15 October 2020 - Deborah Wilkes
HRA Pharma’s ellaOne brand has become the first emergency contraceptive pill in Italy to be made available without a prescription to women under 18 years of age. David Wright, HRA Pharma’s chief executive officer, described the development as a “milestone achievement”.
The Italian Medicines Agency (AIFA) commented that the move should help lower the conception rate for women under the age of 18 years. The regulatory agency said it was a turning point for protecting the physical and psychological health of adolescents.
HRA Pharma said it was “delighted” that national regulatory authorities had allowed equal access to ellaOne for all women. “Italian women are now equated with the rest of European women,” added the French consumer healthcare company.
Complex and challenging task
Cristián Dufeu, general manager of HRA Pharma in Italy, said the company’s global and local cross-functional teams had been striving to accomplish this “complex and challenging task” since 2008. “We hope to bring about a change in the way young Italian women use and understand emergency contraception from here onwards,” added Dufeu.
Wright pointed out that making ellaOne readily available to women of all ages across the globe without a prescription had been the vision of HRA Pharma for over a decade.
“I hope this will be a turning point both for ellaOne and for the way people perceive emergency contraception more broadly,” commented Wright.
EllaOne (ulipristal acetate) was switched to non-prescription status for emergency contraception in 2015 through the European Union's centralised procedure. The authorisation says it is “suitable for any woman of child bearing age, including adolescents” (click here to read the News story).
HRA Pharma said ellaOne had been launched as a non-prescription medicine in Italy in May 2015 for women aged 18 years and above. Minors still required a prescription.
Noting that the legal age for sexual consent in Italy was 14 years, HRA Pharma said this meant there had been a four-year period when minors might be having sex but were unable to access emergency contraception easily.
“The different status of ellaOne for women of legal age and minors meant that the strict regulations around the pill were creating a divisive barrier for young women,” stated the company.