On January 8th 2015 HRA Pharma announced that the European Commission, in a historic ruling, has authorised its advanced emergency contraceptive, ellaOne® (ulipristal acetate, 30mg), to be accessible direct from pharmacies without the need for a prescription from a doctor. This is the first ever decision of its type regarding any oral contraceptive product applicable to all EU member states, according to national implementation procedures. This new ruling will empower over 120 million women across the whole EU to gain direct access to emergency contraception.
The move follows an earlier positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), which concluded that ellaOne® works best if used during the first 24 hours, and can be used safely without a medical prescription.
Despite widespread use of regular contraceptives, 44% of all pregnancies in Europe are still unintended and a large European survey of over 7000 sexually active women has shown that 30% reported having unprotected sex at least once in the last 12 month, whilst not wanting to get pregnant. Today’s decision is a further testament to the acceptance of the need for women to be offered improved access to superior emergency contraceptive option such as ellaOne®.
Erin Gainer, CEO of HRA Pharma commented, “Since its launch in 2009, ellaOne® has increasingly been recognised amongst healthcare professionals as a new standard in emergency contraception and over 3 million women, in 70 countries have used ellaOne® since it became available. It is more effective than the existing option when taken within 24 hours of unprotected sex because it is shown to work when pregnancy risk is at its highest, right before ovulation."
She went on to add. “As both a woman and the CEO of a company committed to innovation in women’s healthcare I see this as a breakthrough moment where, for the first time, a single decision has given so many women across European Union the freedom to decide their own future.”
ellaOne® will first be available in pharmacy without a prescription in some European countries from next month (February 2015) with a full launch program taking place across the EU during the rest of the year.