scholarly journals Authorization of Vaccines in the European Union

2021 ◽  
pp. 1-8
Author(s):  
Ana Hidalgo-Simon ◽  
Radu Botgros ◽  
Emil Cochino
Keyword(s):  
Public Health ◽  
European Union ◽  
Healthcare Professionals ◽  
Product Information ◽  
Time Pressure ◽  
Marketing Authorization ◽  
Clinical Use ◽  
The European Union ◽  
Relevant Evidence ◽  
Effective Use

The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pressure. The marketing authorization is a necessary gateway that protects public health and provides healthcare professionals and the general public with reliable and relevant evidence reflected in the product information to allow the safe and effective use of these vaccines. Regulators have the expertise and the duty to evaluate vaccines’ benefits and risks and, importantly, monitor safety during clinical use. This evaluation is more important than ever during a pandemic—and must be allowed to be as thorough as ever.

Communicable and Other Infectious Diseases

2020 ◽  
Author(s):  
Markus Frischhut
Keyword(s):  
Public Health ◽  
European Union ◽  
Infectious Diseases ◽  
Disease Transmission ◽  
Eu Law ◽  
The European Union ◽  
Ethical Perspective ◽  
Health Measures ◽  
Environment Agency ◽  
And Control

This chapter discusses the most important features of EU law on infectious diseases. Communicable diseases not only cross borders, they also often require measures that cross different areas of policy because of different vectors for disease transmission. The relevant EU law cannot be attributed to one sectoral policy only, and thus various EU agencies participate in protecting public health. The key agency is the European Centre for Disease Prevention and Control. Other important agencies include the European Environment Agency; European Food Safety Authority; and the Consumers, Health, Agriculture and Food Executive Agency. However, while integration at the EU level has facilitated protection of the public's health, it also has created potential conflicts among the different objectives of the European Union. The internal market promotes the free movement of products, but public health measures can require restrictions of trade. Other conflicts can arise if protective public health measures conflict with individual human rights. The chapter then considers risk assessment and the different tools of risk management used in dealing with the challenges of infectious diseases. It also turns to the external and ethical perspective and the role the European Union takes in global health.

INTRODUCTION: HEALTH TECHNOLOGY ASSESSMENT AND THE EUROPEAN UNION

2000 ◽  
Vol 16 (2) ◽  
pp. 299-302 ◽  
Author(s):  
David Banta ◽  
Wija Oortwijn
Keyword(s):  
Public Health ◽  
Decision Making ◽  
European Union ◽  
Health Technology Assessment ◽  
European Commission ◽  
Technology Assessment ◽  
Health Technology ◽  
The European Union ◽  
European Level

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.

Human rights restrictions during the COVID-19 pandemic in Poland and Russia. Legal and comparative aspects

2021 ◽  
Vol 2(24) ◽  
pp. 323-340
Author(s):  
Marta Pietras-Eichberger
Keyword(s):  
Public Health ◽  
European Union ◽  
Human Rights ◽  
Public Interest ◽  
The European Union ◽  
Human Rights Law ◽  
The Public ◽  
Safety And Health ◽  
Research Problems ◽  
The Impact

The study analyzed selected issues related to the scope of human rights and freedoms during the COVID-19 pandemic in Poland and Russia. The author wanted to compare the regulations issued by a Member State of the European Union and a country outside the European Union, often using undemocratic methods of exercising power. The work focuses on research problems related to the principles of protection, the confrontation of individual interests with the public interest, and the impact of the regimes introduced during the COVID-19 pandemic on human rights law in both countries. The thesis of the study is that in the event of a threat to public health, analogous restrictions on human rights are introduced both in an undemocratic country and in a country belonging to international structures identifying with democratic values. The state of the COVID-19 pandemic has exposed, and in some area even contributed to the creation of mechanisms reserved for crisis situations, posing a direct and real threat to public safety and health.

scholarly journals Law, market building and public health in the European Union

2017 ◽  
Vol 18 (1) ◽  
pp. 45-61 ◽  
Author(s):  
Chris Holden ◽  
Ben Hawkins
Keyword(s):  
Public Health ◽  
European Union ◽  
The European Union

scholarly journals Interim European surveillance case definition for anthrax

2001 ◽  
Vol 5 (44) ◽  
Author(s):  
A Nicoll
Keyword(s):  
Public Health ◽  
European Union ◽  
Early Warning ◽  
Single Case ◽  
Case Definition ◽  
National Surveillance ◽  
The European Union ◽  
Health Centres ◽  
The Subject

The heads of national surveillance and public health centres, at a meeting in Luxembourg on 30 October 2001, agreed an interim surveillance case definition for anthrax for Europe (box). While anthrax is not formally notifiable internationally at the present time (click here), it was agreed that ascertainment of a single case of confirmed or probable human anthrax should be the subject of an “early warning” within the European Union under the provision of Decision no. 2119/98/EC of 24 September 1998 (Network Decision).

scholarly journals Are undocumented migrants’ entitlements and barriers to healthcare a public health challenge for the European Union?

2016 ◽  
Vol 37 (1) ◽  
Author(s):  
Elisabetta De Vito ◽  
Chiara de Waure ◽  
Maria Lucia Specchia ◽  
Paolo Parente ◽  
Elena Azzolini ◽  
...  
Keyword(s):  
Public Health ◽  
European Union ◽  
Undocumented Migrants ◽  
The European Union ◽  
Health Challenge ◽  
Public Health Challenge ◽  
Barriers To Healthcare

scholarly journals Losartan reduces the burden and cost of ESRD: Public health implications from the RENAAL study for the European Union

2002 ◽  
Vol 62 ◽  
pp. S68-S72 ◽  
Author(s):  
William C. Gerth ◽  
Giuseppi Remuzzi ◽  
Giancarlo Viberti ◽  
Thierry Hannedouche ◽  
Alberto Martinez-Castelao ◽  
...  
Keyword(s):  
Public Health ◽  
European Union ◽  
The European Union ◽  
Health Implications
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