Az Európai Bizottság felülvizsgálta az Európai Unió gyógyszeripari szabályozását, és új lépésekre tett javaslatot 2023 első negyedévében. A kutatók és a jogalkotók számos hiányosságot tártak fel: az EU-n belül például nincs összehangolva, és gyakran több helyen is párhuzamosan folyik az egészségügyi kutatás és fejlesztés, nem átlátható a közpénzek felhasználása, illetve az ilyen ráfordítások nem állnak arányban a klinikai teljesítménnyel.

Új európai gyógyszerstratégia van születőben - magyar

European food safety policy aims are twofold: to protect human health and consumers’ interests, and to foster the smooth operation of the European single market.

The EU thus ensures that control standards are established and adhered to in the areas of feed and food-product hygiene, animal health, plant health and the prevention of food contamination from external substances. The Union also regulates labelling for food and feed products.

In the wake of a series of human food and animal feed crises, EU food safety policy underwent substantial reform in the early 2000s. The ‘Farm to Fork’ approach was defined, guaranteeing a high level of safety at all stages of the production and distribution process for all food products marketed within the EU, whether produced within the EU or imported from third countries.

Food safety

Vaccines are a key part of a long-term strategy to bring SARS-CoV-2 under control. It is essential to roll out vaccination rapidly to protect as many people as possible and to lower the opportunities for the virus to evolve further. Any vaccine must be authorised by the European Medicines Agency (EMA).

The European Commission has secured up to 4.4 billion doses of COVID-19 vaccines so far - and negotiations are underway for additional doses. However, countries are facing different challenges around the disinformation or vaccine acceptance. The European Parliament is trying to keep an eye on the purchase and safety of these vaccines. During June plenary the EP adopted a resolution calling for COVID-19 vaccine patent waiver. Parliament proposed negotiations start for a temporary waiver of the WTO TRIPS Agreement on patents to improve global access to affordable COVID-19-related medical products and to address global production constraints and supply shortages. The EP approved also the Digital Green Certificate to facilitate the safe free movement of citizens within the EU during the pandemic.

EU Vaccine Strategy

The EU Digital COVID Certificate aims to facilitate safe free movement inside the EU during the COVID-19 pandemic.The certificate should&nbsp;be available in either digital or paper format. It attests that a person has been vaccinated against coronavirus or has a recent negative test result or has recovered from the infection.

&nbsp;A common EU framework is&nbsp;allowing member states to issue certificates that will then be accepted in other EU countries. The EU Digital Covid Certificate regulation should be&nbsp;in place for 12 months. The certificate should&nbsp;not be a precondition to exercise the right to free movement and is&nbsp;not&nbsp;considered a travel document.

Member states should not impose additional travel restrictions in response to the COVID-19 pandemic, such as quarantine, self-isolation or testing, “unless they are necessary and proportionate to safeguard public health”. Member states must accept vaccination certificates issued in other member states for persons inoculated with a vaccine authorised for use in the EU by the European Medicines Agency (EMA).

It is&nbsp;up to the member states to decide whether they also accept vaccination certificates that have been authorised by other Member States following national authorisation procedures or for vaccines listed by the World Health Organisation (WHO) for emergency use. The Regulation entered&nbsp;into force on&nbsp;1 July 2021.
 Parliament and EU member states’ negotiators have agreed to keep the EU Digital COVID Certificate framework in place for another year, until June 2023

EU Digital COVID certificate

Virginijus Sinkevičius, born on 4 November 1990 in Vilnius, is a Lithuanian politician. Commissioner-designate for Environment, Oceans and Fisheries.

After the hearing by the Committee on Fisheries (PECH) and the Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament, the committees prepare an evaluation letter on the candidate.

Hearing of Virginijus SINKEVIČIUS, Commissioner-designate

Frans Timmermans, born on 6 May 1961 in Maastricht, is a Dutch politician. Timmermans is Executive Vice-President and Commissioner designate for European Green Deal.

After the hearing by the Committee on Environment, Public Health and Food Safety (ENVI) of the European Parliament, the committee prepares an evaluation letter on the candidate. Parliament is expected to vote on the new Commission as a whole on 23 October.

Hearing of Frans TIMMERMANS, Executive Vice-President-designate

Stella Kyriakides, born on 10 March 1956 in Nicosia, is a Cypriot psychologist and politician.

After the hearing by the Committee on Environment, Public Health and Food Safety (ENVI) of the European Parliament, the committee prepares an evaluation letter on the candidate. Parliament is expected to vote on the new Commission as a whole on 23 October.

Hearing of Stella KYRIAKIDES, Commissioner-designate, Health

Teresa RIBERA RODRÍGUEZ was the Third Deputy Spanish Prime Minister and Minister for the Ecological Transition and the Demographic Challenge. She is now Executive Vice-President-designate of the European Commission for a Clean, Just and Competitive Transition, for the von der Leyen Commission II.

Confirmation hearing of Teresa RIBERA RODRÍGUEZ, Executive Vice-President designate, Clean, Just and Competitive Transition

Stéphane Séjourné was a Member of the European Parliament from 2019 to 2024, Chair of the Renew Europe Group of the European Parliament in 2021 and French Minister for Europe and Foreign Affairs in 2024. He is now Executive Vice-President-designate of the European Commission for Prosperity and Industrial Strategy, for the von der Leyen Commission II.

Confirmation hearing of Stéphane SÉJOURNÉ, Executive VIce-President designate, Prosperity and Industrial Strategy

Wopke Hoekstra was Dutch Minister for Finance from 2017 to 2022, Dutch Deputy Prime Minister and Minister for Foreign Affairs from 2022 to 2023 and European Commissioner for Climate Action and acting Commissioner for Transport in the von der Leyen Commission I. He is now European Commissioner-designate for Climate, Net Zero and Clean Growth, for the von der Leyen Commission II.

Confirmation hearing of Wopke HOEKSTRA, Commissioner-designate for Climate, Net Zero and Clean Growth

Olivér Várhely was European Commissioner for Neighbourhood and Enlargement in the von der Leyen Commission I. He is now European Commissioner-designate for Health and Animal Welfare, for the von der Leyen Commission II.

Confirmation hearing of Olivér VÁRHELYI, Commissioner-designated, Health and Animal Welfare

Hadja Lahbib was Belgian Minister for Foreign Affairs, European Affairs and Foreign Trade, and the Federal Cultural Institutions since 2022. She is now European Commissioner-designate for Preparedness and Crisis Management, and European Commissioner-designate for Equality, for the von der Leyen Commission II.

Confirmation hearing of Hadja LAHBIB, Commissioner-designate, Preparedness and Crisis Management

Jessika Roswall was Swedish Minister for EU Affairs since 2022. She is now European Commissioner-designate for Environment, Water Resilience and a Competitive Circular Economy, for the von der Leyen Commission II.

Confirmation hearing of Jessika ROSWALL, Commissioner-designate, Environment, Water Resilience and a Competitive Circular Economy

ENVI IMCO - Trilogue on Green Claims Directive

ENVI - public hearing on ' The way to a European Water Resilience Strategy - An EU Blue Deal '

ENVI  Extraordinary meeting - Exchange of views with Paulina Hennig-Kloska, Minister of Climate and Environment, Polish Council Presidency

ENVI AGRI joint committees - Public Hearing - Forest Monitoring for resilient European Forests

ENVI - Bilateral meeting with the Polish Presidency of the Council

IMCO - Bilateral meeting with the Polish Presidency of the Council

ENVI - Presentation of the responsibilities and activities of the following agencies under ENVI competence - Exchange of views with Dr. Yukiko Nakatani, WHO Assistant Director-General, on Antimicrobial Resistance

ENVI - Presentation of the responsibilities and activities of the following agencies under ENVI competence -  Presentation of the responsibilities and activities of the following agencies under ENVI competence

AGRI ENVI joint committee meeting

ENVI ECON ITRE -  Confirmation hearing of Teresa RIBERA RODRÍGUEZ, European Commissioner-designate for Clean, Just and Competitive Transition - Press point

ENVI ECON ITRE -  Confirmation hearing of Teresa RIBERA RODRÍGUEZ, European Commissioner-designate for Clean, Just and Competitive Transition

ITRE IMCO ENVI ECON -  Confirmation hearing of Stéphane SÉJOURNÉ, European Commissioner-designate for Prosperity and Industrial Strategy - Press point

ITRE IMCO ENVI ECON -  Confirmation hearing of Stéphane SÉJOURNÉ, European Commissioner-designate for Prosperity and Industrial Strategy

ENVI ITRE ECON - Confirmation hearing of Wopke Bastiaan HOEKSTRA, European Commissioner-designate for Climate, Net-Zero and Clean Growth.- Press point

ENVI ITRE ECON - Confirmation hearing of Wopke Bastiaan HOEKSTRA, European Commissioner-designate for Climate, Net-Zero and Clean Growth

ENVI AGRI -  Confirmation hearing of Olivér VÁRHELYI, European Commissioner-designate for Health and Animal Welfare

DEVE FEMM ENVI - Confirmation hearing of Hadja LAHBIB, European Commissioner-designate for Preparedness and Crisis Management Equality - Press Point

DEVE FEMM ENVI - Confirmation hearing of Hadja LAHBIB, European Commissioner-designate for Preparedness and Crisis Management Equality

Jytte GUTELAND (S&D, SE), rapporteur and Pascal CANFIN (Renew, FR), ENVI Chair, give a press confenrece following the trilogue on Climate law, in the European Parliament in Brussels.

Press conference by Jytte GUTELAND (S&D, SE), rapporteur and Pascal CANFIN (Renew, FR), ENVI Chair following the trilogue on Climate law

Views of the trilogue meeting (20/04) and statements by Jytte GUTELAND (S&D, SE), rapporteur, and Pascal CANFIN (Renew, FR), ENVI Chair, following the agreement reached on the EU’s climate law. The new legislation increases the EU’s 2030 emissions reductions target from 40% to at least 55%, while boosting the contribution from removals that can bring the target to 57%.

Outcome of the trilogue on Climate law: views of the meeting, statement by Jytte GUTELAND (S&D, SE), rapporteur, and Pascal CANFIN (Renew, FR), ENVI Chair, and extracts of the press conference

Members of the Environment, Public Health and Food Safety (ENVI) Committee had an exchange of views on a new legislation for a faster authorisation procedure for COVID-19 vaccines that have already received EU authorisation, but which are being adapted to be effective against variants of the virus.

Quicker authorization procedure for adapted COVID-19 vaccines: exchange of views and statement by Cristian-Silviu BUŞOI (EPP, RO), Chair of the EP Committee on Industry, Research and Energy

Emer COOKE, European Medicines Agency (EMA) Executive Director update MEPs from the Environment, Public Health and Food Security Committee on the state of play in the evaluation and market authorisation of vaccines against COVID-19 and the next steps. And Members of the Budgets Control Committee and the Commission’s Director-General for Health and Food Safety (SANTE), Sandra GALLINA, discuss the current state of the EU’s advance purchase agreement on vaccines against COVID-19.

Update of purchase, evaluation and authorization of COVID-19 vaccines: extracts from the exchanges of views with Sandra GALLINA, Director-General of DG SANTE (CONT) and with Emer COOKE, EMA Executive Director (ENVI)

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) exchange views on the update of evaluation and authorization of COVID-19 vaccines, with Emer COOKE, Executive Director of the European Medicines Agency's (EMA), in the European Parliament in Brussels. Opening statements by Pascal CANFIN, ENVI Chair, and Emer COOKE. This transcription speech is the result of an automatic process. Check against delivery.

Update of evaluation and authorization of COVID-19 vaccines - Exchange of views with Emer COOKE, EMA Executive Director: opening statements by Pascal CANFIN, ENVI Chair, and Emer COOKE

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) exchange views on the update of evaluation and authorization of COVID-19 vaccines, with Emer COOKE, Executive Director of the European Medicines Agency's (EMA), in the European Parliament in Brussels. Questions & answers

Update of evaluation and authorization of COVID-19 vaccines - Exchange of views with Emer COOKE, EMA Executive Director: questions & answers

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) exchange views on the update of evaluation and authorization of COVID-19 vaccines, with Emer COOKE, Executive Director of the European Medicines Agency's (EMA), in the European Parliament in Brussels. Closing statements by Pascal CANFIN, ENVI Chair, and Emer COOKE.

Update of evaluation and authorization of COVID-19 vaccines - Exchange of views with Emer COOKE, EMA Executive Director: closing statements by Pascal CANFIN, ENVI Chair, and Emer COOKE

The Environment, Public Health and Food Security Committee (ENVI) hold a debate on COVID-19 variants and how effective vaccines are against them with representatives from the European Medicine Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO). Following this meeting, Pascal CANFIN (RE, FR), ENVI Chair, gives a statement on a faster authorisation process for updated vaccines and on the role of vaccination certificates.

COVID-19 variants and the vaccines' efficacy: statement by Pascal CANFIN (Renew, FR), ENVI Chair

Members of the EP Committee on Environment, Public Health and Food Safety exchange their views on COVID-19 variants and the vaccines' efficacy. Opening statements by Pascal CANFIN (Renew, FR), ENVI Chair, Marco CAVALERI, Head of Biological health threats and vaccines strategy and Chair of the COVID-19 Emergency Task Force, EMA, Bruno CIANCO, Head of Surveillance section, ECDC and Katherine O’BRIEN, Department of Immunization, Vaccines and Biologicals Director, World Health Organization, (WHO)

Exchange of views on COVID-19 variants and the vaccines' efficacy: opening statements by Pascal CANFIN (Renew, FR), ENVI Chair, Marco CAVALERI (EMA), Bruno CIANCO (ECDC) and Katherine O’BRIEN (WHO)

Members of the EP Committee on Environment, Public Health and Food Safety discuss the HERA Incubator - Anticipating the threat of COVID-19 variants. MEPs debate. Questions and answers

HERA Incubator - Anticipating the threat of COVID-19 variants: MEPs debate. Questions and answers

Members of the EP Committee on Environment, Public Health and Food Safety exchange their views on COVID19 variants and the vaccines' efficacy. MEPs debate. Questions and answers

Exchange of views on COVID19 variants and the vaccines' efficacy: MEPs debate. Questions and answers

Members of the EP Committee on Environment, Public Health and Food Safety discuss the HERA Incubator - Anticipating the threat of COVID-19 variants. Opening statement by Commission. This transcription speech is the result of an automatic process. Check against delivery.

HERA Incubator - Anticipating the threat of COVID-19 variants: Opening statement by Pierre DELSAUX, Deputy Director General DG SANTE, European Commission

During the plenary session of the European Parliament in Brussels (08-11 March 2021), MEPs participate in a joint debate on the European Semester: opening remark by Valdis DOMBROVSKIS, Executive Vice-President of the European Commission in charge of an Economy that works for People, and Commissioner for Trade. Opening statements by Markus FERBER (EPP, DE), Lina GÁLVEZ MUÑOZ (S&D, ES), rapporteurs, Margarida MARQUES (S&D, PT), (BUDG); Nils UŠAKOVS (S&D, LV) BUDG, Ana Paula ZACARIAS, Portuguese Presidency, President in office of the European Council, and Valdis DOMBROVSKIS, Executive Vice-President of the European Commission in charge of an Economy that works for People, and Commissioner for Trade, and Nicolas SCHMIT, European Commissioner for Jobs and Social Rights, Pascal CANFIN (Renew, FR) (ENVI) and Victor NEGRESCU (S&D, RO) (CULT). This transcription speech is the result of an automatic process. Check against delivery.

European Semester: Opening statements

Members of the Public Health (ENVI) and Industry (ITRE) committees debate how to increase capacity and improve delivery of COVID-19 vaccines with pharmaceutical companies (AstraZeneca, Moderna, CureVac, Novavax, Johnson & Johnson, Pfizer Group and Sanofi Pasteur) and Commissioners Thierry Breton and Stella Kyriakides. Statements of MEPs : CANFIN Pascal (Renew, FR), BUŞOI Cristian-Silviu (EPP, RO), GUTELAND Jytte (S&D, SE), BALDASSARRE Simona (ID, IT). Statements of CEOs of pharmaceutical companies : SORIOT Pascal, CEO AstraZeneca, BANCEL Stéphane, CEO Moderna, HAAS Franz-Werner, CEO Curevac, ERCK Stan, CEO Novavax, HWANG Angela, CEO Pfizer, STOFFELS Paul, CEO Johnson & Johnson, TRIOMPHE Thomas, CEO Sanofi.

How to increase the capacity of COVID 19 vaccine production and improve delivery: extracts from the Joint ENVI-ITRE hearing

Statements by Pascal CANFIN (Renew, FR), ENVI chair, and by Cristian-Silviu BUŞOI (EPP, RO), ITRE Chair, following the exchange of views with CEOs of the pharmaceutical industry on COVID 19 vaccine production and delivery.

COVID 19 vaccine production and delivery: statements by Pascal CANFIN (Renew, FR) ENVI chair, and Cristian-Silviu BUŞOI (EPP, RO), ITRE Chair

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) and the Committee on Industry, Research and Energy (ITRE) have a joint hearing on "How to increase the capacity of COVID 19 vaccine production and improve delivery". Exchange of views with CEOs of the pharmaceutical industry on COVID 19 (Corona) vaccine production and delivery. Closing remarks by Thierry BRETON, European Commissioner for Internal Market.

Joint ENVI - ITRE Hearing Joint hearing of the ENVI and ITRE Committee - "How to increase the capacity of COVID 19 vaccine production and improve delivery": Statement by Thierry BRETON, European Commissioner for Internal Market

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) and the Committee on Industry, Research and Energy (ITRE) have a joint hearing on "How to increase the capacity of COVID 19 vaccine production and improve delivery". Session 2- Presentations by Paul STOFFELS, Vice Chair of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, Angela HWANG, President Global Biopharma, Pfizer Group, accompanied by Germain MORIN, VP Vaccines Supply Chain, Thomas TRIOMPHE, Executive Vice-President, Head of Sanofi Pasteur, Suerie MOON, Co-Director, Global Health Centre, Graduate Institute of International and Development Studies, Geneva.

Joint hearing of the ENVI and ITRE Committee - "How to increase the capacity of COVID 19 vaccine production and improve delivery": Session 2 - CEOs of the pharmaceutical industry

Members of the Committee on the Environment, Public Health and Food Safety (ENVI) and the Committee on Industry, Research and Energy (ITRE) have a joint hearing on "How to increase the capacity of COVID 19 vaccine production and improve delivery". Session 1- Presentations by Pascal SORIOT, Chief Executive Officer, AstraZeneca, Stéphane BANCEL, Chief Executive Officer, Moderna, Franz-Werner HAAS, Chief Executive Officer, CureVac, accompanied by Antony BLANC, Chief Business Officer, Stan ERCK, President & Chief Executive Officer, Novavax.

Joint hearing of the ENVI and ITRE Committee - "How to increase the capacity of COVID 19 vaccine production and improve delivery": Session 1 - CEOs of the pharmaceutical industry

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