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March 2020

Avicenna Monthly Newsletter 

Key highlights

  • The Avicenna Alliance is proud to announce the new membership of Servier
  • Launch of the Avicenna Members webinars
  • Join the International school on in silico trials
  • The Avicenna Alliance answers the consultation for Europe’s Beating Cancer Plan
  • Key Highlights of the new Industrial Strategy for Europe
  • European Commission's Pharmaceutical Strategy is on its way!
     
Welcome to our new Avicenna Member!
The Avicenna Alliance is proud to announce the new membership of Servier

 
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22 000 people worldwide.
 
Entirely independent, the Group reinvests on average 25% of its turnover (excluding generics) every year in research and development and uses all its profits for development.
Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.

Find out more about Servier …
Policy Updates

                  European Commission's Pharmaceutical Strategy is on its way!
 

The European Commission plans to publish a roadmap for a new Pharmaceutical Strategy in the coming days which will pave the way for the planned Pharmaceutical Strategy due in the last quarter of 2020. The European Commission is planning on re-opening a number of files related to the pharmaceutical industry.



Main objectives of the Commission:

  • The roadmap will aim to review items such as the Orphan and Pediatric Regulations, legislation on fees for the European Medicines Agency (EMA), as well as pharmaceutical legislation dating back to 2001;
  • The roadmap will seek to address the affordability of medicines for national health systems and patients, especially in smaller markets. They point to market failures, lack of competition, high prices, lack of transparency and pricing mechanism as primary factors for innovative and promising therapies not reaching patient;
  • The Commission aims to enhance EU cooperation on assessing the cost-effectiveness of drugs value, as well as pricing and reimbursement through information sharing;
  • The Commission will aim to ensure that the industry will put more focus on unmet medical needs and will become more environment-friendly by reducing pollution throughout the whole life circle of pharmaceuticals.  

This information confirms the content of the previously published Commission Work Programme for 2020 which included many of the same items and files such as the evaluation of the Orphan Medicinal Product and Paediatric Regulations and that of a Pharmaceutical Strategy.

Commission launches initiative AI-ROBOTICS vs COVID-19
 
On 25 March the European Commission launched an initiative AI-ROBOTICS vs COVID-19 with the aim to collect ideas about deployable artificial intelligence and robotic solutions as well as information on other initiatives that could help face the ongoing COVID-19 crisis. This is the first information collection launched by the Commission where stakeholders are invited to provide their input on solutions and ideas deployable immediately or within weeks to face the current healthcare crisis.

The initiative aims to create repositories that are easily accessible to all citizens, stakeholders and policymakers. Stakeholders are invited to submit input to the Commission through 3 different ways:
 
(1)    By suggesting an AI or robotic solution that have been developed and that can be deployed either immediately or in the short to mid-term in the context of disease prevention, diagnosis or treatment. 
(2)    By providing information on an AI & robotics initiative launched by individuals or stakeholders, involving a community and other stakeholders in a discussion on the role that technology and AI could play during the current healthcare crisis.
 
(3)    By suggesting ideas and exchange relevant information (including other initiatives) with the European AI Alliance through the publicly accessible forum dedicated to the discussion of ideas and exchange of information.
By launching this initiative, the Commission aims at creating two repositories, one on AI and the second on robotics in health, publicly accessible. The Commission believes that these repositories will be an additional resource part of the common European response to the outbreak of COVID-19 as this will allow the sharing of information to boost the potential of suggested solutions at an EU level.
 
The development of a quantum communication infrastructure (QCI) across Europe
 

On February 27 Austria, Bulgaria, Denmark and Romania have agreed to work together with 20 other EU Member States towards the development of a quantum communication infrastructure (QCI) across Europe. The objective now is for the signatory countries to complete their preliminary work and, by the end of this year, prepare an action plan towards building a QCI in Europe.


The purpose of the QCI will be to develop in Europe the Quantum Internet, interconnecting quantum computers, simulators and sensors to distribute information and quantum resources securely all over Europe. This initiative aims at reaching a competitive European industry in quantum technologies to make Europe a leader in the future global industrial landscape.

The European Commission, together with a large number of EU Member States, considers the settlement of a quantum secure communication infrastructure as essential to ensure the long-term storage of sensitive data in the field of healthcare. It is worth noting that the use of this new technology is in line with the objectives set by the Commission in its Communication on the European strategy for data, including the ones referring to cybersecurity and the setting up of EU Health Data Space.

During the period 2021-2027 quantum technologies will be supported by the Digital Europe programme, which will develop and reinforce Europe's strategic digital capacities, as well as the Commission’s Horizon Europe programme, contributing to research and space applications.
 
The European Consumer Organisation's publication on Europe's Digital Future and its position paper on AI in healthcare
 
On 19 February the European Consumer Organisation (BEUC) expressed its position on Europe’s Digital Future. The European Consumer Organisation had already published its position paper on Artificial Intelligence in healthcare in December 2019.





BEUC has proposed key recommendations to ensure AI’s applications in healthcare would benefit consumers and patients:
  1. Enforceable rights when it comes to the application of AI: 
    • right to transparency, explanation, and objection;
    • right to safety and security;
    • right to reliability and robustness;
    • right to accountability and control;
    • right to access to justice;
    • right to non-discrimination;
    • right to fairness.
  2. The EU should ensure that legal frameworks are established and specific safeguards are added to the legislation for the protection of health data;
  3. The EU should ensure both horizontal (cross-sectoral) and vertical (sector-specific) regulation of AI;
  4. The EU should promote the use of high-quality data to minimise potential biases and errors of AI-based decision-making.
  5. Member States and the EU should develop guidelines to ensure that the MDR is implemented in view of the new AI technologies.
  6. Member States and the EU must ensure diligent implementation of the GDPR principles and adequate use of provisions and exemptions on health research.
  7. The European Commission should evaluate the need to establish rules on anonymisation techniques of health data; data access and control when it comes from multiple sources; quality and safety standards where health data is processed;
  8. The EU should establish a network of Health Research Ethics Committees (HREC) that would develop guidelines for AI assessment in health research.
BEUC's recommendations to cover the promise of AI in health and care signifies well the tremendous promise this technology can have in healthcare.

Please have a closer look to the BEUC’s publication on Europe’s Digital Future  and its position paper on Artificial Intelligence in healthcare.
 
Advocacy

             The Avicenna Alliance answers the consultation for Europe’s Beating Cancer Plan




On 3 March 2020, the Avicenna Alliance has submitted feedback on the roadmap of Europe’s Beating Cancer Plan. With this feedback, the Alliance wishes to emphasise the role that computer modelling and simulation can play in the prevention, early detection, diagnosis and knowledge of cancer.

 
Providing feedback to the Roadmap was important as it informs about the specific issues within the cancer field that the EU will aim to tackle, such as knowledge gaps and implementation of best practices, uneven access to preventive measures, treatment and cancer care, unfit healthcare models and skills.
 
Europe’s Beating Cancer Plan is a key priority of the European Commission and recognised as essential as it aims to reduce the burden of cancer for patients and families, as well as health systems. The plans' overall objective is to improve EU cancer prevention, detection, treatment and management while reducing health inequalities between and within the European Member States.
 
This consultation was, therefore, an opportunity for the Avicenna Alliance to provide feedback and possibly have an impact in the drafting of the final European Cancer Plan. The Avicenna Alliance would like to thank in particular Novadiscovery's crucial contribution in stressing the need to use computer modelling and simulation solutions in the fight against cancer!
 
Please have a read through the feedback given by the Avicenna Alliance to the European Commission.

Scientific and regulatory news
Key Highlights of the new Industrial Strategy for Europe
 

On 10 March 2020, the European Commission has published its New Industrial Strategy for Europe aiming at delivering on three key priorities: maintaining European industry's global competitiveness, making Europe climate-neutral by 2050, and shaping Europe's digital future for the five coming years.



The New Industrial Strategy for Europe reflects the Commission’s ambitions set in the European Green Deal and the European Digital Strategy, and further aims to better grasp the challenges as to the digital transition as well as to better equip the European industry in the face of international competition. The Strategy is structured around two main ambitions:
  1. A more digital and sustainable European industry
 The Strategy proposes a set of actions, for SMEs and big companies, start-ups, research centres, service providers, suppliers and social partners, to address the seven conditions needed to enable twin industrial transformations. Among the 40  actions that were identified as key to meet the fulfilment of the conditions, we have:
  • Communication on the Future of Research and Innovation and the European Research Area to map out a new approach to innovation and ensure the EU budget is used with maximum impact,
  • the launch Public Private Partnerships in the Horizon Europe programme and the follow-up to the European Data Strategy to develop an EU data economy, including the launch of common European data spaces in specific sectors and value chains.
  1. A strong and strategic autonomous European industry
On the innovation side, the Commission is willing to support the development of key enabling technologies, including biotechnologybiomedicine, nanotechnologies, pharmaceuticals, robotics, high performance computing and data cloud infrastructure and blockchain. Cybersecurity challenges are also taken into consideration as the Commission will follow-up to the 5G Communication and the Recommendation on cybersecurity of 5G networks.
 
On the pharmaceutical side, the Commission will adopt a new EU pharmaceutical strategy in 2020, including actions to secure supplies and ensure innovation for patients. With this, the Communication also outlined that the strategy would focus on the availability, affordability, sustainability and security of supply of pharmaceuticals – noting that access to pharmaceuticals and medical products are crucial to Europe’s security and autonomy as highlighted by the recent events linked to the COVID-19 outbreak.

           Postponing of the date of application of the European Medical Devices Regulation


On 25 March, the European Commission announced that they intend to postpone the date of application of the Medical Devices Regulation (MDR) for one year.The Directorate-General for Health and Food Safety (DG SANTE) ’s Medical Devices Unit (B2) informed that they have evaluated the impact of Covid-19 on the Joint Implementation Plan and on the MDR and therefore decided to work on a proposal to postpone the date of application for one year.
 

The Commission intends to submit this proposal early April. They call the European Parliament and the Council to adopt it quickly as the original deadline for the application of the MDR is on 26 May.
 
This measure was taken to relieve pressure from national authorities, notified bodies, manufacturers, and others, to enable focus on the current crisis.
 
In their communication, the European Commission calls on all actors to “ensure that this additional year is used appropriately”, and call for completion of all work currently incomplete. This suggests that by the end of the postponed date of application, the European Commission will be less likely to further postpone it or to accept incomplete works.

International news

A thematic session on Good Regulatory Practice organized by the World Trade Organization (WTO)  

On 25 February 2020 the Avicenna Secretariat followed a thematic session on Good Regulatory Practice organized by the World Trade Organization (WTO) in Geneva. There were two panels, one on Medical Devices and another on New Vehicle Technologies.




The Thematic Session focused on encouraging regulatory compatibility and cooperation. It included several presentations from the United States, Canada, the EU, and Japan. The various presenters introduced the current Medical Device context of their regions, and collectively discussed some challenges for auditing medical devices, as well potential solutions, and the role of the WTO.

Overall, four main regulatory challenges were listed by attending stakeholders:

  1. The fast rate of innovations in the health field poses regulatory challenges. International regulatory cooperation was highlighted as one possible way of overcoming this;
  2. The WTO’s Technical Barriers to Trade (TBT) agreement is not implemented by most medical device regulators, who may not even be aware of it or the IMDRF guidance;
  3.  Medical devices are often improperly regulated as drugs;
  4. Regulatory differences can ultimately prevent businesses from engaging in trade.

This Thematic Session was interesting to follow as it provided a global overview of the regulatory medical device landscape, including common international frameworks.

Key EU-related issues were highlighted during this Thematic Session such as transitional challenges regarding the MDR, including the low number of Notified Bodies designated under the MDR and the delay of the European database on medical devices (EUDAMED).

Events and webinars

                                           Launch of the Avicenna Members webinars


The Avicenna Alliance plans to organize webinars for Avicenna Members on a monthly basis until the end of 2020. The objective of those webinars is to enable Avicenna Members to get to know each other better and share their knowledge about their main activities and expertise in therapeutic areas.




This initiative is essential to deepen relationships among Avicenna Members. More concretely, webinars will enable Avicenna Members to share their ideas and best practices in core areas related to in silico trials and in silico medicine. Those exchanges of experiences will certainly pave the way to the development of new common projects!

Members Webinars are a great opportunity for further collaboration between industry and research members!

Please do not hesitate to contact the Avicenna Secretariat should you be willing to present a  Member Webinar in the comings months…

                                       Join the International school on in silico trials

The University of Bologna is organising, in collaboration with the VPH Institute and the Insigneo Institute, a three-day intensive International School on In Silico Trials specifically targeted for decisions-makers in medical industries, research hospitals, contract research organisations, regulatory agencies and notified bodies.

This summer school will take place from 7 to 9 September 2020 at the University of Bologna in Italy.

 The organisers of this summer school, under the initiative Prof. Marco Viceconti, member of the Industrial Engineering Department of the University of Bologna, offer a reduced participation fee of €2,200 for companies member of the Avicenna Alliance.

Usually companies pay €2700 and not-for profit entities pay €1300. The participation fee for VPHi members is of €1000.

If you are interested in following intensive lectures on In Silico Trials, please find more information regarding the programme here and the registration here.

The description of the school has been added to the VPHi website and on Insigneo website.
 
The international School on In Silico Trials will offer a systematic, non-technical review of the strengths and weaknesses of in silico trials. This is a great opportunity for Avicenna Members to have a better and deeper understanding of the threats and opportunities that modelling and simulation presents!
 

Join the Avicenna Alliance!
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