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Boosting cooperation on health technology assessment

15-07-2021

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While ...

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While Member States could choose to delay participation in the joint work until three years after the rules enter into force, it would become mandatory after six years. Stakeholders broadly welcomed the Commission proposal. National parliaments, however, are divided in their appreciation of it. The provisional agreement, applauded by some stakeholders, has been criticised by the pharmaceutical industry, in particular, for its lack of ambition. The European Parliament adopted its final position at first reading on 14 February 2019. In the Council, work was carried out under seven consecutive presidencies. On 24 March 2021, the co-legislators reached a provisional agreement in interinstitutional trilogue negotiations. The Council's Permanent Representatives Committee endorsed the provisional agreement on 30 June 2021. Parliament's ENVI committee voted in favour of the text on 13 July 2021. Council and then Parliament are expected to formally adopt it in the coming months. Fourth edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Strengthening EU cooperation on health technology assessment

18-06-2018

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical ...

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical technologies sector (95 %), more emphasis could have been put on analysing the impacts of the retained options on them. The stakeholders' views have been illustrated in a satisfactory way. The evidence included or referenced in the IA is copious and up to date. The IA appears to have addressed most of the RSB's recommendations. Finally, the legislative proposal appears to be consistent with the analysis carried out in the IA.

Understanding European Reference Networks: Cooperation on rare diseases across Europe

09-06-2017

European Reference Networks (ERNs) are newly established virtual platforms for voluntary cross-border collaboration between specialists in rare and complex diseases. ERNs were set up under Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, and go back to a 2009 Council recommendation on an action in the field of rare diseases. Since specialist knowledge of rare diseases is both scarce and scattered across countries, the EU-level cooperation afforded by ERNs is ...

European Reference Networks (ERNs) are newly established virtual platforms for voluntary cross-border collaboration between specialists in rare and complex diseases. ERNs were set up under Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, and go back to a 2009 Council recommendation on an action in the field of rare diseases. Since specialist knowledge of rare diseases is both scarce and scattered across countries, the EU-level cooperation afforded by ERNs is regarded as bringing added value through maximising synergies. Currently, 24 thematic ERNs involve more than 900 specialised healthcare teams in over 300 hospitals in 25 EU Member States plus Norway. A public consultation fed into the establishment of the ERNs, and a number of stakeholder views were presented on the occasion of their launch. The ERN initiative has generally been well received. According to stakeholders, its strengths include opportunities for carrying out research and new treatments, breaking the isolation of specialists and patients, reducing inequalities in care, and fostering patient involvement. Among the challenges that need to be addressed, stakeholders mention questions concerning reimbursement, interoperability and data confidentiality, and legal issues. The ERNs are currently in their deployment phase, and expected to reach full capacity over the next five years.

Medical devices and in vitro diagnostic medical devices

10-05-2017

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June and confirmed by Parliament's ENVI Committee on the same day. Both draft texts were adopted by the Council on 7 March 2017, and Parliament's second-reading vote on 5 April completed the adoption procedure. The regulation on medical devices will become fully applicable in May 2020, and that on in vitro diagnostic medical devices in May 2022.

Public expectations and EU policies - Health and social security

30-06-2016

Almost two thirds of EU citizens would like to see more EU engagement in the areas of health and social security. The EU's main role in these policies is to support and complement the activities of Member States, and it can encourage cooperation and best practice. EU health policy aims to foster good health, protect citizens from health threats and support dynamic health systems. Social policy promotes social cohesion equality as well as solidarity through adequate, accessible and financially sustainable ...

Almost two thirds of EU citizens would like to see more EU engagement in the areas of health and social security. The EU's main role in these policies is to support and complement the activities of Member States, and it can encourage cooperation and best practice. EU health policy aims to foster good health, protect citizens from health threats and support dynamic health systems. Social policy promotes social cohesion equality as well as solidarity through adequate, accessible and financially sustainable social protection systems and social inclusion policies. The EU encourages national pension reforms to ensure they are both adequate and sustainable. In the EU budget, the Health Programme 2014-2020 is the only programme specifically created for this policy area, but other programmes contribute in part to health objectives. EU spending on social security is tied to labour market measures.

Medical devices and in vitro diagnostic medical devices

07-06-2016

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the tenth trilogue meeting, agreement was reached on both proposals on 25 May 2016. The compromise centres on stricter requirements for notified bodies, stronger pre-market scrutiny and post-marketing surveillance; strengthened rules for high-risk devices and certain other categories of devices; and increased transparency and traceability. This updates a previous edition from December 2015: PE 572.819. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html

What if others could read your mind?

08-04-2016

Brain-computer interface technology has been advancing rapidly and will continue to do so as our knowledge of how the brain works increases. Could this transform our understanding of life as we know it? A brain-computer interface (BCI) is a direct communication pathway between the brain and an external device. This technology can be used to restore motor and sensory capacities which may have been lost through trauma, disease or congenital conditions. For example, combined with limb-replacement ...

Brain-computer interface technology has been advancing rapidly and will continue to do so as our knowledge of how the brain works increases. Could this transform our understanding of life as we know it? A brain-computer interface (BCI) is a direct communication pathway between the brain and an external device. This technology can be used to restore motor and sensory capacities which may have been lost through trauma, disease or congenital conditions. For example, combined with limb-replacement technology, BCI may allow patients not only to move prosthetic limbs, but also to feel the sensation of touch. The technology can either be implanted (invasive) or used externally (non-invasive). Invasive BCIs, including neuroprosthetics and brain implants, are devices which connect directly to the brain and are placed on its surface or attached to the cortex. A key application area for contemporary brain implant research is the development of biomedical prostheses to circumvent areas of the brain that have become dysfunctional after a stroke or other trauma. With deep brain stimulation, a 'brain pacemaker' sends electrical impulses to specific parts of the brain for the treatment of disorders such as Parkinson's disease, dystonia and major depression. Non-invasive BCIs consist of a range of technological devices which provide a similar interface between the brain and other machines without the need for surgery. There are several technologies capable of measuring and recording brain activity, although the signal quality may be weaker than is possible with implanted devices. Nonetheless, non-invasive BCIs have been used effectively, for example to control prosthetic hands.

Need for action on dementia recalled

12-02-2016

Dementia is one of Europe's biggest challenges in the context of demographic change. It has wide-ranging social and economic con