Whether the HPRA was justified in refusing access to certain parts of the Executive Summaries of Periodic Safety Update Reports (PSURs) relating to the drug Epilim

10 December 2020

Background

This review arises from a decision made by the HPRA on a request to which section 38 applied in part. The original request, dated 20 June 2019, sought all documentation relating to Sodium Valproate/Epilim. The request was subsequently refined and broken down into two parts, with Part 2 seeking all supporting documentation grounding the licensing of Epilim in this jurisdiction. Part 2 of the request was then further refined to exclude quality data and also data unrelated to product strengths of 500mg and 1000mg.

Most, but not all, of the records remaining within the ambit of Part 2 of the request were subject to the third party consultation procedure under section 38 of the FOI Act. Section 38 applies to requests which, apart from the required notification procedure, would fall to be granted in the public interest under section 35(3), 36(3), or 37(5)(a) of the FOI Act. The relevant exemptions relate to confidential information, commercially sensitive information, or personal information about third parties, respectively.

In a decision dated 4 March 2020, following consideration of the third party’s submissions, the HPRA granted Part 2 of the request in large part, but refused it in part on the basis of sections 35(1)(a), 36(1), and 37(1) of the FOI Act. On 19 March 2020, the applicant applied to this Office for a review of the HPRA’s decision to refuse the request in part.

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 application for review and her correspondence to this Office dated 24 September 2020. I have also had regard to the submissions made by the HPRA in support of its decision, and I have examined the records at issue. I note that, on 11 November 2020, the applicant was given an opportunity to comment on the HPRA’s updated position on the matter. To date, however, no further comments or other submissions have been received from the applicant. I have now decided to conclude the review by way of a formal, binding decision.

Scope of the Review

In her letter dated 24 September 2020, the applicant clarified that personal information may be excluded from the scope of the review. In preparing its response to this Office’s request for submissions, the HPRA agreed to release certain additional details that had previously been redacted, but it also identified additional records or parts thereof as “quality data”, or as unrelated to product strengths 500mg and 1000mg, which should have been treated as outside the scope of the request in the first instance. The HPRA explained that the only remaining information that is not outside scope consists of the estimated number of patient treatment-years worldwide that has been redacted from the Executive Summaries of the PSURs relating to the drug Epilim on the basis of section 36(1) of the FOI Act.

Accordingly, this review is now concerned solely with the question of whether the HPRA was justified in refusing access under section 36(1) of the FOI Act to the relevant parts of the PSURs containing the estimated number of patient treatment-years worldwide.

Analysis and Findings

Section 22(12)(b) of the FOI Act provides that a decision to refuse to grant a request shall be presumed not to have been justified unless the FOI body shows to the satisfaction of the Commissioner that the decision was justified. The onus is therefore on the HPRA to justify its decision to refuse access to the records concerned.

In its submissions, the HPRA notes that the estimates redacted from the PSURs were derived from sales figures known only to the company and could be used to provide an indication of market share. It says that the estimates are calculated on the basis of patient years of treatment, assuming a defined dose of treatment of the product, and that it could be used to give an indication of market share. It claims that the information qualifies for exemption under section 35(1)(a) and sections 36(1)(a), (b), and (c) of the FOI Act. Having regard to the information concerned, I find that section 36(1)(b) is the most relevant exemption to consider in the circumstances of this case. 

Section 36(1)(b) provides that a request shall be refused 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". Section 36(1) does not apply if the public interest would, on balance, be better served by granting rather than by refusing the request (section 36(3) refers).

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 Supreme Court recently confirmed in University College Cork v The Information Commissioner [2020] IESC 58 that the standard of proof in relation to the second limb of section 36(1)(b) is “very low”. Nevertheless, it is not sufficient for a 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. A party opposing release should explain why disclosure of the particular records could prejudice its competitive position.

The HPRA contends that sales data in a competitive marketplace such as the pharmaceuticals industry would comprise a trade secret. The HPRA notes that the data varies for each reference period, showing variance in sales at a global level. It states that “[th]e release of this information would allow other manufacturers to tailor their marketing strategies for competing products to gain market share at the expense of the manufacturer in question here”. According to the HPRA, sales data of this nature is regarded as highly confidential by manufacturers and critical for organisations seeking to maximise their sales capacity and to adapt to changing market conditions.

This Office questioned the sensitivity of the information given its age. However, the HPRA maintains:

“Notwithstanding the age of the data, past sales data may still be valuable to competitors of the manufacturer in question as it gives indications of market share at a point in time, as the incidence of a particular disease will be well known at population level. This will allow competitor companies to tailor their marketing strategies accordingly – in some cases, perhaps not marketing a product if the market is almost exclusively the purview of a single product, or perhaps deciding to introduce a similar, but cheaper product, in this scenario. Where a market is more fragmented, this is also information that is useful to competitor manufacturers, and that can be derived from sales figures.”

I note the HPRA’s claims of confidentiality and commercial sensitivity in relation to the sales data are supported by the objections made by the company concerned during the third party consultation process carried out by the HRPA in response to the request. Based on the submissions made, I accept that the information concerned is commercially sensitive within the meaning of section 36(1)(b) of the Act.

In relation to the public interest test contained in section 36(3), I wish to emphasise that 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. In sum, section 11(3) recognises the need to enhance public scrutiny and accountability of government and public affairs, particularly the activities and decision making of FOI bodies. However, in another recent judgment delivered on 25 September 2020, The Minister for Communications, Energy and Natural Resources v The Information Commissioner & Ors [2020] IESC 57) (“the eNet case”)), the Supreme Court held that general principles of openness and transparency do not provide a sufficient basis for directing the release of otherwise exempt information in the public interest. Rather, a “sufficiently specific, cogent and fact-based reason” is required “to tip the balance in favour of disclosure”. Moreover, while the Court stated that the public interest balancing test involves a “weighing of the respective private and public interests in the analysis of the records in issue”, it did not disturb the guidance that it previously gave in The Governors and Guardians of the Hospital for the Relief of Poor Lying-In Women v. the Information Commissioner [2011] IESC 26 ("the Rotunda Hospital case") in which it drew a distinction between private and public interests. Relevant private interests are those that are recognised by law and, in particular, through the protection afforded by the exemption provisions.

In this case, the HPRA notes that it has released key safety data from the PSURs in relation to the overall assessment provided in the Executive Summaries together with requested data from studies presented in section 7 of the PSURs. It considers therefore that the public interest is better served by refusing access to the sales information in order to ensure that companies are confident that key commercial data relating to their medicines can be protected and that they consequently will continue to put products on the Irish market. The HPRA states that Ireland because of market size struggles to have sufficient medicines on the market. In the eNet case, the Court observed 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”. Moreover, as stated in previous decisions, the Commissioner takes the view that the FOI Act was designed to increase openness and accountability in the way in which public bodies conduct their operations; generally speaking, it was not designed as a means to open up the operations of private enterprises to scrutiny. I see no basis for concluding in the circumstances that it would serve the public interest to grant access to the redacted sales information. Accordingly, I am satisfied that section 36(1)(b) applies.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the decision of the HPRA in this case.

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 not later than four weeks after notice of the decision was given to the person bringing the appeal.

Stephen Rafferty

Senior Investigator