Whether the HPRA was justified in granting partial access to records relating to an inspection carried out

30 May 2023

Background

This review arises from the HPRA-�s decision to grant partial access to records relating to an inspection undertaken pursuant to an FOI request to which section 38 of the FOI Act applies. Section 38 applies to cases where, at some stage in the decision making process, the public body has formed the view that the records in question qualify for exemption under one or more of the relevant exemptions in the FOI Act (ie. sections 35, 36 and 37 -� relating to information that is confidential, commercially sensitive or personal information about third parties, respectively) but that the records 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 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. This case concerns an application for review made by an affected third party.

In a request dated 30 November 2022, the requester sought access to any replies sent to the HPRA by a number of specified companies in response to reports of inspections carried out by the HPRA relating to nonconformities/breaches regarding the Medicinal Products (Control of Advertising) Regulations 2007 (the 2007 Regulations). 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 inspections. The applicant in this case is one such company.

The HPRA notified the applicant of the request on 14 December 2022. It informed the applicant of its preliminary view that the public interest would, on balance, be better served by granting partial access to two records, namely a cover letter and a response from the applicant to a report of an inspection undertaken by the HPRA in 2019. It provided the applicant with a copy of the records and identified the sections of the records it intended to redact. On 10 January 2023, the applicant provided submissions to the HPRA in which it argued 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. On 27 January 2023, the applicant sought a review by this Office of the HPRA-�s decision.

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. I have decided to conclude this review by way of a formal, binding decision.

Scope of Review

The two records at issue comprises a short cover letter to which the HPRA decide to grant access with certain redactions under section 37 of the FOI Act and the applicant-�s response to the HPRA-�s report of its findings following an inspection undertaken, to which the HPRA decided to grant access with redactions under sections 35, 36 and 37 and on the basis that certain information in the record was outside the scope of the original request.

The applicant-�s submissions to this Office focused solely on the response document. It argued that the record, even partially redacted, should not be disclosed under the FOI Act, pursuant to sections 35(1)(a), 36(1)(b) and 36(1)(c). It made no submissions in respect of the HPRA-�s decision to part-grant the cover letter. Accordingly, I am satisfied that the cover letter is outside the scope of this review. Moreover, the relevant parts of the response document that the HPRA decided to redact are outside the scope of this review.

This review is therefore concerned solely with whether the HPRA was justified in its decision to grant access to the remaining information in the response document.

Preliminary Matters

Before I address the substantive issues arising, I wish to make a number of preliminary comments. 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, I note that the applicant has asked that submissions made to this Office be treated as confidential. Section 22(10) of the FOI Act provides that the Commissioner shall give reasons for his decisions. Accordingly, I believe that I must make adequate reference to matters I have considered in reaching a decision, including submissions made by the parties. That said, section 25(3) of the FOI Act requires me to take all reasonable precautions in the course of a review to prevent the disclosure of information contained in an exempt record. This means that the extent to which I can describe the contents of the record is limited.

Analysis and Findings

The record in question

As noted above, I am limited in the description of the contents of the record that I can provide. However, I believe that it would be useful to provide some high-level detail in respect of the record and the functions of the HPRA.

In its submissions, the HPRA said that it regulates the advertising of human medical products in Ireland. It said that its role is to ensure that advertisements for medical products are in compliance with the 2007 Regulations. It said that 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 that it ensures compliance with the 2007 Regulations in a number of ways. It said that 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 record in question is the applicant-�s response to a report following an inspection undertaken by the HPRA in September 2019. The record comprises a restatement of findings and the applicant-�s responses to those findings. The applicant-�s position is that the entirety of the record is exempt from disclosure under sections 35(1)(a), 36(1)(b) and 36(1)(c) of the FOI Act.

Section 35(1)(a) -� information obtained in confidence

Section 35(1)(a) provides for the protection of certain information given to an FOI body in confidence. For a record to be exempt under section 35(1)(a), 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 its submissions to this Office, the applicant said that at the time of the inspection, it cooperated with the HPRA as completely as possible. It said that it has provided detailed information in the record in respect of the findings of the HPRA. It said that it made personnel available -�to the greatest possible extent-� and it said that it responded to the HPRA-�s questions -�in detail and with candour-�. It said that it provided responses -�on the understanding that the information provided (which included commercially sensitive information) was given in confidence and on the understanding that it would be treated as confidential by the HPRA-�.

The applicant said that the record contains information about its marketing plans, interactions with healthcare professionals, organisations and vendors, brand planning, external funding and other activities. It said that the specifics of the information are not in the public domain. It referenced the publication of information contained in the record by the HPRA in March 2020 but said that such publication was in an -�anonymous form-�. It said that within its organisation, information contained in the record is considered sensitive and access is reserved for selected senior and regulatory personnel. It referenced the -�potential harm that could result in disclosure of this information to our competitors or the wider public-�.

The applicant-�s position is that the redactions made by the HPRA -�do not fully reflect the extent of the confidential information contained in the record-�. It said that information in respect of promotional and non-promotional strategy and vendor relations is information that was provided on the basis of confidentiality. It said that should the information be disclosed it -�may have to consider the process by which it discloses information to the HPRA as part of these types of inspections-� though it said it recognises that it is required by law to cooperate.

The HPRA-�s position is that -�information that is commercially sensitive is prima facie confidential-�. In its submissions, it said that it redacted information which it understood comprised commercially sensitive information which was therefore given to the HPRA in confidence. It said that the findings of a deficiency, while considered commercially sensitive and also therefore confidential, were not redacted. It said that it considers such findings 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 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 supply 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.

As I have outlined above, the first two requirements for section 35(1)(a) to apply are that (i) the record sought contains information given to an FOI body in confidence, and (ii) the information was given on the understanding that it would be treated as confidential. The record in question contains the findings of the HPRA as a result of the inspection process carried out and the applicant-�s responses to those findings. The fact that information provided by the applicant may have formed the basis for the HPRA-�s findings is not, of itself, sufficient for section 35(1)(a) to apply unless the findings themselves disclose information given to the HPRA. I do not accept that the applicant could reasonably have understood that the HPRA findings would be treated as confidential, in circumstances where the HPRA has agreed to redact specific details, nor is it apparent that the findings disclose information provided by the applicant.

Moreover, I am not satisfied that the release of the applicant-�s responses and proposed actions in respect of the HPRA-�s findings 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. 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 similar information.

I find, therefore, 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 Act.

Section 36(1)(b) -� commercially sensitive information

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 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 in the record is extensive and provides a snapshot of the applicant-�s marketing plans, interactions with vendors, relationships with healthcare professionals and organisations, brand planning, external funding and other activities. It said that if its competitors had access to the information, they would be able to form a view as to its strategy in certain areas. It said that this would provide competitors with significant information on the applicant-�s future direction and could -�serve to undercut-� the applicant in the market. It said that the information could be used to target the applicant, for example in respect of its engagement with vendors and healthcare stakeholders. It said that the record contains -�valuable information-� for its competitors on the particular markets in receipt of funds as indicative of its wider market positioning strategy.

The applicant said that information in respect of the inspection is already in the public domain having been presented by the HPRA in an anonymised format during a presentation. It also said that information regarding payments made by the applicant to healthcare professionals is already in the public domain through the annual transfer of value disclosure process. The transfer of value process is led by the Irish Healthcare Pharmaceutical Association.

The applicant acknowledged that the information in the records dates from 2019/2020. It said that the information is still relevant to its competitors. It said that disclosure of the record would compromise its ability to compete in the pharmaceutical industry in Ireland.

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.

The HPRA also referenced the applicant-�s submissions in respect of the transfer of value process. It said that in its response to the HPRA, the applicant identified that certain information was already in the public domain. 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, is therefore 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-�.

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 record 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 record contains information in respect of the activities of the applicant in the context of HPRA findings and responses. Such information relates to financial activities, sponsorship, external event participation and engagement with third parties. The question at issue is whether the release of this 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 2017, 2018 and 2019. 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 four to six 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 position on the market, particularly in light of the transparency initiatives in train within the industry. In particular, I note the applicant-�s own submissions that information relating to payments it made to certain healthcare providers is -�already in the public domain-� through the above-referenced annual transfers of value disclosure process.

Given the passage of time since the activities referenced in the record and noting the applicant-�s own submissions in respect of the previous publication of certain information, I am not satisfied that the release of particular information in the record relating to the activities of the applicant could reasonably give rise to the harms outlined in section 36(1)(b).

In respect of the HPRA-�s findings and responses provided by the applicant, I accept that the proposed release of such information could prejudice the applicant-�s competitive position. Given the lower bar associated with the harm test in the second part of subsection (b), I accept that the release of such information could impact public confidence and prejudice the applicant-�s competitive position. However, I would note that I believe that the inclusion in the record of responses and outlined actions from the applicant serves to reduce the harm associated with the disclosure of findings. The proposed release of this information allows for the contextualisation of findings and the disclosure of actions which have been, or are proposed to be, taken. Notwithstanding the above, I accept that the relevant harm test has been met.

I find that section 36(1)(b) applies to information in the record relating to HPRA findings and responses provided by the applicant. This finding is subject to a consideration of whether sections 36(2) or 36(3) serve to disapply section 36(1).

Section 36(2) and 36(3)

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. In carrying out any review, this Office has regard to the general principles of openness and transparency set out in section 11(3) of the FOI Act. That section recognises the need to enhance public scrutiny and accountability of government and public affairs, particularly the activities and decision making of FOI bodies. However, in a judgment delivered on 25 September 2020 (The Minister for Communications, Energy and Natural Resources and the Information Commissioner & Ors, available on our website), the Supreme Court held that general principles of openness and transparency do not provide a sufficient basis for directing the release of otherwise exempt information in the public interest. Rather, a -�sufficiently specific, cogent and fact-based reason-� is required -�to tip the balance in favour of disclosure-�.

In respect of the public interest provision at section 36(3), the applicant said that the public interest is better served by refusing to disclose the record. It said that disclosure would have a chilling effect on the dialogue generally required between regulators and regulated entities. It said that disclosure, in some but not all cases, would be to the detriment of functional and effective regulation. It said that it appreciated that there is a specific public interest in ensuring that regulated entities act within the confines of the law. However, it again referenced a presentation given by the HPRA which included anonymised information in respect of deficiencies. It said that the public is therefore already aware of the potential issues that arise in relation to non-compliance with advertising and documentation rules.

The applicant drew a distinction between the current case and a previous decision of this Office which related to the regulation by the HPRA of fertility clinics (108970). The applicant said that the details of the current case -�arguably have less of an immediate impact on individuals-�.  It said that disclosure will not benefit the public as findings have -�since been remedied-�.

The HPRA-�s position is that the findings of a deficiency, while considered commercially sensitive and also confidential, were not redacted and that such findings 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. The HPRA referenced previous decisions of this Office and said 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. It said it sought to release the majority of information in respect of findings. It said that release of such information allows the public to know how a regulated entity-�s legislative obligations are enforced by the HPRA. It said the public have a strong interest in knowing that advertising activities are undertaken within the standards prescribed by law. It said that it is important for the public, -�for public health reasons generally and specifically for those who use the products-�, that findings of deficiencies are something that can be accessed.

In relation to the harm which could be caused by disclosure of the information, I have identified potential prejudice to the competitive position of the applicant. 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 in relating to specific findings made by the HPRA and responses provided by the applicant. The HPRA has not sought to release the entirety of the record.

I consider that there is a significant public interest in 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. In my view, there is a strong public interest in knowing how the HPRA enforces the regulations and that the functions assigned to the HPRA achieve the purpose of the relevant legislation. I do not accept that the public interest has been sufficiently served by the prior publication of anonymised information relating to findings. I also do not accept the distinction drawn by the applicant in respect of the nature of its business and its position that it has less of an impact on individuals than other regulated areas. I believe that there is a strong public interest in knowing that the marketing and advertising of medicinal products is undertaken within regulated parameters and that the body responsible for such regulation is carrying out its functions.

I find that the public interest would, on balance, be better served by granting access to information in the record relating to the findings of the HPRA and the applicant-�s provided responses. I find, therefore, that section 36(3) serves to disapply section 36(1)(b) in this case.

Section 36(1)(c) -� contractual negotiations

Section 36(1)(c) provides for the mandatory refusal of a request if the record concerned contains information whose disclosure could prejudice the conduct or outcome of contractual or other negotiations of the person to whom the information relates. The standard of proof required to meet this exemption is relatively low in the sense that the test is not whether prejudice or harm is certain to materialise but whether it might do so. Having said that, this Office expects that a person seeking to rely on this exemption would be able to show that contractual or other negotiations were in train or were reasonably foreseen which might be affected by the disclosure and would be able to explain how exactly the disclosure could prejudice the conduct or the outcome of such negotiations.

The applicant made submissions in respect of the application of section 36(1)(c) to the record. It said that disclosure of the detail contained in the record would reduce its ability to secure value in negotiations with healthcare professionals and in respect of other sponsorship relationships. It also referenced a particular third party and said that disclosure of particular information could affect the confidence of that vendor in its ability to meet its contractual obligations. It said that this information is not the subject of disclosures under the transfers of value process. It further said that disclosing certain information could affect the confidence of patient association representatives in engaging with the applicant in future.

The applicant has referenced the disclosure of its relationship with a particular third party. However, I note that in the copy of the records provided to this Office, the HPRA has proposed to withhold the name of the third party. Even if the third party could identify itself from the remaining information, I am not satisfied that the level of information or the content of same could reasonably be expected to prejudice the conduct or outcome of contractual or other negotiations.

The applicant also said that disclosing details of patient support groups and support provided to them could affect their confidence in engaging with the applicant. It provided limited submissions in this regard and has not identified specific contractual or other negotiations. Having considered the contents of the records, I note that only high-level references are made to patient support groups. I am not satisfied that disclosure of this information could prejudice the conduct or outcome of contractual or other negotiations.

Having considered the applicant-�s submissions and the content of the record, I am not satisfied that release of the information could prejudice the conduct or outcome of negotiations. Accordingly, I find that the applicant has not satisfied this Office that section 36(1)(c) applies to information in the record.

Other provisions cited

In its submissions to this Office, the applicant referenced a number of other provisions of the FOI Act which I propose dealing with briefly.

With reference to the applicability of section 15(1)(d), it said that -�relevant sections of the findings from the regulatory inspection are already in the public domain-�. Section 15 provides for the refusal to grant FOI requests on specified administrative grounds. Section 15(1)(d) provides for the discretionary refusal of a request where the information is already in the public domain. It seems to me that it would not be appropriate for me to direct the HPRA to redact occasional sentences or pieces of text from the record on the ground that the applicant can identify such information as being in the public domain. Furthermore, it would not be readily apparent to the reader of the record that such information is publicly available. Moreover, I note that section 15(1)(d) is not mandatory and provides that an FOI body -�may-� refuse to grant the request in certain circumstances.

The applicant also argued that the release of a redacted copy of the record is not appropriate where the redactions would -�render the released material of negligible value-�. It referenced section 18 of the FOI Act in this regard. It also said that the entirety of the record, -�other than salutations-�, should be redacted. In its application to this Office, the applicant said that the record in question is a letter of response explaining the reasons for some findings and outlining its plan of remediation and correction. It said that releasing the letter on its own would be misleading. I have considered the applicant-�s arguments in respect of confidentiality and commercial sensitivity above. Section 18(1) provides, that "if it is practicable to do so", access to an otherwise exempt record shall be granted by preparing a copy, in such form as the head of the FOI body concerned considers appropriate, of the record with the exempt information removed. Section 18(1) does not apply, however, if the copy provided for thereby would be misleading (section 18(2) refers). I am satisfied that the copy of the record for release that is in line with my findings in this case would not be misleading.

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 report 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