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Assessing #HealthTechnology in the EU: Commission proposes to reinforce co-operation among member states

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Today (31 January) the Commission has put forward a proposal to boost co-operation among member states for assessing health technology. Greater transparency will empower patients, by ensuring their access to information on the added clinical value of new technology that could potentially benefit them. More assessments could lead to effective, innovative health tools reaching patients faster. For national authorities it means being able to formulate policies for their health systems based on more robust evidence. Furthermore, manufacturers will no longer have to adapt to different national procedures.

Vice President Katainen said: "Reinforcing Health Technology Assessment co-operation at EU level boosts innovation and improves competitiveness of the medical industry. The health-care sector is a crucial part of our economy, it accounts for approximately 10% of the EU's GDP. We are proposing a regulatory framework that will bring benefits to patients all over Europe, whilst encouraging innovation, helping the take-up of high-quality medtech innovations and improving the sustainability of health systems across the EU."

Health and Food Safety Commissioner Vytenis Andriukaitis added: "Today, the Commission has put the wheels in motion for better quality, innovative health care for the benefit of patients, especially those with unmet medical needs. I also expect this initiative to result in a more efficient use of resources by member states through the pooling of resources and exchanges of expertise, thereby avoiding duplications in the assessment of the identical products."

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The proposed Regulation on Health Technology Assessment (HTA) covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas. Member states will be able to use common HTA tools, methodologies and procedures across the EU, working together in four main areas: 1) on joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients; 2) on joint scientific consultations whereby developers can seek advice from HTA authorities; 3) on identification of emerging health technologies to identify promising technologies early; and 4) on continuing voluntary cooperation in other areas.

Individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.

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Next steps

The proposal will now be discussed by the European Parliament and the Council of Ministers. It is expected that once it is adopted and enters into force, it will become applicable three years later. Following the date of application, a further three-year period is envisaged to allow for a phase-in approach for Member States to adapt to the new system.

Background

The proposal comes after more than 20 years of voluntary cooperation in this area. Following the adoption of the Cross-border Healthcare Directive (2011/24/EU), a voluntary EU-wide network on HTA composed of national HTA bodies or agencies was established in 2013 to provide strategic and political guidance to the scientific and technical co-operation at EU level. This work, complemented by three consecutive Joint Actions[1] on HTA, has enabled the Commission and member states to build a solid knowledge base on methodologies and information exchange with regards to the assessment of health technology.

Cooperating on HTA on a sustainable basis at EU level should ensure that all EU countries can benefit from the efficiency gains, maximising EU-added value. Strengthened EU-cooperation in this area is widely supported by stakeholders interested in patients' timely access to innovation. Stakeholders and citizens who responded to the Commission's public consultation showed overwhelming support, with almost all (98%) acknowledging the usefulness of HTA and 87% agreeing that EU cooperation on HTA should continue beyond 2020.

More information

Q&A: Commission proposal on Health Technology Assessment

@EU_Health

[1] EUnetHTA Joint Action 1, 2010-2012,) EUnetHTA Joint Action 2, 2012-2015 and EUnetHTA Joint Action 3, 2016-2019

European Central Bank (ECB)

ECB's Lagarde keeps door open to higher inflation

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Inflation in the eurozone could exceed the European Central Bank's already raised projections but there are few signs of this already happening, ECB President Christine Lagarde (pictured) said on Monday (27 September), writes Balazs Koranyi, Reuters.

"While inflation could prove weaker than foreseen if economic activity were to be affected by a renewed tightening of restrictions, there are some factors that could lead to stronger price pressures than are currently expected," she told lawmakers at the European Parliament.

"But we are seeing limited signs of this risk so far, which means that our baseline scenario continues to foresee inflation remaining below our target over the medium term," she added.

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European Commission

NextGenerationEU: European Commission disburses €231 million in pre-financing to Slovenia

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The European Commission has disbursed €231 million to Slovenia in pre-financing, equivalent to 13% of the country's grant allocation under the Recovery and Resilience Facility (RRF). The pre-financing payment will help to kick-start the implementation of the crucial investment and reform measures outlined in Slovenia's recovery and resilience plan. The Commission will authorise further disbursements based on the implementation of the investments and reforms outlined in Slovenia's recovery and resilience plan.

The country is set to receive €2.5 billion in total, consisting of €1.8bn in grants and €705m in loans, over the lifetime of its plan. Today's disbursement follows the recent successful implementation of the first borrowing operations under NextGenerationEU. By the end of the year, the Commission intends to raise up to a total of €80 billion in long-term funding, to be complemented by short-term EU-Bills, to fund the first planned disbursements to member states under NextGenerationEU.

The RRF is at the heart of NextGenerationEU which will provide €800bn (in current prices) to support investments and reforms across member states. The Slovenian plan is part of the unprecedented EU response to emerge stronger from the COVID-19 crisis, fostering the green and digital transitions and strengthening resilience and cohesion in our societies. A press release is available online.

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Cyprus

NextGenerationEU: European Commission disburses €157 million in pre-financing to Cyprus

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The European Commission has disbursed €157 million to Cyprus in pre-financing, equivalent to 13% of the country's financial allocation under the Recovery and Resilience Facility (RRF). The pre-financing payment will help to kick-start the implementation of the crucial investment and reform measures outlined in Cyprus' recovery and resilience plan. The Commission will authorise further disbursements based on the implementation of the investments and reforms outlined in Cyprus' recovery and resilience plan.

The country is set to receive €1.2 billion in total over the lifetime of its plan, with €1 billion provided in grants and €200m in loans. Today's disbursement follows the recent successful implementation of the first borrowing operations under NextGenerationEU. By the end of the year, the Commission intends to raise up to a total of €80bn in long-term funding, to be complemented by short-term EU-Bills, to fund the first planned disbursements to member states under NextGenerationEU. Part of NextGenerationEU, the RRF will provide €723.8bn (in current prices) to support investments and reforms across member states.

The Cypriot plan is part of the unprecedented EU response to emerge stronger from the COVID-19 crisis, fostering the green and digital transitions and strengthening resilience and cohesion in our societies. A press release is available online.

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