European Union

On 10-12 December, the European Citizens’ Panel on "European democracy / Values and rights, rule of law, security" will meet for the third and final time.

Source : © European Union, 2021 - EP

On 10-12 December, the European Citizens’ Panel on "European democracy / Values and rights, rule of law, security" will meet for the third and final time.

Source : © European Union, 2021 - EP

Written by Luisa Antunes with Laia Delgado Callico.

Substance-based medical devices (SBMD) are health products with physicochemical properties and without a pharmacological, immunological or metabolic mode of action – such as nasal and eye sprays, cough syrups, hand and vaginal creams, and toothpaste. To ensure these devices are safe to use, they were recently placed under new classification rules by the EU Medical Devices Regulation (Regulation (EU) 2017/745), which applies from May 2021.

To discuss this new regulatory framework and present current research on non-pharmacological health products, the European Parliament’s Panel for the Future of Science and Technology (STOA) organised a hybrid workshop ‘Medical devices made of substances: Opportunities and challenges‘, which took place on 16 November 2021.

Member of the European Parliament and STOA Panel member Patrizia Toia (S&D, Italy), opened the workshop, highlighting the importance of understanding the definition of SBMD and how to differentiate them from pharmacological products, as well as discussing ‘orphan devices’ – those which do not fall under any legislation. Paul Piscoi, Policy Officer with the Directorate-General for Health and Food Safety (DG SANTE) at the European Commission moderated the event.

Panel 1 – The science of substance-based medical devices

Three presentations discussed the science of SBMD. Marco Racchi, Professor of Pharmacology at the University of Pavia (Italy), focused on the importance of carefully defining the concept of non-pharmacological modes of action, and its distinction from therapeutic effect. A substance with a therapeutic effect is either a medicinal product or a medical device, depending on its mechanism of action. However, SBMD often have more than one mechanism of action concurring to the claimed therapeutic effect. Natural substances are composed of a very high number of molecules acting in synchrony and are best represented by the concept of ‘system’, something that is more than the sum of its components.

Annamaria Staiano, Professor of Pediatrics at the University Federico II, Napoli (Italy), highlighted the role of natural complex substances in paediatrics. Both structural and functional interactions can occur between the many natural substances contained in a therapeutic product. Professor Staiano presented the results of a clinical study using a medical device made of 100 % natural substances. It demonstrated a safe and effective clinical response, comparable to the standard of care and with at least equally high benefit-to-risk ratio.

Peter Malfertheiner, Professor of Medicine at the University Hospital Ludwig Maximilian University (LMU) in Munich (Germany), discussed SBMD in the management of patients with gastrointestinal diseases. Professor Malfertheiner provided two examples of how natural substances can treat gastroesophageal reflux disease and metabolic syndrome. Current pharmacological management of patients with metabolic dysfunctions does not offer alternatives to the administration of as many drugs as the number of different metabolic disorders. Here, SBMD are a highly effective therapeutic option, a valid alternative to synthetic drugs, and complementary in certain conditions to conventional pharmacological therapies.

Panel 2 – Regulatory aspects of substance-based medical devices

The second panel focused on the regulatory aspects of SBMD. Olga Tkachenko, Policy Officer with DG SANTE at the European Commission, gave an overview of the new rules for SBMD defined by the Medical Devices Regulation. The new regulatory framework provides higher standards of evidence, more transparency and traceability, and greater alignment among actors, whilst also considering technological progress, such as cybersecurity and sales over the internet. Furthermore, the new rules serve to ensure the safety and performance of these devices, through appropriate risk classification and assessment procedures. The guidance documents issued by the Medical Device Coordination Group and guidance on therapeutics which are positioned on the borderline with medicines, which is currently under revision, will assist in the aligned application of these new rules.

Oliver Hartmann, Legal and Regulatory Affairs Manager at the Association of the European Self-Care Industry (AESGP), discussed the industry perspectives on a fit-for-purpose regulatory framework for SBMD. The first step in the assessment of an SBMD, as a borderline product, is to confirm its regulatory status and risk classification, by using proportionality and a case-by-case assessment. Clear and workable definitions of pharmacological, immunological and metabolic means are required: to apply the SBMD regulation; to distinguish SBMD from medicinal products; and to avoid an indirect, extended scope of the definitions, rendering a product category ineffective. Regulators require expertise in assessing the physical or mechanical mode of action together with knowledge of classification criteria and different legal definitions.

Emiliano Giovagnoni, Innovation and Medical Science Director at Aboca (Italy), focused on the opportunities for innovation in healthcare offered by SBMD. The new regulation increases the level of evidence needed to demonstrate the safety and the efficacy of SBMD following an evidence-based medical approach. The therapeutic properties of SBMD can be identified by describing their mechanisms of action in a scientific, but non-pharmacological, approach using biological sciences. Strengthening the post-marketing surveillance introduced by the regulation allows real-world evidence data to be collected to ensure a continuous reassessment of the efficacy and safety of products, even after placement on the market. The major challenge of implementation is defining pharmacological means and borderline products, particularly herbal products. While Chapter 1.2.4.4. of MEDDEV 2.1/3 Rev. 3 is dedicated to setting classification criteria for products containing ‘medicinal plants’, the criteria proposed to distinguish between a drug or a medical device do not follow a case-by-case approach. A revision of the framework for traditional herbal medicinal products is therefore required.

Member of the European Parliament Simona Bonafè (S&D, Italy) closed the workshop, noting that the approval of the regulation was a major step forward for the European health system and demonstrated the European political will to recognise the important role that SBMD play in the prevention and treatment of diseases. Within the Green Deal framework, Simona Bonafè emphasised that natural complex substances have a lower impact on the environment since they are 100 % biodegradable.

The full recording of the workshop is available here.

Your opinion counts for us. To let us know what you think, get in touch via stoa@europarl.europa.eu.

European Union finance ministers agreed on Tuesday (7 December) to change EU rules so that they can cut the Value Added Tax (VAT) on goods and services linked to fighting climate change, health protection and the transition towards a more digital economy.

EDA Chief Executive Jiří Šedivý this afternoon closed the Agency’s 2021 Annual Conference devoted to ‘Innovation in European Defence’ with a call for Member States, and Europe as a whole, to invest more and better in defence innovation “and to do it together”, reflecting a general assessment expressed throughout the conference.

He also expressed the hope that 2022 will become “the year of European defence” and that Europe will take further decisive action to live up to its defence aspirations, also with respect to innovation. “The choice is clear”, he said repeating what many speakers and panelists expressed throughout the day: “Either we innovate in defence or we will become defence irrelevant”.

Main takeaways

Mr Šedivý singled out a number of commonalities expressed during the conference which could serve as the main takeaways of today's event, such as:

• in terms of defence innovation, Europe is clearly stagnating vis-a-vis its main competitors, especially the US but also other global powers. This widening gap could, at some point, put at risk Europe’s interoperability with its partners;
• to catch up, Europe needs to be open to partners both in Europe and outside, also across the Atlantic: “We need complementarity with NATO rather than competition”. Openness also means a readiness to work with civil industry, SMEs and start ups;
• to boost innovation, there is a need for cultural change and a change of mindset throughout Europe’s Ministries of Defence, including a tolerance for failure;
• the final test of European defence innovation will be in its operational output, i.e. the capacity to deliver usable high-end capabilities that are needed by our Armed Forces;
• Europe’s defence relevance will also stand or fall with the robustness, resilience and competitiveness of its defence industrial and technological base, including the security of supply chain;
• EDA’s role in innovation is unique because, under the same roof, it deals with capability prioritisation and development, research and development, industrial synergies and civil-military cooperation as well as support to PESCO, CARD and the EDF. “Innovation is in the Agency’s DNA since its very start”; now, it is the time to use its expertise and experience to bring defence innovation forward in Europe.

EUMC Chair Graziano: Innovation must respond to military needs

Previously, addressing the Annual Conference for a last time in his capacity of EU Military Committee Chairman, departing General Claudio Graziano, whose mandate will expire end in May 2022 after more than three years, said that European Defence were at an “historical moment with wind of change blowing from everywhere”. Now is the moment for Europe to show “assertiveness and the capacity to adapt” if it wants to play a “responsible role for a sustainable future”: “Either we succeed as a group, or we all fail as a group”. The upcoming Strategic Compass offers the EU an opportunity for aligning its defence tools, also financial, and consolidating its role as a global security provider, the General stated: “If we miss this train of credibility, I’m afraid it will be long before we catch another one, if any at all”. Innovation in defence is of course a key part of this endeavour because it is an indispensable path for Europe towards achieving operation superiority and being able to project power, rapidly and effectively.  “In this context, the EU Rapid Deployment Capacity is not just the most tangible sign of a renewed EU commitment, but also a clear demonstration that the EU understands the winds of change”, he said. The defence industry and, in general, Europe’s defence industrial and technological base will be crucial for Europe’s future defence posture. “At the same time, the defence industry can only succeed of it is not undermined by other EU policies such as the possible extension of the EU sustainability taxonomy to social aspects, inter alia. One must be wary of that!”, Mr Graziano stressed. He also called for making sure that defence innovation is driven by the operational needs and requirements of the Armed Forces on the ground; the end-users’ perspective must always be decisive and guide innovation, he said.

EIB Vice-President Kris Peeters: “Hope that next year will be the year of defence”

Conference attendees also witnessed an interesting fire side chat with Kris Peeters, the European Investment Bank’s (EIB) Vice-President. He recalled the Bank’s decision, back in 2017, to launch the ‘European Security Initiative’ with a budget of 6 billion euros of which, so far, 4 billion have already been invested in dual-use projects benefiting to security and defence. 47% of those 4 billion euros have gone into innovation, Mr Peeters said, stressing that the funding was allocated as loans to both Member States and private companies (including start-ups) as well. Even though security and defence are still “sensitive” topics at the EIB which, as a European organisation, “is defending European values”, one should not forget that against the backdrop of increasing threats everywhere, “security and defence are also important values for European citizens”. “If we don’t invest in this sector, we cannot talk about European strategic autonomy, sovereignty or resilience. We must not be naive”, he said. There is a “momentum” to push for more investments in security “and I hope that next year, 2022, will be the year of defence”.

Lively and interactive panel discussions

Throughout the day, following the various keynote speeches (see other related news on the opening speeches and the ministerial debate), conference attendees also enjoyed two lively, interactive and highly interesting panel debates, each of them focusing on a specific aspect of defence innovation.

Moderated by EDA Deputy Chief Executive Olli Ruutu, the first panel entitled ‘How to foster defence innovation?’ featured Emmanuel Chiva, Executive Director of the French Defence Innovation Agency (AID), Vice Admiral Louise K. Dedichen, Norwegian Military Representative to NATO, Timo Pesonen, Director General of DG DEFIS at the European Commission, Kusti Salm, Permanent Secretary at the Estonian Ministry of Defence, and David van Weel, Assistant Secretary General for Emerging Security Challenges at NATO. In this panel, representatives of national governments and European institutions discussed the potential and requirements for greater innovation in European armed forces, from new technologies, concepts and processes to doctrines and decisions.   

The second panel, moderated by Pieter Taal (EDA Head of Unit Industry Strategy and EU Policies), was entitled ‘Innovation capacity of the European defence industry’ and featured Peppas Antonios (CEO ETME), Domitilla Benigni (CEO and COO of Elettronica), Hervé Dammann (Senior Vice-President Europe, Thales) as well as Jan Pie (Secretary General, Aerospace and Defence Industries Association of Europe, ASD). The panel discussed how the industry is adapting to the new defence innovation environment which is increasingly based on synergies between the Ministries and Defence with the civil sector, and what the current and future challenges and opportunities are for the industry.

 

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EDA today announced the two winners of the 2021 EDA Defence Innovation Prize. Launched in March, this year’s contest looked for the most innovative ideas, technologies and solutions related to Human-Machine Interfaces enabling Human-Machine-Teaming for Defence. After a thorough assessment of all applications received, the jury decided to announce two winners, each of whom is rewarded with €30,000.

ASTARTES

The first of the two winning projects is called ASTARTES (Air Superiority Tactical Assistance Real-Time Execution System) and was proposed by Design AI, a German deep tech start-up specialized in Artificial Intelligence.

Frederik Mattwich, the company’s co-founder and Chief Technical Officer (CTO), explains his team’s winning project as follows:

“Supporting human pilots with their tactical decision-making speed is an expected future role of Artificial Intelligence (AI). In order to overcome the ethical and technical challenges such an AI assistance system poses, many steps will be necessary to gain confidence and understanding of how AI decisions are made. We have identified one such step which is scientifically reproducing the published results from Google Deepmind’s AlphaStar. A planned next step is to transfer the results from a reproduced AlphaStar to ‘Command:Professional Edition’ which is used (among others) to teach air combat tactics in the German Officer Academy in Fürstenfeldbruck. Through this serious gaming approach, ASTARTES aims to visualise AI assisted tactical decisions and thus make it transparent as well as explainable, and also to facilitate its evaluation from a military personnel perspective. It will be essential for all stakeholders to understand the strengths and, most importantly, the drawbacks and limitations of AI in the context of military applications. Our overall vision for ASTARTES is the development of a digital (super) human-level AI assistance system, which will combine the data from all platforms and provide real time tactical support to a human commander in every situation, reduce his workload in the NGWS (Next-Generation Weapon System) context and speed up the OODA loop (observe–orient–decide–act) drastically. The AI is planned to potentially also support pilot training in an Live-Virtual-Constructive context as well as tactical scenario analysis”.

COMBI

The second of the two winning projects is called COMBI (Bidirectional Communicator) and was proposed by Thales, a global high technology company active, among others, in digital and “deep tech” innovations.

Marc Gatti, Human Autonomy Teaming (HAT) Department Director at Thales AVS/DMS France, explains his team’s winning project as follows:

 “COMBI is a high-level operator ‘intentions’ translator from and to operator to and from plural intelligent systems within his working area.

The future of defence operations are expected to become even more complex. A similar mission to one carried out today will include several intelligent systems that combine the operator’s platform with those controlled remotely (teammates, drones, etc.). A more complex environment will not only increase the operator’s workload but also further distance from him to the vital decision-making process. Genuine collaborative work (from a human point of view) between humans and intelligent systems will be a game changer for future defence operations whatever the environment: ground, sea, sky or space.  Classically, the distribution of roles between human and artificial agent is called "authority sharing". It is limited to the analysis of the tasks to be performed (task analysis) and to the development of related autonomous functions. The operator is then responsible for adapting this assistance, to meet the technical parameters for carrying out the mission. However, authority sharing is not enough to tackle complex future defense missions (time consuming and technical skills). The collaboration level between human and artificial agents should be increased and this is the objective of the Human-Autonomy Teaming (HAT) concept. One of the most important characteristics of HAT is efficient dialogue between participants. This is the way to establish a shared representation of the situation to reduce misunderstandings and improve decision-making. However, the way dialogue is performed depends on the situation. To reduce the cognitive workload of managing complex systems, the communication level must be conducted at a high level of abstraction.

COMBI is composed of: - a top-down transfer function that translates pilot's high-level intentions into intelligible parameters for the solvers, optimizing their treatment; - and a bottom-up transfer function that translates solver results into the high-level pilot referential operational intentions and parameters”.

About the winners

Design AI GmbH is a German deep tech start-up specialized in Artificial Intelligence. It focuses on bringing state-of-the-art innovations from AI research to the industry in the areas of Reinforcement Learning, Computer Vision, Natural Language Processing, Business Intelligence and Predictive Analytics. It manages to bridge the gap between user-centered concept development and agile research and development of AI systems, especially through the combination of Design Thinking and Artificial Intelligence. Experienced in various industries, the company is focused on the defence sector, where it successfully brings state-of-the-art AI into the field of mission planning and execution.

Thales is a global high technology leader investing in digital and “deep tech” innovations: connectivity, big data, artificial intelligence, cybersecurity and quantum technology. The company provides solutions, services and products that help its customers (businesses, organisations and states) in the defence, aeronautics, space, transportation and digital identity and security markets to fulfil their critical missions, by placing humans at the heart of the decision-making process.  In the field of aeronautics, Thales supports aircraft manufacturers, armed forces, airlines, operators, pilots, crews and passengers in making improvements to flight efficiency, safety and comfort. The secure, natively connected systems that Thales designs allow aircraft, helicopters and drones to fly under all conditions and to interface with all parts of the aeronautical ecosystem, on the ground or in flight.

About the EDA Defence Innovation Prize

The award, organised by EDA since 2018, aims to stimulate defence technological innovation in Europe, in particular by reaching out to non-defence R&T communities and innovators set to play an ever-bigger role in developing and producing Europe’s future defence capabilities. It is also meant to provide non-traditional defence stakeholders (civil industries, SMEs, research organisations, universities, etc.) with an opportunity to showcase their know-how in domains relevant for defence, maximize dual-use synergies and engage in partnerships with the defence sector.

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Belgian Minister Ludivine Dedonder said defence innovation should have three main characteristics: “It should be collaborative, capability-driven and, at the same time, adaptive and continuous”. Collaboration is crucial especially for countries of moderate sizes such as Belgium because for them, it is not possible to analyse, evaluate, develop and finance all new defence innovations on their own, the Minister stressed. At the same time, avoiding duplication is also imperative “because we cannot afford to finance duplicative programmes”.  Innovation must remain capability-driven, she added, “as one of its goals is to deliver top-notch military capabilities in support of the security and defence policies of our nations and the EU”. And it must be constantly adapted to the changing operational needs of the Armed Forces, Ms Dedonder insisted. EDA has a pivotal role to play “as it brings together research, technology watch, innovation, capability development and wider links with industry”. Creating synergies with other actors, including NATO, is also a role the Agency can take on, avoiding unnecessary duplication, the Belgian Minister said. “Innovation is key to make our Armed Forces more robust, more resilient, more agile and more precise in their engagements. In short: to build a better European military instrument of power”, she concluded.

Slovenian Minister Matej Tonin said that for ensuring its strategic autonomy and upholding the credibility of its security and defence policy, Europe needs “fresh, cutting-edge ideas and innovative thinking” in order to be able to face today’s new threats and keep up with the technological developments that are driving both the civil and military world. “In this respect, I want to put a special emphasis on the small and medium-sized enterprises, the SME’s, which can be vehicles for development because they are able to adapt and respond rapidly to innovative ideas”, he stressed.  Mr Tonin also underlined the need for Europe to cooperate also with its allies, especially NATO.   He expressed Slovenia’s support and appreciation for NATO’s work, especially the recent efforts to establish a Defence Innovation Accelerator for the North Atlantic (DIANA) and a NATO innovation Fund, stressing the need of avoiding duplication with those initiatives. Creating a European Defence Innovation Hub within EDA is “a step in the right direction”, the Minister said, “but it should not create additional layers of administrative and financial burden” for Member States: “Complementarity and non-duplication between the EU and NATO are key”.

The Polish Deputy Minister, Marcin Ociepa, called on Europe and its Member States to be “open” to all types of stakeholders and innovation players, inside and outside Europe, “because the broad spectrum of threats and challenges today requires a broad-spectrum response”. “We are all witnessing today the power and unpredictability of hybrid warfare. Therefore it is crucial to enhance cooperation on developing creative and innovative defence capabilities to protect our citizens, borders and values”. In this respect, the technological independence of Europe is of great importance, Mr Ociepa pursued: “By all means, we should continue to develop the mechanisms facilitating the cooperation and protecting the European innovations and technologies. We cannot, however, curb the collaboration opportunities with other like-minded partners such the US, South Korea, Japan, Australia to just name a few (…) we all face the same challenges and threats. Defence innovation is a team game”. We also have to invest in defence innovation, “but in a smart manner”, the Deputy Minister said: “Increasing our defence budgets is not always the only answer. We have to make sure that each and every mechanism is complementary and coherent with existing EU funding instruments, namely the European Defence Fund, Horizon Europe or the European Innovation Council. We cannot afford to duplicate our efforts”. With NATO doing its work through the Defence Innovation Accelerator for the North Atlantic (DIANA) and a NATO innovation Fund, “EDA, as the potential host of the European Defence Innovation Hub, could and should facilitate EU-NATO cooperation in this domain and create interlinks between the instruments of both organisations”. And Mr Ociepa to conclude: “You can count on our support on this and on other topics”.  

 

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