During the plenary session in the European Parliament in Brussels (13-16 May 2020), debate on vaccines and therapeutics in the context of Covid-19 (corona). Links related to this program Opening statements by Nikolina BRNJAC, Croatian Presidency and by Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life.

Brussels

debate

plenary session

medical research

healthcare safety (T)

SCHINAS, Margaritis (EPP-DE, EL, EC)

vaccination

BRNJAC, Nikolina (HR)

Coronavirus outbreak (T)

Vaccines and therapeutics in the context of Covid-19: Opening statements by Council and Commission

https://api.multimedia.europarl.europa.eu/documents/20125/6154904/I191153Chapters%5BSD-EN%5D.srt

SOUNDBITE (Original), Nicola BEER, EP Vice-President, Opening the debate

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency On behalf of the Croatian presidency of the council. It is my honour to contribute to the parliament's discussion today on the vaccine Senat Therapeutics in the context of the colvard 19 pandemic. This pandemic constitutes an a unprecedented challenge for Europe and the world.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency It has brought huge human losses suffering as well as social and economic damages to millions of people. Both our heart care system under exceptional pressure. It has wide ranging implications for all of us in every part of the European Union. As we gradually start lifting confinement measures.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency We will have to learn to live with the coronavirus under strict conditions and constant monitoring. Only the development, production and deployment of effective and safe vaccines and treatments will hopefully provide us with a lasting solution to this global health crisis.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency Vaccines and treatments will be crucial for Europe, but they will be even more critical for our most vulnerable partners with fragile health systems such as Africa. Our ultimate and common goal, therefore, is to accelerate the development manufacture and delivery of vaccines and treatments for everyone everywhere at affordable price in the shortest possible time.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency The EU and its member states have embarked on a worldwide race to find safe and effective vaccine and treatments to counter the spread of the coronavirus. Regarding activities at the EU level already on the 10th of March, at their first meeting after Covid 19 pandemic reached reached Europe. EU leaders committed to supporting research as part of our common response to the outbreak.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency On 7th April, the coratian presidency organised an informal videoconference where ministers responsible for research and innovation showed their determination to coordinate their actions and welcome to turn actions for immediate response to the crisis.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency On 7th of May, in an informal video conference organised by the commission, many member states supported the idea of preparing a Code 19 vaccination immunisation plan to accelerate Corona beta virus. The commission has launched a dedicated Covid19 data portal that enables researchers to upload access and analyse research data.

OUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency Currently, there are more than 19 vaccines in the development around the globe, but only eight areso far subject to clinical trials. Candidates for vaccines are receiving support from EU funding through the research programme Horizon 2020. Member states are also investing in several candidates moving to treatments.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency It is encouraging to note that there are so far more than 40 developers of potential treatments for covid 19 have contacted the European Medicines Agency and the member states for scientific advice. Most of the treatments proposed arm medicines scali authorised for other diseases.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency Clinical trials are currently ongoing to determine their efficiency for the treatment of the covid19 patients. The EU has allocated allocated resources via Horizon 2020 to discovery an EU wide clinical trial to test treatments, enrolling more than 3000 European patients.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency The EU has already committed over hundred five 500 million to different research and innovation initiatives that include approximately 40 eight million euros to 18 project on vaccines and treatments via Horizon 2020 research programmes.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency 72 million in public funds for a therapeutic send diagnostic sivir innovative medicine initiative with additional 45 million of expected contribution from the industry. Additionally, the EU has redirected 150 million euros from SME and start-ups for innovative solutions to tackle the outbreak via the European Innovation Council acceleration programme.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency Up to 80 million euros to cure work and European vaccine developer by our common commissioner A.B initiative in order to respond to the urgency of the European Medicines Agency, will speed up its regulatory procedures so that marketing authorisation of safe, effective and high quality covid 19 relate medicine and vaccines can be guaranteed guaranteed without unnecessary delay.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency Turning now to activities today at the international level, on 24th the febrile April, the W.H.O. launched the global cooperation for the acceleration in development, production and equity, the equitable access to diagnostics, therapeutics and vaccines.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency In response to this call on Fourth of me, the European Union, several member states and other G20 countries co-hosted an International Coronavirus Global Response Pledging Conference. The initiative has raised 7.4 billion, including 4 billion from the EU and its member states.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency This is a very promising and important first step. There are a number of key challenges. Once new third therapies are indentify, the challenge will be to scale up production and distribution to make them available to patients throughout the world at affordable price.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency As regards vaccines, a first challenge is a patient's safety and to produce vaccine in extremely high quantities. Since the demand is global at a European level. Already in December 2018, the council adopted the recommendation on the strength of cooperation against vaccine preventable diseases, which has a double aim of reducing inequalities between member states and increasing security of vaccine supply.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency EU instruments such as joint procurement could be used in that spirit to help ensuring fair distribution and solidarity among all member states in order to tackle other important issues such as securing sufficient and autonomous production capacity in the European Union. Fair licencing and fair intellectual property rights conditions. It is necessary to involve all concerned actors, including industry and the public public sector.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency In this context, I find it very encouraging to see that several manufacturers have agreed to pull their resources public authorities, pharmaceutical companies, multilateral organizations must work together to reach the common goal of making vaccines and treatments available. As many as possible.

SOUNDBITE (Original), Nikolina BRNJAC, Croatian Presidency President. Honourable members, we will defeat the Colvard 19 crisis and we will do it so with the shared spirit of European and global solidarity and responsibility. Thank you very much.

SOUNDBITE (Original), Nicola BEER, EP Vice-President, Thank you very much for those words. Now we come to the commission. Commissioner, she knows you have the floor.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Thank you, Madam President. Madam Secretary of State number honourable members from the very first day of this crisis for us in the European Commission, one consideration was evident.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life No country in the European Union or worldwide can battle this pandemic alone. We need to take bold steps and we need to take them together. Containment measures have proved efficient so far and allow us to diminish the spread of the virus, but they will not eradicate it.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life For this, we need further action and we need further action on three areas. First, early diagnosis. Second, targeted treatments for the. And third a vaccine.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life A vaccine that will ensure immunization. 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.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life This is why the European Union is taking the lead in organising a Coronavirus Global Response Pledging Initiative, which took place on the fourth of May. And the aim was precisely to lead the world effort to develop diagnostics, vaccines and therapeutics against the virus.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life As soon as possible, not only to make possible to get to these objectives, but also ensure that they are accessible on a fair and equitable basis once they are discovered. And I am delighted to have this opportunity on behalf of the commission to discuss a bit in more detail these issues with you. This afternoon. first, vaccines on vaccines. There is no doubt that this is the best way to truly exit the pandemic and avoid the resurgence of the disease. However.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life 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 the Fourth of May that the European Union led at global level. First, we managed to attain our overall objective with an ambitious level of funding raised.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life We mobilised seven point four billion euros eight billion dollars in pledges of which five billion came from Team Europe. Second, and equally important aspect of this pledging conference was that we send as a European Union every sounding message of unity and solidarity across the world. And we also proved that in today's turbulent times, the European Union remains a force of good for the planet.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life And this was only the beginning. The pledging marathon remains open until the 23rd of 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.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Obviously. Here comes the big question where are we on the vaccines as the Croatian presidency just indicated? The W.H.O. has identified eight vaccine candidates in clinical and clinical evaluation and 94 candidates in pre-clinical evaluation.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Three candidates are receiving support from the commission through our Horizon 2020 and member states are also investing in several candidates. We need to focus efforts on finding the most promising solutions. And that's why the commission has proposed to set up an EU wide network for clinical trials.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Such a network will ensure a clinic, a critical mass of data from patients helped to identify the most promising vaccine candidates or therapeutics and to swiftly move them into the most appropriate clinical trials.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Once developed, of course, a vaccine will 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, as quickly as possible.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Without, however, compromising on safety and efficacy, honourable members 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.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life And there are many tools that we could use to achieve this from public private partnerships, to increase manufacturing capacity, to advance purchase agreements to ensure production.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life And 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 to purchase and deploy deployment of vaccines.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life All options are on the table and we do not exclude any of it. Last week. Health ministers discussed the possibility of a uniform covid 19 immuno humanization strategy throughout the European Union. This would also help us to maximize access to the vaccine when it becomes available.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life And I look forward also to hearing your thoughts this afternoon. On these approaches. Let me now turn to therapeutics. The commission has reacted efficiently to support member states in this regard.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life I don't want to beautify the situation, will know that the early stage of the crisis was not the example of optimal coordination. Many measures were taken rapidly under pressure at national level without the necessary coordination.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life But once this first stage went through and our member states saw the added value of cooperation and the interdependence that binds us, binds them together, as a European Union, with the help of the commission, we reacted efficiently to support them. And let me recall some of these actions.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Since day one, we have coordinated closely with all important actors. The European Medicines Agency, the CDC, the national agencies industry to avoid or tackle bottlenecks to better anticipate future shortages and to assist in the adaptation of production.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life In parallel, we have issued concrete guidance on the rational supply of medicines, regulatory flexibility and clinical trials to avoid availability of treatments. And we have activated the rescue new stockpile of medical equipment, including therapeutics, vaccines, and we have established the Corvette Clearinghouse Mechanism that facilitates the matching of the needs for medical equipment with available supplies.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Thankfully, the situation is now beginning to stabilize in the EU, but we must continue working also on the supply side. And with this in mind, we are supporting a dedicated industry cooperation project to increase supply of critical intensive care unit medicines.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Parallel to that, the European Medicines Agency and the Commission have put in place mechanism to support the rapid development authorisation of New Covid 19 medicines and vaccines. And as we speak, we are currently preparing a joint procurement for Assad's ICU medicines.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Honourable members, let me conclude by saying that we are discussing today, of course, about the short order, which is saving lives and winning the battle to the virus. On the medical side.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life But I would like to finish with a few words about the medium and long term.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life The pandemic has revealed and amplified important issues with our supply chain for medicinal products. I'm very aware 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.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life The commission is preparing a new pharmaceutical strategy that will take account of the lessons learned during the pandemic and make the use pharmaceutical system future proof and crisis resistant.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life The occasion to give you a bit of more detail of our very intensive work on the recovery initiative, which is to be expected in the next few days.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life And I would say that part of building this resilience for Cahiers and resistant European societies pass from a very rigorous health project, health program that would bridge this a symmetry 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.

SOUNDBITE (Original), Margaritis SCHINAS, Vice-President of the European Commission in charge of promoting our European Way of Life Commissioner Maria Teresa and I, we will look forward to working very closely with this house on this endeavour. But first, I'm keen to hear your thoughts on the challenges and solutions. And I'm very willing to take them on board and report back to you at my earliest convenience. Thank you all.