The first commercially available pill, Enovid (progestin and oestrogen combined pill), was marketed in the USA in 1960 following Dr Carl Djerassi’s development of a steroid contraceptive in 1951. However, its purpose was initially described only as the regulation of menstruation, any public material about contraception at that stage being defined as ‘obscene’ under the Comstock Law.
In the UK, oral contraception was made available from the Family Planning Association in 1961 for married women only; a woman’s sexuality was seen as inseparable from reproduction. This continued until 1967, when the introduction of the NHS Family Planning Act allowed local health authorities to offer birth control advice to women regardless of their marital status. Seven years later, the NHS Reorganisation Act of 1974 ensured that all contraceptive advice and prescriptions via the NHS were available free of charge, regardless of age or marital status.
This did not mean that the category was suddenly without stigma, which exists to this day. However, each change is a step forward, and in the last two decades there has been a noticeable shift in perspective, partly thanks to the change in classification of emergency contraceptive (‘morning after’) pills.
The prescription-only medicine (POM) to P switch of the levonorgestrel morning after pill in 2001, followed by the switch of ellaOne (ulipristal acetate) in 2015 and its subsequent approval as an OTC medicine available to under-16s, sparked controversy, but importantly gave people a way to access emergency contraception away from a clinic setting.
Thanks to this reclassification, consumer advertising of OTC morning after pills was now permitted, and just two years ago (2019) an advert for a morning after pill (ellaOne) was shown in cinemas for the first time. Notably, the ellaOne campaigns have sought to break through the air of taboo, mystery and embarrassment that many people feel when discussing and accessing emergency contraception, and in doing so have played their part in raising awareness of the morning after pill, female sexuality and reproductive choices.
Like the ellaOne campaigns, advertising of the newly available OTC desogestrel pills could lead to greater openness surrounding contraceptive choices, particularly those made by women, who are so often expected to bear the responsibility quietly and unacknowledged.
The switch has implications for broadening access to self care, a core aim of PAGB, and a theme that has been emphasised during the COVID-19 pandemic. Removing the need for a GP appointment not only crucially frees up spaces for health services, but also benefits busy consumers, giving them quicker and more flexible access to their contraceptive pill.
Being able to access a birth control pill via a pharmacy also has the potential to highlight pharmacists’ expertise to a large part of the population, some of whom may, as a result, be more inclined than they were previously to consider pharmacists as a first port of call for self-treatable conditions.
PAGB has worked closely with member companies HRA Pharma (ellaOne and Hana) and Maxwellia (Lovima) to support them through the reclassification process, including helping them to prepare effective, engaging material within the boundaries of the Advertising Codes.
We await with optimism the response to the reclassification, the take-up of the product over the counter and the impact on NHS resources.
One thing is certain: in the UK, we have outlived the days when a wedding ring – borrowed or otherwise – was the only passport to reliable female contraception.
How and why PAGB supports reclassification
With the right processes in place, reclassifying a medicine from prescription-only to OTC status has benefits for individuals, health service providers and the consumer healthcare industry.
Whether the switch is to a P classification, making it available for sale under the supervision of a pharmacist, or to a GSL product, allowing it onto the shelves of supermarkets and corner shops, it widens access to effective and appropriate self care.
PAGB member companies have led the way with highly successful reclassifications in recent years (see below) and we’re committed to helping more brands do the same.
PAGB has worked with the Medicines and Healthcare products Regulatory Agency (MHRA) for many years to help evolve the reclassification process and continues to liaise with them about optimising the model. PAGB also provides support to companies with their switch applications and assists members during both the pre-submission and submission phases.
We advise on activities such as naming, umbrella branding and the development of risk minimisation measures. We also support companies if they’re asked by the MHRA to provide more information.
Our horizon-scanning exercise, in which we ask PAGB members twice a year about their proposed reclassification applications for the following two years, gives the MHRA a longer-term view of prospective switches.
Our Reclassification Working Group has been feeding into the MHRA’s updated guidance on switching and is developing new switch templates to encourage more reclassifications.
PAGB also helps members to shape compliant but effective advertising campaigns, offering early- concept advice all the way through to final copy approval prior to launch. Early-concept advice can be especially beneficial for a company launching its first OTC medicine and navigating unfamiliar advertising rules.
With any switch, removing the need for a GP or clinic appointment reduces the load on health services, freeing up time and resources for those who cannot self care. It offers consumers faster and more flexible access to medicines; a local shop (for GSL products) or pharmacy (for P and GSL products) is likely to stay open later than many GP surgeries and may be more conveniently located closer to work or home.
For some people – such as those seeking advice for problems that remain stigmatised, or those who feel they don’t have time to see a GP – a pharmacy consultation may feel less daunting than a formal appointment.
Medicines available via a pharmacy also give consumers a clear reason to visit, which in turn presents an opportunity to open conversations about other aspects of self care, promoting pharmacy as a first port of call for self-treatable conditions.
Milestone switches
In 2015, Nexium Control (esomeprazole) was switched to GSL, making it the first proton pump inhibitor (PPI) with this classification in the UK. The move was noteworthy also because the product went straight from a POM to GSL classification, avoiding the usual P medicine stepping-stone.
The switch offered an additional immediate option alongside the antacids and alginates already available over the counter, empowering more heartburn sufferers to select the most appropriate treatment for their symptoms. Those for whom a PPI was the most suitable option, but whose symptoms were short-term, could self-treat, freeing GP appointments for those with more severe or long-term heartburn.
The switching of Viagra Connect (sildenafil) to a P classification in 2018 provided an opportunity to tackle the stigma surrounding erectile dysfunction; the brand’s campaigns have worked to dispel myths about both the condition and drug, which are often inaccurately portrayed and humourised on screen.
This increased awareness, and the option of a walk-in pharmacy consultation over a pre-booked GP appointment, offered a route for more men to seek advice and arguably helped ease the embarrassment often suffered by those experiencing erectile dysfunction.
Similarly, advertising campaigns for OTC emergency contraceptive pills have striven to banish misconceptions and stigma surrounding the category. Switching provided a new way to access the medicine for those who might otherwise have “risked it”, because of shame or difficulty in visiting a sexual health clinic or GP surgery.
It also accelerates access to emergency contraception when time is very much of the essence for maximising efficacy, particularly in areas where, and at times when, health services are limited or under pressure.
We look forward to the similarly positive impact of future reclassifications in different therapeutic categories on public health and attitudes towards self care.
For more information or support on reclassification, contact regulatory@pagb.co.uk
