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12.36 am

The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman): I congratulate my hon. Friend the Member for Eltham (Clive Efford) on securing this debate on the prescribing of Roaccutane and on the efforts he is making on behalf of his constituent. He is a strong and persistent advocate. I also congratulate my hon. Friend the Member for Liverpool, Walton (Mr. Kilfoyle) on the efforts that he is making on behalf of his constituent. I understand the distress faced by both my hon. Friends' constituents—their condition and the symptoms from which they are suffering must make things extremely difficult for them. Nothing that I say tonight diminishes the Government's sympathetic view of their condition. I listened carefully to my hon. Friend the Member for Eltham—I promise to read his comments in the Official Report, and shall make sure that all the officials in the Department involved with the issue read them as well. If there are points that I do not deal with today, I shall write to him.

Neither of my hon. Friends would want me to try to intervene on the Floor of the House in any dispute between their constituents and the makers of Roaccutane, and neither of them have asked me to do so. If they have not done so already, I am sure that they will both advise their constituents to seek appropriate legal advice. I will, however, try to address the general points that have been raised. I shall discuss the broad issues around the use of the drug, its prescription and regulation, and am grateful to my hon. Friend the Member for Eltham for giving me the chance to update the House on these issues. I will also try to address the

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serious concerns that he raised about the safety of the drug, including the debilitating chapping and inflammation of the lips known as cheilitis.

Roaccutane is the brand name for the drug substance known as isotretinoin, which is the name that I shall use for the remainder of my speech. Isotretinoin is the active component of Roaccutane, and is an important medicine that has been on the market for about 20 years. Without in any way minimising the distressing side effects suffered by my hon. Friends' constituents, it is important to recognise that it has helped very many people during that time and has changed many lives for the better. I can assure both my hon. Friends that whenever this issue is raised in public, the Department of Health receives many letters from people whose lives have been changed for the better by the drug, and who want to make sure that we are aware of their experience as well as the negative experience of others.

Isotretinoin, as my hon. Friend the Member for Eltham said, is a derivative of vitamin A that is used for the treatment of severe and resistant acne. Acne is a common condition that affects about 80 per cent. of adolescents at one time or another and occasionally affects adults. Although it is not life-threatening, it can have a significant impact on the lives of sufferers. In its severe forms, acne can be extremely debilitating and distressing, and can cause disfigurement and permanent scarring. Many forms of acne will respond well to treatment with topical preparations or systemic antibiotics, but for severe and resistant acne, effective treatment options are very limited, and isotretinoin is one of the limited number of effective treatments available.

Isotretinoin has been authorised in the UK since 1983. It is available worldwide, has been used by millions of people, and is a highly effective oral treatment for the type of severe and resistant acne that I have described. It is important that hon. Members understand that all effective medicines have side effects. There is always the risk of side effects in some people, and unfortunately it is often impossible to predict which individuals will suffer a side effect from a medicine. A medicine will be issued with a licence for use in certain circumstances only if it is considered that, in those circumstances, the benefits of treatment outweigh the risk of side effects. The risks and benefits of isotretinoin were carefully considered at the time of licensing, and because of the known safety profile of the drug, it is licensed for use only in severe forms of acne that are resistant to other treatment.

Clive Efford: There has been an inquiry at Leeds infirmary, where a number of cases came to light in which people with mild forms of acne were prescribed Roaccutane. If it is decided that Roaccutane can be used, there must be stricter guidelines because it is not being prescribed in accordance with the licence issued back in 1987.

Dr. Ladyman: I understand my hon. Friend's point, but I emphasise that we issue a licence that describes the conditions under which the drug should be used. It is open to any clinician at any time to issue a particular

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type of treatment to an individual if they think that it is in that patient's best interest. If clinicians depart from the licence conditions, they do so on their own responsibility because they believe that it is in the clinical interest of their patient. They must answer for that decision under the terms of normal clinical governance—in other words, what happens in those cases becomes the doctor's responsibility. Those are the only cases in which it is possible to diverge from the licence arrangements. I shall have my officials look into the case that my hon. Friend mentions. Unless the doctors involved can answer for their decision to depart from the licence conditions, they are in the wrong. That needs to be investigated and they need to answer for it.

I emphasise that when isotretinoin is to be prescribed in cases of severe acne, it should be used—this is another of the licence conditions—only when other treatments have been tried and have failed. It is a treatment that should be considered last, not first.

Since licensing, the safety of isotretinoin has been closely monitored by the Medicines and Health Care Products Regulatory Agency—formerly the Medicines Control Agency—with expert advice from the Committee on Safety of Medicines. Isotretinoin is a highly effective medicine, but it is widely understood that it is associated with some serious side effects, and these must be considered when the clinician decides to use it.

Most importantly, isotretinoin is extremely harmful to the unborn foetus and therefore must not be taken during pregnancy or when there is a risk of pregnancy. Other common known side effects include dryness of the skin and the lining of the mouth, nose and eyes. The dryness of the skin associated with isotretinoin can take the form of cheilitis, which is the cracking or inflammation of the lips, a condition that can become severe, chronic and debilitating in some patients. It sounds very similar to the symptoms experienced by the constituent of my hon. Friend the Member for Eltham. There has also been significant concern about the possibility that isotretinoin may be associated with depression and suicidal behaviour.

Isotretinoin is licensed only for use in severe forms of acne that are resistant to other treatment. That narrow indication is not the only restriction to its use in the UK. Isotretinoin can currently be given only by or under the supervision of a consultant dermatologist—one of the conditions that my hon. Friend said needed to be strictly adhered to. In addition, the supply of isotretinoin is restricted to availability through hospital pharmacies or specified retail pharmacies at the request of a consultant dermatologist. The intention of restricting prescribing in that way is that it is those health professionals with most experience and who are best placed to give patients advice about the important safety issues related to the prescribing of isotretinoin who are making prescribing decisions.

My hon. Friend referred to the internet, which is not a legal and licensed source for the drug. It might be available there, but I fear that many things that are not in our constituents' best interests are available on the internet these days.

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To underpin the process, all licensed medicines have a summary of product characteristics. The summary, which my hon. Friend described, contains important information for prescribers. Licensed medicines are also accompanied by an information leaflet for patients. These documents are changed and new information is added as it becomes available. The patient information leaflet is an essential document if the patient is to be fully aware of the possible risks of treatment and make informed choices about their care. In the case of skin dryness and inflammation, there is clear advice to expect such effects and on how to relieve or minimise symptoms.

My hon. Friend mentioned that the leaflet contained no advice about permanent risk. I was not aware that that was the case, and I shall ensure that the people responsible for drafting the leaflet and other officials are aware of that concern. I shall have the matter investigated and I shall ensure that it is acted on if it is within my power to do so.

Clive Efford: I thank my hon. Friend for that statement. Many people are suffering permanent conditions as a result of having taken Roaccutane. That is the issue that is of most concern and the reason why I have initiated this debate.

Dr. Ladyman: If there is a risk of permanent side effects, they should be described in the leaflet. I certainly promise to ensure that that is looked into.

Despite the guidance in the British National Formulary about the narrow licensed indication for isotretinoin in the UK, its use is not always restricted to patients with severe and resistant acne. Ultimately, the clinical care of an individual patient is the responsibility of their doctor and it is an important principle that doctors can prescribe medicines outside the licensed indication if they consider that that is in the best interests of the patient. The doctor is responsible for the safe use of the product in those circumstances and is answerable under clinical governance rules.

Because of the harmful effects of isotretinoin during pregnancy, it has been the aim of regulatory authorities in Europe and worldwide to introduce measures to ensure that no one takes isotretinoin while pregnant. The summary of product characteristics lays down stringent conditions for use in women who are of childbearing potential. However, the current safeguards have not succeeded in preventing all exposed pregnancies, which has highlighted the need for further measures to be introduced.

My hon. Friend has also given me the opportunity to update the House on some important European work on the safety of isotretinoin. The UK and France have led a recent European initiative to harmonise the product information for the drug. The aim of the review was to get up to date and consistent product information for prescribers and patients across all member states. The procedure has also developed a set of important principles for nationally agreed pregnancy prevention programmes. The completion of the procedure is imminent, and the Medicines and Health Care Products Regulatory Agency is having discussions with key stakeholders to plan communication of these important new prescribing principles to health professionals and patients who use isotretinoin.

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The UK lead in the European review has allowed us to ensure that the important restrictions on isotretinoin use that are present in the UK now are not relaxed and are taken forward in Europe. The UK input into the review has been informed by an expert working group of the Committee on Safety of Medicines. The group includes representatives specialising in dermatology, general practice, family planning and psychiatry.

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I hope that I have dealt with all the points that my hon. Friend made. I assure him that I shall write to him if I have missed any and that I will take action on whether the product description should include information about possible permanent side effects.

Question put and agreed to.

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