AUSTRALIAN MINNOW, LAWLEY PHARMACEUTICALS, TAKES PBAC TO FEDERAL COURT

MEDIA RELEASE – Wed 11 February 2026

AUSTRALIAN MINNOW, LAWLEY PHARMACEUTICALS, TAKES PBAC TO FEDERAL COURT

A small Perth-based pharmaceutical company is stepping up to challenge a decision of the PBS regulator to refuse PBS listing of its testosterone treatment for distressing low libido in post-menopausal women. The product is the only female-specific treatment of its kind available anywhere in the world.

The only Australian-owned manufacturer of menopause hormone products, Lawley Pharmaceuticals lodged an application in the Federal Court of Australia on 9 January 2026 seeking judicial review of the decision by the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2025 to not recommend listing of AndroFeme 1, a topical treatment for post-menopausal women, on the Pharmaceutical Benefits Scheme (PBS).

Lawley’s founder, CEO and pharmacist, Michael Buckley, said:

“This rejection means women will pay between 14 to 16 times more for treatment than their male counterparts pay for the treatment of similar sexual dysfunction conditions – that’s simply unaffordable to many with limited financial means and, quite frankly, un-Australian.”

Australian men currently have access to no less than eight PBS-subsidised male-specific formulations, whereas women have none.

AndroFeme 1 is specifically indicated for the treatment of hypoactive sexual desire dysfunction (HSDD) in post-menopausal women. It is the only female-specific formulation for HSDD with marketing authorisation anywhere in the world, with approvals in Australia, the United Kingdom, New Zealand and South Africa. It was registered in the Australian Register of Therapeutic Goods by the Therapeutic Goods Administration in November 2020 and is presently available as a private prescription.

Listing the product on the PBS would enable Australian women to access the product on a subsidised basis – as men are currently able to do for several similar products available for them – significantly reducing its cost and thereby improving access to therapy for women experiencing HSDD.

Mr Buckley commented:

“This decision is an astounding rejection of the physical, mental and sexual needs of post-menopausal women. To not challenge the decision would be tantamount to endorsing the PBAC’s flawed approach and accepting that Australian women do not deserve cost-effective access to the kind of product that Australian men can obtain cheaply and easily.”

Lawley considers that the PBAC non-recommendation was affected by jurisdictional error because it made its decision in a procedurally unfair way, failed to have regard to a mandatory consideration under the National Health Act 1953 (Cth), and made a decision that involved irrational or unreasonable findings. Lawley also contends that the PBAC failed to deal with a substantial, clearly articulated argument that the listing of AndroFeme 1 was required to redress inequitable access to sexual dysfunction products for women.

“We have fought for more than two decades to obtain marketing authorisation and public subsidisation for AndroFeme in Australia and elsewhere. It is a global product that is desperately needed by many Australian women who are unable to afford it without PBS subsidisation. What adds to my frustration is that the UK Department of Health accepted AndroFeme’s NHS List Price with minimal fuss, yet we have abandoned our own here in Australia,” lamented Mr Buckley.

More information available on AndroFeme 1 here plus HSDD and women’s hormonal health here

For interviews and media enquiries please contact Anna Lensky at Pitch anna@pitchprojects.com or 0425 766 780

ABOUT LAWLEY

Founded in 1995 by community pharmacist Michael Buckley, Lawley Pharmaceuticals is a privately owned, Perth-based Australian company and global leader in the research and development of transdermal androgen hormone therapies for both women and men.

For more than two decades, Lawley has contributed to the scientific and clinical knowledge in androgen physiology in both men and women.

In 2020, Lawley’s work culminated in Australian regulatory approvals that marked global breakthroughs in androgen hormone treatments for women and men.

Lawley is focused on developing therapies that are designed to work in harmony with the body’s natural endocrine systems. It remains committed to supporting clinicians through evidence-based research, high-quality manufacturing standards and ongoing scientific engagement.

Lawley’s priority is to advance understanding of androgen physiology and to provide healthcare professionals with clinically relevant information that supports informed prescribing decisions.