S.L. 524.1 Art. 18Measures which may be taken.

(1) Without prejudice to any other provisions under the Act and, or these regulations, or any other law which the Authority is entitled to enforce, the Authority may take the following measures in respect of any person who infringes any provision of the Act and, or these regulations, of the Protocols issued by the Authority, or of any other law which the Authority is entitled to enforce, or who fails to comply with any decision given by the Authority or with any authorisation condition:

(a) the imposition of an administrative fine in accordance with the provisions of this regulation,

(b) the ordering of the cessation of any act or omission which is in breach.

(2) In cases where the Authority considers that a person has seriously and repeatedly infringed the provisions of the Act and, or these regulations, or of any other law or the Protocol which the Authority is entitled to enforce, or of any decision of the Authority or of any authorisation condition, the Authority may withdraw or suspend any related authorisation granted by or under the Act and, or these regulations, or any other law which the Authority is entitled to enforce.

(3) The Authority shall, before proceeding to take any of measures under this regulation, inform the person concerned in writing, warning him of the measure that may be taken and the specific reason why it may be taken, requiring him to cease or rectify his acts or omissions and, or to make his submissions thereto within such period not being more than fifteen days, which period, without prejudice to the provisions of sub-regulation (6), may be abridged if the Authority considers that the continuance of the infringement impacts negatively the effective exercise by the Authority of its regulatory functions and, or warrants the immediate intervention of the Authority: Provided that where the measure is an administrative fine the person concerned shall also be informed of the amount of the fine: Provided further that when issuing a warning under this sub-regulation, the Authority may impose such conditions as it may consider reasonable in the circumstances.

(4) If the person concerned remedies the infringement within the period established by the Authority in accordance with sub-regulation (3), and agrees in writing to abide with any condition that the Authority may impose, the Authority may at its discretion desist from proceeding any further and this without prejudice to any regulatory measures that may have already been imposed.

(5) If after the lapse of the period mentioned in sub-regulation (3), the Authority considers that the person concerned has not given any valid reasons to demonstrate why no measure should be taken against him, the Authority shall notify the person concerned in writing, specifying the nature of the infringement, stating the measure being taken, and if the measure is an administrative fine, stating the amount of the fine being imposed.

(6) Notwithstanding the provisions of sub-regulation (3), where the Authority has prima facie evidence that the infringement represents an immediate and serious threat to public safety, public security or public health it may take urgent measures to interim remedy the situation in advance of reaching a final decision, including ordering the immediate cessation of the act or omission giving cause to the infringement, requiring the cessation or delay of provision of a service or bundle of services, and the imposition of administrative fines. Administrative fines are to be considered as a civil debt: Provided that the person against whom such measures are contemplated shall, thereafter, be given a reasonable opportunity to state his view of the facts and propose any remedies: Provided further that the measures shall be valid for interim a maximum period of three months, subject to an extension of a further period of three months, in circumstances where enforcement procedures have not been completed.

(7) The Authority shall give its reasons for any decision taken under this regulation.

(8) Notwithstanding the provisions of any law, no precautionary warrant or order shall be issued by any court restraining the Authority from the exercise of any of the powers conferred upon it under this regulation.

(9) An administrative fine imposed shall not, unless provided otherwise by or under the Act, exceed three hundred and forty-nine thousand and four hundred euro (€349,400) for each infringement or failure to comply and, or eleven thousand and six hundred euro (€11,600) for each day of infringement or non-compliance as the case may be: Provided that if the act or omission which constitutes an infringement is committed by an undertaking and the Authority considers that such act or omission has especially significant effects to the detriment of the clients and, or patients, the stated amount that may be imposed as an administrative fine may be increased to an amount that is not more than five per cent of the turnover of the undertaking in the calendar year immediately preceding the year when the infringement was committed: Provided further that any daily fine imposed may be back-dated to the date of the commission, or commencement of, the infringement.

(10) In determining the amount of an administrative fine, regard shall be had in particular to the nature and extent of the infringement, its duration and its impact.

(11) The Authority shall establish the administrative fines that may be imposed by it for breaches of the Protocols issued and any other regulations made by the Authority: Provided that the amount of the fines that may be so prescribed shall not exceed the maximum amounts referred to under sub-regulation (9).

(12) Where an administrative infringement of any provision of the Act and, or these regulations, or any other law which the Authority is entitled to enforce is committed by a body corporate and is proved to have been committed with the consent or involvement of, or to be attributable to, any gross negligence on the part of a person being a director, manager, secretary or other officer however so described of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be liable to be proceeded against and found guilty as if he was responsible for the said infringement: Provided that the body corporate as well as the individual person shall be responsible for the payment of the in solidum administrative fines.