The freedom to provide and receive health services throughout the European Union must be accompanied by guarantees of quality and security.
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ACT
Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare.
SUMMARY
This proposal for a Directive makes provision for the introduction of a general framework to guarantee the safety, quality and efficiency of cross-border healthcare provision.
Cross-border healthcare is that which is provided in a European Union (EU) Member State other than where the patient is an insured person or in a Member State other than where the healthcare provider resides, is registered or is established.
The scope of the Directive applies to all public and private healthcare provision, regardless of how the health system is organised, delivered or financed.
Healthcare provided in another Member State
The Member State of treatment organises and provides the healthcare. They are responsible for ensuring the quality and safety of the healthcare provided, in particular by implementing control mechanisms. They also ensure the protection of personal data and equal treatment for patients who are not nationals of their country.
Following the provision of care, it is the Member State of affiliation who takes care of the reimbursement of the insured person on the condition that the treatment received is provided for in their national legislation. The amount of the reimbursement is equivalent to the amount which could have been reimbursed by the statutory social security system if the care was provided in their country. It must not exceed the actual costs of the care.
Prior authorisation for reimbursement for non-hospital care provided in another Member State cannot be required by the statutory social security system of a Member State of affiliation. However with regard to cross-border hospital care, the State of affiliation can implement a system of prior authorisation in order to avoid the risk of undermining the planning and/or financing of their health system.
Administrative procedures relating to the provision of healthcare must be necessary and proportional. They should be implemented in a transparent manner, within fixed deadlines and based on objective and non-discriminatory criteria.
Patients must have access to information on healthcare and conditions of care, as well as on their entitlements and rights of appeal. National Contact Points must be established in Member States to inform and support patients on legal options open to them or out-of-court settlement schemes.
Cooperation on healthcare
Member States will cooperate on the implementation of the Directive. In particular, they will support the creation of European reference networks of healthcare providers, which aim to facilitate access to highly specialised care through the concentration and joining up of available resources and expertise. In addition, a health technology assessment network shall facilitate cooperation between the appropriate national authorities.
Member States shall recognise the validity of medical prescriptions issued in other Member States if those medicines are authorised in their country. Measures must be taken to help health professionals mutually recognise and verify the authenticity of prescriptions.
E-health systems or services also enable the provision of cross-border care. The Commission shall monitor the interoperability of these systems when they are introduced by Member States.
Comitology
The Commission has the authority to take accompanying measures for implementing the Directive. The Commission is helped in this task by the “Committee on safe, high-quality and efficient cross-border healthcare”, composed of representatives from Member States and presided over by a Commission representative.
The Commission shall submit a report on the performance of the Directive after five years.
Context
The proposal is in line with the Court of Justice jurisprudence that established the right of patients to benefit from medical treatment in a Member State other than their own. It does not bring into question the Regulation principles on the coordination of social security systems, in particular the principles regarding equality between resident and non-resident patients of a Member State and the Health Insurance Card.
Key terms of the act
Member State of affiliation: the Member State where the patient is an insured person.
Member State of treatment: the Member State on whose territory cross-border healthcare is actually provided.
Hospital care: healthcare which requires overnight accommodation of the patient in question for at least one night. Or healthcare that does not require overnight accommodation of the patient for at least one night and which are included in a list limited to:
- healthcare that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment;
- healthcare involving treatments presenting a particular risk for the patient or the population.
REFERENCES AND PROCEDURES
Proposal COM(2008) 414 – Procedure COD/2008/0142
