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

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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.

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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.

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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.”

Belgium

Commission approves €45 million Belgian scheme to support companies affected by the coronavirus outbreak

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The European Commission has approved a €45 million Belgian scheme to support companies active in the Brussels-Capital region affected by the coronavirus outbreak and the restrictive measures that the Belgian government had to implement to limit the spread of the virus. The public support was approved under the State Aid Temporary Framework. Under the scheme, which goes under the name 'la prime Relance', the aid will take the form of direct grants. Eligible beneficiaries are companies of all sizes active in the following sectors: nightclubs, restaurants and cafés (‘ReCa') and some of their suppliers, events, culture, tourism, sport and passenger transport. In order to be eligible, companies must have been registered in the Central Bank for Enterprises (‘la Banque-Carrefour des Enterprises' ) by 31 December 2020. The Commission found that the Belgian scheme is in line with the conditions set out in the Temporary Framework. In particular, the support (i) will not exceed €1.8 million per company; and (ii) will be granted no later than 31 December 2021.

The Commission concluded that the measure is necessary, appropriate and proportionate to remedy a serious disturbance in the economy of a member state, in line with Article 107(3)(b) TFEU and the conditions set out in the Temporary Framework. On this basis, the Commission approved the measure under EU state aid rules. More information on the Temporary Framework and other actions taken by the Commission to address the economic impact of the coronavirus pandemic can be found here. The non-confidential version of the decision will be made available under the case number SA.64775 in the state aid register on the Commission's competition website once any confidentiality issues have been resolved.

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European Commission

Macro-financial assistance: EU disburses €125 million to Bosnia and Herzegovina and €50 million to the Republic of Moldova

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The European Commission, on behalf of the EU, has carried out another round of disbursements under the €3 billion macro-financial assistance package for ten enlargement and neighbourhood partners. The programme is a concrete demonstration of the EU's solidarity with its partners to help respond to the economic impact of the COVID-19 pandemic. The Commission has disbursed €125 million to Bosnia and Herzegovina and €50 million to the Republic of Moldova. This support is provided through loans at very favourable rates. With these disbursements, the EU has successfully completed five out of the 10 MFA programmes in the €3 billion COVID-19 MFA package, and disbursed the first tranches to all partners. The Commission continues to work closely with the rest of its MFA partners on the timely implementation of the agreed policy programmes. 

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NextGenerationEU: European Commission endorses Finland's €2.1 billion recovery and resilience plan

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The European Commission has adopted a positive assessment of Finland's recovery and resilience plan. This is an important step towards the EU disbursing €2.1 billion in grants to Finland under the Recovery and Resilience Facility (RRF). The financing provided by the RRF will support the implementation of the crucial investment and reform measures outlined in Finland's recovery and resilience plan. It will play a significant role in enabling Finland to emerge stronger from the COVID-19 pandemic.

The RRF is the key instrument at the heart of NextGenerationEU which will provide up to €800bn (in current prices) to support investments and reforms across the EU. The Finnish plan forms part of an unprecedented coordinated EU response to the COVID-19 crisis, to address common European challenges by embracing the green and digital transitions, to strengthen economic and social resilience and the cohesion of the Single Market.

The Commission assessed Finland's plan based on the criteria set out in the RRF Regulation. The Commission's analysis considered, in particular, whether the investments and reforms contained in Finland's plan support the green and digital transitions; contribute to effectively addressing challenges identified in the European Semester; and strengthen its growth potential, job creation and economic and social resilience.

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Securing Finland's green and digital transitions  

The Commission's assessment finds that Finland's plan devotes 50% of the plan's total allocation on measures that support climate objectives. Finland has announced an ambitious target for achieving carbon neutrality by 2035. The reforms and investments included in the plan will make an important contribution to Finland achieving this objective. The plan addresses each of the highest emitting sectors in turn, namely energy, housing, industry and transport. It includes reforms to phase out the use of coal in energy production, changes to taxation to favour cleaner technologies, and a reform of the Waste Act with increased targets for recycling and reuse. On the investment side, the plan will finance clean energy technologies and related infrastructure, industry decarbonisation, the replacement of oil boilers with low- or zero-carbon heating systems and private and public charging points for electric cars.

The Commission's assessment finds that Finland's plan devotes 27% of its total allocation on measures that support the digital transition. The plan includes measures to improve high-speed internet connectivity, particularly in rural areas, support the digitalisation of businesses and the public sector, enhance digital skills of the workforce and support the development of key technologies such as artificial intelligence, 6G and microelectronics.

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Reinforcing Finland's economic and social resilience

The Commission considers that Finland's plan includes an extensive set of mutually reinforcing reforms and investments that contribute to effectively addressing the economic and social challenges outlined in the country-specific recommendations addressed to Finland in recent years.

It contains a broad set of reform measures to raise the employment rate and strengthen the functioning of the labour market, ranging from the transformation of Public Employment Services to improving and facilitating access to social and healthcare services. The plan includes specific measures to provide integration support for young people and people with partial work-capacity. The plan also includes measures to strengthen the effective supervision and enforcement of Finland's anti-money laundering framework.

The plan represents a comprehensive and balanced response to the economic and social situation of Finland, thereby contributing appropriately to all six pillars referred to in the RRF Regulation.

Supporting flagship investment and reform projects

Finland's plan proposes projects in all seven European flagship areas. These are specific investment projects, which address issues that are common to all Member States in areas that create jobs and growth and are needed for the green and digital transition. For instance, Finland has proposed to provide €161 million to investments in new energy technologies and €60m toward the decarbonisation of industrial processes to support the green transition. To support the digital transition, the plan will invest €50m in the rollout of rapid broadband services and €93m to support the development of digital skills as part of continuous learning and labour market reforms.

The Commission's assessment finds that none of the measures included in the plan significantly harms the environment, in line with the requirements laid out in the RRF Regulation.

The Commission considers that the controls systems put in place by Finland are adequate to protect the financial interests of the Union. The plan provides sufficient details on how national authorities will prevent, detect and correct instances of conflict of interest, corruption and fraud relating to the use of funds.

Commission President Ursula von der Leyen said: “I am delighted to present the European Commission's endorsement of Finland's €2.1bn recovery and resilience plan. I am proud that NextGenerationEU will make a significant contribution to support Finland's goal to become carbon neutral by 2035. The plan will also help bolster Finland's reputation for excellence in innovation with support for the development of new technologies in areas such as artificial intelligence, 6G and microelectronics. We will stand with Finland throughout the plan's implementation to ensure that the reforms and investments it contains are fully delivered.”

An Economy that Works for People Executive Vice President Valdis Dombrovskis said: “The Commission has today given its green light for Finland's recovery and resilience plan, which will set the country on a greener and more digital path as it recovers from the crisis. This plan will help Finland to meet its ambitious carbon-neutrality target by 2035, with reforms and investments that will reduce carbon emissions from energy production, housing, industry and transport. We welcome its focus on high-speed connectivity, particularly for sparsely populated areas to help maintain their economic activity, and on digitalising smaller businesses and the public sector. With reforms to boost employment and strengthen the labour market, Finland's plan will promote smart, sustainable and inclusive growth once it is put into effect.”

Economy Commissioner Paolo Gentiloni said: “Finland's €2.1bn recovery and resilience plan is strongly focused on the green transition. No less than 50% of its total allocation is set to support climate objectives, helping to speed the country towards its ambitious target of carbon neutrality by 2035. The plan also contains an array of measures to boost Finland's already strong digital competitiveness. I particularly welcome the Finnish plan's strong social elements, with measures to raise the employment rate, tackle youth unemployment and facilitate access to social and healthcare services.”

Next steps

The Commission has today adopted a proposal for a decision to provide €2.1bn in grants to Finland under the RRF. The Council will now have, as a rule, four weeks to adopt the Commission's proposal.

The Council's approval of the plan would allow for the disbursement of €271m to Finland in pre-financing. This represents 13% of the total allocated amount for Finland.

The Commission will authorise further disbursements based on the satisfactory fulfilment of the milestones and targets outlined in the recovery and resilience plan, reflecting progress on the implementation of the investments and reforms. 

More information

Questions and Answers: European Commission endorses Finland's €2.1bn recovery and resilience plan

Factsheet on Finland's recovery and resilience plan

Proposal for a Council Implementing Decision on the approval of the assessment of the recovery and resilience plan for Finland

Annex to the Proposal for a Council Implementing Decision on the approval of the assessment of the recovery and resilience plan for Finland

Staff-working document accompanying the proposal for a Council Implementing Decision

Recovery and Resilience Facility

Recovery and Resilience Facility: Questions and Answers

Recovery and Resilience Facility Regulation

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