What is EU Health Law and can you mention some key aspects? | EU Health Law refers to the body of legislation and policies developed by the European Union (EU) to regulate and protect public health, ensure the safety of health products and services, and promote high-quality healthcare across member states.
Aspects such as Health data, life-style products andpublic-health issues |
How did the European Union evolve from economic cooperation to a unified community of values? Describe the roles of the 1951 ECSC, the 1969 Stauder case, the 1992 Maastricht Treaty, and the 2007 Lisbon Treaty in this process. | The European Union was established after the second world war as a union for resources, with the aim to safeguard peace. It was the chosen alternative for punishment. The original ideas were to:
Create a black pool: for coal and steel trade
Create a green pool: agricultural sector;
Create a white pool: European Health Community;
Create a European Defence Community.
Due to several socio-political factors, only the black pool came into existence. The European Union started as a community of economic integration of six countries (1951). The next dimension of the EU was added in (1969) when the European Court of Justice was established, concerning human rights. The Maastricht treaty of 1992 also added the dimension of political integration and finally the Lisbon treaty (2007) added the dimension of a community of values, adding up to a total of 4 dimensions. |
What is Copenhagen criteria? | Criteria that the country needs to fulfill to be apart of the union. Includes democracy, respect for human rights, economic stability |
What is Schengen aquis? | Set of rules and legislation integrated to the EU which regulate the abolition of border controls at the internal borders within the Schengen Area, as well as the strengthening of border controls at the external borders. |
What is the Council of Europe? | Internaztional political organisaztion that work with human rights, democracy and the rule of law of Europe. Is not assosieted with the EU. |
Define regulations? | Regulations are binding legislative acts that apply directly and uniformly across all EU Member States without the need for national transposition into local law. Once a regulation is adopted, it becomes immediately enforceable in its entirety. Example: GDPR- data protection regulation |
Define directives? | Directives are binding as to the result that must be achieved, but they allow Member States the flexibility to choose how to implement them in their national laws. Each Member State is required to "transpose" the directive into domestic law within a certain time frame. Example: Habitat directive 92/43/EEC( promote the conservation of natural habitats, wild fauna, and flora across Europe) |
State the difference between soft law and hard law | Soft laws are principles or rules that are often followed by states in practice, but where the practice is not consistent enough, widespread enough or merely enough to argue the rule in question has become customary international law or is a general principle of law. In the EU it is opinions, recommendations, communications etc. Example is covid regulations. Can have bigger impact and are not binding.
Hard laws are legal obligations that are binding on the parties involved and which can be legally enforced before a court. Like regulations etc. |
What is the Euro Area? | Refers to the group of European Union (EU) countries that have adopted the euro (€) as their official currency. |
What is the European Economic Area/EEA? | A regional agreement that allows for the free movement of people, goods, services, and capital among its member states. |
What is Schengen Area? | A group of European countries that have abolished passport and other types of border control at their mutual borders. This allows for the free movement of people between member countries. |
What is European Customs Union? | A key component of the European Union (EU) that facilitates trade and economic cooperation among its member states. |
What is the EU’s internal market? | The EU's internal market is an area with no internal borders for trade, allowing free movement of goods, people, services, and capital among Member States. This means:
Goods, workers, and money can flow easily across countries.
There is no discrimination based on nationality in economic activities. |
How does EU law affect national law and individuals' rights, especially in healthcare? | EU law requires Member States to adjust their national laws to meet EU regulations and directives. For instance, countries must ensure medical devices are safe and support patient access to cross-border healthcare. If a country fails to implement these correctly, like the Patients' Rights Directive, it may limit patient rights or access to care across EU borders. When directives are clear, individuals can sometimes use them directly to claim rights—such as challenging a government for denying healthcare reimbursement. Overall, EU harmonization strengthens individuals' rights and healthcare protections across Member States. |
What are the EU's fundamental economic freedoms, and how do they apply to people, products, and capital? | These freedoms support different groups in the EU:
People:
Freedom of establishment: Self-employed individuals can set up businesses long-term across the EU.
Freedom to provide services: Self-employed people can offer short-term services in other Member States.
Free movement of workers: Allows people to work long-term in any EU country.
Posting of workers: Short-term employment in another EU country.
Products and Capital:
Free movement of goods and capital to facilitate easy trade and investment across borders. |
How does the freedom of services work in the EU, and what are the different ways it can be applied across borders? | Freedom of Services:
Active services: The provider travels to another country to offer a service.
Passive services: The customer travels to receive a service.
Combined: Both the provider and customer travel.
Only the service: The service itself crosses the border (e.g., online services).
These freedoms apply to EU and EEA (European Economic Area) countries. |
How does EU legislation support the internal market, and what is the role of harmonization in Member States? | To support the internal market, the EU Parliament and Council create laws that align (harmonize) Member States’ regulations. This harmonization: Removes national laws that restrict economic freedoms.
Establishes similar standards across countries to make the internal market function smoothly. |
Explain MS Watts case study | British woman travels to France for urgent hip replacement. Had to pay for the treatment. Would not get it reimbursed by the British government, she went to national court, who decided that she was right for getting it reimbursed, because in the country she has the right to get healthcare in due time. Home country decide which treatment is available for you and how much you get reimbursed. |
What is the difference between regulations and directives in EU law? | Regulations apply directly in all EU states, while directives set goals that states achieve through their national laws. |
What are the main goals of the European Health Union? | To set minimum standards for primary care, enhance data-sharing, improve cross-border healthcare access, and increase health workforce sharing across member states. |
What is the European Court of Human Rights? | A judicial body ensuring compliance with the European Convention on Human Rights across member states. |
What is the role of the European Commission in legislation? | To propose laws, ensure their application, and manage EU spending programs. |
What is the role of the European Council? | It represents EU heads of state, setting general political directions and policies for the EU. |
Under what conditions can EU rights be limited? | Only when legally provided, respecting the essence of rights, and ensuring measures are proportional to achieve their purpose. |
What is the European Charter of Fundamental Rights? | A legally binding document that outlines the EU’s commitment to human rights, including protections for everyone, even migrants. |
What is the Eurozone? | A group of EU countries that use the Euro as their currency, overseen by the European Central Bank (ECB), which manages economic and monetary policy. |
What is the Beveridge healthcare system model? | A system where healthcare is provided by the government for all citizens, funded through income tax (e.g., Norway and Italy). |
Describe the Bismarck healthcare system model. | A system where people contribute to health funds that pay for healthcare services, with care provided by both public and private entities (e.g., Austria, Germany). |
How is healthcare structured in Norway? | It has three tiers: Local government (municipalities) for primary care, County government for dental and transport services, and Central government for hospitals and secondary/tertiary care. |
What are the key financing methods for healthcare in Norway? | Funded primarily by taxes with equity grants for regional and local governments, activity-based funding for hospitals, and user fees for cost efficiency. |
What significant healthcare reform did Italy implement in 1978? | Italy introduced the National Health Service (SSN), making healthcare universal and accessible to all citizens, funded by the state with copayments for some services. |
How is Italy’s healthcare managed regionally? | Regions in Italy manage healthcare funding, quality assessment, and copayment policies, adapting the National Health Benefits Package based on local needs. |
What is unique about Austria’s healthcare system? | It combines public and private healthcare with most funding from social health insurance (SHI) for outpatient care and state funds for inpatient care, though there’s a lack of coordination between the two. |
How are doctors compensated in Austria? | Doctors are mostly paid through fee-for-service, with some under SHI contracts and others opting out for more profitable private arrangements. |
How is consumer choice maintained in the Dutch healthcare system? | Citizens can choose insurers and providers annually, with options for in-kind or reimbursement-based coverage and voluntary deductibles. |
What are the key features of Norway’s healthcare system? | It is tax-funded with high quality and access, and the government is both a provider and financer. |
How does Italy’s healthcare system ensure coverage? | It is tax-funded and decentralized, providing universal coverage through regional adaptation of the national health package. |
What is the primary funding source for Austria's healthcare system? | A mix of SHI and taxes, with the state handling inpatient care and SHI covering outpatient care. |
How does the Dutch healthcare system ensure affordability and access? | Through mandatory insurance premiums and a risk equalization fund to prevent adverse selection. |
What is exclusive competences? | Areas in which the EU alone is able to legislate and adopt binding acts. Member States are able to do so themselves only if given the powers by the EU to implement these acts. EX: customs union, fisheries policy and common commercial policy |
What is shared competences? | The EU and its Member States are able to legislate and adopt legally binding acts. Member States exercise their own competence where the EU does not exercise, or has decided not to exercise, its own competence. Ex: Internal market, social policy and environment |
What is supported competences? | The EU can only intervene to support, coordinate or complement the action of its Member States. Legally binding EU acts must not require the harmonisation of the laws or regulations of the Member States. EX: industry, culture and tourism |
What is harmonization? | Harmonization in the EU refers to the process of creating common standards or rules across member states in specific areas, often through directives or regulations. EX: GDPR |
What is coordination? | Coordination is the process of aligning policies and actions among EU member states in areas where national sovereignty remains strong, like healthcare or social policy. |
Explain the special features of the italian syste, | Decentralization of services provided by the state to promote local autonomies.
Each region has a National Health Benefits package( minimum care, all residents are entitled to, emergency, pharma etc) and adapts and expands.
They also:
-Choose level of copayment/ how much money each individual pays for each service and basic healthcare package
-Health protection/vaccine etc
- Financing local health authority and hospitals |
Explain the history of the italian healthcare | Before 1978:
Had Bismarck model.
Municipalities oversaw infectious disease, food safety and management of pharmacies. In charge of state-sponsored activities.
1919- post ww2: National security established, made compulsory for employees of private and public sectors. Only 35% were actually insured. Only the poor could be covered by muncipialities for their fees for healthcare services
1978: Health funds were abolished and integrated into National Health Service/Italian health insurance. Private care can be established freely and are often integrated w SSN. Universal, coverage is based on income.
1980-1990:
Introduced more, mostly for financial reasons
-Accountability
-Cost-effectiveness
-Value for money- patient as a customer |
Explain the special features of the norwegian health care system? | Semi-decentralized, taxed-based healthcare system, some out of pocket
Central government sets out general national priorities, proposes legislation, National health plans are the key strategi planning tools in the sector.
Central state: Tasked with supervision and control
Four regional health authorities: responsible for managing hospitals and specialist services
Muncipialities:
Primary healthcare such as gps, nursing homes, home care services
Private healthcare providers ofter offer elective procedures and specialized services |
can you explain the three funding approaches in norwegian healthcare? | Taxed-based healthcare system.
Central grants: Taxation given from government.
Risk-adjusting: Regions with higher health demands receive more funding
Activity-based funding: Fundng based on actual services provided |
Explain the history of the netherlands health system | . Universal Coverage and Equal Access (1940s-1970s):
Sickness Fund Decision (1940s): Established mandatory sickness fund membership for employees up to a certain income level, funded by income-related premiums. However, this system had no incentives for cost containment.
NHI Proposals (Early 1900s): Proposals for mandatory national health insurance failed due to resistance from doctors and private insurers, who feared losing profitable private business and faced concerns about income redistribution.
2. Two-Tier System (1941-2005):
Mandatory Public Health Insurance (Sickness Fund Insurance - SFI): Covered about two-thirds of the population (lower-income individuals), funded by income-related premiums.
Voluntary Private Health Insurance (PHI): Available to higher-income individuals, but faced issues with risk-rating and selection.
AWBZ (Exceptional Medical Expenditure Act, 1968): Provided long-term care and nursing home services but led to stringent controls, rationing, and expenditure caps.
3. Incentives and Competition (2000s):
Dekker Reforms: Shifted towards regulated competition, with mandatory health insurance for all, effectively merging public and private health insurance.
Introduced a role for private insurers as purchasers of care, deregulated prices and capacity, but maintained government oversight to ensure affordability and quality.
Health Insurance Act (2006): Mandated all residents to purchase private health insurance, offering a standard benefit package with broad coverage, open enrollment, and community rating. A mandatory deductible of €385 was introduced for adults, allowing selective contracting and vertical integration. |
Explain the special features about the netherlands system | Decentralised system.
Individuals have the autonomy to choose their health insurers and specific insurance contracts annually. Can opt for sickness funds or reimbursement coverage(private) or a combination of both.
Insurers negotiate contracts with healthcare providers, creating a network of contracted providers that deliver care without upfront costs. Can purchase additional coverage for services not included-> physio, dental care.
Uninsured individuals in the Netherlands must pay out-of-pocket for services but are entitled to receive acute, necessary care for life-threatening situations at no cost. |
explain the key features of the austrian system | Public sector:
State-wide Holding Organizations: Each state in Austria has created holding companies that manage healthcare facilities. This means that hospitals function primarily as sites under these holding organizations rather than as independent entities.
Municipal Responsibility: Municipalities are responsible for the operation of hospitals, leading to variations in the quality and availability of services across different regions.
Outpatient care: Funded by Social Health Insurance (SHI), which is mandatory for employees with progressive contributions.
• No copayments for outpatient care, except for pharmaceuticals.
• Patients can choose any GP without disincentives. |
How is the austrian system funded? | Federal, state, and SHI funds all contribute to healthcare funding, with the system supported by a combination of public funding sources. SHI coverage is nearly universal, with 99.9% of the population covered as of 2021. People are assigned to SHI funds based on residence or occupation. Out-of-pocket (OOP) payments are primarily for services not fully covered by SHI, such as visits to doctors without SHI contracts and certain copayments.
SHI funds outpatient care; states and municipalities fund inpatient care. Lack of coordination creates issues for expensive or long-term treatments like cancer or dialysis.
Nine Federal States (Länder) are responsible for providing and funding hospital care within their jurisdictions. They also handle capital expenditure in the hospital sector. |
How is the netherlands system funded? | All residents are required to purchase basic health insurance from private insurers. This is funded through income-based premiums.
In addition to private premiums, there are also income-related contributions collected by the government, which are used to subsidize health insurance for lower-income individuals.
The Dutch healthcare system is funded primarily through mandatory private health insurance premiums, supplemented by income-related contributions and government allowances for lower-income residents. |
What is european medicine agency? | Agency within the european health union, that responsile of scientifc evaluation and supervision and safety monitoring of medicines |