Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification.Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection.Results: The results show that varying levels of detail are provided for the biomarker and the diagnostic test, including variability in where the information was presented. The overall results demonstrate transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR.Conclusions: With the introduction of the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices, medicines regulatory authorities' will be required to be consulted during the review of CDx conformity assessment and so, there is opportunity for more consistent and transparent information on CDx to be provided in the SmPC and EPAR.
Aim: Antimicrobial resistance (AMR) is one of the major health challenges of the future, but the concrete impact of counteracting measures is still unclear. To study possible outcomes within the European Union, a scenario analysis for the year 2050 was performed on the possible influence of the European Commission (EC).
Methods: Scenario planning and development of strategies based on different scenarios.
Results: Rational use of antimicrobials in animals and humans, surveillance and monitoring, new antimicrobial therapies, travel and globalization, exposure to the environment, and awareness were recognized as the main driving elements. Four Scenarios were developed: An efficient and impli-cated EC sorts out AMR; An implicated but unsuccessful EC withstands AMR; AMR is managed regardless of the EC disinterest; and A neutral and inefficient EC fails to manage AMR.
Conclusion: All the strategies developed on the basis of the four scenarios probe for an increase in European Union's dedication to achieve positive outcomes. These include the development of effective legislation and international coordination.
Acknowledgment: Peter Schröder-Bäck, Helmut Brand and Kiranjeet Kaur’s contribution is co-funded through a grant of the European Commission within the Erasmus+ programme (Project: Prevent it. Project reference: 598515-EPP-1-2018-1-IN-EPPKA2-CBHE-JP).
Conflict of interests: None declared.
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