May 2020

Avicenna Monthly Newsletter 

Key highlights

  • The EU Health Ministers discuss access to medicines and European Pharmaceutical Strategy
  • The European Commission publishes proposal for an extensive COVID-19 recovery plan and introduces new stand-alone EU4Health Programme
  • Commission publishes guidelines on the adoption of Union-wide derogations for medical devices
  • The Exscalate4CoV project expanded and supported by a budget of €3 million EU emergency funding to support pharmaceutical companies, research institute and biological laboratories
  • European Innovation Council publishes its new vision for the period 2021-2027 to support world-class science and innovations
Policy Updates
Members of the European Parliament call for supporting health policies and health systems in the EU’s long term budget
On 1 May, Members of the European Parliament (MEPs) sent a letter to Ursula von der Leyen, President of the European Commission, and Charles Michel, President of the European Council, calling to ensure the support of health policies and health systems in the next EU’s long-term budget for 2021-2027, also called the “Multiannual Financial Framework” (MFF).

In the letter, MEPs stated that the COVID-19 outbreak emphasised the need for the EU to re-think the healthcare preparedness and strengthen European social welfare systems. They, therefore, call on the Commission and the European Council to: 
  • ensure the support of health policies and health systems as a new priority in the next EU budget;
  • increase the budget of the new ‘health strand’ in the ESF+;
  • re-think and expand the use of the ‘health strand’ instrument;
  • increase the budgets of other key financial instruments (social fund, research, digital market, regional- and cohesion funds) that support health-related activities and policy mechanisms.
Through this communication, MEPs exerted political pressure on the Commission and the European Council to increase the share of the long-term EU budget for health care in the new MFF proposal.
Have a closer look at the letter here for further information regarding the main claims of the MEPs’ co-signatories.
The EU Health Ministers discuss access to medicines and European Pharmaceutical Strategy
On 12 May Croatian Presidency of the European Council invited European Health Ministers to discuss access to medicines and provide input on the new Pharmaceutical Strategy for Europe.

The European Commissioner for Health and Food Safety, Stella Kyriakides, the Executive Director of EMA and EFTA Professor, Guido Rasi, and the Croatian assistant Minister of Health, Dr. Vera Katalinić-Janković were also invited to participate in the ministerial discussions.
 The discussion between Member States and European Officials addressed different issues:
  • The importance of access to medicines and of early detection of shortages of medicines;
  • The increase of the EU’s production of medicines and guaranteeing the EU’s supply of medicines;
  • More coordination and cooperation between the European Commission and EU Member States to ensure accessibility and affordability of medicines;
  • The importance of not duplicating the work of the European Medicines Agency (EMA) when it comes to medicines shortages;
  • The COVID-19 pandemic and its impact on healthcare systems;
  • The establishment of a platform for regular dialogue to facilitate communication between national authorities and stakeholders.
As a next step, the European Commission is expected to publish a roadmap for a new Pharmaceutical Strategy paving the way for the planned Pharmaceutical Strategy due in the last quarter of 2020.
Stakeholders’ input ahead and during the videoconference, makes it clear that a sustainable and independent approach to the supply of medicines will be at the top of the EU’s list of priorities. The strategy will also concern the quality and safety of medicines while limiting the growing costs of innovative medicines
Commission Executive Vice-President shares views on the Europe's response and future actions to the COVID-19 crisis

On 4 May, the European Parliament’s IMCO Committee (Internal Market and Consumer Protection) held an exchange views with Margrethe Vestager, Commission Executive Vice-President, on the Europe's response to the COVID-19 crisis. The debate touched upon a large array of issues, including digital technologies, contact tracing apps, possibilities for EU joint procurement for pharmaceutical products and the EU's industrial sovereignty.

During the debate, Margrethe Vestager insisted on few key points:
  • The need for strategic and strong medical supply chains in the EU to reduce the dependence on third countries and to further diversify trade flaws.
  • To carry on harnessing new technologies (such as AI and supercomputers) and strategic digital infrastructures to get control of the COVID-19 pandemic. 
  • To support SMEs by mobilising all tools available to ensure an efficient access to both funding and digitisation assistance.
  • To create the next EU’s long-term budget with a recovery fund included that works towards a digital and green recovery.
These key points touched upon during the debate allows us to better understand the vision of the European Commission on the actions it plans to take in light with of the COVID-19 crisis.

                                                 New vision for the next European Innovation Council

On 7 May, the Advisory Board of the pilot European Innovation Council (EIC)established by the European Commission, has published its new vision for the period 2021-2027 to support world-class science and innovations. 
This new vision highlights three clear conclusions as to what the EIC should achieve within the next Horizon Europe Programme for the period 2021-2027.
1.      European solutions to global challenges
The EIC to become the hallmark of excellence for impact-oriented innovators by integrating two of its highly successful existing programmes:

  • Future and Emerging Technologies (FET) projects to support creating novel breakthrough technologies from the research base; and
  • SME Instrument funding to support start-ups and SMEs develop and scale up innovations to the stage where they can attract private investment. 
2.      A €10 billion budget to crowd in €30-50 billion impact investments
Boost the opportunities for visionary ideas, disruptive technologies and innovation in Europe with a minimum budget of €10 billion over the period 2021-2027, while attracting between €30 and 50 billion from other investors.
3.   The investor of choice for those with visionary ideas
  • Accept high-impact ideas in science-driven deep-tech, which are usually considered too high risk for common investments.
  • Bring together science and entrepreneurship communities that have been disconnected, or poorly connected.
  • Support deep-tech interdisciplinary research while being entrepreneur centric.

Following this vision paper, the Advisory Board will prepare a report to set out the EIC’s views on how it can be put quickly into reality, and how to measure success

New Director of the ERC Executive Agency Confirmed
On 14 May, the European Commission re-appointed Dr Waldemar Küttst as the new Director of the European Research Council Executive Agency (ERCEA), the administrative arm of the European Research Council (ERC). He has been the acting director of the executive agency since August 2019 when he took over after Pablo Amor
Waldemar Kütt holds a doctor’s degree in Physics from the Technical University Aachen in Germany. Mr Kütt joined the Commission in 1997, served two Research Commissioners (Mr. Potocnik and Ms. Geoghegan-Quinn) from 2008-2015 and recently held several Head of Unit positions in the Bioeconomy Directorate of DG for Research and Innovation.

In his latter positions, he dealt with various health-related topics such as the review of the 2012 Bioeconomy Strategy and Action Plan and the EU Framework Programme for Research and Innovation, Horizon 2020.

As Director of the ERCEA, Waldemar Kütt will ensure the transition period from Horizon 2020 to Horizon Europe, the next EU research and innovation programme (2021-27). His main task will be the implementation of the ongoing Work Programme 2018-2020 and the next work programmes, as defined by the ERC Scientific Council and adopted by the Commission.

His mandate as Director of the Agency runs over four years until May 2024 and may be extended once.
The Commission publishes proposal for an extensive COVID-19 recovery plan and introduces new stand-alone EU4Health Programme

On 27 May, the European Commission published its proposal for an extensive recovery plan. This has been done by means of a newly developed recovery instrument called Next Generation EU, and a reinforced Multiannual Financial Framework (MFF) for 2021-2027 which is  a new proposal for the EU long-term budget. Both financing mechanisms will contribute to a new stand-alone EU4Health Programme

The new EU4Health Programme will be mainly financed by Next Generation EU (i.e. € 7.7 billion) whereas the remaining part will come from the MFF (i.e. 1.7 Billion); nearly 23 times as much as was originally foreseen. Initially, the Commission had planned to earmark the health strand € 413 million for 2021-2027!

The primary goal of this new health budget is to ensure the European Union’s (EU) preparedness and overall capacity in responding to potential future public health crises. This is, of course, a consequence of the crisis we have been experiencing during the COVID-19. It also seeks to reinforce the resilience of health systems and promote the development and access to innovation in healthcare. 

For more information on the new EU4Health Programme 2021-2017 please have a look at the Commission’s proposal here.
Scientific and regulatory news

           Guidance document on the regulatory requirements for ventilators and related accessories

On 24 April, the European Medical Device Coordination Group (MDCG), omprising up to two medical device experts from each EU Member State, published a guidance document on the regulatory requirements for ventilators and related accessories. The guidance document sets out several regulatory options for supporting production and/or placing ventilators and related accessories on the market during the COVID-19 pandemic.

The document outlines the following options, provided under the Medical Devices Directive (MDD):

  • Manufacturers of medical devices can select additional suppliers of parts or components in case quality system certification are qualified, approved and controlled by the manufacturer.
  • Manufacturers of ventilators can also entrust their production entirely to a subcontractor by providing the specifications of the ventilator including parts of the technical documentation to them. However, the manufacturer keeps the role of the legal manufacturer according to the Medical Devices Directive (MDD).
  • In case new manufacturers start producing ventilators, they will be required to comply with all regulatory requirements of the MDD before attaching the CE mark to their products.

Considering the increased demand for ventilators in the context of the COVID-19 outbreak, several industries have expressed their willingness to support and scale up the production of ventilators. Against this background, this guidance encourages manufacturers to start producing or increase the production of ventilators and their accessories.

This guidance gives clarity on regulatory requirements for ventilators that are of particular relevance for Avicenna Members!

 Commission's guidelines on the adoption of Union-wide derogations for medical devices

On 19 May, the European Commission published a guidance document on the adoption of Union-wide derogations for medical devices.  The Guidelines provide information on the adoption process of Union-wide derogations from the conformity assessment procedures for placing on the market a medical device. They set out the criteria necessary for the determination and justification of extensions to the territory of the Union of a national derogation.

The steps followed by the Commission to determine Union-wide derogations are the following:

  1. The Commission will consult the Member States, by means of the Medical Device Coordination Group (MDCG), to identify whether a notified national derogation for a certain medical device could be of Union relevance;
  2. If that is the case, the Commission will assess whether certain procedural requirements (listed in the guidance) are met;
  3. If those procedural requirements are met, the Commission  will determine whether adopting a Union-wide derogation in the case at hand would be duly justified. 

The Commission shall adopt  Union-wide derogations by means of implementing acts. However, the process may be accelerated in case of urgency relating to the health and safety of humans. Union-wide derogations, however, may lay down stricter conditions for placing a medical device on the market than those laid down in national derogations already in place for a device and should remain in force for a limited period not exceeding  six months.

Clearly, these guidelines have been adopted in light of the COVID-19 pandemic, as the Union-wide derogations are measures of last resort, only to be considered in exceptional cases to ensure patient health or safety or to protect public health. Against this background, these measures aim to enable the Commission and the Member States to address potential shortages of vitally important medical devices in an effective way across Europe.

For more information, the Commission’s communication can be found here.

                 The Commission issues Implementing Regulation to simplify the process for                                                                                 renewing notified body designations 


On 19 May, the European Commission published a new implementing Regulation (EU 2020/666) amending implementing Regulation 920/2013 as regards to the renewal of designations and the surveillance and monitoring of notified bodies. 

In light of the public health measures taken in the context of COVID-19 pandemic, the original Implementing Regulation has been amended to allow designating authorities to derogate from the procedures for designation of notified bodies and temporarily relax the rules on surveillance and monitoring.

In particular, the new Implementing regulation provides that:

  • By way of derogation, during the period from 19 May 2020 to 25 May 2021, the designating authority of a Member State may decide to renew a designation as notified body without having recourse to the procedures laid down in Article 3 of the implementing regulation 920/2013;
  • To decide on the renewal of a designation as notified body, the designating authority shall carry out an assessment in order to verify the continuous competence of the notified body and its ability to perform the tasks for which it was designated;
  • The decision on the renewal of a designation as notified body shall be adopted before the end of the validity period of the preceding designation and shall automatically become void at the latest on 26 May 2021;
  • The designating authority that renew designations without following the normal procedures must notify the Commission and provide substantive reasons for its decision by means of The ‘New Approach Notified and Designated Organisations’ Information System (NANDO)’;
  • However, Member States are still required to carry out any measures to ensure an adequate level of surveillance that remain possible and assess an appropriate number of the notified body’s reviews of the manufacturer’s technical documentation.

COVID-19 has had a significant impact on different areas of the medical devices field, including the designation and work of notified bodies. Against this background, the European Commission has issued this implementing act to simplify temporarily the process for renewing notified body designations. This complements Regulation 2020/561 which deferred by one year the application of the MDR.

For more information, the Commission’s Implementing Regulation can be found here.

Funding opportunities

                        European digital infrastructures in support of coronavirus research

On 30 April, the European Commission published a summary of relevant EU initiatives that have been launched with the aim to  support researchers in addressing the COVID-19 outbreak and finding a treatment.

The initiatives are split between ‘Open Access initiatives’ and ‘Cloud Services initiatives’. 

1.      Open access to data

2.      Cloud services
  • The HADDOCK (High Ambiguity Driven protein-protein DOCKing), biology simulation tool supports complex simulations as the model interaction between the virus proteins and human one, or the docking of small molecules to targets such as the COVID-19 protease .
  • The DEEP-Hybrid Data Cloud has the capacity to process huge amounts of data, develop and share deep learning applications.
  • The OCRE (Open Clouds for Research Environments) project, recently launched a distribution of OCRE COVID19 research vouchers for early career researchers carrying out research on COVID19 and related topics. 

The European Commission is at the forefront of supporting research and innovation and coordinating European research efforts, including preparedness for pandemics. Next to the different initiatives, we also notice a strong commitment to mobilising additional research funds through specific EU instruments such as Horizon2020 and the Innovative Medicines Initiative!

                 The Commission published an article on the expansion of the Exscalate4CoV project

On 4 May the European Commission published an article on the expansion of the Exscalate4CoV project. The main goal of this initiative is to support the introduction of European supercomputers in pharmaceutical companies to discover new drugs and consequently fight the COVID-19. 

This initiative is joined by pharmaceutical companies, research institutions and biological laboratories. 

To rapidly find a treatment against COVID-19, the project Exscalate4CoV (E4C) has been supported by a budget of €3 million emergency funding from the European Commission to support pharmaceutical companies and research institute and biological laboratories.

Coordinated by the Italian pharmaceutical company Dompé, the E4C is disposing of three powerful high-performance computing (HPC) centers in Bologna, Barcelona and Jülich which are used to match the digital signature of coronavirus proteins against molecules from a chemical library, in the aim of identifying a drug.

Since the beginning of the COVID-19 crisis, 8 European pharmaceutical companies including – Pierre FabreAlfasigmaAlmirallAxxamEsteveLillySanofi and Greenpharma joined the E4C project and discussions with other international companies, such as MerckTakedaAbbott are ongoing.  By joining, pharma companies provide their medical libraries to testing and donating molecules via the DrugBox data platform to facilitate access to drugs and enlarge the E4C’s database.

The project has so far identified 93 antiviral molecules that are now under biological screening at KU LeuvenFraunhofer IME and the University of Cagliari to determine the potency of each compound to undergo clinical trials.
Based on the results of this initiative, the consortium will be discussing with the European Medicine Agency the future regulatory process to have a smooth transition from clinical testing to the approval stage of the possible cure!

                 The Commission launched a new call for advanced health approaches
                                                    to rapidly respond to COVID-19


On 19 May the European Commission launched a new call for an Expression of Interest with a budget of €56 million for advanced health approaches to rapidly respond to COVID-19 and to deliver results for a higher level of preparedness of health systems.

The focus of the Commission’s call is not to develop new diagnostics, therapeutics or vaccine compounds or solutions, but rather to complete and deploy readily available solutions to increase the EU response capabilities to this coronavirus crisis, improve the recovery, and better prepare for future such crises or waves.
The call for expression of interest covers five focus topics:

  1. Repurposing of manufacturing for vital medical supplies and equipment;
  2. Medical technologies, Digital tools and Artificial Intelligence analytics to improve surveillance and care at high Technology Readiness Levels;
  3. Behavioural, social and economic impacts of the outbreak response;
  4. Pan-European COVID-19 cohorts;
  5. Networking of existing EU and international cohorts of relevance to COVID- 19.

By this call for an Expression of Interest the Commission wants to support initiative solutions, such as computer modelling and simulation tools developed by Avicenna Members to enhance the protection of healthcare practitioners and the general public.

Stakeholders interested in this call for expression of interest please have a look here for more information. Submissions should be submitted at the latest by 11 June 2020 - 5.00 pm (CET)!

Events and webinars

              Virtual Conference on “European Research Infrastructures for a smarter future”

On 15 May, the Virtual Conference on “European Research Infrastructures (RI) for a smarter future” was co-organised by the Croatian Presidency of the Council of the EU and the European Strategy Forum on Research Infrastructures (ESFRI). During the Conference, several discussions took place during which experts of various disciplines discussed issues related to RIs in the EU.
The overall objective was to explore the potential of European RI to make a meaningful impact on the European research priorities and identify the means in which this could be achieved.
Several experts, affiliated to organisations involved in Research Infrastructures (RI), expressed their opinion about which actions should be taken to increase the impact of European RI. It was stressed that collaborations between ESFRI and other stakeholders, sustainable funding, and ensuring excellence are necessary to consolidate the European RI ecosystem and to strengthen its research capacity.
Different experts and stakeholders also shared their views regarding concrete initiatives that need to be supported in the EU to limit the impact of COVID-19 crisis on RI. For instance, Caterina Biscari, Director of the AlBA Synchrotron and Chair of the LEAPS, considered there is an opportunity to strengthen links between national research programmes to link them to national data spaces. She also highlighted some risks related to COVID-19 such as limited research budgets, restrictions of movement and lack of collaborations.

Between the workshops, Jan Hrusak, the ESFRI Chair, presented the ESFRI White paper ‘making science happen – a new ambition for research infrastructures in the European research area’.The White paper was published by ESFRI in April 2020 and constitutes ESFRI’s response to the new challenges to come Europe. It shows how RI contribute to the main priorities of the renewed European Research Area (ERA) such as increasing Europe’s competitiveness and identifying solutions to global challenges.

Do you want to learn more about the outcomes of the ERI Conference? Have a look here

Must read paper as recommendation

                                       Interview with new JRC Director-General Stephen Quest

On 8 April 2020, the European Commission has appointed Stephen Quest as the new head of the Joint Research Centre (JRC).

Mr Quest first joined the European Commission in 1993. He has significant experience at senior management level and has been Director-General of the Commission’s department for Taxation and Customs Union (TAXUD) since 2016, a position that he held up until coming to the JRC.

As he takes up his new role, the interview aims at highlighting how Stephen Quest sees the JRC adding value at the interface of science and policy, during this very challenging time and beyond.

For Stephen Quest, the biggest challenge facing us right now is the COVID-19 pandemic and the EU response to it. Yet more broadly, he also underlines the twin challenges of climate change and the need for a green transformation, and the deep and pervasive impact of digitalisation on our societies and economies.

The JRC has a key role to play in providing the knowledge, understanding and scientific underpinning to guide and support our policy responses to these shared challenges!
If you wish to read more about this interview please have a look here!

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