Payers And Regulators Raise The Bar In Europe

Solna, Sweden – European economies are slowly recovering from economic crises and a number of austerity measures undertaken throughout the last five years. At the same time, payers and regulators within the health care sector are increasing their requirements in order to ensure safe, effective and affordable medicines to its populations. With the full implementation of new pharmacovigilence legislation and the fact that HTA organizations are requiring more and more sophisticated evidence, research activities in real-world evidence is booming.

In the article, “Payers and Regulators Raise the Bar in Europe – Consequences for Using Research in Real-World Evidence,” published in ISPOR CONNECTIONS, Dr. Patrik Sobocki, MSc, PhD from Pygargus in Stockholm, Sweden, states that countries with reimbursement systems that are based on value-based pricing principles (e.g. the Nordics) are driving the use of Real-World Evidence, especially those based on retrospective data sources. The Nordic countries represent an ideal environment for Real-World Outcomes research due to the universal implementation of electronic medical record systems in health care and national population-based health registers made available for research since the 1950’s. Furthermore, in the Nordic region, data can be linked at a patient-level from different data sources through unique personal identifiers. Integrated data sets providing longitudinal and high-quality patient-level information will be pivotal in order to adequately respond to the increased requirements from payers and regulators.

Dr. Sobocki predicts that in the next decade, Real-World Evidence will become a top priority for academia, health care providers and the life science industry in order to ensure that health technologies are safe, effective and cost-effective to the patient and society. Countries with the right prerequisites to generate high-quality Real-World Evidence will become global attractive environments for this type of research.


ISPOR CONNECTIONS (ISSN 1538-5108), the bimonthly news & technical journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), strives to provide timely communications on methodological and health policy issues of interest to Society members.

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.

For more information: www.ispor.org

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