Select Committee on Health Written Evidence


Memorandum by PharmacyHealthLink (PI 44)


  PharmacyHealthLink (PHLink) is a registered charity set up to improve the health of the public by conducting research, providing training and information, and developing the skills of pharmacists to promote the health of the public and educate them in matters affecting their health. The beneficiaries of the charity are the UK general public and specifically those who use pharmacies or obtain pharmacy advice.


  PHLink is dedicated to improving the public's health by improving their access to high quality and effective healthcare advice and provision of services through pharmacies in all settings, but mainly community, hospital and primary care. The Charity relies on reviews of published evidence and the opinion of experts, pharmacy staff and the public to help inform its work.



  Our main evidence in this submission comes from our experience of the field of smoking cessation. Reducing the prevalence of adult smoking remains one of the Government's key priorities for improving health[22] and PHLink have been working closely with the Department of Health, the NHS and other organisations to help them meet one of the key public health targets[23]—specifically "800,000 smokers from all groups successfully quitting at the four week stage by 2006".

  Since 1997 a number of policy initiatives have been implemented to help reduce smoking prevalence. One was to increase access to effective smoking cessation treatments—specifically, bupropion hydrochloride (Zyban™) and nicotine replacement therapy (NRT)—by making them available on NHS prescription. This happened in June 2000 for buproprion and in April 2001 for all NRT products. Many NRT products were already available to the public before that time either as Pharmacy-Only (P) or as General Sales List (GSL) medicines.

  PHLink responded to the original consultations from the (then) Medicines Control Agency (MCA) on these issues and supported the proposal to make NRT reimbursable on the NHS as well as the reclassification of certain NRT products to GSL status. PHLink also submitted evidence into the technology appraisal of smoking cessation treatments[24] run by the National Institute for Clinical Evidence (NICE). Since then it has been working with a range of healthcare organisations to improve access to smoking cessation treatments on the NHS through pharmacies, GP surgeries and other premises—this has been primarily achieved through writing and distributing template Patient Group Directions for Smoking Cessation Therapies.[25]

Issues arising from the supply of smoking cessation therapies on the NHS

  The main issues arising of relevance to the Committee's Inquiry are as follows:

  1.  The influence that the pharmaceutical industry has on prescribing practice in the NHS—via the decisions individual companies make when applying for a licence for its products, specifically:

    (a)  In deciding what category a medicine should be placed in when applying for a licence (Prescription Only—POM; Pharmacy Only—P; or General Sales List—GSL).

    (b)  In deciding what research to undertake, and with which groups of individuals or patients, in determining which medicines category to apply for a licence.

    (c)  In deciding, on the outcomes of the above, which groups of individual or patients should be included/excluded from the licensed supply of the product.

  2.  The role of the Medicines and Healthcare products Regulatory Agency (MHRA) in "safeguarding public health."

  A brief outline only of each of these issues will be made in the next few pages. PHLink is willing to submit more evidence, either oral or written, in support of these statements on request.


  As the Committee will no doubt be aware, some of the most important decisions made in relation to the supply of medicines on the NHS are made by individual pharmaceutical companies during the process of submitting an application for a product to be licensed by the Medicines and Healthcare products Regulatory Agency (MHRA). These decisions affect key factors, such as the category of medicine that the product is supplied under (which has a huge influence on access to supply), the research that is conducted to determine its safety and efficacy (and for which groups of individuals/patients), and also the specific licensed "indication" of the product which ultimately determines its use and purpose.

  Whilst PHLink accepts that strict confidentiality is needed for commercial purposes by the pharmaceutical industry when new products are being submitted for licence, the Charity believes, that after an agreed period of time post-licensing, or when competitor products have already been licensed for similar purposes, there should be much greater scope for the advice of external organisations, such as the NHS and health-related charities, to influence subsequent revisions of the product licences. This would further enhance patient safety as well as reduce bureaucracy and cost in providing medicines on the NHS, particularly where unnecessary licence restrictions are in place.

  Using the example of smoking cessation treatments, there are over 20 licensed NRT products currently available for essentially the same licensed indication "the relief of nicotine withdrawal symptoms as an aid to smoking cessation"[26]. Despite having some differences in method of delivery[27] of the active agent (nicotine) these products are very similar in terms of their pharmacological properties and physiological effects. However, their Summary of Product Characteristics (SPCs) vary in content, specifically with regards to contra-indications, cautions, dosage, maximum length of use and other characteristics. As a result, many health professionals are confused about product safety and efficacy in certain patient groups and consequently advise using NRT far more cautiously than clinically necessary or is desirable to be effective. The Charity, and other healthcare organisations, have made a number of (so far unsuccessful) approaches to individual pharmaceutical companies and the MHRA to:

    (a)  remove unncessary restrictions on existing product licences (eg supply of NRT to under 18 year olds);

    (b)  to extend the range of "therapeutic indications" that NRT products are licensed for (eg to cover temporary abstinence—not just treatment of dependence or relief from withdrawal symptoms);

    (c)  to ensure consistency between existing product licences (eg having similar contra-indications and recommendations on maximum daily dosage).

  Appendix 1[28] to this submission illustrates this point in more detail by comparing a "typical" SPC for a 2 mg nicotine gum with the proposed revisions for an SPC that would both "harmonise" existing SPCs as well as provide more accurate information on risk posed by these products to both patients and health professionals.

  Appendix 2[29] to this submission illustrates the administrative "hoops" that NHS organisations currently have to negotiate if they are to increase access to supply of NRT on the NHS through professionals other than doctors (Improving Access to Smoking Cessation Therapies on the NHS through Patient Group Directions, PHLink, 2003). The extra administration is primarily required as a result of having to circumvent existing licence restrictions.


  Despite the huge public health gains that could be achieved with more smokers using effective smoking cessation treatments as an aid to quitting, current attempts by NHS professionals to persuade smokers to use NRT[30] in cessation attempts are hindered by unnecessary licence restrictions, which are beyond the power of the NHS to remove, but lie with the relevant pharmaceutical companies and MHRA.

  An outline of the role of the pharmaceutical industry in submitting applications for product licensing to the MHRA has already been made. However, the picture would be skewed without also outlining the role of the MHRA in approving product licences.

  The area of smoking cessation is possibly a unique area for the MHRA in that the "agreed approach" they use in assessing the safety and efficacy of a medicine is rendered inappropriate in this instance by the presence of a parallel "nicotine market" in tobacco. Unfortunately the delivery mechanisms for nicotine via tobacco use are much less regulated but also "dirtier" (ie they contain recognised and regulated toxins[31]) than delivery of nicotine through medicinal products. In order to "safeguard public health"[32] the MHRA needs to recognise the existence of this parallel "nicotine market" and to adapt its regulatory approach to reflect the real risks being posed to the public from these different nicotine delivery devices. Unfortunately the MHRA has historically shown very little interest in adapting its approach to deal with either the existing inconsistencies in the regulation of nicotine products, or the risks posed by new nicotine delivery devices entering the tobacco market.


  The role of the pharmaceutical industry and (inseparably) its association with the MHRA has a major influence on the supply and use of medicines within the NHS.

  At present, the relationship between the two players (from the outside at least) appears to be symbiotic in that confidentiality over product licence applications and their revision is maintained and there appears to be very little room for external parties to influence proceedings (other than for "equired consultations", for example, the reclassification of a medicine). Whilst this is fully understandable for applications for new product licences, it appears to be less appropriate for established markets where relatively minor changes to product licences to better suit the NHS and patients could be justifiably made.

  In addition, the role of the MHRA in smoking cessation does not appear to sit easily with its current approach to licensing medicines. If the MHRA was to change its approach to better reflect its stated aim of "safeguarding public health" then it might be appropriate for its role in regulating product licences for smoking cessation to continue. Without that change, however, it is likely to be more in the public's interest for the regulation of nicotine and tobacco products to sit within a different framework, which might be more concordant with the approach of another regulatory body.

  PharmacyHealthLink believes that the time is right for a thorough (external) review of the methodology that is currently used for licensing pharmaceutical products and the degree of scrutiny that the process is currently subject to. In our view, in line with developments in UK regulation elsewhere,[33] there should be room for wider public and professional involvement, particularly at the post-licensing stage. PHLink believes the Health Select Committee Inquiry is ideally placed to conduct such a review and make recommendations on how this process could be "modernised" in line with other social and healthcare developments.—psa—ch3.pdf

22   HM Treasury Spending Review 2004.  Back

23   National Standards, Local Action: Health and Social Care Standards and Planning Framework 2005-06-2007-08, Department of Health, 2004. Back

24   National Institute of Clinical Excellence. (2002, March). Technology Appraisal Guidance-No 39. Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. London. Back

25   Improving Local Access to Smoking Cessation Therapies by Using Patient Group Directions, PHLink, 2003. Back

26   A few products (eg Nicotinell transdermal patches) state "the treatment of nicotine dependence" as their therapeutic indication. Back

27   There are currently six different forms of NRT licensed for use: chewing gum, transdermal patch, inhalator, nasal spray, lozenge and sub-lingual tablet. Back

28   The use of NRT in cessation attempts is known to double the success rate in quitting. Higher rates of success can be achieved if the patient also receives specialist behavioural support during their attempts to quit. Back

29   Nicotine Addiction in Britain. A report of the Tobacco Advisory Group of the Royal College of Physicians (2000). Back

30   "Safeguarding public health" is the strapline of the logo of the MHRA. Back

31   See, for example, Learning from Bristol: the Department of Health's response to the Report of the Public Inquiry into children's heart surgery at the Bristol Royal Infirmary 1984-95. Back

32   Not printed. Back

33   Not printed. Back

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