Question for Written Answer

Total Page:16

File Type:pdf, Size:1020Kb

Question for Written Answer Question for written answer E-006170/2020 to the Commission Rule 138 Damian Boeselager (Verts/ALE), Tilly Metz (Verts/ALE), Kim Van Sparrentak (Verts/ALE), Michèle Rivasi (Verts/ALE), Rasmus Andresen (Verts/ALE), Jutta Paulus (Verts/ALE), Margrete Auken (Verts/ALE) Subject: Lack of human resources at the EMA for the rapid evaluation of COVID-19 vaccines and therapeutics The second wave of the COVID-19 pandemic continues to cause havoc across the EU, affecting both its economies and healthcare systems. It is clear that the national measures taken to try to contain the spread of the disease have had limited success. Meanwhile, COVID-19 vaccines are being developed around the world and a few of them have entered phase III clinical trials. Applications for the authorisation of the most advanced vaccines have started to reach the European Medicines Agency (EMA). It is important to authorise novel vaccines and therapeutics as quickly as possible. However, the required evaluations must be thorough – not only to ensure the safety and efficacy of such vaccines and therapeutics, but more importantly, to reassure the public and avoid a potential backlash. Unfortunately, worrying information1 has come to light about the lack of human resources at the EMA – 25 % of its staff chose not to move from London to Amsterdam earlier this year. Additionally, the EMA is reported to have lost direct access to experts belonging to the UK’s Medicines and Healthcare products Regulatory Agency. 1. Does the Commission consider that the EMA has the resources it needs to fully assess novel treatments and vaccines against COVID-19 and to prevent any undue delays in their evaluation? 2. If not, what steps will it take to tackle this situation? 1 Source: Sciencebusiness https://sciencebusiness.net/live-blog/live-blog-rd-response-covid-19-pandemic, news report published on 5th October 2020. PE661.295v01-00.
Recommended publications
  • Letter to the Commission Regarding Printers Voluntary Agreement
    Brussels, Wednesday 26th of May To: Mr Virginijus Sinkevičius, European Commissioner for Environment, Oceans and Fisheries Mr Thierry Breton, European Commissioner for the Internal Market Mr Frans Timmermans, European Commission Executive Vice-President for the European Green Deal We urge the European Commission to keep its promises and propose a regulatory measure addressing the durability and repairability of printers as well as the reusability of cartridges as part of the forthcoming Circular Electronics Initiative. And we ask that the Commission rejects the proposed voluntary agreement drafted by manufacturers. The Commission's flagship Circular Economy Action Plan, adopted in March 2020, has set out to address the entire life cycle of products and tackle their premature obsolescence notably by promoting the right to repair for ICT products. In addition to mobile phones, laptops and tablets, the Plan has rightfully identified printers as a particularly wasteful product category, and has included a commitment to tackle them by means of a dedicated regulatory instrument “unless the sector reaches an ambitious voluntary agreement” by September 2020. Nearly one year later, the discussions on the voluntary agreement have not yielded any tangible results. Voluntary approaches clearly do not work. We need strong regulatory action now. We are extremely concerned by this situation. Not only because of the negative impacts of short-lived printers on the environment and on consumers but also because we are witnessing promises made being walked back on. Printers are one of the most iconic examples of premature obsolescence. Our analysis of printers in use today suggests that over 80% of them have been in use for less than 3 years, and only about 4% have been in use for 5 years or longer.
    [Show full text]
  • 16.10.2020 A8-0200/1343 Amendment 1343 Bas Eickhout, Martin Häusling, Tilly Metz, Francisco Guerreiro, Ernest Urtasun, Caroline
    16.10.2020 A8-0200/1343 Amendment 1343 Bas Eickhout, Martin Häusling, Tilly Metz, Francisco Guerreiro, Ernest Urtasun, Caroline Roose, Thomas Waitz, Yannick Jadot, Marie Toussaint, Sylwia Spurek, Gwendoline Delbos-Corfield, Pär Holmgren, Alice Kuhnke, Jakop G. Dalunde, Manuela Ripa, Saskia Bricmont, Sarah Wiener, Jordi Solé, Diana Riba i Giner on behalf of the Verts/ALE Group Michal Wiezik, Marisa Matias, José Gusmão, Eugenia Rodríguez Palop, Silvia Modig, Anja Hazekamp, Eleonora Evi, Ignazio Corrao, Piernicola Pedicini, Rosa D'Amato, Mick Wallace, Clare Daly, Mario Furore, Younous Omarjee, Manuel Bompard Report A8-0200/2019 Peter Jahr Common agricultural policy - support for strategic plans to be drawn up by Member States and financed by the EAGF and by the EAFRD (COM(2018)0392 – C8-0248/2018 – 2018/0216(COD)) Proposal for a regulation Article 3 – paragraph 1 – point f a (new) Text proposed by the Commission Amendment (f a) 'concentrated animal feeding operation' means a livestock holding rearing animals at a density beyond that permitted by the area and natural resources, or carrying capacity, of the holding, or in the case of cattle and ruminants, where the animals are without access to grazing or without the appropriate amount of supporting forage hectares to support pasture- or grassland- based grazing or foraging; Or. en AM\P8_AMA(2019)0200(1343-1352)EN.docx PE658.380v01-00 EN United in diversityEN 16.10.2020 A8-0200/1344 Amendment 1344 Bas Eickhout, Martin Häusling, Tilly Metz, Francisco Guerreiro, Ernest Urtasun, Caroline Roose, Thomas Waitz, Yannick Jadot, Marie Toussaint, Sylwia Spurek, Gwendoline Delbos-Corfield, Pär Holmgren, Alice Kuhnke, Jakop G.
    [Show full text]
  • Members of the European Parliament Mr Janusz
    Members of the European Parliament Mr Janusz Wojciechowski Commissioner for Agriculture European Commission Rue de la Loi 200 B-1049 Bruxelles Mr Virginijus Sinkevičius Commissioner for Environment, Oceans and Fisheries European Commission Rue de la Loi 200 B-1049 Bruxelles Brussels, 11 November 2020 Subject: Deforestation and illegal logging of Romania’s primary forests Dear Commissioners, we, the undersigned Members of the European Parliament, are addressing you to express our deep concerns about massive violations of the protection of Natura 2000 areas, primary and ancient forests and UNESCO World Heritage Sites in Romania. In Romania, deforestation caused by illegal logging is continuing on an alarming scale. It threatens the last and irreplaceable primary forests in the EU, which are more crucial than ever in the fight against climate change and for the preservation of biodiversity. According to expert estimates, up to two thirds of the EU’s remaining primary forests are located in Romania. Largely untouched areas in the Romanian Carpathian Mountains and the Făgăraș Mountains have survived until today – a European if not global heritage of invaluable ecological value. Some of these forests are also included in the List of World Heritage Sites UNESCO.1 Now, ruthless greed and large-scale corruption are seriously endangering these European natural treasures and the time for protective measures is running out. If no immediate action is taken, the still existing forests will soon be lost forever. Since the launch of the European Commission’s infringement procedure against Romania on 12 February 2020 for failing to establish effective measures against illegal logging2, thousands more hectares were destroyed.
    [Show full text]
  • European Alliance for a Green Recovery
    Launch of the European alliance for a Green Recovery Press Release Under embargo until 14/04 7:00am At the initiative of Pascal Canfin, Chair of the Environment Committee at the European Parliament, 180 political decision-makers, business leaders, trade unions, NGOs, and think tanks have come together to form a European alliance for a Green Recovery. In the face of the coronavirus crisis, the biggest challenge Europe has faced in peacetime, with devastating consequences and a shock to the economy tougher than the 2008 crisis, Ministers from 11 countries, 79 cross-party MEPs from 17 Member States, 37 CEOs, 28 business associations representing 10 different sectors, trade union confederation representing members from 90 national trade union organisations and 10 trade union federations, 7 NGOs and 6 think tanks, have committed to working together to create, support and implement solutions to prepare our economies for the world of tomorrow. This first pan-European call for mobilisation on post-crisis green investment packages will work to build the recovery and transformation plans which enshrine the fight against climate change and biodiversity as a key pillar of the economic strategy. Sharing the belief that the economic recovery will only come with massive investments to protect and create jobs and to support all companies, regions and sectors that have suffered from the economy coming to a sudden halt, the alliance commits to contribute to the post-crisis investment decisions needed to reboot and reboost our economy. Covid-19 will not make climate change and nature degradation go away. The fight against this crisis will not be won without a solid economic response.
    [Show full text]
  • Brussels, 21 January 2020 Dear President of the European
    Brussels, 21 January 2020 Dear President of the European Parliament, David Sassoli, Dear President of the Spanish Government, Pedro Sánchez, On 26 May 2019, EU citizens elected their 751 representatives in the European Parliament. One of them was Oriol Junqueras, who was elected by over one million votes. Mr Junqueras was then and currently is imprisoned, deprived of his freedom for 810 days, for organising a referendum on self- determination. In the context of criminal proceedings arising from an affair of undeniably political nature, on 19 December 2019 the Court of Justice of the European Union clarified that the status of Mr Junqueras as a Member of the European Parliament arises solely from his election and was acquired by virtue of the official declaration of those results by the competent national authority, a circumstance that occurred on 13 June 2019. The Court also stressed that, once the electoral results are declared, all Members enjoy immunity as provided for under EU law. Despite this situation, the Spanish judicial authorities prevented Mr Junqueras from attending Parliament's inaugural session in Strasbourg on 2 July 2019 and insist in their position when they prevent him from attending January’s session. If his rights had been respected by the Spanish courts, Mr Junqueras should have been free since last June. Respect for the European institutions is what makes the European Union project strong. Thus, by preventing Mr Junqueras from performing his functions as a Member of the European Parliament in representation of his constituents, despite the ruling of the CJEU, the Spanish Supreme Court is attacking upon the fundamental values of the European project.
    [Show full text]
  • Brussels, 18Th September 2020 UNESCO Intergovernmental
    Brussels, 18th September 2020 UNESCO Intergovernmental Committee for the Safeguarding of the Intangible Cultural Heritage Place de Fontenoy 7 75007 Paris FRANCE Subject: Opposition to the classification of Bullfighting as Intangible Cultural Heritage in Need of Urgent Safeguarding Dear Director-General of UNESCO, Ms. Audrey Azoulay, It came to our attention that an application to consider bullfighting as part of UNESCO’s Intangible Cultural Heritage in Need of Urgent Safeguarding was submitted by the International Tauromaquia (Bullfighting) Association on 7 June 2020. In accordance with the provisions of the 2003 Convention, the application will most likely be discussed by the Bureau of the Intergovernmental Committee at its meeting in October this year. We recognize and fully support UNESCO’s vital mission of seeking to build peace through international cooperation in Education, the Sciences and Culture. Nevertheless, just like expressed in UNESCO’s mandate, we also agree that peace must be built upon the intellectual and moral solidarity of humanity. It is our view that intellectual and moral solidary of humanity necessarily encompasses solidarity towards all living beings. Bullfighting is an activity that depicts and glorifies abuse, violence and cruelty towards animals for the sake of the entertainment of a limited number of individuals around the globe. In addition to the brutality experienced by the animals involved, bullfighting also has serious mental repercussions on those of young age that are habituated to witness it and, consequently, not educated with the desirable ideals of peace and kindness towards all living beings. This way, from our perspective, bullfighting has no place in UNESCO’s Intangible Cultural Heritage in Need of Urgent Safeguarding.
    [Show full text]
  • Greens/EFA Group - Distribution of Seats in EP Parliamentary Committees
    Seats in Committees Update 04.02.2021 Greens/EFA group - Distribution of Seats in EP Parliamentary Committees Parliamentary Committees Seats FULL Members SUBSTITUTE Members Foreign Affairs (AFET) Marketa GREGOROVÁ Alviina ALAMETSÄ Pierrette HERZBERGER- Reinhard BÜTIKOFER FOFANA Viola VON CRAMON Sergey LAGODINSKY 7 Jordi SOLE Katrin LANGENSIEPEN Tineke STRIK Hannah NEUMANN Thomas WAITZ Mounir SATOURI Salima YENBOU Ernest URTASUN Agriculture (AGRI) Claude GRUFFAT Benoit BITEAU 5 Anna DEPARNAY- Francisco GUERREIRO GRUNENBERG Martin HÄUSLING Pär HOLMGREN Bronis ROPĖ Tilly METZ Sarah WIENER Thomas WAITZ Budgets (BUDG) Rasmus ANDRESEN Damien BOESELAGER 4 David CORMAND Henrike HAHN Alexandra GEESE Monika VANA Francisco GUERREIRO Vacant Culture & Education (CULT) Romeo FRANZ Marcel KOLAJA 3 Niklas NIENASS Diana RIBA Salima YENBOU Vacant Development (DEVE) Pierrette HERZBERGER- Alviina ALAMETSÄ FOFANA Benoit BITEAU 3 Erik MARQUARDT Caroline ROOSE Michelle RIVASI Economic & Monetary Affairs Sven GIEGOLD Damien CARÊME (ECON) Claude GRUFFAT Karima DELLI Stasys JAKELIŪNAS Bas EICKHOUT 7 Philippe LAMBERTS Henrike HAHN Kira PETER-HANSEN Ville NIINISTÖ Ernest URTASUN Mikulas PEKSA Piernicola PEDICINI Vacant Committee seats - UPDATE 30.9.20 Employment & Social Affairs Kira PETER-HANSEN Romeo FRANZ 4 (EMPL) Katrin LANGENSIEPEN Terry REINTKE Mounir SATOURI Kim VAN SPARRENTAK Tatjana ŽDANOKA Sara MATTHIEU Environment, Public Health & Margarete AUKEN Michael BLOSS Food safety (ENVI) Bas EICKHOUT Manuela RIPA Pär HOLMGREN Sven GIEGOLD Yannick JADOT Martin HÄUSLING
    [Show full text]
  • A Look at the New European Parliament Page 1 INTERNATIONAL TRADE COMMITTEE (INTA)
    THE NEW EUROPEAN PARLIAMENT KEY COMMITTEE COMPOSITION 31 JULY 2019 INTRODUCTION After several marathon sessions, the European Council agreed on the line-up for the EU “top jobs” on 2 July 2019. The deal, which notably saw German Defence Minister Ursula von der Leyen (CDU, EPP) surprisingly designated as the next European Commission (EC) President, meant that the European Parliament (EP) could proceed with the election of its own leadership on 3 July. The EPP and Renew Europe (formerly ALDE) groups, in line with the agreement, did not present candidates for the EP President. As such, the vote pitted the S&D’s David-Maria Sassoli (IT) against two former Spitzenkandidaten – Ska Keller (DE) of the Greens and Jan Zahradil (CZ) of the ACRE/ECR, alongside placeholder candidate Sira Rego (ES) of GUE. Sassoli was elected President for the first half of the 2019 – 2024 mandate, while the EPP (presumably EPP Spitzenkandidat Manfred Weber) would take the reins from January 2022. The vote was largely seen as a formality and a demonstration of the three largest Groups’ capacity to govern. However, Zahradil received almost 100 votes (more than the total votes of the ECR group), and Keller received almost twice as many votes as there are Greens/EFA MEPs. This forced a second round in which Sassoli was narrowly elected with just 11 more than the necessary simple majority. Close to 12% of MEPs did not cast a ballot. MEPs also elected 14 Vice-Presidents (VPs): Mairead McGuinness (EPP, IE), Pedro Silva Pereira (S&D, PT), Rainer Wieland (EPP, DE), Katarina Barley (S&D, DE), Othmar Karas (EPP, AT), Ewa Kopacz (EPP, PL), Klara Dobrev (S&D, HU), Dita Charanzová (RE, CZ), Nicola Beer (RE, DE), Lívia Járóka (EPP, HU) and Heidi Hautala (Greens/EFA, FI) were elected in the first ballot, while Marcel Kolaja (Greens/EFA, CZ), Dimitrios Papadimoulis (GUE/NGL, EL) and Fabio Massimo Castaldo (NI, IT) needed the second round.
    [Show full text]
  • Brussels, 24 February 2021
    Brussels, 24 February 2021 Declaration from Members of the European Parliament to urge the Commission and Member States not to block the TRIPS waiver at the WTO and to support global access to COVID-19 vaccines We, Members of the European Parliament, urge the European Commission and the European Council to review their opposition to the TRIPS waiver proposal at the World Trade Organisation (WTO), which serves to enable greater access to affordable COVID-19 health technologies, including vaccines, in particular for developing and middle income countries. This call comes in view of the European Council meeting of 25 February 2021 and the crucial decision to be made by all Member States at the WTO General Council on 1-2 March 2021. Since the beginning of the pandemic, the need to ensure global open access to COVID-19 health technologies and to rapidly scale up their manufacturing and supply has been widely acknowledged. However, despite efforts and statements made by the European Commission and several heads of state in support of treating COVID-19 medical products as global public goods, this has not yet translated into actionable realities. In this context, the EU’s open opposition to the TRIPS waiver risks exacerbating a dangerous North-South divide when it comes to affordable access to COVID-19 diagnostics, personal protective equipment, treatments and vaccines. The WTO decision on a potential waiver offers a crucial and much-needed act of effective solidarity, as it is an important step towards increasing local production in partner countries and, ultimately, suppressing this pandemic on a global scale.
    [Show full text]
  • Brussels, 17 September 2020 Dear Prime Minister Stefan Löfven, Dear
    Brussels, 17 September 2020 Dear Prime Minister Stefan Löfven, Dear Deputy Prime Minister and Minister for Environment and Climate Isabella Lövin, We, Members of the European Parliament, are writing to ask the Swedish government to stop the expansion of the Preemraff oil refinery in Lysekil. As we have been made aware, it is now in the hands and power of your government to stop this huge fossil fuel project, locking our societies into further fossil fuel dependency. The message from scientists and the global environmental movement is unambiguous: Fossil fuels are not the future. If your government would grant Preemraff permission to expand, the refinery’s emissions would increase by 1 million tons of carbon dioxide per year, making it Sweden’s single biggest source of carbon dioxide emissions. As you are well aware, climate change is one of the most pressing issues of our time. Several parliaments around the world, including the European Parliament, have declared a climate urgency. A global youth movement, spearheaded by Swedish activist Greta Thunberg, is calling for an immediate, radical change to fight the global warming of the planet. Two years ago, the Swedish Climate Act was passed in the parliament, obliging the government’s climate policy to be aligned with the climate targets leading to zero net greenhouse gas emissions by 2045 and to negative net emissions after 2045. In your annual government declaration, on September 8, you stated that ”We are the leading nation in the world fighting climate change.” We recognize the international voice and the important work done by the Swedish government to counteract climate change, and we welcome Sweden’s ambition to be a model nation in promoting and implementing progressive climate policies.
    [Show full text]
  • Brussels, 23Rd April 2021 Dear Commissioner Johansson, Dear
    Brussels, 23rd April 2021 Dear Commissioner Johansson, Dear Vice-President Schinas, Since the opening of the new Mavrovouni camp in Lesbos in September 2020, several concerns have been raised over the risk of lead poisoning in a camp built partially on top of a repurposed military firing range.1 The Greek Government is aware of this risk since results of testing conducted in December 2020 confirmed lead contamination in parts of the Mavrovouni camp which currently house around 6,000 migrants and asylum seekers. It is well known that pregnant women and children are those most at risk when living on and playing with soil and dust contaminated by lead. On January 27, 2021, the Greek government published the results2 of limited soil testing that were conducted by the Greek Institute of Geology and Mineral Exploration (EAGME) in November 2020. 12 samples were taken in the camp and only 3 samples were taken from the area of the camp most at risk: the shooting range. No comprehensive testing has taken place assessing the risks for people living in the camp. These results were examined by two environmental and one medical expert specialised in lead consulted by Human Rights Watch who said that the reported testing was not sufficient in scope to fully assess the extent and severity of lead contamination at the Mavrovouni camp. Moreover, they reported that the methodology used by the EAGME was not clearly described.3 Experts were also concerned that wrong standards have been applied to some of the test results. According to the results of the testing, elevated lead levels were found in two samples: “MAV- 1” (with very elevated lead levels of 2,233 mg lead/soil) and “MAV-12” (with elevated lead levels of 330 mg lead/kg soil).
    [Show full text]
  • 3.2.2021 A9-0008/1 Amendment 1 Margrete Auken, Mick Wallace
    3.2.2021 A9-0008/1 Amendment 1 Margrete Auken, Mick Wallace, François Alfonsi, Rasmus Andresen, Marc Angel, Konstantinos Arvanitis, Pernando Barrena Arza, Malin Björk, Michael Bloss, Manuel Bompard, Saskia Bricmont, Delara Burkhardt, Reinhard Bütikofer, Anna Cavazzini, David Cormand, Ignazio Corrao, Ciarán Cuffe, Rosa D’Amato, Jakop G. Dalunde, Clare Daly, Anna Deparnay-Grunenberg, Bas Eickhout, Cornelia Ernst, Eleonora Evi, Laura Ferrara, João Ferreira, Daniel Freund, Niels Fuglsang, Alexis Georgoulis, Sven Giegold, Francisco Guerreiro, José Gusmão, Henrike Hahn, Heidi Hautala, Anja Hazekamp, Pär Holmgren, Yannick Jadot, Łukasz Kohut, Petros Kokkalis, Stelios Kouloglou, Alice Kuhnke, Sergey Lagodinsky, Katrin Langensiepen, Chris MacManus, Marisa Matias, Sara Matthieu, Karen Melchior, Silvia Modig, Niklas Nienaß, Ville Niinistö, Grace O’Sullivan, Dimitrios Papadimoulis, Jutta Paulus, Piernicola Pedicini, Sandra Pereira, Kira Marie Peter-Hansen, Morten Petersen, Manu Pineda, Sira Rego, Manuela Ripa, Eugenia Rodríguez Palop, Caroline Roose, Mounir Satouri, Christel Schaldemose, Andreas Schieder, Ivan Vilibor Sinčić, Miguel Urbán Crespo, Monika Vana, Idoia Villanueva Ruiz, Nikolaj Villumsen, Marianne Vind, Sarah Wiener, Michal Wiezik, Tiemo Wölken, Salima Yenbou Report A9-0008/2021 Jan Huitema New Circular Economy Action Plan (2020/2077(INI)) Motion for a resolution Paragraph 119 Motion for a resolution Amendment 119. Underlines the importance of 119. Underlines the role that Carbon Capture Storage and Utilisation environmentally safe Carbon
    [Show full text]