Plan to include pregnant women in drug trials ‘a generational change’

When Emma decided to try for a baby, she began to come off some of the medicines she relied on to manage her Ehlers-Danlos syndrome. The complex condition affecting connective tissues has left the 35-year-old without a bladder and being fed via a tube into her small bowel. But there were some drugs she couldn’t safely go without. That’s when Emma realised no one could tell her for sure whether those drugs could harm her baby.

“The vast majority of the information that’s available is like, ‘To be used if there’s no other options, no research done’. And without the medication, I will end up in hospital, so I don’t really have an option but to take it,” Emma says. The lack of information left her feeling “guilt and anxiety”.

More than 90% of medicines have never been tested in pregnancy, leaving millions of women around the world making this impossible choice: go without treatment or take it without full-throated reassurance from doctors that it’s safe. This year, in the biggest step change in a generation – since the Thalidomide scandal of the 1950s and 1960s – the World Health Organisation (WHO) will begin to work with scientists, doctors and drug developers to change this.

“People have been scared to treat pregnant women since the thalidomide tragedy,” says Mariana Widmer, a maternal health scientist at WHO.

“There’s no one single organisation or one individual that can make this change. This change is huge. This takes time,” she adds. “We need collaboration and we need partnerships. And this is what we at WHO would like to do ... bring together all these players at the table and work together to make this change, that’s the only way to do it.”

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Source: The Independent, 14 January 2026