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Resounding success for EAPM round table
Yesterday (17 December) EAPM conducted a very successful virtual round table, ‘Forward together with innovation: Understanding the need and framing the discussion for Serology testing for SARS-CoV-2’. Comprising notable stakeholders and keynote speakers from across the health spectrum, the objective of the round table was to assess the factors, understand the need and frame the discussion for Serology testing for SARS-CoV-2 at a country level by engaging with experts.
Speaker included Bettina Borisch, Executive Director World Federation of Public Health Associations (WFPHA) (10 Minutes); Vicki Indenbaum, Laboratory expert working on sero-epidemiological Studies, World Health Organisation (10 minutes); Charles Price, Health security and vaccination Unit, European Commission; Stefania Boccia, Professor, Department of Health Sciences and Public Health, Università Cattolica del Sacro Cuore & Jean-Charles Clouet, Siemens
The round table concluded that a key target audience is decision-making (public health professionals, public health institutes, medical authorities as WHO Europe, and EMA) so as to understand the barriers and enablers so that serology testing in vaccination surveillance systems can be adopted.
EU4Health: MEPs reach deal with Council
The new EU health programme, EU4Health, worth €5.1 billion, will help to fix shortcomings exposed by COVID-19 and boost quality and resilience of EU health systems. Parliament negotiators agreed on a deal with member states to significantly step up the EU’s action in the health sector through a dedicated EU4Health Programm” as part of the EU’s recently agreed long-term budget.
The new programme will support actions in areas where the EU’s contribution will clearly be valuable, invest in health promotion and disease prevention measures and prepare European health systems to face future health threats. The COVID-19 crisis has highlighted many weaknesses in national health systems including their dependence on non-EU countries to supply medicines, medical devices as well as personal protective equipment.
The programme will therefore support actions, which foster the production, procurement and management of such crisis-relevant products in the EU in order to make them more available and affordable. Actions to develop medicinal products and medical devices that are less harmful for the environment are also eligible.
Health top of the bill for incoming Portuguese EU Presidency
Portugal is declaring as its aims helping to shift Europe out of the coronavirus and an ambitious broader programme on health, according to senior diplomat João Lança. Improving access to medicines; reinforcing the EU’s ability to respond to crises; and championing digital health will be the country’s three main approaches, as well as making forward progress on the European Health Union.
Vaccination campaigns begin across EU
Italy, Spain, Germany, Malta, Portugal and a number of other EU countries are set to begin their vaccination campaigns before the new year, on 27 December, after the regional drug regulator accelerated its approval process following the launch of immunization campaigns in the United States and Britain. The European Medicines Agency (EMA) said an expert panel would convene on Monday 21 December to evaluate the vaccine made by US company Pfizer and German partner BioNTech.
While EMA’s mandate is to issue recommendations on new medical treatments, the European Commission has the final say on approval and typically follows EMA’s advice. EMA said its expert meeting was brought forward after the companies had provided more data, as requested, and the EU Commission would fast-track its procedures to rule on approval “within days”.
Germany should start giving coronavirus shots 24 to 72 hours after the BioNTech/Pfizer vaccine gets EU approval and could begin as soon as Christmas, Health Minister Jens Spahn said. “On 27, 28 and 29 December vaccination will start across the EU,” Commission President Ursula von der Leyen tweeted. However, the Dutch government is facing criticism because it still hasn’t drawn up its vaccination plan. Health Minister Hugo de Jonge said the country’s vaccinations will begin on 8 January.
Merkel convinced of need for a European Health Union
The European Council welcomed the positive announcements on the development of effective vaccines against COVID-19 and the conclusion of advance purchase agreements by the Commission. German Chancellor Angela Merkel said that co-operation has improved since the start of the pandemic and that she was convinced of the need for a future European Health Union.Health has always been an area that has been jealously guarded by EU member states. While there has always been some degree of cooperation between states in this field, the pandemic demonstrated how the EU could help strengthen national responses.
The EU will now take forward proposals for a Health Union.The President of the European Commission, Ursula von der Leyen, said that the EU was working full speed on vaccine approval. However, she added that vaccinations and not vaccines saved lives and she called on all countries to finalize their preparations for the timely deployment and distribution of vaccines, including the development of national vaccination strategies, to ensure that vaccines are made available to people in the EU in good time and in a co-ordinated manner.
Gene therapy
And for those who want some excellent additional reading over the festive season, EAPM has released a paper on gene therapy, based on its recent policy discussion, ‘Propelling Health Care with Advanced Therapy Medicinal Products’. The paper is available here, and it covers specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data, and patient registries or standardization of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for Advanced Therapy Medicinal Products (ATMPs).
Italy prepares for Christmas lockdown
Italy is getting ready to impose another set of restrictive measures to apply over the Christmas break, Italian media reports. While the exact rules are still being debated, the idea would be to apply a uniform “red zone” over the entire country and restrict travel between regions. Some ministers are pushing for an even tougher line.
Regional Affairs Minister Francesco Boccia says everyone should have to spend Christmas “in their house” according to La Repubblica. Ministers were due to meet later today (18 December) and the official text of the rules is expected to be published tonight.
UK and EU agree deal on reciprocal health treatment in event of Brexit talks failure
Existing EU reciprocal health-care arrangements are tied to freedom of movement, and provide citizens of EU and EEA nations, as well as Switzerland, with the ability to access health and social care services while in another of those nations. Care accessed through these schemes is provided on the same terms as it would be for a resident of the nation providing the treatment, with its cost met by the recipient’s home country. Brexit could lead to significant changes in the UK’s existing reciprocal healthcare arrangements with the EU.
This will not just affect access to care for UK, EU and EEA citizens, but it could also significantly increase pressure on health and social care services and their funding. However, under a deal announced Thursday (17 December), Britain and the EU agreed a temporary, time-limited deal targeted at patients who need regular treatment for chronic conditions. It is intended to prevent disruption to treatments such as oxygen therapy or chemotherapy. The agreement, covering the European Economic Area and Switzerland, will last for a year, covering travel between 1 January and 31 December 2021.
And that is everything from EAPM for this week – do check our gene therapy paper, available here, have an excellent, safe weekend, and see you next week for the last EAPM updates of 2020.
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