Cinneadh
Mr X and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-155087-N4T1N0 / OIC-160547-F9N1H4
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-155087-N4T1N0 / OIC-160547-F9N1H4
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Whether the HPRA was justified under sections 29(1), 30(1)(a), 35(1), 36(1) and 37(1) in refusing access to records relating to specified regulatory activities regarding a named company, and to a specified HPRA pilot project
7 November 2024
By way of background, the HPRA regulates the advertising of human medicines in Ireland. In this role, it is required by the Medicinal Products (Control of Advertising) Regulations of 2007 (S.I. No. 541 of 2007) (“the 2007 Regulations”) to ensure that advertisements for medicines are accurate, not misleading and in line with approved product information. To this end, the HPRA carries out inspections at the offices of Marketing Authorisation Holder (MAH) companies which advertise human medicines in Ireland, on foot of which it may identify certain “deficiencies” against the requirements of the relevant regulations. The HPRA also issues guidance regarding so-called Advisory Board meetings, which are meetings convened by MAHs to gain advice from healthcare professionals on matters that may be specific to a certain medicines, clinical trial outcomes, the use of a particular medicine in the Irish population and healthcare system, etc. A guidance note on the HPRA’s website states that Advisory Board meetings “…should not in any way be promotional in content or promotional in its design or in its arrangements”.
In a request dated 4 November 2024, the applicant sought access to the following records:
1. A copy of the HPRA inspection report concerning a third-party private company (“the company”) arising from an HPRA inspection of the company in September 2023, along with any related/associated correspondence concerning the inspection
2. Copies of all correspondence between the HPRA and the company relating to the latter’s Advisory Board meetings, from 2017 to the date of the request
3. Copies of any final report, review, etc, in relation to a pilot project referred to on the HPRA's website as having been "carried out in 2016 and 2017 to evaluate the compliance status" of Advisory Board meetings with the Medicinal Products (Control of Advertising) regulations 2007.
In a decision dated 23 December 2024, the HPRA part-granted the request, withholding certain material from the 12 records it had identified as relevant, pursuant to sections 29(1), 30(1)(a), 35(1)(a), 36(1) and 37(1) of the FOI Act.
The HPRA refused access to the relevant parts of records 1 to 11 based on its view that section 38 of the FOI Act applies to the information at issue in those records. Section 38 applies to cases where, at some stage in the decision making process, the public body has formed the view that the record(s) in question qualify for exemption under one or more of the relevant exemptions in the FOI Act (i.e. sections 35, 36 and 37 – relating to information that is confidential, commercially sensitive, or personal information about third parties, respectively) but that the record(s) should be released in the public interest. Where section 38 applies, the public body is required to notify an affected third party before making a final decision on whether or not the exemption(s), otherwise found to apply, should be overridden in the public interest. The requester, or an affected third party, on receiving notice of the final decision of the public body, may apply directly for a review of that decision to this Office. In this case, the HPRA notified the company of its view that section 38 applied to records 1 to 11. The HPRA has provided this Office with copies of the relevant correspondence exchanged between it and the company, in the course of which the company did not make any detailed submissions but indicated that it agreed with the redactions that the HPRA had made to the records. On 7 January 2025, pursuant to the procedure set down in section 38, the applicant sought a review from this Office of the HPRA’s decision on records 1 to 11.
In relation to record 12, the applicant sought an internal review of the HPRA’s decision on 14 January 2025. In its internal review decision dated 5 February 2025, the HPRA varied its original decision on record 12, by releasing to the applicant additional information in the record that it had initially withheld from release. The HPRA again relied on sections 29(1), 30(1)(a), 35(1)(a), 36(1) and 37(1) to withhold the remaining information in record 12. When the applicant had sought a review from this Office of the HPRA’s decision on records 1 to 11, he had included record 12 in his application. However, this pre-dated the issuing of the HPRA’s internal review decision of 5 February 2025 in respect of record 12. On 2 July 2025, the applicant confirmed that he remained dissatisfied with the HPRA’s internal review decision on record 12 and wished it to be included as part of this review.
It should also be noted that, pursuant to section 38, in the course of conducting this review I contacted the company to put it on notice of the review and to afford it the opportunity to make any submissions that it wished in relation to the HPRA’s decision on the records that potentially affected its interests (i.e. records 1 to 11). No submissions were received from the company.
I also note that the HPRA withheld from release certain information in the records that it considered to fall outside the scope of the applicant’s FOI request. I address this matter further below.
I have now completed my review in accordance with section 22(2) of the FOI Act. In carrying out my review, I have had regard to the submissions made by the HPRA and the comments of the company (in correspondence with the HPRA), as well as the applicant’s arguments in his application to this office for a review of the HPRA’s decision. I have also had regard to the contents of the records at issue. I have decided to conclude this review by way of a formal, binding decision.
For administrative reasons, the applicant’s applications for review in relation to the HPRA’s decision on records 1 to 11, and its decision on record 12, were processed as separate cases. The former was processed under reference number OIC-155087-N4T1N0 and the latter under OIC-160547-F9N1H4. For the sake of the convenience of all parties, I have decided to issue a composite decision on both cases, addressing the HPRA’s decision on all 12 records.
As noted above, the HPRA withheld certain information on the basis that it falls outside the scope of the applicant’s FOI request. This relevant information is, in record 1, at page 3, the sentence redacted from the email of 27 November 2023 (sent at 10:11) and, at page 4 the sentence redacted from the email of 24 November 2023 (sent at 11:19); in record 7, the entire email at the top of page 1 in its entirety; and, in record 10, the file name of the second attachment to the email of 4 October 2024 (sent at 09:10). I have examined this material, and I accept that it relates to matters that fall outside the scope of the FOI request, and thus of this review. Accordingly, this review is solely concerned with whether the HPRA was justified, under sections 29(1), 30(1)(a), 35(1)(a), 36(1) and 37(1) in refusing access to the remaining within-scope material that it withheld from the records.
Before I address the substantive issues arising, I wish to make a number of preliminary comments. Firstly, section 22(12)(b) of the FOI Act provides that a decision to refuse to grant a request shall be presumed not to have been justified unless the head of the relevant FOI body shows to the Commissioner's satisfaction that its decision was justified. This means that the onus is on the HPRA of satisfying this Office that its decision to redact certain information from the records sought was justified.
Secondly, section 25(3) of the FOI Act requires me to take all reasonable precautions in the course of a review to prevent disclosure of information contained in an exempt record. This means that the extent to which I can describe the contents of the records at issue is limited.
As noted above, the HPRA identified 12 records that fall within the scope of the applicant’s FOI request, as follows. Record 1 comprises emails exchanged between the HPRA and the company between 29 August 2023 and 18 December 2023, in relation to the HPRA’s inspection of the company which took place on 4 September 2023. Records 2 to 6 comprise letters exchanged between the company and the HPRA between 4 and 18 December 2023 regarding the inspection. Record 7 is an internal HPRA email of 23 March 2017, forwarding an email to the HPRA from the company of the same date, notifying the HPRA of an Advisory Board meeting in April 2017. Records 8 and 9 respectively are the agenda for, and a notification form completed by the company in respect of, this Advisory Board meeting.
Record 10 is an email of 4 October 204 from the company to the HPRA notifying the HPRA of an Advisory Board meeting in November 2024, and record 11 is a notification form from the company to the HPRA regarding this meeting. Record 12 is a compliance report by the HPRA in respect of its Advisory Boards pilot project.
Having regard to the nature of the information at issue, it seems to me that section 36(1)(b) is the most appropriate exemption provision to consider at the outset. The HPRA cited section 36(1)(b) of the FOI Act as a basis for withholding certain information in records 2, 3, 4, 8, 9, 11 and 12. The HPRA also to rely on section 36(1)(c) in relation to a small amount of information in records 2 and 8.
Section 36(1)(b) provides for the mandatory refusal of a request if the record concerned contains information whose disclosure could reasonably be expected to result in a material financial loss or gain to the person to whom the information relates, or could prejudice the competitive position of that person in the conduct of his or her profession or business or otherwise in his or her occupation. Section 36(3) provides that section 36(1) does not apply if the public interest would, on balance, be better served by granting the request.
The harm test in the first part of section 36(1)(b) is that disclosure "could reasonably be expected to result in material loss or gain". This Office considers that the test to be applied is not concerned with the question of probabilities or possibilities but with whether the decision-maker's expectation is reasonable. This Office does not have to be satisfied that the adverse effect will definitely occur. It is sufficient for the FOI body to show that it expects such an outcome and that its expectations are reasonable, in the sense that there are adequate grounds for them.
The harm test in the second part of section 36(1)(b) is that disclosure of the information "could prejudice the competitive position" of the person in the conduct of their business or profession. The standard of proof to be met here is considerably lower than the "could reasonably be expected" test in the first part of this exemption. However, this Office takes the view that, in invoking "prejudice", the damage which could occur must be specified with a reasonable degree of clarity. While an FOI body may have particular expertise in an area, unless it is readily apparent how the release of the information might cause the relevant harm, it is incumbent on the FOI body making the claim to provide a specific and coherent explanation in support of its position.
In its submissions on section 36(1)(b), the HPRA noted that MAHs are commercial entities that manufacture medicines and which compete with each other for market share and sales of their product, through interaction and advertisement to the public, and through interaction and advertisement with healthcare professionals and others working in the sector. The HPRA stated that often a number of branded products may be on the market that are quite similar to each other and are in direct competition with each other. Certain products may have multiple indications and while functionally dissimilar, may be prescribed for the same (or a similar) medical condition in a given instance. Further, the HPRA noted that there may be originator and generic medicines on the market for a particular indication that will be in direct competition in terms of branding, marketing and cost. The HPRA stated that it had accordingly redacted product names and other information that may have given an indication of market share, market strategy or marketing activities and would thereby provide competitors with information to tailor their own competitive strategies in response to this information to increase their own sales, to the detriment of the relevant MAH.
In the case of deficiencies found, the HPRA argued that the release of such information may cause a financial loss to an MAH in that it may impact public confidence in the MAH and reduce market share and sales. It stated that findings of lack of regulatory compliance may impact on share price, contractual negotiations, financing arrangements and other commercial activity. The HPRA stated that, in respect of information in the records relating to deficiencies found on the part of the company, a number concerned a medicine the company marketed and distributed on behalf of another company. The HPRA argued that the release of this information may impact confidence in the company and hinder its future marketing and distribution contracts with other MAHs. In addition, the HPRA noted that records 10 and 11 relate to an Advisory Board meeting about a product which had not launched in Ireland at the time. It argued that the release of the information in these records may give an indication of market share, market strategy or other marketing activities and would thereby provide competitors with information to tailor their own competitive strategies in response to this information to increase their own sales, to the detriment of the MAH to which the information relates.
The HPRA also noted that it had decided to release, in the public interest, information relating to a deficiency that it had identified through its inspection process (albeit that it considered such material commercially sensitive), while withholding other commercially sensitive information, in particular Standing Operating Procedures (SOPs) and internal controls, staff numbers working in a given area and specific product names, due to its reasonable expectations of the commercial harms that would flow from their release. I address the public interest arguments regarding the redacted material in more detail below.
The applicant argued that the redactions made by the HPRA were excessive, particularly in relation to the extent of the redactions made to record 12. He argued that this was particularly striking in circumstances where the HPRA had found breaches of its regulations concerning Advisory Boards but had withheld the specific details, including the names of the companies and meetings to which they related. He stated that all redactions, apart from those he characterised as relatively minor and relating to personal information, should be removed.
I have considered the above arguments of the parties in the context of the contents of the records, and find as follows in relation to section 36(1)(b). It seems to me that the HPRA has distinguished between information relating to deficiencies and regulatory findings, which it has left unredacted, and information relating to the commercial operations of specific third parties, which it has withheld from release. Given the relatively low bar associated with section 36(1)(b), I accept that the release of information relating to specific commercial products, internal processes and procedures and certain external engagements and service providers in the context of HPRA findings could prejudice the competitive position of the relevant third parties. I believe it is reasonable to expect that certain information could give competitors an insight into strategies or internal processes. I accept that the relevant companies operate in a competitive market and that release of the relevant information in the context of the associated HPRA findings could prejudice their competitive position. Given the nature of the pharmaceutical market and the length of time that medicines are on the market, I am not satisfied that the reports are sufficiently historical to negate the potential harms associated with the disclosure of certain information in the records. Certain withheld information relates to deficiencies identified by the HPRA, and I consider it reasonable to expect that the release of this information could negatively impact the public’s perception of the relevant third parties.
In particular, I wish to address further record 12 in the context of section 36(1)(b). I note that the applicant made a point in his submissions of drawing the attention of this Office to the redactions made by HPRA to the record, arguing that these were “wholly excessive”. I note that the HPRA redacted pages 33 to 47 from record 12, comprising the appendices to its report, in their entirety. I sought further information from the HPRA as to the basis on which it considered that pages 33 to 47 were exempt from release in full under section 36(1)(b). In additional submissions, the HPRA argued that the appendices are exempt on the basis that they contained commercially sensitive information provided by MAHs, including information about market share, market strategy and marketing activities which are specific and proprietary to particular MAHs. The HPRA argued that the release of such information would make the relevant MAHs less competitive in the market as it would provide their competitors with information that would allow them to tailor their own competitive strategies in response to this information.
I have considered the above arguments and find as follows. On balance, given the descriptions of events, companies, products and subject matter contained in the appendices, I accept the HPRA’s arguments regarding commercial sensitivity in respect of the vast majority of the material in the appendices. While some incidental material – for example, the dates on and locations of Advisory Board meetings – might not be said to be commercially sensitive in and of itself, the view of this Office is that section 18(1) of the FOI Act (relating to granting access to parts of records) does not require the extracting of particular sentences or occasional paragraphs from records for the purpose of granting access to those particular sentences or paragraphs. I am satisfied that the appendices that comprise pages 33-47 of record 12 are subject as a whole to section 36(1)(b) of the FOI Act.
However, there is certain additional information in the records which the HPRA sought to withhold under section 36(1)(b) which I do not accept comes within the scope of the exemption. For instance, the HPRA withheld a number of references to medical conditions and general products to treat same. For example, it withheld the names of certain medical conditions, infections and treatments in record 11, in particular by way of the following redactions:
• the first, third, fourth, fifth, sixth, seventh, ninth and tenth redactions to page 3
• all the redactions made to page 4
• the first, second, third, fourth and sixth redactions made to 5
• the first, second fourth and fifth redactions under the heading “Information on the types and number of persons who may be invited to attend the meeting” at page 6.
In its additional submissions regarding this information, the HPRA argued that the specificity of these references meant the brand name of the relevant medicine would be easily identified, should the information be released. It noted that, at the time of the FOI request, the medicine in question had not been launched in Ireland (although I note that it now appears to be available). The context in which the relevant information appears in record 11 is a notification form completed by a pharmaceutical company and submitted to the HPRA to notify it of an Advisory Board meeting, and the relevant medical terms are referenced in the record as items for discussion. It is unclear to me how the fact alone that the name of a particular medicine for treating a specific condition might be derived from the release of this information, as it appears in the context of the record, could reasonably be expected to result in the harms provided for in section 36(1)(b).
In addition, the HPRA withheld from record 12 the name of a certain medical condition that appears at pages 2, 18 and 25, and the name of a treatment that appears at pages 2 and 25. The names of the relevant conditions appear in a general discussion of issues that emerged from the HPRA’s Advisory Board Pilot Project. I cannot envisage a manner in which the release of this information in the context in which it appears in either record could result in commercial loss or gain to any party.
In relation to the table at the top of page 14 of record 12, I note that in its submissions the HPRA stated that, while the names of the MAHs featured on the table was commercially sensitive, the remainder of the graph could be released. Based on my analysis above, I accept that the names of MAHs in this table is commercially sensitive information for the purposes of section 36(1)(b). However, noting the suggestion from the HPRA that the graph itself can be released, I find that the remainder of the information is not commercially sensitive and not subject to section 36(1)(b).
With the exception of the information above that I have found not to be subject to section 36(1)(b), I find that the exemption applies to the remainder of the material in the records in respect of which it was cited by the HPRA. In light of this finding, I must go on to consider the applicability of sections 36(2) and section 36(3) of the FOI Act.
Section 36(2) provides for the release of information to which section 36(1) is found to apply in certain circumstances. I am satisfied that none of the circumstances identified at section 36(2) arises in this case.
Section 36(3) provides that section 36(1) does not apply to a case in which the FOI body considers that the public interest would, on balance, be better served by granting than refusing to grant the request. As noted above, in its submissions, the HPRA stated that its view was that release in the public interest of the fact of a deficiency, in terms of compliance with legal requirements governing the advertising of medicines, was the correct approach, and noted that accordingly it had not redacted the majority of the detail around such findings. However, it went on to argue that the private interests in withholding details of particular SOPs and internal controls, staff numbers working in a given area and specific product names in regulated entities over-rode any public interest in release. It argued that there is also a public interest in the maintenance of commercial sensitivity from the point of view of the availability of medicines on the Irish market. It argued that the release of this information may cause a financial loss to the company, in that it may impact confidence in it and hinder future marketing and distribution contracts with other MAHs. The HPRA also argued that that the public interest lies in knowing it monitors the occurrence of Advisory Board meetings, and noted that to this end the majority of details relating to same had been released. However, it argued that, in terms of purely commercial data deriving from the company, there was a competing public interest in ensuring that that key commercial information relating to its medicines can be protected, which would ensure the company could continue to put products on the Irish market. The HPRA noted that Ireland, because of market size, struggles to have sufficient medicines on the market. It stated that it considered that private interests in not releasing such information over-rode any public interest in release.
In his application to this Office for a review of the HPRA’s decision on his FOI request, as outlined above the applicant noted that the HPRA had found breaches of their regulations concerning Advisory Boards but had withheld the specific details, including the names of the companies and meetings they related to. He argued that there is an obvious public interest in releasing this information.
In considering the balance of the public interest I have had regard to the requirements of section 11(3) of the FOI Act and the Supreme Court Judgment inThe Minister for Communications, Energy and Natural Resources and the Information Commissioner & Ors [2020] IESC 57 (“the eNet case”). Section 36(1) is an express recognition of the fact that there is a public interest in the protection of commercially sensitive information. As a general principle, I do not believe that the FOI Act was designed as a means by which the operations of private enterprises were to be opened up to scrutiny. The third parties in question are private enterprises, but they are also engaged in regulated activities. The HPRA has released information in the records relating to the third parties’ compliance with the 2007 Regulations, including details of deficiencies found. What is at issue here is information relating to particular products, procedures and activities of the third parties.
It seems to me that Directive 2001/83/EC, to which the 2007 Regulations give effect, and the Regulations have at their heart the protection of public health. For example, Recital 2 of the Directive provides that “the essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health”, while Recital 45 provides that “Advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered. Advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined”.
I consider that there is a significant public interest in the public knowing that entities involved in the advertising of human medicines operate within the standards prescribed by law, in this case the 2007 Regulations which the HPRA is required to enforce. There is also, to my mind, a strong public interest the public knowing how public bodies carry out inspections in individual cases and that the regulatory functions assigned to them achieve the purpose of the relevant regulations.
I have carefully considered the content of the records and the submissions made by the parties. I accept the applicant’s argument that there is a public interest in the public having an insight into certain practices in the marketing and promotion of drugs, particularly in circumstances where the regulator has been critical of such practices. However, in my view, that public interest has been served to a large extent by the decision of the HPRA to disclose details of the deficiencies identified during its regulatory activities. It is important to note that the deficiencies identified relate to the advertising of the products as opposed to the products themselves. Having considered the specific contents of the records, it seems to me that the public interest is sufficiently served by the release of information about the advertising activities of the relevant companies. I do not accept that the public interest weighs in favour of the disclosure of product names in circumstances where it is the advertising activities which form the subject of the records. While I accept that the disclosure of the identities of the specific drugs might provide even greater insight, it is important to recall that it is the public body carrying out the inspection that is subject to the FOI Act and not the private enterprises inspected. I take the view that the FOI Act was designed to increase openness and transparency in the way in which FOI bodies conduct their operations and, in general terms, it was not designed as a means by which the operations of private enterprises were to be opened up to scrutiny. The third parties referenced in this case are private enterprises. It seems to me that the HPRA has sought to strike a balance between enhancing its transparency and accountability in terms of how it performs its functions while seeking to protect the commercial interests of the relevant third parties from undue harm.
Having regard to the findings of the Supreme Court in the eNet judgment referenced above, I find that the public interest would not, on balance, be better served by the release of the information to which I have found section 36(1)(b) to apply. I find, therefore, that section 36(3) does not apply. Accordingly the information I have found to come within the scope of section 36(1)(b) is exempt from release under that provision of the FOI Act.
I have noted above that the HPRA relied on section 36(1)(c) in relation to a small amount of information in the records. However, in circumstances where I have found that information to be exempt under section 36(1)(b), I am not required to consider section 36(1)(c) in detail. In addition, the HPRA also relied on section 35(1)(a) to withhold from release certain material that I have found to be exempt under section 36(1)(b), and I need not examine the applicability of section 35(1) to this information.
I propose to examine section 37(1) of the FOI Act next, in circumstances where it was cited as a basis to withhold material from each of the records at issue. Section 37(1) provides that, subject to the other provisions of the section, an FOI body shall refuse to grant a request if access to the record concerned would involve the disclosure of personal information relating to third parties. The effect of section 37 is that, generally speaking, access to a record shall be refused if it would involve the disclosure of personal information relating to individual(s) other than the requester, unless one of the other relevant provisions of section 37 applies.
Section 2 of the FOI Act defines personal information as information about an identifiable individual that either (a) would ordinarily be known only to the individual or to members of his/her family or to his/her friends, or (b) is held by an FOI body on the understanding that it would be treated by the FOI body as confidential. Furthermore, the FOI Act details 14 specific categories of information that is personal information without prejudice to the generality of the foregoing definition, including at point (iii) information relating to the employment or employment history of the individual. In addition, Paragraph (I) of section 2 of the FOI Act excludes certain information from the definition of personal information, including "... in a case where the individual holds or held office as a director, or occupies or occupied a position as a member of the staff, of a public body, the name of the individual or information relating to the office or position or its functions or the terms upon and subject to which the individual holds or held that office or occupies or occupied that position or anything written or recorded in any form by the individual in the course of and for the purpose of the performance of the functions aforesaid ...".
In its submissions, the HPRA stated that the names and positions of individuals employed at entities regulated by HPRA is information which may not be in the public domain and therefore in the course of ordinary events would not be known to the general public. The HPRA stated that the information it had redacted under section 37(1) relates to the employment or employment history of individuals, in satisfaction of point (iii) of the definition of personal information in section 2 of the FOI Act.
In his application to this Office, the applicant argued that, apart from what he described as “relatively minor” redactions “that relate to individual phone numbers, email addresses, etc”, the information withheld under section 37(1) related to individuals in their employment capacity, and as such was clearly not personal information.
I have reviewed the contents of the records and do not accept the arguments of the applicant. As the HPRA correctly states, and as I have noted above, point (iii) of the definition of personal information in section 2 of the FOI Act provides that the term applies to information relating to the employment or employment history of the individual. The FOI Act therefore specifically envisages that such information is personal for FOI purposes and within the scope of section 37(1). On that basis, as well as the general definition of personal information in section 2, I am satisfied that the majority of the information that the HPRA redacted from the records is personal and thus within the scope of section 37(1).
However, I make a different finding in relation to some of the material withheld under section 37(1). In particular, I consider that certain material redacted from the following records does not relate to an identifiable individual (or individuals), but rather refers to generic job titles and/or role profiles:
• the third redaction made to page 1 of record 3 (I note that this information is duplicated at page 6 of record 2)
• the first redaction made to page 10 of record 2 (I note that this information is duplicated at page 11 of record 3)
• the redactions made to page 2 of record 9
• the sixth redaction made to page 6 of record 11 (after the word “Seniority:”).
In respect of the material I have found to fall within the scope of section 37(1) of the FOI Act, the matter does not end there as section 37(1) is subject to the other provisions of section 37. Section 37(2) provides that section 37(1) does not apply in certain circumstances. I am satisfied that no such circumstances arise in this case and that section 37(2) does not, therefore, apply.
Section 37(5) provides that a request that would fall to be refused under section 37(1) may still be granted where, on balance (a) the public interest that the request should be granted outweighs the right to privacy of the individual to whom the information relates, or (b) the grant of the request would benefit the person to whom the information relates. I am satisfied that section 37(5)(b) of the FOI Act does not apply.
Before I consider the applicability of section 37(5)(a), there are a number of important points to note. First, section 13(4) provides that, subject to the legislation, in deciding whether to grant or refuse an FOI request, any reason that the requester gives for the request and any belief or opinion of the FOI body as to the reasons for the request shall be disregarded. In relation to the question of the public interest, this means that I cannot have regard to the applicant's motives for seeking access to the records at issue, except in so far as those motives reflect, or overlap with, what might be regarded as true public interest factors in favour of release of the records, i.e. insofar as the concerns raised in relation to the request may also be matters of general concern to the wider public.
Secondly, it is important to note that the release of records under the FOI Act must be regarded, in effect, as release to the world at large, given that the legislation places no constraints on the uses to which a record released under FOI can be put. With certain limited exceptions provided for under the FOI Act, such as under sections 37(2)(a) and 37(8) (which I consider below), FOI is not about granting access to information to particular individuals only and as noted above, a requester's reasons for making a request are generally not of relevance. Thus, records are not released under FOI for any limited or restricted purpose.
All of this means that in considering whether a right of access exists to records under section 37(5)(a) of the FOI Act, any decision to grant access would be on the basis that there is an overriding public interest in the release of the records effectively to the world at large that outweighs the privacy rights of the third-party individuals concerned.
In considering where the balance of the public interest lies in this case, I have had regard to section 11(3) which provides that in performing any functions under the FOI Act, an FOI body must have regard to, among other things, the need to achieve greater openness in the activities of FOI bodies and to promote adherence by them to the principles of transparency in government and public affairs and the need to strengthen the accountability and improve the quality of decision making of FOI bodies. However, in doing so, I have also had regard to the judgment of the Supreme Court in the aforementioned Enet case. In that case, the Supreme Court found that a general principle of openness does not suffice to direct release of records in the public interest and “there must be a sufficiently specific, cogent and fact-based reason to tip the balance in favour of disclosure”. Although the Court’s comments were made in cases involving confidentiality and commercial sensitivity, I consider them to be relevant to the consideration of public interest tests generally.
In its submissions on section 37(5), the HPRA stated that it had been unable to identify any public interest in favour of the release of names of individuals working for entities that it regulated. In correspondence with this Office, the applicant did not address section 37(5)(a) specifically, but made arguments in relation to the public interest generally, which I have outlined above.
The FOI Act recognises the public interest in the protection of the right to privacy both in the language of section 37 and the Long Title to the legislation (which makes clear that the release of records under FOI must be consistent with the right to privacy). It is also worth noting that the right to privacy has a constitutional dimension, as one of the unenumerated personal rights under the Constitution. Privacy rights will therefore be set aside only where the public interest served by granting the request (and breaching those rights) is sufficiently strong to outweigh the public interest in protecting privacy. Moreover, even where an overriding public interest in granting the request exists, there is a discretionary element to the application of section 37(5)(a).
While I accept that the applicant has identified a valid public interest in the release of the information withheld by the HPRA generally, I do not consider that the release of the material withheld under section 37(1) specifically would further this interest in any significant manner. While the relevant information might not be described as inherently sensitive or private, nonetheless I have accepted that it is personal information for the purposes of section 2 of the FOI Act and I must regard its release as being effectively, or at least potentially, to the world at large. In the circumstances, I do not accept that the public interest in releasing the records outweighs, on balance, the privacy rights of the relevant individuals. I find, therefore, that section 37(5)(a) does not apply.
Accordingly, I find that the HPRA was justified in refusing access, under section 37(1) of the FOI Act, to the material I have identified as comprising personal information.
The HPRA relied on section 35(1)(a) of the FOI Act to withhold from release certain information in record 12. In respect of the material in the record withheld under both sections 35(1)(a) and 36(1)(b), I am only required to examine the applicability of the former to the information that I have not found to be exempt under the latter – namely, the names of certain medical conditions at pages 2, 8 and 25 of the record. Moreover, I must also consider the applicability of section 35(1)(a) to the material in record 12 that the HPRA withheld under that provision alone (ie. not in conjunction with section 36(1)(b) of the FOI Act), namely all the redactions made to pages 7, 8, 9 and 12. I note that the HPRA also argued that the table at the top of page 14 of record 12 was exempt under section 35(1)(a). However, having found that the names of the MAHs listed in this table are exempt under section 36(1)(b), and concurring with the HPRA’s suggestion that the graph itself can be released if such names were withheld, I do not need to consider the extent to which section 35(1)(a) exempts from release the remainder of the information.
Section 35(1)(a) relates to confidential information and contains four requirements, all of which must be satisfied in order for a record to be exempt under this provision. It is necessary for an FOI body relying on section 359(1)(a) to show:
• that the information was given to an FOI body in confidence, and
• that the information was given on the understanding that it would be treated by the FOI body as confidential, and
• that disclosure of the information would be likely to prejudice the giving to the body of further similar information from the same person or other persons, and
• that it is of importance to the body that such further similar information should continue to be given to the body.
In its submissions on section 35(1)(a), the HPRA stated that it had applied this exemption to information on pages 7, 8, 9 and 12 of record 12 as it comprises third party confidential information received from medicines regulators in other EU countries. The HPRA stated that that, at the time it was communicating with other EU member states and medicines regulators, it understood such communications to be confidential.
The HPRA argued that it was obliged to protect information that was provided to it in confidence, while also serving the interests of the public by releasing information when requested under FOI. It argued that, if parties providing such information to the HPRA could not do so with an assurance of confidentiality, this could impact on their willingness of providing future information which would in turn have a detrimental impact on HPRA in fulfilling its statutory functions, and thus the public interest would not be served
In the first instance, I would note that I am not satisfied that certain material withheld under section 35(1)(a) meets the first two requirements of the exemption. For example, as noted above, the material in pages 2, 18 and 25 of record 12 which the HPRA withheld under both sections 35(1)(a) and 36(1)(b), consists of the names of a medical condition and a type of treatment for a second condition. The context in which these conditions are mentioned is a comment in the HPRA’s report on its pilot project, and in particular are given as general examples of the matters in respect of which the Advisory Board meetings enable the HPRA to gain an insight. In the general context in which they appear in the record, I cannot accept that the names of two medical conditions comprise information that was given to the HPRA in confidence, or on the understanding that it would be treated as confidential. I am also not satisfied that the material redacted solely under section 35(1)(a) at page 12 of record 12 meets the first two criteria under this provision of the FOI Act. This information appears to me to relate to some quite basic and uncontroversial information about one unspecified Advisory Board meeting. I cannot envisage a manner in which this might be said to be information that was given to the HPRA in confidence or on the understanding that it would be treated confidential. Accordingly, this material is not exempt from release under section 35(1)(a).
I am more satisfied that certain other material meets the first two requirements. In particular, in relation to the pages 7 and 8 of record 12, I note that the relevant redactions have been made to a table outlining the approach of competent authorities in a number of other European countries to Advisory Board meetings. I am minded to accept the HPRA’s arguments – that it had understood information received from medicines regulators in other EU member states to have been communicated in confidence – in respect of this information, and I accept that the first two requirements of section 35(1)(a) are met on this basis. I make a similar finding in relation to the redaction made to page 9 of record 12, which is information received from the HPRA’s UK equivalent and is information which I accept the HPRA is entitled to regard as having been received in confidence.
In order to meet the third requirement of section 35(1)(a), it should be shown that disclosure of the information would be likely to prejudice the giving to the FOI body of further similar information from the same person or other persons. It is not necessary that disclosure would definitely prejudice the supply of information; rather what is required is that disclosure would be likely to prejudice the supply of similar information.
In relation to the information at pages 7, 8 and 9 of record 12, I am satisfied that the third requirement is met. It seems to me that it is reasonable to suggest that, for example, the medicines regulators in other states who provided the information at pages 7, 8 and 9 might be less forthcoming with future similar information, should the material at issue be released.
Given the nature of the information that the HPRA withheld under section 35(1)(a) at pages 7, 8 and 9 of record 12, I accept that is important that further similar information should continue to be given to it. The material at issue is information provided to the HPRA by its equivalent bodies in other states, and I accept that for the purposes of carrying out its statutory function generally, it may from time to time be required to liaise with such bodies. I can easily foresee how such interactions would be impaired if the bodies felt unable to provide the HPRA with requested information.
I therefore find that the information redacted from pages 7, 8 and 9 of record 12 fulfils all four requirements of section 35(1)(a).
The matter does not end there, however, as section 35(1)(a) is subject to a public interest test in section 35(3), which provides that section 35(1)(a) shall not apply where, on balance, the public interest would be better served by granting the request than by refusing it.
In its submissions, the HPRA stated that it had identified no public interest that would be served by the release of the information at issue. It argued that the public interest in the release in the records generally had been met by the information in the records that it had already released. The general public interest arguments made by the applicant, which I have set out above, also apply to the public interest test in section 35(3).
I have considered the arguments of the parties and the content of the information at issue, and again I have had regard to the requirements of section 11(3) of the FOI Act and the Supreme Court Judgment in the eNet case. I consider that the HPRA has attempted to strike a balance between the requirements of confidentiality and the public interest by its release of the material in the records that it did not redact. In particular, as noted above in my analysis of section 36(3), in my view the public interest in the release of the information in the records generally has been served to a large extent by the decision of the HPRA to disclose details of the deficiencies identified during the relevant regulatory activities. I do not consider that this public interest would be furthered to any significant degree by the release of the information that I have found to come within the scope of section 35(1)(a).
Accordingly, I find that section 35(3) does not serve to disapply section 35(1)(a) in respect of the relevant material. I find that the information redacted under section 35(1)(a) from pages 7, 8 and 9 of record 12 is exempt from release under that provision of the FOI Act.
The HPRA cited section 29(1) of the FOI Act as a basis to withhold from release material from record 12, specifically:
• page 20 –bullet points 3 and 4 under the heading “Option 1”, and the bullet point under the subheading “Disadvantages” beneath the same heading
• page 21 – bullet points 2, 3 and 4
• page 21 –bullet points 1 and 2 under the heading “Option 2”, and the bullet point under the subheading “Disadvantages” under the same heading
• page 22 – bullet point 1 under the heading “Option 3”, and the bullet point under the subheading “Disadvantages” under the same heading
• page 22 –bullet point 1 under the heading “Option 4”, and the bullet point under the subheading “Advantages” beneath the same heading.
Section 29(1) provides that an FOI body may refuse to grant access to a record if (a) the record concerned contains matter relating to the deliberative processes of an FOI body (including opinions, advice, recommendations, and the results of consultations, considered by the body, the head of the body, or a member of the body or of the staff of the body for the purpose of those processes), and (b) the granting of the request would, in the opinion of the body, be contrary to the public interest. Without prejudice to the generality of paragraph (b), the FOI body is required, in determining whether to grant or refuse to grant the request, to consider whether the grant thereof would be contrary to the public interest by reason of the fact that the requester concerned would thereby become aware of a significant decision that the body proposes to make.
Thus, the exemption at section 29(1) has two requirements: the record must contain matter relating to the deliberative process, and its disclosure must be contrary to the public interest. These are two independent requirements and the fact that the first is met carries no presumption that the second is also met. It should also be noted that the exemption does not apply in so far as the record(s) contain any of the information or matter referred to in section 29(2) of the Act. Thus, where an FOI body is relying on section 29(1) for the refusal of a record, it must also consider whether section 29(2) is applicable.
In its submissions on section 29(1), the HPRA noted that record 12 is an evaluation report of its Advisory Boards pilot programme, adding that pages 19 to 23 of the report outline five options for the HPRA to consider to it to ensure compliance levels in this area. It stated that the five options detail the advantages, disadvantages and resource implications in relation to each option. The HPRA argued that parts of this information comprise its deliberative processes, on the basis that it detailed aspects that the HPRA may introduce in the future. It also argued that resourcing considerations in respect of any such activity also comprised a deliberative process.
I have reviewed the material withheld from record 12 by the HPRA under section 29(1), in the light of its submissions, and I accept that the withheld information demonstrates the HPRA to be engaged in some weighing up or evaluation of competing options or the consideration of proposals or courses of action. I find that this material constitutes material relating to the HPRA’s deliberative processes, in satisfaction of section 29(1)(a).
The public interest test at section 29(1)(b) is a strong test, and any arguments against release should be supported by the facts of the case and it should be shown how release of the record(s) would be contrary to the public interest. This Office has previously held that the FOI Act clearly envisages that there will be cases in which disclosure of the details of an FOI body’s deliberations – whether before or, in some cases, after a decision based on those deliberations has been made – would be against the public interest. However, this is not to say that such disclosure is always, as a matter of principle, against the public interest. Any arguments against release under section 29 should be substantiated and supported by the facts of the case. It is important that the FOI body shows to the satisfaction of this Office how granting access to the particular record(s) would be contrary to the public interest, e.g. by identifying a specific harm to the public interest flowing from release.
In its submissions, the HPRA noted that, during the pilot programme, serious non-compliance issues had been noted and, while many good practices were also observed, it was clear that there are risks in not having a formal compliance programme in this area. The HPRA argued that, in light of this situation and in order to ensure the effectiveness of any measures that it might introduce to address same in the future to ensure compliance in this area (thus benefiting the public health), its view was that the exemption was correctly applied and outweighed the public interest in the release of the relevant information. The HPRA argued that the public interest lies in it being afforded the space to deliberate on decisions that are not yet finalised and as such, the public interest does not lie in favour of release of the relevant information.
In relation to the above, I would first of all note that the HPRA’s arguments appear to envisage some balancing of public interest factors for and against release. This is not the correct test to be applied in the case of section 29(1)(b) which, as outlined above, is that release must be contrary to the public interest. In order for section 29(1)(b) to apply, what must be demonstrated is that a specific harm to the public interest would flow from release. This being said, I would accept that the HPRA has essentially identified potential public interest harms that would flow from the release of the relevant information. In particular, it has effectively argued that release may compromise the effectiveness of any measures it might introduce to ensure compliance with the requirements of Advisory Boards, with a knock-on adverse effect on its ability to effectively carry out its regulatory function, which in turn might harm the public health generally. I would accept that such harms, should they come to pass, would be contrary to the public interest. I am also satisfied that it is not unreasonable to expect the release of the relevant material could lead to such harms. I am therefore satisfied that the test in section 29(1)(b) has been met, and I find that the information withheld from record 12 by the HPRA is exempt from release under section 29(1) of the FOI Act.
I note that the HPRA also relied on section 30(1)(a) to withhold some of the same the information in respect of which it relied on section 29(1). As I have found this material to be exempt from release under section 29(1), I need not consider the extent to which it might also be exempt under section 30(1)(a).
The HPRA relied on section 30(1)(a) of the FOI Act to withhold certain information from record 12, namely:
• page 18 – bullet points 3 and 4
• page 19 – the last sentence of the sixth paragraph
• page 20 – bullet point 5 under the heading “Option 1”
• page 23 – bullet point 1 under the heading “Option 5”, and bullet point 2 under the subheading “Disadvantages” beneath the same heading.
Section 30(1)(a) provides that an FOI body may refuse to grant an FOI request if access to the record concerned could, in its opinion, reasonably be expected to prejudice the effectiveness of tests, examinations, investigations, inquiries or audits conducted by or on behalf of an FOI body, or the procedures or methods employed for the conduct thereof.
Where an FOI body relies on section 30(1)(a) it should, firstly, identify the potential harm in relation to the relevant function specified in paragraph (a) that might arise from disclosure and, secondly, having identified that harm, consider the reasonableness of any expectation that the harm will occur. The FOI body should explain how and why, in its opinion, release of the record(s) could reasonably be expected to give rise to the harm envisaged. A claim for exemption under section 30(1)(a) must be made on its merits and in light of the contents of each particular record concerned and the relevant facts and circumstances of the case.
In its submissions, the HPRA argued that release of the information it had withheld under section 30(1)(a) could result in a number of adverse effects to its investigation processes. It argued that the release of the information could prejudice the ability of its inspectors to carry out inspections in the future. It stated that the inspection process could be further negatively impact where a non-compliance is found, in that the release of the information could allow MAHs that are not members of the Irish Pharmaceutical Healthcare Association (IPHA) or Medicines for Ireland (MFI) to argue that the HPRA had a pre-informed view that their practices are not in line with the regulations. In addition, the HPRA argued that certain information redacted under section 30(1)(a) is not generally available to MAHs and thus, if released, could negatively impact its inspection process. The HPRA also noted that it had redacted information relating to a risk assessment tool, information relating to potential resources issues, and information relating to the number of Advisory Board meetings that it proposed to attend. It argued that the release of any of this material could also prejudice its ability to carry out inspections.
I have examined the relevant information in light of the HPRA’s arguments and the requirements of section 30(1)(a) and find as follows. I would first of all note that I am not satisfied that the HPRA’s expectation of harms to inspection process could reasonably be expected to flow from the release of certain of the information at issue. For example, the redactions made to page 18 under section 30(1)(a) (at bullet points 3 and 4) comprise suggestions regarding the number, and appropriate level of expertise, of HPRA staff that should attend at Advisory Board meetings. This seems to me to comprise relatively straightforward, non-controversial information. I cannot envisage a manner in which the release of this information could reasonably be expected to hinder the HPRA’s inspection process in any way. I therefore find that this information is not exempt under section 30(1)(a). I should note that information redacted from bullet point 4 contains information relating to the name of a specific MAH and the nature of a particular Advisory Board meeting that it organised, and I consider this information to be exempt from release under section 36(1)(b) of the FOI Act (my analysis of that provision, above, refers).
I make a different finding in relation to the other redactions made under section 30(1)(a). In relation to page 19 of record 12, the relevant material relates to companies that are not IPHA or MFI members, and the HPRA has argued that its release could allow any such companies to argue that it had pre-informed opinion regarding their compliance. While I somewhat doubt that such a result would definitely flow from the release of the information, as laid out above for the purposes of section 30(1)(a) I need not be satisfied that the harms posited by an FOI body will unequivocally come to pass. It is sufficient that the body’s expectation of harm is reasonable. I consider this to be the case in respect of the relevant information in page 19, and it thus comes within the scope of section 30(1)(a). Similarly, I am of the view that the same harms to the inspection process can reasonably be expected to come to pass if the relevant information at pages 20 and 23 were to be released, for the reasons outlined in the HPRA’s submissions. I am therefore satisfied that this information is subject to section 30(1)(a).
The matter does not end there, however, because section 30(1)(a) is subject to section 30(2), which provides that the former shall not apply in relation to a case in which in the FOI body’s opinion, the public interest would, on balance, be better served by granting than by refusing to grant the FOI request concerned. I have outlined above the public interest arguments of the parties in the context of the other relevant provisions of the FOI Act and do not consider it necessary to repeat them here. On balance, I take the view that the public interest would be better served by the withholding of the information that I have found to come within the scope of section 30(1)(a). I therefore find that it is exempt from release under that provision of the FOI Act.
Based on my analysis above, I find that the following information is not exempt from release:
• the third redaction made to page 1 of record 3 (and the same information duplicated at page 6 of record 2)
• the first redaction made to page 10 of record 2 (and the same information duplicated at page 11 of record 3)
• the redactions made to page 2 of record 9
• in record 11, the first, third, fourth, fifth, sixth, seventh, ninth and tenth redactions to page 3; all the redactions made to page 4; the first, second, third, fourth and sixth redactions made to 5; and the first, second fourth and fifth redactions under the heading “Information on the types and number of persons who may be invited to attend the meeting” at page 6.
• the name of a medical condition that appears at pages 2, 18 and 25, and the name of treatment that appears at pages 2 and 25, of record 12
• the table at the top page 14 of record 12 (not including the names of MAHs that appear in the table)
• the redaction made at page 12 of record 12
• the redactions made to page 18 of record 12 under section 30(1)(a) at bullet points 3 and 4 (aside from the information in bullet point 4 relating to the name of a specific MAH and the nature of a particular Advisory Board meeting that it organised, which is exempt from release).
This material aside, I find that the HPRA was justified in refusing access to the information it withheld from release under sections 29(1), 30(1)(a), 35(1)(a), 36(1) and 37(1) of the FOI Act.
Having carried out a review under section 22(2) of the FOI Act, I hereby vary the HPRA’s decision. I find that it was justified in withholding from release the material redacted from the records under the various provisions of the FOI Act on which it relied, with the exception of the information specified immediately above. I find that the HPRA was not entitled to withhold this information, and I direct its release.
Section 24 of the FOI Act sets out detailed provisions for an appeal to the High Court by a party to a review, or any other person affected by the decision. In summary, such an appeal, normally on a point of law, must be initiated by the requester not later than eight weeks after notice of the decision was given, and by any other party not later than four weeks after notice of the decision was given.
Neill Dougan
Investigator