Test questions Flashcards
Which article contains the specific objectives of the EU health policy?
Art. 168 of the TFUE
Which type of harmonization is provided by implementing the principle of equal treatment between men and women in the access to and supply of goods and services
Minumum harmonization since its handled by a directive and the implementation is up to the member states.
What is “One Health”
an integrated, unifying approach to balance and optimize the health of people, animals and the environment.
What does a “harmonised standard” mean?
is a standard adopted by one of the European standardization organization following request of the European Commission; the standards might be voluntary but once they have been introduced there is a presumption of conformity and a belief that the product will be the same among all member states. These organizations are based in Brussels
and divided according to their competence, set up with technicians from different member states.
They are :
- European Committee for Standardization (CEN)
- European Committee for Electrotechnical Standardization (CENELEC)
- European Telecommunication Standards Institute (ETSI)
Assessed contributions are the amounts each of the 196 Members and Associate Members must pay to the World Health Organization on an annual basis. They cover
20% of the total budget
Regarding the treaty on pandemics the EU:
the EU is one of the first supporters of an international treaty on pandemics,
Its aim is to strengthen national, regional and global capacities and resilience to future pandemics, while its main topics are the early detection and prevention of pandemics, the
response to any future pandemics and lastly proposing a stronger International health framework with the WHO as the
coordinating authority.
The European Shortage Monitoring Platform (ESMP):
was established under Regulation (UE) 2022/123 on the reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices as an EMA monitoring platform
The EU Health Emergency Preparedness and Response Authority (HERA):
was launched as a new European Commission Directorate-General in 2021, in the aftermath of the COVID-19 pandemic
Are IP rights a necessary requirement in order to commercialise a medicinal product in the EU market?
Actually they are not necessary per se in order to sell medicinal products, however they are a means through which pharmaceutical companies are able to protect the result of their costly and timeconsuming activities of research and development of new and improved products, as well as to recoup the costs and the risks incurred in during that process. Patents are the primary IP rights associated with medicinal products.
The conformity assessment procedure is required:
Is required for medical devices in order to ensure that they are safe and compliant for being placed on the market.
What is the European Professional Card?
an electronic procedure that can be used to have certain professional qualifications recognised in another EU country allowing the applicant to keep track of his/her application online and to avoid uploading the same documents again when applying in another EU country
According to the Beveridge system
Financing is public and care is normally provided free of charge
How is prior authorization treated in the EU.
Under Regulation (EC) No 883/2004 prior authorisation is the rule while under Directive 2011/24it is the exception
What is the MyHealth@EU under the proposal of the European Health Data Space?
A voluntary cross-border infrastructure for primary use of electronic health data that facilitates telemedicine, mobile health, access by natural persons to their translated health data, exchange or verification of health-related certificates
What are the requirements that a wellness application, interoperable with an electronic health record, shall meet?
in any case, the requirements laid down in the Digital Governance Act
The EU regulatory approach for the digital sector (the so-called “EU way”) aims at:
Reconciling the respect of the EU values with the need to become leader in the global digital market through a solid normative framework.
The software intended to provide information that is used to make decisions for diagnostic or therapeutic purposes is classified as:
class IIa, except if such decisions have an impact that may cause death or irreversible impairment of a person’s state of health in this case it’s IIb
Why has the creation of a European Health Data Space been proposed?
to support natural persons’ control over their personal electronic health data at the national and cross-border levels and to favour the secondary uses of electronic health data
According to the approach adopted by the ECJ in the A v Veselības ministrija case (C-243/19), the Lativian refusal of authorisation:
does not amount to a discrimination based on religion, because the refusal was considered justified by the legitimate objective of financial stability
Under the Data Act, data holders shall make data available to a public sector body:
only when the public sector body demonstrates the existence of an exceptional need to use the data requested
Very broadly explain the EU’s competencies in the field of public health.
The primary responsibility for health protection and healthcare systems continues to lie with the Member States. However, the EU has an important role to play in improving public health, preventing and managing diseases, mitigating sources of danger to human health, and harmonising health strategies between Member States1. EU member states are responsible for organising and delivering health services and medical care. The EU’s role in health policy is therefore complementary to national policies.
in the process of digitalization what risks and rights may we refer to?”
Some of the risks include cybersecurity, privacy and market power. The lack of normative and technical infrastructures, lack of training, the public health workforce organization in silos, data accessibility and interoperability constraints are some of the major barriers to enhance digitalisation in health2. The European Health Data Space (EHDS) is an initiative that aims to create a secure and protected space where citizens can access their health data across borders
what kind of act is a regulation
In the EU context, a regulation is a legal act that is directly applicable in all Member States without the need for national implementing measures. It is binding in its entirety and directly applicable in all Member States.
what kind of act is a directive
In the EU context, a directive is a legal act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to decide how they will go about achieving this goal. Directives are binding as to the result to be achieved but leave the choice of form and methods to the Member States.
What kind of act are recommendations and opinions ?
Recommendations and opinions are non-binding legal acts. Recommendations are addressed to all EU countries or to certain Member States or to one or more categories of Member States with a view to coordinating their action. Opinions are addressed to the institutions, bodies, offices and agencies of the Union, or to the governments of the Member States.
