9 July 2021 - Deborah Wilkes
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given the go-ahead for two oral contraceptive pills – HRA Pharma’s Hana and Maxwellia’s Lovima – to be sold without a prescription.
Michelle Riddalls – chief executive officer of the Proprietary Association of Great Britain (PAGB) – said switching the progestogen-only contraceptive pills was “an historic milestone for women and women’s health”.
Hana and Lovima, which are both supplied as film-coated tablets containing 75 microgram desogestrel, will be available from pharmacies at the end of July.
The products are available in two pack sizes – a one-month supply of 28 pills and a three-month supply of 84 pills. Maxwellia said the retail price of Lovima would be around GBP10.00 (USD14.00) per month.
Both companies have developed comprehensive pharmacy training materials to support the launches.
HRA Pharma, which already offers the ellaOne (ulipristal acetate) emergency contraceptive without a prescription in the UK, said Hana would be backed by a “significant above the line media investment which will include television and digital advertising”.
Maxwellia’s website for Lovima declares that “This pill has been liberated”, while HRA Pharma’s website for Hana focuses on the message “Daily contraception without prescription”.
Switch follows public consultation
The switch of desogestrel from prescription-only to pharmacy (POM to P) status in the UK follows a public consultation on applications from HRA Pharma and Maxwellia (click here to read the News story).
The PAGB’s Riddalls pointed out this is the “first time that any form of daily contraceptive pill has been licensed for OTC sale in the UK”. She added that “enabling women to buy the progestogen-only pill in pharmacies will be particularly beneficial at a time when accessing sexual health services has become more challenging in parts of the UK because of pressure on National Health Service (NHS) resources and the COVID-19 pandemic”.
Riddalls highlighted that both Hana and Lovima would be “sold only under the supervision of qualified pharmacists who can offer expert advice on the products and their suitability for women seeking contraceptive options”. “They will be able to pinpoint any issues that might warrant further consultation with a general practitioner or specialist,” she added.
“Increasing the number of medicines available over the counter offers people faster and easier access to effective products, encouraging self care where appropriate and reducing pressure on general practitioners and the NHS generally,” commented Riddalls.
June Raine, the MHRA’s chief executive, said the switch was “good news for women and families”.
“We have consulted a wide range of people to enable us to reach the decision to make this contraceptive available for the first time in the UK without prescription,” said Raine. “We received many responses to our consultation, the majority of which supported this approach.”
The MHRA received 494 responses to the public consultation, of which more than 80% were in favour of the switch to P status.
Desogestrel would still be available free of charge from doctors, commissioned services and sexual health clinics, noted the MHRA.
Support for the switch
Edward Morris, president of the Royal College of Obstetricians and Gynaecologists (RCOG), said his organisation had called for this switch “for some time”.
“This announcement is a huge win for women and girls who will no longer face unnecessary barriers when accessing this type of contraception,” commented Morris.
“Even before the pandemic, too many women and girls were struggling to access basic women’s health services,” he added. “The consequences of this include an increase in the number of unplanned pregnancies, which can result in poorer outcomes for women and their babies. Enabling women and girls to access the progestogen-only pill more easily and conveniently will give them more control over their reproductive health, which can only be a good thing.”
Frédérique Welgryn, chief strategic operations and innovation officer at French consumer healthcare company HRA Pharma, said: “We firmly believe that regular contraception should be widely and easily accessible to women, allowing them to make contraceptive decisions on their own terms. We are delighted to be leading the way, leveraging our expertise in women’s health and contraception, to help make this a reality for thousands of women following the efforts to achieve the reclassification of desogestrel.”
Maxwellia specialises in switches
Based in the UK, switch specialist Maxwellia says it is “converting and developing a range of prescription-only medicines into the next generation of consumer healthcare pharmacy brands which will treat a range of conditions in major public health categories including women’s health”.
The company is led by founder and chief executive officer Anna Maxwell who has spent more than 30 years working as a registered pharmacist and in the pharmaceutical industry.
“This game-changing decision is the first, but momentous, step on our journey in enabling pharmacists to broaden their front-line role,” commented Maxwell. “As a registered pharmacist, I know that pharmacists can play an even greater role in helping people take more control of their own health, which is why we are 100% focused on our switch strategy.”
“We are developing a portfolio of medicines that we know pharmacists are suited to advise on and sell,” added Maxwell.