<p>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).</p>

<p>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.</p>

EU Vaccine Strategy

ENVI - Exchange of views with Emer Cooke, Executive Director of the European Medicines Agency (EMA)

ENVI Committee - Exchange of views with Ms Emer Cooke, Executive Director of the European Medicines Agency (EMA)

EP Plenary session - European Medicines Agency

Vaccination campaign

Press point ' Relocation of the European Medicines Agency '

Milan for EMA puts public health first.

The Executive Director of the European Medicines Agency (EMA), Emer Cooke debates with the members of the Environment and Public Health Committee the latest developments in the COVID-19 vaccination campaign (including reviews, authorisations for paediatric use and boosters), as well as recent developments around COVID-19 therapeutics and the general epidemiological situation

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency (EMA) - ENVI Committee: Exchange of views

Members of the EP Committee on the Environment, Public Health and Food Safety exchange with Emer COOKE, Executive Director of the European Medicines Agency (EMA). Emer COOKE stressed that people will need to extend the protection againt COVID with a booster again, especially with the threat of the new variant Omicron. Some MEP's pointed out that citizens have the right to be informed and to have access to the clinical trial data.

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency (EMA): Extracts - ENVI Committee

Exchange of views with Emer COOKE, Executive Director of the European Medicines Agency (EMA) - ENVI Committee: Opening statements

During the plenary session (5-8 July 2021) of the European Parliament in Strasbourg, MEPs debate on European Medicines Agency.

European Medicines Agency: MEPs debate

During the plenary session (5-8 July 2021) of the European Parliament in Strasbourg, MEPs debate on European Medicines Agency: closing statement by Stella KYRIAKIDES, European Commissioner for Health and Food Safety.

European Medicines Agency: closing statement by Stella KYRIAKIDES, European Commissioner for Health and Food Safety

During the plenary session (5-8 July 2021) of the European Parliament in Strasbourg, MEPs debate on European Medicines Agency: opening statements by Nicolás GONZÁLEZ CASARES (S&D,ES), Rapporteur and by Stella KYRIAKIDES, European Commissioner for Health and Food Safety. This transcription is the result of an automatic process. Please check against delivery.

European Medicines Agency: opening statements by Nicolás GONZÁLEZ CASARES (S&D, ES), Rapporteur and by Stella KYRIAKIDES, European Commissioner for Health and Food Safety

Press conference prior to the debate in Plenary on a stronger role for the European Medicines Agency and extending its mandate to prepare for crises and manage medicinal products and medical devices, following lessons learned from the COVID-19 pandemic.

Press conference by Nicolás GONZÁLEZ CASARES (S&D, ES), rapporteur, on reinforcing the mandate of the European Medicines Agency

For a drug to be prescribed to a patient, it must first be rigorously tested for efficacy and safety and subsequently be approved by relevant authoritative bodies, such as the European Medicines Agency (EMA). However, the current framework of drug development is heavily ‘drug-focused’ rather than ‘patient-focused’. This means that the end users of the drug, the patients, are not generally placed at the centre of the drug development paradigm. Medical treatment is insufficiently personalised, especially when fighting cancer. In other words, achieving regulatory approval is seen as the ultimate goal, eclipsing somewhat the use of a drug in its real-world setting. This is not helped by the lack of regulatory demands or incentives for gathering such real world data. Restrictions: ©The material may not be edited and must be shown entirely.

European Medicines Agency

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