Pfizer Pty Ltd v Birkett

The case of Pfizer Pty Ltd v Birkett involves a dispute between Pfizer, an applicant for a pharmaceutical benefit, and the Pharmaceutical Benefits Advisory Committee (PBAC) over the listing of sildenafil on the Pharmaceutical Benefits Scheme (PBS). The primary issue in the case is whether the PBAC's decision to reject Pfizer's application was unreasonable and whether the PBAC took into account irrelevant considerations. The court examines whether the PBAC's decision was so unreasonable that no reasonable person could have reached it and whether the PBAC considered matters outside the scope of its authority under the legislation.

The court found that the PBAC's primary concern was not the absence of head-to-head trials between sildenafil and alprostadil, but rather the lack of data that enabled direct comparisons between the effectiveness and cost of the two therapies. The court noted that the PBAC had communicated this concern to Pfizer on numerous occasions. Regarding the complaint that the PBAC failed to make similar inquiries to limit the use of sildenafil, the court found that the PBAC's inquiries into the use of alprostadil were reasonable and did not unfairly treat Pfizer.

The court concluded that there was no substance in Pfizer's complaint that the PBAC failed to take relevant considerations into account. The court found that the PBAC's concerns about the overall cost to government of listing sildenafil on the PBS and the potential for "misuse" or "overuse" of the drug were legitimate considerations under the statutory framework. The court dismissed Pfizer's application and ordered that the applicant pay the respondents' costs.