Smeaton v Secretary of State for Health, Court of Appeal - Administrative Court, April 12, 2002, [2002] EWHC 610 (Admin)

Resolution Date:April 12, 2002
Issuing Organization:Administrative Court
Actores:Smeaton v Secretary of State for Health
 
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Case No: CO/928/2001

Neutral Citation Number: [2002] EWHC 610 (Admin)

IN THE HIGH COURT OF JUSTICE

QUEENS BENCH DIVISION

ADMINISTRATIVE COURT

Royal Courts of Justice

Strand,

London, WC2A 2LL

Thursday 18 April 2002

Before :

THE HONOURABLE MR JUSTICE MUNBY

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Between :

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(Transcript of the Handed Down Judgment of

Smith Bernal Reporting Limited, 190 Fleet Street

London EC4A 2AG

Tel No: 020 7421 4040, Fax No: 020 7831 8838

Official Shorthand Writers to the Court)

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Mr Richard Gordon QC, Mr James Bogle and Mr Martin Chamberlain (instructed by Coningsbys) for the Claimant

Mr Kenneth Parker QC, Mr James Eadie and Mr Simon Hattan (instructed by the Office of the Solicitor to the Department) for the Secretary of State

Mr David Anderson QC and Miss Jemima Stratford (instructed by CMS Cameron McKenna) for Schering Health Care Limited

Ms Nathalie Lieven (instructed by Leigh Day & Co) for Family Planning Association

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Judgment

As Approved by the Court

Crown Copyright ©

Mr Justice Munby:

  1. This case raises medical and legal questions of great complexity, difficulty and interest. It raises also moral and ethical questions of great importance. But it is no exaggeration to say that the outcome of this case may potentially affect the everyday lives of hundreds of thousands, indeed millions, of ordinary men and women in this country.

  2. This judgment is necessarily very long. I have had to summarise and analyse a large mass of medical and legal material, much of it of consuming interest. But it is, I believe, vitally important that the law should be accessible to all and that those who wish to understand my decision should be able to do so without having to read the full judgment. Accordingly I begin this judgment with an overview which summarises the issues and my decision. I have used what I hope is plain and straightforward language, avoiding as much as possible in this part of my judgment all technical medical and legal language.

    OVERVIEW

  3. This case concerns the legality of the prescription, supply and use of the morning-after pill.

  4. The claimant, John Smeaton, who acts on behalf of the Society for the Protection of Unborn Children ("SPUC"), says that such prescription or supply amounts in principle to a criminal offence under sections 58 and/or 59 of the Offences against the Person Act 1861 ("the 1861 Act").

  5. In reality the allegations which SPUC makes extend to this: that a woman who takes the morning-after pill is herself potentially committing a criminal offence under the 1861 Act.

  6. Furthermore, and whatever SPUC may say, these allegations of serious criminality which it makes extend to cover any form of birth control which may have the effect of discouraging a fertilised egg from implanting in the lining of the womb - that is to say, not merely the morning-after pill but also IUDs, the mini-pill, and even the pill itself.

  7. Put shortly, the effect of sections 58 and 59 of the 1861 Act, taken together with the relevant parts of the Abortion Act 1967, is that abortifacient substances - substances which cause miscarriage or abortion - may be administered only if two doctors certify that the conditions set out in the 1967 Act are satisfied. Otherwise, the use of such substances is in principle criminal.

  8. SPUC's case is that, whatever it may be called, the morning-after pill is not in fact a contraceptive. It is, says SPUC, an abortifacient, in other words it causes miscarriages. Accordingly, says SPUC, unless the procedures laid down by the 1967 Act are complied with the supply and use the morning-after pill may involve the commission of criminal offences.

  9. Compliance with the procedures laid down by the 1967 Act requires, as I have said, the involvement of two doctors. So if SPUC is right the use of the morning-after pill will in effect be lawful only if it has been prescribed by two doctors.

  10. In order to understand SPUC's argument I need to explain the relevant medical facts. Put very simply, there are two key stages in the biological process following sexual intercourse:

    i) The first is fertilisation. This takes place after the man's sperm and the woman's egg have met in the fallopian tube. It is a process which commences hours, or even days, after sexual intercourse. The process itself takes many hours.

    ii) The other key stage is implantation. This takes place after the fertilised egg has moved into the womb. It involves a process by which the fertilised egg physically attaches itself to the wall of the womb. The process does not start until, at the earliest, some four days after the commencement of fertilisation. The process of implantation itself takes some days.

  11. Put in its simplest terms, SPUC's case is that any interference with a fertilised egg, if it leads to the loss of the egg, involves the procuring of a "miscarriage" within the meaning of the 1861 Act, even - and this is the important point - if the interference takes place before the egg has implanted in the wall of the womb. So, says SPUC, any so-called contraceptive which can in fact operate to prevent a fertilised egg implanting itself in the wall of the womb is not in fact a contraceptive. It is, says SPUC, an abortifacient.

  12. The precise ways in which the pill, the mini-pill and the morning-after pill operate are still not fully understood. It is known, however, that the pill, the mini-pill and the morning-after pill are all capable of operating either to prevent fertilisation and/or to prevent implantation. So, according to SPUC, the morning-after pill is an abortifacient. And that is why, if SPUC's case is correct in relation to the morning-after pill, then the same legal consequences must follow also in the case of the pill and the mini-pill.

  13. What is also clear, however, is that:

    i) The morning-after pill (like the pill and the mini-pill) cannot cause a fertilised egg which is implanted to de-implant - that is, it cannot work after the process of implantation is complete.

    ii) The morning after-pill, if it is to be effective, has in any event to be taken at a time - no later than 72 hours after intercourse - when implantation will not have begun.

  14. So much for the biology.

  15. Reduced to essentials SPUC's legal argument comes down to this:

    i) The word "miscarriage" was generally understood by medical opinion in 1861 as including the failure or prevention of implantation.

    ii) Parliament's intention in 1861 was to give effect to that contemporary medical understanding. In other words, Parliament's intention in 1861 was to prohibit all attempts to procure abortion from the stage of fertilisation onwards.

  16. In my judgment SPUC's legal argument is erroneous. SPUC's application must be dismissed.

  17. In essence this is because:

    i) As a matter of law my decision must ultimately turn not on what the word "miscarriage" was understood to mean in 1861 but rather on what it means today.

    ii) Whatever it may or may not have meant in 1861 the word "miscarriage" today means the termination of an established pregnancy, and there is no established pregnancy prior to implantation. There is no miscarriage if a fertilised egg is lost prior to implantation. Current medical understanding of what is meant by "miscarriage" excludes results brought about by the pill, the mini-pill or the morning-after pill. That is also, I should add, the current understanding of the word "miscarriage" when used by lay people in its popular sense.

  18. It follows that since the morning-after pill is used before the process of implantation has even begun, and because it cannot make an implanted egg de-implant, the morning-after pill cannot as a matter of law bring about a "miscarriage".

  19. I should add that I do not in any event accept SPUC's case as to the meaning of the word "miscarriage" in 1861. Some of the leading and most authoritative medical works of the time strongly supported the idea that miscarriage becomes possible only after implantation.

    THE PROCEEDINGS

  20. These are judicial review proceedings commenced on 8 March 2001 by John Smeaton on behalf of SPUC seeking to challenge the making by the Secretary of State for Health on 8 December 2000 of The Prescription Only Medicines (Human Use) Amendment (No 3) Order 2000, SI 2000/3231 ("the 2000 Order"). The 2000 Order was laid before Parliament on 12 December 2000 and came into force on 1 January 2001. There were debates on the 2000 Order in the House of Commons Standing Committee on Delegated Legislation on 24 January 2001 and in the House of Lords on 29 January 2001.

  21. The 2000 Order is part of the statutory regime regulating the sale and supply of medicinal products which is governed by the Medicines Act 1968 ("the 1968 Act") and associated subordinate legislation. The ability to place a medicinal product on the market is regulated by the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994, SI 1994/3144. Nothing turns on the precise provisions of those Regulations so I say no more about them.

  22. The 1968 Act distinguishes between three different classes of medicinal products: (i) those which are on the so called `general sale list' and may therefore be supplied by persons other than registered pharmacists (section 51), (ii) those which are not on the `general sale list' and which (subject to exception in the case of supply direct by medical practitioners) may only be supplied by or under the supervision of a registered pharmacist (section 52) and (iii) those available only on prescription from a medical practitioner (section 58) - so called prescription only medicines. The Prescription Only Medicines (Human Use) Order 1997, SI 1997/1830 ("the 1997 Order") specifies those medicines which, for the purposes of section 58 of the 1968 Act, are to be prescription only medicines.

  23. There are two bodies, established under the 1968 Act, which I...

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