Debate: Pharmaceutical strategy for Europe
Date: THURSDAY, 26 NOVEMBER 2020
Speaker: Stella Kyriakides
Language: EN

First of all, there were questions on the need to revise the rules for rare diseases and children. I want to say that we have already evaluated the legislation on medicines for rare diseases and children. This evaluation has shown that there are already a number of shortcomings. The main problems identified here are insufficient development and in the areas of the greatest unmet medical needs, as I have mentioned. So we will be holding more consultations with stakeholders in the next year and we will be moving forward in order to be able to have a fair and balanced system where we refer to rare diseases and children.  Again, in the same area, there were some questions on how we can push pharmaceutical companies to invest in rare diseases and unmet needs. For example, paediatric cancers appear to be of limited interest for the industry. We need to look at this. Our first step will be to review the legislation on medicines for children and rare diseases. Our objective is simple: to improve the therapeutic landscape and address unmet needs through more tailored incentives. We will foresee the adoption of a new proposal by 2022.  On AMR: there were several questions on antimicrobial resistance. It is a major threat. COVID—19 has further highlighted this. Currently, we see that there’s a weak and challenging business case to invest in the development of new antimicrobials. One of the reasons is that its use must remain restricted once placed on the market. We will be aiming to tackle this in two ways: to measure the reduce and use and ensure the appropriate use of antimicrobials, and also incentivise the development of new classes of antimicrobials. This will be done through both legislative and non-legislative proposals.  Another point that was raised by several of you is access to medicines, a huge issue. This is a key priority. I have said it from the beginning. There can be no first and second-class citizens in the EU. Everyone should have the right of access to the same treatments and the inequalities we see at the moment are simply unacceptable. We need to change this so we will be proposing concrete actions. We will be linking incentives for innovation with obligations for the companies, we will be initiating with the European Medicines Agency (EMA) and Member States a pilot to engage in this, and we will be improving access for generics and biosimilars, which many of you have mentioned. Regarding environmental challenges, the strategy will be addressing the whole lifecycle of pharmaceuticals and we will be proposing to reform our pharma legislation to ensure environmental sustainability, but not only, by also strengthening cooperation with our international partners to ensure quality and environmental sustainability of active pharmaceutical ingredients (APIs) currently imported from non-European countries.  I mentioned generic and biosimilars. This is a very important question because it really can provide patients with access to affordable treatments. We will look to reform the pharma legislation to better promote competition of such products. Regarding affordability, availability of medicines goes hand in hand with affordability so we’ll be promoting and supporting cooperation between national authorities to exchange best practice and will also be looking at improving transparency on the methods for establishing the research and development of medicines. On the issue of data, next year we will be presenting the European health data space. This will aim to facilitate access and the exchange of health data. This would really change the way that health systems and patient access are being seen at the moment. But we do need to understand that health data is also very sensitive so we need to ensure a high level of protection. We will be engaging closely with citizens to make sure that they can understand this. In terms of the production of medicinal products and because I have mentioned strategic autonomy and there were some questions on this, I want to be absolutely clear that the EU will remain open and promote open trade. Protectionism is not in the DNA of the European Union, but strategic economy is a political objective of this strategy and it’s also a major lesson learned from COVID—19. But, first of all, we need to have a better understanding of the supply chain design and identify its vulnerability in order to be able to move forward, while continuing to diversify our supply sources, wherever necessary manufacturing in Europe, and working more closely with our third—country trading partners. Trade came up again when we were discussing the security of supply. We are exploring, in the context of the World Trade Organization, the launching of an initiative facilitating trade in health products in emergency situations and also looking at how we can explore with the EU’s trading partners to conclude a multilateral agreement on tariff elimination on pharmaceutical and medical goods. Regarding intellectual property and the pharmaceutical strategy, I will try to be very brief. Any revisions to the rules of intellectual property and pharmaceutical investment incentives will address the need to foster innovation and make medicines available to all patients at an affordable price. So innovation needs to match the needs and match the needs of patients.  We have already addressed shortages, but what we need to understand is that what we all need to work on together is to ensure that medicines are available to patients in need and at all times, whether it is a time of crisis or not. The patient is really at the heart of this initiative. Because the causes of medicine shortages are complex, before moving forward we have launched a study on the root causes of medicine shortages. This will be finalised in the second half of 2021 and we will then be able to promote specific actions.  Regarding what we done in the last few months – because there were several questions on that – to address it, I won’t list all the actions, but I can say that, from the very beginning of this pandemic, I personally, and with Commissioner Breton, have engaged with industry, asking them to increase production capacity where we identified increased demand. We adopted guidelines to promote optimal supply of medicines and we launched joint procurement to address shortages of critical hospital medicines. So a great deal has been done, but we need to put this into place so that, at a time of crisis, we already have everything in place that we need to have. Regarding innovation, this is really one of the things at the heart of the pharmaceutical legislation proposals and we need to make the necessary adaptations in order for our legislation to be really more innovation friendly. This will also deal with bottlenecks and improve regulatory gaps that we may have. We need to give incentives to industry, but we also expect accessibility to medicines to be improved and inequalities of access to disappear from the EU. There were one or two questions on cancer. The Europe Beating Cancer Plan is shortly going to be presented before you, but we know that cancer is a major cause of death in children after infancy and so we are looking at the revision of the Orphan and Paediatric Regulation to ensure this. We need to do more in the treatment of paediatric cancers and this pharmaceutical strategy will interact very closely with the Europe Beating Cancer Plan because it will support the goal of sustainable cancer prevention with the right incentives for innovation, for a vaccination against treatable infections that cause cancer and much more. And, yes, we propose to amend the role of the European Medicines Agency (EMA). I have already analysed this when presenting the European health union. I have absolutely no doubt that this is the way forward for a stronger European health union. We will need to strengthen our agencies in order for them to deliver what we expect them to deliver. I’d like to end by answering what several honourable Members mentioned on the issue of competencies. We are very well aware of the competencies, as of course is the European Parliament and the Council, but we’re also very well aware of the importance of solidarity and coordination. Everything we have put forward, in terms of the European health union and in terms of the pharmaceutical strategy, takes into account and is well within the Treaty. But we have also learned from COVID—19 that we need to be flexible and we need to try and work, using the Treaty, to all the limits that it can give us and all the boundaries so that we can move forward. I very much look forward to your support for this strategy. We need to have the support of the European Parliament. I want to thank you on a personal basis, because I’ve had the opportunity to speak with many of you over the last few months, for the support for EU for health and the increase in the budget. This is a very important part for us.  What I can end by saying is that, with President von der Leyen and with all my colleagues, all the Commissioners, we are going to leave no stone unturned until we find the way out of this pandemic. We need to seize the opportunity of this crisis to come out stronger, stronger in the area of health, and deliver to citizens what they expect – a stronger European health union. This is what they have asked us for from the beginning of this crisis and this is what we should all be working together to deliver.