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Opinion, Comment & Reviews
  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.
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