scholarly journals Off-label prescription of medicines: what do we know about the legislation in EU member states?

2021 ◽  
Author(s):  
Renske Caminada ◽  
Max Polano ◽  
Anna M. G. Pasmooij ◽  
Violeta Stoyanova-Beninska
Keyword(s):  
Treatment Guidelines ◽  
European Medicines Agency ◽  
The European Union ◽  
Off Label Use ◽  
Drug Label ◽  
Member States ◽  
National Legislation ◽  
Off Label ◽  
Eu Member States ◽  
Label Use

Aim: Off-label prescription is not regulated on the European Union (EU) level and therefore not harmonised in the EU Member States (MS). Despite this, the use of medicines outside of the drug label occurs in clinical practice, and it can be included in treatment guidelines and/or reimbursed in some cases. It is, however, currently not clear to what extent off-label use can be included in regulatory discussions at a European level at the different committees at the European Medicines Agency. In this article, we provide an overview of the current legislation on MS level regarding off-label prescription in order to support EU regulatory discussions. Methods: Relevant national legislation regarding off-label prescription from MS was identified by distributing a questionnaire to EMACOLEX. Case law was excluded. The identified categorical elements and prerequisites in the national legislation were then categorised. Subsequently, a comparison was made to the five Good Off-Label Use Practice (GOLUP) principles. Results: Based on the obtained responses from 10 MS, we observed a large heterogeneity in the legislation of MS regarding off-label prescription. Five (out of 10) MS regulate off-label prescription explicitly and seven (out of 10) MS have prerequisites. One or more prerequisites per MS were reflected in the GOLUP principles as formulated in 2017. Conclusion: The main contribution of this work is to flag that off-label prescription actually needs to be well defined and understood before it can be appropriately taken into consideration in regulatory discussions. There is a heterogeneity in legislation regarding off-label prescription in the investigated MS, which may lead to different perspectives. A common understanding of the concept and more alignment in off-label prescription practices and their regulation at MS level may contribute to further regulatory discussions.

scholarly journals Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart?

Pharmaceutics ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1176
Author(s):  
Bethany Faulkner ◽  
M. Begoña Delgado-Charro
Keyword(s):  
Cardiovascular Diseases ◽  
Health Technology ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Off Label Use ◽  
Off Label ◽  
Treat Heart Failure ◽  
Paediatric Medicines

This work aimed to establish whether paediatric needs in cardiovascular diseases have been met by paediatric investigation plans (PIPs) produced since the development of the European Union Paediatric Regulation in 2007. The European Medicines Agency repository was searched for patterns in the development of paediatric medicines in general. Next, positive PIPs related to cardiovascular diseases were scrutinized for outcomes and compared to specific paediatric cardiovascular needs. In total, 1866 PIPs were identified with 12% corresponding to decisions taken for cardiovascular medicines. However, despite this therapeutic area having the greatest number of overall PIPs, only 14% of established needs in paediatric cardiovascular diseases were addressed by PIPs with positive decisions. Further, 71.9% of PIPs with decisions in cardiovascular disease corresponded to full waivers, so the product would not be studied in paediatrics. Despite the progress found in overall numbers of PIPs published, cardiovascular products are still commonly used off-label in paediatrics. Particularly, there is a need to develop products to treat heart failure and hypertension, two areas with clear unmet clinical needs in paediatrics. A case study on valsartan showed that industry, regulators, health technology assessment bodies, and prescribers should work together to reduce off-label use of paediatric cardiovascular diseases (CVD).

Resolution 2300 (Council of Eur. Parl. Assembly)

2020 ◽  
Vol 59 (3) ◽  
pp. 487-494
Author(s):  
David Lewis
Keyword(s):  
European Union ◽  
Human Rights ◽  
The European Union ◽  
Council Of Europe ◽  
Member States ◽  
National Legislation ◽  
Eu Member States ◽  
Eu Directive ◽  
The Eu

This Resolution was adopted in October 2019 following a report of the Committee on Legal Affairs and Human Rights. It has to be seen in the context of previous Council of Europe activity on this topic as well as the European Union (EU) Directive on the protection of persons who report breaches of Union law. The content of the EU Directive was agreed earlier in 2019 and EU Member States are obliged to transpose it into national legislation by December 2021.

scholarly journals Regulatory and Legal Enforcement of Cyber Security in Countries of the European Union: The Experience of Germany and France

Teisė ◽  
2021 ◽  
Vol 121 ◽  
pp. 135-147
Author(s):  
Sviatoslav Kavyn ◽  
Ivan Bratsuk ◽  
Anatoliy Lytvynenko
Keyword(s):  
European Union ◽  
Information Security ◽  
National Security ◽  
Legal Regulation ◽  
Vector System ◽  
The European Union ◽  
Member States ◽  
National Legislation ◽  
Eu Member States ◽  
The Eu

This article is devoted to the study of information security in the EU member states, in particular Germany and France, in the context of the analysis of their national legislation, state, national programs and regulations. Particular attention is paid to the study of the features of regulatory and legal security of information security of Germany and France in the context of the study of their national legislation in terms of economic security as an inherent component of national security. In the course of this study the peculiarities of the functioning of the institutional and legal mechanism of cyber defense in the context of the multi-vector system of international security and legal regulation of international cooperation are analyzed. The article substantiates the expediency of developing an integrated, coordinated information policy of the EU member states in order to unify approaches to information security.At the same time, the current realities of European Union policy require comprehensive research in the context of ensuring national interests, developing effective mechanisms for protecting the information space, and legal mechanisms for shaping the economic system as a strategic factor of national security. Accordingly, the approaches to information security adopted in the European Union are currently not unified due to the geopolitical specifics of the EU’s countries. Therefore, the research, evaluation, and implementation of the positive experience of Germany and France in this area, according to the authors, is important in building the information security system of the European Union in the context of reliable protection against cyber threats.

scholarly journals Analysis of primary outpatient data for off-label use of medicines in neurology

Pharmacia ◽  
2019 ◽  
Vol 66 (4) ◽  
pp. 165-170
Author(s):  
Maria Drenska ◽  
Savina Elitova ◽  
Velina Grigorova ◽  
Emilia Naseva ◽  
Ilko Getov
Keyword(s):  
Product Information ◽  
National Level ◽  
The European Union ◽  
Off Label Use ◽  
Off Label ◽  
Medical Needs ◽  
Wide Range ◽  
Adults And Children ◽  
The One ◽  
Label Use

Introduction: The off-label use of medicines is a common practice that covers a wide range of therapeutic areas in both, adults and children. So far, the extent of off-label use among neurology patients in Bulgaria has not been studied. The aim of this study is to provide data on the off-label use in neurology patients in Bulgaria and to contribute to planning actions by the European Commission and EMA to provide a harmonized guideline and to regulate the off-label use of medicines within the European Union. Materials and methods: The data on prescriptions of 360 neurology outpatients, treated in a 1 – year period, were recorded and provided for analyses. The Summaries of Product Characteristics, were used as reference documents for assessment of prescriptions. Results: The results from this study show that most neurology patients (63%) were exposed to off-label use. Most of the medicines prescribed off-label (90%), were used for a therapeutic indication, other than the one listed in the authorized product information. Meloxicam is found to be the most commonly prescribed off-label medicine. Other medicines, like trasadone, pentoxyfylline and fupentixol / melitracen were prescribed less frequently, but deserve special attention, as they were found to be used off-label to a very large extent, some of them in 100% of prescriptions. Half of the top 10 medications, most commonly used off-label in neurology, were found to be non-steroidal anti-inflammatory drugs. Conclusion: The results reveal a big gap between the authorized medicines and the real medical needs. Further studies based on a larger number of medical centers are needed to establish more accurate data on off-label prescribing in neurology patients on a national level.

scholarly journals Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union

2017 ◽  
Vol 44 (1) ◽  
pp. 17-21 ◽  
Author(s):  
M. Drenska ◽  
I. Getov
Keyword(s):  
European Union ◽  
European Countries ◽  
Time Range ◽  
The European Union ◽  
Off Label Use ◽  
Medicinal Products ◽  
Weak Point ◽  
Off Label ◽  
Regulatory Information ◽  
Label Use

Abstract Despite the increasingly strict legislation on medicinal products, the „off-label use“ or „use of medicinal product outside the approved summary of product characteristics (SmPC)“ is a weak point of today’s drug regulation and raises many questions about the risk, ethics, and legality of this type of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to regulation, adopted by some member states as well as to summarize the efforts in demand of common harmonized approach to solve this problem within the European Union. In the study, we used the available regulatory information in different electronic resources associated with the off-label drug use in selected European countries without limited time range. The results show that decisions taken to regulate the issue have significant differences and specific approach, while none of them is enough satisfactory and comprehensive. In conclusion, it can be claimed that the existing regulatory rules in various countries require significant improvement and update.

Institute of Licensing of Economic Activities in the EU Countries: Lessons for Ukraine

2019 ◽  
Vol 9 (5) ◽  
pp. 1839
Author(s):  
Olena R. ZELDINA ◽  
Yevheniia V. AVERIANOVA
Keyword(s):  
European Union ◽  
Great Britain ◽  
Economic Activity ◽  
Mutual Recognition ◽  
The European Union ◽  
Economic Activities ◽  
Member States ◽  
National Legislation ◽  
Eu Member States ◽  
The Eu

The article examines the licensing systems of economic activity, which are enshrined in the national legislation of such countries of the European Union as Germany, Great Britain and Poland. The authors identify the situation inherent in licensing systems of the above-mentioned EU member states and substantiates the expediency of using these provisions in further reforming of the licensing system of economic activity in Ukraine. The legislation of the European Union aimed at regulating the implementation of certain activities across the whole of the EU, and legislation relating to rules for the mutual recognition of permits and qualifications of specialists in EU member states was analyzed.

scholarly journals The knowledge and experience with the off-label use – results of a survey

Pharmacia ◽  
2019 ◽  
Vol 66 (4) ◽  
pp. 217-221 ◽  
Author(s):  
Maria Drenska ◽  
Emilia Naseva ◽  
Ilko N. Getov
Keyword(s):  
Current Knowledge ◽  
National Level ◽  
Medical Doctors ◽  
Off Label Use ◽  
Inclusion Criteria ◽  
Off Label ◽  
Eu Member States ◽  
Local Current ◽  
Statistical Program ◽  
Label Use

Introduction: The aim of this survey is to assess the current knowledge and experience of medical doctors in regard to off-label use and to determine whether it is legal, according to them, as the local current legislation on medicinal products does neither prohibit nor explicitly permit such use. Materials and methods: One hundred medical doctors from inpatient and outpatient medical care participated and answered 10 questions. The inclusion criteria were to have a degree in medicine and right to prescribe medications. Statistical analysis was performed using the SPSS v19.0 statistical program. Results: The results show that 8 out of 10 medical doctors have knowledge in regard to the meaning of the term “off-label”. More than half (62%) stated they have prescribed off-label medicine in their medical practice. Half of the respondents (49%) experienced some kind of trouble when prescribing off-label. In regard to whether the law allows this practice, opinions were divided. To a larger extent (88%), medical doctors support the introduction of clearer rules for off-label use in Bulgaria. Conclusion: Edical doctors have significant knowledge about off-label use, but feel uncertainty in their actions when they use medicines off-label. It is necessary to consider regulating this use at a national level, following the good examples of other European Union (EU) member states, until a harmonized solution within EU is found.

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