Cinneadh
Mr X and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-53225-W7D3L5 (160439)
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-53225-W7D3L5 (160439)
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Whether the HPRA was justified in refusing further access to records concerning scientific animal protection inspections of premises owned by a named company, including correspondence, for the period of January 2013 to January 2016
18 December 2019
In a request dated 27 May 2016, the applicant sought access to copies of all scientific animal protection inspection reports of premises owned by a named company and related correspondence for the period of January 2011 to January 2016. In a decision dated 15 June 2016, the HPRA explained that it became the competent authority for scientific animal protection inspections in January 2013 and therefore did not hold relevant records for the years 2011 and 2012. In relation to the records held for the period of January 2013 to January 2016, the HPRA granted the request in part but refused it in larger part under sections 29, 30(1)(a), 32(1)(b), 35(1)(a), 36(1), and 37(1) of the FOI Act. On 16 June 2016, the applicant requested an internal review in relation to the HPRA’s claims for exemptions for the records withheld. On 22 July 2016, the HPRA affirmed its original decision.
On 10 October 2016, the applicant applied to this Office for a review of the HPRA’s decision. The application for review was accepted, but the review was then suspended pending the outcome of a High Court appeal of the decision made in Case 160089, available on our website at www.oic.ie. Case 160089 was remitted on consent by order of the High Court dated 14 March 2019. This review was subsequently reactivated in May 2019.
I have now completed my review in accordance with section 22(2) of the FOI Act. In carrying out my review, I have had regard to the submissions made by the HPRA on 22 May 2019. I note that, on 3 May 2019, this Office wrote to the applicant at the email address on file at the time for the purpose of inviting him to make submissions in relation to any matter that he considered relevant to my review. When no reply was forthcoming, this Office called the applicant to confirm that he had received the invitation to make submissions given the passage of time since the last contact with him. The applicant said that he had not received the invitation, because his email address had changed. Accordingly, the invitation to make submissions was reissued to the applicant’s new email address on 4 June 2019. However, no submissions have been received from the applicant to date. I now consider it appropriate to bring this matter to conclusion by way of a formal, binding decision.
Following the reactivation of this review, the HPRA agreed to release the inspection dates in the reports requested. The question before me is whether the HPRA was justified in refusing to grant further access to the requested inspection reports and related correspondence with the named company for the period of January 2013 to January 2016.
Before setting out my findings, I should point out that while I am required by section 22(10) of the FOI Act to give reasons for my decisions, this is subject to the requirement of section 25(3) that I take all reasonable precautions to prevent disclosure of information contained in an exempt record or matter that, if it were included in a record, would cause the record to be exempt. This constraint means that, in the present case, the extent of the reasons that I can give is limited.
I also wish to explain the approach of this Office to the granting of access to parts of records. Section 18 of the FOI Act provides for the deletion of exempt information and the granting of access to a copy of a record with such exempt information removed. This should be done where it is practicable to do so and where the copy of the record thus created would not be misleading. However, this Office takes that the provisions of section 18 do not 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, this Office is 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.
As noted in the decision made in Case 160089, the HPRA’s functions in relation to facilities that use animals for scientific or educational purposes are governed by EU-based Regulations, namely, the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012 (SI 543/2012). These Regulations were adopted to give effect to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Regulation 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 (Regulation 73). The Regulations grant extensive powers to the HPRA to enable it to carry out its functions (Regulation 72), and create a number of relevant criminal offences, including obstructing or interfering with the HPRA in the performance of its functions (Regulation 84).
However, prior to the High Court appeal in Case 160089, it was not highlighted by the HPRA that the Regulations also include provisions for the protection of confidential information. Specifically, Regulation 70 requires the HPRA to take "all necessary steps to ensure that intellectual property and confidential information, including commercially sensitive information, communicated pursuant to these Regulations is protected". Under Regulation 33, the HPRA must publish non-technical project summaries of authorised projects but “[s]ubject to safeguarding intellectual property and confidential information”. These provisions are evidently intended to serve the purpose of the Directive as set out in Recital 41, which states:
“To ensure that the public is informed, it is important that objective information concerning projects using live animals is made publicly available. This should not violate proprietary rights or expose confidential information. Therefore, users should provide anonymous non-technical summaries of those projects, which Member States should publish. The published details should not breach the anonymity of the users.”
Other references to safeguarding intellectual property and confidential information are found at Article 38(4) and Article 43(1) of the Directive. In addition, Regulation 84(2) provides that a person who discloses any confidential information to which he or she has access by virtue of the Regulations, otherwise than in accordance with the Regulations, is guilty of an offence.
The HPRA no longer seeks to rely on section 29 of the FOI Act, but it claims that sections 30(1)(a), 32(1)(b), 35(1)(a), 35(1)(b), 36(1), and 37(1) apply to the records at issue. Having regard to the Regulations, the submissions, the contents of the records at issue, I find that section 30(1)(a) of the FOI Act is the most relevant exemption to consider in this case. Section 30(1)(a) provides that an FOI body may refuse access to a record if it considers that 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. Where an FOI body relies on section 30(1)(a), it should 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. To establish the reasonableness of the decision, it is necessary for the FOI body to explain how and why it believes release of the particular records at issue will give rise to the harm envisaged. Section 30(1) is subject to a public interest test under section 30(2).
In its submissions, the HPRA states that it is primarily concerned with the protection of animals used for scientific purposes on the one hand and the protection of individuals and establishments involved in the use of animals for scientific purposes on the other. It highlights the intimidating atmosphere in which the staff of research establishments using animals for scientific purposes operate because of the threatening behaviour of certain animal rights activists. The HPRA also emphasises that Scientific Animal Protection (SAP) inspections are distinguishable from other public body inspections. It states:
“The central tenet of the inspection process is to protect the welfare of animals used in research. These animals are all owned by the research establishments. The animals obviously cannot communicate and there is no third party outside of the animal facility to speak up for the animals (in contrast to the situation in nursing homes, crèches, hospitals, schools etc. where relatives can act as a voice for patients/young children). Therefore, if we are to continue to ensure that animal welfare is best protected, it is critical that the HPRA can operate in an environment of openness and transparency.”
The HPRA explains that it therefore has worked closely with research establishments to develop an open and positive relationship in line with the guidance provided by the European Commission on inspections and enforcement under Directive 2010/63/EU. The guidance document, entitled “Caring for animals: aiming for better science” encourages a “culture of care” within the establishments and promotes openness and transparency between ‘inspectorate’ and establishments. According to the HPRA, its approach has resulted in a “culture of voluntary cooperation” and thus a very high level of self-reporting of non-compliances, with a rate of 41% being achieved in 2017.
The HPRA states, however, that all non-compliances, including self-reported non-compliances, are recorded in its inspection reports as observational findings, because this facilitates an environment of openness. Self-reporting can also lead to targeted inspections in areas where problems may be perceived. As targeted inspections are a “vital component in raising the standard of animal welfare”, the HPRA considers that “there is a direct link between the records being requested and the effectiveness of [its] inspections (audits)”.
The HPRA argues that a critical part of this environment of openness is the “absolute understanding that these findings will be kept confidential”. It explains:
“Unfortunately, issues can and do arise with animals in research. With self-disclosure and open inspections, the HPRA can focus its inspection on critical areas, can make recommendations for improvement and follow up at subsequent inspections. It is the absolute belief of our veterinary inspectors that damaging that openness through disclosure will negatively impact on animal welfare and their ability to carry out effective and constructive investigations, inquiries or audits.”
Moreover, it is the HPRA’s position that its findings, including its observational findings, are “reflective of the co-operation and the open and transparent relationship where those inspected can speak freely on the basis that the discussions and findings are confidential”. The HPRA also argues that any information, including references to species other than rodents, that could lead to the identification of personnel or establishments is likewise entitled to confidentiality
As a related matter, the HPRA notes that the role of inspectors is also to advise on opportunities for improvement. It says that, as identifying opportunities for improvement can be viewed as a criticism of the existing structures, disclosure of the inspection reports will prejudice its ability to have constructive, open discussions around opportunities for improvement, which in turn will impact on its ability to ensure the best possible outcome for animal welfare.
The HPRA has supported its submissions with submissions from a number of the research establishments that it regulates. The supporting submissions are anonymised but I note that the company named in the applicant’s request objected to the disclosure of information affecting its interests in Case 160089 on numerous grounds, including confidentiality and commercial sensitivity. The HPRA also notes that the objective of its inspections must be considered by having regard to the legislative intention of the Regulations and the Directive, including Recital 41. In addition, it notes that the Commission’s guidance document defines a good and effective inspection programme as follows:
“A good and effective inspection programme is one which provides positive support to establishments, encouraging compliance and preventing non-compliance, and actively facilitating good practice and communication. It should report key findings relating to legislative requirements to establishments and to the public, whilst maintaining confidentiality.”
The HPRA notes that it complies with the guidance on reporting key findings to the public through the annual statistical report that it publishes each year on animals used in Ireland under scientific animal protection legislation.
Thus, the HPRA argues that the circumstances of its inspections are distinguishable from those arising in Sheedy v Information Commissioner [2005] IESC 35, where the Supreme Court found that a mere assertion of an expectation of non-cooperation from teaching staff in the context of school reports was not sufficient evidence of prejudice, particularly in light of their statutory obligations to cooperate with the school inspectors. The HPRA states:
“Treating the effectiveness of the inspections as being limited solely to compliance with the Regulations is incorrect. The real concern for the HPRA and the third parties who made submissions is the impact the disclosure of the inspection reports will have on the ability of the HPRA to perform its functions to protect animals used for scientific purposes and improve animal welfare over and above the baseline standards required by the legislation.”
The HPRA acknowledges that the establishments are required under the Regulations to comply with the inspection regime, but it argues that the level of cooperation will be significantly impacted upon if the inspection reports are released, because the voluntary cooperation that presently exists, and which enhances the welfare of the animals concerned, would reasonably be expected to cease. It explains:
“The protection of animals used for scientific purposes is best served by a system of voluntary cooperation, where the HPRA can guide and support research establishments to ‘do better’, operating within a framework of a statutory inspection scheme. This system has brought to light historical breaches of the Regulations which would not have come to light in the absence of openness and transparency between personnel in the breeder/supplier/user establishments and HPRA inspectors. These disclosures were not a requirement of the Regulations but were notified because there is an understanding that information documented will be treated as confidential. This level of voluntary cooperation is what ensures that the objective of the legislation is fulfilled and that animal welfare is appropriately protected and enhanced.”
Examples of voluntary disclosure are provided in Appendix 2 of the HPRA submissions. In the circumstances, the HPRA maintains that the public interest favours the redaction of the inspection reports to avoid prejudicing the effectiveness of the inspection process.
I accept that the HPRA relies on confidentiality and voluntary cooperation to enhance the effectiveness of its animal welfare inspection regime. The Directive, the Regulations, and the Commission’s guidance document all refer to the need to maintain confidentiality. I note that neither the Directive nor the Regulations define the term “confidential information”, and I am not aware of any European case law addressing the meaning the term, or any other issues, in relation to Directive 2010/63/EU. However, in Mahon v. An Post Publications [2007] IESC 15, at para. 69, Fennelly J indicated that the "internal workings" of any individual or organisation may generally be entitled to confidentiality.
The use of animals in scientific research is indisputably a highly sensitive and emotive matter, so much so that a primary aim of Directive 2010/63/EC is to promote the principles of the “3Rs”: replacement, reduction, and refinement. The Directives states at Recital 10, however, that “[w]hile it is desirable to replace the use of live animals in procedures by other methods not entailing the use of live animals, the use of live animals continues to be necessary to protect human and animal health and the environment”. The continued use of live animals, in turn, generates much controversy, as discussed in Case 160089, to the extent that staff of such research establishments are subjected to intimidation and abuse.
As the HPRA’s submissions explain, it is in this context that the Commission’s guidance document encourages a culture of care within the research establishments and an open and positive relationship between the establishments and the ‘inspectorate’. I accept that the relationship is built on a general understanding of confidentiality and trust. I also accept that, if the HPRA were required to rely regularly on its enforcement powers to ensure compliance with the Regulations, it would undermine the positive and cooperative environment that it has developed, which in turn could reasonably be expected to result in a lower rate of self-reported incidents of non-compliance. It is also reasonable to expect that it would have a detrimental impact on the open lines of communication needed to identify and pursue opportunities for improvement. In the circumstances, I am satisfied that, subject to the public interest, section 30(1)(a) applies.
In applying section 30(2) of the FOI Act, I note that there is a strong public interest in openness and accountability in relation to the manner in which the HPRA carries out its regulatory functions in relation to the protection of animals used in scientific research. However, it would not serve the public interest if the effectiveness of the inspection regime were undermined. Moreover, there is a distinction to be drawn between information that may be of interest to the public in the sense that it may satisfy public curiosity and a true public interest for the purposes of the FOI Act.
I further note that, while the applicant referred in his internal review request to the release of inspection reports of other facilities such as nursing homes, crèches, and food outlets, the company named in the request is a private entity that does not provide services to the public. Rather, as the HPRA explained in its internal review decision, the company is involved in confidential, and highly controversial, scientific research. Nevertheless, in an effort to shed some light on its regulatory activities and compliance with the applicable legislation, the HPRA has made a limited amount of summary information about compliance issues relating to the company available in response to this request. It also granted partial access to the inspection reports and correspondence requested. In addition, as referenced above, the HPRA publishes annual statistical reports in addition to the summary information that it is required to publish under the Directive and the Regulations. I consider that this information serves the public interest in openness and accountability to a certain extent. I conclude that the public interest would not, on balance, be better served by granting access to further parts of the inspection reports and correspondence at issue. I am therefore satisfied that the HPRA’s decision in this case was justified on the basis that section 30(1)(a) applies.
For the sake of completeness, I wish to add that section 32(1)(b) is also very relevant in this case. Section 32(1)(b) provides that an FOI body may refuse to grant an FOI request if access to the record concerned could reasonably be expected to endanger the life or safety of any person. As indicated above, and in Case 160089, I accept that the staff of research establishments that use animals in scientific research are subjected to intimidation and abuse, including threats of violence. The request in this case is focused on a specific company and thus release would disclose further details of the inspections and related correspondence together with the identity of the company. I am satisfied that further access to the records sought could reasonably be expected to endanger the life or safety of the individuals working in the company and that section 32(1)(b) therefore applies. I consider it unnecessary for me to determine whether the other exemptions claimed by the HPRA may also apply.
Having carried out a review under section 34(2) of the FOI Act, I hereby affirm the decision of the HPRA in this case.
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