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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.

Brexit

Germany’s Merkel urges pragmatic approach to Northern Ireland

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German Chancellor Angela Merkel (pictured) called on Saturday for a “pragmatic solution” to disagreements over part of the Brexit deal that covers border issues with Northern Ireland, Reuters Read more.

Prime Minister Boris Johnson said Britain will do "whatever it takes" to protect its territorial integrity in a trade dispute with the European Union, threatening emergency measures if no solution was found.

The EU has to defend its common market, Merkel said, but on technical questions there could be a way forward in the dispute, she told a news conference during a Group of Seven leaders' summit.

"I have said that I favour a pragmatic solution for contractual agreements, because a cordial relationship is of utmost significance for Britain and the European Union," she said.

Referring to a conversation she had with U.S. President Joe Biden about geopolitical issues, Merkel said they agreed that Ukraine must continue to remain a transit country for Russian natural gas once Moscow completes the controversial Nord Stream 2 gas pipeline under the Baltic Sea.

The $11 billion pipeline will carry gas to Germany directly, something Washington fears could undermine Ukraine and increase Russia's influence over Europe.

Biden and Merkel are due to meet in Washington on July 15, and the strain on bilateral ties caused by the project will be on the agenda.

The G7 sought on Saturday to counter China's growing influence by offering developing nations an infrastructure plan that would rival President Xi Jinping's multi-trillion-dollar Belt and Road initiative. L5N2NU045

Asked about the plan, Merkel said the G7 was not yet ready to specify how much financing could be made available.

“Our financing instruments often are not as quickly available as developing countries need them,” she said

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Brexit

'Whatever it takes', UK's Johnson warns EU over post-Brexit trade

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Britain will do "whatever it takes" to protect its territorial integrity in a trade dispute with the European Union, Prime Minister Boris Johnson said on Saturday (12 June), threatening emergency measures if no solution was found, write Elizabeth Piper and Michel Rose.

The threat by Johnson seemed to break a temporary truce in a war of words over part of the Brexit deal that covers border issues with Northern Ireland, the focus for tensions since Britain completed its exit from the EU late last year.

Despite US President Joe Biden encouraging them to find a compromise, Johnson used a G7 summit to indicate no softening in his position on what is called the Northern Ireland protocol that covers border issues with the British province.

"I think we can sort it out but ... it is up to our EU friends and partners to understand that we will do whatever it takes," Johnson told Sky News.

"I think if the protocol continues to be applied in this way, then we will obviously not hesitate to invoke Article 16," he added, referring to a safeguard clause that allows either side to take measures if they believe the agreement is leading to economic, societal or environment difficulties.

"I've talked to some of our friends here today, who do seem to misunderstand that the UK is a single country, a single territory. I just need to get that into their heads."

His comments came after he met French President Emmanuel Macron, German Chancellor Angela Merkel and top EU officials Ursula von der Leyen and Charles Michel at a Group of Seven summit in southwestern England.

The EU told the British government once again that it must implement the Brexit deal in full and introduce checks on certain goods moving from Britain to Northern Ireland. Britain repeated its call for urgent and innovative solutions to ease the friction.

The province has an open border with EU member Ireland so the Northern Ireland protocol was agreed as a way to preserve the bloc's single market after Britain left.

The protocol essentially kept the province in the EU’s customs union and adhering to many of the single market rules, creating a regulatory border in the Irish Sea between the British province and the rest of the United Kingdom.

Anti-Brexit protesters holding a banner and flags demonstrate outside the Houses of Parliament in London, Britain January 30, 2020. REUTERS/Antonio Bronic
Britain's Prime Minister Boris Johnson, European Commission President Ursula von der Leyen and European Council President Charles Michel remove their protective face masks as they meet during the G7 summit in Carbis Bay, Cornwall, Britain, June 12, 2021. REUTERS/Peter Nicholls/Pool

Since Britain exited the bloc's orbit, Johnson has unilaterally delayed the implementation of some provisions of the protocol, including checks on chilled meats such as sausages moving from the mainland to Northern Ireland, saying it was causing disruption to some supplies to the province.

"Both sides must implement what we agreed on," von der Leyen, European Commission president, said after meeting Johnson alongside Michel, the European Council president.

"There is complete EU unity on this," she said, adding that the deal had been agreed, signed and ratified by both Johnson's government and the bloc.

Germany's Merkel said the two sides could find pragmatic solutions on technical questions, while the EU protected its single market.

Earlier this week, talks between the two sets of negotiators ended in an exchange of threats over the so-called "sausage wars". An EU official said at the G7 that there was a need for the rhetoric to be toned down.

The head of the World Trade Organization said she hoped the tensions would not escalate into a trade war.

The United States has also expressed grave concern the dispute could undermine the 1998 Good Friday peace deal.

That agreement largely brought an end to the "Troubles" - three decades of conflict between Irish Catholic nationalist militants and pro-British Protestant "loyalist" paramilitaries in which 3,600 people were killed.

Though Brexit was not part of the formal agenda for the G7 summit in the English seaside resort of Carbis Bay, it has more than once threatened to cloud the meeting.

France's Macron offered to reset relations with Britain as long as Johnson stood by the Brexit deal - a characterisation of the meeting that was rejected by the British team. Read more.

Brexit has also strained the situation in Northern Ireland, where the pro-British "unionist" community say they are now split off from the rest of the United Kingdom and the Brexit deal breaches the 1998 peace deal. But the open border between the province and Ireland was a key principle of the Good Friday deal.

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Keeping the UEFA EURO 2020 championship safe

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Between 10 June and 12 July 2021, Europol will host an operational centre to support safety and security during the UEFA EURO 2020 football championship. Coordinated by the Dutch Police, the International Police Cooperation Centre (IPCC) of the National Football Contact Points will host about 40 liaison officers from 22 participating and hosting countries. This special operational set-up is created to enable swift cooperation and provide the necessary operational support for a safe and secure championship.

The IPCC will serve as a central information hub for national law enforcement authorities. To that end, Europol has created a special Task Force EURO 2020 to enable keeping officers on the ground 24/7 to easily exchange information and swiftly receive leads on ongoing investigations. The operational activities will focus on public safety and criminal threats, which may threaten security during the tournament. Enforcement authorities will target threats such as cybercrime, terrorism, match-fixing, trafficking counterfeit goods including fake COVID-19 certificates, and other intellectual property crimes.

Europol’s Executive Director, Catherine De Bolle, said: ‘The UEFA EURO 2020 championship is a unique tournament both for football and for law enforcement. With 24 national teams playing in 11 cities across Europe, teaming up is paramount for the safety of the tournament. Europol will enable this cooperation by hosting the dedicated operational centre. Backed by Europol’s capabilities, officers on the ground will be better prepared to ensure a smooth and safe championship.’

The IPCC’s chief of staff, Max Daniel, said: ‘Combining information about public order issues, supporters, places of stay and travel movements by road, air and rail results in an up-to-date and integrated picture. Being able to easily share that information between countries has proven to be very valuable in the past. Police intelligence officers of all participating countries are doing their utmost to ensure that this unique UEFA EURO 2020 championship will be as safe as possible.’

IPCC UEFA EURO 2020 Participants (total number):

EU Member States: Austria, Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Slovakia, Spain, Sweden, the Netherlands. 

Non-EU Countries: Azerbaijan, North Macedonia, Russian Federation, Switzerland, Turkey, Ukraine, United Kingdom.

Organisations: INTERPOL and UEFA

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