Protected Disclosures

The purpose of the Protected Disclosures Act, 2014, is to provide a framework within which workers can raise concerns regarding potential wrongdoing that has come to their attention in connection with their work. The Act provides protection from penalisation if it results from the making of a protected disclosure.

The HPRA may receive protected disclosures from external persons in relation to the regulatory functions performed by the HPRA. For these types of disclosures:

  • The person making the disclosure must be a current or past worker in a company which carries out activities regulated by the HPRA.

  • The worker must reasonably believe that the information disclosed and any allegations it contains regarding potential wrongdoing (as defined in the Act) are substantially true.

Disclosure should be made by email to protecteddisclosures@hpra.ie or by letter to:

Chief Executive
Health Products Regulatory Authority
Kevin O’Malley House,
Earlsfort Terrace
Dublin 2,
D02 XP77

The correspondence should state that the disclosure is being made under Section 7 of the Protected Disclosures Act 2014 and provide:

  • description of the relevant wrongdoing

  • copies of information that tends to show the wrongdoing in order to assist the investigation of the matters, and

  • preferred contact details.

The HPRA will use the information provided to decide whether or not to investigate. The nature of the disclosure may be such that a ‘for cause’ investigation is carried out, or the matter might be investigated at the next routine inspection, or in some cases, no investigation may be deemed warranted by the matters disclosed. The decision to investigate - or not - is the responsibility of the HPRA, on the basis of the information provided and in accordance with its regulatory remit and its own procedures. The discloser may be informed of the outcome, in general terms only.

The HPRA will protect the identity of the discloser if possible but may be obliged to reveal the identity so that a proper investigation can be carried out. Anonymous disclosures will be investigated in so far as is practicable with the information supplied.