Debate: Vaccines and therapeutics in the context of Covid-
Date: THURSDAY, 14 MAY 2020
Speaker: Margaritis Schinas
Language: EN

Containment measures have proved efficient so far and have allowed us to diminish the spread of the virus. But they will not eradicate it. For this, we need further action on three areas: first, early diagnosis; second, targeted treatments for the ill; and, third, a vaccine that will ensure immunisation. We will also need all three to be widely accessible and affordable because, as long as the virus exists in the world, no one can be safe.  This is why the European Union is taking the lead in organising a coronavirus global response pledging initiative, which took place on 4 May. The aim was precisely to lead the world effort to develop diagnostics, vaccines and therapeutics against the virus as soon as possible, not only to make it possible to get to these objectives, but also to ensure that they are accessible on a fair and equitable basis once they are discovered. I am delighted to have this opportunity, on behalf of the Commission, to discuss these issues with you in a bit more detail this afternoon.  First, vaccines. On vaccines, there is no doubt that this is the best way to truly exit the pandemic and avoid a resurgence of the disease. However, developing a vaccine is a complicated process that depends on close coordination, financial support and unity. Each of these considerations was evident during the pledging event of 4 May that the European Union led at global level. First, we managed to attain our overall objective with an ambitious level of funding raised. We mobilised EUR 7.4 billion (USD 8 billion) in pledges, of which EUR 5 billion came from Team Europe. The second – and equally important – aspect of this pledging conference was that we sent, as the European Union, a resounding message of unity and solidarity across the world, and we also proved that, in today’s turbulent times, the European Union remains a force for good for the planet.  This was only the beginning. The pledging marathon remains open until 23 May, so I take this opportunity to encourage all of you to engage in helping to find new donors, public or private, and to join forces in this unique worldwide effort.  Here comes the big question: where are we on the vaccines? As the Croatian Presidency has just indicated, the WHO has identified 8 vaccine candidates in clinical evaluation and 94 candidates in pre—clinical evaluation. Three candidates are receiving support from the Commission through our Horizon 2020 programme, and Member States are also investing in several candidates. We need to focus efforts on finding the most promising solutions. That’s why the Commission has proposed that an EU—wide network for clinical trials be set up. Such a network will ensure a critical mass of data from patients, help to identify the most promising vaccine candidates or therapeutics, and swiftly move them into the most appropriate clinical trials. Once developed, of course, a vaccine would need to pass a rigorous approval process, and we in the Commission will work very closely with the European Medicines Agency to ensure that this process moves as swiftly and as quickly as possible without, however, compromising on safety and efficacy.  Producing the vaccine is only half of the battle ahead of us. We should also ensure fair, widespread and equitable access to the vaccine as early as possible, not only to all Europeans, but also to the rest of the world. There are many tools that we could use to achieve this – from public—private partnerships to increased manufacturing capacity, to advance purchase agreements to ensure production. The Commission is currently in intensive discussions with both our Member States and vaccine producers to identify clearly how we can best support Member States in the purchase and deployment of vaccines. All options are on the table and we are not excluding any of them. Last week, health ministers discussed the possibility of a uniform COVID-19 immunisation strategy throughout the European Union. This would also help us to maximise access to the vaccine when it becomes available and I look forward to hearing your thoughts on these approaches this afternoon. Let me now turn to therapeutics. The Commission has reacted efficiently to support Member States in this regard. I don’t want to beautify the situation. We all know that the early stage of the crisis was not an example of optimal coordination. Many measures were taken rapidly under pressure at national level without the necessary coordination. But, once this first stage went through and our Member States saw the added value of cooperation and the interdependence that binds them together as the European Union, with the help of the Commission, we reacted efficiently to support them. Let me recall some of these actions.  Since day one, we have coordinated closely with all important actors – the European Medicines Agency, the European Centre for Disease Prevention and Control (ECDC), the national agencies, industry – to avoid or tackle bottlenecks, to better anticipate future shortages and to assist in the adaptation of production. In parallel, we have issued concrete guidance on the rational supply of medicines, regulatory flexibility and clinical trials to avoid unavailability of treatments. We have activated the rescEU stockpile of medical equipment, including therapeutics and vaccines, and we have established a COVID clearing house mechanism that facilitates the matching of the needs for medical equipment with available supplies.  Thankfully, the situation is now beginning to stabilise in the EU, but we must also continue working on the supply side. With this in mind, we are supporting a dedicated industry cooperation project to increase the supply of critical intensive care unit medicines. Parallel to that, the European Medicines Agency and the Commission have put in place a mechanism to support the rapid development and authorisation of new COVID-19 medicines and vaccines and, as we speak, we are currently preparing a joint procurement for such intensive care unit (ICU) medicines. Let me conclude by saying that today we are, of course, discussing the short term, which is saving lives and winning the battle with the virus on the medical side, but I would like to finish with a few words about the medium and long term. The pandemic has revealed and amplified important issues with our supply chain for medicinal products. I’m very aware of how dependent we are on important pharmaceutical products or ingredients. So we need to come together quickly and identify solutions to the three emerging weaknesses from the crisis: how to strengthen our coordination mechanisms and supply chains, how to boost our preparedness, and how to improve our society’s overall strategic resilience. The Commission is preparing a new pharmaceutical strategy that will take account of the lessons learned during the pandemic and make the EU’s pharmaceutical system future proof and crisis resistant. Yesterday, President von der Leyen had the opportunity to give you a bit more detail about our very intensive work on the recovery initiative, which is to be expected in the next few days. I would say that part of building this resilience for cohesive and resistant European societies passed from a very rigorous health programme that would bridge this asymmetry between what Europeans expect from Europe in the area of public health and what Europe has in terms of legal competence to face up to this challenge.  Commissioner Kyriakides and I will look forward to working very closely with this House on this endeavour. But first, I am keen to hear your thoughts on the challenges and solutions and I am very willing to take them on board and report back to you at my earliest convenience.