Health News

Urgent need to apply new rules on medical devices 14-10-2019

 
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ESIP argues for no delay in application of the MDR

At the end of May 2017, after long and intensive political debate, the new European Medical Device Regulation (Regulation EU 2017/745; MDR) entered into force. Its main goals are to increase the safety of medical devices placed on the market, to raise the requirements for the clinical evaluation of high-risk devices, to establish transparency by implementing a central database that is at least in part publicly accessible, and to harmonise the quality of Notified Bodies throughout Europe.

Regulation on orphan medicines: a target for abuse 14-06-2019

 
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Adressing the market failures in the orphan medicinal products

At the end of 2017, the European Commission launched a joint evaluation of the legislation on paediatric and orphan medicinal products (OMPs). The European Social Insurance Platform (ESIP), welcomes the initiative of evaluating Regulation nº 141/2000 on OMPs and takes this opportunity to raise concerns regarding its implementation.

For an ambitious role of the EU in health 07-05-2019

 
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ESIP position paper on EU health policy

Within its strategic recommendations to EU leaders, the European Commssion stated that the European Union needs to support high-quality, affordable and accessible healthcare. In order to ensure that this is indeed the case, healthcare payers represented by ESIP put forward a position paper on the future health policy of the EU.

Ensuring stronger rules and transparency on medical devices 27-02-2019

 
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Public health stakeholders call for timely application of new medical devices rules

The European Association of Hospital Pharmacists (EAHP), the European Hospital and Healthcare Federation (HOPE), the European Social Insurance Platform (ESIP), the International Association of Mutual Benefit Societies (AIM), Prescrire and the Standing Committee of European Doctors (CPME) call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed.

Timely application of the new medical devices rules 23-01-2019

 
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ESIP's reaction to the "Implant files"

A recent international investigation on medical implants has shed light again on the weaknesses of the system of certification of medical devices. Since 2012, ESIP has been advocating forstrengthening the rules concerning the marketing of medical devices asking in particular for an independent centralised authorisation system for the marketing of high-risk medical devices, better market transparency and improved protection for patients. 

Statement on SPC Regulation amendment 22-10-2018

 
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Public payers call for a more ambitious text on Supplementary Protection Certificates

The European Social Insurance Platform (ESIP) calls on EU legislators to ensure that patients’ access to high quality and affordable healthcare is put at the centre of the discussions on the Commission proposal to amend the EU Regulation on Supplementary Protection Certificates (SPC).

 

Moving towards effective EU cooperation on HTA 03-10-2018

 
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Adoption of the HTA report in plenary

The European Social Insurance Platform (ESIP) welcomes the adoption of the ENVI report in the plenary session of the European Parliament. The outcome of the vote largely supported the work of the ENVI Committee on the proposal for a Regulation on Health Technology Assessment (HTA), with few additional amendments.

Multi-stakeholder workshop on biosimilars 14-09-2018

 
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A crucial milestone in achieving increased patient access to biological therapies

The European Commission today organised its 4th annual workshop on biosimilar medicines, bringing together patients, specialist nurses, doctors, pharmacists, payers, academics, public authorities, and industry across Europe.

Adoption of the ENVI report on HTA 13-09-2018

 
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ESIP welcomes a balanced approach to HTA at EU level

The European Social Insurance Platform warmly welcomes the outcome of the vote in the ENVI Committee of the European Parliament on the proposal for a Regulation on Health Technology Assessment (HTA).

Medical devices in the HTA Regulation 06-07-2018

 
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ESIP supports the inclusion of a broad scope of medical devices

In view of the forthcoming votes of the European Parliament, the statutory healthcare payers represented by the European Social Insurance Platform (ESIP) advocate for the inclusion of the clinical assessment of medical devices within the scope of the EU Proposal for a Regulation on Health Technology Assessment (HTA).