University of Geneva Archives - European Industrial Pharmacists Group (EIPG)

EMA’s pilot scheme for academic and non-profit development of ATMPs


by Giuliana Miglierini Advanced therapy medicinal products (ATMPs) are often developed by academic and non-profit organisations, because of their high level expertise in the biotechnological techniques that underpin many new therapeutic approaches. On the other hand, these organisations often lack Read more

Lessons learnt to transition from Horizon 2020 to the new FP10


by Giuliana Miglierini The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020. The report identifies several areas of possible improvement, which may be taken into Read more

Approvals and flops in drug development in 2023


by Giuliana Miglierini Approvals and flops in drug development in 2023 The European Medicines Agency published its annual highlights, showing 77 medicines were recommended for marketing authorisation, and just 3 received a negative opinion (withdrawals were 19). In 2023 some highly expected Read more

UK will participate to European research programmes

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by Giuliana Miglierini

The divergent road opened as a consequence of the Brexit, in January 2021, between the European Union (EU) and the United Kingdom (UK) is now converging again as for the possibility for UK researchers to participate to Horizon Europe (HE) and Copernicus scientific programmes. The agreement in principle reached on 7 September 2023 by the European Commission and the UK Government was facilitated by the previous Windsor Framework Agreement. It shall now be ratified by the Council of the European Union, and then adopted by the Specialised Committee on Participation in Union Programmes.

The EU and UK are key strategic partners and allies, and today’s agreement proves that point. We will continue to be at the forefront of global science and research.”, said the Presi-dent of the European Commission, Ursula von der Leyen.

The possible association of the UK to Horizon Europe animated a vigorous debate in the past couple of years among the scientific international community, as well as that of other third countries such as Switzerland (those association is still pending, see below).

The current agreements in place between the UK and the EU are not comprehensive of the participation of UK’s students to the Erasmus+ programme, participation that was cancelled by the UK government in 2020.

The financial terms of the agreement

The new association of UK to both HE and Copernicus programmes will become operative star-ting 1 January 2024, superseding the previous transitional agreement that allowed UK researchers to apply and be evaluated as other potential beneficiaries under HE calls. It will become possible for UK researcher to access HE’s 2024 Funding Programme and Work Programme (including the coordination of consortia), and to participate in the European Research Council and Marie Skłodowska-Curie Actions.

According to the European Commission, the estimated annual contribution of the UK to Horizon Europe and the Copernicus component of the Space programme should be on average €2.6 billion, in line with the terms agreed in the Trade and Cooperation Agreement. The EU Commission will issue twice a year a call for funds to the UK corresponding to the due contribution. The overall EU budget for Horizon Europe is €95.5 billion, plus contributions due by the various associated countries.

The agreement is also comprehensive of a correction mechanism referred to Horizon Europe, aimed to compensate the contribution of the UK, should its receipts in grants be higher than its contribution for grants. Under the terms of the Trade and Cooperation Agreement, an automatic correction to the UK’s contribution would occur if it reached a threshold of 8% over two successive years. A balance mechanism has also been put in place to compensate for the UK receiving significantly fewer grants than its contribution. In this instance, the level of UK participation may be improved, or (should it overpays by more than 12%), the issue may be object to scrutiny by the joint Specialised Committee on Participation in Union Programmes to agree upon the measures needed to balance the situation.

A temporary and automatic mechanism has been also agreed to address any risk of critical underperformance by the UK should the imbalance exceed 16%, based on the consideration the country did not fully participate in HE in the past two years.

The main fields of collaboration

UK’s participation to European research programmes will focus on area of mutual interest, i.e. emerging technologies, climate change and health. The participation to strategic parts of Horizon Europe – including those related to strategic assets, interests, autonomy or security – is subject to the previous assessment of UK participants on equal terms with other associated countries (Art. 22(5) of the Horizon Europe Regulation). The participation to other parts of HE will occur on equal terms with researchers and organisations from EU Member States.

Copernicus is part of the European space programme. The association will allow the UK to access a state-of-the art capacity to monitor the Earth and its services. Among the main goals of the programme is the understanding and acting on environmental and climate change related challenges. The UK will also have access to EU Space Surveillance and Tracking services.

The reactions

The announcement of the agreement on the association of the UK to European research pro-grammes found very positive reactions among the different parties interested in solving the issue.

Joining the Horizon Europe programme is a huge win for the scientific research community, who have been pushing for resolution over the past few years. UK innovation and research de-pends on international collaborations which are crucial for driving advancements in all areas of science, including the discovery and early development of new medicines and vaccines”, said Janet Valentine, ABPI Executive Director, Innovation and Research Policy. “The UK accession to Horizon enables the two sides to reinvigorate their longstanding partnership in R&D, and directly contributes to UK growth and competitiveness in the life sciences sector by making the UK an attractive destination for talented researchers.”

This decision represents a long-awaited signal for renewed international collaboration on fundamental frontier research in Europe. It will strengthen the research of all involved, both in the EU and in the UK. At the ERC, we look forward to welcoming back researchers based in the UK, after the trying last few years. They have been sorely missed, and will now be able to participate again as from our 2024 grant competitions”, said the President of the ERC, Maria Leptin.

The academic world represented by Cesaer highlighted the reintegration of UK into Horizon Eu-rope and Copernicus reaffirms the commitment of both the EU and the UK to advancing global scientific excellence. The association of the European universities of science and technology also supports further progress in building a wider international scientific community, with particular reference to Switzerland.

Today, Europe’s universities celebrate the end of a long road that began in 2016 and look for-ward to rebuilding and further developing close partnershipssaid Josep M. Garrell, President of the European Universities Association.

We are extremely grateful for the efforts of everyone in the European research community who has worked tirelessly to help secure this agreement”, added Jamie Arrowsmith, Director of Universities UK International.

Switzerland is still waiting for the association

Despite Switzerland being a very important country for research in life sciences, and location of many of the major pharmaceutical industries, the country is still waiting to restart the negotiations with the EU for its association to the European research programmes. The exclusion of Switzerland from any form of collaboration was the result, in 2021, of the political divergence with the EU on many issues.

We feel alone in the middle of Europe,” Yves Flückiger, rector of the University of Geneva, told Business|Europe.

According to the article by David Matthews, the incumbent Swiss federal elections in October 2023 and the European elections of 2024 may slow down the negotiations on the new political relationship. The association of Switzerland to EU’s research programmes might then not occur before 2025. Some explanatory talks would be already ongoing, adds the article. Sympathy for researchers in Switzerland was expressed by the ERC President, Maria Leptin. “They are not alone in the sense they are loved by all the rest of us,” she said. “There is very high-level research being done in Switzerland, same as in the UK. We all want to be one group that competes at the same level and is evaluated by the same high-level panels.


The Swiss interoperable national eHealth infrastructure

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by Giuliana Miglierini

The new model of a personalised and interconnected healthcare asks for the interoperability of data in order to precisely access all the information needed to make the correct diagnosis and decide the most appropriate treatment for each patient.

Interoperability is at the core of the new Swiss strategy used to build the national eHealth infrastructure; the strategy has been developed by a team of scientists from the University of Geneva (UNIGE) and the University Hospitals of Geneva (HUG), in collaboration with the Swiss Institute of Bioinformatics (SIB) and the Lausanne University Hospital (CHUV), under the auspices of the Swiss Personalized Health Network (SPHN) and in close collaboration with representatives from all five Swiss university hospitals and eHealth Suisse.

A journey started in 2015

The new national infrastructure strategy will be adopted by all Swiss university hospitals and academic institutions. The announcement of the new strategy follows a long-lasting work to adequate the Swiss legislation, started in 2015 with the approval of the new federal law on patients’ electronic health records (EHR) (see more on Health Policy).

According to the Swiss law (entered into force in April 2017), adoption of the interoperable infrastructure is voluntary for ambulatories and private practices. In the same year, the Swiss Personalized Health Network (SPHN) also created by the government, an initiative led by the Swiss Academy of Medical Sciences in collaboration with the SIB.

Despite major investments over the past decade, there are still major disparities”, says Christian Lovis, director of the Department of Radiology and Medical Informatics at the UNIGE Faculty of Medicine and head of the Division of Medical Information Sciences at the HUG. “This is why we wanted, with our partners and the SPHN, to propose a strategy and common standards that are flexible enough to accommodate all kinds of current and future databases.”

A semantic framework integrating with the existing standards

The new infrastructure will be implemented to complement the existing tools already used by the Swiss eHealth community. Synergy and flexibility are the principles that inspired its development, which is based on a common semantic framework that does not aim to replace existing standards. The final target is to make a step forward towards the application of personalized medicine, so to better respond to the needs of both patients and the Swiss healthcare system. The new infrastructure has been officially presented by an article published in the JMIR Medical Informatics.

Its stepwise implementation has already started at mid-2019, within the framework of the Swiss Personalized Health Network. “Swiss university hospitals are already following the proposed strategy to share interoperable data for all multicentric research projects funded by the SPHN initiative”, reports Katrin Crameri, director of the Personalized Health Informatics Group at SIB in charge of the SPHN Data Coordination Centre. Some hospitals are also starting to implement this strategy beyond the SPHN initiative.

In the JMIR Medical Informatics article, the authors describe the process that led to the new strategy, starting from the deep analysis of various approaches to interoperability, including Health Level Seven (HL7) and Integrating Healthcare Enterprise (IHE). Several domains have been also addressed, including regulatory agencies (e.g. Clinical Data Interchange Standards Consortium [CDISC]), and research communities (e.g. Observational Medical Outcome Partnership [OMOP]).

The semantics of the infrastructure was mapped according to different existing standards, such as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT), the Logical Observation Identifiers Names and Codes (LOINC), and the International Classification of Diseases (ICD).

A resource description framework (RDF) allows for the storing and transportation of data, and for their integration from different sources. Data transformers based on SPARQL query language were implemented to convert RDF representations to the required data models.

A common semantic approach

The three pillars on which is built the new infrastructure reflect the three essential components of communication: the commonly shared meaning we give to things, a technical standard producing the “sound” and the organisation of the meaning and sound with sentences and grammar so that communication becomes intelligible. The same occurs with data, where the agreed semantic significant is used to represent conceptually what has to be communicated. “Then we need a compositional language to combine these meanings with all the freedom required to express everything that needs to be expressed. And finally, depending on the projects and research communities involved, this will be ‘translated’ as needed into data models, which are as numerous as the languages spoken in the world”, explains Christophe Gaudet-Blavignac, a researcher in the UNIGE team.

Unification of vocabularies instead of creation of new ones has been a major target for scientists involved in the effort; this new common vocabulary will be now used to communicate within any type of grammar, without need to learn a ‘new language’. “In this sense, the Swiss federalism is a huge advantage: it has forced us to imagine a decentralised strategy, which can be applied everywhere. The constraint has therefore created the opportunity to develop a system that works despite local languages, cultures and regulations” says Christian Lovis.

This approach is expected to provide a robust guarantee of mutual understanding and significant time savings for researchers called to prepare relevant documentation, as specific data models will be applied only as the last step of the procedure. The chosen modalities shall provide the needed flexibility to adapt to the formats required by a particular project, for example those typical of the FDA in the case of collaboration with an American team.

The challenges of interoperability

The new infrastructure takes also into due account the many challenges related to the sharing of data. Instruments that create interoperability and their implementation have to face the regulatory framework that governs data accessibility and protection, for example with reference to the GDPR regulation on personal data. “The banking world, for example, has long since adopted global interoperability standards, – comments Christophe Gaudet-Blavignac. – A simple IBAN can be used to transfer money from any account to any other. However, this does not mean that anyone, be they individuals, private organisations or governments, can know what is in these accounts without a strict legal framework

Interoperability is even more a challenging goal to be achieved in the biomedical field, due to the very great heterogeneity of data involved in the diagnosis and treatment of a certain disease, and the consequent need to interconnect and integrate many different systems to achieve a robust communication. This issue has been made fully explicit during the pandemic, when a huge amount of data of different types were produced: even if lifting all technical, legal and ethical constraints to their interoperable use, the data remain difficult to analyse because of semantic ambiguities, notes the Swiss scientists.

Big data and new technologies

The digital opportunity in the Swiss healthcare system has been also examined by PricewaterhouseCoopers (PwC) in a report of February 2019. Many new informatics technologies may prove useful to boost the eHealth Swiss landscape, suggest the analysts, from the use of big data and data management to the spreading of wearable devices and sensors among patients.

According to PwC, the first ones are expected to transform the diagnosis process from a subjective experience to an objective, data-driven process. This would allow also to improve its transparency, providing a rationale for the choice and effectiveness of treatments.

Wearables and sensors are expected to further expand this vision to self-diagnosis, monitoring and remote treatment, thus supporting the transition towards a prevention-based healthcare industry pursuing very early-stage identification of pathologies and related therapeutic interventions.

The PwC’s study – comprehensive of 38 interviews with patients and industry experts – ran in collaboration with the University of St Gallen. Six different categories of patients were identified: the Health enthusiast, the Sceptic, the Healthy Family, the Chronic, the Frail elderly and the Mentally stressed. For each of them, a map identifying pain points along the patient journey were also derived in relation to the domains of Time, Emotions, Information and Resources.

Lack of trust in the healthcare system, insufficient availability and accuracy of resources and the time is spent in waiting rooms are among the main issues experienced by Swiss patients, according to PwC. All of them can be tackled using the new digital technologies, including big data, wearables and sensors, artificial intelligence, robotics, telemedicine and mobile health, digital simulation, body augmentation and remediation.