14 August 2018

Whether HIQA was justified in its decision under section 35(1)(a) of the FOI Act to refuse access to a submission file provided for the purposes of a health technology assessment

Background

The background to this review concerns HIQA's role in carrying out Health Technology Assessment's (HTA's). HTA's involve the collection and summary of information about a health technology, including clinical effectiveness, safety and cost-effectiveness. HIQA is a member of the European Network for Health Technology Assessments (EUnetHTA). In February 2016, HIQA was the lead author of a pilot assessment published by EUnetHTA in relation to the use of certain medical devices for the treatment of stroke. As part of this assessment, submissions were requested from Stryker Neurovascular who manufacture these devices.

On 21 July 2017, the applicant made an FOI request to HIQA for the following records which relate to this assessment: 

"1. All letters, faxes and emails between HIQA and personnel working therein and Stryker Neurovascular relating to mechanical thrombectomy for stroke and devices used in mechanical thrombectomy for stroke between 31 December 2009 and 21 July 2017.
2. All minutes of meetings, minutes of telephone conversations, memoranda and file notes between HIQA and personnel working therein and Stryker Neurovascular relating to mechanical thrombectomy for stroke and devices used in mechanical thrombectomy for stroke between 31 December 2009 and 21 July 2017.
3. A copy of the submission file submitted by Stryker Neurovascular as referred to in publication "Endovascular therapy using mechanical thrombectomy devices for acute ischaemic stroke" Version 1.4 February 2016, Pilot ID: WP5-SB-16 published by EUnetHTA as authored by HIQA."

On 31 August 2017, HIQA refused access the records requested at parts one and two of the applicant's request under section 15(1)(a) of the Act on the basis that these records do not exist. HIQA stated that, in accordance with EUnetHTA processes for pilot assessments, there was a coordinator appointed for this assessment and all communications with Stryker were carried out through the coordinator and not through HIQA. HIQA refused access to the submission file requested at part three of the applicant's request under section 35(1)(a) of the Act on the basis that the submission file was provided in confidence. On 19 September 2017, the applicant requested an internal review of HIQA's decision. On 13 October 2017, HIQA affirmed its original decision.

On 13 April 2018, the applicant applied to this Office for a review of HIQA's decision. Both the applicant and HIQA made submissions in the course of this review. HIQA also provided this Office with submissions from the EUnetHTA secretariat in support of its decision to refuse access to the submission file. Following a request from this Office, Stryker Neurovascular also provided submissions.

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 submissions of the parties, and to the provisions of the FOI Act 2014. 

Scope of Review

Having regard to the terms of the application for review, my review is concerned only with whether HIQA was justified in its decision under section 35(1)(a) of the FOI Act to refuse access to the submission file submitted by Stryker.

Preliminary Matters

Section 13(4) of the Act provides that, subject to the Act, in deciding whether to grant or refuse an FOI request, any reason that the requester gives for the request and any belief or opinion of the FOI body as to the reasons for the request shall be disregarded. Thus, while certain provisions of the Act implicitly render the motive of the requester relevant, as a general rule, the actual or perceived reasons for a request must be disregarded in deciding whether to grant or refuse an access request under the FOI Act.

Section 18(1) provides, that "if it is practicable to do so", records may be granted in part, by excluding the exempt material. Section 18 shall not apply if the copy of the record provided would be misleading. This Office takes the view 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.

Although I am obliged to give reasons for my decision, section 25(3) requires all reasonable precautions to be taken in 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 and the material that I can refer to in the analysis is limited.

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. 

Analysis and Findings

Section 35 - Information obtained in Confidence 
Section 35(1)(a) provides a mandatory exemption for records containing information given to an FOI body in confidence. Section 35(2) provides that section 35(1) does not generally apply where a record is prepared by a member of staff of an FOI body or a service provider, unless disclosure would constitute a breach of a duty of confidence which is owed to a person other than an FOI body, member of staff of an FOI body or a service provider. Section 35(3) provides that section 35(1)(a) does not apply where the public interest would, on balance, be better served by granting than by refusing to grant the FOI request.

In order for section 35(1)(a) to apply, it is necessary to show the following:

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

All four of these requirements must be satisfied in order for a record to be considered exempt from release under section 35(1)(a) of the Act.

Applicant-™s Submissions

The applicant states that in February 2016, HIQA authored a pilot assessment on the use of mechanical thrombectomy devices in the management of stroke. She states that this pilot assessment referred to the requested submission file. The applicant states that in January 2017, HIQA prepared a presentation report entitled "Health Technology Assessment of a national emergency endovascular service for mechanical thrombectomy in the management of ischaemic stroke". According to the applicant, this document constitutes a formal recommendation to the Minister for Health in relation to the safety and suitability of deploying these devices in the Irish Health service. However, the applicant claims that five years before HIQA made its formal recommendation to the Minister, one of these devices was deployed in an Irish Hospital. She argues that, in these circumstances, there is a public interest in release of the requested submission.

HIQA-™s Submissions
HIQA states that the requested submission file was provided by Stryker in confidence and on the understanding that it would be treated as confidential. It states that a fundamental part of a HTA is to request the manufacturer to make a submission using a standardised submission template. According to HIQA, manufacturers would modify their approach to these submissions if the submissions were to be published i.e. manufacturers would require the submissions to undergo reviews by their legal and their communication teams. HIQA states that although information marked as confidential may not be published in the assessment, it often provides very valuable context to the assessment. HIQA argues that publishing the manufacturer's submission without informing them that this is likely prior to submission would potentially diminish the quality and relevance of assessments.

EUnetHTA Submissions
In its submission, the EUnetHTA Secretariat states that Health Technology Assessments are at the core of any procedure that leads to decisions related to reimbursement of new medicinal products and thereby constitute the "relevant gatekeeper for access". The highest possible standard of quality in Health Technology Assessments can, it says, only be achieved by assessing the full set of available data sets. According to EUnetHTA, submission of "important and partly confidential data from industry" is relied upon and, without this, assessments would be delayed which in turn would mean significant delays for patient access to new therapies.

Stryker's Submissions
In its submissions, Stryker states that it does not wish the data submitted to the EUnetHTA to be released. It states that the submission contains confidential information; in particular, modules 2.3 and 4.5. Stryker states that it instructed on the cover page of the submission document that the information is "for administrative purposes only" in assisting the EUnetHTA pilot.

First and Second Requirements of section 35(1)(a)
The Commissioner's approach to the first two requirements of section 35(1)(a) is informed by the decision of the Supreme Court in  The Governors and Guardians of the Hospital for the Relief of Poor Lying-in Women v. The Information Commissioner [2011] IESC 26 (referred to as "the Rotunda case") Macken J. in her judgment in the Rotunda case stated that what is protected under section 26(1)(a) (now section 35(1)(a) of the 2014 Act) "stems from the circumstances in which the material is given, and not from the nature of the material itself". In response to queries about the expectations of and any statement or assurances given to or by the parties, HIQA provided this Office with email correspondence between Stryker and the pilot assessment team co-ordinator  outlining the circumstances in which the information was imparted and received.

While I cannot give details of the emails involved, I have examined them carefully and formed conclusions based on the context and the content of the exchanges. I accept that Stryker provided modules 1.4, 2.2, 2.3 and 4.5 of its submission in confidence and on the understanding that they would be treated as confidential. However, while there was an assurance that the submission file would not be distributed outside the team, Stryker was informed that any non-confidential information contained in its submission file may be published once the assessment is finalised and may therefore be accessed by the public. Stryker did not request that any other parts of its submission should be treated as confidential. I attach no significance to Stryker's reference to the information being for "administrative purposes only" since that has no bearing on the tests for confidentiality. It is clear that Stryker accepted that the remainder of its submission could be included in the published assessment and could be accessed by the public. I am not satisfied that Stryker provided the remainder of its submission in confidence and on the understanding that it would be treated as confidential.

Third and Fourth Requirements of section 35(1)(a)
As I have found that the first two requirements of section 35(1)(a) are met with respect to modules 1.4, 2.2, 2.3 and 4.5; I must now decide whether disclosure of this information would be likely to prejudice the giving to HIQA of further similar information from the same person or other persons and whether it is of importance to HIQA that further similar information should continue to be given to it.

It is in the interests of health technology companies to provide submissions in order to facilitate HTA's of their products. This is because, as stressed by EUnetHTA, HTA's are central to any procedure that leads to decisions related to reimbursement of new medicinal products. However, submissions are provided on a voluntary basis and I accept that if parts of a submission which are marked as "confidential" are released, it is likely that manufacturers would exclude similar information from future submissions. I also accept that it is of importance to HIQA to have a full set of available data when carrying out assessments.

I note that in this case, the assessment team requested further information in relation to modules 1.4, 2.2 and 2.3 of the submission. While this information was not included in the published assessment at Stryker's request, it was clearly of importance to the assessment team. I am satisfied that the third and fourth requirements of section 35(1)(a) are met with respect to modules 1.4, 2.2, 2.3 and 4.5. I have taken account of section 18 of the FOI Act as referred to earlier in this decision and I am satisfied that release of the submission with the redaction of these modules is practicable and would not result in a record which is misleading. I find that modules 1.4, 2.2, 2.3 and 4.5 are exempt from release on the basis of section 35(1)(a) of the Act
 subject to the provisions of section 35(2) and section 35(3) which I examine below.

Section 35(2) 
Section 35(2) provides that section 35(1) does not apply to a record which is prepared by an FOI body or a service provider to an FOI body. I am satisfied, that section 35(2) does not apply in this case.

Section 35(3) the Public Interest
Section 35(3) provides that section 35(1)(a) does not apply where the public interest would, on balance, be better served by granting than by refusing to grant the FOI request. In determining the public interest, the Commissioner has regard to the comments of the Supreme Court in the Rotunda case referred to above. In that case, Fennelly J. held that section 26(3) (now section 35(3)) did not apply where the reason for seeking access to a record was exclusively private. He found that the request in that case was made "by a private individual for a private purpose" and that it was not made in the public interest.

The Commissioner takes the view that both section 13(4) of the FOI Act and the Rotunda case stand for the principle that a requester's private interest in certain records cannot be construed into a public interest based on the requester's own motives for seeking access to the records. The Commissioner does not exclude the possibility that a private interest in making a request could be accompanied by a public interest in disclosure. He takes the view that, in the context of determining whether to grant a request in the public interest, the reasons given for the request may be considered only insofar as they reflect a true public interest i.e. insofar as the concerns raised in relation to the request may also be matters of general concern to the wider public.

In this case the concern raised by the applicant is that a medical device was deployed on a person known to her five years before HIQA made formal recommendations to the Minister as to its suitability for deployment in the Irish Health service. It seems to me, that the applicant has a private interest in making this request. Nevertheless, I accept that there is also a public interest in openness and accountability in relation to HIQA's role in carrying out HTA's. These assessments play an important role in decisions related to reimbursement of new medical products for deployment on members of the public.

The information in modules 1.4, 2.2, 2.3 and 4.5 concerns the characteristics of Stryker's stent retriever technology, its uses and details of sales figures. It seems to me that this information is more relevant to Stryker's operations as a private enterprise than HIQA's role as a statutory body carrying out health assessments. I consider that the public interest in openness and transparency is served by the fact the HIQA's pilot assessment was published in February 2016 and its HTA was published in January 2017. The public interest in openness and accountability is also served, to a certain extent, by the release of the remainder of Stryker's submission. I find that, on balance, the public interest would be better served by refusing access to modules 1.4, 2.2, 2.3 and 4.5 of Stryker's submission.

Academic Articles
I note that when Stryker provided its submission file it included seven academic articles. I considered whether these formed part of the "submission file" at all. While there is a doubt about whether the request and this review is confined to the submission file record only, on balance, I consider that I should deal with the articles given that there is a passing reference to them in the version of the submission file furnished by HIQA. It seems to me that as these records appear to be published articles, they would be exempt under section 15(2) as available to the public for purchase or inspection. I direct however that HIQA make available a list of the articles so that the applicant can identify them. This should also avoid any possible copyright issues.

Decision

Having carried out a review under section 22(2) of the Freedom of Information Act 2014, I vary HIQA's decision and direct it to release the submission and a list of the academic articles associated with it subject to the redaction of modules 1.4, 2.2, 2.3 and 4.5.

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.

Elizabeth Dolan
Senior Investigator