The
Pharmaceutical Journal Vol 266 No 7132 p115
After months of deliberation and consultation, Levonelle has been deregulated
and has become available in over-the-counter packs to women aged 16 and over
at a cost of £20. Deregulation has been welcomed by family planning campaigners,
but opponents of the move have criticised the morality and safety of this decision.
Analysis of the coverage in the lay press that occurred in the week following
the announcement of the deregulation highlights the fact that the supply of
emergency hormonal contraception (EHC) exists within a social and moral context.
It is unique to date among deregulated medicines in the amount of public interest
it has aroused.
Many newspapers made explicit or implicit associations between deregulation
of EHC and the Government’s policies to reduce unwanted teenage pregnancies.
The Independent on Sunday described how “the morning-after pill will
go on sale over the counter in chemist shops . . . in a controversial move by
the Government to try to curb Britain’s number of unwanted teenage pregnancies”.
This is in spite of a Government statement that deregulation had not been introduced
as part of the strategy to reduce teenage pregnancies and “is about reducing
the number of unwanted pregnancies for all women aged 16 and over”. Although
improving access to contraception is part of the Government’s sexual health
strategy, as with any other deregulated medicine, the decision followed the
normal legal process of an application from the manufacturer of the product,
Schering Health Care, to the Medicines Control Agency. A period of assessment
and consultation followed, culminating in the MCA’s decision that Levonelle
was safe to be supplied by pharmacists to women aged 16 and over. A Government
spokesman described the Government’s stance on deregulation as a “neutral” one,
but this is an issue which arouses strong emotions and the Guardian argues
that “the moral debate on contraception and abortion has tested efforts of the
Department of Health and the Royal Pharmaceutical Society to make what some
consider a simple medical matter acceptable to Middle England”.
Opponents were quick to assess the impact, with representatives of the Conservative
party and pro-life organisations arguing that increasing the availability of
EHC “sends the wrong message about the need for responsible sexual activity”
and “will openly encourage under-age sex” (Independent). It is interesting
to note that while many commentators focus on the potential impact on teenage
sexual activity, few make reference to the fact that EHC will not be available
OTC to women under 16. There is no evidence to suggest that increasing the availability
of EHC will lead to increased sexual activity. Studies where women have been
given advance supplies of EHC to keep at home have found that women did not
use it repeatedly1 and were more likely to use barrier
methods than previously.2A recent UK study suggests
that use of EHC may cause young women to reappraise existing contraceptive practices
and, conversely, could lead to regular contraceptive use.3
Concerns that young women will “abuse” the drug through repeated use seem unlikely,
given both the disruptive effect of the drug on the menstrual cycle and the
price, which may be beyond the pockets of many women. There is little evidence
that abuse occurs when EHC is free, so it seems unlikely to occur more frequently
when women have to pay for it.
Some have suggested that the decision to deregulate EHC was rushed through by
the Government to prevent a debate. While critics were “appalled’” that such
a “far-reaching policy change” (Daily Mail) had been made without a full-scale
debate or a free vote in Parliament, this would constitute unprecedented interference
in what is ostensibly an independent decision made by the MCA. Another common
misconception was that the patient group direction schemes operating in London
and Manchester were Government-sponsored pilot schemes to assess the feasibility
of selling EHC over the counter. In fact, both were local initiatives to tackle
high rates of unwanted pregnancy.
Pharmacist’s competence to dispense EHC over-the-counter has been questioned
by some: Shadow Health spokesman, Dr Liam Fox, stated that pharmacists are “utterly
untrained” (Times) for the sale of EHC. Responding in defence of pharmacists,
Mrs Christine Glover (President of the Royal Pharmaceutical Society) argued
that pharmacists were well equipped to meet this challenge and “the training
we are talking about is just to bring them up to speed with some of the difficult
issues and sensitive issues”. It is interesting to note, that just two weeks
earlier, in this very journal, Dr Fox had described pharmacists as “the most
underused facilities we have”.4 Research with pharmacists
suggests that many feel that they need additional training to enable them to
supply this product over-the-counter, both to consolidate existing knowledge
and to help them to deal with customers requesting EHC.5,6
Typical EHC users are often stereotyped as feckless teenagers, which rarely
acknowledges that older women may have unprotected sex or experience contraceptive
failure and need to use EHC (Sun). Moreover, EHC use may be a rational
or responsible act, utilising the most appropriate form of contraception for
a particular individual.
Claims have also been made about the safety of EHC, often in contradiction of
the medical evidence. One correspondent even appears to make an implicit link
between EHC and cancer (Daily Mail). There is no evidence-base for this
claim; indeed, levo-norgestrel has been an ingredient in oral contraceptives
for many years. The Government, acting on evidence from the Committee on Safety
of Medicines, clearly believes that it is “safe and effective for avoiding pregnancy,
otherwise we would not have approved it”.7
At present, it seems likely that the existing PGD schemes will continue and
there is some indication that these schemes might expand in areas where health
authorities feel that their local population would not be able to afford the
OTC product.8 The Government has clearly placed
this decision with local health authorities, arguing that “it is for local areas
to develop their own strategy for tackling teenage pregnancy, in collaboration
with key stakeholders. Pilots where EHC is issued under the PGD route are for
all women, not just those aged under 16.”7 Supporters
of the PGD route for EHC supply have expressed concern that the high retail
price of the product may create a two-tier system, which may exacerbate existing
health inequalities. Media reporting of the deregulation of Levonelle suggests
that EHC is not considered as a public health matter but is placed within a
much wider moral perspective.
Liz Seston is a research associate at Manchester university
school of pharmacy and pharmaceutical sciences