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Whistleblowing (Protected Disclosures)

Whistleblowing is more formally known as making a 'protected disclosure’. The information below provides guidance on making a protected disclosure to the Health Products Regulatory Authority.

The law protects you if you raise concerns about a possible wrongdoing in a workplace you currently or previously worked in. Specifically, the Protected Disclosures Act 2014, as amended (the ‘Act’), makes provision for the protection of workers, from the taking of action against them (or penalisations), in respect of the making of certain disclosures. Any worker may make a protected disclosure where they believe they have information that tends to show one or more relevant wrongdoings, and such information came to their attention in connection with their employment.

What qualifies as a protected disclosure

The HPRA may receive protected disclosures from external persons in relation to the regulatory functions performed by the HPRA.

To quality for protection under the Act, the following conditions apply:

  1. The discloser must be a worker and the relevant information must come to their attention in connection with their employment.
  2. The information disclosed must tend to show one or more ‘relevant wrongdoings’. The full list of relevant wrongdoings is available in section 5(3) of the Act. There are also certain exceptions in section 5. 
  3. The discloser must have a reasonable belief that the information is substantially true and comes within the categories of matters for which the Chief Executive of the HPRA is a prescribed person.
  4. The disclosure must be in the manner prescribed in the Act, as amended.

How to make a protected disclosure to the HPRA

Preferably, you can make a protected disclosures to the HPRA by email to protecteddisclosures@hpra.ie.

You can also make a disclosure by post, telephone or via a physical meeting at the following:

Chief Executive
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Terrace
Dublin 2
D02 XP77
01 6343416

What to provide in a protected disclosure

When making a protected disclosure to the HPRA, it is recommended to confirm the following:

  • that the disclosure is being made as a protected disclosure
  • the discloser’s name, position in the organisation, place of work and confidential contact details. Although we accept anonymous protected disclosures, please note that this may affect the investigation.
  • information in respect of the alleged wrongdoing (what is occurring/has occurred and how)
  • the date of the alleged wrongdoing (if known) or the date the alleged wrongdoing commenced or was identified, and whether it is still ongoing
  • whether the alleged wrongdoing has already been disclosed and if so, to whom, when, and what action was taken
  • the name of the person(s) allegedly involved in the alleged wrongdoing (if a name is known and the discloser considers that naming an individual is necessary to expose the wrongdoing disclosed)
  • any other information that the PD maker believes relevant

After a protected disclosure is received

The HPRA will promptly, and in any event within seven working days, acknowledge receipt of the information.

A designated person will review the information provided. You will be informed as to whether the information provided qualifies as a protected disclosure, whether it relates to a matter for which the HPRA is prescribed (and who should be notified if not), or whether there is insufficient information to initiate an investigation.

The HPRA will endeavour to provide feedback to you on the status or outcome of the investigation within three months, or six months in duly justified cases. Please note that, while feedback may be provided, the need to maintain confidentiality may prevent the HPRA from providing you with specific details of the investigation and/or any actions taken.

Confidentiality

Section 16 of the Act provides that a person to whom a protected disclosure is made, and any person to whom a protected disclosure is referred in the performance of that person’s duties, shall not disclose to another person any information that might identify the discloser. There are exceptions to this, as outlined in the Act.

All reasonable steps will be taken to protect the identity of a discloser and to ensure the disclosure is treated in confidence in line with the provisions of the Act. The HPRA will not disclose the identity of the person, however if a decision or action is required which may directly or indirectly identify the discloser, they will be consulted in advance that this may occur, unless there are certain prescribed circumstances not to do so (as defined in the Act).

Records will be maintained in compliance with relevant confidentiality requirements. Any personal data collected will be processed in accordance with the provisions of the Data Protection Act 2018, Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725. The discloser’s identity will be protected in line with the obligation in section 16 of the Protected Disclosures Act.

Penalisation

The Act provides remedies for you should you be penalised by your employer for making a protected disclosure. The definition of penalisation is defined in the Act under Section 3(1).

Complaints of penalisation are treated separately to the actual report of wrongdoing. If you are penalised or threatened as a result of making a protected disclosure, you can make a complaint to the Workplace Relations Commission using the online complaint form available on workplacerelations.ie. You should make a complaint within six months (although this time can be extended to 12 months if there is a valid reason for the delay).

It is up to your employer to prove that they did not penalise you for making a protected disclosure. The adjudicator's decision on your complaint may require your employer to take a specific course of action and may award you compensation.

Advice and further information

Transparency International Ireland is an independent, non-governmental organisation. Transparency International Ireland operates a confidential helpline and provides access to free legal advice on making a protected disclosure through the Transparency Legal Advice Centre. The helpline can provide free referrals for professional counselling on request.

Further information and advice on protected disclosures can be found on the following websites:


Reporting

Each public body is required under section 22 of the Act to provide an annual report to the Minister for Public Expenditure and Reform (provided by 1 March in each year). The information is provided in such a way that it does not enable the identification of reporting persons or persons concerned.
Protected disclosures annual report 2023