, um, that when applying such measures, member States will be required to avoid any negative impact on other member states.”
  Covid-19 vaccines procurement
• “This act is about the availability or let's put it differently. Avoiding shortages. Once medicines are available in Europe, then we need to have good and ambitious rules that there are excess accessible in all Member States and to all groups of citizens. I couldn't agree more. And that is precisely why the pharmaceutical package, which is before this House, has a very important chapter on access. And I think that's one of the things that is being discussed there. How we coordinate between the member States and how it feeds to existing national. So the act fully, very much respects the competence of the Member States for a range of measures. There is a clear need for European joint action, and there is the Critical Medicines Coordination Group, again, something flexible that it's trying to make sure that the different national initiatives are channelled and used. And we're not financing the same thing three times. And I'd like to have then the security of supply for another medicine. So there's a critical medicines coordination group foreseen in there. And that is really aiming to achieve this.”
  Public and private sectors role in healthcare services