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Government reacts to HSC

The government has made its response to the Health Select Committee report, on the influence of the UK's pharmaceutical industry over prescribers and it has received a ìbroad welcomeî from the BPI

The government has made its response to the Health Select Committee report, on the influence of the UK's pharmaceutical industry over prescribers, and it has received a ìbroad welcomeî from the Association of the British Pharmaceutical Industry (ABPI).

Speaking on the reaction, which lays out ways in which the industry and associated bodies should act in the future to address several 'problem areas', Richard Ley, spokesman for the ABPI, said that there were ìsome points where we don't see eye to eye, although we often agree with the principle behind itî.

With regard to the marketing and promotion of the UK's medicines, the government's official reaction opens with 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'. Yet, a statement shortly after adds: 'There is no indication that the measures currently in place are not effective.'

In its recommendations, the HSC was critical of the industry's approach to its marketing practices: `The intensive marketing which encourages inappropriate prescribing of drugs must be curbed. Present methods of supplying independent information are inadequate. We recommend thatÖ consideration be given to limiting those who can prescribe a new drug in the two years following launch.'

The government responded: '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 [Prescription Medicines Code of Practice Authority] to consider proposals to strengthen their code to reflect these concerns.'

Specifically, 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'.

Yet, the government also recognised that as the UK's doctors have succeeded in driving up the level of generic prescribing to nearly 78 per cent (in 2003) it is clear that they are making wholesome and appropriate decisions about their patients' health, rather than `writing prescriptionsÖ by individual company product'.

Ley told Pharmaceutical Marketing: ìBy and large I think it is a very reasonable response.î

However, the government has listened to its HSC and has called for a number of changes, enhancements and metaphorical safety nets with regard to the pre-vetting of all promotional material for new medicines, as well as some regulatory activities.

One key issue is that the Medicines and Healthcare products Regulatory Agency (MHRA) should pre-vet the promotional material for all new drugs, which currently stands at an approximate total of 20 per year.

The ABPI raised concerns that this move might delay new products coming onto the UK marketplace. In a statement, it said: 'It is important that this action does not further delay innovative, new medicines from reaching patients [and] the government must ensure that the MHRA has the appropriate levels of staff with the right levels of expertise.'

Ley added: ìClearly it is a danger that there might be extra delays and that's why we've issued a warning signal - that it is not acceptable to start adding days, weeks, or, even worse, months onto the approval process.î

In its official response, the government commented: 'Pre-vetting for new products can be planned into the licensing timetable [and] need not delay launch of a product. The MHRA will reprioritise its existing activities to achieve the change within existing staff resource.î

Government also noted however, that ìthere is a need to look at whether there is a safer way of introducing new drugsî.

  • The October issue of Pharmaceutical Marketing magazine will explore the reaction in full detail. The government's response is available to read on the Department of Health's website.

30th September 2008

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