OTCs in Action Episode 25: Switches empower European Women, Brazilians


Women are empowered by OTCs this month as Nicholas Hall’s OTC.Newsflash reports that ellaOne (HRA Pharma, ulipristal acetate) emergency hormonal contraceptive became available without a prescription in France, the UK, Germany, Ireland and Poland, following the EU centralised switch in January 2015. At our recent Paris conference, Nicholas Hall & Company awarded ellaOne the Most Innovative European New Product of the Year.

In France, a survey by Harris Interactive found that, although 94% of French women aged 15-50 years are aware of EHC, 65% believe that they are misinformed on the subject, and 78% would like more information. However, ellaOne cannot be advertised, since under French regulations, it’s a “semi-ethical” drug that qualifies for partial insurance reimbursement when prescribed. Approved in mid-April, ellaOne will be promoted in France via a website, Facebook and Twitter.

Separately, effective 1st April 2015, ellaOne is available direct from pharmacies in the UK & Ireland without the need for a prescription. Alongside this move to pharmacy OTC status, the NHS and trade price of the emergency hormonal contraceptive is reduced from £16.95 (US$25.48) to £14.05 (US$21.12).

In Poland, Health Minister Bartosz Arlukowicz has signed a decree authorising the non-prescription sale of ellaOne, although this is limited to those aged 15+ years. Legislation came into force on 16th April 2015.

In related news, Brazil’s regulatory group, ANVISA, has proposed a new framework for Rx-to-OTC switch. Nicholas Hall’s Network Partner in Brazil, Henry Adler, explained: “ANVISA’s intention is to make sure that all products reclassified as OTCs are actually switched or lose their registration. And that applies to those products that are legally OTC but continue to be treated as if they are Rx or OTX. So, ANVISA is finally getting round to cleaning up the market: soon there will be Rx, OTCs, generics and equivalents. The aim appears to be to increase competition and keep prices low. In that way, the Ministry of Health will work towards its strategic objective of increasing the population’s access to medicines.

Currently, an OTC must be listed by therapeutic group and indication in the List of Groups & Specified Therapeutic Indications, which has not been updated since 2003. Open for Public Consultation until 15th June 2015, the proposed regulations include:

  • OTCs, their active principles and their indications will be defined by ANVISA according to the Guide to Therapeutic Classes of OTCs (GCTMIP)
  • To be considered for switch, medicines must have been sold for at least 10 years under prescription in Brazil, or OTC or Rx in countries whose regulatory agencies have a co-operation agreement with Brazil, and have demonstrated a high safety profile
  • Once approved, switched products must be dispensed by the pharmacist for 12 months
  • New medicines may come to market straight away as an OTC if they meet relevant safety requirements
  • ANVISA will update the GCTMIP periodically, but at least at yearly intervals. Companies marketing products that can be switched following changes in the GCTMIP have 180 days to reclassify them. If they fail to do so, their product registration will be cancelled.

Meanwhile, in the US, we await Pfizer’s decision on whether or not it will attempt to switch Lipitor (atorvastatin) from Rx-to-OTC. Last year the company conducted a clinical trial to determine the viability of the switch. Over the years, other marketers  have tried to pioneer the Rx-to-OTC switch of this class of drugs …. watch OTC.Newsflash and sister weekly bulletin OTC.NewDirections, which focuses on switch and science, for the latest news.