Following the European Commission’s decision in January to switch HRA Pharma’s emergency contraceptive EllaOne (ulipristal acetate) to OTC status, the reaction of both government policymakers and healthcare professionals in pushing through the switch at national level has made for exciting viewing, particularly given the historically stubborn opposition to the free sale of EHCs, both among ruling politicians and GPs.
Regulatory authority BfArM, which makes regular switch proposals to the Health Ministry (BMG), had suggested the Rx-to-OTC switch of EHC levonorgestrel way back in 2003, with the recommendation last reviewed and updated in January 2014, only for Health Minister Hermann Gröhe and Jens Spahn – both CDU centre-right politicians – to resolutely reiterate the party’s age-old stance that the morning after pill would remain Rx. But the European Medicines Agency’s recommendation in November last year that ulipristal be made OTC prompted a sudden announcement by Gröhe that its classification would be reviewed, to the delight of centre-left coalition party the SPD, and the Greens.
Nevertheless, given the CDU’s resistance in the past, the speed with which the BMG initially planned to adopt the Commission’s centralised switch was surprising. Within a day of the announcement, a popular pharmacist publication quoted a BMG spokesperson as saying, “As far as we’re concerned, (the new classification)… is valid from today”, leading to a flurry of confused questions from pharmacist associations…Today? How… but… what?… Really? Manufacturer HRA Pharma even put in a request for pharmacists to be able to sell Rx packs without prescription as it had no packs ready for OTC sale, although this was refused by a local authority.
Things have slowed down a bit. As it stands, the Health Ministry has set out a decree, proposing both ulipristal and levonorgestrel be switched to OTC status, to be passed by the parliamentary Federal Council, with 15th March set as the date when consumers will actually be able to roll into a pharmacy and buy an EHC without a prescription.
Still to be decided on is whether consumer advertising should be restricted, what advice pharmacists will have to be provided alongside an EHC sale, and if a strict in-store protocol should be laid out, with GP associations extremely vocal about what they see as pharmacists’ lack of qualifications in advising on such a sensitive product, together with the frequent lack of an appropriate space for discussion between pharmacist and consumer. However, bespoke training programs and seminars led by female GPs are already underway in preparation, which should help to allay many of the safety concerns held by Health Minister Gröhe.
So despite initial confusion, the switch looks to be going ahead and it is undoubtedly a positive move, with around 60% of German consumers in favour according to a 2014 survey by research body Mingle. It is likely that the situation will be monitored for some time, to avoid the pills being dispensed “like smarties” as Mr Spahn feared they might be. German politicians need only look to responsible retailing in UK and France, where the birth rate is also markedly higher than in Germany, to see that pharmacists are unlikely to forget the “emergency” part of emergency contraception in a hurry.