Whether the Department was justified in refusing access, under sections 30(1)(b) and 36(1)(b) of the FOI Act, to a number of records held in the email accounts of the Minister for Health, the Secretary General of the Department, or the Chief Medical Officer referring or relating to supplies of the AstraZeneca vaccine to Ireland, to cover the period 7 January 2021 to 31 January 2021

22 February 2022

Background

In a request dated 31 January 2021, the applicant sought access to any records held in the email accounts of the Minister for Health, the Secretary General of the Department, or the Chief Medical Officer referring or relating to supplies of the Astrazeneca vaccine to Ireland, to cover the period 7 January 2021 to 31 January 2021. As the Department failed to issue a decision on the request within the statutory time-frame, the applicant sought an internal review of the deemed refusal of his request.

As the Department also failed to issue an internal review decision within the required time-frame, the applicant sought a review by this Office of the deemed refusal of his request on 2 August 2021. Following correspondence with this Office, the Department issued its effective position on the request on 31 August 2021. It identified 20 records as falling within the scope of the request, of which it granted access to 10 and refused access to eight, under sections 30(1)(b) and 36(1)(b) of the FOI Act. Access to the remaining two records was refused on administrative grounds under section 15(1)(d) of the Act, on the grounds that they were already in the public domain. In addition, the Schedule of Records provided by the Department indicated that a small amount of personal information had been redacted from two of the released records. On 10 September 2021, the applicant informed this Office that he wanted the review to proceed.

During the review, AstraZeneca, a group of companies that includes AstraZeneca Pharmaceuticals (Ireland) DAC, was invited to make a submission on the release of the records at issue and it did so. 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 applicant’s comments in his application for review, to the submissions made by the Department in support of its decision, and to the submissions of AstraZeneca. I have also had regard to the contents of the records concerned.  I have decided to conclude this review by way of a formal, binding decision. In referring to the records at issue, I have adopted the numbering system used by the Department in the Schedule of Records it prepared when notifying the applicant of its effective position on the request.

Scope of Review

In correspondence with this Office, the applicant confirmed that he was happy to consider the administrative refusal of Records 5 and 6 under section 15(1)(d) of the Act, and the redaction of certain personal information from Records 10 and 14, as outside of the scope of the review. Accordingly, those aspects of the Department’s decision will not form part of this review.

In addition, in its submissions to this Office the Department indicated that, in light of the passage of time since its decision on the request, Record 12 was suitable for release subject to the redaction of personal information contained therein. Subsequently, the Department confirmed the release of the record to the applicant. As such, Record 12 is now outside the scope of this review.

Accordingly, this review is solely concerned with whether the Department was justified in withholding records 1, 2, 3, 7, 8, 9, and 11 under sections 36(1)(b) and 30(1)(b) of the Act.

Preliminary Matter

As I have indicated above, this review is not concerned with the redactions the Department made to Records 10, 12, or 14. Nevertheless, I fail to see how the Department can reasonably argue that the official email addresses or telephone contact numbers of staff members of FOI bodies, or of individuals who hold or held any other office or position remunerated from public funds in an FOI body, comprises personal information having regard to the definition set out in the Act and the accompanying exclusions.

Analysis and Findings

Section 36(1)(b)

Section 36(1)(b) provides that an FOI body shall refuse to grant an FOI request if the record concerned contains financial, commercial, scientific or technical or other information whose disclosure could reasonably be expected to result in a material financial loss or gain to the person to whom the information relates, or could prejudice the competitive position of that person in the conduct of his or her profession or business or otherwise in his or her occupation. 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 subsection (1)(b) of section 36 is whether disclosure of the information “could reasonably be expected to result in material financial 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 nature of the harm envisaged and a basis for a claim that such harm could reasonably be expected to result from disclosure of the particular information in the record(s) at issue should be shown by an FOI body or a third party relying on this provision.

The harm test in the second part of subsection (1)(b) of section 36 is whether disclosure of the information “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 standard of proof necessary to meet this test is considerably lower than the standard required to meet the test of "could reasonably be expected to" in the first part of section 36(1)(b).  This notwithstanding, this Office has previously held that, in invoking the phrase "prejudice", the damage which could occur as a result of disclosure of the information must be specified with a reasonable degree of clarity. In the High Court case of Westwood Club v The Information Commissioner [2014] IEHC 375, Cross J held that the explanation, as finally given by the FOI body to the Commissioner, did little more than repeat the requirements of what is now section 36(1)(b) and referred to the nature of the documents held. Cross J stated:

“It does not in any sense engage with the proper question ... as to why these particular documents, if disclosed, could prejudice the financial position.... In particular, the point properly made ... as to the antiquity of the documents was not dealt with at all by the email [from the FOI body]”.

The High Court decision in Westwood Club makes it clear that it is not sufficient for the party relying on section 36(1)(b) to merely restate the provisions of the section, list the documents and say that they are commercially sensitive. The FOI body or the third party opposing release should explain why disclosure of the particular records could prejudice the competitive position of the third party.

In considering the applicability of section 36(1)(b) to records that FOI bodies have sought to withhold, this Office has previously held that that factors such as the availability or otherwise of the information and whether it is in the public domain; the passage of time; and the broader context and rate of change in the relevant industry are elements that may be taken into account.

In his application to this Office, the applicant argued that section 36(1)(b) should not apply to the records given the passage of time and the fact that the AstraZeneca vaccine no longer formed a significant part of Ireland's vaccination programme.

In its submissions to this Office, the Department argued that the release of the records at issue could reasonably be expected to result in a material financial loss or gain as they related to discussions on contractual obligations that were subject to a confidentiality agreement, and that there would be an adverse impact on both the Department and the company concerned. In particular, the Department argued that the records contain commercially sensitive information relating to a private company. It stated that the records contain discussion of factors effecting delivery including identification of manufacturing sites experiencing difficulties, supply chains and commentary on non-performance of contractual obligations. The Department argued that Ireland had procured vaccine supplies from AstraZeneca via the European procurement mechanism, and was also party to the legal case between the Commission and AstraZeneca that was settled in early September 2021 after the decision was made in relation to this FOI request. It stated that this long running dispute involved the very matters discussed in the records, and as a result it was essential that their release was refused.

The Department argued that Ireland had ongoing obligations with AstraZeneca to procure COVID-19 vaccines, and that it was vital that this commercial relationship was not damaged through the release of these records. The Department stated that it was further satisfied that the release of the records would damage the company and impact its competitive position through the disclosure of commercially sensitive material.

The Department further stated that it had weighed up the public interest factors at play, and had considered the right of the public to have access to information and the need for an open and accountable civil service. It stated that it had concluded that the public interest was best served through the refusal to release the records. It stated that Ireland’s commercial relationship with the vaccine manufacturer was vital to ensuring surplus vaccines can be equitably distributed to those who need them in developing countries where the manufacturer’s assistance was important due to the significant level of logistical and technical support needed, as evidenced in Ireland’s recent donation of AstraZeneca vaccines to Uganda.

Having considered the Department’s submission, it is not clear to me why the Department contends that the harms it has identified might arise as a result of the disclosure of the particular information contained in the records. It has not identified or specified the particular material that is contained in the records whose release it considers might give rise to hose harms. Rather, it seems to me that the Department has sought to apply the exemption in section 36(1)(b) to records as a whole, without analysis of the particular information contained therein. I do not consider that such an argument is sustainable under section 36(1).

I note that the most recent record of those withheld was created on 29 January 2021. In other words, the records at issue are now over a year old. It is clear that the situation with regard to the AstraZeneca vaccine has moved on considerably in the intervening twelve months. It is of particular relevance that the issues regarding the supply difficulties of the AstraZeneca vaccine across the EU, and the legal action taken by the European Commission against AstraZeneca, are in the public domain and were covered at some length by contemporary media reports. It is also of note that the legal dispute between the Commission and AstraZeneca has since been settled.

I note in addition that the Department did not make any arguments in relation to the level of detail which the records contain in relation to information that might be commercially sensitive. Again, it is not sufficient for the purposes of section 36(1)(b) for an FOI body to simply state that it is the case that the prejudice it has identified would follow from the release of the records sought. Noting again that the Department has not tied its arguments in relation to section 36(1) to the specific information contained within the records, it is not evident from its submissions how it considers that the release of the particular information contained therein would prejudice either its own competitive position or that of the company.

AstraZeneca’s submissions

In its submissions, AstraZeneca provided copies of the records marked with redactions that it considered it appropriate to make before any of the records were released. It referred to the material that it proposed for redaction as “Astrazeneca Confidential Information”, and characterised this information as:

1. Forecast supply information, which it stated was competitively sensitive as it related to AstraZeneca’s manufacturing capacity and progress in relation to the vaccine. AstraZeneca argued that the release of this information would increase the risk that third parties may improperly access and acquire this and other information about its manufacturing capacity and programs. This, it stated, would be both damaging to AstraZeneca’s business and to the wider interest of promoting competition among manufacturers.
2. Information identifying AstraZeneca’s key supply partner for Europe and a specific description of the problems faced by that supply partner and the related impact on batch production for AstraZeneca’s COVID-19 vaccine. AstraZeneca argued that this was competitively sensitive and valuable information, the public release of which would increase the risk that third parties may improperly access and acquire this and other information about the AstraZeneca’s manufacturing supply chain and capacity. It argued that this was both damaging to AstraZeneca’s business and to the wider interest of promoting competition among manufacturers. Moreover, it stated that it had an on-going business relationship with this supplier to fulfil its wider supply obligations in Europe, and that the disclosure of this information at the current time would be potentially damaging to that contract. Further, AstraZeneca stated that it was public knowledge that one of its competitors had signed a letter of intent to use this supplier for its future supply chain, which according to AstraZeneca underscored the broader competitive sensitivity of this information and the likelihood it would be of value to one of its business competitors.

AstraZeneca further indicated that it considered the information contained in the records to be private, and reasonably believed that the Department would maintain the privacy of confidential information pertaining to AstraZeneca. It stated that it had not previously released or published any of the information in the records, and that this information had been distributed internally at AstraZeneca on a need to know basis and under an expectation of confidentiality. It stated that the relevant information had not been provided to third parties absent appropriate confidentiality measures.

I have noted the redactions that AstraZeneca has proposed should be made in advance of any release of records. In particular, I note that many of the redactions it proposes relate to supply issues with the AstraZeneca vaccine. Again, it must be noted that these issues are now a matter of historical record, occurring over twelve months ago and receiving significant coverage at the time. I cannot see how the release of the material proposed for redaction by AstraZeneca – at a remove of over twelve months from the period when matters relating to the supply of the AstraZeneca vaccine were live issues – could prejudice its competitive position today, especially in circumstances where the issues are largely in the public domain. In addition, certain other redactions that AstraZeneca has proposed relate to information that, according to AstraZeneca, identified its supply partner and related manufacturing problems. However, I consider again that this information – specifically the identify of AstraZeneca’s supply partner and associated manufacturing issues – is in the public domain, having received contemporaneous media coverage (for example, a report in biopharma-reporter.com from January 2021 both identifies the supply partner and references the issues relating to the supply of the vaccine).

I have examined the withheld records and considered the submissions made by the Department, the applicant and AstraZeneca, and cannot discern any information, over and above that which is already widely in the public domain, that would suggest that the release of the records could prejudice the competitive position of AstraZeneca at this point in time. On this basis, I find that the neither the Department nor AstraZeneca have shown how the release of the records could rise to the harms identified in the exemption, nor is it apparent to me as to how such harms might arise. In these circumstances, I do not consider that a case has been made for the applicability of the exemption provided for by section 36(1)(b) of the Act. I find, therefore, that section 36(1)(b) does not apply. Having so found, I am not required to consider the other provisions of section 36 to which section 36(1)(b) is subject.

Section 30(1)(b)

The Department also cited section 30(1)(b) of the Act as a basis for withholding each of Records 1, 2, 3, 7, 8, 9 and 11. Section 30(1)(b) provides that an FOI body may refuse to grant a request if it considers that access to the record concerned could reasonably be expected to have a significant, adverse effect on the performance by an FOI body of any of its functions relating to management (including industrial relations and management of its staff).

Section 30(1)(b) is a ‘harm based’ exemption, i.e. it applies where the granting of access to a record can reasonably be expected to cause a particular prejudice or harm. An FOI body seeking to rely on section 30(1)(b) of the Act must show how the harm anticipated could reasonably be expected to result from the release of the record(s). In particular, the body should identify the potential harm to the performance by an FOI body of any of its functions relating to management that might arise from disclosure and, having identified that harm, consider the reasonableness of any expectation that the harm will occur.

Furthermore, an FOI body seeking to rely on section 30(1)(b) of the Act should explain how and why, in its opinion, release of the record(s) could reasonably be expected to give rise to the harm envisaged. A claim for exemption under these provisions must be made on its merits and in light of the contents of each particular record concerned and the relevant facts and circumstances of the case. A claim for exemption pursuant to paragraph (b) which is class-based is not sustainable e.g. a claim for exemption for ‘any’ draft report.

When invoking section 30(1)(b), the FOI body must make an assessment of the degree of importance or significance attaching to the adverse effects claimed. Establishing "significant, adverse effect" requires stronger evidence of damage than, for example, "prejudice" (as per section 30(1)(a) of the Act). In other words, not only must the harm be reasonably expected, but it must also be expected that the harm will be of a significant nature.

The wording of section 30(1)(b) makes it clear that the words "industrial relations and management of its staff" are, in the context of that section, a subset of "functions relating to management". Other than the specific references to industrial relations and the management of staff, section 30(1)(b) does not indicate what other management functions are embraced by the term "functions relating to management". This Office has held that management is a word of wide import and that it is apt to cover a variety of activities of an FOI body apart from management of staff and industrial relations. In previous decisions, we have determined that the term “functions relating to management” covers such matters as strategic planning, the management of financial resources and the management of operational matters; management of operations, including reviewing how those operations are carried out, and devising and testing new methods of conducting the operations through the use of pilot projects; investigating complaints against a body, members of its staff and parties under contract to it; and attending to complaints from or about members of staff.

It should be noted that the exemption provided for in section 30(1)(b) is subject to a ‘public interest override’, by virtue of section 30(2) of the Act. In other words, even where the requirements of section 30(1)(b) have been met, the exemption does not apply where the public interest would, on balance, be better served by granting access than by refusing to grant the request. Where section 30(1)(b) of the Act is being relied on for the refusal of a record, the body must go on to consider the public interest test provided for in section 30(2) in relation the record concerned.

In its submissions on the applicability of section 30(1)(b) of the Act, the Department argued that the release of the records would have a significant, adverse effect on its performance and its ability to carry out its functions. It argued that its ability to plan, organise and lead a vaccination programme in response to the COVID-19 pandemic would be significantly impacted. The Department stated that the procurement of COVID-19 vaccines from pharmaceutical companies and its ability to negotiate the purchase of vaccines would be affected by the release of commercially sensitive information contained in the records. Furthermore, the Department argued that the negotiations of the European vaccine steering board required a high degree of confidentially owing to their commercially sensitive nature (noting that participants were required to sign confidentially agreements), and stated that the disclosure of information obtained from these meetings would have a negative impact on the ongoing vaccination programme.

In respect of public interest considerations under section 30(1)(b), the Department stated that it had considered the right of the public to have access to information and the need for an open and accountable civil service, and that it was satisfied that on balance the public interest strongly favoured refusal rather than release of the records.

In relation to the question of whether the Department has identified “functions relating to management” for the purposes of section 30(1)(b), I find that, although it did not highlight a specific function (or functions) relating to management in its submissions, the planning, organising and rolling out of a vaccination programme can be said to fall within the scope of the term. As outlined above, “management” is a term of broad import that covers a wide variety of activities. In particular, I consider that the planning, organising and rolling out of a vaccination programme management falls within the ambit of strategic planning, the management of financial resources and the management of operational matters, such as to render it a management function for the purposes of section 30(1)(b).

In terms of a “significant, adverse effect” on these functions that would follow from the release of the records, in its submissions the Department outlined how disclosure of the records would harm its ability to procure and purchase COVID-19 vaccines. It tied this argument to its submissions relating to the further exemption it cited under section 36(1) of the FOI Act, relating to the release of commercially sensitive information.

I accept that the result as set out by the Department, should it occur, could potentially constitute a “significant, adverse effect” on its management functions in relation to strategic planning, the management of financial resources and the management of operational matters. However, as outlined above, a claim for exemption under section 30(1)(b) must be made on its merits and in light of the contents of each particular record concerned and the relevant facts and circumstances of the case, and a claim for exemption under section 30(1)(b) which is class-based is not sustainable. In the case at hand, I do not consider that the Department has made its case with reference to the contents of any of the specific records at issue, but instead appears to seek to exert a blanket exemption for all the records at issue on the basis of section 30(1)(b).

Moreover, I do not consider that the Department has demonstrated the basis on which it considers that the significant adverse effect it has identified can be reasonably expected to occur. It should be noted that the test in this regard is not concerned with the question of probabilities or possibilities. It is concerned with whether or not the decision maker's expectation is reasonable. It is sufficient for an FOI body seeking to assert an exemption under section 30(1)(b) to show that it expects an outcome and that its expectations are justifiable in the sense that there are adequate grounds for the expectations, and the body is not required to demonstrate that such an outcome will definitely occur. This being said, the FOI body should show how release of the record could reasonably be expected to cause the harm envisaged, i.e. it should show the link between granting access to the record concerned and the harm identified. It should do this by reference to the specific record being considered for release: what is it about the particular record or the particular information in the record which, if released, could reasonably be expected to cause the harm envisaged? An FOI body’s arguments in this regard should be sufficiently detailed to demonstrate that link, and a general prediction without any supporting evidence is not sufficient to satisfy the requirement that access to the record could reasonably be expected to result in the outcome envisaged. In this instance I find that the Department has asserted the existence of a potential significant adverse effect but has not tied this to the contents of any of the particular records at issue, or demonstrated how the contents of any of the particular records could reasonably be expected to result in the adverse outcome envisaged.

In specific relation to the Department’s argument that that the negotiations of the European vaccine steering board required a high degree of confidentially owing to their commercially sensitive nature, while I accept this statement, it is also the case that the information in the records that pertains to meetings of the European vaccine steering board meetings is now largely in the public domain.

On the basis of the above analysis, I find that the Department has not shown how the release of the records could reasonably be expected to give rise to the harm identified in the exemption, nor is it apparent to me as to how such harm might arise. In these circumstances, and in the absence of arguments based on the contents of each particular record, I do not consider that the Department has made out its case for the applicability of the exemption provided for by section 30(1)(b) of the Act.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby annul the decision of the Department. I find that it was not justified in refusing access, under sections 30(1)(b) and 36(1)(b) of the Act to refuse access to the seven records it withheld in response to the applicant’s request, and I direct the release of those seven records.

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 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