Cardiovascular, neurological, and pulmonary events following vaccination with the BNT162b2, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines: An analysis of European data

This book explores the interface between European data protection and the freedom of expression activities of traditional journalism, professional artists, and both academic and non-academic writers from both an empirical and normative perspective. It draws on an exhaustive examination of both historical and contemporary public domain material and a comprehensive questionnaire of European Data Protection Authorities (DPAs). Empirically it is found that, notwithstanding an often confusing statutory landscape, DPAs have sought to develop an approach to regulating the journalistic media based on contextual rights balancing. However, they have struggled to secure a clear and specified criterion of strictness as regards standard-setting or a consistent and reliable approach to enforcement. DPAs have appeared even more confused as regards other traditional publishers, largely abstaining from regulating most professional artists and writers but attempting to subject all academic disciplines to onerous statutory restrictions established for medical, scientific, and related research. From these findings, it is argued that balancing contextual rights has value and should be both generalized across all traditional publishers and systematically and sensitively developed through structured and robust co-regulation. Such co-regulation should adopt the new code of conduct and monitoring provisions included in the General Data Protection Regulation (GDPR) as a broad guideline. DPAs should accord strong deference to any codes and monitoring bodies which verifiably meet the accredited criteria but must engage more proactively when these are absent. In any case, DPAs should also intervene directly as regards particularly serious or systematic issues and have an increasingly important role in ensuring a joined-up approach between traditional publishing and new media activity.

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Uptake of biosimilar trastuzumab in Denmark compared with other European countries: a comparative study and discussion of factors influencing implementation and uptake of biosimilars

European Journal of Clinical Pharmacology ◽

10.1007/s00228-021-03155-4 ◽

2021 ◽

Author(s):

Samuel Azuz ◽

Max Newton ◽

Dorthe Bartels ◽

Birgitte Klindt Poulsen

Keyword(s):

Comparative Study ◽

Market Share ◽

European Countries ◽

Sales Volume ◽

Eu Countries ◽

Factors Influencing ◽

European Data ◽

Similar Strategy ◽

Rapid Dissemination

Abstract Purpose The aim of this study was to describe the implementation and uptake of biosimilar trastuzumab in Denmark compared with other European countries. Methods European data for usage of trastuzumab was supplied by IQVIA™, using the MIDAS® dataset. A comparison was performed based on market share estimated in sales volume. A separate comparison was undertaken between countries with a full two-fold switch between different biosimilars. Data was collected spanning the time from first registered sales of biosimilar trastuzumab until the 1st quarter of 2020. Results Denmark had the fastest and most thorough uptake of biosimilar trastuzumab compared with other EU countries. After 3 months, the market share of biosimilar trastuzumab had increased to 90% while the second fastest country had a 50% market share after 3 months. Only two other countries had undergone a full second switch between biosimilars, Hungary and Norway. All of the three countries made near complete switches between biosimilars while only Denmark had reduced the use of biooriginator below 10%. Conclusion The implementation of biosimilar trastuzumab in Denmark was rapid and achieved high overall uptake compared with other EU countries. The switch from one biosimilar to another was also achieved quickly and thoroughly. We believe that the rapid dissemination of information and involvement of all stakeholders — administrators, pharmacies, prescribers, nurses, and patients — constitute the backbone of the Danish success. A similar strategy is recommend for biosimilar implementation in other countries.

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