What Catherine spoke about.

Madam President, Mr Vice-President, dear Margaritis Schinas, the challenge of pharmaceutical legislation is to remake Europe into a strategic power for the development and production of medicines, a protective power. We are building this Europe of medicines fairly, with voluntary cooperation between Member States, in particular on the price of medicines, the extension of joint purchases for many treatments, including against rare diseases, and also the impossibility of prohibiting or restricting access to contraceptive and abortive medicines in Europe. We build it securely, with demanding assessments, with the commitment of all stakeholders in the fight against shortages, with hospital exemptions for the preparation of innovative therapies, as close as possible to patients. We build it innovatively, together: large research centres, start-ups, bioclusters, R&D, production units, disruptive innovation, digital, AI. We are building it incentivised and simplified, with legal stability for investors in Europe and regulatory flexibility to adapt to the next 20 years. We build it sustainable, with better management of environmental risks and biological balances, also with the transition to packaging to dispense the right amount prescribed. Our work on this legislative package advances the Health Union that Europeans expect, an ambition that we have in mind.

Madam President, Commissioner, life expectancy has increased by five years between 2000 and 2015, it is estimated, although there are differences between regions of the world. This increase is mainly related to health progress. At the same time, however, the ageing of the population is accompanied by an increase in the prevalence of chronic diseases and cancers, which calls into question the guarantee of access to care and the ability of health systems to leave no one behind. The aim must be to improve healthy life expectancy. For this, prevention has a major role. The prevention component is particularly successful in the European Plan to Fight Cancer, which is known to be preventable for 40% of cancers. Targeted risk factors also help to control many other pathologies whose risk increases with age. As such, we regret that the revision of legislation on tobacco products and nutrition labelling is not yet complete, as is the Chemicals Regulation and their classification. The multidisciplinarity of prevention is at the heart of the principle enshrined in our treaties: ‘Health in all policies". . . Health, in fact, in policies relating to the environment and climate, employment, sport, education, housing and all the fight against inequalities. These are all levers for improving the health of our citizens throughout their lives.

Mr President, Commissioner, ladies and gentlemen, the proposal to revise the legislation on medical devices and in vitro medical devices was published on 26 September 2012, following the health tragedy of PIP breast prostheses, which speaks - oh how much! – to the hospital practitioner I was then. Ten years later, the implementation of this legislation is still under discussion. Unfortunately, we must admit that the application of these regulations is far from being resolved. Not only because there are too few notified bodies, in particular those responsible for certification, but also because of the lack of anticipation and the lack of specialised staff. For several months now, all those involved in this assessment have been making this observation and alerting the competent authorities, manufacturers and notified bodies. Responding with pragmatic solutions that are acceptable to all is, of course, necessary. If we are forced to adapt the regulation again to avoid supply disruptions that could be dangerous for patients, this adaptation must be conceived in a very provisional way, because there is no question of calling into question this necessarily ambitious regulation because it is absolutely necessary for the safety of European patients, especially for high-criticality devices. Because patient safety cannot in itself be an adjustment variable, health standards are absolutely essential in our European legislation.

Madam President, Commissioner, ladies and gentlemen, this agreement illustrates our desire for a green transition that leaves no one behind: – because it will protect millions of workers, in particular in the renovation of buildings and batteries and their recycling; – because it will protect their jobs by not excluding them because of too high a blood lead, while monitoring them better (we avoid what could have been a broad social plan); – because it will protect entire sectors of activity – the cultural heritage sector, for example – by providing for a transitional period for the introduction of essential protection measures; – because it will protect women in the labour market by avoiding discriminatory measures in the monitoring of blood lead. It is also an agreement that illustrates the progressive ambition of our Parliament on occupational health. Endorsing this agreement will give a mandate to the European Commission to start work to protect workers from all endocrine disruptors.

Madam President, Commissioner, the COVID-19 crisis has shown us how any decision-making in the prevention, management and treatment of a disease depends on the availability and analysis of reliable, secure, comparable and even interoperable health data. This crisis has revealed the wide-ranging benefits of establishing a genuine European health data space. This new health data sharing space will: citizens to obtain, share and monitor their personal health data in all Member States, thereby strengthening the right conditions for the free movement of Europeans; health professionals to improve prevention, diagnosis and treatment, and to ensure safer and more effective care by avoiding breaks in pathways; researchers to access more (and more robust) health data for research and innovation while being less costly; industry to accelerate the development of new medicines and medical devices through this wider data sharing; policymakers and regulators to develop more evidence-based policies and more resilient health systems. In full respect of data protection, the European Union must swiftly exploit the enormous potential of the European Health Data Space to better prevent, diagnose and treat diseases in all Member States in an equal way.

Mr President, Commissioner, ladies and gentlemen, we have all become aware, throughout Europe, that the current model no longer guarantees us access to medicines, even essential medicines, in any situation. With the aim of the strategic autonomy that you support, Commissioner, a European law on critical medicines would serve our ambition to preserve, in equal rights, every European from a loss of opportunity in the face of the disease due to a lack of medicines. This law is to be drafted in close connection with the important revision of the European pharmaceutical legislation that we are embarking on today. Thus, with a European portal for traceability of medicines flows capable of enabling, in the event of shortages, a joint distribution of stocks between Member States, through joint purchases negotiated at European level, but also by the relocation of critical active ingredients to Europe, while moving towards decarbonised production in line with the Green Deal, by harmonising clinical trials and placing on the market, by the multiplication of ‘bio clusters’, innovation ecosystems in Europe and strong support for innovation and research, these texts should build a new medicine policy that is attractive for a sovereign, solidarity-based and sustainable Europe.

Mr President, Commissioner, ladies and gentlemen, asbestos is a long-term tragedy. For those who have been exposed, these are years of anxiety to fear the diagnosis of cancer. When the disease is finally diagnosed, tracing its origin is not easy, decades after exposure. The text we are about to vote on represents an important step in preventing occupational cancers by putting in place appropriate protective measures. And it is also a text that removes the derogations from medical monitoring and registration of exhibitions. From now on, all workers exposed, even sporadically, will be able to benefit from these essential provisions to establish the occupational origin of a disease. We owe these advances to Véronique Trillet-Lenoir, for me a long-time colleague in the field of oncology, to whom I too wish to pay tribute. We are taking up the torch to continue to build with rigour and determination an ambitious and social health Europe.