Decision
X & The Health Products Regulatory Authority
From Office of the Information Commissioner (OIC)
Case number: OIC-152966-S6C4N5
Published on
From Office of the Information Commissioner (OIC)
Case number: OIC-152966-S6C4N5
Published on
Whether the HPRA was justified in deciding to grant access to certain correspondence between the applicant and the HPRA in relation to applications for marketing authorisation approval for dimethyl fumarate products made by generic drug manufacturers.
13 April 2026
This review arises from a decision of the HPRA to grant partial access to certain correspondence pursuant to an FOI request to which section 38 of the FOI Act applies. Section 38 applies where, at some stage in the decision making process, the FOI body has formed the view that the records at issue qualify for exemption under one or more of the relevant exemptions in the FOI Act (i.e. sections 35, 36 and 37 - relating to information that is confidential, commercially sensitive, or third party personal information, respectively) but that the records should be released in the public interest. Where section 38 applies, the FOI body is required to notify an affected third party before making a final decision on whether or not the exemptions, otherwise found to apply, should be overridden in the public interest. The requester, or an affected third party, on receiving notice of the final decision of the FOI body, may apply directly to this Office for a review of that decision.
On 19 August 2024, the HPRA received an FOI request for the following records: “Any correspondence from (or on behalf of) the company trading as Biogen Netherlands B.V. (including but not limited to any parent, subsidiary, related company, agent or affiliate) (collectively “Biogen”) to the HPRA in relation to applications for marketing authorisation approval for dimethyl fumarate products made by generic drug manufacturers.” When processing the request, the HPRA formed the view that the release of the records could affect the interests of a third-party Biogen.
In a letter dated 2 September 2024, the HPRA notified Biogen’s Irish lawyers of the request and provided copies of the records at issue. It outlined its preliminary view that included in the records is material that appears to contain commercially sensitive information of Biogen, however in its view, on balance, the public interest would be better served by granting the requester this information than by refusing it. On 1 October 2024, Biogen’s lawyers made a submission to the HPRA saying it had no objection to release of five of the records identified but that it objected to release of records 1, 1a, 1b, 2 and 2a. It submitted that these records are exempt under section 35(1)(a) and 36(1)(b) of the FOI Act and that the public interest does not favour their release.
On 4 October 2024, the HPRA informed Biogen lawyers of its decision to part-grant access to the records. It explained that it had decided to withhold record 1(b) and part of record 1(a) having considered Biogen’s submissions. However, it said that in its view, the public interest would be better served by the release of the remaining correspondence. On 17 October 2024, Biogen’s lawyers sought a review by this Office of the HPRA’s decision. For the avoidance of doubt, references to communications with the applicant (Biogen) in this decision include communication with its lawyers.
In the course of the review, the HPRA, the applicant, and the requestor all provided submissions. As the HPRA’s submissions contained new material information, to ensure procedural fairness, the applicant and the requestor were notified of this information and both parties provided additional submissions.
In the particular circumstances of this case, I considered it appropriate to issue a draft of this decision to the parties prior to concluding matters. All three parties were informed that it was open to them to make a further submission on foot of my draft decision, but that any such submission should be confined to an additional point of fact, an error of fact or an error of law. The requestor did not provide further submissions. The applicant confirmed to this Office that it did not wish to provide further submissions. The HPRA did make further submissions seeking certain non-material clarifications in relation to the draft decision and this Office clarified those matters with the HPRA.
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 parties to date. I have also had regard to the contents of the records at issue and to the provisions of the FOI Act. I have decided to conclude this review by way of a formal, binding decision.
As outlined above, the applicant contends that records 1, 1(a) (the remaining part), 2 and 2a are exempt from release under sections 35(1)(a) and 36(1)(b) of the FOI Act. This review is concerned solely with whether the HPRA was justified in its decision to grant access in full or in part to these records having regard to sections 35(1)(a) and 36(1)(b) of the FOI Act. It is not concerned with the information the HPRA had already decided to redact from records 1 and 2 under section 37(1) as such information did not form part of the section 38 notification process.
It is important to note that under section 22(12)(a) of the FOI Act, a decision to grant a request to which section 38 applies shall be presumed to have been justified unless the person to whom the information relates shows to the satisfaction of the Commissioner that the decision was not justified. This means that the onus is on the applicant to satisfy this Office that the HPRA's decision to grant access in full or in part to the records at issue was not justified.
Although I am obliged to give reasons for my decision, section 25(3) of the FOI Act requires me to take all reasonable precautions in the course of a review to prevent disclosure of information contained in an exempt record. This means that the extent to which I can describe the contents of the records is limited.
The HPRA says the applicant owns the European marketing authorisation for Tecfidera, a medicine which treats multiple sclerosis. It says Tecfidera contains an active substance called dimethyl fumarate. It says on 5 May 2021, the General Court of the European Union issued a judgment in Case T611/18 Pharmaceutical Works Polpharma v EMA which addressed Tecfidera’s marketing authorisation and the right of generic drug companies to apply for authorisation of generic dimethyl fumarate products in the EU, in the context of Directive 2001/83. The HPRA says on foot of the General Court’s judgment and subsequent related events, the HPRA and national medicines agencies in other EU member states began to accept applications from generic drug companies, for the authorisation of generic versions of Tecfidera in accordance with Directive 2001/83. It says prior to the General Court judgment such applications would have been refused until a later time, on the basis that Tecfidera still had ‘data exclusivity’ under article 10 of Directive 2001/83.
The HPRA says in the time between the General Court judgment of 5 May 2021, and its invalidation by the CJEU’s appeal judgment of 16 March 2023, the applicant wrote to the HPRA. It says this correspondence was received on 12 May 2022 and includes records 1, 1a, 2 and 2a. The HPRA says the correspondence argues that Tecfidera was still entitled to exclusivity in the EU and that this had an impact on applications for generic dimethyl fumarate authorisations received by national competent authorities before its exclusivity ended. It says the correspondence also sets out the applicant’s disagreement with actions taken by the EMA’s Committee on Human Medicinal Products on foot of the General Court judgment.
Section 36(1) – Commercially Sensitive Information
The applicant argues that records 1, 1a, 2 and 2a should be withheld on the basis of sections 35(1)(a) and 36(1)(b) of the FOI Act. I will consider section 36 first. Section 36(1)(b) provides for the mandatory refusal of a request where the record sought 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 test in section 36(1)(b) of the FOI Act does not concern the nature of the information, but rather it takes account of the nature of the harm which might be occasioned by its release. The harm test in the first part of section 36(1)(b) is that disclosure “could reasonably be expected to result in material 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 records 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 section 36(1)(b) is that disclosure of the information "could prejudice the competitive position" of the person in the conduct of their business or profession. The standard of proof to be met here is considerably lower than the "could reasonably be expected" test in the first part of this exemption. However, this Office takes the view that, in invoking "prejudice", the damage that could occur must be specified with a reasonable degree of clarity.
The applicant argues that release of the information at issue will provide its proposed competitors with data which is not in the public domain and to which they would not normally have access through the regulator, with potential competitive prejudice to the applicant and their interests. The applicant says it is currently engaged in ongoing litigation at EU and national levels in order to protect and/or enforce its rights to regulatory data protection with respect to this product. It says this litigation concerns the information and arguments disclosed in the confidential records. The applicant acknowledges that the HPRA has agreed to redact some text in record 1a (which describes legal arguments). It submits these redactions do not fully protect the confidential and commercially sensitive information contained in the record, which has not been disclosed to date in the litigation.
The applicant says it disagrees with the HPRA that the information contained in records 1a and 2a state facts already in the public domain. It says records 1a and 2a contain a level of detail and specifics not contained in the publications the HPRA refers to in its decision. In these circumstances, the applicant submits that releasing the confidential records would prejudice its position in the ongoing litigation, e.g. by enabling the counter-parties in the litigation to prepare opposing positions with information that they do not have and/or enabling entities which are not parties to the litigation to be informed of its position which would give rise to the competitive prejudice to its interests.
The HPRA says that in response to the section 38 consultation, the applicant stated that the contents of record 1b had not been disclosed during ongoing litigation and could impact the outcome of this litigation. It says on this basis, it decided to refuse this record and a section of the letter in record 1a which described the arguments in record 1b. The HPRA says it did not consider that that the remainder of the information in record 1a, and records 1, 2 and 2a was submitted in confidence. It said it was also questionable that the information comprised commercially sensitive information, but if it did, the HPRA considered that the public interest lay in favour of its release in accordance with section 36(3).
The HPRA says the correspondence in question consists of arguments made to the CMDh against the early access of more affordable generic medicines to the market and of descriptions of decisions taken by the EMA’s Committee for Human Medicinal Products and disagreement with same. It says this information is broadly in the public domain, excluding the fact that Biogen wrote to the HPRA on 12 May 2022, which it understands is not in the public domain. It says the fact that Biogen made legal and regulatory arguments regarding Tecfidera to the CMDh and the CHMP after the General Court judgment referenced above is noted in documents published by the CMDh and CHMP respectively. It says the fact that Biogen appealed the General Court decision which impacted Tecfidera’s Global Marketing Authorisation, is a matter of public record. It says the CHMP’s conclusions on Biogen’s application for an additional year of marketing protection are in the public domain, as are the CHMP’s report on its re-examination of Tecfidera and the CHMP’s recommendations on MA applications for generic dimethyl fumarate products.
The applicant says it is not sufficient to argue that the information contained in the confidential records is “broadly in the public domain”. It says the fact that it may have made arguments to the CMDh and/or the CHMP is not the same as bringing the detail of those arguments into the public domain. It says the same argument applies in relation to the fact that the CHMP’s conclusions concerning its application for an additional year of marketing protection, and its report and its recommendations on generic MA applications are in the public domain. It says the contents of records 1a (remainder) and 2a disclose information beyond that contained in the CHMP conclusions, report and/or recommendations. It says record 1a comprises a precise formulation of its position in response to the relevant EU General Court decision and concerning the CHMP opinions, along with a summary of its legal position. It says this particular formulation of position is not in the public domain and is in fact confidential to and commercially sensitive of the applicant. The applicant says record 2a is a letter from its Irish lawyers dated 22 May 2022, and it discloses the letter from its Dutch lawyers and the appendix provided to the CMDh and what those communications concerned; it also discloses and summarises the key legal position of the applicant in respect of the legal protection to which its relevant product is entitled. It says this particular formulation of position is not in the public domain and remains confidential to and commercially sensitive of the applicant.
The applicant says since 2014 there have been multiple legal cases, and many of these cases are still pending, before both the European and national courts concerning the right to file and market protection for Tecfidera. It says since then, numerous document access requests have also been submitted and dealt with in which national and/or European institutions have been requested to disclose documents relating to Tecfidera's right to file and market protection. It says for example, record 1a has already been the subject of a request for disclosure addressed to the European Medicines Agency (“EMA”), which held that record. It says this request was closed by the EMA in 2024 and is registered as 'Tecfidera (dimethylfumarate)-ASK-114758-EMA'. It says it was consulted by the EMA on this request and objected to the disclosure of record 1a stating that the document related to court proceedings pending before the CJEU and that disclosure of the document pending those proceedings could undermine the integrity of those proceedings. It says the text of the EMA’s email says “We would like to inform you that EMA, following its assessment in accordance with Regulation (EC) No 1049/2001 has decided to refuse access to the requested document. In particular, EMA considers that the requested document comes under the protective scope of Article 4(2), second indent, of Regulation (EC) No 1049/2001, as it is linked to a case that is currently litigated before the General Court and to which Biogen is a party (Case T-256/23; the same considerations apply in respect of (the separate) Cases T257/23, T-258/23 and T-278/23). In addition, EMA did not identify at this stage any overriding public interest which would override the protection of the interest set out above and consequently justify disclosure of the requested document.”
The applicant says that after taking into account all the facts and circumstances, the EMA considered that its opposition to the disclosure of those documents was well founded. The applicant says the EMA thus refused to disclose Record 1a in its entirety on the grounds that this could damage the integrity of pending litigation. It said that as regards the cases cited by the EMA, that the EU General Court ruled on them on 24 September 2025, however these rulings are not yet irrevocable because the European Commission and Biogen can appeal against these rulings. The applicant says there are also lawsuits pending before the EU General Court from, among others, the same generic parties, in which they raise exactly the same legal questions about Tecfidera's right to file and market protection and, in that context, the correct interpretation of the judgments of the EU General Court and the CJEU and the Ad-Hoc opinion addressed by Biogen in record 1a. The applicant says its position is that the reasons put forward by the EMA against the disclosure of record 1a and which applies equally to Record 2a in this context are still valid and also preclude disclosure of those same documents by the HPRA. It says that as regards records 1 and 2, its position is that these records are inextricably linked to records 1a and 2a and cannot be disclosed separately from those records. The applicant says that in a recent decision, the Dutch Medicines Evaluation Board (the MEB) decided that record 1a and its annex (record 1b) cannot be disclosed in light of the EMA’s previous decision on the same documents and the pending EU litigation.
The requestor says the mere existence of litigation does not justify withholding the records under the FOI Act, particularly in circumstances where correspondence was voluntarily submitted by the applicant to a public regulator and concerns regulatory decisions that directly affect third parties. It says disclosure cannot reasonably be said to prejudice legal proceedings, especially when the records were not solicited by the HPRA and were submitted in the context of influencing public regulatory outcomes. The requestor submits that unsolicited regulatory correspondence concerning public regulatory decisions should be accessible to the applicants for generic market authorisation directly affected by the correspondence.
Record 1a is a letter from the applicant’s Dutch lawyers to the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh). Record 2(a) is a letter form the applicant’s Irish lawyers to the HPRA, it refers to record 1a. Record 1 is a cover email dated 12 May 2022 attaching record 1a. Record 2 is a cover email also dated 12 May 2022 attaching record 2a. Records 1 and 2 are single line cover emails that simply attach the substantive documents, they do not contain any financial, commercial, scientific or technical information. I am not satisfied that the records 1 and 2 are commercially sensitive.
The applicant says it is not sufficient for the HPRA to argue that the information contained in the confidential records is “broadly in the public domain”. It says the fact that it may have made arguments to the CMDh and/or the CHMP is not the same as bringing the detail of those arguments into the public domain. In my view, the HPRA has redacted the detail of arguments made by the applicant from the records. It redacted the precise legal issues identified by the applicant from record 1a. Moreover, it refused access to Record 1b, which contains a much more detailed account of the legal issues identified by the applicant.
It seems to me that the parts of record 1a that remain at issue contain, in essence, a summary of the events that have taken place to date. In my view, record 1a simply discloses the fact that Biogen disagrees with the opinions issued and asked the CMD(h) to examine the issues it has raised (which issues have been redacted by the HPRA). I note that the applicant did not appear to identify any specific information in the records that might cause any of the harms set out in section 36 apart from making general assertions. In my view, record 2a essentially summarises record 1a. I do not accept, therefore, that releasing records 1a and 2a could give competitors a deeper understanding of the applicant’s position or allow them identify weaknesses in their position which could be used in the ongoing litigation and which could prejudice the applicant’s competitive position. Accordingly, I am not satisfied that section 36(1)(b) applies to any of the information at issue.
I would add that even if I had found section 36(1)(b) to apply, I would be required to proceed to consider the public interest balancing test in section 36(3). For completeness, I will proceed to consider section 36(3) and the public interest test below.
Sections 36(3) – the Public Interest
Section 36(3) provides that section 36(1) does not apply if the public interest would, on balance, be better served by granting rather than by refusing the request. The public interest test involves a balancing exercise between the public interest served by granting the request and the public interest served by refusing it. The FOI body must carry out that balancing exercise, by weighing the competing interests at play in the particular circumstances of a request, and then explain the basis on which it has decided where the balance of the public interest lies.
In carrying out any review, this Office has regard to the general principles of openness and transparency set out in section 11(3) of the FOI Act. To summarise, section 11(3) recognises the need to enhance public scrutiny and accountability of government and public affairs, with particular regard to the activities and decision making of FOI bodies. However, it is important to note that inThe Minister for Communications, Energy and Natural Resources and the Information Commissioner & Ors [2020] IESC 57 (the Enet judgment), the Supreme Court found that a general principle of openness does not suffice to direct release of records in the public interest and “there must be a sufficiently specific, cogent and fact-based reason to tip the balance in favour of disclosure”. It also found that section 36(1) recognises that there is a public interest in the protection of commercial sensitivity, and this may be normally served by the operation of the exemption itself, which provides for the refusal of an FOI request. It stated that “… the scheme of the Act is to make the refusal of certain records mandatory, unless the public interest could, following an analysis of the contents, rationally be said to lead to the conclusion that disclosure of the records is in the public interest by reason of their contents.”
The applicant says there is a legitimate public interest in market authorisation holders being able to provide their commercial information and related legal arguments to a national regulator such as the HPRA and to organisations such as the CMDh without fear or expectation of this information being disclosed into the public domain and/or to their competitors. It says as per the Supreme Court decision in Enet, the FOI Act already caters for transparency and openness in its very existence; therefore, the HPRA needs to rely on more specific public interest reasons than openness, transparency and accountability in making a decision to release what are otherwise confidential and commercially sensitive records. It says any decision by the HPRA to, for example, refuse a generic applicant on the basis of the applicant’s rights would be contained in a separate record, e.g. a decision of the HPRA which would itself contain the reasons of the HPRA. It says this would satisfy the HPRA’s accountability and transparency obligations in terms of its decision-making, without having to breach the applicant’s confidentiality.
The requestor says there are specific, cogent and fact-based public interest reasons favouring the release of the records in this case. It says that a fundamental point is that the availability of generic medicines is itself in the public interest as it significantly reduces costs to both patients and the State. It says this was recognised by the Irish Government in 2013 with the introduction of compulsory generic medicines substitution through the Health (Pricing and Supply of Medical Goods) Act 2013. It says since then, medicines have become more cost-effective for both patients and the State through a combination of increased competition, price-reduction strategies and generic substitution. It says due to the importance of generic medicines to the public, it is crucial that the HPRA is transparent and accountable in the performance of its role as the regulatory body for medicines and the release of the records will contribute to this.
The HPRA says there is a public interest in release of the correspondence as it relates to the legal requirements for the entry of more affordable generic medicines to the EU market and to actions taken by the originator company disputing the timing of the entry of such medicines to the market.
It seems to me that the HPRA has sought to strike a balance in this case by withholding commercially sensitive information concerning the precise legal concerns that the applicant has identified whilst also striving to serve the relevant public interest factors in disclosure by release of the remaining information. I accept that there is a public interest in the availability of generic medicines. They are a safe alternative to brand-name medicines; however they are significantly cheaper. I accept that generic medicines help to lower costs for patients and the healthcare system which helps to make healthcare more affordable for the public and increases public access to medicines. I agree with the HPRA’s submission that there is a public interest in release of the correspondence at issue as it relates to the legal requirements for the entry of more affordable generic medicines to the EU market and to actions taken by the originator company disputing the timing of the entry of such medicines to the market. Therefore, even if I was satisfied that the records which the HPRA proposes to release contain commercially sensitive information to which section 36(1)(b) applies, I would find that section 36(3) serves to disapply section 36(1)(b) in this case.
Section 35(1)(a) – Information obtained in confidence
Section 35(1)(a) applies to a record containing information given to an FOI body in confidence. Four requirements must be satisfied for a record to be exempt under section 35(1)(a), as follows:
• the information was given to an FOI body in confidence;
• the information was given on the understanding that it would be treated by the FOI body as confidential;
• 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
• it is important to the body that such further similar information should continue to be given to the body.
In its submissions to this Office, the applicant says the information contained in records 1a and 2a is specific to the applicant and their product rather than relating to third parties or their products as such. It argues that in that sense, the information is no different to the other product-specific information held on the HPRA’s files concerning applications for marketing authorisations and the data which supports those applications, all of which information is normally treated as strictly confidential of the MA holder by the HPRA. It says release of that information will have a chilling effect on full disclosure by MA holders to a national regulator of information relevant to the maintenance of MA holder rights which they are entitled to provide to the regulator on a confidential basis in the same manner as data supporting an application for a marketing authorisation.
The applicant says it does not dispute that record 1a was shared with other Member States. However, it queries the HPRA’s reliance on this. It says the purpose of supplying the information in record 1a was to assist the HPRA and the CMDh by summarising recent developments and issues that its client considered relevant for the assessment of national marketing authorisations for generic copies of its client’s product Tecfidera (dimethyl fumarate) that were pending in various decentralised procedures. It says this information, similar to record 2a, is specific to the applicant and their product, and, as such, the applicant had an expectation that this information was provided to national regulators, such as the HPRA, on a confidential basis.
The requestor says the central purpose for its FOI request to the HPRA was to understand possible reasons for the delay in the marketing authorisation (MA) process. It says one such possible reason is a right holder trying to interfere with third party competitor marketing authorisation applications (MAAs). It says the records involve correspondence between the HPRA and Biogen in relation to the MA applications of third-party generics. It says the conduct of the HPRA in this regard is crucial to its role. It says as the body tasked with remit over MA approvals, it is essential that the HPRA is transparent and accountable to the public vis-à-vis the approval of medicines, including the factors it considers when making a decision whether to approve a medicine, and the role of third-party submissions to the HPRA in this process. It says this includes information as to why an MA might be delayed. The requestor argues that there can be no expectation by a right holder of providing information in confidence if, in providing said information, you are interfering with third party MAAs.
The HPRA says it does not agree with the applicant’s argument that the information is ‘no different to the other product specific information held on the HPRA’s files concerning applications for marketing authorisations and the data which supports those applications’. It says the correspondence did not relate to a Biogen application made to the HPRA. It says generic companies had dimethyl fumarate applications with the HPRA at this time, but the applicant did not. It says even if the correspondence did relate to a Biogen application, the HPRA does not consider cover emails or cover letters for applications to be confidential or commercially sensitive on a blanket basis, and the HPRA releases parts of applications that are not confidential or commercially sensitive.
The applicant says in their experience the HPRA treats all parts of an application for MA approval as confidential and does not release any records relating to an application under FOI. The applicant says it did not argue that the records are related to an application, but rather that they should be treated no differently to application-related records, in that they are in a similar category of intended confidential communications with the HPRA qua regulator. It argues that if application records are treated as confidential and commercially sensitive, then there is no reason why communications, which may be relevant to the HPRA’s treatment of such applications, should not also be confidential and commercially sensitive.
In determining whether the information was given in confidence and on the understanding that it would be treated as confidential a number of factors may be relevant, e.g. the expectations of the person giving the information to the FOI body; any statements or assurances given at the time the information was given; the purpose for which the information was sought or provided; the practice, procedure or policy of the FOI body with regard to such information generally. The applicant argues that the purpose of the correspondence was to assist the HPRA and the CMDh by summarising recent developments that it considered relevant for the assessment of national marketing authorisations for generic copies of its product Tecfidera. The HPRA has described the correspondence as actions taken by the originator company disputing the timing of the entry of generic medicines to the market. It seems in its view, the purpose of the applicant in providing this information to the HPRA was to protect its position in the market and to delay the entry of generic versions of its product Tecfidera into the market. In my view, it is not reasonable for the applicant to expect that unsolicited correspondence which it sent to the HPRA disputing the timing of the entry of competing generic medicines to the market would be treated as confidential.
A number of factors may be relevant in determining whether the giving of further similar information is likely to be prejudiced. For example, it may be in the interests of the supplier of the information to continue to give further similar information as they may stand to benefit in some way from providing the information. In this case, the applicant stands to benefit from providing this type of information to the HPRA as its purpose is to delay the entry of competitors into the market. As such, it is not apparent to me that the release of the information at issue in this case would prejudice the future supply of such information to the HPRA.
The fourth requirement which must be met in order for a record to be exempt under section 35(1)(a) is that it must be of importance to the FOI body that further similar information should continue to be given to the body. The nature of the information and its relevance to the exercise of the FOI body’s powers or the performance of FOI body’s functions are matters for consideration. The HPRA says it had not sought submissions from the applicant, it says the correspondence was unsolicited and it has not said that it is important for it to receive this type of correspondence in order for it to carry out its functions.
Accordingly, I am not satisfied that the four requirements for a record to be exempt under section 35(1)(a) are met in this case. I find therefore that section 35(1)(a) does not apply to the records at issue.
Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the HPRA’s decision. I find that the HPRA was justified in its decision to grant access in full or in part to the records at issue having regard to sections 35(1)(a) or 36(1)(b) of the FOI Act.
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