Cinneadh
Siobhán Maguire of The Sunday Times and the Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: 160089
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: 160089
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
This decision was appealed to the High Court by the Health Products Regulatory Authority.
It was subsequently agreed between the parties that the decision be set aside and remitted back to the Information Commissioner for a fresh determination.
Whether the HPRA's decision to partially grant a request for access to records concerning inspections of premises using animals for scientific or research purposes was justified under sections 29, 30, 32, 35, 36 and 37 of the FOI Act
Conducted in accordance with section 22(2) of the FOI Act by Stephen Rafferty, Senior Investigator, who is authorised by the Information Commissioner to conduct this review
30 August 2016
On 8 December 2015, the applicant submitted a request to the HPRA for all 2015 inspection reports of premises using animals for scientific or educational purposes, all correspondence with facilities where breaches of legislation were discovered in 2015, and all correspondence with a named third party in 2014 and 2015. On 27 January 2016, the HPRA decided to part-grant the request, with the majority of the records heavily redacted. On 28 January 2016, the applicant sought an internal review of the HPRA's decision. On 25 February 2016, the HPRA varied its original decision and released some additional information from the inspection reports. On 25 February 2016, the applicant sought a review of that decision by this Office.
During the course of the review, Simon Noone, Investigator, notified a number of third parties about the review and invited them to make submissions on the matter In total, 18 organisations were notified, and 15 replied, the majority of which objected to the release of the relevant information, either wholly or in part, although two stated that they had no objection to release.
I have decided to conclude this review by way of a formal binding decision. In conducting this review, I have had regard to the contents of the records, to the correspondence between the HPRA and the applicant, to the correspondence between this Office and both the HPRA and the applicant, and to the submissions received from the third parties notified by Mr Noone. In referring to the records at issue, I have adopted the numbering system and description of the records as used by the HPRA in the schedule provided to the applicant.
As the original request was made on 8 December 2015, this review can only consider records created on or before that date. Completed Inspection reports 19 (recs 121-127), 21 (recs. 135-140), and 23 (recs. 149-155) and draft inspection reports 1 (recs. 156-161) and 2 (recs. 162-168) were created after 8 December, and consequently are outside the scope of this review.
Therefore, the scope of the review is concerned with solely whether the HPRA was justified in partially granting and/or refusing access to the Inspection reports 1 to 18, 20, and 22 and to the correspondence with the third party specified by the applicant in her request.
Before I address the substantive matters arising in this review, I would like to make the following comments. Firstly, it should be noted that a review by the Commissioner under section 22 of the FOI Act is de novo, which means that it is based on the circumstances and the law as they pertain at the time of his decision.
Secondly, it should be noted that the courts have taken the view that, under FOI, records are released without any restriction as to how they may be used and, thus, FOI release is regarded, in effect, as release to the world at large. Additionally, while I am required by section 22(10) of the FOI Act to give reasons for decisions, this is subject to the requirement of section 25(3) that I take all reasonable precautions during the course of a review to prevent disclosure of information contained in an exempt record. This means that the description which I can give of the records at issue is limited.
Finally, section 18(1) of the Act 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 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 take the view that neither the definition of a record under section 2 of the Act nor the provisions of section 18 envisage or require the extracting of particular sentences or occasional paragraphs from records for the purpose of granting access to those particular sentences or paragraphs. Generally speaking, therefore, I am not in favour of the cutting or "dissecting" of records to such an extent. Being "practicable" necessarily means taking a reasonable and proportionate approach in determining whether to grant access to parts of records.
The records under review were created in the context of the HPRA's responsibilities under the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012 (SI 543/2012) which give effect to Directive 2010/63/EU. Reg. 5 provides that, for the purposes of the regulations, "the functions of the State and of the competent authority under the Directive shall be performed by the IMB" (the HPRA was formerly known as the IMB). These functions include, inter alia, granting research project authorisations (part 5), ensuring enforcement of the regulations (part 11), and conducting "regular inspections of breeders, suppliers and users and their establishments", some of which are to be unannounced (reg. 73). The regulations grant extensive powers to the HPRA to enable it to carry out its functions (reg. 72), and create a number of relevant criminal offences, including obstructing or interfering with the HPRA in the performance of its functions (reg. 84).
The HPRA has cited a number of exemptions for refusing access to certain information contained in the records at issue.
Section 29
The HPRA cited section 29 as a ground for refusing access to three letters that formed part of the HPRA's correspondence with the specified third party (recs. 188, 192 and 195-196). Section 29 is a discretionary exemption that protects the deliberative processes of FOI bodies. It is subject to a strong public interest test; i.e. it applies only where the granting of a request would be contrary to the public interest.
A deliberative process can be described as a thinking process which informs decision making in FOI bodies. It involves the gathering of information from a variety of sources and weighing or considering carefully all of the information and facts obtained with a view to making a decision or reflecting upon the reasons for or against a particular choice. Thus, it involves the consideration of various matters with a view to making a decision on a particular matter. It would, for example, include some weighing up or evaluation of competing options or the consideration of proposals or courses of action.
This Office has drawn a distinction between an FOI body being engaged in a monitoring or supervisory role and being engaged in a deliberative process. In Case Number 98078 (Wall and Department of Health and Children, on www.oic.ie), the previous Commissioner stated that "Correspondence from the Department warning agencies that they must keep to budget or must take measures to ensure budget allocations are not exceeded do not, in my opinion, relate to the deliberative process. They relate to the administrative or regulatory role of the Department in overseeing the expenditure pursuant to allocation."
The HPRA submitted that the relevant letters "contain information that relate to an ongoing process of decision making. The letters also relate to decisions that are not routine or administrative functions of the HPRA but refer to ongoing activities within the research establishment and the HPRA's advice on how to proceed with the project authorisation."
The letters at issue address concerns of the HPRA regarding compliance by the third party with certain project authorisations granted to it. As set out above, the granting of authorisations, and the monitoring and enforcement of the terms upon which the authorisations are granted, are functions of the HPRA under the 2012 Regulations. Therefore, I am of the opinion that the correspondence was issued by the HPRA in its regulatory role, and it was not engaged in a deliberative process as envisaged by section 29 of the FOI Act. Consequently, I find that section 29 does not apply
Section 30
The HPRA has refused access to all of the records within scope under section 30(1)(a) of the FOI Act. This exemption provides that access to a record may be refused if such access could 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." It is subject to a public interest balancing test (subsection (2)).
In its submissions to this Office, the HPRA stated that "The information contained within the inspection reports is sensitive and confidential. The release of such information would have a detrimental effect on future inspections of these establishments in terms of ensuring full participation and disclosure of issues by the research establishments. Another consequence could include deterioration of relationships between the HPRA and the establishments. In addition, while inspections may be announced or unannounced, the auditee will be unaware in advance of the specific areas the inspection will focus on. The release of additional information from these inspection reports into the public domain may provide significant insight into the approach the HPRA takes in conducting such inspections and potentially diminish the effectiveness."
When refusing access to records under section 30, an FOI body must, firstly, identify the potential harm to the functions covered by the exemption that might arise from disclosure and, having identified that harm, consider the reasonableness of any expectation that the harm will occur. The test of whether the expectation is reasonable is not concerned with the question of probabilities or possibilities. It is concerned simply with whether or not the decision maker's expectation is reasonable. In Sheedy v Information Commissioner [2005] IESC 35, [2005] 2 I.R. 272, Kearns J held that the onus to produce evidence of prejudice falls on the FOI body and, in the absence of such evidence, this Office is entitled to hold against the FOI body. In that judgment, the Supreme Court considered the application of section 21 of the 1997 Act, which is the predecessor to section 30 of the 2014 Act. The court held that the Commissioner was entitled to find that, in circumstances where teachers were required by statute to cooperate in the provision of information leading to the compilation of school reports, no prejudice or adverse effect could follow a direction to release the reports, because cooperation would still have to be forthcoming from teachers and school staff on foot of their statutory obligations.
I am satisfied that similar considerations pertain in this instance. Individuals and establishments involved in animal testing for scientific purposes are obliged, by virtue of SI 543/2012, to cooperate and engage with the HPRA in the performance of its functions under the regulations. Therefore, I do not accept that the release of these records could reasonably be expected to prejudice or harm the effectiveness of future investigations of animal testing establishments by the HPRA. While the HPRA has contended that the release of records "may provide significant insight into the approach the HPRA takes in conducting such inspections" and thereby prejudice the procedures or methods employed for the conduct of the investigations, this seems to me to constitute little more than a mere assertion of harm. In any event, it appears that each organisation receives a copy of its own inspection report. Accordingly, I consider that the HPRA has not demonstrated that the harm identified could reasonably be expected to occur. Consequently, I find that section 30 does not apply to the records under review.
Section 32
The HPRA has sought to protect the names and addresses of the research establishments and the individuals mentioned in the records under section 32(1)(b). This is a discretionary exemption which protects records, the release of which could reasonably be expected to "endanger the life or safety of any person". The exemption is not commonly used and it should not be applied without careful consideration having been given to whether the expectation of endangerment is a reasonable one in all the circumstances. An assessment of the expected consequences of releasing particular records in terms of endangering life or safety is required. It is not necessary, or indeed possible, to establish that such physical harm will definitely occur, but the FOI body must show that there is reasonable expectation of such harm arising.
The HPRA has submitted that "The names of individuals employed and the location of these research establishments is not information that is in the public domain...Animal testing is an emotive subject for many people and although the HPRA recognises the concern that people have for animal welfare, staff and animal research establishments have in the past been threatened here and abroad. Based on this, it is the opinion of the HPRA that the release of names of personnel within the research establishments and the location of the establishments could endanger the safety of these individuals and their families. In addition HPRA staff are very conscious of the strong views held by some individuals in respect of animal testing. Our inspectors do not want their names or the locations of inspections to be in the public document as they feel this may represent a threat to their safety."
Most of the third parties that made submissions to this Office also expressed concerns for the safety of their staff if names and addresses are released. One establishment referred to previous incidents in Ireland and the United Kingdom and stated that such incidents "have created great anxiety in the research and technical community in Ireland and in [this establishment] and provide evidence of legitimate fears for personal and public safety and concerns around the destruction of private property if individual identities or related material are disclosed."
Scientific research on animals is an issue that generates much controversy and on which many people hold strong opinions. While the vast majority of opponents of animal research are entirely peaceful, I am satisfied that there exists a small minority who are willing to use violence against those involved in such research. I am satisfied that previous examples of activists targeting the staff of organisations which are engaged in animal testing demonstrate that there is a continuing threat of abusive and violent behaviour posed by some activists. I am conscious that some limited information is already in the public domain in respect of a number of organisations that engage in animal testing. However, this does not, in my view, undermine the potential for the safety of the staff of those organisations to be compromised if the identities and addresses of the organisations and their staff were to be released in this case along with details of the contents of the various inspection reports.
While the majority of establishments that replied to this Office objected to release of identifying information, two stated that they had no objection to full release. However, given the sensitivity of the material, I am of the view that it would not be desirable to have full identifying details released about only two establishments, while the others remain protected. In my opinion, the disclosure of information revealing the location of the research institutions, and the identities of individuals involved in such research and engaged in inspections could reasonably be expected to endanger the life or safety of such individuals. Consequently, I find that the HPRA was justified in deciding that section 32(1)(b) applies to the details of the organisations, their staff, and the details of those individuals involved in conducting inspections, as contained in the records at issue. Section 32(3) provides that section 32(1) shall not apply in certain limited circumstances, none of which are applicable in this instance.
In respect of the inspection reports, I find that the following information could be used to identify individuals and I direct that it be redacted from the reports:
On the other hand, I do not accept that the release of dates of inspections, or the breeds of animals kept by the establishments, could reasonably be expected to endanger the life or safety of any person and I find that this information is not exempt under section 32(1)(b). I note that one of the third parties suggested that the disclosure of the breed of animals involved may serve to allow for the identification of that organisation. Having examined the contents of the particular report, it is not clear to me that this would be the case.
As for the application of section 32(1)(b) to the correspondence between the HPRA and the specified third party, the circumstances are somewhat different. While I do not accept that the disclosure of the contents of the inspection reports with the redaction of identifying information could reasonably be expected to endanger the life or safety of any person, it seems to me that different considerations arise in respect of the correspondence sought in view of the fact that the identity of the organisation is known. Indeed, the applicant's request specified correspondence with that organisation by name. The release of the correspondence sought would disclose information of a type set out in the inspection reports along with the identity of the relevant organisation. In my view, the disclosure of the correspondence could reasonably be expected to endanger the life or safety of the staff of that organisation. I find, therefore, that section 32(1)(b) applies to the redacted parts of the correspondence sought and that the HPRA was justified in refusing access to that information.
Having found that the HPRA was justified in granting only partial access to the correspondence with the specified third party, I do not need to consider the applicability of any further exemptions to those records. Accordingly, I will now proceed to consider the applicability of the remaining exemptions cited to the contents of the inspection reports alone.
Section 35
The HPRA has claimed that section 35(1)(a) applies to to the inspection reports. This is a mandatory exemption that protects confidential information. In order for section 35(1)(a) to apply, four cumulative conditions must be met:
The HPRA submitted that "The research establishments and the HPRA have a mutual understanding that information documented during the inspection process will be treated as confidential. The information contained within the inspection reports is sensitive and confidential and in some cases commercially sensitive...If parties submitting such data to the HPRA could not do so with an assurance of confidentiality, this could impact on the willingness of the establishment to submit any requested data, which would in turn have a detrimental impact on animal health and welfare and thus the public interest would not be served."
A distinction may be drawn between information communicated to an FOI body and information which comprises the opinion or observation of the FOI body itself. This Office takes the view that, where 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, and thus the first two requirements of section 35(1)(a) are not met. This approach was affirmed by Kearns J in Sheedy v Information Commissioner [2005] IESC 35. It seems to me, having examined the inspection reports created by the HPRA, that they primarily consist of the observations and opinions of the HPRA officers carrying out the inspections, rather than information imparted to them by the establishments. Consequently, I consider that section 35(1)(a) does not apply to protect these reports.
More generally, as set out above in respect of section 30, the establishments involved in animal testing are obliged by law to engage with the HPRA and to cooperate with its inspection regime. Therefore, I do not accept the HPRA's contention that the release of the reports would be liable to impact on the willingness of an establishment to furnish requested information, and I find that the HPRA has not demonstrated that the release of the records would be likely to prejudice the future supply of such information. I find, therefore, that section 35(1)(a) does not apply to the inspection reports.
Section 36
This is a mandatory exemption that protects commercially sensitive information. Section 36(1) provides for the refusal of a request if the record concerned contains-
The HPRA contends that section 36(1)(b) applies to all of the inspection reports. In its submissions it stated that "Scientific research by its nature is confidential until published, is commercialised or sold on to a third party. Other testing relates to the regulatory testing of medicines and is part of the confidential medicinal product authorisation process. While much research may ultimately not have a financial benefit its purpose is always to further develop science often with the potential for related commercial or scientific success." It argued that the public interest favoured protecting the records from release.
Some of the third parties consulted in respect of the inspections reports have contended that all three elements of section 36 should apply to the reports. One establishment submitted that "The work described concerns research supporting the national innovation agenda and specifically in partnership with industrial partners or part of highly competitive scientific bids." Another establishment stated that "The relevant records contain commercially [sic] and scientific information that if released could prejudice the future commercialisation or publication of the results of such research in the future. The purpose of research in this area is primarily or medical advancement and therefore [the establishment] is of the opinion that the public interest is better served in this instance by the non-release of this information..."
I accept the HPRA's contention that ongoing scientific research may well be commercially sensitive. However, no such scientific or other commercially sensitive information has been specifically identified either by the HPRA or the relevant third parties. The reports primarily consist of observations from the HPRA inspection officer(s) about the welfare of the animals and the conditions in which they were kept. There are also comments on the record management systems of the establishments in respect of project authorisations. There are no details provided of the scientific research projects being carried out, and there are no references to the planned uses for the research. I am not satisfied that the information within these reports comes within any of the categories of commercial information set out in section 36(1), particularly in light of my finding that the identifying features as contained in the reports in exempt under section 32(1)(b). I find, therefore, that section 36 does not apply to the inspection reports.
Section 37
The HPRA contended that names of people employed in the research establishments was personal information and should not be released. However, as I have found that this information is protected under section 32, I do not need to consider this exemption further.
Having carried out a review under section 22(2) of the Act, I hereby vary the decision of the HPRA. While I find that it was justified in its decision to grant only partial access to the correspondence with a specified third party, I find that the main contents of the inspection reports are not exempt and should be released, subject to the redaction of the following information under section 32(1)(b):
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 applicant 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.
Stephen Rafferty
Senior Investigator