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Redefining the Unmet Needs in Healthcare and the Regulatory Challenge
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Redefining the Unmet Needs in Healthcare and the Regulatory Challenge

A special issue of Healthcare (ISSN 2227-9032). This special issue belongs to the section "Health Policy".

Deadline for manuscript submissions: closed (15 November 2023) | Viewed by 39616

Special Issue Editors

Dr. Denis Horgan

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Guest Editor
European Alliance for Personalized Medicine, Avenue de l’Armee/ Legerlaan 10, 1040 Brussels, Belgium
Interests: personalised medicine; incentives in healthcare; health literacy; decision making frameworks
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Gabriella Pravettoni

E-Mail Website
Guest Editor
1. Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
2. Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy
Interests: psychoncology; cognitive processes; decision making and error prevention; medical humanities; health and centrality of patient
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Servaas A. Morré

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Guest Editor
Institute for Public Health Genomics (IPHG), Department of Genetics and Cell Biology, Research Institute GROW, Faculty of Health, Medicine & Life Sciences, University of Maastricht, 4-6, 6211 LK Maastricht, The Netherlands
Interests: epidemiology; diagnostics; immunogenetics; infectious diseases; valorization and translation; Chlamydia trachomatis
Special Issues, Collections and Topics in MDPI journals
Dr. Vijay Tripathi

E-Mail Website
Guest Editor
Department of Molecular and Cellular, Engineering, Sam Higginbottom University of Agriculture, Technology and Sciences, Uttar Pradesh 211007, India
Interests: environmental microbiology; antibiotic resistance; microbial genomics; bioinformatics

Special Issue Information

Dear Colleagues,

From the distinct perspectives of diagnostics, data, medicines and cancer, this Special Issue will examine how impending regulatory change could help transform prospects for the health of Europe's and global citizens. The principal issue that emerges is that integrating personalised medicine into clinical practice in Europe and different regions globally will allow unmet needs to be more effectively tackled—but only if a more comprehensive implementation strategy can be established that is focused on patients and involves national decision makers, regulators, healthcare professionals and all stakeholders in the healthcare field. Through the assessment of obstacles and the exploration of solutions, this Special Issue will provide a framework to progress towards this development.

Dr. Denis Horgan
Prof. Dr. Gabriella Pravettoni
Prof. Dr. Servaas A. Morré
Dr. Vijay Tripathi
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Healthcare is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • artificial intelligence
  • pharmaceutical legislation
  • incremental innovation
  • policy
  • access
  • diagnostics
  • value
  • real-world evidence
  • global
  • index
  • orphan
  • EU
  • global
  • member states
  • barriers
  • enablers
  • research
  • translational
  • data governance
  • cancer
  • rare disease

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Published Papers (10 papers)

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33 pages, 2455 KiB  
Article
Framework for Adoption of Next-Generation Sequencing (NGS) Globally in the Oncology Area
by Denis Horgan, Yosr Hamdi, Jonathan A. Lal, Teresia Nyawira, Salomé Meyer, Dominique Kondji, Ngiambudulu M. Francisco, Roselle De Guzman, Anupriya Paul, Branka Bernard, Krishna Reddy Nallamalla, Woong-Yang Park, Vijay Triapthi, Ravikant Tripathi, Amber Johns, Mohan P. Singh, Maude E. Phipps, France Dube, Hadi Mohamad Abu Rasheed, Marta Kozaric, Joseph A. Pinto, Stephen Doral Stefani, Maria Eugenia Aponte Rueda, Ricardo Fujita Alarcon and Hugo A. Barrera-Saldanaadd Show full author list remove Hide full author list
Healthcare 2023, 11(3), 431; https://doi.org/10.3390/healthcare11030431 - 2 Feb 2023
Cited by 8 | Viewed by 6181
Abstract
Radical new possibilities of improved treatment of cancer are on offer from an advanced medical technology already demonstrating its significance: next-generation sequencing (NGS). This refined testing provides unprecedentedly precise diagnoses and permits the use of focused and highly personalized treatments. However, across regions [...] Read more.
Radical new possibilities of improved treatment of cancer are on offer from an advanced medical technology already demonstrating its significance: next-generation sequencing (NGS). This refined testing provides unprecedentedly precise diagnoses and permits the use of focused and highly personalized treatments. However, across regions globally, many cancer patients will continue to be denied the benefits of NGS as long as some of the yawning gaps in its implementation remain unattended. The challenges at the regional and national levels are linked because putting the solutions into effect is highly dependent on cooperation between regional- and national-level cooperation, which could be hindered by shortfalls in interpretation or understanding. The aim of the paper was to define and explore the necessary conditions for NGS and make recommendations for effective implementation based on extensive exchanges with policy makers and stakeholders. As a result, the European Alliance for Personalised Medicine (EAPM) developed a maturity framework structured around demand-side and supply-side issues to enable interested stakeholders in different countries to self-evaluate according to a common matrix. A questionnaire was designed to identify the current status of NGS implementation, and it was submitted to different experts in different institutions globally. This revealed significant variability in the different aspects of NGS uptake. Within different regions globally, to ensure those conditions are right, this can be improved by linking efforts made at the national level, where patients have needs and where care is delivered, and at the global level, where major policy initiatives in the health field are underway or in preparation, many of which offer direct or indirect pathways for building those conditions. In addition, in a period when consensus is still incomplete and catching up is needed at a political level to ensure rational allocation of resources—even within individual countries—to enable the best ways to make the necessary provisions for NGS, a key recommendation is to examine where closer links between national and regional actions could complement, support, and mutually reinforce efforts to improve the situation for patients. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
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31 pages, 759 KiB  
Perspective
Fighting Cancer around the World: A Framework for Action
by Denis Horgan, Rizwana Mia, Tosan Erhabor, Yosr Hamdi, Collet Dandara, Jonathan A. Lal, Joel Fokom Domgue, Oladimeji Ewumi, Teresia Nyawira, Salomé Meyer, Dominique Kondji, Ngiambudulu M. Francisco, Sadakatsu Ikeda, Chai Chuah, Roselle De Guzman, Anupriya Paul, Krishna Reddy Nallamalla, Woong-Yang Park, Vijay Tripathi, Ravikant Tripathi, Amber Johns, Mohan P. Singh, Maude E. Phipps, France Dube, Kate Whittaker, Deborah Mukherji, Hadi Mohamad Abu Rasheed, Marta Kozaric, Joseph A. Pinto, Stephen Doral Stefani, Federico Augustovski, Maria Eugenia Aponte Rueda, Ricardo Fujita Alarcon and Hugo A. Barrera-Saldanaadd Show full author list remove Hide full author list
Healthcare 2022, 10(11), 2125; https://doi.org/10.3390/healthcare10112125 - 25 Oct 2022
Cited by 5 | Viewed by 5179
Abstract
Tackling cancer is a major challenge right on the global level. Europe is only the tip of an iceberg of cancer around the world. Prosperous developed countries share the same problems besetting Europe–and the countries and regions with fewer resources and less propitious [...] Read more.
Tackling cancer is a major challenge right on the global level. Europe is only the tip of an iceberg of cancer around the world. Prosperous developed countries share the same problems besetting Europe–and the countries and regions with fewer resources and less propitious conditions are in many cases struggling often heroically against a growing tide of disease. This paper offers a view on these geographically wider, but essentially similar, challenges, and on the prospects for and barriers to better results in this ceaseless battle. A series of panels have been organized by the European Alliance for Personalised Medicine (EAPM) to identify different aspects of cancer care around the globe. There is significant diversity in key issues such as NGS, RWE, molecular diagnostics, and reimbursement in different regions. In all, it leads to disparities in access and diagnostics, patients’ engagement, and efforts for a better understanding of cancer. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
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20 pages, 370 KiB  
Perspective
Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring
by Denis Horgan, Tanja Čufer, Francesco Gatto, Iwona Lugowska, Donatella Verbanac, Ângela Carvalho, Jonathan A. Lal, Marta Kozaric, Sinead Toomey, Hristo Y. Ivanov, John Longshore, Umberto Malapelle, Samantha Hasenleithner, Paul Hofman and Catherine Alix-Panabières
Healthcare 2022, 10(9), 1714; https://doi.org/10.3390/healthcare10091714 - 7 Sep 2022
Cited by 14 | Viewed by 3669
Abstract
Liquid biopsy (LB) is a minimally invasive method which aims to detect circulating tumor-derived components in body fluids. It provides an alternative to current cancer screening methods that use tissue biopsies for the confirmation of diagnosis. This paper attempts to determine how far [...] Read more.
Liquid biopsy (LB) is a minimally invasive method which aims to detect circulating tumor-derived components in body fluids. It provides an alternative to current cancer screening methods that use tissue biopsies for the confirmation of diagnosis. This paper attempts to determine how far the regulatory, policy, and governance framework provide support to LB implementation into healthcare systems and how the situation can be improved. For that reason, the European Alliance for Personalised Medicine (EAPM) organized series of expert panels including different key stakeholders to identify different steps, challenges, and opportunities that need to be taken to effectively implement LB technology at the country level across Europe. To accomplish a change of patient care with an LB approach, it is required to establish collaboration between multiple stakeholders, including payers, policymakers, the medical and scientific community, and patient organizations, both at the national and international level. Regulators, pharma companies, and payers could have a major impact in their own domain. Linking national efforts to EU efforts and vice versa could help in implementation of LB across Europe, while patients, scientists, physicians, and kit manufacturers can generate a pull by undertaking more research into biomarkers. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
15 pages, 312 KiB  
Perspective
Tackling Mantle Cell Lymphoma in Europe
by Denis Horgan, Jan Walewski, Igor Aurer, Carlo Visco, Eva Giné, Bogdan Fetica, Mats Jerkeman, Marta Kozaric, Maria Gomes da Silva and Martin Dreyling
Healthcare 2022, 10(9), 1682; https://doi.org/10.3390/healthcare10091682 - 3 Sep 2022
Cited by 4 | Viewed by 2261
Abstract
An expert panel convened by the European Alliance for Personalized Medicine (EAPM) reflected on achievements and outstanding challenges in Europe in mantle cell lymphoma (MCL). Through the prism of member state experience, the panel noted advances in outcomes over the last decade, but [...] Read more.
An expert panel convened by the European Alliance for Personalized Medicine (EAPM) reflected on achievements and outstanding challenges in Europe in mantle cell lymphoma (MCL). Through the prism of member state experience, the panel noted advances in outcomes over the last decade, but highlighted issues constituting barriers to better care. The list notably included availability of newer treatments, infrastructure and funding for related testing, and shortages of relevant skills and of research support. The prospect of improvements was held to reside in closer coordination and cooperation within and between individual countries, and in changes in policy and scale of investment at both national and EU levels. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
14 pages, 299 KiB  
Perspective
European Health Data Space—An Opportunity Now to Grasp the Future of Data-Driven Healthcare
by Denis Horgan, Marian Hajduch, Marilena Vrana, Jeannette Soderberg, Nigel Hughes, Muhammad Imran Omar, Jonathan A. Lal, Marta Kozaric, Fidelia Cascini, Verena Thaler, Oriol Solà-Morales, Mário Romão, Frédéric Destrebecq and Edith Sky Gross
Healthcare 2022, 10(9), 1629; https://doi.org/10.3390/healthcare10091629 - 26 Aug 2022
Cited by 22 | Viewed by 5951
Abstract
The May 2022 proposal from the European commission for a ‘European health data space’ envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need [...] Read more.
The May 2022 proposal from the European commission for a ‘European health data space’ envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need to be freed from traditional silos to flow more easily and to cross artificial borders. Wide engagement will be necessary among healthcare professionals, researchers, and the patients and citizens that stand to gain the most but whose trust must be won if they are to allow use or transfer of their data. This paper aims to alert the wider scientific community to the impact the ongoing discussions among lawmakers will have. Based on the literature and the consensus findings of an expert multistakeholder panel organised by the European Alliance for Personalised Medicine (EAPM) in June 2022, it highlights the key issues at the intersection of science and policy, and the potential implications for health research for years, perhaps decades, to come. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
13 pages, 272 KiB  
Perspective
Tackling Thyroid Cancer in Europe—The Challenges and Opportunities
by Denis Horgan, Dagmar Führer-Sakel, Paula Soares, Clara V. Alvarez, Laura Fugazzola, Romana T. Netea-Maier, Barbara Jarzab, Marta Kozaric, Beate Bartes, James Schuster-Bruce, Luigino Dal Maso, Martin Schlumberger and Furio Pacini
Healthcare 2022, 10(9), 1621; https://doi.org/10.3390/healthcare10091621 - 25 Aug 2022
Cited by 5 | Viewed by 2552
Abstract
Thyroid cancer (TC) is the most common malignancy of the endocrine system that affects the thyroid gland. It is usually treatable and, in most cases, curable. The central issues are how to improve knowledge on TC, to accurately identify cases at an early [...] Read more.
Thyroid cancer (TC) is the most common malignancy of the endocrine system that affects the thyroid gland. It is usually treatable and, in most cases, curable. The central issues are how to improve knowledge on TC, to accurately identify cases at an early stage that can benefit from effective intervention, optimise therapy, and reduce the risk of overdiagnosis and unnecessary treatment. Questions remain about management, about treating all patients in referral centres, and about which treatment should be proposed to any individual patient and how this can be optimised. The European Alliance for Personalised Medicine (EAPM) hosted an expert panel discussion to elucidate some of the challenges, and to identify possible steps towards effective responses at the EU and member state level, particularly in the context of the opportunities in the European Union’s evolving initiatives—notably its Beating Cancer Plan, its Cancer Mission, and its research funding programmes. Recommendations emerging from the panel focus on improved infrastructure and funding, and on promoting multi-stakeholder collaboration between national and European initiatives to complement, support, and mutually reinforce efforts to improve patient care. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
21 pages, 376 KiB  
Perspective
How Can the EU Beating Cancer Plan Help in Tackling Lung Cancer, Colorectal Cancer, Breast Cancer and Melanoma?
by Denis Horgan, Anne-Marie Baird, Mark Middleton, Zhasmina Mihaylova, Jan P. Van Meerbeeck, Jens Vogel-Claussen, Paul E. Van Schil, Josep Malvehy, Paolo Antonio Ascierto, France Dube, Michael Zaiac, Jonathan A. Lal, Grażyna Kamińska-Winciorek, Marco Donia, Thierry André, Marta Kozaric, Pia Osterlund, Dan Lucian Dumitrascu and Luca Bertolaccini
Healthcare 2022, 10(9), 1618; https://doi.org/10.3390/healthcare10091618 - 25 Aug 2022
Cited by 3 | Viewed by 3422
Abstract
Cancer is the second leading cause of mortality in EU countries, and the needs to tackle cancer are obvious. New scientific understanding, techniques and methodologies are opening up horizons for significant improvements in diagnosis and care. However, take-up is uneven, research needs and [...] Read more.
Cancer is the second leading cause of mortality in EU countries, and the needs to tackle cancer are obvious. New scientific understanding, techniques and methodologies are opening up horizons for significant improvements in diagnosis and care. However, take-up is uneven, research needs and potential outstrip currently available resources, manifestly beneficial practices—such as population-level screening for lung cancer—are still not generalised, and the quality of life of patients and survivors is only beginning to be given attention it merits. This paper, mainly based on a series of multistakeholder expert workshops organised by the European Alliance for Personalised Medicine (EAPM), looks at some of those specifics in the interest of planning a way forward. Part of this exercise also involves taking account of the specific nature of Europe and its constituent countries, where the complexities of planning a way forward are redoubled by the wide variations in national and regional approaches to cancer, local epidemiology and the wide disparities in health systems. Despite all the differences between cancers and national and regional resources and approaches to cancer care, there is a common objective in pursuing broader and more equal access to the best available care for all European citizens. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
11 pages, 277 KiB  
Perspective
Making Sure That Orphan Incentives Tip the Right Way in Europe
by Denis Horgan, Jasmina Koeva-Balabanova, Ettore Capoluongo, Beata Jagielska, Ivana Cattaneo, Marta Kozaric, Birute Tumiene, Jean-Paul El Ahl, Jonathan A. Lal, Dipak Kalra and Núria Malats
Healthcare 2022, 10(9), 1600; https://doi.org/10.3390/healthcare10091600 - 23 Aug 2022
Cited by 2 | Viewed by 2425
Abstract
The delicate balance of funding research and development of treatments for rare disease is only imperfectly achieved in Europe, and even the current provisional equilibrium is under a new threat from well-intentioned policy changes now in prospect that could—in addition to the intrinsic [...] Read more.
The delicate balance of funding research and development of treatments for rare disease is only imperfectly achieved in Europe, and even the current provisional equilibrium is under a new threat from well-intentioned policy changes now in prospect that could—in addition to the intrinsic complexities of research—reduce the incentives on which commercial activity in this area is dependent. The European Union review of its pharmaceutical legislation, for which proposals are scheduled to appear before the end of 2022, envisages adjusting the decade-old incentives to meet objectives that are more precisely targeted. However, researchers, physicians, patients and industry have expressed concerns that ill-considered modifications could have unintended consequences in disrupting the current balance and could reduce rather than increase the flow of innovative treatments for rare diseases. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
17 pages, 492 KiB  
Perspective
Towards Better Pharmaceutical Provision in Europe—Who Decides the Future?
by Denis Horgan, Tanja Spanic, Kathi Apostolidis, Giuseppe Curigliano, Joanna Chorostowska-Wynimko, Hans-Peter Dauben, Jonathan A. Lal, Rafal Dziadziuszko, Christine Mayer-Nicolai, Marta Kozaric, Bengt Jönsson, Iñaki Gutierrez-Ibarluzea, Marie-Helene Fandel and Ruth Lopert
Healthcare 2022, 10(8), 1594; https://doi.org/10.3390/healthcare10081594 - 22 Aug 2022
Cited by 2 | Viewed by 3014
Abstract
Significant progress has been achieved in human health in the European Union in recent years. New medicines, vaccines, and treatments have been developed to tackle some of the leading causes of disease and life-threatening illnesses. It is clear that investment in research and [...] Read more.
Significant progress has been achieved in human health in the European Union in recent years. New medicines, vaccines, and treatments have been developed to tackle some of the leading causes of disease and life-threatening illnesses. It is clear that investment in research and development (R&D) for innovative medicines and treatments is essential for making progress in preventing and treating diseases. Ahead of the legislative process, which should begin by the end of 2022, discussions focus on how Europe can best promote the huge potential benefits of new science and technology within the regulatory framework. The challenges in European healthcare were spelled out by the panellists at the roundtable organised by European Alliance for Personalised Medicine (EAPM). Outcomes from panellists’ discussions have been summarized and re-arranged in this paper under five headings: innovation, unmet medical need, access, security of supply, adapting to progress, and efficiency. Some of the conclusions that emerged from the panel are a call for a better overall holistic vision of the future of pharmaceuticals and health in Europe and a collaborative effort among all stakeholders, seeing the delivery of medicines as part of a broader picture of healthcare. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
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9 pages, 259 KiB  
Perspective
Meeting the Need for a Discussion of Unmet Medical Need
by Denis Horgan, Bettina Borisch, Bogi Eliasen, Peter Kapitein, Andrew V. Biankin, Stefan Gijssels, Michael Zaiac, Marie-Helene Fandel, Jonathan A. Lal, Marta Kozaric, Barbara Moss, Ruggero De Maria, Marius Geanta, Frédérique Nowak, Antoni Montserrat-Moliner and Olaf Riess
Healthcare 2022, 10(8), 1578; https://doi.org/10.3390/healthcare10081578 - 19 Aug 2022
Viewed by 3653
Abstract
As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European [...] Read more.
As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now emerging, and more is proposed, including in relation to tackling “unmet medical need” (UMN). This initiative—directing attention to the future of treating disease and contemplating incentives to stimulate research and development—is welcome in principle. But the current approach being considered by EU officials merits further discussion, because it may prove counter-productive, impeding rather than promoting innovation. This paper aims to feed into these ongoing policy discussions, and rather than presenting research in the classical sense, it discusses the key elements from a multistakeholder perspective. Its central concern is over the risk that the envisaged support will fail to generate valuable new treatments if the legislation is phrased in a rigidly linear manner that does not reflect the serpentine realities of the innovation process, or if the definition placed on unmet medical need is too restrictive. It cautions that such an approach presumes that “unmet need” can be precisely and comprehensively defined in advance on the basis of the past. It cautions that such an approach can reinforce the comfortable delusion that the future is totally predictable—the delusion that left the world as easy prey to COVID. Instead, the paper urges reflection on how the legislation that will shortly enter the pipeline can be phrased so as to allow for the flourishing of a culture capable of rapid adaptation to the unexpected. Full article
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
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