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Recommendation 6 (paragraph 33)

Recommendation 6 (paragraph 33): The intensive marketing which encourages inappropriate prescribing of drugs must be curbed. Present methods of supplying independent information, as described by Lord Warner, are inadequate. We recommend that all the promotional material for a new product be pre-vetted by the MHRA prior to publication, and that consideration be given to limiting those who can prescribe a new drug in the two years following launch. Drug and Therapeutics Committees would be well-placed to implement this. Wider prescribing rights would be permitted once comparative studies, and trials investigating the potential adverse effects of the medicine in large populations, had been undertaken and after formal evaluation of the value of the product in clinical practice had been confirmed by the Licensing Authority and/or NICE.

The Government agrees that there must be proper controls in place to ensure that marketing carried out by pharmaceutical companies is acceptable, and does not adversely impact on prescribers clinical judgement. It is important to remember that clinicians are responsible people who have undergone years of training and make critical decisions about the health of their patients each day.

There is no indication that the measures currently in place are not effective. The fact that generic prescribing has risen to nearly 78% (in 2003) clearly indicates that clinicians are writing prescriptions generically and not by individual company product.

The current measures in place are:

* Medicines (Advertising) Regulations 1994 (regulation 21 'inducements and hospitality') govern the promotion of medicines by a pharmaceutical company to anyone who is qualified to prescribe.

* The Departmental guidance Standards of Business Conduct for NHS Staff, and Commercial Sponsorship - Ethical Standards for the NHS (November 2000) give clear guidance to NHS employers and staff in maintaining strict ethical standards in the conduct of NHS business, including on receiving sponsorship. The Department has again reminded the NHS of the need to adhere to the guidance. NHS Employers will highlight the need for NHS staff to adhere to these guidelines through their communication channels.

* All NHS staff have to follow a Code of Conduct. A model code is attached to the guidance and makes it quite clear that staff are expected to declare gifts, benefits or sponsorship of any kind and refuse gifts which may be seen to compromise their personal judgement or integrity.

* Health professionals are subject to their own codes of conduct which are maintained by their professional colleges and councils such as the GMC guidance Good Medical Practice.

* Self Regulation. The ABPI established the Prescription Medicines Code of Practice Authority (PMCPA) in 1993 to operate its code of practice on promoting medicines to health care staff of prescription only medicines. Where NHS staff (or anyone else) believe that the code of practice has not been adhered to they can make a formal complaint to the PMCPA.

The Government recognises that concerns have been raised about the controls on marketing after launch and on promotion by representatives from pharmaceutical companies during this period. It has therefore asked the PMCPA to consider proposals to strengthen their code to reflect these concerns. This might include limits on the spend, amount or rate of issue of material for newly licensed products or those with new indications, new patient populations, etc.

The Government accepts the Committee's recommendation that promotional material for new products be pre-vetted. The MHRA already undertakes pre-vetting according to published criteria, which has included some new chemical entities. This will now be extended to all such products. This amounts to around 20 products in a year in total. In context, the MHRA pre-vetted the advertising of 30 products according to its published criteria in the last financial year. Pre-vetting for new products can be planned into the licensing timetable, need not delay launch of a product and is normally considered by the MHRA in a matter of days. The MHRA will reprioritise its existing activities to achieve the change within existing staff resource and will continue to focus its activities primarily according to its published criteria.

The Government agrees that clinicians should receive independent advice on medicines. Guidance and advice is offered at national and local level already from local Drugs and Therapeutics Committees and from NICE respectively. In addition, the Department of Health purchases the Drug and Therapeutics Bulletin (DTB) for all NHS doctors in England. The DTB is an independent eight-page bulletin, published monthly by the Consumers' Association. It provides critical impartial reviews of treatments.

There are a range of measures that regulate marketing of products by companies, and prescribers receive independent advice from a number of sources. We believe by enhancing the current arrangements in the ways described above, we will continue to ensure that prescribers make decisions based on the clinical need of the patient. However, we do recognise the importance of monitoring these measures to make sure that they remain adequate, and we will therefore continue to keep these under review.

The Government agrees that there is a need to look at whether there is a safer way of introducing new drugs. The Ministerial Industry Strategy Group is beginning three strands of work looking at developing long-term strategies for the UK based industry. One of these strands is looking at regulatory issues and this will bring all stakeholders, including patient groups and prescribers, together to do some 'blue skies' thinking to consider whether there might be better controls at the time of release of new medicines into clinical use, and better ways of proactively gathering safety data to avoid sudden scares. A range of options from changes in EC and UK law, through to enhancements to the Yellow Card Scheme, will need to be considered.

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