Judicial Review - Fair procedures - Certiorari sought - Application for product authorisation for drug - Respondent to make decision in consultation with National Drug Advisory Board - Board recommended rejection of application - Whether respondent had delegated decision to board - Whether respondent entitled to accept board's advice - Whether applicant should have known all reasons for recommendation - Whether decision-making process in breach of natural justice - Whether respondent should have given reasons for refusal - Medical Preparations (Licensing, Advertisement and Sale) Regulations (SI 210 of 1984) - EC Directives 65/65, 78/318 and 91/507.
The High Court (Miss Justice Carroll); judgment delivered 11 July 1997.
When evaluating an application for product authorisation, the Minister for Health, while entitled to seek advice from the National Drugs Advisory Board, must be in a position to make his own evaluation of the advice received, based on the relevant documentation submitted.
The High Court so held in granting the applicant an order of certiorari in respect of the respondent's decision to reject its application for product authorisation for a drug it wished to manufacture.
Paul Gallagher SC and Donal O'Donnell SC for the applicant; John Finlay SC and Feichin McDonagh BL for the respondent.
Miss Justice Carroll said that the law relating to product authorisation for drugs was governed by EC Directive 65/65, as amended, by Directives 75/318 and 91/507. This provides that authorisation should be refused if the product is harmful or its therapeutic efficacy is lacking or insufficiently substantiated by the applicant. This directive was implemented by the Medical Preparations (Licensing, Advertisement and Sale) Regulations 1984, which designate the respondent as the authority for the grant of product authorisations. The regulations provide that the respondent may refuse an application where the applicant fails to submit sufficient documentation, or, where the respondent is satisfied, following examination of such information, documents, samples or other materials provided, that the therapeutic efficacy is lacking or unsubstantiated.
Miss Justice Carroll said that the product concerned in this case was Edelfonsine, which was intended for use in cases of inoperable small cell lung cancer. The applicant was an associated company of the German company which had invented the drug and planned to manufacture it in Ireland if permitted. The application for product authorisation was made by Shandon Clinic, Waterford, on 7 March 1991.
The application was acknowledged and it was indicated by the respondent that the application would be processed in consultation with the National Drugs Advisory Board ("the NDAB"). Thus it was necessary to furnish the NDAB with all the necessary documentation. The initial application was in German and found to be impossible to assess. It was returned and the NDAB inquired as to whether it was intended to undertake phase III clinical trials. The applicant then took over the conduct of the application and a dossier in English was submitted on 20 May 1992. On 7 April 1993 the committee of the NDAB advised the applicant that it would be suggesting that the NDAB recommend to the respondent the rejection of product authorisation. The NDAB said that the data on the pre-clinical studies was based on published reports, from which it was impossible to extract original data, and no phase III clinical trials had been carried out.
Correspondence ensued in which the applicant refuted the inadequacy of the data and provided supplementary data. The NDAB, however, upheld its original decision. By letter dated 18 August 1993, the applicant requested the NDAB to indicate in detail why the product had been rejected and nominate some person with whom the applicant could liase. In addition the applicant sought a list of the NDAB members together with details of their professional qualifications. The NDAB refused to supply any additional information. Further correspondence ensued between the applicant and NDAB until the latter formally recommended the rejection of the product by the respondent on 2 December 1993.
The applicant then wrote to the respondent criticising the recommendation and enclosing a booklet of correspondence between the applicant and the NDAB. On 7 January 1994 the NDMA wrote to the respondent setting out the reasons for its recommendation. It repeated what it had communicated to the applicant but also referred to additional grounds for refusal. The matter was submitted to the respondent on 20 January 1994. When arranging a meeting with the NDAB the applicant asked for copies of all correspondence between the NDAB and the respondent. This request was declined.
After the meeting the applicant wrote to the respondent complaining that the meeting had not involved a discussion or debate on the medicinal or ethical aspect of the application. The applicant claimed that the respondent was obliged to consider not only the advice he had received but the applicant's response thereto; thus it was necessary for the applicant to be appraised of all correspondence between the respondent and the NDAB so as to enable it to respond. In addition the applicant complained that the NDAB had misinterpreted the EC directives when it stated that proof of efficacy was required in the form of phase III trials. The applicant requested a formal hearing with the respondent to allow it to contest any contrary views to its application. This request was refused. The application for product authorisation was refused by the respondent on 20 May 1994. The applicant now sought an order of certiorari to quash this decision.
The first point to consider, said Miss Justice Carroll, was the respondent's claim that the applicant had no standing to bring this application as the Shandon Clinic had been the applicant for product authorisation. The respondent claimed that there was no provision for the assignment of rights under such an application. However Miss Justice Carroll said that the only relevant point was whether the applicant had sufficient interest to prosecute the proceedings in respect of the decision made. Despite the lack of documentary evidence to prove this, Miss Justice Carroll was satisfied that the applicant did have that interest.
The applicant submitted that the respondent was in breach of natural and constitutional justice and Directive 65/65, when he failed to exercise independent judgment by getting advice from the NDAB; failed to consider the information supplied by the applicant; took into account information not available to the applicant; and failed to give reasons for his decision. While accepting that the respondent was entitled to seek advice, Miss Justice Carroll found that he was not entitled to rely on advice in the form of conclusions without reference to the basic material on which those conclusions were based, as decided in Flanagan v University College Dublin [1988] IR 724 and Jeffs v New Zealand Dairy Production and Marketing Board [1967] 1 AC 551.
The respondent, said Miss Justice Carroll, had to be in a position to make his own evaluation of the advice received based on the relevant documentation submitted. However he had failed to do this. The advice which the respondent had received had not dealt with the point made by the applicant that phase III trials were neither possible or necessary. The decision-making process was additionally flawed by the failure to disclose to the applicant all the grounds that the NDAB had sent to the respondent to support its recommendation. Applying the decision in Geraghty v Minister for Local Government [1976] IR 153, Miss Justice Carroll said that the applicant had been entitled to know what were the final grounds put forward by the NDAB, so that it could respond to them.
In relation to the respondent's failure to give reasons for his decision, Miss Justice Carroll said that this was not just required by natural and constituional justice but was specifically required by article 12 of Directive 65/65 which requires a refusal to be notified in writing, stating in detail the reasons on which it was based. She concluded that for these reasons an order of certiorari should issue.
Solicitors: O'Flynn Exhams & Partners (Dublin) for the applicant; Chief State Solicitor for the respondent.