Healthcare News

Snapshot: private enforcement of healthcare laws and regulations in Portugal


Private enforcement

Causes of action

What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?

Citizens and other private bodies may use administrative and judicial mechanisms to enforce healthcare regulations or relevant laws.

Citizens or other private bodies have the right to request a declaration of invalidity, revocation, annulment, modification, or substitution of an administrative act that fails to comply with regulations or law, and to request the enforcement of an unlawfully omitted act, by means of a complaint directed at the author of the act or the omission, or by a hierarchic appeal. However, such an appeal is only available when an administrative body was responsible for the act or omission and is subject to the hierarchical powers of another.

Among the available judicial mechanisms, citizens and other private bodies may request an administrative court:

  • declare invalid or annul an administrative act that fails to comply with healthcare regulations or law;
  • order an administrative body to perform an act that is legally due or not perform an unlawful act;
  • recognise subjective legal situations deriving directly from healthcare regulations or law; and
  • order an administrative body to repair damages caused.

 

An administrative body that fails to comply with a healthcare regulation or law is subject to three levels of accountability.

 

Civil liability

Civil liability may occur whenever damages and losses arise from infringements of civil law or contractual provisions. Whenever an infringement concerns a rule of civil law, state and other public entities (ie, individuals and entities of the public healthcare sector) may be held liable under specific extra-contractual civil liability.

 

Criminal liability

Criminal liability exists if a crime is undertaken by an individual and the conduct is classified as a crime. The following crimes are to be highlighted:

  • medical and surgical treatments in violation of current and common medical practices (article 150, No. 2 of the Portuguese Criminal Code (PCC);
  • medical and surgical treatments against the patient’s will (PCC, article 156);
  • dissemination of disease and provision of medicinal substances disregarding a medical prescription (PCC, article 283);
  • refusal of medical aid (PCC, article 284); and
  • breach of secrecy (PCC, article 195).

 

Disciplinary liability

Disciplinary liability mainly occurs whenever deontological law or rulings are breached. Depending on the sector (public or private) in which the healthcare provider commits the infringement, enforcement of the law or ruling may be of a public or private nature.

Framework for claims

What is the framework for claims of clinical negligence against healthcare providers?

The framework may correspond to the violation of the good practices established for healthcare professionals and healthcare institutions as well as of guidelines issued by public agencies, such as the General Health Directorate. Apart from the specific rulings arising from these practices and guidelines, the general standard is that every healthcare professional shall act with the diligence and correctness that a ‘normal’ and typical healthcare professional would act in that specific situation.

From a civil perspective, it is widely accepted by Portuguese courts that the requirements for civil liability are the following:

  • an action or relevant omission;
  • a breach of law or of contractual provisions;
  • the occurrence of damage;
  • guilty behaviour; and
  • causality between the damage and the defaulting conduct.

 

Courts are not reluctant to penalise public or quasi-public healthcare providers if legal requirements are fully satisfied.

Seeking recourse

How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?

Users may submit complaints and report events and even submit suggestions to the National Authority of Medicines and Health Products IP (Infarmed) on the following areas and subjects:

  • services provided by entities regulated and supervised by Infarmed;
  • products regulated by Infarmed; and
  • services provided by Infarmed.

 

Besides the civil and criminal liability and respective grounds, product liability and adverse reactions may also serve as grounds.

Compensation

Are there any compensation schemes in place?

There are no specific compensation schemes. Compensation is determined on a case-by-case basis and is fixed in accordance with the court criteria and respective assessment of the facts and means of proof, and in accordance with the nature and extension of the damages and losses.

Class and collective actions

Are class actions or other collective claims available in cases related to drugs, devices and provision of care?

The ação popular (popular action), governed by Law No. 83/95 of 31 August, as amended, is a collective claim that can be brought by those seeking compensation for offences against public health or quality of life. In accordance with specific legislation, this action may be of administrative (public) or civil nature.

Review

Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?

Public institutions are subject to administrative and judicial review. The statute of limitations for the interested parties to challenge the respective acts or omissions depends on the nature of the infraction. Remedies may consist of the revocation, suspension, and amendment of an act or decision in the breadth of administrative offence or by judicial review. The enforcement of specific conduct or the performance of a specific act, and compensation of damages may also be granted by a judicial decision. In this regard, public entities may also be challenged for damages within the parameters of the extra-contractual civil liability regime pointed out above. Such claims are handled by administrative courts.

The challenging of private institutions may be of an administrative nature if the grounds of the complaint relate to infringements of regulatory duties, in which case the complaint may be enforced at the start before the competent regulatory authority and may be subsequently submitted to the competent courts. In the case of damages of a civil nature, challenges are subject to judicial civil review. The statute of limitations for interested parties to challenge acts or omissions of these private entities also depends on the nature of the infraction, and the remedies may be the same as the ones quoted for public entities.

Whistle-blowers

Are there any legal protections for whistle-blowers?

Law No. 93/2021 of 20 December, which is motivated by corporate compliance concerns and is responsible for the transposition of Directive (EU) 2019/1937 of the European Parliament and the Council of 23 October 2019, applies mainly to companies and respective employees, including ex-workers and individuals who, despite not having entered into a professional relationship with a company, somehow obtain relevant information for this law’s purposes at a pre-contractual negotiation stage regarding the company or its employees.

With this law’s entry into force, companies in the public and private sector with more than 50 employees must adopt internal denunciation channels appropriate and proportionate to their area and scope of activity. The law enshrines means of protection for whistle-blowers who, in good faith, and having good reason to believe that the information is at the time of reporting or public disclosure true, internally or externally report or publicly disclose (in accordance with the rules of precedence foreseen under the law) an infringement, including guaranteeing the confidentiality of the whistle-blower’s identity, a prohibition on retaliating against a whistle-blower in a professional context, and the right to legal protection.

Infringements may relate to the following issues, among others:

  • public procurement;
  • financial markets and prevention of money laundering and terrorist financing;
  • product safety and conformity;
  • food safety for animal and human consumption;
  • animal health and animal welfare;
  • public health;
  • environmental protection;
  • radiation protection and nuclear safety;
  • consumer protection;
  • protection of privacy and personal data and security of network and information systems;
  • violent criminality;
  • especially violent and highly organised crime;
  • passive corruption and embezzlement.

 

Furthermore,  there are specific regimes established for denouncing crimes related to corruption and fraud, money laundering, terrorism, and the trafficking of drugs.

Whistle-blowers may be held criminally and civilly liable for defamation in cases involving persons of high reputation.

Does the country have a reward mechanism for whistle-blowers?

There is no reward mechanism for whistle-blowers in Portugal.

Are mechanisms allowing whistle-blowers to report infringements required?

As mentioned above, there is an obligation for companies in the public or private sector with more than 50 employees to adopt internal denunciation channels appropriate and proportionate to their area and scope of activity, which must be prepared so that the presentation of denunciations, whether anonymous or not, can be made in writing or verbally. Internal denunciation channels must:

  • enable the secure submission and tracking of denunciations in order to ensure the completeness, integrity and conservation of the denunciation;
  • ensure the whistle-blower’s anonymity or their identity is kept confidential;
  • ensure the identities of third parties mentioned in the denunciation are kept confidential; and
  • prevent access by unauthorised persons.

 

In general, denunciations must be registered and preserved for a period of at least in general five years.

A company may choose to retain responsibility for the channel internally. In such cases, the person who receives alerts and takes responsibility for contacting whistle-blower(s) should be independent of the company. Alternatively, the company can opt to have an external entity operate the denunciation channel, but this entity may only receive the denunciations.

The National Anti-Corruption Mechanism is responsible for policing these denunciation mechanisms.

There are also specific mechanisms to report corruption and fraud on the website of the Central Bureau of Investigation and Prosecution of the Attorney General’s Office, and to report money laundering and the financing of terrorism on the website of the Commission for the Prevention of Money Laundering and Terrorist Financing.



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