Billy Allgenders hot-shoe shuffle

Women were not historically overlooked in medical research because of their gender identity. Females were inadequately studied because they were female.

Billy Allgenders hot-shoe shuffle
Photo by Kelly Sikkema / Unsplash

By Sandra Adams, former Independent Seanad candidate and advocate for sex-based rights and fact-based education.


Fianna Fáil MEP Billy Kelleher is doing a hot-shoe shuffle around the language of women’s health. But even if he had the dexterity of dancing hero Billy Elliot, he would struggle to avoid tripping over two rather important words: sex and gender.

Kelleher was appointed rapporteur for the European Parliament’s report Gender inequalities in health, specifically as regards gender-specific conditions. This is not a bill or binding EU law. It’s a report that seeks to address genuine deficiencies in women’s healthcare including the historic under-representation of women as a subject group in research.

To give Kelleher his due, he clearly believes that the deficiency should be corrected. The difficulty is that the language surrounding the project risks becoming part of the very problem it is supposed to solve.

Speaking in the European Parliament on September 16th, Kelleher said medical research must recognise “sex and gender-based differences”. Yet when MEPs challenged terminology in the report, he accused some of trying to “weaponize” it to fuel “cultural wars”, saying that “picking apart terminology” was “ridiculous and shameful” and declaring: “It is clear that your interests are not the interests of women.”

But terminology is not an irritating distraction. In this instance, terminology is part of the science.

Sex and gender do not describe the same variable. Pregnancy is a female reproductive process, while breastfeeding and lactation are rooted in female mammary and reproductive physiology. If medical research is attempting to repair the consequences of female physiology having been inadequately studied, researchers need terminology capable of identifying that physiology unambiguously.

And, inconveniently for anyone tempted to dismiss this concern as culture-war nit-picking, the pharmaceutical industry itself has raised precisely this objection.

The European Medicines Agency (EMA) is the EU agency at the centre of medicines regulation. It is involved in the development of ICH E21, an international guideline intended to improve the evidence available about the use of medicines during pregnancy and breastfeeding. ICH, the International Council for Harmonisation, brings medicines regulators and the pharmaceutical industry together to establish common technical standards.

The EMA currently describes E21 as the guideline on the inclusion of “pregnant and breastfeeding individuals” in clinical trials.

During consultation, however, the European Federation of Pharmaceutical Industries and Associations (EFPIA) objected explicitly to that terminology. Its submission stated:

“The use of the term ‘individual’ diminishes the scientific basis whereby females have been excluded from medicines development research historically…. this issue is entirely limited to the female sex”

It told the Expert Working Group responsible for developing the guideline that “female is the key term”.

Their argument is not without compassion.  They accept that trans identifying women should not disappear from medical research. Quite the opposite. A female person who identifies as a man remains relevant to research into pregnancy precisely because gender identity does not change the biological variable being studied. EFPIA made it clear that that E21 applies to “the female sex, regardless of how one identifies.”  

Their intervention makes Kelleher’s impatience with people “picking apart terminology” harder to dismiss as another front in a culture war. The people developing medicines are saying that sex specific words matter because they identify the population being studied.  Women were not historically overlooked in medical research because of their gender identity. Females were inadequately studied because they were female.

Unfortunately, the institutional use of language does not always remain within institutions. Sometimes it leaves the reservation and takes hold in the wild. Ireland has just witnessed an extraordinary example of this involving the Association of Lactation Consultants in Ireland (ALCI), an organisation founded to support breastfeeding mothers and their babies.

ALCI invited American lactation consultant Jacob Engelsman to address its annual conference on lactation support for gender-diverse families. Engelsman’s published writing discusses men inducing ‘lactation’ via a cocktail of hormones and other drugs. In explaining their motivations, he writes that they may wish to do so for among other reasons “curiosity, fun or sexual gratification.” Describing using babies to satisfy male sexual desire caused a public outcry.  The conference venue cancelled the booking; the event was moved online and Engelsman was removed from the programme.

Billy Kelleher did not cause the ALCI controversy, and his report does not instruct breast feeding support workers to promote male ‘lactation’, But the controversy demonstrates this is about more than semantics, it’s about reality and defending it.

Once institutions like the EU and individuals like Billy Kelleher become reluctant to acknowledge that pregnancy, maternity and breastfeeding are uniquely female experiences dependent upon female biology, the door opens to allow men to lay claim to experiences they can’t have.  Mother becomes individual. Breastfeeding becomes chest-feeding. And a professional organisation whose purpose is to support breastfeeding women, and their babies finds itself defending the inclusion of a man who promotes ‘lactation for kinksters’ and its reputation is left in tatters.

If Kelleher wants better healthcare for women, he needs to make an unambiguous distinction between sex and gender.  For decades female biology was insufficiently studied, making using the word female harder would be a peculiar way of achieving equality and those doing the research agree.