Whether the HPRA was justified in granting partial access to records relating to an inspection carried out in connection with the Medicinal Products (Control of Advertising) Regulations 2007

17 January 2024

Background

This review arises from a decision of the HPRA to grant partial access to certain records pursuant to an FOI request to which section 38 of the FOI Act applies. Section 38 applies where, at some stage in the decision-making process, the FOI body has formed the view that the records at issue 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 third party personal information, respectively) but that the records should be released in the public interest.

Where section 38 applies, the FOI body is required to notify an affected third party before making a final decision on whether or not the exemptions, 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 FOI body, may apply directly to this Office for a review of that decision. This case concerns an application for review made by an affected third party company (the applicant).

The review has its background in a previous review involving the same parties that are involved in this review. In the earlier case, the requester sought records relating to particular inspections undertaken by the HPRA. He specified that the request related to non-conformities or breaches with regards the Medicinal Products (Control of Advertising) Regulations 2007 (the 2007 Regulations). In response to that request, the HPRA decided to grant partial access to a report of an inspection undertaken by the HPRA in 2017 relating to the applicant. The applicant subsequently sought a review by this Office of the HPRA's decision, following which I affirmed the HPRA's decision to grant partial access to the report in question (CaseOIC-133065refers).

In this case, the same requester made a request for "any replies sent to the HPRA from each company, in which they are asked to address any deficiencies set out in the inspection reports". While processing the request, the HPRA formed the view that the release of the records could affect the interests of the pharmaceutical companies that were the subject of the reports, including the applicant.

The HPRA notified the applicant of the request on 14 December 2022. It informed the applicant that it was considering granting partial access to two records; a covering letter from the applicant to the HPRA and an accompanying corrective and preventive action (CAPA) plan in response to the 2017 inspection report. The HPRA provided the applicant with a copy of the records and identified the sections of the records it was proposing to release. It outlined its preliminary view that, on balance, the public interest would be better served by part-granting the request than by refusing it. On 9 January 2023, the applicant provided submissions to the HPRA in which it outlined its position that the records should be refused in full.

On 20 January 2023, the HPRA informed the applicant that it had decided to grant partial access to the records in question. It said that while the information in the records it had decided to release "may comprise confidential and/or commercially sensitive information", it considered that the public interest favoured its release in accordance with section 35(3) and 36(3).

On 3 February 2023, the applicant sought a review by this Office of the HPRA's decision. The original requester was notified of the review and invited to make submissions. During the course of the review, and given the content of submissions received from the HPRA, this Office wrote to the applicant notifying it of certain material matters therein. The applicant provided further submissions on foot of this notification.

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 applicant, the original requester and the HPRA. I have also examined the records at issue. In its submissions to this Office, the applicant requested that I take into consideration submissions it made in the earlier case OIC-133065. While I do not propose to reference all of the points made in the earlier submissions, I confirm that I have had regard to them. I have decided to conclude this review by way of a formal, binding decision.

Scope of Review

Record 1 comprises a short covering letter while record 2 comprises a 26-page CAPA plan that the applicant sent to the HPRA containing its response to findings following the 2017 HPRA inspection. The HPRA decided to grant partial access to both records, with the redaction of certain information on the basis that it was either exempt from release or fell outside the scope of the request.

During the course of a related review, the requester agreed to remove certain information relating to identifiable third parties from the scope of the review in question and related ongoing reviews. Such information is contained in record 2 in this case, namely details of an individual's job title and location (page 4, subsection 1.d, column 4,). Accordingly, on the understanding that the HPRA will redact same, I will not consider this information within the scope of this review.

In its application to this Office, the applicant argued that the records should be exempt from disclosure in their entirety under sections 35 and 36 of the FOI Act. Accordingly, this review is concerned solely with whether the HPRA was justified in its decision to grant access to the remaining parts of the two records, excluding both the information that the HPRA has decided not to release, and the specific information relating to an identifiable third party as referenced above.

Preliminary Matters

Before I address the substantive issues arising, I wish to make a number of preliminary comments. First, it is important to note that under section 22(12)(a) of the Act, a decision to grant a request to which section 38 applies shall be presumed to have been justified unless the person to whom the information relates shows to the satisfaction of the Commissioner that the decision was not justified. This means that the onus is on the applicant to satisfy this Office that the HPRA's decision to grant partial access to the record at issue was not justified.

Secondly, in its application to this Office, the applicant made limited submissions that the FOI request in question was flawed and should be rejected on procedural grounds. It referenced the "very broad" and "non-descript" nature of the request. Section 12 of the FOI Act provides that a person who wishes to exercise the right of access must make a request for access to the record sought and the request must contain sufficient particulars in relation to the information concerned to enable the record to be identified by the taking of reasonable steps. I am satisfied that the request in this case was clear and unambiguous and the HPRA had no issue in identifying the records sought. Accordingly, I do not accept that the request was flawed.

Thirdly, in further submissions received, the applicant referenced earlier decisions made by this Office in respect of similar requests that had been appealed to the High Court. It argued that a decision should not issue in respect of the current review "pending further clarification to be provided by the competent Courts as to the appropriate extent of disclosure". As the appeals in question are no longer pending before the Courts, I am satisfied that it is appropriate to proceed with a decision in this case.

Finally, it is important to note that a review by this Office is considered to be "de novo", which means that in this case, it is based on the circumstances and the law as they pertain at the time of the decision and is not confined to the basis upon which the FOI body reached its decision.

Analysis and Findings

The records at issue

In its submissions, the HPRA said it regulates the advertising of human medical products in Ireland and that its role is to ensure that advertisements for medical products are in compliance with the 2007 Regulations. It said the 2007 Regulations set out the requirements for medicinal product advertising in Ireland and compliance ensures that advertisements are accurate, not misleading and in line with approved product information.

The HPRA said it ensures compliance with the 2007 Regulations in a number of ways. It said it performs pre-planned and random compliance reviews of advertisements and also carries out inspections at the offices of Marketing Authorisation Holder companies which advertise human medicinal products in Ireland. Information in respect of the HPRA's approach to advertising compliance is available on its website.  

In its submissions, the HPRA said that its inspection process may be summarised as follows:

1. Inspection organised

2. Inspection carried out

3. Deficiencies against requirements of regulations identified

4. Report written by inspectors and sent to inspected party

5. Responses (corrective action) and timeframes submitted to HPRA and reviewed by inspectors

6. Further responses may be required or a further inspection may be required, based on the responses received

7. Close out of inspection

As noted above, the records in this case comprise a covering letter and the applicant's response to the 2017 HPRA inspection report. Record 2 includes a restatement of the findings of the HPRA as contained in the inspection report. The applicant's position is that the records are exempt in their entirety under sections 35 and 36 of the FOI Act.

Section 35 - information obtained in confidence

Section 35(1)(a) of the FOI Act provides for the refusal of a request if the record concerned contains information given to an FOI body in confidence and on the understanding that it would be treated by it as confidential (including such information as aforesaid that a person was required by law, or could have been required by the body pursuant to law, to give to the body) and, in the opinion of the head, its disclosure would be likely to prejudice the giving to the body of further similar information from the same person or other persons and it is of importance to the body that such further similar information as aforesaid should continue to be given to the body.

The applicant said the records at issue, which it described as "its response", comprise the CAPA plan prepared with a view to addressing the points raised by the HPRA during the 2017 inspection. In its submissions to the HPRA during the processing of the request, it said its response was prepared and submitted to the HPRA in confidence and on the understanding that it would be treated as confidential. It said its response was clearly marked as 'Private and Confidential'. It said its response includes actions undertaken by the applicant to address the points raised during the HPRA inspection, including enhancements to its processes and policies that are highly confidential and not accessible to the general public, including its competitors.

The applicant added that the confidential nature of information provided by companies to the HPRA is also recognised in the HPRA's Code of Conduct, which provides in Section 4.1 that;

"much of the information provided to the HPRA is of a confidential nature, relating to patients, healthcare professionals and the industries the HPRA regulates. Members of the Authority, committees, external experts and staff are obliged not to disclose any information obtained while performing, or as a result of performing, any activities on behalf of the HPRA."

The applicant argued that the disclosure of its response would raise serious concerns about the protection afforded by the HPRA to confidential company information in the context of future inspections and make it less likely that other companies will engage proactively and collaboratively with the HPRA beyond the confines of their statutory obligations, which could ultimately undermine the HPRA's effectiveness in exercising its statutory functions.

Similarly, in its application for review by this Office, the applicant argued that it provided a thorough and detailed plan to the HPRA in good faith, and on the understanding that the details provided in the plan would not be released to the public. It said the robust response provided obviated the need for the HPRA to devote further time and resources on the matters identified in the inspection report. It argued that the release of the record would have a chilling effect on the provision of such detailed information by pharmaceutical companies to the HPRA in future, with a potential knock-on effect of hampering the HPRA in carrying out its regulatory duties. It argued that the requirements for section 35(1)(a) to apply were satisfied in this case and it referenced a recent decision of this Office in caseOIC-117242.

The HPRA said in its submissions that "information that is commercially sensitive is prima facie confidential". It said it redacted information which it understood comprised commercially sensitive information which was therefore given to the HPRA in confidence. It said that information related to findings of deficiencies in terms of advertising compliance, while considered commercially sensitive and also therefore confidential, were not redacted. It said that it considers such information should be released in the public interest.

In respect of the question of whether release would be likely to prejudice the giving to the FOI body of further similar information, the HPRA said that "given the powers of the HPRA in terms of obtaining information, it is arguable that this limb of the confidentiality test is difficult to demonstrate". With reference to the specific subsection in question, it said that "the FOI Act clearly foresaw eventualities whereby confidential information included information that was required to be given to the FOI body under law". It said that the exchange and collection of the relevant information is necessary for the HPRA to adequately and appropriately conduct inspections.

The HPRA also drew my attention to a European guidance document produced by the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) (available here). The guidance document relates to the release of information after the granting of a marketing authorisation. Section 3.3 of the document concerns information on inspections and states that;

"information on the outcome of inspections (e.g. compliance/non-compliance/outstanding issues to be addressed) is not regarded as confidential, however specific details e.g. information regarding facilities and equipment are considered commercially confidential".

The HPRA said that it expects that marketing authorisation holders are aware of this pan-EEA approach in terms of findings of non-compliance or deficiencies. It noted that its approach is slightly more nuanced in that it accepts that the information may be commercially sensitive but should be released in the public interest.

Having considered the above, the Investigator notified the applicant of the potential relevance of the above guidance document. The applicant made submissions in response. It acknowledged that the guidance could provide useful direction to help distinguish between categories of data. However, it said that section 3.3 does not address the question of company proprietary documents such as the CAPA plan. Its position is that "information on the outcome of inspections" can be construed as referring to an official document capturing the findings of an inspection, such as an inspection report. It said that it strongly disagrees that this notion can be extended to include documents prepared pursuant to an inspection, where their purpose is not to set out findings but corrective/preventative actions.

The original requester also made submissions to this Office. He referenced the four requirements under section 35(1)(a) and said that he "cannot see how the four requirements are met in this case". He said that where the information in the record consists of opinions and observations formed by members of staff of an FOI body, the opinions and observations are not imparted by anyone, meaning the first two requirements cannot be fulfilled. He also referenced the question of the future supply of information and said that the HPRA is acting within its statutory powers by carrying out its compliance inspections, which are underpinned by a regulatory framework. He said that the information supplied is clearly not voluntary but part of a regulatory process and the company in question has a duty to cooperate with HPRA inspectors and provide candid responses. He said that the suggestion that releasing unredacted reports or related records would imperil future inspections is not credible.

My analysis

For section 35(1)(a) to apply, four requirements must be satisfied, namely that;

• the information was given to an FOI body in confidence;
• the information was given on the understanding that it would be treated by the FOI body as confidential;
• 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
• it is important to the body that such further similar information should continue to be given to the body.

In relation to the first two requirements, it is the circumstances in which the information was imparted and received that is important in determining whether these first two requirements of section 35(1)(a) are met. This Office has previously drawn a distinction between information given or imparted to an FOI body and information which comprises the opinion or observation of the FOI body or its staff. The Commissioner takes the view that in so far as information consists of opinions and observations formed by members of staff of an FOI body, the opinions and observations concerned are not 'imparted' to them by anyone. However, I accept that the disclosure of findings may, in certain cases, also involve the disclosure of information provided by a relevant party. It can occasionally be difficult to separate observations formed by staff members from information provided. The former may be predicated on the latter. That said, even if information provided by a third party is contained within an opinion or observation, such information would still need to meet the four requirements of the subsection in order to be considered exempt. As such, even if I was to accept that the findings restated in the plan contain information given to the HPRA, for the reasons outlined below I am not satisfied that the information was given in confidence or on the understanding that it would be treated as confidential, nor do I consider the applicant's responses or the information in the covering letter to have been given to the HPRA on such an understanding.

While I note that the covering letter is marked "Private and Confidential", such labelling is not sufficient, of itself, for me to find that the first two requirements have been met. The applicant in this case is engaged in regulated activities and the HPRA is the relevant regulatory body. Having considered the EMA/HMA guidance referenced above and the nature of the relationship between the two parties, I do not accept that a mutual understanding of confidence could have existed between the parties in respect of findings and the responses to such findings following a regulatory inspection.

I note the applicant's argument that section 3.3 of the guidance, which provides that information on the outcome of inspections (e.g. compliance/non-compliance/outstanding issues to be addressed) is not regarded as confidential, cannot be extended to include documents prepared pursuant to an inspection, where their purpose is not to set out findings but corrective/preventative actions. I disagree. In my view, the guidance reflects a general position that information on the outcome of inspections is not confidential, a position that is not limited solely to the findings themselves. I consider the engagements between the applicant and the HPRA to comprise information on the outcome of inspections.

Moreover, on the matter of the applicability of the third requirement for section 35(1)(a) to apply, I am not satisfied that the release of the covering letter, the restated findings, or the applicant's responses and proposed actions in respect of same would prejudice the giving to the HPRA of further similar information from the same person or other persons. Compliance with the 2007 Regulations is required and the Irish Medicines Board Act 1995 provides that contravention is an offence. I note, for example, that the 2007 Regulations require marketing authorisation holders to ensure that, in relation to an advertisement relating to that medicinal product, any decision taken by the HPRA is immediately and fully complied with and to ensure that any advertising of medicinal products carried out conforms with the requirements of the Regulations. In such circumstances, it seems to me that it is very much in the interest of relevant entities to provide information to the HPRA during the course of an inspection and to provide responses and action plans in respect of regulatory findings. Accordingly, I am not satisfied that disclosure would prejudice the giving of further similar information.

On the matter of the applicant's comments concerning the HPRA's Code of Conduct, it seems to me that the provision cited is intended to ensure that confidential third party information the HPRA receives in the course of the performance of its functions is not inappropriately disclosed. It does not, in my view, support a wider proposition that all information relating to such third parties must be treated as confidential.

Having considered the submissions received and the content and context of the records, I find that the applicant has not satisfactorily shown that the information at issue in the record is exempt from release under section 35(1)(a) of the FOI Act.

Before I go on to consider the applicability of section 36, I wish to comment briefly on case OIC-117242, which was referenced by the applicant in its submissions. The case concerned an FOI body's investigation into anti-competitive practices in the insurance industry. In that case, summonses were issued and interviews were held under oath. Witnesses were informed before hearings that the FOI body was prohibited from any unauthorised disclosure of information gathered during the hearings. The Senior Investigator in that case provided a detailed and fact-specific analysis to support her finding that section 35(1)(a) of the FOI Act applied to certain records. Having considered the detail of that decision, and the factual circumstances and context of the current case, I am satisfied that the two can be sufficiently differentiated.

Section 36 - commercially sensitive information

Section 36 of the FOI Act provides for the protection of what is commonly described as commercially sensitive information. While the applicant did not cite any particular subsection of section 36(1) as applying to the records at issue, having considered its submissions, I am satisfied that the applicant considers the records to be exempt under subsection (b).

Section 36(1)(b)

Section 36(1)(b) of the FOI Act provides that an FOI body shall refuse to grant a request if the disclosure of the record sought 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 the person in the conduct of his or her profession or business or otherwise in his or her occupation. The essence of the test in section 36(1)(b) is not the nature of the information but the nature of the harm which might be occasioned by its release.

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 takes the view 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. 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 that could occur must be specified with a reasonable degree of clarity.

In its submissions, the applicant said that the information contained in the records provides highly sensitive insights into its policies, processes and strategy. It said that it is likely that the information disclosed will be shared and therefore made available to its competitors. It said that, given the "intensely competitive nature of the pharmaceutical market in Ireland", the disclosure of its response to the HPRA inspection is capable of seriously undermining its competitive position on the market.

It said that it was very concerned that the proposed disclosure could "unfairly present the public with a biased and inaccurate picture" of its activities. It said that it does not believe that the records provide an accurate view of its behaviour and commitment to compliance with the applicable rules. It said release is likely to result in "significant damage" to its reputation, its collaborations with stakeholders and its competitive position on the market.

The HPRA said that in the case of deficiencies found, release of such information may cause a financial loss to the applicant in that it may impact public confidence and reduce market share and sales. It said that release may impact share price, financing arrangements and other commercial activity. It said that information about market share, strategy or activities are proprietary and release would make the company less competitive in the market as competitors could tailor their own strategies in response. It said that it considered that such information is commercially sensitive. It said that details in respect of Standard Operating Procedures and internal controls, staff numbers, specific product names and personal information relating to staff in regulated entities were redacted as the HPRA considered that such information was exempt from disclosure and that the public interest did not weigh in favour of release.

The HPRA also noted that the Irish Pharmaceutical Healthcare Associated (IPHA) publishes information on transfers of value from pharmaceutical companies to doctors and other healthcare professionals. It said that while the publication of such information is not an activity that the HPRA regulates, it appears that the financial information in the inspection reports that was not redacted was published since 2016, has therefore been in the public domain, and would not be amenable to exemption under the FOI Act. It said that "no specific instance of an item of financial information that should have been redacted as not being in the public domain was provided by the third party". The applicant also mentioned this transfers of value process in its submissions to this Office.

In his submissions, the original requester said that it is unclear as to what specific harm could reasonably be expected to occur were the records to be released. He also referenced the fact that the records are a number of years old.

As I have outlined above, the relevant parts of the records at issue that fall within the scope of this review essentially comprise a restatement of the HPRA's findings and responses and actions outlined by the applicant. The cover letter also includes general commentary from the applicant in respect of the HPRA findings. The CAPA plan contains information in respect of the activities of the applicant in the context of HPRA findings and responses. Such information relates to certain financial activities, sponsorship, external event participation and engagement with third parties. The question at issue is whether the release of the relevant information could reasonably give rise to the harms outlined in section 36(1)(b).

At the outset, I note that the information in question relates to matters arising in 2015, 2016 and 2017. This Office may have regard to the historic nature of the information contained in records in considering the effect of its disclosure and whether the harm test has been met. The information in question relates to the commercial activities of the applicant six to eight years ago. It does not relate to product pricing, but to certain marketing and sponsorship activities of the applicant. While disclosure might provide some insight in respect of the applicant's marketing activities a number of years ago, I am not satisfied that the record discloses sufficient detail to enable competitors to undermine the applicant's competitive position, particularly in light of the transparency initiatives in train within the industry. In particular, I note the applicant's own reference to the IPHA transfers of value process.

Certain third parties are referenced in the CAPA plan in the context of the applicant's marketing and advertising activities. I have considered the level of detail provided in the record and the historical nature of the engagements in question. I am not satisfied that any of the relevant harms outlined in section 36(1)(b) could flow from release of this information, either to the applicant or to the third party itself.

Given the passage of time since the activities referenced in the record took place, the level of detail provided, and noting the publication of certain information through the IPHA transfers of value process, I am not satisfied that the release of particular information in the record relating to the activities of the applicant could give rise to the harms outlined in section 36(1)(b).

Furthermore, as I have outlined above, in case OIC-133065 I affirmed the HPRA's decision to grant partial access to the inspection report to which the records at issue in this case relate. Accordingly, the details of the HPRA's findings which are also contained in the records at issue in this case have already been released to the requester. It is also important to note that the release of a record under the FOI Act is essentially regarded as release to the world at large as the Act places no constraints on the uses to which a record released under the Act may be put. It seems to me that this serves to significantly undermine the applicant's claims as to the nature and extent of the harms that might arise from the release of these particular records.

Nevertheless, given the low threshold associated with the harm test in the second part of subsection (b) (could prejudice the competitive position), I am willing to accept that the release of the information relating to the HPRA findings and the applicant's response could impact public confidence and prejudice the applicant's competitive position. In the circumstances, I am willing to accept that section 36(1)(b) applies to information in the records relating to HPRA findings and responses provided by the applicant. This finding is subject to a consideration of whether sections 36(2) or 26(3) serve to disapply section 36(1). 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

The Public Interest

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.

In respect of the public interest provision at section 36(3), the applicant said that the HPRA decision provided "no clear rationale" as to why it decided to part-grant the requester access to the records. However, it then referenced the HPRA's statement that there is a "specific public interest in the compliance of marketing authorisation holders with requirements around control of advertising in a human medicinal products context and the outcomes of inspections by the HPRA as the regulator of human medicinal products in Ireland". The applicant said it disagreed with this reasoning. It said that the findings raised by the HPRA were comprehensively addressed through the actions provided. It said that the HPRA did not apply any sanctions and the plan provided by the applicant was deemed satisfactory. It said that the record does not provide this context.

The applicant added that the HPRA inspection concerned an area of its activities that would never involve the general public as such marketing or advertising is prohibited. It said that the findings had "no discernible impact on the general public". It further said that any public interest in interactions between pharmaceutical companies and healthcare professionals or organisations is "already recognised and addressed" through processes such as the IPHA transfers of value process. The applicant again referenced case OIC-117242 in this regard. It said that the HPRA failed to consider the potential impact of the release of records obtained by means of legal compulsion on the efficacy of HPRA investigations in future. It said that it disagrees with the HPRA's assertion that there is a public interest which is specific and robust enough to supersede the exemption provision. The applicant also provided detail in respect of its adherence to "the highest standards of ethical conduct". It said that the proposed disclosure could unfairly present the public with a biased and inaccurate picture of its activities.  

The HPRA's position is that the findings of a deficiency, while considered commercially sensitive and also confidential, should be released in the public interest. In its submissions, it said that details of particular Standard Operating Procedures and internal controls, staff members working in particular areas and specific product names were redacted as it regarded such information as commercially sensitive and considered that private interests overrode any public interest in release. It said that there is a public interest in the maintenance of commercial sensitivity in respect of the availability of medicines on the Irish market.  

The HPRA referenced previous decisions of this Office, specifically OIC-108970, OIC-109419, OIC-127873, OIC-127630, OIC-020533 and OIC-67447. It referred to this Office's decision-making in those cases and cited reasoning in respect of the public interest. The HPRA said that its decision-making in this case is analogous to the previous reviews and that it believes that release in the public interest of the fact of a deficiency in terms of compliance with legal requirements in terms of advertising or medicinal products is the correct approach. The HPRA said that in previous decisions this Office distinguished between releasing information on deficiencies, in order for the public to know how a regulated entity's legislative obligations are enforced by the HPRA, and refusing information specific to a company which is not in the public interest to release.

In respect of information on deficiencies, the HPRA referenced an interest in the public knowing "how a regulated entity's legislative obligations are enforced by the HPRA". It said that it is of the view that "the public interest lies in findings of a deficiency being made available to the public". It said that "the HPRA regulates certain activities relating to the advertisement of medicines and the public have a strong interest in knowing that advertising activities are undertaken within the standards prescribed by law and it is important to the public, for public health reasons generally and specifically, for those who use the products of the MAH in question, that the findings of deficiencies are something that can be accessed by the public, under the provisions of the FOI Act or otherwise". It said "the primary driver of the advertising regulations is, at its heart, the protection of public health in the public interest".

The HPRA further said that the applicant has the ability to mitigate any harm by contextualising the factual scenarios evident from the partially released records. It also said that the fact that the applicant cannot market certain medicinal products to the general public ignores the fact that it is the public who are prescribed medicinal products and they have a strong interest in knowing that the medicinal products they are prescribed are prescribed on the basis of objective medical needs, rather than as a result of "inducement or non-compliant advertisement to healthcare professionals".

Following receipt of the HPRA's submissions and considering the content of same, the Investigator notified the applicant of the detailed submissions received. The applicant made further submissions in response. It noted the many of the previous decisions referenced by the HPRA related to requests for inspection reports. It said that it does not believe the same reasoning can be extended to the records at issue in this case, in particular the CAPA plan. It said that the document was prepared by the applicant and was not intended to list regulatory findings pursuant to the HPRA inspection. It said its purpose was to indicate the internal controls implemented or revised following the inspection and that the information falls within the category of information redacted by the HPRA as commercially sensitive.

The applicant also strongly disputed the HPRA's "implication that prescribing decisions of [the applicant] would have been made 'as a result of inducement or non-compliant advertisements to healthcare professionals'". It referenced specific findings and said that no breach of applicable legislation was identified. It said that the CAPA plan was accepted by the HPRA and no further action was requested of the applicant. It said that no sanction was applied. It said that it abides by the principles set forth in the IPHA Code of Practice and "is committed to the utmost standards of ethical conduct in its interactions with healthcare professionals and healthcare organisations". It said that it strongly rejects any allegation that that deficiencies identified were tantamount to inducements or unlawful advertisements. On this point, I am satisfied that the HPRA's arguments related to a general public interest in the appropriate prescription of human medicinal products, rather than any specific commentary on the applicant's practices.

In considering where the balance of the public interest lies in this case, I have had regard to section 11(3) of the Act which provides that in performing any functions under the 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 inThe Minister for Communications, Energy and Natural Resources and the Information Commissioner & Ors[2020] IESC 57 ("the 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".

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. However, as noted above, information relating to the particular products and internal procedures has been redacted by the HPRA, as well as information which it considers outside the scope of the request. What is at issue here is information relating to specific findings of the HPRA and responses and commentary provided by the applicant. The HPRA has not sought to release the entirety of the record. It seems to me that by making redactions, the HPRA has sought to mitigate the risks of releasing information that might give rise to the harms identified in section 36(1)(b). Moreover, it seems to me that the inclusion in the record of the applicant's responses and outlined actions in respect of the HPRA findings serves to contextualise those findings, thereby significantly reducing the harm associated with the disclosure of those findings. Accordingly, having carefully examined the parts of the records that the HPRA has decided to release, my view is that the impact of disclosure on the interest underpinning the exemption is low.

I would also note that while the applicant is a private enterprise, it is one engaged in regulated activities. The disclosure of the information at issue would disclosure information relating to the applicant's compliance with the 2007 Regulations and the inspection process in respect of same. 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 again note the applicant's reference to case OIC-117242. The applicant said that, in that case, the public interest in protecting information given in confidence in the context of an investigation outweighed the public interest in disclosure. Such analysis related to the finding that section 35(1)(a) applied to the information in question. However, I have considered the applicant's arguments in the context of my findings in respect of section 36(1)(b). I would again note that the particular factual circumstances of the above case are relevant. In addition, in case OIC-117242, an investigative report had been published by the FOI body. Having considered the detail of that decision, and the factual circumstances and context of the current case, I am satisfied that the two can be sufficiently differentiated. I do not find the applicant's arguments in respect of the case persuasive.

Having considered the matter, it seems to me that there is a significant public interest in;

• the public knowing that entities involved in the advertising of human medicinal products operate within the standards prescribed by law, in this case the 2007 Regulations which the HPRA is required to enforce, and
• 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.

Having considered the content of the records in this case, my view is that release of the specific information in those records will serve these public interests by demonstrating the extent of the applicant's compliance with legal standards and by demonstrating the extent of the enforcement activity carried out by the HPRA following the inspection of the applicant.

While noting the applicant's arguments distinguishing between the records at issue in this case and inspection reports, it seems to me that the public interests identified above extend to the full HPRA inspection process, as outlined at the outset. Engagement with regulated entities on foot of findings and a requirement that corrective and preventative action plans be provided would appear to be a crucial aspect of such regulation and forms part of the HPRA's stated inspection process.

In my view, the public interests identified are even stronger in circumstances where the matters involved concern public health. It seems to me that the HPRA's decision to part-grant the request was aimed at striking a balance by deciding to release relevant information that would serve these public interests whilst simultaneously striving to protect sensitive commercial information relating to the applicant whose release might affect its interests. As I have indicated above, a number of factors serve to mitigate any harms which could arise from disclosure of the relevant records. These include the historical nature of the information, the fact that responses and actions are included in the records, and the fact that information relating to findings has been released to the original requester on foot of a separate review.

In the circumstances, I am satisfied that the public interest would, on balance, be better served by granting access to the information at issue. I find, therefore, that section 36(3) serves to disapply section 36(1)(b) in this case.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the HPRA's decision. I find that it was justified in its decision to grant access to specific information in the records which the applicant argued to be exempt from release under sections 35 and 36 of the FOI Act.

Right of Appeal

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 not later than four weeks after notice of the decision was given to the person bringing the appeal.
 

Stephen Rafferty
Senior Investigator