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European Alliance for Personalised Medicine

EAPM: EU pushes pharma strategy, COVID health pass en route

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Welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week – among other issues, we have news on the EU’s pharma strategy, COVID-19 rapid antigen tests and progress on the COVID health pass, writes EAPM Executive Director Dr. Denis Horgan.

ITRE committee publishes draft opinion on pharma strategy

A draft report from the European Parliament health committee aims to ensure access to medicines, promote competitiveness and improve crisis-response mechanisms. Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. The report stresses the need to cut national approval times and align them with European Medicines Agency (EMA) workflows. ENVI also called on the European Commission to talk to member states about new pricing criteria such as whether a drug is ‘Made in Europe’.

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU”. ENVI also urged the Commission to develop appropriate regulatory frameworks for advanced therapy medicinal products and to work with EMA “to consider extending the application of rolling reviews to other emergency medicines”. The rolling review idea is based on the experience of authorizing COVID-19 vaccines. The report also addresses bolstering the resilience of supply chains. The committee wants the Commission to “facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and co-ordinating responses to them”.

Coronavirus: Health Security Committee updates common list of COVID-19 rapid antigen tests

The Health Security Committee (HSC) has agreed to update the common list of COVID-19 rapid antigen tests (RATs), including those whose results are mutually recognised by EU member states for public health measures. Following the update, 83 RATs are now included in the common list, of which the results of 35 tests are being mutually recognised.

Health and Food Safety Commissioner Stella Kyriakides said: “Rapid antigen tests play a crucial role to slow down the spread of COVID-19. Diagnostics are a central element for member states in their overall response to the pandemic. Having a wider list of recognised rapid antigen tests will also make it easier for citizens to benefit from Digital Green Certificates and to facilitate safe free movement inside the EU in the coming months.”

In addition, the Commission and the Joint Research Centre have agreed on a new procedure for updating the list of common and mutually recognised RATs in the future. From today onwards, RATs manufacturers will be able to submit data and information for certain tests that meet the criteria agreed by the Council on 21 January 2021. This includes only those rapid tests that are being carried out by a trained health professional or other trained operator and excludes rapid antigen self-tests. Moreover, as part of the new procedure, the HSC is setting up a technical working group of national experts to review the data submitted by countries and manufacturers and to propose updates to the HSC.

EPP seeks separate health committee in Parliament

The European People’s Party is aiming to create a committee devoted to health issues in the European Parliament to deal with the pandemic’s impact, according to Andrzej Halicki, a senior member of the EPP. 

“The pandemic has changed our lives and it has raised the expectations of citizens,” the Polish MEP said. “We should be prepared as Parliament to talk, to decide how to implement the tools which are connected with our health security.” 

Beyond COVID-19, Halicki pointed to other looming health files, including the Pharmaceutical Strategy and medical devices. 

An EPP spokesperson confirmed that the group had rallied around Halicki’s proposal, and it will now be up to other political groups to support it, with a view to securing final adoption in the Parliament’s Conference of Presidents.

EU's COVID health pass to be operational in June

The EU is "fully on track" to ensure all its citizens and residents are able to have a free COVID health pass next month to ease travel, a spokesman said on Monday (10 May). The European Union is keen for anybody living in its 27 countries to be able to get a digital health pass - which the Commission refers to as a "green certificate" - to display their vaccination status, results of COVID-19 tests and whether they had recovered from a coronavirus infection.

"It will be ready for summer to facilitate safe travelling, so it will be ready to use... by the end of June," a European Commission spokesman, Christian Wigand, told a news conference.

Another spokesman, Johannes Bahrke, added that 18 EU countries plus non-member Iceland would test the digital document over the next two weeks to make sure any bugs were ironed out. It is seen as a key tool to save the European summer vacation period, allowing countries dependent on tourists to reopen to visitors less likely to bring Covid with them. Other countries around the world have moved in the same direction, including Israel with its "green pass", and Britain, which has told its citizens that some international travel will be permitted in a week with an app from its National Health Service (NHS) showing vaccinations received.

The EU's health pass will initially be used only for travel within the European bloc. But the European Commission is working on it being mutually recognised with certificates from non-EU countries, particularly the United States. There have been no discussions between Brussels and London so far on the EU system recognising Britain's NHS app. France, Malta and the Netherlands are among the countries piloting the EU's pass. The test involves making sure that digital keys used to authenticate the passes work correctly, and that it is interoperable across different countries' systems. The pass, while mostly designed to be accessed via smartphone app, also has to be able to be authenticated in paper form.

Health Commissioner Kyriakides proposes joint approach to develop COVID drugs

Last week, the European Commission proposed that EU nations join forces to develop and deploy COVID-19 drugs across the 27-nation bloc. In addition to the vaccine contracts already secured through a similar joint procurement, the EU's executive arm said it will set up a portfolio of 10 potential COVID-19 treatments, with the aim of authorizing three new ones to treat COVID-19 by October. So far, the antiviral medicine remdesivir is the only drug authorized across the EU for treating coronavirus patients. "Vaccinations save lives, but they cannot yet eradicate COVID-19. We need a strong push on treatments to limit the need for hospitalization, speed up recovery times and reduce mortality," said Stella Kyriakides, the bloc's health and food safety commissioner. The Commission said vaccines alone will not eradicate coronavirus overnight and efficient drugs and treatment plans will be required to treat patients in hospitals or at home, including those affected by long-term symptoms of the disease. Joint procurements can be launched with the agreement of member states, with a minimum of five EU countries required to start a procedure.

The Commission said it will invest €90 million ($108m) in studies and clinical trials and an extra €40m ($48m) to support manufacturing and access for COVID-19 drugs and treatments. In addition to the three drugs it plans to authorize in October, the executive branch said two more treatments could get approved by the end of the year. As part of its vaccine strategy, the Commission acted as an investor to provide funding to pharmaceutical companies developing vaccines, speed up production capacities and research. The European Commission has secured up to 2.6 billion doses of COVID-19 shots and is in negotiations with drugmakers for extra doses. But some EU nations have criticized the coordinated approach, blaming the EU for the initial slow rollout of COVID-19 vaccine shots across the region of 450 million people amid a contract dispute with AstraZeneca and production delays at other vaccine makers. Vaccinations have since sped up and a quarter of all EU residents have now received a first dose of coronavirus vaccine, according to Commission President Ursula von der Leyen. She says the bloc has secured enough doses to vaccinate 70% of all adults in the EU by the end of July.

Impact of the pandemic on cancer care

During an exchange of views with stakeholders, members of the Parliament’s Special Committee on Beating Cancer (BECA) identified the key messages emerging from the recent public consultation developed to draw lessons from the ongoing COVID-19 pandemic. The survey findings emphasize the need to build more resilient and equal health systems for disease and crisis preparedness across the EU. Additionally, the EU and its member states need to find ways to increase and improve cross-border collaboration for cancer prevention programmes and other cancer services.

This will help tackle health inequalities within and between member states, not only in cancer prevention, but also in screening, diagnosis and treatment. Another crucial point identified is the need to increase and strengthen specialised medical workforce. Finally, there is a need for a mechanism to help prevent shortages and mitigate disruptions of crucial medicines supply across the EU.

BECA Chairman Bartosz Arłukowicz (EPP, PL) said: “I very much welcome the pertinent recommendations from the BECA survey that will feed into our final report expected by the end of this year. The COVID-19 pandemic has created huge challenges for cancer patients to access care. However, cancer care can’t wait – for these patients, every day counts! It is our Committee’s mission, together with other politicians, the cancer community, public health organisations and medical experts, to do all we can to ensure that cancer patients receive the treatment they need at all times. In this context, I warmly welcome European-wide initiatives to tackle the challenges of the pandemic, such as the Time to Act campaign to be launched by the European Cancer Organization.”

BECA Rapporteur Véronique Trillet-Lenoir (Renew Europe, FR) said: “The COVID-19 pandemic constitutes a stress test for our health care systems with disproportionate negative effects on cancer care and patients. We need robust digital solutions and tele-medicine to be able to monitor cancer patients remotely and clear communication between patients, healthcare professionals and public authorities on emergency public health measures.”

And that is all from EAPM for now – stay safe, stay well, see you soon.

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EAPM: 2nd Bridging Presidency Conference on 'Innovation, Public Trust and Evidence' beckons: Register now!

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Good morning, health colleagues, and a warm welcome to the European Alliance for Personalised Medicine (EAPM) update. We have exciting news this morning as an upcoming 2nd Bridging Presidency conference during the Slovenian Presidency of the EU will take place on 1 July, writes EAPM Executive Director Dr. Denis Horgan.

Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems – Registration Open

The theme of EAPM’s 2nd Bridging Presidency conference, which will be held on Thursday,  1 July, during the auspices of the Slovenia Presidency of the EU, will be ‘Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care’

The conference is divided into five sessions which cover the follows areas: 

  • Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trust
  • Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening
  • Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data
  •  Session 4: Securing patient Access to Advanced Molecular Diagnostics

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register, here, and download your agenda here!

So, what are among the topics on the table?

The current COVID-19 crisis has thrown many European, and indeed global, healthcare issues into sharp relief.  It has also raised important questions, not necessarily new ones, but ones that have shifted more into focus during the pandemic.

One such question is whether the EU should have a bigger role in public health – and particularly in the provision of health technology. This, of course, would impinge upon the closely guarded member state competence in healthcare so, if this were to happen, how would that be?

Another question is how can the now very evident gaps be bridged in order to better protect Europe’s health ahead of another crisis and how do we identify potential patients? What are the priorities?  Should the EU develop Lung and Prostate Cancer Screening Guidelines?  The broader question, as mentioned above, is whether it’s time to give the EU a bigger role in Europe’s health protection.

Meanwhile, at the heart of personalised medicine, is the hugely expanding use of health data. This is a sensitive topic. There’s certainly a need for the health-science community to talk more openly about using personal health data in research to enhance human health and eradicate diseases such as cancer and the public has to be at the centre of any and all discussion.

Many national and international initiatives rely on comprehensive data analytics to drive evidence-based solutions to improve health outcomes.

Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field. We’ll be discussing, at some point during the day, most or all of what we’ll be talking about below.

You can register, here, and download our agenda here!

In other news…

500million BioNTech/Pfizer doses set for global distribution from US

The Biden administration plans to purchase 500 million doses of Pfizer coronavirus vaccine to distribute to other nations, significantly adding to its ongoing efforts to inoculate populations around the world, according to three people familiar with the plans. The move by the U.S. government could lead to 200 million Pfizer doses being sent worldwide this year, followed by another 300 million across the first half of 2022, according to the individuals familiar with the plan. President Joe Biden will announce the plan ahead of the G-7 meeting in the United Kingdom. 

Pfizer and its development partner BioNTech have boasted in recent weeks that they are vastly expanding manufacturing capabilities and expect to deliver billions of doses within the next few years.

EU Digital COVID Certificate

MEPs see the EU Digital COVID Certificate as a tool to restore freedom and urge EU countries to implement it by 1 July. The certificate aims to enable easier and safer travel by proving someone has been vaccinated, had a negative COVID test or recovered from the disease. The infrastructure for it is in place and 23 countries are technically ready, with nine already issuing and verifying at least one type of certificate. 

In a plenary debate on 8 June, Juan Fernando López Aguilar (S&D, Spain), the lead MEP regarding the certificate, said that freedom of movement is highly prized by EU citizens and that the negotiations on the COVID Certificate "have been completed in record time”. 

“We want to send out the message to European citizens that we are doing everything we can to restore freedom of movement.” 

Justice Commissioner Didier Reynders said: "The certificate, which will be free of charge, will be issued by all member states and will have to be accepted across Europe. It will contribute to a gradual lifting of restrictions." Member states have to apply the rules The COVID certificate is “the first step towards getting rid of restrictions and that is good news for many people in Europe - people who travel for work, families that live in border areas, and for tourism,” said MEP Birgit Sippel (S&D, Germany). 

She said it is now up to EU countries to harmonise the rules on travel. “All citizens in the European Union rightfully expect to be able to use this system by the start of summer and member states must deliver,” said Jeroen Lenaers (EPP, the Netherlands). He said that this means not only the technical implementation of the certificate, but much more: “European citizens want to finally have some co-ordination and predictability on our internal borders.”

Plenary vote on waiver

MEPs will today (10 June) vote on a resolution on the TRIPS waiver discussions — the European Parliament endorsed a resolution on Wednesday (9 June) calling for a temporary waiver of COVID-19 vaccine patents, while the Commission remained firm in its opposition to such measures and said it has different plans to speed up the global vaccine rollout. 

The Parliament voted in support of waiving COVID-19 vaccine intellectual property (IP) rights with 355 to 263 and 71 abstentions. The vote came after a debate on whether the EU should join other countries such as South Africa and India in demanding a waiver of IP rights in the context of the World Trade Organisation (WTO). MEPs were largely split: while some called on the Commission to support the waiver, others, particularly from the centre-right European People’s Party (EPP), argued that this would not accelerate the provision of vaccines and would harm innovation. 

Lawmakers in the European Parliament’s trade committee expressed their pro-waiver position on 25 May, after adopting a report on the trade-related aspects and implications of COVID-19. The report urged the EU to engage in constructive talks with the WTO for a temporary waiver from the IPR protection on COVID-19 vaccines, to ensure that countries do not face retaliation over COVID-19-related patent infringements. According to the Greens leader, one tool to bring this forward and boost global vaccine production is the temporary waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as compulsory licensing and knowledge sharing for countries of the south of the world.

And that is all for this week from EAPM – don’t forget to register for the upcoming EAPM/Slovenian EU Presidency here and see the agenda here, and have a safe and very enjoyable weekend.

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Oncogenomics and pediatric health - Call for Papers and G7, HTA

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Good afternoon health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week. Work between EAPM and different journals is now ongoing concerning a special issue relating to the diagnosis and treatment of cancer and blood diseases in children in developed and developing countries, writes EAPM Executive Director Dr. Denis Horgan. 

Oncogenomics and pediatric health:  Call for Papers

The landscape for pediatric blood cancer therapy is just beginning to realize the potential predicted by precision oncogenomics. These developments have created a new environment, one in which parents with a child newly diagnosed find themselves navigating a very different landscape than the one a parent might have encountered in 2010. 

In this Special issue, we invite authors from developed and developing countries to contribute original research and review articles focusing on different aspects of pediatric cancer development, causes, maintenance, and therapeutic strategies. 

Topics include, on developments, challenges, and opportunities in the diagnosis and treatment of cancer and blood diseases in children in developed and developing countries.  

This special issue has a global reach, so articles are being sought not only from the EU but also Africa, Asia, Latin America and the Middle East. 

The contents of this Topic should provide an insight into current pediatric cancer precision medicine efforts in developed and developing countries, reflecting only a microcosm of the current applications of oncogenomics in this bustling space of clinical translation. The Topic will publish research, commentaries, policy perspectives, historical insights, and clinical and laboratory observations. 

The findings from the Topic will be presented in an international conference in the second half of 2021 – the deadline for abstract submissions is 1 September 2021 and the deadline for manuscript submissions is 1 October 2021.  For more information, please see link

Trialogues on the European Health Union 

September could be the month for the European Health Union plans, with a Commission official highlighting that trilogues on the three EHU files could start after the summer recess if all goes according to plan. 

G7 health ministers agree to clinical trials charter

Health ministers from some of the world’s largest democracies have committed to a new international agreement making it easier and quicker to share results from vaccine and therapeutic trials to tackle COVID-19 and prevent future health threats. Following the conclusion of the UK-hosted, in-person G7 Health Ministers’ meeting in Oxford, a Therapeutics and Vaccines Clinical Trials Charter will be rapidly implemented. This will help deliver high-quality, reliable and comparable evidence from international clinical trials to speed up access to approved treatments and vaccines, benefiting people in the UK and globally. 

This will include stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children. The charter will also help to avoid unnecessary duplication of efforts, more quickly eliminate medicines that do not work, and produce robust clinical evidence that can be extrapolated to a larger number of populations and places to save more lives. The agreement follows news that industry leaders are joining forces to step up collective efforts to save lives from diseases and tackle global pandemics, with a new commitment to protect against future pandemic threats and slash time to develop and deploy new diagnostics, therapeutics and vaccines to just 100 days.

Health technology assessment

The Commission, Council and Parliament met last week for the latest trilogue talks on the health technology assessment (HTA) file — HTA and increasingly aggressive pricing methods have put drug manufacturers under pressure, but an EU diplomat said they made made good progress: “The co-legislators confirmed the work done at technical level and exchanged views on the Council and EP positions on almost all political issues … and decided to continue the technical discussions in order to prepare for the next and hopefully last trilogue, already scheduled to 21 June.”

EU Beating Cancer Plan

The stakeholder contact group of Europe’s Beating Cancer Plan — a mix of some 200 representatives from the world of patient groups, NGOs, and industry — met virtually for the first time on Friday (4 June) to discuss the Commission’s cancer strategy. The EU’s Cancer Mission — not to be confused with Europe’s Beating Cancer Plan — was also discussed during the contact group meeting. It is one of the five missions of the EU’s research agenda, known as Horizon Europe. According to one participant of the stakeholder meeting, however, all may not be well: When asked about the likelihood of the mission not going ahead, Jan-Willem van der Loo, the team leader for Cancer at the Directorate-General for Research and Innovation, said that the “review process on the missions is being tough” and declined to “give a percentage answer on that, seemingly acknowledging there was some kind of issue,” according to a participant.

Some 50% of Europeans dissatisfied with EU pandemic management

Nearly half of European respondents are unsatisfied with the EU's measures in response to the COVID-19 pandemic, a new survey has revealed. It found 49% were unhappy with measures taken by the bloc, while 43% were satisfied and 8% undecided. The highest proportion of dissatisfaction was found in Greece, Luxembourg and Belgium, the Eurobarometer poll found. The findings, which stems from a survey conducted between 12 February and 11 March across the 27 EU countries and 12 other countries outside the EU, including the UK, showed dissatisfaction with the EU over coronavirus was up by five percentage points since last summer. It also compares to 43% of people who said they were satisfied with the EU's COVID-19 measures - down two percentage points since the summer - and 8% who said they "don't know" how they feel about the EU's coronavirus response, down three percentage points. 

The highest proportions of satisfaction were found in Denmark (68%), Lithuania (67%) and Portugal (66%). Meanwhile, 12 member states had a majority of respondents express dissatisfaction, with Greece leading the way at 68%, followed by Luxembourg (63%) and Belgium (61%). In Spain and the Netherlands, public opinion was evenly divided, with 44% satisfied and 44% not satisfied in the former country and latter seeing the same, but at 43%.

And that is all from EAPM for now – don’t forget, there is more information to be found here on the diagnosis and treatment of cancer and blood diseases in children Special Issue, stay safe, have an excellent week, see you soon.

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EAPM: Medical access, medical devices, jabs for kids

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Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – there is controversy afoot concerning access to new medicines across Europe, doubts expressed over sufficiency of COVID testing alone for foreign travel, and the end of the Medical Device Regulation’s transition period, writes EAPM Executive Director Dr. Denis Horgan.

Stark divide on access to new medicines globally and in Europe

The coronavirus pandemic is far from over, WHO Director-General Tedros Adhanom Ghebreyesus stressed this week, as he lamented new variants, vaccines shortages, and a global disparity in access to inoculations.

"There is a huge disconnect growing, where in some countries with the highest vaccination rates, there appears to be a mindset that the pandemic is over, while others are experiencing huge waves of infection," Tedros said. He expressed further concern about areas experiencing a continued high number of COVID-19 cases and places that had previously made progress are facing a new wave of cases and hospitalization. "The pandemic is a long way from over," he said, "and it will not be over anywhere until it's over everywhere."In the fight against the coronavirus, some countries are faring better than others. In the United States, for example, cases have been dropping as more and more people get vaccinated.

President Joe Biden has set a goal to have at least 160 million Americans fully vaccinated by the July Fourth holiday. But in India, a second wave of COVID-19 has been devastating, killing thousands of people a day and setting world records for daily infections. Medical facilities have started to run out of oxygen, ventilators and beds, and workers have been stretched thin.

Countries in Northern and Western Europe access new medicines much more quickly than their Southern and Eastern European neighbors, with patients in some countries waiting more than seven times longer, according to research.

Access is the fastest in Germany, with an average of 120 days between marketing authorization and availability in the country, while in oncology, several countries — Poland, Lithuania, Romania, Slovakia Bosnia, Latvia, Iceland, Macedonia and Serbia — have no availability to new cancer medicines that were approved in 2019.

Meanwhile, while there was a much smaller number of orphan medicines approved in 2019, over half of the countries in the study hadn’t made any of these medicines available in 2020.

ECDC warns EU: Testing alone not enough to ensure safe travel

The European Centre for Disease Prevention and Control (ECDC) doesn’t think that only testing for COVID-19 to avoid entry restrictions for travellers in the EU is enough to prevent the possible spread of COVID-19 from incoming travellers. Speaking on the matter, ECDC Director Andrea Amon explained that only a portion of the EU’s population has received COVID-19 vaccines, meaning that the virus is still active and “testing alone doesn’t do the trick” for Europeans to travel freely, SchengenVisaInfo.com reports.

“We should keep in mind that the proof of a full-course vaccination, prior infection or lack of current infection as defined by a PCR [test], which are the three elements that are included in the certificate, have very different levels of certainty regarding the risk of the individual,” Ammon added.

The European Council and Parliament recently reached the agreement to establish the EU Digital COVID-19 Certificate, which will serve as evidence to prove if the holder has been vaccinated against the virus, has recovered from the disease in the recent months or tested negative for COVID-19 within the timeframe set by the EU destination country. These three are expected to be individual certificates and ease citizens movement across Europe.

MDR transition period ends

As of 26 May — after being delayed from 2020 — the Medical Device Regulation’s (MDR) transition period ended. Serge Bernasconi, MedTech Europe’s CEO, said he planned to open a half bottle of champagne to mark the occasion. “You will not see the full effect of the new regulation on May 26,” Bernasconi said, underscoring the fact that many legacy devices were recertified so as to remain on the market until 2024. “It’s only half a bottle of champagne,” Bernassconi said, “because I continue to believe there is still a lot to be done to make the system really operational.”

“Please don’t believe or think that this critical date is like an end — that’s what worries me the most,” Bernasconi said. “Please do not divert resources away from [the MDR], while at the same time, please pay enormous attention to what’s happening for IVDs. People might not see it, because there’s this huge medical device thing in front — but this thing is coming.”

Parliament committee endorses COVID certificates deal

The Civil Liberties Committee has endorsed the EU digital Covid Certificate package with 52 votes in favour, 13 votes against and 3 abstentions (EU citizens) and with 53 votes in favour, 10 votes against and five abstentions (third country nationals). The EU Digital Covid Certificate will be issued by national authorities and be available in either digital or paper format.

A common EU framework will allow member states to issue certificates that will be interoperable, compatible, secure and verifiable across the EU. More information here. LIBE Chairman of the Civil Liberties Committee and rapporteur Juan Fernando López Aguilar (S&D, ES) said:

“The Parliament started negotiations with very ambitious objectives in mind and has managed to achieve a good compromise through painstaking negotiations. The text voted today will ensure that freedom of movement will be safely restored across the EU as we continue to fight this pandemic, with due respect for the right of our citizens to non-discrimination and data protection.”

Update from the 74th World Health Assembly

A new resolution urges member states to raise the priority given to the prevention, diagnosis and control of diabetes as well as prevention and management of risk factors such as obesity. It recommends action in a number of areas including: the development of pathways for achieving targets for the prevention and control of diabetes, including access to insulin; the promotion of convergence and harmonization of regulatory requirements for insulin and other medicines and health products for the treatment of diabetes; and assessment of the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for diabetes medicines and health products. Delegates asked WHO to develop recommendations and provide support for strengthening diabetes monitoring and surveillance within national noncommunicable disease programmes and to consider potential targets. WHO was also asked to make recommendations on the prevention and management of obesity and on policies for diabetes prevention and control More than 420 million people are living with diabetes, a number that is expected to rise to 578 million by 2030. One in two adults living with diabetes type 2 are undiagnosed. Globally, 100 years after the discovery of insulin, half of the people with type 2 diabetes who need insulin are not receiving it.

Vaccine for children aged 12 to 15 expected to get green light from European Medicines Agency

The first COVID-19 vaccine for children aged 12 to 15 is expected to be given approval by the European Medicines Agency (EMA) today (28 May). The vaccine, made by Pfizer BioNTech, has already been given the green light by the FDA in the United States. The EMA will hold a top-committee meeting tomorrow to give its final assessment on the vaccine. The National Immunisation Advisory Committee (Niac) will examine evidence around the vaccine before recommending whether or not it should be rolled out here.

It could mean the jab is offered to secondary school students before the start of the next academic year. Read More Fishing crews stage port protest to highlight problems facing industry It comes as it emerged the cyber attack on the HSE has delayed vaccination appointments for some people at high risk of COVID-19 due to underlying illness.

Those aged 16 to 64, whose GP is not involved in administering the vaccine, were due to be referred by their doctors instead of registering for their vaccination jab on an online portal. However, because of the cyber attack this has been put on hold and the current portal is only open to people over 45. The HSE is attempting to put an alternative system in place for this group.

And that is all from EAPM – stay safe and well and have an excellent weekend, see you next week.

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