Health competences in action

Question 1

What is the principle of conferral

Answer 1

The principle of conferral is a fundamental principle of European Union law. According to this principle, the EU is a union of its member states, and all its competences are voluntarily conferred on it by its member states.

Under this fundamental principle of European Union (EU) law, laid down in Article 5 of the Treaty on European Union, the EU acts only within the limits of the competences that EU Member States have conferred upon it in the treaties.

Question 2

Why is the principle of conferral important?

Answer 2

The limits of EU competences are governed by the principle of conferral (also known as principle of attributed powers). This principle ensures that the EU does not extend its powers beyond those conferred by the EU Treaties

Question 3

Public health and its protection are state prerogatives however

Answer 3

however this practices are highly influenced by international law and EU law.

Question 4

The right to access medical treatment is protected, as well as the right to health, in the international covenant and in many international treaties. However, the quality of the medical treatment …

Answer 4

is unfortunately not granted because,
as many things in the world, rights and especially health protection requires money which sometimes is not always there

Question 5

Article 35 of the Charter of Fundamental Rights of the European Union

Answer 5

Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices.

Question 6

Article 9 of TFEU

Answer 6

in defining and implementing its policies and
activities, the Union shall take into account requirements linked to the promotion of a high level of employment, the guarantee of
adequate social protection, the fight against social exclusion, and a high level of education, training and protection of human
health.

Question 7

What is the European Semester and why is it important:

Answer 7

A yearly exercise that aims to coordinate economic, fiscal, employment and social policy within the European Union. It is part of the EU’s economic governance framework and during the European Semester Member states align their budgetary and economic policies with the rules agreed at EU level.

The importance of this yearly coordination is given by the attempt to harmonize and create a homogenous “international” framework of rules among EU Member States.

Question 8

Some examples of shared competences between the EU and member states are

Answer 8

Internal market, Consumer protection, environmental protection, Energy.

Question 9

Public health is neither a shared competence or a exlusive competence but a

Answer 9

Parallel coordinated competence

Question 10

Public health is neither a shared competence or a exclusive competence but a

Answer 10

Parallel coordinated competence

Question 11

What are some first generation rights related to health?

Answer 11

• Right to life
• Dignity
• Family life
• Reproductive health.

Question 12

What are some second generation rights related to health?

Answer 12

• Right to access healthcare
• Right access to medical records.

Question 13

Why stress the difference between first and second generation rights?

Answer 13

Second generation are prestational rights, The state has to do something for them to be guaranteed. you can say the right to health but if you don’t have a system it’s not going to happen.

Question 14

What is the Beveridge health model:

Answer 14

The Beveridge model provides health care for all citizens and is financed by the government through tax payments. This “socialized medicine” model is currently found in Great Britain, Spain, Italy etc.

Question 15

What is the Bismarck health model:

Answer 15

this system of providing health care would look fairly familiar to Americans. It uses an insurance system — people pay a fee to a fund that in turn pays health care activities, that can be provided by State-owned institutions, other Government body-owned institutions, or a private institution.
Example in Netherlands, Germany, France.

Question 16

What are some overarching values present in the EU regardless of health system? And what do they mean.

Answer 16

Universality, access to a good quality care equity and solidarity.

• Universality means that no-one is barred access to health care
• Solidarity is closely linked to the financial arrangement of our national health systems and the need to ensure accessibility to all.
  -Equity relates to equal access according to need, regardless of ethnicity, gender, age, social status or ability to pay.

Question 17

Article 21 of the EU charter:

Answer 17

establishes anti-discrimination on any ground, according to which any discrimination on grounds of nationality shall
be prohibited

Question 18

Article 35 of the EU charter:

Answer 18

Concerns health care, arguing that everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. This article aims to set a high level of human health protection and shall be ensured in the definition and implementation of all the Union’s policies and
activities

Question 19

Article 19

Answer 19

Once again restates the prohibition of discrimination, stating that the Council may take appropriate action to combat
discrimination based on sex, racial or ethnic groups, religion or belief, disability, age or sexual orientation.

Important may take action.

Question 20

What is a problem on the prohibition of discrimination on the EU framework:

Answer 20

EU law protects against both direct and indirect discrimination only on rounds of gender and racial or ethnic
origin when accessing healthcare, under Directive 2000/43 (race and ethnic origin) and 2004/113 (gender)

Other causes of discrimination are not covered, like religious discrimination in the case of Roma or Muslim people, Age discrimination. Or an intersectional discrimination situation.

Question 21

What are the operating principles of Health in the EU system:

Answer 21

• Quality (continuous training of healthcare staff, stimulating innovation and spreading good practice)
• Safety (monitoring of risk factors and misleading advertising of health products and treatments)
• Care based on evidence and ethics (balancing the needs of individual patients with the financial resources available)
• Patient involvement (right to be fully informed, choice between different health care service providers),
• Redress (clear information about liabilities and specific forms of redress)
• Privacy and confidentiality (protection of personal data)

Question 22

What are directives 2004/113 and 2000/43

Answer 22

Directives regarding the prohibition of discrimination on health services.

both directives contemplate the reversal of the burden of proof in case of prima facie evidence of discrimination and victimization
both directives require Member States to guarantee effective administrative and judicial protection
both directives provide for adequate sanctions (including compensation or reparation)
both directives prescribe the establishment of equality bodies

EU law protects against (direct and indirect) discrimination only on grounds of gender (Directive 2004/113) and racial or ethnic origin when accessing healthcare
EU law and the law of most Member States do not specifically recognize or make provision for dealing with multiple discrimination

Question 23

What is proposal COM/2008/0426 and what are some limits to it ?

Answer 23

A proposal to prohibit:
Discrimination based on religion or belief, disability, age or sexual orientation in: social protection, including social security and health care; social advantages; education; access to and supply of goods and services which are available to the public, including housing (art. 3)

A limit to its adoption is funding as it often is with prestational rights.

Question 24

Whare are the Objectives and actions of the European Health Union

Answer 24

Objectives
-better protect the health of our citizens
-equip EU and MS to better prevent and -address future pandemics
- improve resilience of Europe’s health systems

Actions
- On crisis preparedness and response measures (+ coordination and powers to ECDC and EMA, HERA)
- On pharmas (modernise regulatory framework, support research and technologies, diversified supply chains, environmental sustainability)
- Cancer plan (detection, diagnosis, treatment, quality of life)

Question 25

what is harmonization in the EU legal system?

Answer 25

harmonize legislations so that there is no restriction in the legislation of the member states that opposes free movement of goods and in our specific case, pharmaceuticals and medical devices in particular.

What we want to do is harmonize and tell the producers what they need, what qualities they need to provide in order for their products to be interoperable

Question 26

What kinds of harmonization are there?

Answer 26

• minimum: setting a minimum standard to reach a minimum convergence among Member States; environmental protection is characterized by a minimum harmonization.
• maximum: determining normative convergence at national level by not leaving the Members States any margin of appreciation setting the clear conditions that cannot be escaped from.
• optional: will not be an obligation for Member States, as the name states it will be optional and states are not
  forced to comply.
• preventive: intended as a measure to prevent an eventual problem in the future, for example harmonize the
  legislation of Member States in a matter that will help and make things easier in the future, for example with the regulation of
  the data space and handling of data among Member States.
• corrective: s pretty self-explanatory and is on the same line as the preventive harmonization, only taking place
  once a problems presents itself. When the Commission finds that there is a distortion between Member States on a matter and
  tries to harmonize the distortion.

Question 27

What is a harmonized standard:

Answer 27

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 a belief that the product will be the same among all member states.

Question 28

Which are the European Standardization Organizations:

Answer 28

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)

Question 29

What is the new approach for standardization:

Answer 29

In light of the shortcomings (and failure) of the so-called old approach (total harmonization via legislative instruments):
* European directives (Arts. 114/168(4) TFEU) define the ‘essential requirements’ to ensure a high level of protection of health, safety, consumer protection, or the protection of the
environment.
* European standardisation organisations are mandated to draw
up the corresponding harmonised standards
* Harmonized standards accepted by Commission are published in OJ

Question 30

What are the benefits of the new approach:

Answer 30

The use of standards promotes the proper functioning of the internal market and guarantees legal certainty:

• products that comply with harmonised standards are presumed to meet the corresponding essential requirements (presumption of conformity, CE marking) and Member States must accept the free movement of such products
• use of standards by manufacturers remains voluntary (but if alternative standards are followed need to prove compliance with essential requirements)

Question 31

The three main pillars of the European Data Space are

Answer 31

the presence of a strong system of data governance and rules for data exchange, the quality of data and a strong infrastructure
and interoperability.

Question 32

What is the European Health Data Space?

Answer 32

A health-specific ecosystem comprised of rules, common standards and practices, infrastructure and a governance framework that aims to empower individuals through an increased digital access and a better control of their electronic personal data both at national and EU level.

Question 33

What are the consequences of the EU health data space plan?

Answer 33

The plan for the establishment of a European health data space would foster a genuine single market for electronic health record systems, relevant medical devices and high risk AI systems, as well as providing a
trustworthy and efficient set-up for the use of health data for matters like research and innovation.

Question 34

The EHDS is needed especially in

Answer 34

The aftermath left behind by the Covid-19 pandemic, which has shown even further the importance of electronic health data for the
development of policy in response to health emergencies. It also highlighted the imperative of ensuring timely access to personal electronic health data for health threats preparedness and response, as well as for treatment, but also research, innovation, patient, safety, regulatory purposes, policymaking, statistical purposes or personalized medicine.

Question 35

What is a possible issue of the EHDS

Answer 35

it could also exclude the very
groups that need help the most. The current proposal for EHDS has the potential to worsen existing inequalities if digitally abled
people were able to mobilize their health data during healthcare visits, while other people that are not so skilled with technology
could not, and arguably it would refer to the older population which actually would need help the most.