This is the monthly newsletter on public affairs sent by ESTRO to national societies
This is the ESTRO Public Affairs newsletter: a monitoring service offered by ESTRO to national societies of the radiation oncology area to keep up-to-date with oncopolicy issues.
This issue of the newsletter is dedicated to "Medical Devices in the European Union" 
Focus of the Month
Medical Devices in the European Union 
Happening Across Europe at a Glance

Other News
  • E-health and cross-boarder healthcare
  • IARC launches the CanScreen5 website
  • IMI targets innovative therapies in the new cycle of calls for proposals
  • Calls for Proposals 
Medical Devices in the European Union

Between the Member States, the European Commission and the European Parliament the topic of  medical devices is being discussed. Last month, Health ministers met in Luxembourg to discuss their concerns over the implementation of the EU medical devices regulation and Health Technology Assessment. Delegates from the Health Council discussed concerns of the implementation of Regulation (EU) 2017/745 on medical devices (MDR). Several delegations expressed concern about the readiness to implement the regulation by 2020. The concern is mainly related to the availability and capacity of notified bodies for medical health devices under the new regulation. Challenges here-with are at the national and EU – level largely looking at the requirement of technical systems and secondary legislation.

The Council further discussed the state of paly on the proposal for a regulation on health technology assessment, congratulating the work carried out by the previous Presidency. Mainly for, the  accomplishments on outcomes of joint scientific consultations on the identification of emerging health technologies and the support framework to tackle these issues.

Ministers wrapped up the meeting by discussing key EU funding programmes in the 2021 -2027 multi-annual financial framework. These include:

Horizon Europe, the Digital Europe Programme, the Connecting Europe facility, the Health Strand in the European Social Fund Plus (ESF+), the Cohesions Policy funds and the Invest EU Programme.

Developments on this dialogue is expected by the end of 2019. 

Read more here

Medical devices: more safety, more traceability
"Pre-market scrutiny of high-risk devices was a priority for the Parliament so I'm particularly pleased that we successfully pushed for this and that these devices will now undergo additional assessment from expert panels"
- Glenis Willmot former ENVI Rapporteur S&D
2017 EP press release  

BELGIUM >>  promotes health apps and shows the interest to invest  Read more here
>> For a list off apps validated by the Belgian authorities visit the platform 

FRANCE >> confronted with important decisions on subsidized medicines and medical treatment. The ANSM is reviewing the medical cannabis trial's proposals while taking steps back on homeopathy reimbursement.  
>> continues the watch on the opioid matter. A group of 90 doctors met to discuss the associated risk of a crises in the future Read more here

IRELAND >> green light to use of limited cannabis after a new law Read more here 

ITALY >> pushes for transparency on drug pricing Read more here 


The UK >> the government presented a plan to ensure continued supply of medicines and medical products to patients across the UK in the case of a no-deal EU exit on October 31 Read more here
>> Lloyd’s Register Quality Assurance announced that it would withdraw its application to work under the new Medical Device Regulation (MDR) Read more here

GERMANY & FRANCE  >> signed an agreement to enhance cross-border cooperation Read more here  

ITALY & the UK  >> falsified drugs have traveled from Italy to the UK without being identified by Europe's track and trace system. The directive still has to be implemented Read more here  

EU  >> The European Cancer Leagues (ECL) released a position paper on drug pricing and transparency of medicines and calls on the member states to share net prices through the EURIPID database

E-Health and cross-border healthcare 

According to the new study “Benchmarking Deployment of eHealth among General Practitioners (2018)”, the number of general practitioners who are willing to adopt e health solutions, across the EU, has doubled from 2013 to 2018. However, gaps of accessibility across the EU are recognised.  

Read more

IARC launches CanScreen5 website   

The International Agency for Research on Cancer (IARC) has presented the CanScreen5 website as a global project and good practice to collect, analyse and share information on cancer screening programmes and activities in 5 continents.  It holds data from 28 EU Member States. 

Read more

IMI targets innovative therapies in the new cycle of calls for proposals 

The Innovative Medicines Initiative (IMI) have selected advanced therapies as the core topics of the new IMI calls for proposals aimed at accelerating research and innovation for Advanced Therapy Medicinal products 

Read more here
Calls for Proposals 
IMI2 – Calls 18 & 19: updated topic texts published deadline 26 June 

Future topics:  
Call 18: two-stage
Central repository of digital pathology slides to support the development of artificial intelligence tools
Supporting the development of engineered T cells
Accelerating research & innovation for advanced therapy medicinal products
Establishing international standards in the analysis of patient reported outcomes and health-related quality of life data in cancer clinical trials
Improving patient access, understanding and adherence to healthcare information: an integrated digital health information project
Call 19: a single-stage restricted call designed for existing successful IMI consortia

For more information on the calls visit the IMI website or sign-up to the webinars from 14 -26 June


MSCA-IF-GF Global Fellowships in the area of research and innovationDeadline 11 September 

RIA Research and Innovation action: Improving low-dose radiation risk appraisal in medicine deadline 25 September 2019
CSA Coordination and support action: Research roadmap for medical applications of ionising radiation deadline: 25 September 2019

RIA Research and Innovation action: Further integrating Radiation Protection research in the EU deadline: 25 September 2019
CSA Coordination and support action: Optimised use of European research reactors deadline: 25 September 2019
RIA Research and Innovation action: Optimised fuels for production of medical radioisotopes deadline: 25 September 2019

For a list calls on the topics under the Euratom Research and Training Programme
click here
If you have any questions  please contact Gabriella Axelsson
ESTRO Public Affairs Project Manager
Copyright © 2019 ESTRO, All rights reserved.

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