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Carefully crafted

In attempting to reshape pharmaceutical marketing, the government has tempered its response to the recommendations of the HSC

Pot makingIf you've ever rowed a boat through a cross wind, you'll know how it can make you feel as though you're being urged to take a certain path to go with it, or to compensate. The metaphorical question is: if the doctors in the country are rowing the boat, are pharma's wind blowers knocking it off course?

The answer to the centre-point question in the Health Select Committee (HSC) inquiry into pharma's influence over prescribers is, according to the government's official response in September, that it depends, of course, on where the boat needs to go. Yet, the oarsmen shouldn't feel obliged to row only with the wind because it's faster and easier. In other words, it's most often best if the doctors are able to steer the vessel, but if pharma doesn't provide the oars and educate GPs on paddling technique, the whole thing could be heading down towards Davey Jones' locker.

Back on dry land, the government's verdict on marketing and promotion in the pharmaceutical industry looks to be a fair one, if not as antagonistic as some might have expected. There's a distinct woolliness in some key areas, and a peppering of non-commital phrases in the official 24-page reaction.

Yet, there are also sharp teeth on some of the plans, including new, deeper legal holes to fall into, a set of new risk:benefit reporting obligations and a new (much weightier) classroomslipper to throw at any firm that breaches the rules governing advertising. From this point on, the list of those named andshamed may be written in indelible ink.

The HSC, many have agreed, managed to achieve its task successfully: it probed and questioned the role of marketing practices and then suggested ways in which certain areas couldbe tightened up for the benefit and safety of patients, and forclarity of purpose regarding promotion. It also pointed to the murkiness in the government's relationship with the pharma industry and challenged whether the closeness of the industryas a partner and a supplier is as wholesome as it could be.

However, in responding authoritatively to its Select Committee's recommendations for enhancement, the government has had to tread a careful path through something of a minefield.

Government clearly does not want to panic the herd of nervous pharma antelope and see them charge off across the savannah and over the horizon, so it's constructed a masterpiece of a reply that won't upset the back-benchers and won't upset pharma, says healthcare policy commentator and broadcaster, Roy Lilley.

We [in the UK] are slow adopters of new medicines - NICE doesn't help, generic targets and web-based procurement are making life difficult for pharma, and a lack of access to prescriber decision makers, formularies and frameworks add to its woes. The government has to balance trade issues, employment and tax in an increasingly globalised environment, so the fact that it has kicked this into the long grass is no surprise. The NHS knows where its bread is buttered - without pharma, for example, there would be next to no post-graduate education!

Former specialist adviser to the HSC and independent policy analyst, Ray Rowden, spoke of his relief that the government had acknowledged upfront pharma's major contribution to the education of its - the NHS' - staff. These days, the major companies provide for a much wider range of people in their education programmes, including allied health professions, nurses, practice managers, user groups, carer groups - they're all going to a much wider audience. I'm glad that someone has recognised that for the record.

The key points
The Association of the British Pharmaceutical Industry (ABPI) gave a broad welcome to the government's response, endorsing in particular its emphasis given to patient safety.

On the marketing side however, the ABPI raised concerns that the extra measures called for, including pre-vetting all healthcare advertising material for any new chemical entity, could further delay entry of innovative new products on to the marketplace.

The HSC recommendation read: 'The intensive marketing which encourages inappropriate prescribing of drugs must be curbed [and hence] we recommend that all the promotional material for a new product be pre-vetted prior to publication, and that consideration be given to limiting those who can prescribe a new drug in the two years following launch.'

The latter point is particularly pertinent regarding the 'bombardment' of new and less experienced doctors with promotional material, and the new marketing activities targeting freshly-empowered nurse- and pharmacist-prescribers.

In response, the government - which agrees that there must be proper controls in place to ensure marketing carried out bypharmaceutical companies does not adversely impact on prescribers clinical judgement - has asked the Prescription Medicines Code of Practice Authority (PMCPA), which handles complaints about adverts, to consider limiting the spend, amount or rate of issue of marketing material for newly licensed products, or for those with new indications or patient populations etc...Any changes are yet to be announced.

The MHRA has been charged with pre-vetting promotional material for new products - a task, the ABPI points out, it already accomplishes. However, pre-vetting formerly only pertained to some new chemical entities - the Code does not currently require anything more - whereas going forward, advertising for all new drugs will be judged. This, the government says, can be achieved within existing staff resource at the MHRA, requiring it only to reprioritise its existing activities.

Yet Richard Ley, at the ABPI, is concerned that this may be more difficult to implement than the government thinks: The government must ensure that the MHRA has the appropriate staff with the right levels of expertise to carry out such pre-vetting without delaying the medicine's availability. It's not acceptable to start adding on weeks or, even worse, months to that 'approval' process - but clearly that is a danger, and it's why we've issued a warning signal.

He adds, however, that this may be just an extra safety net, asthe number of complaints upheld under the Code each year is comparatively small and often relate to points of detail in pharma's advertising material, rather than major points of principle.

Pre-vetting work and limiting early post-launch marketing are two examples of three key measures that regulate marketing of products by companies supported by the government in response to the HSC's suggestions. The third is to ensure that clinicians receive independent advice on medicines.

Again, this is already provided in today's environment in the form of guidance and advice from local and national Drugs and Therapeutics Committees, and of course from NICE. Furthermore, the Drug and Therapeutics Bulletin, which is purchased by the Department of Health for the benefit and use of all doctors in the country, provides critical impartial reviews of treatments.

However, we do recognise the importance of monitoring these [three] measures to make sure that they remain adequate, and we will therefore continue to keep these under review, the government states.

The launch of brand new drugs onto the market is up for more of a shake down, however. The HSC called for a slower roll out of new products - for which the safety data is relatively limited - and even then only to patients who are in clear and definite need of them. This is to try and avoid another Vioxx situation - and quite rightly, nobody wants that - though several big pharma firms, such as Lilly and Pfizer, have already made disparaging noises towards the idea of slowing market entry yet further, particularly considering that the UK is one of the most sloth-like in adopting new medicines, and recent budget cuts mean that NICE is also dragging its feet.

Yet, the government does not, at least yet, intend to worsen this problem. The Ministerial Industry Strategy Group is beginning three strands of work with the aim of developing long-term strategies to temper the launch of new products and this will involve consultation and blue skies thinking with all stakeholders, under the remit of understanding whether there might be better controls at the time of release of new medicines into clinical use.

Indeed, the PMCPA will consider whether limits on promotion following product launch could be achieved through self-regulation. Yet at this time, the government has only agreed that there is a need to look at - and not to change - current practice, as well as ways to proactively gather safety data.

In part, it's about avoiding sudden scares. Though of course the idea of 'drip-feeding' a scare could also make for good debating society fodder.

So, it is possible that there will be stronger restrictions to come in the future, pending the completion of a number of supplementary enquiries, yet for now aside from a few tweaks it seems that the government is content to leave many aspects of marketing alone, if under closer scrutiny, as long as pharma's behaviour befits its hoped-for place in society - ie, more Mark Darcy than Wayne Rooney.

New sanctions
On a related note (though strictly speaking unconnected to the HSC's official recommendations) regarding the submission of information to the MHRA in support of a marketing authorisation is the introduction (from August 1 2005) of a new offence by law. Any company failing to provide, or providing false or misleading, information will be guilty of a criminal offence and can be prosecuted under law as such.

This point is highlighted in the government's response to the HSC in that, as part of a more determined attempt to watch over new and newly launched medicines, plans are in place for the MHRA to undertake random inspections of marketing authorisation applications to ensure that Good Clinical Practicestandards are attained.

Indeed, if any one part of the HSC's work could be regarded as notably zealous, it is the proposals to sanction pharma companies whose promotional efforts overstep the mark.

'Marketing practices that appear to be illegal should be reported by the pharmaceutical industry and others to the MHRA,' is one HSC suggestion. Another reads: 'When companies are found to be in breach of advertising or marketing regulations by the MHRA, we recommend that corrective statements always be required and that such statements are given as much prominence as the original promotional piece. The publication of misleading promotional material is a criminal offence and the punishment should befit such a status.'

Strong words; but the government's response to this, in essence, is that we have already overseen a number of enhancements to processes underpinning the advertising complaints and regulation systems. Already, procedures have built-in audit, are more open and transparent, provide quicker determinations of breach and useful access to available sanctions. This has, for example, resulted in a reduction in the average time for completion of external complaints from 16 to 6 weeks (see Int J Pharm Med 2003; 17: 5-6), the government states in its document.

Only subject to further public consultation on the regulation of medicines advertising, through a review of its Blue Guide, will the MHRA even consider the need for anywider review than what has already been undertaken.

Regarding the naming and shaming plan, the government deems it appropriate but is quick to highlight that to require corrective statements on every occasion, regardless of the nature of the breach, would not be proportionate and would run the risk of trivialising the impact of corrective statements.

Finally, there is a thorn in pharma's side in the form of a threat to cut research and promotion allowances under the Pharmaceutical Price Regulation Scheme (PPRS) for companies that breach the advertising rules. However, this may only come into force after the government has consulted with the ABPI at the next negotiation of the PPRS, in 2009. On the flip side, the government will also enter into discussion on the mechanism on how best to reward companies for innovation.

A new image
With the Labour conference ongoing in Brighton, and not running as smoothly as Blair had hoped, this pharma reaction will likely not make the front page of the Financial Times. People say this whole investigation was the swansong of a very left-wing former HSC chairman, David Hinchcliffe. Yet, it may have proved to be a valuable learning experience for the government, whose perception of pharma prior to the inquiry, it could be argued, was outmoded and a little off the mark.

Out of date? Very. says Rowden. In fact Pfizer invited the whole HS committee down to its plant in Sandwich, to say 'come and have a look at what we do', which I thought was a smart move because they could then see for real how the company worked and what its issues were.

Rowden believes that the government response will have been welcomed by an industry that feared a good deal worse, and the key message is that pharma's efforts to educate healthcare prescribers about the diseases and the products it makes to combat them are, with a few tweaks, safe enough for now.

The Author
Rob Skelding is deputy editor of Pharmaceutical Marketing

2nd September 2008

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