Why do human rights not count?

Why are we still waiting for lamotrigine to be subsidised for bipolar disorder? This post provides the answer, but also poses a question because of the wait.

The Pharmaceutical Benefits Advisory Committee (PBAC) is the gatekeeper to all changes on the PBS, nothing can be changed without their recommendation.

When the Advisory Committee on Medicines reviewed the safety of valproate in 2018, they recommended that lamotrigine be available on the PBS for women of childbearing potential with bipolar disorder or epilepsy. The PBAC refused on the grounds that would constitute sex discrimination. However, the discrimination would have been of the type that is required under human rights even if on a temporary basis – Article 4, Convention on the Elimination of All Forms of Discrimination against Women (CEFDW)).

In 2019, the Epilepsy Society of Australia lobbied the PBAC to make lamotrigine subsidised for women with epilepsy. The PBAC refused in the first instance but later changed that decision; on-the-basis of medication safety the restriction was changed at the beginning of 2021; but only for women with epilepsy. Bipolar disorder was not mentioned.

In April 2024 when there was another review of valproate, the ACM recommended that lamotrigine be subsidised for bipolar disorder. By November there had been no apparent action and the PBAC did not respond to emails asking if the recommendation had been refused or when action could be expected if it had been accepted.

In November 2024 (by coincidence it was on the same date that the minutes of the ACM meeting were received under an FOI request), another brand of lamotrigine had bipolar disorder added as an indication. By mid-March 2025, two more had bipolar added. There are currently 6 more brands on the Australian Register of Therapeutic Goods (ARTG) yet to add the indication. It is presumed that this is occurring to meet the necessary requirement that all medicines have a TGA approved indication for PBS listing.

However, the delay is unnecessary according to the United Nations under a treaty ratified by Australia. The International Convention on Economic, Cultural & Social Rights (ICESCR) states that every person has the right to the “enjoyment of the highest attainable standard of physical and mental health.” The Convention on the Rights of Persons with Disability (CRPD) which has a similar statement on the right to health states that a general obligation is “to take all appropriate measures, including legislation, to modify or abolish existing laws, regulations, customs and practices that constitute discrimination against persons with disabilities”. (Emphasis mine; bipolar disorder is classified as a disability.)

So I can’t help but ask, in the context of the Convention on the Elimination of All Forms of Discrimination against Women, why was lamotrigine not added for bipolar disorder a year ago in April 2024?