WUNRN
European Society of Contraception & Reproductive Health
Historic
Decision from the European Commission Grants 120 Million Women Direct Access to
ellaOne® Emergency Contraceptive across the European Union.
09/01/2015
- 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.