Whether the HPRA was justified in refusing access to records that relate to an application for authorisation to market a veterinary medicinal product

7 April 2020

Background

This review arises from a decision made by the HPRA to refuse access to parts of records following a request to which section 38 of the FOI Act applies. Section 38 applies to cases where, at some stage in the decision making process, the FOI body has formed the view that the records in question 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 personal information about third parties) but that the record(s) 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 exemption(s), 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 for a review of that decision to this Office.

In a request dated 19 March 2019, the applicant sought access to:

1. The bioavailability studies submitted by a pharmaceutical company to demonstrate the bioequivalence of a named veterinary product with a reference product;

2. The comparison of product composition submitted by a pharmaceutical company in respect of the two veterinary medicinal products;

3. All records relating to any consideration by the HPRA or competent authorities of the other Member States of whether the application for approval of the named veterinary product was properly submitted under the relevant EU Directive;

4. All records relating to any consideration by the HPRA of whether the named veterinary product is a biological veterinary product within the meaning of the relevant EU Directive;

5. All correspondence between the HPRA and the competent authorities of any other Member States relating to an application for a marketing authorisation in respect of the named veterinary product;

6. All metadata relating to the email allegedly sent by the HPRA on 30 October 2018 at 09:39 to a named party.

The HPRA formed the view that the release of certain records that fall within the scope of parts 3 and 4 of the applicant’s request would affect the interests of third parties. The HPRA informed the applicant that a process of consultation with affected third parties under section 38 of the Act was required. The HPRA notified the third parties of the request and that it was considering the release of certain information in the public interest. The HPRA provided the third parties with copies of the relevant records and informed them that they are entitled under section 38 of the Act to make submissions to it about access to the records. The affected third parties subsequently wrote to the HPRA outlining their views.

On 27 May 2019, the HPRA issued its decision. It provided the applicant with a schedule of all of the records that fall within the scope of each part of its request. The HPRA stated that it had carried out third party consultations in relation to the records under parts 3 and 4 of the request marked with an asterisk. It refused access to parts of those records under section 37 of the Act. The HPRA stated that if the applicant wished to request a review of its decision in relation to those records, it may apply directly to the Commissioner.

On 11 June 2019, the applicant applied directly to this Office for a review of the HPRA’s decision in relation to the records that were subject to third party consultation. My decision in this case covers those records in parts 3 and 4 only.

In its original decision of 27 May 2019, the HPRA also refused access to records within the scope of parts 1, 2, 5 and 6 of the request under sections 35, 36 and 37 of the Act. The applicant requested an internal review this decision. The HPRA affirmed its original decision. On 6 September 2019, the applicant applied to this Office for a review of the HPRA’s decision. My decision under case reference number OIC-56375-F1B4N2 will issue separately.

This Office provided the applicant, the HPRA and the affected third parties with an opportunity to make submissions. 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 to date, I have also examined the records at issue. I have decided to conclude this review by way of a formal, binding decision.

Scope of the review

The scope of this review is confined to whether the HPRA’s decision to refuse access to certain information contained in the records marked with an asterisk under parts 3 and 4 of the request was justified under section 37 of the FOI Act.

Preliminary Matters

Section 13(4) of the FOI Act provides that the actual or perceived reasons for a request must generally be disregarded by the decision maker, including the Information Commissioner, (except insofar as such reasons are relevant to consideration of the public interest or other provisions of the Act).

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.

Finally, the release of a record under the FOI Act is understood, effectively, to be equivalent to its release to the world at large.

Section 37 - Personal Information

Section 37(1) of the Act provides that, subject to the other provisions of the section, an FOI body shall refuse a request if access to the record concerned would involve the disclosure of personal information. Section 2 of the Act defines "personal information" as information about an identifiable individual that, either - (a) would, in the ordinary course of events, be known only to the individual or members of the family, or friends, of the individual, or (b) is held by an FOI body on the understanding that it would be treated by that body as confidential. Section 2 of Act details fourteen specific categories of information that is personal without prejudice to the generality of the foregoing definition. These categories include (xii) the name of the individual where it appears with other personal information relating to the individual or where the disclosure of the name would, or would be likely to, establish that any personal information held by the FOI body concerned relates to the individual.

The information withheld from the emails comprises names, addresses and telephone numbers for individual staff members in competent authorities of other member states and in the third party company. I note that the HPRA did not redact the names of its own staff from the records but solely the personal information of individuals external to the HPRA. I find that the information at issue is exempt from release on the basis of section 37(1) subject to the consideration of sections 37(2) and section 37(5) which I examine below.

Section 37(2)

Section 37(2) of the FOI Act sets out certain circumstances in which section 37(1) does not apply. I am satisfied that, (a) the information contained in the records does not relate solely to the applicants; (b) the third parties have not consented to the release of their information; (c) the information is not of a kind that is available to the general public; (d) the information at issue does not belong to a class of information which would or might be made available to the general public; and (e) the disclosure of the information is not necessary to avoid a serious and imminent danger to the life or health of an individual.

Section 37(5) The Public Interest

Section 37(5) provides that access to the personal information of a third party may be granted where (a) the public interest that the request should be granted outweighs the right to privacy of the individual to whom the information relates, or (b) the grant of the request would benefit the person to whom the information relates. It has not been argued that releasing the records would benefit the persons to whom the information relates and I am satisfied that section 37(5)(b) does not apply in the circumstances.

In relation to paragraph (a), I must consider whether the public interest in granting the request outweighs, on balance, the public interest in protecting the right of privacy of the individuals to whom the information relates. The FOI Act itself recognises the public interest in ensuring the transparency and accountability of public bodies. On the other hand, however, the language of section 37 and the Long Title to the FOI Act recognise a very strong public interest in protecting the right to privacy, which has a Constitutional dimension, as one of the un-enumerated personal rights under the Constitution. Accordingly, when considering section 37(5)(a), privacy rights will be set aside only where the public interest served by granting the request (and breaching those rights) is sufficiently strong to outweigh the public interest in protecting privacy.

I note that following authorisation, a product is entered on the list of authorised products published on the HPRA website which includes a link to the Summary of Product Characteristics (SPC). I understand that the product label, package leaflet and where relevant any outer carton text are all agreed as part of the procedure and are available on product within the marketplace once the product is marketed. In addition, I note that the HPRA publishes the Public Assessment Report, after deleting any information of a commercially confidential nature and the HPRA has published an assessment report in relation to its decision in this case which is available on its website. In my view the European transparency rules serve the public interest in openness and accountability with respect to the HPRA’s regulatory processes in ensuring the safety, efficacy and quality of medicinal products. In my view, release of names, addresses and telephone numbers of individuals employed by the affected third parties would not further enhance the public interest in transparency and accountability of the HPRA’s regulatory processes. I find, therefore, that the records do not fall to be released under section 37(5)(a) of the Act.

Decision

Having carried out a review under section 22(2) of the Freedom of Information Act, I affirm the HPRA’s decision in relation to records withheld in part under section 37(1) of the FOI Act.

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.

 

 

Elizabeth Dolan

Senior Investigator