Keeping up with Innovation: Designing a European Sandbox for Fintech. CEPS ECMI Commentary no 58 | January 2019

In the aftermath of the 2007-09 global financial crisis, regulators in all major jurisdictions introduced significant new requirements for financial firms. Certainly justified in purpose, these regulations have increased market barriers, both directly through specific obligations, and indirectly through the sheer magnitude and complexity they involve. Regulators primarily focused on bolstering financial stability and consumer protection, while frequently disregarding their objective of promoting financial innovation. Ten years after the crisis, we believe that it is time to reconsider the appropriate balance between those objectives. In this commentary, we show how EU financial regulation may stifle the innovation of financial services. We use the example of automated investment advice, so-called ‘robo-advisors’, and we show how a proper balance between regulatory objectives could be achieved through establishing a ‘guided’ regulatory sandbox

A comparison of reimbursement recommendations by European HTA agencies : Is there opportunity for further alignment?

Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization. Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations. Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations. Conclusions: In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe.Peer reviewedFinal Published versio

Developing Core Sets for Persons With Traumatic Brain Injury Based on the International Classification of Functioning, Disability, and Health

The authors outline the process for developing the International Classification of Functioning, Disability, and Health (ICF) Core Sets for traumatic brain injury (TBI). ICF Core Sets are selections of categories of the ICF that identify relevant categories of patients affected by specific diseases. Comprehensive and brief ICF Core Sets for TBI should become useful for clinical practice and for research. The final definition of the ICF Core Sets for TBI will be determined at an ICF Core Sets Consensus Conference, which will integrate evidence from preliminary studies. The development of ICF Core Sets is an inclusive and open process and rehabilitation professionals are invited to participate

Patient relevant endpoints in oncology: Current issues in the context of early benefit assessment in Germany

The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA). Current EBA decisions released have unveiled issues regarding the acceptance of some patient-relevant endpoints as G-BA and IQWiG are grading the endpoints, focusing on overall survival as the preferred endpoint in oncology. A taskforce of experienced German outcomes research, medical, health-technology assessment and biostatistics researchers in industry was appointed. After agreement on core assumptions, a draft position was prepared. Input on iterative versions was solicited from a panel of reviewers from industry and external stakeholders. Distinctive features of registration trials in oncology need to be considered when these studies form basis for EBA, especially in cancer-indications with long post-progression survival; and with several consecutive therapeutic options available post-progression. Ethical committees, caregivers and patients often demand cross-over-designs diluting the treatment-effect on overall survival. Regulatory authorities require evaluation of morbidity-related study endpoints including survival of patients without their disease getting worse (i.e., progression-free survival). Also, progression requires treatment-changes, another strong indicator for its relevance to patients. Based on specific guidelines and clinical trial programs that were developed to be consistent with regulatory guidance, endpoints in oncology are thoroughly evaluated in terms of their patient-relevance. This extensive knowledge and experience should be fully acknowledged during EBA when assessing the patient-relevant benefit of innovative medicines in oncology

Commercialisation of eHealth Innovations in the Market of UK Healthcare Sector: A Framework for Sustainable Business Model.

This is the peer reviewed version of the following article: Festus Oluseyi Oderanti, and Feng Li, ‘Commercialization of eHealth innovations in the market of the UK healthcare sector: A framework for a sustainable business model’, Psychology & Marketing, Vol. 35 (2): 120-137, February 2018, which has been published in final form at https://doi.org/10.1002/mar.21074. Under embargo until 10 January 2020. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.Demographic trends with extended life expectancy are placing increasing pressures on the UK state-funded healthcare budgets. eHealth innovations are expected to facilitate new avenues for cost-effective and safe methods of care, for enabling elderly people to live independently at their own homes and for assisting governments to cope with the demographic challenges. However, despite heavy investment in these innovations, large-scale deployment of eHealth continues to face significant obstacles, and lack of sustainable business models (BMs) is widely regarded as part of the greatest barriers. Through various empirical methods that include facilitated workshops, case studies of relevant organizations, and user groups, this paper investigates the reasons the private market of eHealth innovations has proved difficult to establish, and therefore it develops a framework for sustainable BMs that could elimiesnate barriers of eHealth innovation commercialization. Results of the study suggest that to achieve sustainable commercialization, BM frameworks and innovation diffusion characteristics should be considered complements but not substitutes.Peer reviewe

ADC Nonlinearity Correction for the Majorana Demonstrator

Imperfections in analog-to-digital conversion (ADC) cannot be ignored when signal digitization requirements demand both wide dynamic range and high resolution, as is the case for the Majorana Demonstrator 76Ge neutrinoless double-beta decay search. Enabling the experiment's high-resolution spectral analysis and efficient pulse shape discrimination required careful measurement and correction of ADC nonlinearities. A simple measurement protocol was developed that did not require sophisticated equipment or lengthy data-taking campaigns. A slope-dependent hysteresis was observed and characterized. A correction applied to digitized waveforms prior to signal processing reduced the differential and integral nonlinearities by an order of magnitude, eliminating these as dominant contributions to the systematic energy uncertainty at the double-beta decay Q value