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#EAPM: Digital Day to set the ball rolling on one-million genomes project



The European Commission’s Digital Day 2018 takes place tomorrow (Tuesday 10 April) at the ‘Square’ venue in Brussels, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

EAPM has been key to what will be the signing of a major declaration between 15 Member States to commit to a one-million genomes project.

This second, annual one-day event will gather high-level stakeholders in the fields of digital technology and telecommunication, organized by the European Commission under the Bulgarian Presidency of the EU.

The signing session will be launched by Mariya Gabriel, the Commissioner for Digital Economy and Society, and will see member states’ representatives co-sign a Joint Declaration indicating political support for linking existing and future genomic databanks, on a voluntary basis, in order to reach a cohort of one million sequenced genomes accessible in the EU by 2022.

For some time, the Brussels-based EAPM and its stakeholders have pushed the idea of a project that it dubbed ‘MEGA’ (Million European Genomes Alliance) and worked hard to create a coalition of willing member states, urging them to collaborate.

EAPM’s multi-stakeholder Working Group on Big Data originally developed the concept, approved at its annual general meeting as a priority. The subsequent success of the written delegation is based on the foundation that the Alliance has built among affiliates at national level.

This gave the Alliance the political capital to engage with member states’ ministers. And with excellent leadership from the European Commission’s, who played a significant role, the political will appears to have been found.

Writing in magazine Biomedicine Hub, EAPM’s Working Group on Big Data put forward the argument for the project in an article entitled entitled ‘Pulling the Strands Together: MEGA Steps to Drive European Genomics and Personalised Medicine’.

This sets out the framework of why Europe needs more collaboration across EU member states rather than less, certainly in this instance, bearing in mind that healthcare remains a member state competence.

Increasing understanding of the genome is recognised as being one of the main determinants of future improvement in health care.

The availability of genetic data from a large number of individuals increases the ability to investigate questions across many rare and common diseases and in different populations, and also provides more information for understanding clinical care outcomes for an individual.

In Europe, the UK led the way with its 100,000 Genomes Project, which looks at the genome sequences of patients with rare diseases or cancer. Since then there has been an announcement by France to invest €670 million in a genomics and personalised medicine programme.

Speaking before the Digital Day 2018 event, Horgan said: “A co-ordinated, pan-European project such as this would garner crucial genetic information that could have an immeasurable benefit when it comes to the health of current and future EU citizens.”

EAPM, and it seems many others, are convinced that seeking the key to concrete action to chan-nel Europe's wealth of expertise in genomics is long overdue.

Europe not only has formidable potential, but has already yielded world-beating insights in the short history of the science.

Mario Romao said: “Unfortunately, our expertise in the field is widely scattered, which makes it hard for Europe to compete on scale with the US and China.  By signing this declaration countries recognise the need to join forces and move ahead.”

Meanwhile, EAPM board member Mary Baker, a patients’ rights champion, said ahead of the event: “Genomics is increasingly ready to be used to improve health and it can provide a treasure-house of opportunity.

“It is now beginning to move on from specialist areas such as diagnosis of rare diseases and the selection of appropriate cancer therapies, towards the fuller integration of genomics across healthcare systems that will permit wide use of personalised medicine to improve healthcare and reduce costs. In the end, it’s all about the patients.”

EAPM and its working group have highlighted that genomics is allowing clinicians to prevent - or identify and treat - serious adverse drug reactions to certain medicines. Meanwhile, ensuring that the right drugs are targeted to the right patients is eliminating unintended patient harm and life-threatening emergency medical admissions.

Member of the European Parliament Lambert van Nistelrooij, a strong supporter of EAPM’s work, said: “Using genomics, among other benefits clinicians are now able to far more accurately assess each individual's personal risk of breast cancer, reducing the need for regular imaging and some-times invasive procedures that deliver imperfect results.

“This allows a move away from a reactive approach to long-term management plans that combine targeted screening and non-invasive options to prevent breast cancer developing.”

It is clear that genomics is aiding understanding of genetic change in tumours, and new, highly personalised and effective medications are now being used that target the genetically different sub-types of lung cancer.

On top of this, prostate cancer researchers are discovering genetic hallmarks that allow them to use a drug originally developed for ovarian cancer treatment to treat patients who have ceased to respond to more traditional prostate cancer approaches.

Said Horgan: “The rationale for a million genomes project is that there are massive gains within easy reach for science, research, medicine, healthcare resources, and patient outcomes. But these gains are still to be grasped.

“Tomorrow’s Declaration is set to go a long way towards putting all the possible gains firmly in Eu-rope’s hands, for the benefit of patients today and in the future.”


President Sassoli to EU leaders: Help get the budget negotiations moving again



President Sassoli with French President Macron and German Chancellor Merkel at the 15 October summit © KENZO TRIBOUILLARD / POOL / AFP 

In a speech at the EU summit on 15 October, Parliament President David Sassoli insisted it is now up to EU leaders to unlock the stalled negotiations on the 2021-2027 budget.

President Sassoli urged the EU heads of government to update the negotiating mandate they have given to the German Council presidency to make agreement on the EU long-term budget possible.

He noted that Parliament’s negotiators have asked for an additional €39 billion for key EU programmes that benefit Europeans and promote a sustainable recovery. “This is a paltry sum when set against an overall package worth €1.8 trillion, but one which would make an enormous difference to the citizens who will benefit from our common policies,” President Sassoli said, referring to the total amount of the seven-year budget and the Covid-19 recovery plan.

Sassoli noted that if Parliament’s compromise proposal is accepted by the Council, the budget spending ceiling will have to be raised by only €9 billion and this will bring the ceiling of those programmes to exactly the same level of spending as in the 2014-2020 period in real terms.

He said that the interest payments for the debt that the EU plans to issue to finance the recovery must be counted on top of the programme ceilings so as not to further squeeze the financing of these policies. The recovery plan “is an extraordinary commitment, and therefore the cost of the interest should be treated as an extraordinary expense as well. It should not come down to a choice between these costs and the [budget] programmes”.

The President also stressed the need for a binding timetable for the introduction of new types of budget revenue over the coming years and for flexible provisions in the budget to finance unforeseen future events.

Sassoli defended Parliament’s demand for ambitious emission reduction targets. “We must reduce greenhouse gas emissions by 60% by 2030. We need a target, which acts as a bright beacon on the path to climate neutrality. Protecting the environment means new jobs, more research, more social protection, more opportunities.”

“We should use the economic stimuli provided by public institutions to radically change our growth models while guaranteeing a fair transition that works for us and for future generations. No one should be left behind,” he added.

Commenting on the ongoing negotiations on future EU-UK relations, Sassoli expressed concern about the lack of clarity from the UK side. “I hope that our UK friends use the very narrow window of opportunity that remains to work constructively towards overcoming our differences,” he said, adding that the UK should honour its commitments and remove the controversial provisions in its internal market act.

Sassoli also called for a de-escalation of tensions with Turkey. “The Turkish rhetoric is growing increasingly aggressive and the country's intervention in the Nagorno-Karabakh conflict is certainly not helping matters. Now is the time for the EU to fully support German mediation efforts, to stand united and speak with one voice,” he said.

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Parliament launches the Daphne Caruana Galizia journalism prize



Maltese investigative journalist Daphne Caruana Galizia was murdered in a car bomb explosion in October 2017 

The European Parliament has launched a journalism prize in tribute to Daphne Caruana Galizia, a Maltese investigative journalist murdered in 2017. The Daphne Caruana Galizia Prize for Journalism, launched on the third anniversary of her death, will reward outstanding journalism reflecting EU values.

"The Daphne Caruana Galizia Prize will recognize the essential role that journalists play in preserving our democracies and serve as a reminder to citizens of the importance of a free press. This prize is designed to help journalists in the vital and often dangerous work they do and show that the European Parliament supports investigative journalists," said Parliament Vice President Heidi Hautala.

Prize money of €20,000

The €20,000 annual prize will be awarded as of October 2021 to journalists or teams of journalists based in the European Union. Candidates and the eventual laureate will be chosen by an independent panel.

Who was Daphne Caruana Galizia?

Daphne Caruana Galizia was a Maltese journalist, blogger and anti-corruption activist who reported extensively on corruption, money laundering, organised crime, sale of citizenship and the Maltese government’s links to the Panama Papers. Following harassment and threats, she was murdered in a car bomb explosion on 16 October 2017.

The outcry over the authorities’ handling of her murder investigation ultimately prompted the resignation of Prime Minister Joseph Muscat. Critical of failings in the investigation, in December 2019, MEPs called on the European Commission to take action.

Parliament strongly advocates the importance of a free press. In a May 2018 resolution, MEPs called on EU countries to ensure adequate public funding and to promote a pluralist, independent and free media. Parliament has once again underlined the importance of media freedom in the context of the COVID-19 pandemic.

Watch the Facebook live interview about the Daphne Caruana Galizia Journalism Prize.

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Coronavirus risks running out of control in Germany, warns Soeder




The leader of Bavaria’s Christian Social Union (CSU), Markus Soeder (pictured), warned on Wednesday (21 October) that the coronavirus is at risk of spiraling out of control in Germany, writes Paul Carrel.

While Germany’s infection rates are lower than in much of Europe, they have been accelerating and hit a daily record of 7,830 on Saturday, according to the Robert Koch Institute.

“Corona is back with full force ... the second wave is here,” Soeder told the Bavarian state assembly, adding caution and prudence were required.

On Tuesday, residents in the Bavarian district of Berchtesgadener Land went back into lockdown, the first area in Germany to do so since April.

Soeder said he nonetheless wanted to keep open borders with neighbouring countries. Bavaria borders Switzerland, Austria and the Czech Republic. He was also determined to keep the economy functioning and schools and nurseries open as long as possible.

“Our priority is to avoid a blanket lockdown,” he told the Bavarian state assembly, adding that he would introduce a “dark red” alert level with tougher restrictions for areas in Bavaria that have 100 new cases per 100,000 people over seven days.

Earlier, a spokeswoman for German President Frank-Walter Steinmeier said he was staying in quarantine at home until Oct. 29 after a bodyguard tested positive for the virus.

Steinmeier, whose role is largely ceremonial, has now twice tested negative for the virus, the spokeswoman added.

“There is light on the horizon,” said Soeder. “Of course, the vaccine will come, of course the situation will be very different in spring next year ... There is a tomorrow after corona.”

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