What Véronique spoke about.

Madam President, you are right, Commissioner, contrary to what we hear, antimicrobial resistance is not a silent pandemic. 35,000 deaths per year in the EU and every day in our hospitals, from patients infected with multi-drug resistant bacteria. This scourge painfully illustrates the concept of "One Health" and imposes an ambitious response at all levels of governance: at Member State level, raising awareness among citizens and training professionals; at European level, incentivising research and development through CEIPs and HERA; at international level, as part of the future WHO agreement on pandemics. Here we send a united message to the Commission and the Council. Strong legislative measures are needed. With the revision of the pharmaceutical strategy, the European Parliament has an appropriate tool which it will be able to use.

Madam President, Commissioner – dear Stella – we have read this comprehensive strategy well and we are pleased with this very integrative vision of health in all policies, this ambitious proposal and we share it: health no longer as a cost, but as an investment, no longer as a burden, but as an opportunity for Europe. But, then, why reserve it for third countries? Why not apply it to ourselves? Because, finally, are we so exemplary on the fight against inequalities, on a real prevention policy on the strengthening of primary care? The own-initiative report on a care strategy revealed to us the similarity of our weaknesses within the Schengen area itself. So why not take this comprehensive strategy and apply it within the EU? And, even if you are opposed to national prerogatives, why not launch enhanced cooperation programmes between countries fighting for one and the same good cause: the health of Europeans?

Mr President, Commissioner, the triple outbreak of COVID-19, influenza and bronchiolitis is putting pressure on our health systems and creating shortages of essential medicines. But this acute situation occurs against a chronic background of supply tension and we know the main causes: they all have their roots in abnormalities in the development and marketing of the medicinal product within the Union. After a single European marketing authorisation, based on the EMA’s expertise, a new national authorisation, a national assessment mechanism, bilateral price negotiations, a profound lack of interest on the part of manufacturers in medicines that have become unprofitable and national stock management that puts the Member States in competition with each other are observed 27 times, in an uncoordinated manner in each Member State. We must be able to restore the virtuous circle of European sovereignty: joint evaluation of medicines, collective negotiation of prices on the basis of enhanced cooperation, mobilisation of the EMA and ERA agencies. The tools exist, the crisis has shown us that they work. So let us take the opportunity of the revision of the pharmaceutical legislation to strengthen them.

Mr President, Commissioner, ladies and gentlemen, let us never forget that the proposal to revise the legislation on medical devices was published following the tragedy of PIP breast implants in 2012. Ten years later, we are still discussing the implementation of this legislation. This is not in line with our vision of an ambitious, pragmatic and above all independent Health Europe. Patient safety cannot be an adjustment variable. Health standards are also, if not more, imperative than other European legislation. We must indeed admit that the implementation of the Regulation is now at risk, due to the fact that there are probably too few notified bodies, but also due to the lack of anticipation from some manufacturers and the lack of specialised staff. It is true that for several months now, all actors have been sounding the alarm and it is time to respond with pragmatic solutions that are acceptable to all. So, agree to adapt the regulation once again, but provisionally and at the margin, to avoid potentially dangerous supply disruptions, but not to call into question this ambitious regulation, which is absolutely necessary for the safety of European patients.

Madam President, Commissioner, 33 million people in Europe today suffer from diabetes and 90% of them have type 2 diabetes. It must be made clear: Type 2 diabetes is essentially a disease of poor diet, too rich, too sweet and unbalanced. The key to preventing diabetes is education about healthy eating from an early age and simple, understandable and science-based information for consumers about the food products they buy. That is why, Commissioner, the revision of the Nutrition Labelling Directive is one of the key elements of the Healthier Together initiative that you recently launched. And because the risk factors for diabetes are common, among others, to those for cancer and cardiovascular disease, we need a genuine European strategy for the prevention of chronic diseases to integrate the consideration of the determinants of health into all European policies, to establish inclusive governance bringing together in particular consumer and patient representatives, and above all to encourage the Member States to implement ambitious prevention measures without ever yielding to pressure from interest groups.

Mr President, Mr President-in-Office of the Council, Commissioner, dear Stella, the mental health of European citizens, especially young people, is a major public health issue that has been exposed and aggravated by the pandemic. This is common in all European countries and has been mentioned in the European Care Strategy: we need collective awareness, coordinated prevention actions, support for parents, adaptation of our health systems and data sharing. Dear Stella, we indeed look at health as an investment and mental health as a pillar of health in general. Thank you for your initiative. But if this initiative does not rely on robust governance and an adequate funding system, then we will fail to put in place a genuine European health policy. Health care is a national prerogative. Agree, but when a finding is so widely shared, it is necessary to have the courage to convince Member States to go beyond these prerogatives, as they have done in the past.

Mr President, Commissioner, ladies and gentlemen, less than a week ago, on Monday, in this very Chamber, the European Parliament voted by a very large majority in favour of my report ‘Serious cross-border threats to health’. This is a real health emergency plan: we learned the lessons of the health crisis and decided to build a Europe of health that is supportive, coordinated, independent and sustainable. It is now the duty of the COVI Committee, this Parliament as a whole, the European Commission and the Council not to ask the same questions, but to ensure that the legislative provisions of this Regulation are swiftly and fully implemented. In terms of solidarity, let us work together to swiftly put in place the International Treaty on Pandemics, so that a pandemic threat is addressed globally. In terms of coordination, the revised mandate of the European Centre for Disease Prevention and Control, dear Joanna, gives it additional competences for the collection and sharing of digitised data and enhanced protection against disinformation. We will have to make sure of this evolution. To ensure better preparedness for future crises, we will need to implement the comprehensive health principle as well as prevention and health education. On independence, we collectively want more transparency in joint purchasing, and this rule will have to be applied, as well as the exclusivity clause, so that Member States no longer conduct parallel negotiations with industry. We will ensure that the Health Emergency Preparedness and Response Authority coordinates with other agencies. Finally, in terms of sustainability, the involvement of regional authorities should foster cooperation in cross-border regions. Finally, we will pay close attention to the establishment of the Independent Scientific Council, the absence of conflicts of interest of experts and the consultation of all stakeholders – starting, of course, with this Parliament.

Madam President, Commissioner, ladies and gentlemen, as you said, this legislative proposal and the revision of the EMA and ECDC mandates is a major contribution to the Europe of health that we have been building step by step since the beginning of this mandate. I greet again our negotiating team, dear Esther, Sarah, Margrete, Johanna and Katerina. We defended this regulation in a way that is not very legible: 'Serious cross-border threats to health', to make it together a genuine European health emergency response plan. With this agreement, we are responding to the 74% of European citizens who want more European skills in health and crisis management. This construction, dear Stella, will continue with the revision of the pharmaceutical legislation by which, we want it and we will do it, we will move towards a true Europe of medicine. But these legislative overhauls are just the beginning. Our project will continue in the framework of a future convention on the revision of the European Treaties and we are pleased that the Commission, which I also thank for its support during this trilogue, is once again ready to take up this challenge. Ladies and gentlemen, by your vote tomorrow, you can convince the Member States of the relevance of a genuine European health policy, beyond the tensions over national prerogatives which have shown all their limits or even their deleterious effects. Health should no longer be seen as a cost, but as a sustainable investment in the well-being and better living of European citizens. So, on their behalf, I thank you for your support.

Madam President, Commissioner – dear Stella – ladies and gentlemen – for those of you who have remained – the COVID-19 crisis has shown our extraordinary fragility in terms of health. In 2020, our national health systems were overwhelmed, and this powerlessness first pushed them towards national protection reflexes. We say it: Never again! Soon, the temptations to withdraw into oneself gave way to European solidarity and coordination. We must now draw inspiration from this remarkable but improvised response as a matter of urgency. After many months of successful negotiations, I am proud, as rapporteur, to present here the strengths we have defended in order to learn from the past and to make this regulation a real European health emergency plan. Dear colleagues, this notion deserves your attention or, at least, your respect, thank you! We are stronger together, and together we will need a Europe of health that is supportive, coordinated, independent and sustainable. A Europe of health solidarity by tackling health inequalities within the EU – through cooperation between Member States –, strengthening collaboration with third countries – especially the poorest – and strengthening global cooperation – notably through the International Treaty on Pandemics. A coordinated health Europe: coordinated in the collection and sharing of data – which have often been lacking – coordinated to prepare for all health threats – integrating the global health principle as well as the principle of prevention and health education in all European policies – coordinated to better prepare and anticipate the impact of a health crisis on people with chronic diseases – and I am thinking in particular of the many collateral victims in cancer patients – coordinated finally to combat the scourge of disinformation – relying on the CDC as a relay for scientifically verified information. An Independent Medicines Health Europe: we have imposed more transparency vis-à-vis the European Parliament and citizens in the preparation of joint purchasing contracts, we have included the concept of an exclusivity clause to prevent parallel negotiations with the industry and to ensure fair access to medicines for all European citizens, we ask that the ERA health authority has the means to better coordinate with the bodies and we propose an evaluation of these actions to determine whether or not it should become a separate entity. A sustainable health Europe, finally, with the creation of an independent scientific council, with the establishment of provisions on the absence of conflict of interest of experts, with the consultation of all other stakeholders (non-governmental organisations, health professionals, etc.) at the same level as industry, with the strengthening of the role of Parliament – and therefore of citizen representation – and with the involvement of regional authorities – with a view to fostering cooperation in cross-border regions. These major advances would not have been possible without the mobilisation of my dear co-rapporteurs – a 100% female team! They were anything but fictitious. I would like to warmly greet them and their teams before giving them the floor.

Mr President, Commissioner, it is impossible in a minute to pay tribute to carers, who are most often women carers. Impossible in a minute to testify to what we see in our hospitals, like the one where I work: lack of recognition, administrative burden, understaffing. So a minute is just the time to sound the alarm. No progress in care is possible if the interest of patients is lost. No care organisation is effective unless it is articulated with prevention, education, reintegration support and self-reliance. No country can consider that it can do better on its own. That is why we welcome a common European care strategy.

Mr President, Commissioner, thank you for your efforts, but it is time for the Commission to propose a genuine European strategy for mental health. Several instruments exist and already have a mental health dimension. Occupational Health, Minimum Wage, Child Guarantee, European Social Fund: We have to articulate them. To be more effective, our approach will have to be comprehensive. Mental health is determined by individual and collective factors. It must therefore be taken into account in all European policies. This requires commitment from the Member States, but also European coordination of initiatives and actions. We need funding, but also indicators to target priority areas, along the lines of the Cancer Inequalities Register, because here too, reducing inequalities must be a priority.

Mr President, Commissioner, dear Nicolas Schmit, yesterday this Parliament largely adopted a report on the European cancer plan. From prevention to reintegration, the European Union will have a broad public health plan. Today, we are providing the first legislative stone by tackling health inequalities, as the risks are not the same depending on the job and the state and will not be the same if the European Union does not harmonise its prevention rules upwards. By demonstrating that an action against cancer is a model for other pathologies and after three unsuccessful revisions, we have succeeded in extending the scope of this Directive to substances toxic for reproduction. This is a big step forward for reproductive health, especially for women. This is an important step in the implementation of the Simone Veil Pact. Finally, we say that the European cancer plan will not only be for carers, but for them. I have a special thought for the millions of nurses who care for our parents and children against cancer. I know them well. This unwavering commitment must not and cannot come at the expense of their health. However, some drugs are themselves carcinogenic or reprotoxic. The text we will vote on today will provide very concrete answers on the ground. I would like to warmly thank all colleagues, especially the beautiful negotiator Lucia Nicholsonová. While this text is a step forward, it sets the course for tomorrow by setting the ambition for a very broad action plan against cancer at work. Commissioner, we are counting on you.

Madam President, first of all I want to say thank you. Thank you, Commissioner, for accompanying us through all this work. Thank you to all BECA Members - there are still a few in the room - who inspired and supported this work. Thank you to the experts and scientists we heard and listened to. And then, if I may, thank you to my patients, who have inspired me for over 30 years, to those I have treated, to those I am still treating and to those I will be treating. We have produced a report that I understand meets a lot of expectations. But today is not an end, it is a beginning, because everything remains to be done. We still have to work on the legislative proposals that will emerge from this report – the first, in two days, on the revision of the Carcinogens Directive. We still have to continue – and many of you have said so – to rely on science data to inform and protect citizens. Prevention is the lever. The easiest cancer to cure is the one you don’t get. And then, Minister, dear Clement, it will be necessary to deploy this plan. To deploy it, we need the collective and united commitment of the Member States, in particular on all measures that are recommendations, and that, without your support, without your strong involvement, will remain a dead letter. Finally, I would like to send a final message: What we will succeed in cancer prevention, we will succeed in all other chronic diseases. In this way, we will be able to improve the health – the good health – of our citizens. Thank you again for this rich and lively debate, and let's continue together.

Madam President, Commissioner, dear Stella, cancer is an individual and social injustice: cancer affects us all; However, we are totally unequal with the disease. Differences in survival rates can vary by up to 25% across the EU, and this is unacceptable. It is our duty to start reducing these inequalities, supported by the creation of a register of inequalities. It is this priority that has guided the work of the BECA Committee, and I thank its many Members present today. We must respond to the expectations of the millions of citizens concerned. We must respond to the demands for progress of the families and caregivers of the 1.3 million people who die each year from cancer, including 6,000 children. The complexity of the disease justifies excellent research in connection with Mission Europe, independent and multidisciplinary research supported by European universities and the European Health Data Space. We also need a response to the 4 million patients who now need effective treatments. Modelled on vaccines, we propose the virtuous circle of equitable access to available and affordable medicines: joint evaluation, joint procurement, concerted response to shortages and development of innovations through HERA. This Europe of medicine is particularly necessary in orphan therapeutic situations, i.e. rare cancers, primarily childhood cancers. Equitable access to testing and care is part of the collective commitment of Member States on shared quality criteria, for example on care facilities and on support for families and carers. We also owe a response to the 12 million survivors facing the difficult return to normal life. We make strong recommendations for improving the quality of life and reintegration, for example through the implementation of the right to be forgotten in all EU countries. We need a response to the clear will of future generations to be informed and protected. It is essential to develop health education. This is the field of prevention, the implementation of which should prevent four out of ten cancers and six out of ten deaths through effective, courageous and science-based interventions. We share the Commission’s ambitious prevention objectives on tobacco, alcohol, readable and evidence-based nutrition information, and the equitable development of HPV vaccination. We will build on the European Green Deal to support healthy diets, air quality and the fight against environmental carcinogens, especially at work. Finally, we need a response from governments, which are facing the growing economic burden of the disease: €4 billion budget and coordination of efforts between Member States through networking of the 27 National Cancer Plans. Finally, non-binding recommendations should be the subject of a commitment by the 27 Member States on a European Charter of the Rights of Cancer Patients. The trio's declaration in Paris shows the way to this collective, solidarity-based and necessary commitment.

Mr President, I am not going to read what I planned to say about the health crisis. There were many calls this morning for our society to organise itself to fight fake news. Let us start here, where we must invariably denounce the permanent disinformation coming from the extreme right of this Chamber. No, Mr Fitto, it is no better to cure than to prevent. Prevention through vaccination is medically, socially, ethically and economically the best way to fight a pandemic. No, Mrs Donato, it is not because the variants are probably less aggressive that the barrier measures need to be lifted. The opposite is true, because they are more contagious. And Mr. Lacapelle, to spread such false information in the name of people's freedom is abhorrent. Because what you stand for is the freedom of the virus to spread. Merry Christmas!

Madam President, Commissioner, ladies and gentlemen, there is no reason why the added value of any medicinal product should be different between two Member States for the same medical situation. However, after their registration by the European Medicines Agency, health products are assessed at the same time, but without convergence, in all 27 EU countries. This lack of consultation generates unnecessary costs for the 27, a risk of inequity linked to different economic concerns, but above all, given the red tape repeated 27 times for the same healthcare industry, a delay in making innovations available to patients. The new Health Technology Assessment Regulation has finally come out of oblivion thanks to the efforts of the Commission, the Portuguese Presidency of the Council and especially this Parliament, and thanks to Tiemo Wölken for his determination. This regulation will finally make it possible to start joint evaluations focused on science. Unfortunately not until 2024, and unfortunately not for all innovations, but this is a very important first step for the Medicines Europe. Because there is also no reason why the price of a medicine should be different from one country to another. And this first step is the virtuous circle through which the European Union will not only be able to evaluate, but also negotiate health products with one voice and together at their right price, on the model of what we have achieved for vaccines.

Madam President, Commissioner, dear Stella, dear Frédérique, thank you for organising this key debate. Being affected by a rare disease means facing the risk of late diagnosis, difficulties in accessing treatments, clinical trials, and a sense of loss of confidence, uncertainty and isolation. An effective action plan against rare diseases needs to be European because we need this critical mass of skills. The European Union has created the valuable model of European Reference Centres allowing the exchange of practices between specialists, the answering of questions by often deprived doctors, access to quality consultations, databases, expert patients. Let's keep this acquis and strengthen it, so we won't leave anyone behind. These centres need a budget that meets the expectations of the 30 million rare disease patients in the European Union. Commissioner, finance them.

Madam President, Commissioner, dear Stella, Minister, vaccinating the world is a human and medical necessity. It is irresponsible to make false propaganda in front of cameras. Your lies are murderous. We have a beautiful goal. Of course, we must continue to donate through ACT-A and COVAX devices and remove barriers to dose delivery, avoid vaccine losses, increase equipment purchases and focus on easily usable vaccines. But the European Union’s actions must go beyond assistance, towards responsible and sustainable solidarity – as you recalled, Minister – by making a logistical contribution to vaccination campaigns, by training health professionals, by sharing vaccine production know-how and technologies, by combating vaccine hesitancy and disinformation and by drawing up an international treaty on pandemics, supported by the Director of the WHO, Dr Tedros, by the President of the Council of the European Union, Charles Michel, and which I propose together with Stella Kyriakides in my report on serious cross-border threats to health.

Madam President, Commissioner, dear Stella, dear Dolors, it was Linea Søgaard-Lidell who led the negotiations on behalf of the Renew Group, but she is unavailable for this plenary. I welcome her and the whole team of rapporteurs for the very good work they have done. Today, as you said, I repeat, together we are laying the foundations for a true Europe of health and medicine. A Europe capable of ensuring equitable access to controlled, affordable and available medicines for all citizens. Ensuring the health and safety of the patient must be our priority, while remaining attentive to the sustainability of health systems. The implementation of the pharmaceutical strategy will have to include strong legislative measures. We are ready for this on four main pillars. The first: Ensuring access to affordable and safe medicines through the revision of legislation on access to medicines. These laws are outdated, inadequate to prevent and manage tensions, and not only in the event of a crisis. Before the pandemic, too many patients faced these unbearable situations. We in the European Parliament will ensure that this problem is addressed as a whole at all levels of the production chain, with the needs of the patient as a top priority. Secondly, to restore our pharmaceutical independence through a partial repatriation of the production of medicines in Europe. You propose a structured dialogue between industry and authorities. You are right, we need public-private partnerships. We will also be able to accompany these relocations with state aid or other incentives. However, we will not have to sacrifice our environmental and societal demands. Thirdly, to boost research and development of innovative medicines. Very good news: the revision of legislation on paediatric and orphan medicinal products. For too long, these laws have slowed down the development of innovative medicines, for example in the field of cancer. Research and development of medicines from new technologies must also be one of the European Union’s priorities under Horizon 2020. The COVID-19 crisis has shown us how important it is to encourage research policies. Finally, fourthly, we will have to address the issue of the price of medicines. Closer cooperation on pricing, payment processes and pooled purchases of medicines should allow us to transform the very successful trial of pooled purchases of COVID vaccines. I hope that the Commission will propose the revision of the Directive on the transparency of price-fixing measures. All these reforms would allow us to start setting up a virtuous circle, since the joint assessment by HTA technology – which you recalled – effective controls, transparency of pricing procedures and perhaps later reimbursement, securing productions and reserves. There are many challenges, but we are stronger together and together we will succeed.

Mr President, Commissioner, dear Stella, our Renew Europe political group is concerned about the evolution of the COVID crisis in Europe. We are working with you on the regulation on serious cross-border threats, but the urgency is now and now. The number of contaminations and the number of patients in hospitals are of concern, but also of concern is the heterogeneity of Member States’ reactions. We are both armed against the virus, thanks to vaccination, and new disorderly political choices on social isolation measures, on whether or not the vaccine pass or vaccine is mandatory. Here again the freedom of movement within Schengen is being called into question. How do you plan to start the necessary coordination quickly? I heard your efforts. When and how do you discuss these topics in ministerial meetings? And what does your scientific advice offer? We have made a spectacular leap forward with vaccination. Science has demonstrated its ability to find solutions. But, again, we will have to learn together to restore people’s trust and protect them from disinformation that leads to vaccine hesitation. Finally, you have put in place the effective tool of bulk purchasing. We regularly discuss together the value of extending them to other health products. Do you plan to activate them quickly for curative and preventive treatments that are gradually authorised by the EMA?

Mr President, I should like to thank my colleagues for their strong support on this crucial report for the health of our citizens. Following the votes that have just taken place, I would like to request that the serious cross-border threats to health report be referred back to the committee responsible for interinstitutional negotiations, pursuant to Rule 59(4).

Madam President, Commissioner, after the scandal of bone cancer among radium workers and then sinus cancer among woodworkers, the first suspicions about asbestos were raised in the early 1900s. It took a century for a European directive to finally ban it. But fifteen years later, too many buildings are still asbestos. As a cancer specialist, I have seen the ravages of asbestos. As rapporteur for Europe's Beating Cancer Plan, I denounce this leading cause of occupational cancers, a preventable cause. As rapporteur for the occupational health strategy, Commissioner, I will support your ambitious zero-death vision. The Green Deal Renovation Wave offers an unprecedented opportunity to accelerate asbestos removal, but also presents a risk for exposed workers. We can't say we didn't know. Let’s tackle asbestos with a comprehensive upward social convergence strategy: training of workers, precautionary principle on construction sites, diagnosis before work, epidemiological monitoring of mesothelioma, waste management, global ban, recognition and compensation of victims. We know we can count on you, Commissioner, to turn these recommendations into legislation towards a more protective Europe.

Madam President, Commissioner, dear Stella, the European Health Emergency Preparedness and Response Authority (HERA) is one of the key components of our response to the pandemic and of our European health independence. Its missions are highly anticipated: anticipation, support for innovation, joint purchasing, support for industrial production, prevention of medicine shortages: It's all there. Congratulations on this proposal! In terms of form, I have already expressed to you – and you were kind enough to hear it – our disappointment at not being involved in the construction of this great project, which we support. Reducing the role of the European Parliament to an observer in a crisis committee is not in line with the spirit of cooperation that has driven us since the beginning of this pandemic. What we have achieved, we have achieved together. You have heard in this Chamber our calls for a coordinated European response and a health budget. We have joined forces on the health pass and you have responded to our request for transparency by setting up a vaccine contact group. Parliament’s role should not and cannot be limited to the approval of HERA’s budget, especially without being involved in its preparation. We want HERA to give as much importance to civil society as to industry. We want to participate in its governance to guide its actions on behalf of Parliament, i.e. on behalf of citizens. We want HERA to become an integral part of the Cross-Border Threats Regulation, to which it is closely linked and which will ensure that no time is wasted on its implementation. In short, we want to continue to ensure the coherence, transparency, coordination and unity of our common European health policy.

Mr President, Commissioner, ladies and gentlemen, disability policy is a marker of the inclusive Europe we want to build, in line with our motto, ‘United in diversity’. Disability policy must be present in all our policies: employment, education, housing, transport, digital and, of course, health. The report we are going to vote on recalls that almost one in four Europeans reports a degree of functional limitation due to a health problem. Chronic diseases such as diabetes or cancer can lead to a loss of autonomy. An ambitious health policy must be comprehensive, ranging from prevention efforts in physical and mental health to reintegration after a disabling illness. This is also what we stand for in Europe’s Beating Cancer Plan and in the upcoming report on the Strategic Framework for Health and Safety at Work. Yes, we must better prevent and cure, but we must also think about life with and after the disease: too often survivors face a difficult return to a normal social, emotional and professional life.

Madam President, following the votes that have just taken place, I would like to request that the serious cross-border threats to health report, as well as the ECDC file, on behalf of Ms Kopcińska, be referred back to the committee responsible for interinstitutional negotiations pursuant to Rule 59(4).