Fidge v Pfizer Australia Pty Ltd

Case [2024] FCA 161

FEDERAL COURT OF AUSTRALIA

Fidge v Pfizer Australia Pty Ltd [2024] FCA 161  

File number: VID 510 of 2023
Judgment of: ROFE J
Date of judgment: 1 March 2024
Catchwords: PRACTICE AND PROCEDURE – interlocutory applications for summary dismissal under s 31A(2) of the Federal Court of Australia Act 1976 (Cth) and r 26.01(1)(a), (c) and (d) of the Federal Court Rules 2011 (Cth) – applicant alleges that the respondents’ Covid-19 vaccines are, or contain, genetically modified organisms (GMOs) and should have been licenced under the Gene Technology Act 2000 (Cth) – whether the applicant has standing to seek an injunction pursuant to s 147(1) of the Act as “any other aggrieved person” – whether the intended scope and purpose of the Act is to regulate risks to the end user or recipient of a GMO product, in particular the safety and efficacy of a therapeutic GMO product — held: scope of the Act is confined to regulating specific “dealings” (as defined in the Act) with GMOs that pose a biosafety risk to people or the environment, and that the Act is intended to operate in a broader regulatory landscape with other statutes – held: standing under s 147(1) confined to persons aggrieved by the specific conduct regulated by the Act which could constitute an offence under that legislation – authorities on standing considered – whether standing can be established as a “necessary incident” of the applicant’s vocation as a medical practitioner, pursuant to Ogle v Strickland (1987) 13 FCR 306 – standing not established – applications for summary dismissal allowed.
Legislation:

Administrative Appeal Tribunal Act 1975 (Cth)

Administrative Decisions (Judicial Review) Act 1977 (Cth)

Customs Act 1901 (Cth)

Federal Court of Australia Act 1976 (Cth)

Gene Technology (Consequential Amendments) Act 2000 (Cth)

Gene Technology Act 2000 (Cth)

Judiciary Act 1903 (Cth)

Therapeutic Goods Act 1989 (Cth)

Trade Marks Act 1995 (Cth)

Federal Court Rules 2011 (Cth)

Archaeological and Aboriginal Relics Preservation Act 1972 (Vic)
Cases cited:

Alcan (NT) Alumina Pty Ltd v Commissioner of Territory Revenue (2009) 239 CLR 27

Antsis v Secretary, Department of Family and Community Services (2002) 123 FCR 536

Argos Pty Ltd v Corbell (2014) 254 CLR 394

Assa Abloy Australia Pty Ltd v Australian Lock Company Pty Ltd (2005) 147 FCR 126

Australian Conservation Foundation Inc v Commonwealth (1980) 146 CLR 493

Australian National Imams Council Ltd v Australian Communications and Media Authority (2022) 404 ALR 323

Australian Vaccination-Risks Network Inc v Secretary, Department of Health (2022) 292 FCR 1

Australian Vaccination-Risks Network Inc v Secretary, Department of Health [2022] FCA 320

Bateman’s Bay Local Council Aboriginal Land Council v Aboriginal Community Benefit Fund (1998) 194 CLR 247

Cameron v Human Rights and Equal Opportunity Commission (1993) 46 FCR 509

CIC Insurance Ltd v Bankstown Football Club Ltd (1997) 187 CLR 384

Dey v Victorian Railways Commissioners (1949) 78 CLR 62

General Steel Industries Ltd v Commissioner for Railways (1964) 112 CLR 125

Health World Ltd v Shin-Sun Australia Pty Ltd (2010)…

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Details
AGLC
Fidge v Pfizer Australia Pty Ltd [2024] FCA 161
Case
[2024] FCA 161
Decision Date

CaseChat Overview and Summary

The Federal Court was tasked with determining whether Dr. Fidge, a medical practitioner and pharmacist, had the standing to seek an interlocutory injunction against Pfizer Australia and its parent company for alleged breaches of the Gene Technology Act 2000 (Cth). Dr. Fidge contended that the Pfizer Covid-19 vaccines are genetically modified organisms (GMOs) that should have been licensed under the Act. He claimed that he was an "aggrieved person" within the meaning of section 147(1) of the Act, entitling him to seek relief. The court was required to decide if Dr. Fidge had standing to bring the proceeding under the Act and if the proceeding was likely to succeed on its merits.

The court held that Dr. Fidge did not have standing to bring the proceeding as an "aggrieved person" under the Act. The court examined the scope and purpose of the Act, which is specifically focused on regulating "dealings" with GMOs that pose biosafety risks to people or the environment. The court found that the Act does not extend to regulating the safety and efficacy of therapeutic GMO products like the Covid-19 vaccines. The court held that standing is confined to persons aggrieved by conduct that could constitute an offence under the Act. Dr. Fidge’s concerns related to the potential health risks of the vaccines to patients, which falls outside the scope of the Act. The court also considered whether standing could be established as a "necessary incident" of Dr. Fidge’s vocation as a medical practitioner but found that it was not applicable in this context.

Accordingly, the court allowed the respondents’ applications for summary dismissal. The court held that Dr. Fidge had no reasonable prospect of successfully prosecuting the proceeding as he lacked standing. The proceeding was therefore dismissed with costs awarded to the respondents.

Orders

Orders of the court

1. Pursuant to s 31A(2) of the Federal Court of Australia Act 1976 (Cth) and r 26.01(1)(a), (c) and (d) of the Federal Court Rules 2011 (Cth), the proceedings against the first respondent and second respondent be dismissed on the grounds that the applicant has no reasonable prospect of successfully prosecuting the proceedings against the respondents because the applicant is not an “aggrieved person” within the meaning of s 147(1) of the Gene Technology Act 2001 (Cth), and otherwise has no standing to bring the proceeding.

2. The applicant pay the first respondent’s and second respondent’s costs of, and incidental to, the proceeding.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

For the reasons that follow, I do not consider that the applicant has established that he has standing to bring the interlocutory application and therefore I will allow the respondents’ applications for summary judgment. 2. BACKGROUND Pfizer is the sponsor of three Covid-19 vaccines approved by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (Cth) which are registered on the Australian Therapeutic Goods Register (ARTG), and which are available in Australia. The ARTG registrations are:(a)COMIRNATY (tozinameran) (Monovalent):(i)ARTG ID 346290;(ii)ARTG ID 377111; (iii)ARTG ID 377110; and(iv)ARTG ID 393433.(b)COMIRNATY Original/Omicron BA.1 (tozinameran and riltozinameran) (Bivalent 1) – ARTG ID 394890; and(c)COMIRNATY Original/Omicron BA.4-5 (tozinameran and famtozinameran) (Bivalent 2) – ARTG ID 400874. (Pfizer vaccines) Moderna has two Covid-19 vaccines which have been approved by the TGA and which are available in Australia. The ARTG registrations are:(a)SPIKEVAX (elasomeran):(i)ARTG ID 370599;(ii)ARTG ID 388244; and(iii)ARTG ID 388245.(b)SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran):(i)ARTG ID 389513; and(ii)ARTG ID 396452.(c)SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran):(i)ARTG ID 399552;(ii)ARTG ID 399553; and(iii)ARTG ID 406730.(Moderna vaccines) The Pfizer and Moderna vaccines have been endorsed by the Australian Technical Advisory Group on Immunisation and the Australian Medical Association (AMA). As at 23 August 2023, over 65 million Covid-19 vaccine doses had been administered in Australia and a large proportion of those vaccines were either Pfizer vaccines or Moderna vaccines. Dr Fidge is a practicing GP and pharmacist. He provided evidence by way of two affidavits affirmed on 6 July 2023 and 11 September 2023. Dr Fidge gave evidence that he received three doses of the Pfizer vaccine and his two children also received doses of the Pfizer vaccine. Neither he nor his children received doses of the Moderna vaccine. Dr Fidge also gave evidence that he personally provided, or oversaw, the administration of more than 10,000 doses of Covid-19 vaccines to patients. By way of summary, the applicant seeks interlocutory relief upon the bases that:(a)each of the vaccines are, or contain, GMOs as defined by s 10 of the Act;(b)in order to “deal with” the vaccines as defined in s 10 of the Act, the respondents were required by s 40 of the Act to obtain licences from the OGTR but have failed or refused to do so;(c)the respondents knew at the relevant times that:(i)the vaccines are, or contain, GMOs; and(ii)the vaccines were not licensed pursuant to s 40 of the Act.(d)the respondents dealt with and continue to deal with the vaccines in Australia by, among other things, importing, distributing and transporting the vaccines (Vaccine Dealings);(e)these Vaccine Dealings in the absence of a licence are unlawful pursuant to s 32 and s 33 of the Act (the Breaches);(f)Dr Fidge is an “aggrieved person” within the meaning of s 147(1) of the Act in respect of the Breaches because, as stated in his first affidavit, he “recommended to patients, and received these Products [himself], without being fully informed that this new class of drugs is capable of transferring genetic material” (which he considers poses significant adverse health risks).

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

Rule 26.01(1) of the Rules provides:26.01 Summary judgment(1)A party may apply to the Court for an order that judgment be given against another party because:(a)the applicant has no reasonable prospect of successfully prosecuting the proceeding or part of the proceeding; or(b)the proceeding is frivolous or vexatious; or(c)no reasonable cause of action is disclosed; or(d)the proceeding is an abuse of the process of the Court; or(e)the respondent has no reasonable prospect of successfully defending the proceeding or part of the proceeding. In Unions NSW v New South Wales (2023) 407 ALR 277, Kiefel CJ, Gageler, Gordon, Gleeson and Jagot JJ stated at [15]:Exceptional categories aside, there can be no “matter” within the meaning of Ch III of the Constitution unless “there is some immediate right, duty or liability to be established by the determination of the Court” in the administration of a law and unless the determination can result in the Court granting relief which both quells a controversy between parties and is available at the suit of the party seeking that relief. Standing to seek relief is in that way “subsumed within the constitutional requirement of a ‘matter’”.(Citations omitted.) In expressing the same principle, Gageler and Gleeson JJ in Hobart International Airport Pty Ltd v Clarence City Council (2022) 399 ALR 214 at [49] explained the concept of standing: Standing, in the sense of a right to seek from a court an order that would operate to resolve the controversy, is in that way inseparable from justiciability and, therefore, is intrinsic to the existence of the matter without which the federal jurisdiction of the court to make the order cannot exist. That is what has been meant when it has often been said that standing is “subsumed within the constitutional requirement of a matter”. If an applicant lacks standing to bring the proceeding, then there can be no matter before the Court and therefore there can be no prospects of succeeding in that application. Relatedly, an abuse of process arises where the applicant’s case is “foredoomed to fail” which will always be the case where the applicant lacks standing: see Miller v Cimic Group Ltd [2015] FCA 587 at [14] (per Reeves J) referring to the High Court decision of Walton v Gardiner (1993) 177 CLR 378 at 393 (per Mason CJ, Deane and Dawson JJ). It is clear that without standing an applicant has no prospect of success, no reasonable cause of action and the proceeding is an abuse of process. The question of standing therefore entirely resolves the question of whether summary judgment is available, irrespective of where the bar is set for assessing the prospects of the applicant’s success on the substantive matter. As such, it is unnecessary to address the dispute that arose between the respondents and the applicant regarding the construction of s 31A of the FCA Act and whether the cases relied upon by the applicant that pre-dated the insertion of s 31A, such as Dey v Victorian Railways Commissioners (1949) 78 CLR 62 and General Steel Industries Ltd v Commissioner for Railways (1964) 112 CLR 125, remained good law after Spencer v Commonwealth (2010) 241 CLR 118. 4. STANDING

Ratio Decidendi

Legal Principle Established

The applicant contends that the Act has a far broader purpose which includes the general protection of the health and safety of the public. The applicant’s asserted bases for standing all depend on a concern that by being or containing GMOs, the vaccines have the potential to harm patients who are administered a dose of the vaccine. This is a concern with the health of the consumer of a vaccine. Thus, the critical question to determine with respect to the Act is the extent to which, if any, it regulates risks to the end user or recipient of a GMO product, in particular the safety and efficacy of a therapeutic GMO product. The answer to that question will largely resolve whether the applicant is an “aggrieved person” within the meaning of s 147(1) of the Act or, put differently, has a special interest in the subject matter of the proceeding such as to have standing.5.3 Scheme and operation of the Act The object of the Act is set out in s 3: The object of this Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs. Section 4 provides that the object of the Act is to be achieved through a regulatory framework which:(aa) provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation; and(a) provides an efficient and effective system for the application of gene technologies; and (b) operates in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and GM products. Note: Examples of the schemes mentioned in paragraph (b) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods. A number of definitions of terms used in the Act are set out in s 10. Section 10 defines the phrase “deal with” exhaustively: deal with, in relation to a GMO, means the following: (a) conduct experiments with the GMO; (b) make, develop, produce or manufacture the GMO; (c) breed the GMO; (d) propagate the GMO; (e) use the GMO in the course of manufacture of a thing that is not the GMO; (f) grow, raise or culture the GMO; (g) import the GMO; (h) transport the GMO; (i) dispose of the GMO; and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i). Part 3 of the Act establishes the OGTR and sets out its functions and powers in s 27 and s 28. “Dealings with GMOs” are regulated in Pt 4 of the Act. In relation to the “dealings” with GMOs that the GTA seeks to regulate for the purposes of managing risks posed by gene technology, the word “dealing” is not defined. However, the definition of “deal with” covers various categories of conduct or activities involving the handling of GMOs in research, agricultural and commercial settings. It is directed to conduct or activities which could give rise to occupational health and safety risks for individuals who are handling a GMO, or conduct or activities which could lead to the release of a GMO into the environment. Those matters fall within the general category of biosafety risks.