A CHALLENGE TO THE LEGALITY OF SUPPLYING THE ‘MORNING AFTER PILL’ (LEVONELLE-2) WITHOUT A PRESCRIPTION.

1. BACKGROUND.

In June 2000 the Medicines Control Agency consulted on an application under the Medicines Act to reclassify Levonorgestrel 0.75 mg (Levonelle-2), ‘the post-coital pill (PCP)’, from a prescription only medication to pharmacy availability for women of 16 years and over[1].  Levonorgestrel 0.75 mg has been available as a prescription-only medicine (POM) since 1999.  The Medicines Commission will consider the responses to this consultation process and their recommendations presented to Ministers for their consideration.  A favourable response would lead to an Order being laid before Parliament to amend the Medicines Control Act.

2. INTRODUCTION.

The deregulation of Levonorgestrel 0.75 mg is part of a government strategy to make birth control measures widely and freely available in order to reduce ‘unwanted’ pregnancies, especially amongst teenagers. In this article we begin by considering whether Levonorgestrel 0.75 mg is a contraceptive or abortifacient and hence subject to the abortion laws and whether pharmacists with conscientious objection to dispensing it would be protected by the Conscience Clause of the 1967 Abortion Act. The question of liability in supplying Levonorgestrel 0.75 mg from the standpoint of Ministers, doctors, pharmacists and the manufacturers of Levonorgestrel 0.75 mg is also considered.

In conclusion, the deregulation of Levonorgestrel 0.75 mg is fraught with legal difficulties particularly with regards to dispensing to girls under the age of 16 years, conscientious objection to abortion and the potential for negligence claims against pharmacies and pharmacists in the event of pregnancy, including ectopic pregnancy, in users.

3. IS LEVONORGESTREL 0.75 MG (LEVENOLLE-2) CONTRACEPTIVE OR ABORTIFACIENT?

One of the first issues to be decided is whether Levonorgestrel 0.75 mg is contraceptive, a form of emergency hormonal contraception, or abortifacient.  In a written parliamentary reply, Yvette Cooper (Health Minister) stated that: -

“The accepted legal and medical view is that emergency contraception is not a method of abortion. Emergency contraception pills work before implantation and so before a pregnancy has been established”.  Moreover, she went on to explain,

“My right hon. Friend the Attorney-General, in answering a parliamentary question in 1983, stated that medical practitioners would not be prosecuted for illegal abortion if they sought to prevent implantation by the use of the ‘morning-after pill’ or an inter-uterine device (IUD)”.[2] 

It seems strangely contradictory for the Minister to point out that ‘emergency contraception’ is, in fact contraceptive, whilst favourably reporting the Attorney General as saying that even if medical practitioners “sought to prevent implantation by the use of the ‘morning-after pill or an IUD’, they would not be subject to prosecution for abortion.

The term conception is defined as the fertilisation of an egg by a sperm[3].  Furthermore, this definition has been accepted by the US Supreme Court[4].  Contraception refers to means that prevent conception.  An agent acting after conception cannot be contraceptive. Abortifacient drugs and devices are those that cause the expulsion of the conceptus from the womb.

There is ample medical evidence that the inaptly called ‘emergency contraception’ acts as an abortifacient by interfering with implantation of the conceptus in the lining of the womb (endometrium).

Grou has concluded that post-coital drugs act principally by terminating a viable pregnancy by interfering with the endometrium-

“This mode of action could explain the majority of cases where pregnancies are prevented by the morning-after pill”[5].

According to Harper et al-

“Emergency contraceptive pills, also known as morning-after pills, are a postcoital hormonal treatment that appears to inhibit implantation of the fertilized ovum”.[6]

The respected textbook Martindale – The Extra Pharmacopoeia, unambiguously states that:-

            “Methods of contraception which prevent implantation of a fertilised ovum include progestogen-releasing intrauterine devices and postcoital oral contraception (The Yuzpe regimen or so called ‘morning after pill’)”[7]

With regards to the mode of action of morning-after pills, the World Health Organisation states that:-

“Depending on the stage of the cycle when the treatment is given, emergency contraceptives may affect follicular development, ovulation and/or corpus luteum function and there is also evidence suggesting influence on the endometrium”.[8]

Indeed, the product Schering PC4 which is marketed as a form of post-coital contraception acts, according to the manufacturers specification to prevent implantation.

“Schering PC4 is primarily aimed to prevent implantation of the fertilised ovum in the endometrium”.[9]

That conception involves the union of maternal and paternal gametes is now also the Common Law view as stated by Lord Clyde in a House of Lords Judgment[10].  Indeed, the fact that an embryo can be produced in vitro, clearly establishes that implantation is not a part of the process of fertilisation.

“The creation of an embryo from which a foetus is developed requires the bringing together of genetic material from the father as well as from the mother. The science of human fertilisation and embryology has now been developed to the point where the embryo may be created outside the mother and then placed inside her as a live embryo.

It serves to remind us that an embryo is in reality a separate organism from the mother from the moment of its conception. This individuality is retained by it throughout its development until it achieves an independent existence on being born. So the foetus cannot be regarded as an integral part of the mother in the sense indicated by the Court of Appeal, notwithstanding its dependence upon the mother for its survival until birth”.

If ‘the morning after pill’ can prevent implantation of an early embryo, it is biologically plausible that it could also displace a newly implanted embryo by altering the state of the womb lining (endometrium) to become ‘hostile’. Maternal factors such as a poorly developed endometrium, are an important cause of spontaneous early miscarriages.  It is therefore surprising that Ms Cooper can state with such assurance that “Emergency contraceptive pills will not cause an abortion if taken after implantation”.  There is no evidence for this statement.

Yvette Cooper is clearly wrong to state that emergency hormonal contraception is “not a method of abortion”.  There will be times, if Levonorgestrel 0.75 mg is administered to a woman before conception has occurred, that it could have a contraceptive action e.g. by preventing passage of sperm through the cervical mucus or by preventing ovulation.  However, following conception, if Levonorgestrel 0.75 mg is given to prevent pregnancy, it must be acting as an abortifacient. 

Nevertheless, whilst Yvette Cooper is wrong to deny the biological fact that Levonorgestrel 0.75 mg can act as an abortifacient, might she still be correct in affirming that it is not regarded as abortifacient from a legal point of view?

The law regarding abortion is enshrined within three Acts – The Offences Against the Person Act 1861, The Abortion Act 1967 and amendments of the Abortion Act within section 37 of the Human Fertilisation and Embryology Act 1990. Interestingly, the term ‘abortion’ is not specifically defined.

In the Offences Against the Person Act 1861, section 58 states that;-

            “Every woman, being with child, who, with intent to procure her own miscarriage, shall unlawfully administer to herself any poison or other noxious thing, or shall unlawfully use any instrument or other means whatsoever with the like intent, and whosoever, with intent to procure the miscarriage of any woman, whether she be or be not with child, shall unlawfully administer to her or cause to be taken by her any poison or other noxious thing, or shall unlawfully use any instrument or other means whatsoever with the like intent, shall be guilty of a felony……”

Section 59 prohibits the supply or procurement of drugs to procure a miscarriage[11]..  This section would apply to pharmacists supplying an abortifacient drug.

Abortion is not defined. However, the offence under the 1861 Act relates to procuring, or even intending to procure, a miscarriage, whether or not the woman is actually pregnant.  The felony does not rest on whether, or not, implantation has actually occurred.  Notwithstanding the statement by the Attorney General already referred to, it would appear that a pharmacist might still be prosecuted for attempting to procure a miscarriage whether or not the woman is actually pregnant.  This would be a matter of criminal, not civil, law.

A similar case has been argued by Keown, who has proposed that the term ‘miscarriage’ applies from the moment of conception irrespective of implantation in the womb.[12]  Glanville Williams in “Sanctity of Life and the Criminal Law, 1958”[13] initially supported this view:-

“At present both English law and the law of the great majority of the United States regard any interference with pregnancy, however early it may take place, as criminal, unless for therapeutic reasons.  The foetus is a human life to be protected by the criminal law from the moment when the ovum is fertilised”.(p.141).  However, he subsequently seems to have altered this view in his more recent “Textbook of Criminal Law”: -

“There is therefore, nothing to prevent the courts interpreting the word ‘miscarriage’ in a way that takes account of customary and approved birth control practices.[14]””

Why the courts should take account of modern birth control practices is unclear, particularly if an intention to procure miscarriage is sufficient for the offence.  The intention in using Levonorgestrel 0.75 mg would be to prevent the birth of a child. It is difficult to see the ethical or legal distinction between interrupting a pregnancy shortly after conception and several days later.

According to Michael Davies,[15] Section 2(3) of the Human Fertilisation and Embryology Act 1990 ends the matter.

& “For the purposes of this Act, a woman is not to be treated as carrying a child until the embryo has been implanted”. 

There are problems with this interpretation.  First, the 1990 Act refers to an unusual mode of reproduction namely IVF, not natural procreation.  Hence, it is intelligible, that carriage for a woman undergoing in vitro fertilisation should be deemed to start at implantation.  The woman could hardly be regarded as ‘carrying’ frozen embryos that have not been implanted.  The separation of fertilisation, occurring outside the body, in vitro, from implantation within the recipient ‘mother’s’ womb creates this anomaly.  Where natural fecundation occurs, this anomaly cannot occur as insemination occurs within the context of normal sexual relationships and fertilisation and implantation are not artificially separated.  Second, Section 2(3) is specific to the 1990 Act.  Section 1 (2) makes it clear that “This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body”. Indeed, the 1990 Act makes other statements, which whilst defining the law, hardly make any biological sense. Within the Act we are told that the ‘father’ of the embryo is the married partner, even if the sperm was taken from another man, unless the spouse either refused the IVF or insemination (Section 28 2(b)).  However, even a married donor would not be regarded as the ‘father’ if the sperm was used after his death (Section 6 (b)).

However, the Surrogacy Arrangements Act 1985, does define when a woman is deemed to ‘carry a child.’

Section 1 (6) states “A woman who carries a child is to be treated for the purposes of subsection (2)(a) above as beginning to carry it at the time of the insemination or of the placing in her of an embryo, of an egg in the process of fertilisation or of sperm and eggs, as the case may be, that results in her carrying the child”.  A “surrogate mother” is a woman who “carries a child in pursuance of an agreement – (a) made before she began to carry the child and (b) made with a view to any child carried in pursuance of it being handed over to, and parental responsibility being met (so far a is practicable) by, another person or other persons. (Section 1(2) (a & b)).

The Abortion Act 1967, as amended by the Human Fertilisation and Embryology Act 1990, s 37, now means that a registered medical practitioner shall not be guilty of an offence in terminating a pregnancy if two registered medical practitioners have formed the opinion in good faith that the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman or any existing children of her family (s 1(1)(a)); providing the pregnancy has not exceeded its twenty-fourth week. The following reasons for abortion were freed from gestational restriction by the 1990 Act and include; where there is a risk of grave permanent injury to the physical or mental health of the pregnant woman, where the continuance of pregnancy would involve risk to the life to the pregnant woman greater than if the pregnancy were terminated and where there is a substantial risk that the child, if born would suffer severe mental or physical handicap.

The advent of unambiguously medical forms of abortion in the form of antiprogesterones has meant a relaxation of the location rules, which determine the premises where abortions can be carried out. 

 

Conclusion: Levonorgestrel 0.75 mg is abortifacient.

Until the passage of the Abortion Act in 1967, the medical profession had always opposed abortion and attempts to procure abortion. This is clear from the Hippocratic Oath “Nor will I give a woman a pessary to procure an abortion”. Respect for all human life from conception is also affirmed in the Declarations of Geneva[16] and Oslo[17]wwhich were both endorsed by the World Medical Association at Venice in 1983.  As Lord Clyde has pointed out so clearly, the fact that fertilisation can occur outside the mother’s body proves that the conceptus can no longer be regarded as a maternal appendage but constitutes a new individual, who, even in the first moments after conception can exist apart from the mother. The intention in procuring an ‘early’ medical abortion is to prevent the birth of a child who may already have been conceived.  The moral objection to such early abortions, or miscarriages, is derived from the intention to prevent the birth of a child, rather than any putative ethical distinctions between the moral significance of the life of a conceptus immediately before implantation, compared to immediately afterwards.  What is morally relevant is the deliberate attack upon life itself. That is clearly the intention, irrespective of the modus operandi of the means used. The only difference that modern medical scientific knowledge and technology has made to the debate is a better understanding of how precisely post-coital pills work – although the processes of conception and implantation were known by those formulating the Offences Against the Persons Act in 1861. 

The use of the post coital pills should be regarded as attempts to procure miscarriage under the 1861 Act and therefore be subject to the Abortion Act 1967, which decriminalised offences under the 1861 Act under specified circumstances. According to Section 6 “the law relating to abortion’” means sections 58 and59 of the Offences against the Person Act 1861,and any rule of law relating to the procurement of abortion”.  This seems to recognise the equivalence of ‘miscarriage’ and deliberate ‘abortion’ as already alluded to above.

4. CONSCIENTIOUS OBJECTION.

If the use of Levonorgestrel 0.75 mg is a means of procuring abortion, then the Conscience Clause of the Abortion Act should apply to pharmacists.

“Subject of subsection (2) of this section, no person shall be under any duty, whether by contract or by any statutory or other legal requirement, to participate in any treatment authorised by this Act to which he has a conscientious objection”.

However, since conscientious objection is a question of morality, it is the biological rather than the legal definition of pregnancy, which is persuasive in the ethical debate.  In a clinical trial of Levonorgestrel 0.75 mg[18],, it was found that 10% of the women had conceived beforehand.  (This was known because urinary pregnancy tests were taken from all women entering the trial).  Moreover, post-coital drugs are never completely effective and it has been estimated that approximately 1% of women will become pregnant after using PCP following a single act of unprotected intercourse. Hence, notwithstanding the issue of whether or not Levonorgestrel 0.75 mg is abortifacient per se, the issue of referral for abortion will arise for community pharmacies providing post coital medication.  When women return to the Pharmacy with a suspected pregnancy because of ‘failed’ treatment, the issue of conscientious objection will again arise in relation to referring for, or recommending, abortion.

Would pharmacists have a right of conscientious objection in relation to abortion referrals?  In this regard, the case of Mrs Janaway, a typist, who claimed unfair dismissal for refusing to type a referral letter for a termination of pregnancy, is of interest[19]..  The case went to the House of Lords and was rejected on the basis that typing a referral letter did not constitute participation in the abortion itself. The difference, in practice, between a medical secretary typing a letter of referral to a doctor and a pharmacist making a referral for abortion is that the latter has already become involved in birth control advice and provision of ‘services’ and has become involved in the clinical management of the woman in a way that a medical secretary has not. However, the ‘need’ for referral is a contingent possibility of the initial contact between the woman and pharmacist.  It would seem appropriate that account should be taken of whether the pharmacist should be contractually obliged to offer or provide birth control means and advice in the first instance.  Hence, the provision of post-coital services by pharmacists cannot simply be restricted to the dispensing of medication.  In the case of dispensing prescribed medication, the overall legal and clinical responsibility remains with the prescribing doctor.

According to a recent BMJ paper[20],, “Teenagers whose pregnancies end in termination are more likely to have received emergency contraception before conception, emphasising the need for adequate follow up”.  Moreover, the authors concluded that ”Improved knowledge of, and access to, emergency contraception is often advocated as a means of reducing teenage pregnancy.  Teenagers who choose this method, however, may be more at risk of unintended pregnancy, possibly because it is a marker of ”risk taking” in sexual activity.  This emphasises the importance of appropriate follow up to address longterm needs for contraception whenever a teenager consults for emergency contraception.  It also raises questions about the possible supply of emergency contraception by agencies who are unable to provide such follow up”.

5. NEGLIGENCE.

At first sight, it would appear that the deregulation of Levonorgestrel 0.75 mg is a relatively straightforward matter. Providing certain criteria are fulfilled, the Secretary of State, suitably advised by the Committee on Safety of Medicines and the Medicines Control Agency makes a decision that the drug can be safely and effectively supplied without a doctor’s prescription bearing in mind not only the side effects of the drug but any possible consequences of its widespread availability if it is not used correctly.  Hence, ‘deregulation’ appears to require a straightforward ‘operational’ decision by the Minister based upon the medical evidence to make an order to reclassify a drug under the Medicines Act 1968. 

However, making Levonorgestrel 0.75 mg widely available is part of a more general strategy to reduce teenage pregnancy between the Departments of Health and Education which involves both sex education as well as contraception and abortion services.

Government Policy on ‘emergency contraception.’

The deregulation of ‘emergency contraception’ is in keeping with Government policy as outlined in the publication by the Social Exclusion Unit on Teenage Pregnancy (June 1999) regarding “Effective advice and contraception for young people”[21]

“Action plan 14.

New NHS criteria of effective and responsible youth contraception and advice services.

As part of it new Sexual Health Strategy, the Department of Health will provide new guidance on the criteria for provision of effective youth contraception and advice services. This will be used to monitor services under the Health Improvement Programme and develop good practice guidance. Special funding for areas with high rates of teenage pregnancy will be available through the local   implementation fund as described in action point 4. Improving contraception and sexual health services for young people would also be an eminently suitable focus for a lottery funded Healthy Living Centre.  The key principles are that services should be:

• accessible, to young people in terms of location, travelling distance, opening hours, including adequate access to emergency contraception, atmosphere, staff quality and training; and reflect the priority young people give to confidentiality”.;
• publicised, so that all those who may need them know where and when services can be assessed;
• joined up, so staff make the links between e.g. contraception issues and STIs, or pregnancy testing/abortion and future contraception needs; also link to secondary education outside schools and youth services;
• effective, making clear the risks if contraception is not used consistently and what to do if contraception is missed;
• open to all, so boys as well as girls are engaged (may require a review of innovative practices about access to services, e.g. providing condoms) and services accessible to ethnic minorities; and
• responsible, offer counselling, particularly for under 16s”.(p.96)

  The Council of the Royal Pharmaceutical Society acknowledged the Government’s intention in using community pharmacies to make emergency contraception more widely available and that:-

“There was a danger that if pharmacy opposed deregulation of Levonelle-2, the Government would simply use other means and other health care professionals to pursue its policy of widening and speeding up public access to health care”.[22]& 

It is clear that the Government intends to make Levonorgestrel 0.75 mg widely available through Pharmacies without prescription, a view that is clearly acknowledged and endorsed by the Royal Pharmaceutical Society.

“Therapeutic” and “non-therapeutic” medical treatment.

Finally, before considering the issue of possible negligence in relation to the supply of Levonorgestrel 0.75 mg, it must be pointed out that unlike most other forms of medication Levonorgestrel 0.75 mg is a drug, which, strictly speaking, is used for non-therapeutic purposes. The ‘condition’ being treated is possible unintended pregnancy.  The woman presenting for supplies is not suffering from any pathology, but may be experiencing, or about to experience, a normal physiological state – pregnancy.  There can be no doubt that Levonorgestrel 0.75 mg is being supplied not for bona fide medical reasons, but rather for a social, or even ‘recreational’, reason. The distinction between therapeutic and non-therapeutic procedure is well established in relation to ’non-therapeutic’ sterilisation of the mentally handicapped. 

In the case of JSWB and SMB[23],, Mr Justice Brennan sought to define therapeutic and non-therapeutic:

”I would define treatment (including surgery) as therapeutic when it is administered for the chief purpose of preventing, removing or ameliorating a cosmetic deformity, a pathological condition or a psychiatric disorder, provided the treatment is appropriate for and proportionate to the purpose for which it is administered.  “Non—therapeutic’ medical treatment is descriptive of treatment which is inappropriate or disproportionate having regard to the cosmetic deformity, pathological condition or psychiatric disorder for which the treatment is administered and of treatment which is administered chiefly for other purposes”.

The nature of negligence.

Medical negligence is not substantially different from negligence in general.  According to Lord Greene M.R[24].. “Negligence is the breach of a duty to take care. That duty arises by reason of a relationship in which one person stands to another. Such a relationship may rise in a variety of circumstances”. 

Duties of care can arise from common law or statute law and depend upon three criteria, as established in Caparo Industries Plc v. Dickman[25].. There must be;-

1. a proximate relationship between plaintiff and defendant.
2. the forseeability of harm to the plaintiff, to whom a duty is owed and
3. it must be just and reasonable that a duty of care is owed in the circumstances.

Hence, in the recent case of Jolley v Sutton London Borough Council (House of Lords, 18th May 2000), a local council which allowed an abandoned boat to remain on its land in a derelict condition, where held negligent when a child who was attempting to repair the boat, sustained a broken back and consequent quadriplegia.

However, difficulties may arise in determining negligence in the case of the discretionary exercise of statutory powers by authorities.

“On this basis, if an authority acts wholly within its discretion – i.e. it is doing what Parliament said it can do, even if it has to choose between several alternatives open to it, then there can be no liability in negligence.[26]””

This is because, according to Lord Browne-Wilkinson:-

“The courts should proceed with great care before holding liable in negligence those who have been charged by Parliament with the task of protecting society from the wrongdoings of others[27]““.

However, the situation regarding the exercise of statutory powers is complex since the decisions made can relate to policy or operational matters.  As Lord Slynn explained[28],

““Another distinction which is sometimes drawn between decisions as to “policy” and as to “operational acts” sounds more promising.  A pure policy decision where Parliament has entrusted the decision to a public authority is not something which a court would normally be expected to review in a claim in negligence. But again this is not an absolute test. Policy and operational acts are closely linked and the decision to do an operational act may easily involve and flow from a policy decision. Conversely, the policy is affected by the result of the operational act.  (see Reg. V. Chief Constable of Sussex, Ex parte International Trader’s Ferry Ltd [1993] 3 W.L.R 1260)”.

“The ultimate question is whether the particular issue is justiciable…..The two tests (discretion and policy/operational) to which I have referred are guides in deciding the question. The greater the element of policy involved, the wider the area of discretion accorded, the more likely it is that the matter is not justiciable so that no action in negligence can be brought”.

Ministerial liabilities.

The Medicines Act 1968 makes provision for certain drugs to be made available ”off prescription” at the discretion of Ministers. This is a discretionary power which leads to ‘operational;’ decisions by Ministers of the Crown.  Whilst Ministers are advised as to clinical safety of supplying drugs ‘off prescription’, the deregulation of Levonorgestrel 0.75 mg has social implications and, as we have seen above, is already part of Government strategy in dealing with teenage pregnancy.  A decision to deregulate PCP therefore appears to be an ‘operational’ decision arising from the Minister’s discretionary powers, whilst at the same time having the features of a ‘policy’ decision.

Criteria for non-prescription medicines

 The criteria used to determine if a drug can be safely supplied “off prescription” are, first that it can be given without the supervision of a doctor and second, that the drug poses little risk to human health either directly or indirectly[29].

The criteria under Directive 92/96/EEC are as follows: Prescription control is applied to any product which: -

a)    is likely to present a direct or indirect danger to human health, even when used, correctly if used without medical supervision; or

b)   is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or/p>

c)    contains substances or presentations of substances of which the activity requires, or the side effects require, further investigation; or

dd)   normally prescribed by a doctor or dentist for parental administration (not applicable for Levonelle-2).

2. Exemption from prescription control may be made having regard to:

1. the maximum single dose;
2. the maximum daily dose;
3. the strength of the product;
4. its pharmaceutical form;
5. its packaging; or
6. such other circumstances relating to its use as may be specified in the determination.

Direct and indirect effects on human health.

Criterion 1(a) states that it is possible to take into consideration any direct or indirect effects to human health from the supply of Levonorgestrel 0.75 mg. The questions to be addressed therefore include:-

(i)  Side effects of Levonorgestrel

If Levonorgestrel 0.75 mg is to be available without prescription, it should not pose a direct danger to health and there should be no significant contraindications or risks to its use. Since Levonorgestrel 0.75 mg is not strictly being used in a medicinal sense to treat a pathological condition but rather for a social or ‘recreational’ indication, the margin of safety should be greater than for a genuinely therapeutic drug. Where a drug is being used therapeutically the risks and benefits of treatment can be weighted in the light of the pathological condition being treated. 

Schering Health Care Ltd produces Levonorgesterel as the mini-pill, Norgeston, which contains 30 micrograms.  However there are significant discrepancies between the Data Sheet for Norgeston [30]

 and the Summary of Product Characteristics for Levonelle-2[31]..

The Summary of Product Characteristics (SPC) for Levonelle-2 was revised by Schering Health Care Limited on 1st December 1999 after the first authorisation in October 1999.  There are a number of differences and  peculiarities in the SPC compared with the Data Sheet Compendium for Norgeston (Levonorgestrel 30 micrograms) which is used as a progesterone only mini-pill.  The Data sheet for Norgeston lists the contraindications to Levonorgestrel 30 micrograms as: – pregnancy, severe disturbance of liver function, jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; Rotor syndrome; previous existing liver tumours; a history of herpes of pregnancy; mammary carcinoma or a history of this condition; undiagnosed abnormal vaginal bleeding; history of existing thromboembolic process (e.g. stroke or myocardial infarction); severe diabetes with vascular changes; sickle cell anaemia or hypersensitivity to any of the components of the drug. 

In the SPC for Levonelle-2 the specified contraindications are reduced to pregnancy or abnormalities in menstruation or vaginal bleeding.  However, we are told in the most vague of terms that “Progesterone-only contraceptive pills (POPs) are used as a routine method for birth control over longer periods of time, and are contraindicated in some conditions.  It is not known whether these same conditions apply to the Levonelle-2 regimen consisting of the emergency use of two pills”.

This last statement is misleading.  The fact that there are contraindications for the mini-pill such as Norgeston (30 micrograms) would imply that the same contraindications should apply to Levonelle-2 unless the contrary had been proven in clinical trials.  It is simply not sufficient to say “it is not known whether these same conditions apply to Levonelle-2”.  The statement is misleading in suggesting to patients that the long-term use of low dose Levonorgestrel in a dose of 30 micrograms daily is equivalent to taking only two tablets over a much shorter period.  In fact, 25 tablets of the mini-pill Norgeston i.e. equivalent to one tablet of Levonelle-2  (i.e. 25 times 30 micrograms is equal to 750 micrograms or 0.75 mgs of Levonorgestrel in Levonelle-2.  However as two tablets of Levonelle-2 are used 12 hours apart – a ‘course of Levonelle-2 is equivalent to taking 50 mini-pills within 12 hours. 

The Data Sheet for Norgeston mentions that “according to the present state of knowledge, an association between the use of hormonal contraception and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out”. It states reasons for stopping Norgeston immediately.  These include circumstances where there is considered to be a risk of thromboembolic consequences – the first onset or exacerbation of migrainous headaches, or unusually frequent or severe headaches, disturbance of vision, hearing or other perceptual disorders or the first signs of thrombophlebitis or thromboembolic symptoms (e.g. leg swelling or chest pains).  It is also suggested that Norgeston is stopped six weeks before major  operations and for 2 weeks after post operative ambulating.  There is therefore a clear indication that thromboembolic disorders are considered important with Levonorgestrel in the form of the mini-pill.   In the SPC for Levonelle-2 it states that “Traditionally many of the contraindications to combined hormonal contraception have been applied to progesterone-only contraception.  Since the contraindications largely apply to oestrogen this  is inappropriate”.  The word “traditionally” must be unique to this SPC for Levonelle-2 but cannot substitute for a clear reappraisal of the thromboembolic risks of Levonorgestrel. Either there is no risk, in which case, why is it mentioned for Norgeston, or there is a risk in which case it must be specified in the SPC for Levonelle-2.  If Schering Health Care Ltd admits to the thromboembolic potential for Levonorgestrel (in Norgeston) and a woman was to develop a stroke or a pulmonary embolus on Levonelle-2, it would be easy to imagine how litigation might be forthcoming.  Schering would be hard pressed to show that a high dose of Levonorgestrel, in Levonelle-2, was safe whilst stating in the Data Sheet that a lower dose of Levonorgestrel, in Norgeston, was not.

Special warnings and precautions for Norgeston include, diabetes or a tendency towards diabetes, a history or perceived risk of venous or arterial thromboembolic disorders and  breast cancer.  In the SPC for Levonelle-2 special precautions and warnings are mentioned only to be dismissed.  “Since exposure to levonorgesterel with Levonelle-2 is brief, the risks of pregnancy in all women, including those with pre-existing medical conditions, are almost certainly greater than those associated with Levonelle-2”. This astonishing statement seems to imply that all precautions can  be ignored anyway!  This, again is an extraordinary loose statement for a pharmaceutical company to make, but also fails to take into account the simple fact that after a single episode of unprotected intercourse only 8% of women are likely to become pregnant i.e. over 90% would not become pregnant. It must be most unusual for a SPC to itemise precautions and then give broad advice that they can all be systematically ignored whilst admitting that “in individual cases the risk-benefit ratio should be assessed by the practitioner in discussion with the patient”.

There is a list of drug interactions with Norgeston and Levonelle-2. However it is difficult to see how a pharmacist would necessarily be able to appreciate some of these – such as the requirement for oral antidiabetics and insulin resulting form effects on glucose tolerance.  More over a pharmacist may not necessarily be in a position to appreciate the significance of absorption problems in case of malabsorption or diseases such as Crohn’s disease.  Examination of the breasts, pelvis and blood pressure “should precede the prescription of Norgeston and should be repeated regularly”. However, for Levonelle-2 breast or pelvic examination, blood pressure or indeed any “routine laboratory testing” is not required.

In the Data Sheet for Norgeston, the drug should be stopped immediately in case of pregnancy since it is contraindicated and the risk of foetal malformations “cannot be excluded” even though “it  is certain that if a risk exists at all it is very small”.   The advice for Levonelle-2 is that  “the effect of Levonelle-2 on the foetus is unknown”.  It goes on to say “The consensus opinion amongst teratologists is that known teratogens will produce malformations before organogenesis starts, which is later than the 72 hours after fertilisation”. However, this implies that the timing of intercourse and the absence of any preceding pregnancy is known. In the study comparing Levonorgestrel 0.75 mg with the Yuzpe regimen, four women were found to be pregnant at enrollement (on the basis of urine tests) and were excluded from analaysis. An additional 38 women became pregnant during the study (11/976 on Levonorgestrel 0.75 mg and 31/979 in the Yuzpe regimen group).  Hence, of the total number of women enrolled for the study approximately 10% were pregnant – 4 at entry and 38 subsequently).  Hence, in the paper published by the Lancet 10% of the pregnancies that occurred during the study were deemed to have occurred prior to the episode of ‘unprotected intercourse’ i.e. these women were actually pregnant when Levonelle-2 was given – even though this was a well-controlled clinical trial in which the average age of the women was 27 years.  If Levonelle-2 becomes widely available it will be administered outside the strict circumstances of a clinical trial to women and girls who are very much younger and hence less reliable. It is difficult to see how pregnancy can be excluded if history taking is unreliable and “no routine laboratory testing is required”.   It is therefore certainly likely that early pregnancies – around the time of organogenesis – will be exposed to high dose Levonorgestrel.  Moreover in the Lancet study, the pregnancy rate in the women given Levonorgestrel 0.75 mg was 1.1%.  It has been estimated that approximately one million packs of morning-after pills are being prescribed annually – Pharmacy Magazine Feb 2000).  (If 1% of women overall would become pregnant after unprotected intercourse who subsequently took Levonelle-2 this would mean approx. 10,000 women would be found to be pregnant of the 1,000,000 prescriptions annually)

(ii).     Indirect  effects: Sexually transmitted disesease: STDs.

In 1997 there were 455,500 new cases of STD, including 54,400 new cases of chlamydia (an important cause of female infertility), 27,400 cases of herpes and 106,000 of genital warts.  The Chief Medical Officer’s recent Expert Advisory Group on Chlamydia concluded that “action is required to reduce the prevalence and morbidity associated with chlamydia infection.  The sequelae of infection are severe and can have lifelong implications ”.

According to “Teenage Pregnancy”

“In a single act of unprotected sex with an infected partner, teenage women have a 1 per cent chance of acquiring HIV, a 30 per cent risk of getting genital herpes and a 50 per cent chance of contracting gonorrhoea.  Sixteen to nineteen year olds have the highest rate of increase in gonorrhoea of any age group, with a 45 per cent increase in new cases in 1995-1997 alone.  One STI, chlamydia, affects teenage girls more than any other age group.  It is the biggest cause of ectopic pregnancy, and can lead to infertility.  It can cause discharge and pain, but there are usually no symptoms, so the sufferer may never know they are infected.  Diagnoses of chlamydia in Genito-Urinary Medicine clinics of 16-19 year olds rose by around 53 per cent between 1995-1997.  The prevalence of genital warts amongst teenagers has also increased by a quarter over the same period”.a href="#_edn32">[32]

According to the Alan Guttmacher Institute[33]  STDs are a particular problem in teenagers.

“Sexually active teenagers, especially males, tend to engage in riskier behaviour than adults:  They have more partners, have more-high risk partners and often do not use condoms. Consequently, sexually active teenagers, along with adults younger than 25, generally have the highest STD rates of any age-group.  Married adolescent women who themselves may be monogamous are at risk of acquiring STDs if their husbands have sexual encounters outside the marriage.

Additionally, biological and social factors heighten the risk for young girls and teenage women. Young women contract STDs more easily than adults because they have fewer protective antibodies and the immaturity of their cervix facilitates the transmission of an infection.  In some societies, sexual coercion has emerged as a major risk factor for young girls; many of whom are forced to have sex or are given gifts of money in exchange for sex, precisely because they are seen as being disease-free.

Those who are infected with an incurable STD – genital warts, herpes or HIV – bear the debilitating effects of the disease for the rest of their lives.  Many become infertile and are unable to have families of their own”.

Could there be an increase in promiscuous sexual activity arising from the availability of Levonorgestrel 0.75 mg such that women will be more susceptible to the spread of sexually transmitted diseases (STDs)? The Social Exclusion Unit, in its publication on teenage Pregnancy recognises that“the numbers of young people sexually active by age 16 doubled between 1965 and 1991, with the rise most striking for girls. Some more recent estimates put the numbers sexually active before age 16 as high as one in three” (p.43).  STDs arise from sexual encounters and are especially likely to spread where there have been multiple partners, unprotected sexual intercourse, or where they  have engaged in reckless behaviour e.g. under the influence of alcohol or drugs. Young women and girls in particular may be more susceptible than older women to STDs.

Clearly STDs would be an indirect effect of Levonorgestrel 0.75 mg, but tragically chlamydial infection, which may be asymptomatic, is a common cause of sterility in women and viral infections are largely incurable.

Since Levonorgestrel 0.75 mg is not strictly used as a therapeutic product for a medical illness (pregnancy is a physiological, not pathological condition), it can be regarded as a drug used for social, or more accurately, recreational use. Might not its widespread availability therefore encourage promiscuity with a consequent rise in sexually transmitted disease and even cancer of the cervix?

(iii)  Risks from the incorrect use of Levonorgestrel 0.75 mg.

Clause 1 (b) of Directive 92/96/EEC acknowledges that the drug may be used to a wide extent incorrectly, thereby presenting a direct or indirect danger to human health.

(a)  Frequency of use

Whilst there may be a presumption that Levonorgestrel 0.75 mg would only be used occasionally and for 'emergencies' what is the basis for the expectation that this would be the case in practice? What is occasional use? How could the pharmacist verify the frequency of use? Is once or twice in a lifetime acceptable? Should a pharmacist refuse if Levonorgestrel 0.75 mg has been used before in the last 6 months, 3 months, 3 weeks or one week? How can the pharmacist verify the woman's story? Is it not likely that women requesting 'emergency' Levonorgestrel 0.75 mg because of recent unprotected intercourse will tell the pharmacist whatever they think is necessary to obtain a supply. For example, that they are not on any other drugs that may interact, they are not pregnant, they have not used Levonorgestrel 0.75 mg recently, if at all, and that they are entirely healthy? What would be their reason for sowing doubt in the pharmacist's mind that they should be refused Levonorgestrel 0.75 mg?

(b)  Use of Levonorgestrel by those under the age of 16 years: possibilities for abuse

Whilst the application is only for women over 16 years of age, how would this be verified? Young girls may look more than 16 years, and would certainly be expected to raise their age if they were determined to obtain Levonorgestrel 0.75 mg. Indeed, what is to stop older women obtaining Levonorgestrel 0.75 mg legitimately, not for their own use but for other women, perhaps under the age of 16? Might it not be easier for an under age girl to obtain supplies of the Levonorgestrel 0.75 mg informally through the, black market, from older women e.g. prostitutes or drug addicts, than formally from a pharmacy department. Might not young teenage girls be a prey to prostitutes, who were perhaps more streetwise, and who had a drug habit to support. Moreover, might these young girls be open to blackmail? "you cannot obtain Levonorgestrel 0.75 mg from the Chemists - because you are under 16 years and if you approach the pharmacist, I will tell them you are under-aged, or inform your parents”. What would stop unscrupulous women supplying Levonorgestrel 0.75 mg to young girls in nightclubs at a modest profit? Indeed, might not nightclubs become more 'attractive' if it was known that Levonorgestrel 0.75 mg was easily available at a small extra cost, without any questions being asked? (Most street-wise teenagers already know how to obtain other illicit recreational drugs). What would be the legal position in relation to a secondary trade in Levonorgestrel 0.75 mg? If a prostitute was supplying Levonorgestrel 0.75 mg to under-age girls would the pharmacist or prostitute be liable in the event of an adverse event?

©  Lack of monitoring and post-marketing surveillance.

Even after licensing, doctors report side effects and possible adverse events through the “Yellow Card” system to the CSM (Committee for Safety of Medicines) as part of a programme of post marketing surveillance. This is necessary because the use of drugs in the general population covers patients who may not have been represented in the initial trials. Moreover, following general release, far greater numbers of patients will use the drug and for far longer periods than in the clinical trials. Post marketing surveillance is necessary to pick up hitherto unforeseen side effects – which might be unusual or rare or only come about in new clinical situations – e.g. due to interactions with other drugs. It is also necessary to identify long-term problems which might only become apparent after years of drug use or in older patients – e.g. cancer risks or risks of cardiovascular disease. Hence an effect of a drug on cancer incidence, heart disease or stoke usually takes years to become apparent and is best seen from a population perspective.

If Levonorgestrel 0.75 mg is available without medical supervision or follow-up in an unregulated way a number of problems will arise.

1. Because of issues surrounding confidentiality and the keeping of medical records, post-marketing surveillance will be impossible or impracticable.
2. It will not be possible to prevent older women from obtaining supplies and passing them on to under-age girls.
3. Women may obtain ‘advance supplies’ of Levonorgestrel 0.75 mg e.g. before going abroad on holiday, or in anticipation of having intercourse
4. It will be impossible to prevent Levonorgestrel 0.75 mg from becoming used as an alternative form of birth control for many women, especially teenagers. If Levonorgestrel 0.75 mg is regarded as being provided safely, confidentially and without the need for seeing a doctor, it might be reasonable for women/girls to assume that it is ‘better’ than the OCP which is only available on prescription under medical supervision. The WHO acknowledges that Levonorgestrel 0.75 mg if used as the sole means of birth control would have a higher ‘failure’ rate than regular use of the OCP or barrier methods. It would become difficult or impossible to study the probable long-term effects of regular Levonorgestrel 0.75 mg usage on promiscuity – and especially STDs and female infertility. Furthermore doctors (GPs and Consultants) would not be able to establish the cause of unexplained medical or gynaecological problems in patients consulting them –e.g. unexpected thromboembolic disease leading to stroke or pulmonary embolus.

Community pharmacies will be seen as alternative outlets for birth control. Levonorgestrel 0.75 mg is, biologically and legally speaking, abortifacient. It will be recognised by women as a means of interrupting or preventing early pregnancy if the woman is or thinks she is, in the early stages of pregnancy. Is the Royal Pharmaceutical Society prepared for pharmacists to act in this role? What training will they have had to deal with early teenage pregnancy? According to the Lancet paper (1998;352:428-33), 1.1% women in their study became pregnant despite Levonorgesterel. This means that for every 100 women prescribed Levonorgestrel 0.75 mg at least 1 will become pregnant. (Many more (at least 25%) will have other side effects such as nausea, vomiting or menstrual irregularities). How will these women be counselled, advised or helped?

Duties of doctors.

The duties of care of doctors are not specifically relevant to the supply of the post-coital pill to girls via Pharmacies without prescription.   However, contraception, the use of abortifacient drugs and devices and provision of abortion is currently the sole responsibility of the medical profession. It is therefore relevant to mention the duties of care of doctors if this responsibility is to be taken over by pharmacists.  Are pharmacists equally equipped to take on such responsibilities and will the facilities of the High Street Pharmacy be comparable to those of a GPs surgery or Family Planning Clinic?

There are circumstances in which women who have received Levonorgestrel 0.75 mg ought to see a doctor e.g. if pregnancy is suspected or the woman experiences delayed or irregular menstruation or lower abdominal pain. This places the woman’s general practitioner in a somewhat anomalous position even though the dispensing of Levonorgestrel 0.75 mg by the pharmacist is regarded as ‘safe’ without medical supervision.  The doctor would be forced to deal with these eventualities (suspected pregnancy including the risk of an ectopic) even though (s)he was not responsible, or even knew, of the supply of the ‘morning after pill’ in the first instance. Whilst pharmacists may be held negligent if they were to dispense a prescribed drug inappropriately e.g. in too high a dose, the supply of medication by pharmacists which might lead to medical problems would seem to impose a responsibility on the doctor by the pharmacist.   (Of course, this possibility is a good reason why Levonorgestrel 0.75 mg ought not to be made available off prescription).

A doctor is not required by law to provide contraceptive services.[34] However, where a doctor has opted in to provide contraceptive (birth control) services, (s)he is subject to the usual duties of care of a doctor in pursuance of his professional work which is beyond the scope of this article.  However, there are two important aspects of a doctor’s duty of care that does require special attention in relation to the provision of contraceptive services, these are confidentiality and the question of informed consent and ‘Gillick competence’[35]..

Consent is necessary for medical treatment to obviate claims of assault and/or battery.  The way that consent is obtained and the amount of information imparted is governed by the general principles of medical negligence in the case of Bolam[36] .  Failure to give an adequate explanation of the proposed treatment and its attendant risks and benefits may lead to a claim in negligence[37]..

Duties of pharmacists.

It is proposed that Levonorgestrel 0.75 mg will only be available through Pharmacies without prescription to those over the age of 16 years.  To supply the drug without a prescription to girls under 16 would constitute a criminal offence.    How is the age of teenagers to be verified by pharmacists?

To what extent would pharmacies risk criminal prosecution by providing Levonorgestrel 0.75 mg to those whose age is in doubt?  For example, would pharmacies risk prosecution by parents for supplying Levonorgestrel 0.75 mg to their under age-daughters? 

In the Gillick case the question arose as to whether a doctor might be committing an offence of aiding and abetting under-age sex under section 28 of the Sexual Offences Act 1956.  The House decided in the negative.  Justice Woolf had explained in the trial stage of the case that an accessory before the fact must know the material circumstances of the offence, not merely that sexual intercourse might occur at a future date with an unidentified man.  However, this begs the question as to the position of a pharmacist approached by an under age girl for Levonorgestrel 0.75 mg (or a woman exposed to rape or sexual abuse).  Could the pharmacist be regarded as an accessory after the fact, when the circumstances are known?  Might the provision of Levonorgestrel 0.75 mg, which could be seen as a ‘safety net’ for sexual intercourse, be regarded as encouraging promiscuity, under age-sex or even sexual abuse?  Indeed, irrespective of whether Levonorgestrel 0.75 mg is supplied, the pharmacist would be placed in a difficult position if the woman or girl claims to have been raped or abused, or to have been involved in under-age sex.  Might the pharmacist be in a difficult position in not reporting such activity?

Assuming that the pharmacist is dealing with a woman known to be over 16 years, will his/her training be sufficient to undertake the duty of care of the woman with respect to advice, supply of Levonorgestrel 0.75 mg and follow-up?  Will the pharmacy itself have sufficient facilities to allow time and privacy for the necessary discussion?

Potential negligence claims against pharmacists.

It is easy to imagine a number of scenarios, which might lead to litigation. 

1.  The girl is under 16 years of age. 

Supply of Levonorgestrel 0.75 mg to those under the age of 16 years would be in breach of the conditions of deregulation, and hence be unlawful.  Moreover, intercourse with a girl under the age of 13 years is a criminal offence so that supplying  Levonelle-2 to such girls raises the spectre of complicity in criminal activity.

2.  The girl is, in fact, pregnant at the time Levonorgestrel 0.75 mg is used:

Risk of teratogenesis.

Pregnancy is a contraindication to the use of Levonelle-2 and its safety in pregnancy is unclear. According to the Data Sheet for Norgeston (Levonorgestrel, as the mini-pill).  “Pregnancy is a reason for stopping immediately, because it has been suggested by some investigations that oral contraceptives taken in early pregnancy may slightly increase the risk of foetal abnormality. Other investigations have failed to support these findings. The possibility therefore cannot be excluded, but it is certain that if a risk exists at all is very small”.  However Levonelle-2 would be used in considerably higher doses than Norgeston. It would therefore seem incumbent on pharmacists to exclude pregnancy before supplying Levonelle-2.  There is a small risk of foetal abnormality in a seemingly ‘normal’ pregnancy.  There are up to a million prescriptions for ‘morning after pills’ per annum and a significant number of women are pregnant at the time of requesting MAP. Hence, it is very likely that some women will become pregnant after taking Levonelle-2 and have a child with a congenital abnormality.  The onus would then be on the Pharmacist to prove that the risks were explained and for the manufacturers to demonstrate that Levonorgestrel 0.75 mg had not caused the abnormalities.

3.  Ectopic pregnancy. 

The incidence of ectopic pregnancy in the United Kingdom is increasing and in 1994-6 there were 33,500 cases of ectopic pregnancy (incidence of 11.5 per 1,000 pregnancies) which resulted in 12 deaths (a rate of 0.4 per 1,000 ectopic pregnancies) [38]. Risk factors for ectopic pregnancy include pelvic inflammatory disease arising as a result of sexually transmitted disease[39].. However, it has also been suggested that the effects of oral contraceptives have been overlooked. Larimore and Stanford published a review that demonstrated that the ratio of extrauterine to intrauterine pregnancies is increased for women taking combined oral contraceptives and progesterone only pills, compared with control groups of pregnant women not using oral contraceptives.  In other words, if women become pregnant whilst taking the combined or progesterone only contraceptive pill, not only are they more likely to have an ectopic pregnancy, compared with pregnant women who have not taken oral contraceptives, but the use of oral contraceptives might be causally related to ectopic pregnancy. One possible explanation for this might be decreased transit of either the ovum or of the fertilised egg through the fallopian tube, hence increasing the chances of implantation within the fallopian tube rather than the uterus itself.

This is of significance to the pharmacist supplying Levonelle-2 for two reasons:-

1. It is important to recognise the possibility of ectopic pregnancy in women with irregular or delayed menstruation or pelvic pain after use of Levonelle-2.  Failure of the pharmacist to warn of this, to recognise the symptoms of an ectopic and/or to take the necessary steps to deal with an ectopic could all give rise to a claim of negligence.
2. If Levonelle-2 is causally related to ectopic pregnancy, the pharmacist might be regarded as having contributed to causing the ectopic pregnancy and hence having put the woman at risk of a ruptured ectopic with possible fatal consequences.

4.  Abortion referrals and ‘wrongful birth’ claims.

Inevitably, women using Levonorgestrel 0.75 mg will become pregnant. Some will be pregnant at the time of use of Levonorgestrel 0.75 mg from previous acts of unprotected intercourse and a small percentage will become pregnant despite the PCP.  To what extent will there be a legal ‘duty’ to refer for abortion, particularly if there is a fear of foetal abnormality? Pregnancy is a contraindication to PCP but how would the pharmacist prove that the woman was not already pregnant, without taking a urine specimen every time PCP is supplied? 

Would the supply of post-coital pills (PCP) constitute a contract with the woman to ensure that pregnancy does not occur?  Notwithstanding the fact that Levonorgestrel is abortifacient, rather than contraceptive, a pharmacist supplying PCP is providing a drug to prevent pregnancy.  It would seem likely that if the woman was warned that Levonorgestrel 0.75 mg was not 100% effective and that pregnancy may still occur, that the pharmacist would not be held negligent if the woman became pregnant. There would be no breach of contract because the pharmacist had not guaranteed that pregnancy would not occur.  Nevertheless, the situation is far from clear-cut because if the woman turns out to be pregnant, the pharmacist would be ‘expected’ to take action because of the risk of her having an ectopic pregnancy which could place her life at risk. Hence, the question arises as to whether a woman could bring an action for wrongful pregnancy, notwithstanding that PCP is not always succesful per se, on the grounds of an expectation that if it failed, she would be referred for a surgical abortion?  Might it therefore be deemed unreasonable for a pharmacist to supply PCP without providing abortion referral in the event of ‘failure’ to prevent pregnancy?  Indeed, might an aggrieved woman, having experienced a failure with PCP, sue for wrongful pregnancy if the pharmacist had failed to warn her that Levonorgestrel 0.75 mg is not 100% effective?

The Court of Appeal has clarified that a wrongful pregnancy is a personal injury which cannot be separated from its consequences[40]. Hence, in English law unsought children are potential grounds for compensation. The pertinent Scottish case was that of McFarlane and McFarlane v Tayside Health Board. The Lord in Ordinary had ruled that a normal pregnancy resulting in a healthy child could not be regarded as an injury which could be the subject of damages[41]. This ruling was rejected by the Inner House. Lord Justice Clark judged in relation to the basic principles of Scots law in relation to injuria and damnum[42].  Injuria (or the invasion of a legal right, in this instance the right not to be pregnant) occurred when the woman conceived. Damnum  (or the prejudice suffered in respect of a legally recognised interest) arose from the effects of the pregnancy and childbirth on the woman’s bodily integrity.  In Scottish Law, an obligation to make reparation arises when there is both injuria and damnum –which arose once the pregnancy was established[43]. However, the case went to the House of Lords in November 1999.  It was held that whilst the McFarlanes might successfully claim damages in respect of the pregnancy and birth, they were not entitled to the cost of maintenance[44].. “The doctor undertakes a duty of care in regard to the prevention of pregnancy:  it does not follow that the duty includes also avoiding the costs of rearing the child if born and accepted by the family” (Lord Slynn of Hadley).

The McFarlane decision in the House of Lords involves a case of pregnancy following failed vasectomy.  However, if the woman relies upon the ‘morning after pill’ to prevent a pregnancy after unprotected intercourse, assuming that it is “safe and effective”(Yvette Cooper), would the pharmacist be regarded as having entered into contract with the woman to prevent pregnancy, by supplying Levonorgestrel 0.75 mg?  Would the pharmacist be held negligent, if (s)he did not warn of the risk of ‘failure’ and for not providing the necessary advice and referral for abortion, in the event of pregnancy? 

The application from the Department of Health states,

"The CSM (Committee for Safety on Safety of Medicines) considered that all the steps required to safely supply emergency contraception could be successfully completed in a pharmacy. These include providing advice and referral to doctors' clinics where appropriate”.  /p>

TThis suggests that there could well be a reasonable expectation amongst women receiving PCP, that they will receive “advice and referral to doctors’ clinics where appropriate”.

5.  Sexually transmitted disease.

Would the pharmacist be liable for failing to warn the woman of the risk of STD or even for failing to enquire about or recognise the symptoms?

Duties of manufacturer: Product liability.

Once a medicine has been duly licensed through the Medicines Control Agency, the marketing authorisation allows the manufacturer to supply the product under the indications mentioned in the authorisation and included in the Summary of Product Characteristics.  Hence, if a pharmacist is permitted to supply Levonorgestrel 0.75 mg, any claim by women concerning its use could be referred on to the manufacturer.   Any such claim would then come under the general law of negligence or the Consumer Protection Act 1987 (which reflects the EC Product Liability Directive).

The meaning of a product defect is defined in Section 3 of the Consumer Protection Act 1987.

3.  Meaning of ‘defect’.

3 (2) In determing for the purposes of subsection (1) above what persons generally are entitled to expect in relation to a product all the circumstances shall be taken into account, including –

(a)    The manner in which, and purposes for which, the product has been marketed, its get-up, the use of any mark in relation to the product and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product;/p>

(b)    What might reasonably be expected to be done with or in relating to the product; and

((c)    The time when the product was supplied by its producer to another”

It would appear from 3(2) (a) that the woman might have a reasonable expectation that Levonorgestrel 0.75 mg would prevent pregnancy after unprotected intercourse, or, if this was not entirely correct regarding the product itself, that the pharmacist would have an ongoing responsibility to the woman if the pregnancy was to proceed.

In relation to 3(2) (a), the Association of the British Pharmaceutical Industry (APBI) are wary of the unqualified use of the term ‘safe’.  Hence, clause 7.7 of the Code of Practice for the Pharmaceutical Industry states that: -

“Information and claims about side-effects must reflect available evidence or be capable of substantiation by clinical experience.  It must not be stated that a product has no side effects, toxic hazards or risks of addiction.  The word ‘safe’ must not be used without qualification”.[45]

As already noted above, the supply of Levonorgestrel 0.75 mg could be seen as part of Government strategy to reduce teenage pregnancy and has been described as “safe and effective” by Yvette Cooper in a Parliamentary written answer. If in the assessment of customer’s expectations, “all circumstances are to be taken into account” might it not be reasonable for women to consider the ‘authority’ of the Minister.  Might not the weight of a Government strategy to promote ‘emergency contraception’ be seen as part of ‘the manner in which, and purposes for which, the product has been marketed’ and’ its get-up’? These would be matters for the Court to decide.

If a product is supplied for an unlicensed use, the supplier assumes responsibility. Hence, there would be no product liability if Levonorgestrel 0.75 mg was supplied to a girl under 16 years of age. Whereas doctors may use drugs for unlicensed indications e.g. where a doctor prescribes a drug for an individual patient under his direct medical supervision, when there is no other reasonable licensed alternative for the patient’s condition, such an exemption would clearly not apply to pharmacists.

However, there are difficult areas. For example, who would be liable if Levonorgestrel 0.75 mg was, in fact, prescribed during pregnancy?  Pregnancy is a contra-indication to Levonorgestrel 0.75 mg.  However, how can this be excluded in every case? Women may request PCP after recent unprotected intercourse but fail to mention or even consider that they may have become pregnant from earlier sexual activity. Unless pharmacists insist on seeing birth certificates and perform pregnancy tests before supplying Levonorgestrel 0.75 mg, it is difficult to see how the supply of Levonorgestrel 0.75 mg to under-age girls, or women with early pregnancy would be avoided.

Whilst there may be a defence against product liability if the side-effect was not known at the material time, this would not apply to Levonorgestrel 0.75 mg since many of its side effects are already known and published for Levonorgestrel as the mini-pill. Section 4 of the Consumer Protection Act states that:-

 “4 (e) The state of scientific and technical knowledge at the relevant time was not such that a producer of the products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products while they were under his control;”

6.  CONCLUSION.

The deregulation of the ‘morning after pill’ raises important ethical, medical social and legal questions. It is our view that the ‘morning after pill’, often works as an abortifacient after conception has occurred and that therefore it should be subject to the abortion laws in common with other known abortifacients such as the potent antiprogesterone, mifeprostone.   There should be a right of conscientious objection for pharmacists who object either to the use of abortifacient and/or providing abortion advice and referrals for women who become pregnant despite the "morning after pill”. Since Levonorgestrel 0.75 mg is used for ‘social’ rather than bona fide medical indications, the risks and side-effects cannot be weighed against the ‘condition’ being treated. Over 90% of women who receive Levonorgestrel 0.75 mg will not be ‘at risk’ of pregnancy at all. For the remaining 10%, the condition being treated, pregnancy is physiological, rather than pathological. Neverthless, there is a growing trend, especially in Scottish Law to award damages for ‘wrongful birth’ in the event of pregnancy despite attempts to either prevent or interrupt it.  Such claims are often the subject of considerable damages.  The responsibility for the supply of Levonorgestrel 0.75 mg remains unclear, but we have explored the possibility of liability arising anywhere from the manufacturer (product liability) through the pharmacist (professional negligence) though to the Secretary of State, through ‘operational’ decisions, based on pre-determined ‘policy’ decisions made by Government through its Social Exclusion Unit, which may be contrary to medical considerations.

Whatever the decision reached by the Secretary of State for Health, the supply of Levonorgestrel 0.75 mg will depend upon the co-operation of Community Pharmacies throughout the country and would constitute an uncomfortable precedent for pharmacists with objections to any form of ‘chemical abortion’.[46]

 

REFERENCES.