|
|
 |
|
Opinion,
Comment & Reviews
Contraception |
| |
|
| |
Emergency
contraception: why the law should make it available 'over
the counter'
By Dr Melanie Latham
Comments about this paper can be sent to: M.Latham@mmu.ac.uk
The following article appeared in the New Law Journal earlier
this year, and has been made available for this mailing through
kind permission of the author and the New Law Journal.
Emergency contraception: why the law should make it available
'over the counter'
New Law Journal, (12 March 1999), 149, 6879, pp. 366-367.
Dr. Melanie Latham
A deregulation of medicines is currently underway. The Crown
Report, the first half of which was published in March 1998,
attempted to elaborate a system for the prescribing, administration
and supply of medicines which would take account of the new
roles played by various health professionals in the supply
of medicines. To this end it also examined the legality of
group protocols issued under s58(2) of the Medicines Act 1968.
These specify contexts, criteria and sometimes dosage for
the administering of drugs to patients who may not be individually
named, thus enabling their administering by health professionals
other than the doctor. The Report recommended that, though
the administration of medicines should be largely on a patient
specific basis, there could be, 'limited situations where
(the use of group protocols) offers an advantage for patient
care.'1 Emergency contraception is provided to a large extent
in this country by Schering Health Care who manufacture the
principal product used, PC4. Currently, only general practitioners
may prescribe emergency contraception. In a press release
on 12th June 1998, Schering stated their support for the idea
of group protocols being used to enable a wider group of prescribers
than general practitioners to be involved in the supply of
emergency contraception. Arguments in favour of emergency
contraception being added to the list of medicines available
'over the counter' (OTC) in a pharmacy have come from several
quarters. Organisations such as the Birth Control Trust have
argued that women's needs would be met best by having a variety
of providers and OTC emergency contraception would lessen
the stigma attached to requesting such a medicine from a doctor.2
They have now been joined by MPs who published an Early Day
Motion in June 1998 advocating pharmacy prescription of emergency
contraception.3
Several factors would seem to favour this further liberalisation
of the law on contraception. Campaigns for contraceptive liberalisation
have been continual throughout this century leading ultimately
to the National Health Service (Family Planning) Act 1967.
Despite attempts by birth control campaigners to ensure that
contraception became a legitimate part of the health service,
they did not intend it to be controlled by medical practitioners.
However, the 1967 Act only permitted contraceptives to be
prescribed by a doctor, thus contributing to the power of
doctors in this field and, accordingly, the medicalisation
of women's health.4 In the 1990s we are witnessing a sea change
in patient behaviour and a rise in demands for patient autonomy
from women and men. Moreover, the concept of patients' rights
is becoming more firmly established in English law. Should
the law in relation to emergency contraception now be further
liberalised to take account of new attitudes to the OTC supply
of medicines?
The 1967 Act5 cleared up many of the anomalies of birth control
provision. Local Health Authority contraceptive services were
extended to include social as well as medical criteria with
no restriction of provision on grounds of age or marital status.
Section 1 empowered local health authorities in England and
Wales, with the approval of the Minister of Health, to make
arrangements for the giving of advice on contraception, for
medical examination of persons seeking such advice, and for
the supply of contraceptive substances and appliances.
Nevertheless, the Act has been the subject of criticism. Hospital
services were initially inadequate and GPs, despite readily
prescribing the Pill, remained untrained and at odds with
the government over payment (they were not paid for social
treatment in contrast to clinic staff, and they felt underpaid
for medical treatment). Contraceptives were not provided free
on the NHS until circular H.S.C.(I.S.)32, outlining the arrangements
of a comprehensive family planning service, was issued in
May 1974.
Since the passing of the Act a change in attitudes toward
medical control of health services has been evident: amongst
birth control campaigners such as the FPA; amongst campaigners
for women's rights; and amongst users of health services,
both women and men. Increasingly, patients are demanding more
of a say in their own diagnosis and treatment. This can be
seen not only in the doctor's surgery but also in encounters
between pharmacists and their 'customers'.
The concept of patient autonomy has already had some recognition
in the medical law of malpractice. Patients have the right
to be given adequate information in broad terms about a medical
treatment in order for their consent to that treatment to
be valid.6 They have a right not to be harmed by a medical
treatment, as doctors have a duty of care7 and the right to
refuse any form of treatment by the law of battery. These
legal rules are underlined by guidelines governing the conduct
of medical professionals8. Contraception itself is now accepted
as being as much a medical treatment as any other and has
therefore to be administered following the same guidelines,
whether statutory or professional. Thus a GP must offer learned
and prudent advice, must examine his patient competently and
gain her consent for such examination or treatment.9 Family
Planning Clinics must also do so, and bear in mind the general
health of the patient not necessarily pertaining to contraception.10
Pharmacists have a duty to inform customers of the side effects
of emergency contraception, as with any other drug, as part
of their professional standard of care.
Certain legal issues in relation to OTC emergency contraception
remain unresolved, however. In relation to informed consent,
in the Sidaway11 case it was held that a doctor who conforms
to a responsible body of medical opinion when deciding what
to tell a patient about the side effects of a proposed treatment
discharges his duty of disclosure to that patient. Any opinion
a defendant is claiming he or she conformed to must have a
logical basis however.12 It is unclear how far this applies
to pharmacists and remains to be resolved due to the lack
of case law involving pharmacists. It is unclear, for example,
whether the pharmacist needs to ensure that information relating
to a medicine is read, heard and understood for an truly informed
consent. There is also the problem of pharmacists supplying
contraceptives to girls under the age of 16. This is an issue
which Roman Catholic critics have underscored as a reason
to prohibit OTC emergency contraception, though in reality
the number of teenage girls seeking such treatment is likely
to be relatively small. Here the Gillick13 ruling would apply
that a girl would have to appear to be mature enough to understand
any advice she was given, and that the pharmacist felt it
was in the girl's best interests to be given contraceptive
advice and treatment. Problems of liability might be prevented
if a pharmacist was responsible personally for checking a
young girl's age, maturity, and medical history.
Emergency contraception does carry some small risk of causing
medical complications.14 Hormonal contraceptives may cause
thrombosis and strokes. The intrauterine device (IUD), which
can also be used as a post-coital contraceptive, can cause
ectopic pregnancy in a very small number of cases. These risks
should be compared however with the risks associated with
not having contraception. A woman is at a higher risk of thrombosis
from pregnancy than a hormonal contraceptive. An unwanted
and unplanned pregnancy has serious and long-term consequences
for a woman's mental and physical health. Moreover, medicines
which are potentially more dangerous than contraceptives,
such as aspirin and paracetamol are already available over
the counter. It does not follow, therefore, that contraceptives
are too medically dangerous to be available over the counter,
especially when administered by a qualified pharmacist.
There are pharmacists who are reticent. Some see emergency
contraception from a moral standpoint as an abortificacient
and do not want to be involved in the supply of the drug.
Such pharmacists could use their right to conscientious objection.15
Others criticise the lack of financial reward available to
them for supplying contraceptives in contrast to that given
to clinicians. Despite such reservations, Roger Odd of the
Royal Pharmaceutical Society recently stated that, 'surveys
have shown that about 70 per cent of pharmacists would be
happy to dispense emergency contraception, providing there
were strict guidelines.'16
There is a need for safeguards to protect women's health.
These might be provided by pharmacists acting in women's best
interests and keeping themselves and their customers informed
of the potential dangers of such products as emergency contraception.
Further safeguards might also include keeping a record of
personal details of a transaction and liaising with local
general practitioners. In addition, pharmacists might carry
out pregnancy tests before supplying contraceptives. Indeed,
pregnancy testing is a service which pharmacists already provide.
What is certain is that the ability to go down to the local
pharmacy and ask for emergency contraception from a professional
behind a counter is one which can easily be made by responsible
adults taking proper care of their own health. It is a decision
that most women would welcome the opportunity to make. Such
a further liberalisation of contraceptive law would be progressive,
popular and timely.
Dr. Melanie Latham,
School of Law,
Manchester Metropolitan University
1 Report on the Supply and Administration of Medicines under
Group Protocols HSC 1998/051, p. 3.
2 D. Paintin, Twenty Questions about Emergency Contraception
- Answered, Birth Control Trust, March 1998.
3 Early Day Motion on Emergency Contraception, Thursday 11
June 1998.
4 Cf. S. Sheldon, Beyond Control: Medical Power and Abortion
Law, (Pluto, 1997)
5 Superseded by the National Health Service Act 1977.
6 Chatterton v. Gerson [1981] QB 432, though see Bolitho v.
City 7 Hackney [1997] 2 All ER 771.
7 Whitehouse v. Jordan [1981] 1 All ER 267.
8 General Medical Council, Professional Conduct: fitness to
Practice [Bluebook] (June 1990); General Medical Council,
Duties of a Doctor, (October 1995).
9 Sutton v. Population Services Family Planning Ltd The Times
7 November 1981.
10 Ibid.
11 Sidaway v. Board of Governors of the Bethlem Royal and
the Maudsley Hospital [1985] 1All ER 643.
12 Bolitho v. City 7 Hackney [1997] 2 All ER 771.
13 Gillick v. West Norfolk and Wisbech AHA [1985] 3 All ER
402.
14 Under the Consumer Protection Act 1987 a contraceptive
manufacturer would be subject to strict liability for injury
arising from a defect in its product if there were evidence
that the manufacturer failed to act on evidence of risk to
health not justified by the product's contraceptive benefit.
15 K. Mullan, Implications of Refusal to Sell Post-Coital
Contraception, The Pharmaceutical Journal, 252, August 6,
1994.
16 The Times, Friday, June 12 1998.
|
| |
|
|
|
|
