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December 2019

Avicenna Monthly Newsletter 

Key highlights

  • EU Health Ministers discuss Economy of Wellbeing, European pharmaceutical policy and Medical Devices in Brussels

  • The Avicenna Alliance is proud to announce the newest additions to its list of members: Virtonomy & CADFEM Medical!

  • The European Commission’s work on Europe’s Cancer Plan will be officially launched on 4 February 2020

A few words from Thierry Marchal, Secretary General of the Avicenna Alliance

As the year is coming to an end and Christmas is just around the corner, I would like to thank all our members for another fantastic year for the Avicenna Alliance.

2019 has seen a nice increase in the number of members together with a growing impact to promote the adoption of in silico approach.

The activities of the Avicenna Alliance could not be successful without the crucial contribution of its Working Group Leaders and Treasurer working pro bono for the Alliance despite their incredibly busy agendas: 
  • Prof Liesbeth Geris, Managing Director VPHi, Professor at ULiege & KU Leuven, Research & Technology Working Group Leader
  • Emmanuelle Voisin, CEO VCLS, Policy Working Group Leader
  • Markus Reiterer, Distinguished Scientist at Medtronic, International Working Group Leader
  • Francois-Henri Boissel, CEO Novadiscovery, Treasurer
I would like to personally as well as in the name of the Avicenna Alliance thank them for committing so much time and bringing their invaluable contribution to the management and the growth of the Avicenna Alliance.

Let me wish you all a Merry Christmas and a Very Happy and Fruitful New Year!

Thierry Marchal
Policy Updates

EU Health Ministers meeting discusses health and EU's pharmaceutical policy

On 9 and 10 December, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting, gathering all EU health Ministers took place. 

The meeting, chaired by the Finnish Presidency, was structured around two ministerial discussions: health as an essential component of the Economy of Wellbeing and the EU’s pharmaceutical policy.


Economy of Wellbeing
 During the discussion on the Economy of Wellbeing, based on a note from the Council Presidency entitled “Economy of Wellbeing – next steps in investing in health as its key component”, Ministers exchanged views on digital transformation of health and social services, mental health, as well as ageing. 

 With regard to information exchange between Member States, many delegations referred to the creation of a European Health Data Space, pointing out the importance of ensuring the interoperability and transparency of such a space. On this matter, Health Commissioner Kyriakides stated that the Commission considers the EU health data space as a priority and that the cross-border initiation with e-prescriptions has already begun. 


European Pharmaceutical Policy
 The policy debate on “European pharmaceutical policy - strengthened cooperation and coordination with the aim to improve access to medicines” was preceded by the publication of a note from the Council Presidency introducing the issue and referring to the four phases of a medicine’s lifecycle: research and development, new medicines, price competition, and old medicines.

 Stella Kyriakides, European Commissioner for Health and Food Safety, stated that the Commission is working with Member States and the European Medicines Agency (EMA) to tackle medicines shortages, which is one of priorities listed in her mission letter along with medicines affordability.

 It was further explained that the ongoing evaluation of the EU Orphan Regulation as well as Paediatrics Regulation will enable to better assess how to provide access to safe and effective medicines in areas of unmet needs. The evaluation outcome should be available at the beginning of 2020, and further measures will be decided afterwards. Ms. Kyriakides hoped that by the end of 2020 the Commission should be able to publish a new plan for tackling medicine shortages.


Medical Devices
 The Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices (IVDR), will both enter into application in May 2020. The Health Commissioner, Stella Kyriakides, and Health Ministers acknowledged that some of the provisions of the MDR and IVDR will be difficult to implement according to the set timeline.

 The Commissioner acknowledged that the implementation of the European Database on Medical Devices (EUDAMED) could be delayed by two years, outlining that this delay would have no repercussions on the general implementation of the regulations.

For more information, please feel free to contact the Avicenna Secretariat.  

Europe’s Beating Cancer Plan

On 10 December, the new Health Commissioner Kyriakides delivered a keynote speech on Europe’s Cancer Plan. 
 
During her speech, Commissioner Kyriakides informed that, as cancer should be approached horizontally, her Plan will be based on a health-in-all policies approach. In this regard, she highlighted five key focus areas:

  1. Prevention;
  2. Screening and early diagnosis;
  3. Access to optimal treatment;  
  4. Quality of life in survivorship;  
  5. Palliative care & better data and eHealth.
The Health Commissioner Stella Kyriakides made clear that the Commission is eager to work in close collaboration with the European Parliament and all stakeholder groups active in the field of oncology. This is well exemplified by the announcement of a stakeholder event that will take place on 4 February in the European Parliament.
 
On 4 February 2020, the Commission’s work on Europe’s Cancer Plan will be officially launched in an event that will take place in the European Parliament, and will be organised in close collaboration with the MEPs Against Cancer Interest Group. All cancer stakeholders have been invited by the European Commissionner to contribute to this discussion. 

More information about the launch of the European Cancer plan can be found here

European Parliament approves annual budget 2020 

On 27 November the European Parliament endorsed the annual EU budget 2020 by 543 votes to 136, with 26 abstentions. The budget established the expenditures and revenues of one year and focuses on the key priorities such as economic growth and competitiveness, action against climate change as well as policy fields such as security and home affairs.

 The total amount of the budget amounts to €168.68 billion commitments (+1.5% compared to the 2019 budget) and €153.56 billion in payments (+3.4% compared to the 2019 budget).

 With regard to the policy field of health the extension of Horizon 2020’s budget on health programmes and projects can be positively outlined. However, the budget on health is relatively low in comparison to other key policy areas such as competitiveness and climate.

Health

The budget of programmes included within Horizon 2020’s subfield, “Improving lifelong health and well-being”, was increased by €34 million. In light of this, the fight against cancer is explicitly mentioned as a priority. 
The importance of supporting efforts to encourage the dissemination of best practice in the health care sector, and support the uptake of innovations empowering older persons to remain active, was also included in the document.

Research and innovation
The financial support for the European Union’s research programme Horizon 2020 is outlined. The sub-budget for enhancing access to risk finance for investing in research and innovation was shortened by €73,5 million.
However, the financial capacities intended to strengthen research in the future and emerging technologies were raised by €6 million.

For more information, please feel free to contact the Avicenna Secretariat.  

 
Advocacy
Enabling the digital transformation of health and care

On 18 December the European Parliament adopted in plenary a motion for resolution entitled “Enabling the digital transformation of health and care”.  This motion for resolution is a call from the Members of the European Parliament asking the European Commission and Member States to take the necessary steps to guarantee access to and sharing of personal health data while applying the GDPR rules meticulously and to fulfil the need for better health data and for better digital tools.


In order to guarantee access to and sharing of personal health data, the European Parliament:

  • Calls the Commission and the Member States to exchange best practices on the sharing of health data;
  • Calls the Commission to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe; 
  • Asks the Commission and the Member States to use real-world data for regulatory decisions on medicines to complement evidence from randomised-controlled clinical trials.
In order to fulfil the need for better health data, the European Parliament asks the European Commission:
  • To set up a platform on the application of the Medical Devices Regulations to digital therapeutics and combination products, with specific attention to the needs of start-ups and SMEs;
  • To establish European coordinated action to support the secure exchange and linkage in practice of genomic and other health data in order to advance the progress of researchers and personalised medicine.
For more information, please feel free to contact the Avicenna Secretariat.  
 
ECDC's call for expression of interest in digital technologies on public health key functions

The European Centre for Disease Prevention and Control (ECDC) opened a call for expressions of interest on digital technologies for public health key functions. This is an opportunity for European societies, professional associations and industry representations to participate in technical consultation meetings at the ECDC

The aim of the meeting(s) is to support ECDC in assessing the possible beneficial and/or disruptive impact of current and emerging digital technologies on public health key functions within the remit of the Centre and provide a forward look covering a period of 7-10 years.

At the level of the organization, the following requirements of eligibility will apply:

  1. Legally established within the EU/EEA as an umbrella organization, for example, a registered European learned society, professional association or industry representation;
  2. Active in digital technologies and innovations and/or public health key functions as to provide expertise, practical examples and references describing the possible application of digital technologies and innovation to public health key functions;
  3. Able to fund an individual representative’s participation in the activity and ensure high-level expertise and active contribution;
  4. Upon request of ECDC to ensure the submission of an individual declaration of interest and CV, demonstrating relevant competence and expertise of the individual representative;
  5. English language skills.
If you are interested to apply more information can be found here.
Scientific News
René Medema appointed new chair of EU-LIFE

Professor René Medema, Director of Research of the Netherlands Cancer Institute, has been appointed the new chair of EU-LIFE, an alliance of research centres in life sciences which is advocating for excellent research in the life sciences in Europe. EU-Life released, earlier this year, a position paper urging the European Commission to use Horizon Europe to invest more in collaborative research for health and medicine.


René Medema, cell biologist, has served as director of research and chair of the Board of Directors of the Netherlands Cancer Institute. He also leads a cell biology research group and serve as Professor of Experimental Oncology at Utrecht University.

René Medema succeeds Genevieve Almouzni (Institut Curie, Paris). Together with the vice-chair Professor Mónica Bettencourt Dias of (Instituto Gulbenkian de Ciência, Portugal). He will enter in office on 1 January 2020 and is expected  to overview the EU-LIFE strategy for the next 2 years.

More information can be found here.

EU-funded doctoral programme BIOMEP are conducting research that could lead to breakthroughs for the treatment of a variety of diseases

Fifteen students are conducting research in the EU-funder doctoral programme BIOMEP that could lead to breakthroughs for the treatment of a variety of diseases, including osteoarthritis and cancer.

The doctoral programme brings together 8 leading European research groups in the field of Biomedical Engineering and Medical Physics and major private industrial companies and university hospitals.

BIOMEP supports research on bio-signals, brain-scanning techniques, imaging at molecular, cell and tissues levels as well as musculoskeletal biomechanics and biomedical devices and diagnostics. The projects aims to improve the new generation of academics, industry and hospitals experts needs to emerge and fulfill the demand for highly-qualified biomedical engineers and medical physicists in Europe.
More information can be found here.

Welcome to the New Avicenna Members!

Virtonomy

Virtonomy is shortening time-to-market of medical products by conducting data driven studies on virtual patients. Our solution is based on an ever-expanding database to reflect anatomical variability, demographic diversity and pathological conditions.

We support medical device manufacturers in the various phases of the product life cycle, from concept phase, over pre-clinical evaluation to post-market surveillance: better understand the target anatomy, find the optimal fit of the device to treat the maximum number of patients, identify the right in-vivo model, and improve clinical trials by proper sub-population selection.

Virtonomy is headquartered in Munich, Germany, and combines an interdisciplinary team of experts in medical engineering, image and data processing, visualization and clinical practice.

Find out more about Virtonomy...

CADFEM Medical 

CADFEM Medical is a certified manufacturer of software “as a medical device” and offers the innovative simulation platform called docq, which enables manufacturers of medical devices, doctors and medical staff themselves to use simulation for a better and safer patient care.

The CADFEM Medical team also dedicates its consulting services to the application of simulation in the approval process of medical devices and has extensive regulatory know-how in this field of application.

Due to the extensive activities in research, CADFEM Medical is constantly working on new application of simulation in medicine and medical technology and develops these further as products in cooperation with renowned manufacturers

Find out more about CAFDEM Medical...

The Avicenna Secretariat wish you a merry Christmas, happy holidays and a great start into the New Year 2020!
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