Debate: Surge of respiratory infections and the shortage of medication in Europe
Date: TUESDAY, 17 JANUARY 2023
Speaker: Stella Kyriakides
Language: EN

Now I will start with what honourable Member of Parliament Sokol spoke about, and he spoke about needing a European response. And I have already said in my opening remarks – and I will be repeating it in my closing remarks – that yes, we do have a European response and that European response will be the pharmaceutical strategy we will be presenting at the end in March and that I hope we will have the opportunity to discuss within the European Parliament and the Council and that it will lead to the solution of many of the issues that we all recognise, not now because of the pandemic, but for a number of years it has to do with access to medicines and affordability across our Member States. Now, since the pandemic we have all managed to work together, and I think that we also need to recognise that the work that we have done together in the pandemic, which I will not say has not resulted in any significant change, but I think that it is work that we can justifiably in many areas feel that we can take pride in, and it was work of the European Commission, of the Council and of the European Parliament, and a great deal of what has been achieved was achieved because of the constructive discussions we had with this Parliament. And because of our Serious Cross-border Health Threats Regulation, which, as you know, is in place now, we do now have the measures we need to respond. We have now integrated approaches to respiratory viruses. We have more robust sequencing and diagnostic capacities in Member States and we are supporting them with this, and we are reinforcing our healthcare workforce in many areas in this respect. We are still facing a pandemic, and I never said that this was over. But we are better now in the Member States to identify, to assess and to respond to respiratory viruses than we were pre-pandemic. Now, a great deal has been said by the honourable members of the European Parliament. I will stand by some of the words said by MEP Cerdas and MEP Wölken, who spoke about standing together, and I believe that this is what we need to be doing in the areas of health. MEP Ştefănuță spoke about seeing an increase in respiratory viruses and that we are backsliding. I just wanted to mention here that I have been in touch with health ministers from very early on and I would say as early on as in the summer and autumn months, saying that in autumn and winter we would be expecting a surge possibly in respiratory viruses, so we have been working with Member States on the level of preparedness as a Commission from very early on. In the comments that we heard today there was a comment which also spoke of the cancer plan. And here I feel that the cancer plan and the strategy on cancer is really such an important initiative that we can all be proud of as Council and as Parliament. A great deal has been achieved in the last three years with cancer. We presented new screening guidelines recently, and believe me, I never watch passively any issue which is related to citizens’ health, not for any day. It was has also been said by MEP Limmer that we are part of the problem. I just want to say here that the European vaccine strategy I think is one of the biggest successes that we had in dealing with the pandemic, because every single European citizen had access to vaccines in every Member State at the same time. Now whether citizens decided to use those vaccines or not is different, because that’s very much a personal choice. But we did have vaccines available for all citizens. And vaccines do, as science says, prevent serious disease and hospitalisation and the issues of long COVID. And from the very beginning we have always followed very clearly scientific advice when giving recommendations to Member States. Now what are we doing in the case of the drug shortages in the European market? The root cause of shortages of medicines is both very complex and is also multifactorial, and it can range from the vulnerabilities from the pharmaceutical value chain, the manufacturing challenges, the unanticipated increases in demand, and these are detailed in the Commission study that we did on shortages. I heard MEP Metz and Rivasi and Kympouropoulos all ask what we are doing about this. And the European Medicines Agency has been working very closely – I’m very sorry, President, I’m going to take a little bit longer, but there were many questions – have been working very closely with the Member States and industry in order to understand the root causes of medicine shortages, in order to monitor shortages and develop a stronger assessment, I would say, of the demands and the needs. And specifically, for example, the industry has reported the root causes of amoxicillin shortages, and these are due to production capacity issues following a reduction of the production volume during COVID, then an unexpected increase in respiratory infections, particularly in children. And this is not an issue just affecting Member States: it is a global issue. So what are we doing about it? We have strengthened the mandate, working with the European Medicines Agency as part of our proposals for the European Health Union. The European Medicines Agency has been working from day one of this issue with all the national competent authorities, with industry, with all the stakeholders in order to resolve this. We hold very regular exchanges between the EMA and the national competent authorities with a single—contact working party. There are then discussions ongoing with industry in order to identify the problems and to see what correction measures can be taken. And this is really the crucial point. We need to understand that we need to have mitigation measures, including a close engagement with the marketing authorisation holders, including engaging with other manufacturers to determine if we have other production capacity. We are strongly encouraging all the national regulatory authorities to consider and use the regulatory flexibilities available, for example, to allow the exceptional supply of certain medicines or presentations which may be not authorised in one Member State but may be authorised in others, and the EU has the opportunity to grant full or partial exemption to certain labelling or packaging requirements. So a great deal has been going on, also working at national level to advise to avoid hoarding. Now on the issues to do with the open strategic autonomy approach in order to decrease dependency, which is extremely important, I think it was MEP Colin-Oesterlé who opened up with this, we’re working on a very important project here of common European interest to increase production in Europe and the resilience of the European industry post-COVID. But this, of course, is ongoing. But let me be clear that the ongoing shortages we are seeing now are not linked to a shortage of active pharmaceutical ingredients. They are all linked to the huge upsurge of cases of COVID we have in China. In terms of stockpiles, at this stage, the EU does not have an intention to increase stockpiles of medicines on the basis of the current set of circumstances, because where there is insufficient market manufacturing capacity, stockpiling would not be resolving these issues. Now, on pricing, pricing and reimbursement does remain the responsibility of Member States, but the EU does have a role to play, and the pharmaceutical strategy and reform will facilitate the earlier entry of generic, will improve transparency and will support the cooperation between the national authorities so as to exchange, for example, best practices on pricing, on reimbursement and procurement policies. So I will end here by saying that I hope to be able to put forward this proposal in March. We are very aware of the pressure that health systems are under because of the increase of the respiratory viruses and because COVID is still ongoing. And we have been working since the very first days with Member States and all our agencies to see how we can support, but I have also really highlighted this to Member States from very early on, that this was the situation, the challenge that we would be facing in the autumn and winter months. Thank you once again and thank you for the opportunity to be here.