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Lord Peston: My Lords, I am sorry to interrupt the noble Earl and I do so reluctantly. I must declare an interest as an honorary member of the Royal Pharmaceutical Society. My listening to the noble Earl suggests that his view is that the Royal Pharmaceutical Society is, first, irresponsible in strongly advocating this intervention and, secondly, does not speak for the overwhelming majority of its members. Does he accept that the Royal Pharmaceutical Society is completely responsible in what it says and does speak for the overwhelming majority of its members? Will he say that in terms, speaking from the Opposition Front Bench?
Earl Howe: My Lords, I believe that the Royal Pharmaceutical Society has adopted an entirely responsible approach. I could pick holes in the detail of the guidance it has given. I certainly accept that it is acting with the approval of the majority of its members but I am also saying that a significant minority of its members--the noble Lord will know this from reading the pharmaceutical press--are worried and concerned for the reasons that I am now giving.
I have already run through the list of medical contra-indications, any one of which renders the supply of the pill unsafe. I have not read out the long list of other items that a chemist is supposed to cover with each patient--warnings about side effects, about the need to repeat the dose if you vomit within three hours of the first one, about what to do if you are
Before I finish, let me make one thing clear. The issue of unwanted pregnancy and of abortion are ones I understand completely. I understand about busy doctors' surgeries and the embarrassment that girls feel in going to their doctor. But in the light of the risks I have identified, we believe that a better alternative to making the morning-after pill available over the counter would be to allow practice nurses to prescribe it. That measure of deregulation would allow greater flexibility for patients yet keep emergency hormonal contraception within the context of a general practice setting.
Lord Hunt of Kings Heath: My Lords, I am very glad to have the opportunity of responding to the debate on the order. We have certainly had a wide-ranging debate. I listened with great interest to the right reverend Prelate the Bishop of St Albans as he touched on a number of moral, religious and ethical questions. But I want to start with some fairly straightforward points about the background to the order.
I believe that women and their partners have the right to make responsible choices about the size of family they have. As noble Lords have pointed out, the effectiveness of hormonal emergency contraception is greatest the sooner it is taken after unprotected intercourse. The option of rapid availability from a pharmacist without the need for attendance at clinic or GP surgery is therefore to be seen as a welcome addition to responsible family planning measures.
There has been positive support for pharmacy availability from a wide range of professional bodies. I say to the noble Earl, Lord Howe, that pharmacists are professional and responsible and will receive full guidance in the safe supply of this medicine from the Royal Pharmaceutical Society of Great Britain. Pharmacy supply will improve and build on existing links between pharmacists and family planning services. This network will help to ensure that the under-16s and other women who need to see a doctor for contraceptive advice can be referred on quickly.
The background to the order is an application by Medimpex UK to change the legal classification of Levonorgestrel. The application was to change its legal classification from that of a prescription-only status to that of a pharmacy status, which means that it can be sold over the counter by a pharmacist. Under UK law, a medicine is legally classified as "prescription only" if it needs to be supplied under the supervision of a doctor to ensure that it is used safely. It can be sold in pharmacies only if the legal criteria for listing medicines as prescription only no longer apply.
The Government are committed to making medicines more widely available where it is safe to do so. The most effective way of doing that is through the reclassification procedure for licensed medicines as I have described. The UK has considerable experience in this regular and routine procedure. I pay tribute to the last government, who, in 1992, established the well-ordered procedures to enable this to happen. As a result of that action, more medicines have gone down this route and the public have benefited enormously.
It is down this route that Medimpex UK has gone. When the company applied to the Medicines Control Agency, a standard procedure was followed. First, the Medicines Control Agency assessed the safety of the medicine in use in the light of the legal criteria for prescription only status. Then the application was referred to the advice of the Committee on the Safety of Medicines. That committee recommended that the order should be amended to allow the non-prescription supply of this medical product. The matter was then put out to public and professional consultation. Virtually all the main medical and pharmaceutical bodies which responded were in favour of a move to pharmacy supply. Furthermore, they did not raise any concerns about the safety of supply in a pharmacy setting. Both the Committee on the Safety of Medicines and the Medicines Commission carefully considered all the available evidence. They advised that Levonelle can be supplied safely under the supervision of a pharmacist for emergency contraception.
Perhaps I may turn to the safety issues. Considerable experience of worldwide use has been gained. In the UK the active ingredient has been available in other contraceptives and HRT products for 30 years, although only more recently as an emergency contraceptive. It has been used for emergency contraception in other parts of the world since the 1980s. In France it has been available from pharmacists since 1999. I understand that Norway and Portugal have since agreed to do the same.
I am advised that the side-effects of this medicine are usually mild and short-lived. The most common side-effects reported from clinical trials are vomiting and nausea. The committees therefore considered that the medicine had an acceptable safety profile to supply under the professional supervision of a qualified pharmacist and that women would be able to use the product correctly.
Perhaps I may now turn to the safety issue in relation to women aged under 16. I have been asked for reassurance on this point and I am happy to give it. The most important point to make here is that, while under this order the product can be bought from a pharmacist only if the person is aged 16 years or older, the same product can be prescribed by a doctor with no age limits. There is no biological significance to the age limit of 16 years and over. Indeed, the original licensing of the prescription product used evidence from a large, randomised control study that included women under 16 in the trial.
Having considered the safety issues and on the basis of the advice received from the Committee on the Safety of Medicines and the Medicines Control Agency, we have laid the order before the House tonight. In support of this change, the Royal Pharmaceutical Society has set professional standards and developed comprehensive guidance for pharmacists on the retail supply of emergency contraception. I should say to the House that it is primarily the responsibility of the Royal Pharmaceutical Society to enforce the Medicines Act in this area. It is the regulatory body.
While pharmacists are already familiar with the product through prescription supply, additional training is being provided, a distance learning programme is being sent to all pharmacists ahead of the product launch and workshops are also available. The noble Earl, Lord Howe, referred to the minimum standards set by the Royal Pharmaceutical Society. Those are in place to ensure that pharmacists have sufficient knowledge of emergency hormonal contraceptives to deal with requests personally and to decide whether to supply the product or to refer; to ensure that they provide all the necessary advice and information about the medicine to the patient; to handle requests sensitively, respecting a woman's right to privacy; only in exceptional circumstances to supply the product to a person other than the patient; and wherever possible to take reasonable measures to inform the patient about regular methods of contraception, disease prevention and sources of help.
I do not share the concerns expressed by the noble Earl, Lord Howe. The pharmacy profession has had considerable experience in the move of medicines from prescription only to pharmacy. I believe that pharmacists are ideally placed to provide advice on regular methods of contraception and local family planning services to help women avoid the use of emergency contraception in the future. Furthermore, I am satisfied that the overall rigorous approach to regulation within the pharmacy profession will ensure that sufficient safeguards are put in place.
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