First-tier Tribunal (General Regulatory Chamber)

Neutral citation number: [2025] UKFTT 355 (GRC)

Case Reference: FT/EA/2024/0300

First-tier Tribunal

(General Regulatory Chamber)

Information Rights

Decided in the absence of the parties

Heard on: 2 March 2025

Decision given on: 12 May 2025

Before

DISTRICT JUDGE WATKIN

MEMBER SAUNDERS

MEMBER SHAW

Between

 

PETER JOHN SELLEY

Appellant

and

 

THE INFORMATION COMMISSIONER (1)

Respodent

Representation:

For the Appellant: In person

For the Respondent: No attendance

 

Decision: The Appeal is allowed.

 

Substituted Decision Notice:

1.             The Health Research Authority must:

a.      serve this Substituted Decision Notice on Moderna by 4pm on 26 May 2025.

b.      disclose the following documents relating to the NextCOVE trial to the Appellant by 5pm on 10 July 2025:

i.      The Trial Protocol.

ii.    Investigator's Brochure - mRNA 1273 version 8.0 21 December 2021.

REASONS

The following terms are abbreviated:
The Data Protection Act 2018	DPA
The Freedom of Information Act 2000	FOIA
The Information Commissioner	IC
Research Ethics Committee	REC

Where this decision refers to section numbers, the reference is to sections within FOIA.

 

DOCUMENTS

1.              Prior to the hearing, the Tribunal was provided with a 393-page open bundle and a 227-page closed bundle.

2.              The Appellant has also provided a Skeleton Argument and a document entitled "Closed Bundle comments" and an "Agreed Facts" document. The latter document is a response to agreed facts contained within the Response of the IC (page A38).

3.              Any references to page numbers within this decision are to page numbers within the open bundle.

 

BACKGROUND

4.              The Tribunal has considered the appeal (the "Appeal"), by Mr Peter John Selley (the "Appellant ") dated 5 August 2024 which arises following a request for information (the "Request ") made to the Health Research Authority ("HRA") on 3 December 2023 (page 51).

5.              The Request was for the disclosure of information relating to the NextCOVE trial. The information requested was for:

"1.       The date the sponsor submitted their request for approval of this trial.

2.              Information relating to safety studies of the investigational product in animals, including non-human primates, provided by the sponsor to the REC prior to approval having been granted.

3.              The Trial Protocol, including any specified Adverse Events of Special Interest. (AESI).

4.              Details of any modifications to the trial protocol specified by the REC prior to approval.

5.              The Investigator's Brochure."

6.              The HRA provided a response in a letter dated 11 December 2023 ("the Response ") (page 52) disclosing some information but withholding the remaining information under section 43(1) and (2). Within the Response, the HRA confirmed:

a.              the date the sponsor submitted their request for approval of the trial was 31 March 2023 - thereby responding to point 1 of the Request.

b.             the protocol contains detailed and specific information regarding product development plans, including unpublished elements of the study design and regulatory strategy that are not publicly available and have significant commercial value. The HRA stated that the information relates to a Moderna trade secret and was commercially sensitive.

c.              no change requests were made by the REC in relation to the trial protocol during the approval process - thereby responding to point 4 of the Request.

d.             there were two Investigator's Brochures, mRNA - 1273 (21 December 2021) and mRNA - 1283 (21 February 2023).

e.              the Investigator's Brochures contain information relating to a proprietary candidate vaccine with modifications that are trade secret and not in the public domain.

f.               the HRA refused disclosure of the protocol and the Investigator's Brochures pursuant to section 43(1) and (2).

g.             the HRA considered the public interest test in respect of the protocol and the Investigator's Brochures and acknowledged that there was public interest, and that disclosure could enhance public understanding but that as release of the information would prejudice Moderna's ability to participate competitively and cause harm to their commercial interests, the exemptions should be upheld.

h.             the HRA also set out that it does not usually disclose Investigator's Brochures as it is recognised that these documents typically contain information relating to trade secrets and of a commercially sensitive nature but that the HRA will consider requests on a "case by case" basis.

7.              The Appellant requested an internal review. The HRA responded on 12 January 2024, maintaining its position.

8.              A complaint was submitted to the IC on 2 February 2024. The IC carried out an investigation as part of the investigation, requesting that the HRA provide a copy of the withheld information clearly marked to show where section 43(1) and (2) are applied together with details of why disclosure of the information would harm the commercial interests of the HRA/a third party. In its response dated 13 May 2024, the HRA declined to answer, stating only that the information had been previously provided for the purposes of an earlier complaint. The HRA has not provided that information to the Tribunal for the purposes of the Appeal.

9.              The IC provided a decision notice (the "Decision Notice") dated 26 July 2024 (page 5). upholding the decisions of the HRA. The Decision Notice referred to an earlier decision of the IC (the "Previous Decision") in which the same information had been withheld under section 43(2).

 

Procedural Matters

10.          Initial Case Management Directions (the "Directions ") were provided by the Tribunal on 14 August 2024 and sent to the parties and the HRA. By the Directions, the Tribunal invited any third party to indicate whether they wished to take part in the Appeal. On 21 August 2024, a response was received from the HRA indicating that they did not wish to take part in the Appeal. It is not known whether Moderna is aware of the proceedings or was provided with a copy of the Directions. However, it did not request to be made a party.

11.          On 9 January 2025, following an application made by the Appellant in form GRC5, the Tribunal ordered that:

"7.       The Health Research Authority is, in so far as it is able, to provide submissions by no later than 27 January 2025 to the following:

i       clarifying the grounds for not disclosing the second item of the Appellants FOI request for "information relating to safety studies of the investigational product in animals, including non human primates, provided by the response are to the R. AC prior to approval having been granted"."

12.          A response to the above was received from the HRA on 24 January 2025 stating:

"The information relating to safety studies of the investigational product in animals is detailed within the protocol."

13.          Therefore, point 2 of the Request does not need to be separately considered and the Tribunal is only required to consider points 3 and 5 of the Request, the other requests having been dealt with.

THE RELEVANT LAW

Jurisdiction

14.          The Tribunal's jurisdiction is set out at section 58(1) which provides that the Tribunal shall allow the appeal or substitute such other notice as could have been served by the IC, and in any other case the Tribunal shall dismiss the appeal where the Tribunal considers that the notice is not in accordance with the law or that the Commissioner should have exercised his discretion differently.

15.          Section 58(2) gives the Tribunal power to review any finding of fact on which the notice was based.

 

Freedom of Information

16.          Section 1

"(1)   Any person making a request for information to a public authority is entitled—

(a)     to be informed in writing by the public authority whether it holds information of the description specified in the request, and

(b)     if that is the case, to have that information communicated to him."

 

17.          Section 1(4) provides that "the information ...is the information in question held at the time the request is received, except that account may be taken of any amendment or deletion made between that time and the time when the information is to be communicated under subsection (1)(b), being an amendment or deletion that would have been made regardless of the receipt of the request."

 

The Exemptions

18.          Section 2(2) provides that the public authority is not obliged to provide the information as required by section 1(1) where:

a.              an absolute exemption applies (as listed in section 2(3)); or

b.             one of the exemptions set out in Part II (and not listed in section 2(3)) applies and the public interest in maintaining the exemption outweighs the public interest in disclosing the information.

 

19.          The exemption at section 43 is relevant to this Appeal. It is not an absolute exemption and, therefore, the public interest test applies.

 

Commercial Interests

20.          Section 43 provides:

"(1)   Information is exempt information if it constitutes a trade secret.

(2)     Information is exempt information if its disclosure under this Act would, or would be likely to, prejudice the commercial interests of any person (including the public authority holding it).

(3)     The duty to confirm or deny does not arise if, or to the extent that, compliance with section 1(1)(a) would, or would be likely to, prejudice the interests mentioned in subsection (2)."

 

The Public Interest Test

21.          The public interest test is to be carried out on the date that the request for information is decided (Montague v IC and DIT [2022] UKUT 104 (AAC) at [47]-[90]).

22.          In O'Hanlon v IC [2019] UKUT 34 (AAC) at [15], the Upper Tribunal considered:

"The first step is to identify the values, policies and so on that give the public interests their significance. The second step is to decide which public interest is the more significant. In some cases, it may involve a judgment between the competing interests. In other cases, the circumstances of the case may (a) reduce or eliminate the value or policy in one of the interests or (b) enhance that value or policy in the other. The third step is for the tribunal to set out its analysis and explain why it struck the balance as it did".

23.          The Tribunal will weigh up the actual harm that the proposed disclosure may cause with the potential benefits of its disclosure APPGER v IC [2013] UKUT 560 ("APPGER") at [74]-[76] and [146]-[152].  In doing so, the Tribunal will consider the content of the information and the possible consequences of disclosure or non-disclosure. 

 

THE HEARING

24.          The Appeal was considered at a hearing on 3 March 2025. The hearing was attended by the Appellant. The IC had previously indicated that he would not be in attendance.

 

The Appellant's Position

25.          At the hearing, the Appellant introduced himself as a retired medical doctor with an interest in safe prescribing.

26.          The Appellant confirmed that, in light of the HRA confirmation that the information in relation to the studies concerning animals was within the study protocol, that providing the Trial Protocol was provided, he did not separately require the item at point 2 of the Request.

27.          The Appellant indicated that he did not require disclosure of the second Investigator's Brochure (1283) as that document is likely to be largely the same as the earlier version. Therefore, he seeks disclosure of the trial protocol and Investigator's Brochure mRNA 1273 only.

28.          The Appellant explained that the trial protocol was essentially an instruction manual to be followed by the junior researchers implementing the trial and the Investigator's Brochure was the guidance for the medical professional overseeing the trial. He explained that the Trial Protocol is distributed widely to 200 research sites during the course of the trial.

29.          The Appellant relies on his Skeleton Argument and provided further submissions at the hearing. His submissions include the following:

a.              Moderna did not need to include any commercially sensitive information within the Trial Protocol. Therefore, it does not make commercial sense for it to do so and he does not accept that they have done so - particularly due to the risks arising from it being distributed to around 200 research sites. Whilst the researchers could be asked to sign confidentiality agreements, the Appellant considered that the commercial risk would be too great.

b.             Whilst it was more likely that commercially sensitive information was within the Investigator's Brochure than in the Trial Protocol, the Investigator's Brochure does not necessarily contained such information and it could have been redacted.

c.              Matters such as the dose, immunogenicity information, study design etc may be commercial information. However, the Appellant did not agree that the information was sensitive.

d.             Whilst some commercial information may be released within the documents sought, the Appellant considered that Moderna would never release enough within those documents to risk their commercial interest in the trial.

e.              The Appellant did not accept that commercially sensitive information would be scattered throughout the Trial Protocol. He stated that of this were the case, the document would be unusable by those seeking to follow the protocol.

f.               It was not appropriate for the IC to base its decision on the Previous Decision as different arguments are raised in each complaint. He does not accept that the IC had considered the decision of the European ombudsman in complaint 2560/2007/BEH or his submission that the Trial Protocol had been provided to 200 research sites as neither matter was previously put to the IC.

g.             The Appellant referred to a different protocol document and indicated that an amount of the information contained within the document will be references or matters that are already in the public domain.

h.             Trial Protocols are generally released within 12 months of the end of a clinical trial and that the present trial is due to end in around 2026.

i.               The public interest test should be considered from the perspective of a) concerns raised by the medical profession about the lack of access to clinical trial protocols and b) there is no need to include trade secrets or commercially sensitive information in a protocol. He suggests that it would be perverse for a third party to be able to obstruct the disclosure of a document that would otherwise be disclosable simply by including commercially sensitive information within it.

 

The IC's Position

30.          Within the Decision Notice, the IC's position was that Appellant's points had been put to the HRA and that its reasoning (as set out in the Previous Decision) had not changed. This is supported by the IC's Response (page A39) in which the IC indicates that the relevant exemption is at section 43(2). Therefore, he does not appear to be relying on section 43(1).

31.          The IC considers the meaning of the words "would, or would be likely to" and, in particular, quotes Munby J in R (Lord) v Secretary of State for the Home Department [2003] EWHC 2073 (Admin) at 100:

""likely"... a degree of probability where there is a very significant and weighty chance of prejudice to the identified public interests. The degree of risk must be such that there "may very well" be prejudice to those interests, even if the risk falls short of being more probable than not".

32.          Within the Decision Notice, the IC considered that, if redactions were made, they would cover most of the information and implied that the information would not make sense without it. However, no explanation of this was provided. Neither details of the commercially sensitive information nor the proposed redactions were provided to the Tribunal.

33.          It stated that the commercially sensitive information included:

a.              Detailed study dose information and immunogenicity information.

b.             Benefit assessment of the vaccine in comparison with other vaccines

c.              Detailed study design information including the scientific rationale for the study and the scientific justification for the dose.

34.          However, the IC does not set out the information, how it is commercially sensitive or what the consequences of disclosure would be. If there were too much commercially sensitive information within the documents, examples could have been provided, but this did not occur.

35.          The IC stated that the HRA did not disagree that commercially sensitive information did not need to be in a protocol but indicated that it was present. This appears to contradict the suggestion that the information could be redacted. The IC accepted that the HRA had acknowledged the importance of openness and transparency and considered that the public interest remained in maintaining the exemption. The HRA had referred to ability to reproduce the clinical trial as being a compelling argument for maintaining the exemption.

36.          The IC also noted that the HRA and Moderna had accepted that sharing the information with academics and the wider research community would be beneficial and would support understanding. However, disclosure to the public would also result in competitors of Moderna having access to the information and enable them to reproduce the study, giving the competitors an advantage and, thereby, impact on the commercial interests of Moderna as it would provide an insight into Moderna's development plans and impact on the commercial viability of the launch of a pipeline of future products.

37.          The IC concluded that the HRA had explained how the withheld information remained commercially sensitive and agreed that section 43(2) applied. The IC then referred to the public interest test that had previously been carried out in the earlier case.

38.          In the earlier complaint, the IC had noted that the complainant wanted to interrogate and challenge why the REC had thought it acceptable to include healthy children in the study and that the Investigator's Brochures and Study Protocol will have been key to the decision. The IC notes that the HRA accepted that there has been public interest due to children having been included as participants and that there has been safeguarding concerns raised which may be allayed by the production of the information.

39.          The IC also indicates that the HRA considers:

a.              The information about a new vaccine is a trade secret and commercially sensitive information is contained within the documents.

b.             The information is not in the public domain and is classed as confidential.

c.              The information contained within the requested documents contains specific, technical and commercially sensitive information which is unlikely to contribute to the public understanding.

d.             Disclosing the information would prejudice the third party in participating competitively in commercial activity.

e.              HRA needs sponsors to submit confidential information to enable it to carry out its regulatory function and that its functions could be impacted if disclosure is permitted.

40.          The IC accepts the HRA's assessment of the balancing exercise which is that the benefit of maintaining the exemption is not outweighed by the public interest in disclosure. However, the IC, in its Response of the IC quotes APPGER in relation to the approach to assessing whether prejudice has occurred:

"This...requires an appropriately detailed identification of proof, explanation, and examination of both (a) the harm or prejudice, an (be) benefits that the proposed disclosure of the relevant material in respect of which. The exemption is claimed would. (Or would be likely to Or may) cause or promote."

41.          However, no proof, explanation or examination of the harm or prejudice has been provided to the Tribunal. The IC says simply "the information is spread throughout the documents" and references some matters that could contain commercial information. It does not specify how any of the information contained within the withheld information could cause harm or prejudice if disclosed. The IC refers directly to the material within the closed bundle but not to the part of it that is considered commercially sensitive. It is not appropriate to expect the Tribunal to identify the parts that are commercially sensitive, the reasons why the information is so sensitive, how it will cause harm or whether sufficient information is contained for the harm to be caused without further evidence or submissions.

42.          In relation to public interest, the IC contends that the commercial interests of Moderna outweigh the public interests. However, he does not provide evidence of how the interests of Moderna could be damaged based on the information within the closed bundle alone. The IC contends that if further information is required, the HRA or Moderna should be joined to the appeal. The HRA was given the opportunity to be added as Respondent and declined and the HRA was asked to confirm that it had been contacted about the Request by the IC on 30 April 2024, in its letter of 13 May 2024, it declined to respond, stating that it had already done so.

DECISION OF THE TRIBUNAL

43.          The Tribunal has considered whether:

a.              disclosure of the information requested would, or would be likely to, prejudice the commercial interests of any person (including the public authority holding it); and

b.             the public interest in protecting the commercial interest outweighs the public interest in disclosure.

44.          The Tribunal is mindful of the matters raised by both parties. However, the starting point for the Tribunal is whether the disclosure would or would be likely to prejudice the commercial interests of any person.  The relevant "person", is Moderna.

45.          Whilst the Tribunal has been provided with an extensive closed bundle containing the withheld material which may contain commercial information relating to Moderna, it has not been directed to any part of the information that might cause prejudice if disclosed. Neither has any explanation been provided to set out how the commercial interests of Moderna would be damaged.

46.          It appears that the Tribunal is expected to unquestionably accept that the commercial interests of Moderna will be damaged if the information is released.

47.          Whilst the Tribunal notes that it is being told that the competitors of Moderna will take advantage if they have the information, no satisfactory explanation has been provided to set out how that could occur in circumstances where the information relates to a clinical trial that has already been ongoing for a significant period.

48.          Furthermore, the Tribunal is expected to accept, without question or further explanation, that Moderna, a large commercial pharmaceutical company, has included commercially sensitive information (which could cause it prejudice if disclosed) in a document that has been distributed to over 200 locations worldwide.

49.          The Tribunal is required to determine whether the Trial Protocol and Investigator's Brochure 1273 contains information that would prejudice the commercial interests of Moderna if disclosed. The Tribunal is unable to reach that conclusion for the following reasons:

a.              There was no need for commercially sensitive information to be included.

b.             The Tribunal doubts that Moderna would have included information that is likely to cause it prejudice in a document that was distributed to over 200 locations worldwide - particularly as the Tribunal is informed that it did not need to do so.

c.              The HRA has not referred the Tribunal to any specific content within the closed bundle that would cause (or be likely to cause) damage to the commercial interests of Moderna (or any other body or person) if it were to be disclosed and there is no content within the closed bundle that the Tribunal can say, without further assistance from the HRA or Moderna, would cause prejudice to Moderna if it were released.

50.          Furthermore, the Tribunal considers that, if the withheld information does contain commercially sensitive information which may cause prejudice to Moderna, it accepts the Appellant's contention that it cannot be spread throughout the document as that would prevent the Trial Protocol from being implemented by junior researchers who require access to the guidance contained within the document without having to trawl through other unnecessary information.

51.          The HRA has decided not to be a party within the proceedings and not to offer any further information or assistance to the Tribunal. Therefore, the Tribunal can only conclude that there is no more guidance that could be offered to the Tribunal by either the HRA to prove that there would be prejudice to either the HRA or Moderna if it were released.

52.          The Tribunal is conscious of the approach as set out by the Upper Tribunal in APPGER which specifically states that that the assessment of whether prejudice has occurred requires "proof, explanation and examination of .... the harm or prejudice". This has not been provided by the HRA despite it having had the opportunity to provide it, if it exists. Therefore, the Tribunal is not persuaded that prejudice would arise to the HRA or Moderna if the information was disclosed.

53.          As the Tribunal has concluded that it is not satisfied that the commercial interests of Moderna would be prejudiced if the requested information was disclosed, the Tribunal is not required to consider the public interest test. However, it is worth noting that the Appellant contends that if Moderna succeeds in avoiding disclosure as a result of having included commercial information with the Trial Protocol  (where it was not necessary for it to do so) and the Investigator's Brochure , this potentially creates a situation where any pharmaceutical company can avoid having to disclose otherwise disclosable documents simply by including unnecessary commercial information. It would not be in the public interest to allow such an approach to succeed and, if the Tribunal were to consider the public interest test, it would have regard to this potential outcome.

54.          For the reasons set out, the Tribunal, therefore, determines that it is appropriate for the Trial Protocol and the Investigator's Brochure to be disclosed.

APPEAL

If either party is dissatisfied with this decision, an application may be made to this Tribunal for permission to appeal to the Upper Tribunal, Administrative Appeals Chamber, against decisions of the First-tier Tribunal in Information Rights Cases (General Regulatory Chamber). Any such application must be received within 28 days after these reasons have been sent to the parties under Rule 42 of The Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009.

Judge R Watkin

Date : 25 March 2025