June 2019

Avicenna Monthly Newsletter 

Key highlights

  • The Finnish Presidency is ready to chair the working groups of the Council of the EU for the next six months
  • Applications are open to join the European Commission's expert panel of health investments (deadline 15 July 2019).
  • Sign the online petition to promote adoption of in silico trials through EMA’s strategy on Regulatory Science to 2025!
Policy Updates

The Finnish Presidency publishes its work program

Finland's Presidency of the Council of the EU published its program for the next six months (1 July to 31 December 2019). As the middle member of the current Trio of Presidencies, Finland takes over from Romania and will pass on the torch to Croatia at the end of the year. The key priorities of the Finns’ agenda include:

  1. Strengthening common values and the rule of law;
  2. Making the EU more competitive and socially inclusive.
  3. Strengthening the EU’s position as a global leader in climate action;
  4. Protecting the security of citizens comprehensively.

Under the second priority area, the digitalisation of the health sector is seen as an important driver for new business opportunities and social inclusion. Horizon Europe is seen as the key framework help boost the technological change, which includes the exploitation of the full potential of Big Data and artificial intelligence. 

Finland’s openness to digitalisation is an opportunity to the Alliance to push for the inclusion of CM&S into the Council’s work programme.

This Presidency will also seek to finalise the Council negotiations on the multiannual financial framework (MFF) for the period 2021−2027 period.

European leaders adopt future Strategic Agenda 

During the last European Council meeting on 20 June, the EU leaders discussed appointments to the institutions’ top jobs, adopted the new Strategic Agenda and conclusions on EU’s long-term budget.
The Strategic Agenda is intended to guide the work of the European Union for the next institutional cycle, and focuses on four priority areas:  

  1. Protecting citizens and freedoms: notably on migration and asylum policy.
  2. Developing a strong economic base: EU leaders acknowledged the need to ensure that the EU is digitally sovereign, and the EU must work on all aspects of the digital revolution and AI: infrastructure, connectivity, data, regulation and investment. It was also underlined that Member States have to do more to foster innovation and increase research efforts, in particular by addressing the fragmentation of European research, development and innovation, and by encouraging and supporting public and private investments. 
  3. Building a climate neutral, fair and social Europe: the agenda also brings attention to social issues, including good access to healthcare. 
  4. Promote European values on the global stage.

In the European Council Conclusions the European leaders also report the decisions taken regarding the Multiannual Financial Framework 2021-2027. They notably called on Finland’s Presidency (July-December 2019) to continue the work on the file and to further develop the Negotiating Box - the latest version of the document, which will serve to clarify the options on the negotiating table, can be found here. The European Council will hold a more in-depth exchange of views in October, aiming for an agreement before the end of the year. 

More information about the European Council meeting can be found here

European Strategy for High Performance Computing 

On the 17 June, the European Commission published a presentation explaining why they indicated High Performance Computing (HPC) as a priority area for investments, and showing some concrete examples. IThe document notably mentions personalised healthcare and medicines discovery among the top applications, and refers to the concept of digital twins, even if related to the transport sector. This shows that the European Commission is gradually opening to the advocating messages brought forward by the Alliance and its Members. 

Irish and German delegations raise issues on MDR implementation

On 6 June, the Irish and German delegations addressed a note to the Council of the EU, regarding the implementation of Regulation (EU) 2017/745 on medical devices (MDR). With its entry into force in May 2020, an increasing number of discussions are highlighting concern about the challenges facing each stakeholder in the sector (manufacturers, notified bodies, authorised representatives, etc.) in implementing the Regulation on time and effectively. Much of the concern raised to date relates to the availability and capacity of notified bodies for medical devices. A confidential source from DG GROW (DG for the European Internal Market) reported that 40 applications are currently ongoing, while at present only two notified bodies have been confirmed (UK, DE). By the end of 2019, 20 notified bodies should receive a renewed authorisation.

If from one side this represents a challenge for a smooth implementation of the new MDR, on the other side this is also an opportunity for the Avicenna Members to enter into contact with the candidate notified bodies in order to stress the importance of a strong expertise in CM&S. 

Full information on the Irish and German note can be found at this link

Benchmarking of national innovation procurement policies

Interested to know if your country already has an action plan, target, financial incentives and a competence center for boosting innovation procurement?

The European Commission has just released a benchmarking aiming at mapping the progress made in each country on implementing a mix of policy measures to mainstream innovation procurement across all sectors of public interest. It allows to evaluate countries' performance in this field and assesses the maturity of their policy system, enabling the European Commission to better develop policy recommendations to strengthen the public demand drive for innovation in the whole EU. In addition to presenting national scores, an analysis of the main differences and commonalities between countries and clusters of countries is also provided.
Top-3 performers are Finland, Austria and the Netherlands, while the lowest performers are Croatia, Portugal and Switzerland. 

Check out the consolidated results of the benchmarking of the national policy frameworks for innovation procurement across the 28 EU Member States, Norway and Switzerland.

Call for applications for membership of the expert panel of health investments

The European Commission has opened a call for experts to join its multi-sectoral and independent Expert Panel providing advice to the Commission on effective ways of investing in health. The Panel serves as a mechanism to further develop knowledge and expertise of health systems that can inform policies at national and at EU level. The Avicenna Members who are scientific expert may be interested in applying for this opportunity. In parallel, Members who may already be working with experts may find it useful to encourage such experts to submit an application to the Commission to partake in this panel. 
The opinion of such experts may influence the shaping of legislation at the European and Member State levels, allowing to potentially positioning in silico medicine as a priority policy area. The deadline for submission is 15 July 2019.

EFPIA Publishes Opinion Piece on AI and Cancer Data 

The European Federations of Pharmaceutical Industries and Associations (EFPIA) has recently published an opinion piece on cancer data. The piece was drafted by Ivana Cattaneo, the Public Affairs Director Oncology Europe at Novartis, and is entitled “Cancer data: Are you ready to meet your DigiTwin?”.

In her article, Ms. Cattaneo states that the development of predictive models and purpose-built computational approaches, including AI, means that the idea of creating a DigiTwin – a digital twin – is fast becoming a possibility.  Ms. Cattaneo believes that an agreement at EU level – reflected in national cancer plans – is vital to progress on the use of data and would help put in place policies that help turn data into innovation. She believes that data can be used to realise the potential of personalised medicine whilst also making healthcare systems sustainable and efficient. She also states that data can ultimately be used to help balance the issues surrounding the “trilemma” of access, innovation and affordability. This opinion piece indicates that EFPIA, and more specifically its member Novartis, are developing a genuine interest on in silico medicine.

Scientific and Regulatory News
Goods results coming from a clinical trial using digital twin of the patient’s eyes

Optimo Medical has recently published the first clinical study with its digital twin of the patients’ eyes, used in daily clinical practice to plan and predict eye surgery outcomes (JCRS Journal). Virtual surgeries were performed on a cohort of patients to compare the performance of its simulation-based approach to results based on Lindstrom and Donnenfeld nomograms, and to intrastromal interventions. A new approach is proposed to plan arcuate keratotomy based on personalized finite element simulations. Based on this numerical tool, an optimization algorithm was implemented to determine the incision parameters that best met the surgeon’s requirements while preserving the orientation of the astigmatism. The study concluded that using numerical modelling to optimize surgical parameters for arcuate keratotomy leads to more reliable postoperative astigmatism and limits the risks of over-correction.

Funding Opportunities
Open Info Day, Horizon 2020 - 'Health, demographic change and wellbeing'

On the 3 July, the European Commission is organizing an Info Day on to share information on how to apply for Horizon 2020 calls, along with upcoming funding opportunities. 

With the principle of 'better health for all' at its core, Horizon 2020's Societal Challenge 1 (Health, demographic change and well-being) focuses on:

  • personalised health and care
  • infectious diseases and improving global health
  • innovative and sustainable health systems
  • decoding the role of the environment (including climate change) for health and well-being
  • digital transformation
  • cyber security in health and care

Horizon 2020 Societal Challenge 1 work programme for 2020 (2020 Health calls) will be expected to offer calls for proposals with an overall budget of about €650 million. 
If you wish to attend in person you can register here, otherwise the link for the web streaming will be available on 2 July on the Commission website

Events and Webinars
Enhancing Transatlantic Cooperation on AI

The Avicenna Secretariat is attending the event on 3 July on ‘Enhancing Transatlantic Cooperation on AI’. The aim is to consider the strengthening  the partnerships between North America and Europe, with a new focus on AI, in order to fact the growing Chinese influence. Participants will discuss the opportunities for cooperation and collaboration between the United States, Canada, and the EU as they pursue AI strategies, and the ways in which policymakers and stakeholders can enhance these efforts. This event is not limited to healthcare but encompasses all AI strategies. The Secretariat will report back any useful information for the Avicenna Alliance. 

The Future of Better Regulation in the US and in the EU 

During this seminar organised by CEPS’ Governance, Regulation, Innovation, Digital Economy (GRID) unit, the participants will explore avenues for cooperation and convergence between the US and EU regulatory systems. The event will take place in Brussels on 10 July, from 9:30 to 11:30. The agenda and other practical details can be found at this link. If interested, registrations are now open. 

Members' News

Promote adoption of In Silico Trials through EMA’s strategy on Regulatory Science to 2025

Sign the online petition. More signature we collect, more changes we will have to make the difference!

The European Medicine Agency (EMA) has recently published a document that describes its strategy until 2025. It recognizes the importance of emerging technologies in general and modelling and simulation, also known as in silico methods, in particular. However, the document tends to stress the value of in silico methods almost exclusively in connection with the reduction of animal experimentation. While we agree that this is a relevant application for such methods, it is not the only one and likely not the most impactful one for the patient and for the industry. The term In Silico Trials indicates a number of use cases, not only related to pre-clinical evaluation, but also to the reduction, refinement, and in some cases even replacement of clinical trials.

The VPH Institute together with the Avicenna Alliance, the Insigneo Institute for in silico Medicine and the Alma Mater Studiorum, University of Bologna has drafted an open letter, which will be sent to Prof Guido Rasi - the Director of EMA to raise our collective voices on this regard. Here you can find the full text.

We wish to collect signatures on the document by as many experts in academia and industry as possible to make sure our voice is heard. We encourage you all to take a minute of your time to fill up this form and help us raising the awareness of your colleagues on this matter.
Your help will make the difference!

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