Freedom of Information (FOI)
What is FOI?
The FOI Act 2014 provides that every person has the following legal rights:
- the right to access official records held by Government Departments and all public bodies that conform to the provisions of Section 6 of the Act;
- the right to have personal information held on them corrected or updated where such information is incomplete, incorrect or misleading; and
- the right to be given reasons for decisions taken by public bodies that affect them.
These rights mean that from a certain date (21 April, 1998 in respect of this Department), people can seek access to personal information held on them no matter when the information was created, and to other records created after 21 April, 1998.
How does FOI work?
The Act requires public bodies to respond to requests from the public for information they hold. In most cases, public bodies must give their decision on a request within 4 weeks of receiving it.
How can I make a FOI Request to the Health Products Regulatory Authority (HPRA)?
You should send a request either, in writing or by email, to the
Freedom of Information Unit,
Health Products Regulatory Authority
Kevin O’Malley House,
Tel: +353 (1) 6764971
Fax:+353 (1) 6767836
Your request should include the following:
- A statement that the request is being made under the FOI Act;
- As much information as possible about the records being sought;
- In what format you wish to receive any records released (e.g. photocopies)
Can I get access to any information that I seek?
The following records come within the scope of the FOI Acts:
- all records relating to personal information held by the HPRA irrespective of when they were created
- all other records created from the commencement of the FOI Act (21 April 1998)
- any records necessary to the understanding of a current record even if created prior to 21 April 1998
- personnel records of serving staff created from 21st April, 1995 and those created prior to that date where being used or proposed to be used in a way which adversely affects or may affect the person involved.
However, in order to allow the HPRA to be properly conducted, it will sometimes be necessary to exempt from release certain types of information in some circumstances. These are set out in the Act. Among the key exemptions are records relating to:
- Government meetings,
- law enforcement and security,
- Functions and Negotiations of a public body
- Deliberations of a public body
- confidential and commercially sensitive information,
- personal information (other than information relating to the person making the request).
Requests may also be refused if they are deemed too voluminous or unclear but the HPRA is obliged to assist the requester in trying to overcome this.
Can I get personal information amended or corrected?
Yes the FOI Act gives the right to seek amendment of personal records held by public bodies. The Act outlines that such a record may be amended if it is incomplete, incorrect or misleading.
- Information may be incomplete if it does not adequately deal with the relevant facts and circumstances.
- Information that is wrongly recorded, based on a mistake of fact or without proper regard to the evidence in a particular case may be incorrect.
- Information can be said to be misleading if it could lead a person reading it to take a mistaken meaning from it. It may also be misleading if the language or terminology used might have particular meaning to a specialist or professional but convey an alternative meaning to the ordinary reader.
- must be in writing (or such other form as may be determined)
- must specify the record concerned
- must specify the amendment required
It must include appropriate information in support of the application. It is not sufficient for the applicant merely to state that the record in question is incomplete, incorrect or misleading. He or she must provide sufficient evidence to back up the claim e.g. if factual information, such as birth date, is claimed to be incorrect, then evidence of the correct date must be supplied.
The amendment sought must relate to personal information of the individual submitting the application (or a representative properly authorised to act on his or her behalf).
Is there a charge for getting information under the FOI Act?
There is no charge for submitting a request. In respect of non-personal requests, other charges may be applied for the time spent finding records and for any reproduction costs incurred by the HPRA in providing you with the material requested (search, retrieval and copying charges). Where the cost of search, retrieval and copying is less than €101, no fee is charged. Where the cost of search, retrieval and copying is greater than €500 but less than €700, a maximum charge of €500 applies. Where the cost of search, retrieval and copying is greater than €700, the HPRA can refuse to process the request. Details of actual charges relating to your request will be notified to you in writing. Payment should be made by way of Electronic Funds Transfer. Please contact the FOI Unit for bank details. A list of relevant fees is set out below:
List of Fees
- There is no charge for submitting a request
- Search and Retrieval – €20 per hour (for requests that exceed the €100 minimum in terms of search, retrieval and copying), subject to the ceilings mentioned above.
- €0.04 per sheet for a photocopy
- Internal review fee €30 (€10 for medical card holders)
- Appeal to the Information Commissioner €50 (€15 for medical card holders
- There is no charge if the records concerned contain only personal information relating to the applicant, unless there are a significant number of records.
If you are claiming a reduced application fee, the request must be accompanied by the Medical Card registration number, issuing Health Board name and your consent to the verification of these details with that Health Board.
What if I am not satisfied with the decision on my FOI request?
You may appeal any decision issued by the HPRA by writing to the Freedom of Information Unit, Health Products Regulatory Authority, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2 seeking an Internal Review of the matter. A fee of €30 (€10 for medical card holders) may apply for such an appeal. There is no fee for internal review applications concerning only personal information relating to oneself or in relation to a decision to impose a fee or deposit.
You should make your appeal within 4 weeks from the date of response (although late appeals may be permitted in certain circumstances).The appeal will involve a complete reconsideration of the matter by a more senior member of staff of the HPRA and a decision will be communicated to you within 3 weeks.
What if I am not satisfied with the decision on internal review?
You may appeal the decision within six months by writing to the Office of the Information Commissioner. If you make an appeal the Information Commissioner will fully investigate and consider the matter and issue a fresh decision. All appeals should be addressed to:
The Information Commissioner,
18 Lower Leeson Street,
Tel: +353 (1) 639 5689
Locall: 1890 22 30 30
Fax: +353 (1) 639 5674
A fee of €50 (€15 for medical card holders) may apply for such an application. Again, there is no fee for appeals to the Office of the Information Commissioner concerning only personal information relating to oneself or in relation to a decision to impose a fee or deposit.
Can I get help in making a request?
Yes. If you require any help the staff in the FOI Unit will be happy to assist you in the formulation of your request.
Do I need to make a FOI request to get information from the HPRA?
No. The HPRA routinely makes information available to the public through information leaflets, publications and in response to enquiries. This will continue. FOI provides an additional source of information by facilitating access to records not made routinely available.
Where can I get more information on FOI?
Further information on FOI is available from:
The Freedom of Information Unit,
The Department of Public Expenditure and Reform,
Central Policy Unit,
7-9 Merrion Row,
Tel: +353 (1) 631 8258
Fax: +353 (1) 604 5750
The Information Commissioner,
18 Lower Leeson Street, Dublin 2
Tel: +353 (1) 639 5689
Locall: 1890 253 238
Fax: +353 (1) 639 5674
More comprehensive information on Freedom of Information, including the text of the Freedom of Information Act 2014 is available at www.foi.gov.ie.
For access to information from adverse reaction reports (which is available outside the provisions of the FOI Act), please see the Access to information from ADR reports page