Healthy Skepticism Library item: 19836

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Too unlimited
PMLive.com 2005 Dec 13
www.pmlive.com

Full text:

“It’s a licence to operate in today’s world.” This metaphorical remark is how Andrew Curl, deputy director general of the Association of the British Pharmaceutical Industry (ABPI), chooses to denote the magnitude of reputation to a pharmaceutical company.
“Companies build and grow their reputations very carefully – reputation is at the core of what all pharma companies do”, Curl states, responding in a late November interview to the notion that the new ‘name & shame’ clause for punishing companies that infringe conventions in the revised ABPI Code of Practice (CoP) may be limited wallop.
What’s behind the doubt is that pharma firms not only admit readily their lackluster efforts to brand the industry as wholesome, clean living and moral when opportunities arise, but some hardly go out of their way to defend against slurs, accusations and claims of putting marketing before patients during the more difficult periods. In general, companies are seemingly too busy developing, making and selling drugs to worry overly about hearsay.
If this, ostensibly, is how little pharma cares about its own reputation, is a name & shame scheme a deterrent of clout sufficient to ward off deviation from the new restrictions that govern, for example marketing to GPs?
“We considered imposing a fine on companies, but how much do you fine them in order to provide a deterrent? Reputation is behind all that the industry does”, he notes, pointing to the updated CoP as a well prepared, modern set of rules that directs proper conduct between the pharma industry and healthcare professionals, including patient advocacy groups as well as doctors and nurses.
The ABPI expects to have to reprimand a possible half dozen companies (or a deal with a like number of infringements) in 2006, though firms can expect notice of misdemeanors to appear in high profile medical journals, including the Lancet and the British Medical Journal. A further step could be to issue press releases through the ABPI’s website.
The CoP is tweaked every 12 months, but this latest edition brings some of the deepest and broadest reforms seen for some years. Pharma’s representative body engaged in an 18-month consultation with key stakeholders, comprising around 30 interviews with ‘industry active’ parties, before it was ready to unveil the new, up-to-date Code.
It aspires to be a transparent document that people are aware of and understand, and which is in closer keeping with the modern day business arena.
This, crucially, also means greater clarity over the restrictions and freedoms in marketing.
In his London office on Whitehall, Curl agitates himself forward in his chair and states assuredly: There is no place for that in today’s market”. His is a short retort to the question of whether pharma firms can still fly doctors away for a few day’s skiing, or take them for an afternoon driving Ferraris around a race track, provided that time is devoted primarily, or as well as, to delivering medical information in an educational context.
Without hesitation, he brands this type of activity as superfluous and, with seemingly reflex intuition, rules out the possibility of it happening in the future.
What about a lecture followed by dinner in the evening, or even a working lunch at a restaurant? “We realise that time is precious and that people need to eat. So, if sometimes business is discussed over a meal, then fine”. Yet, he is quite clear that the limitations are set out plainly and that, contrary to popular myth, the rules are made to be broken.
The new CoP details the limitations on how far and wide marketing activities will stretch from January 1, 2006, with reference to advertising in medical journals, gifts and hospitality, inducements and promotional items, UK and international meetings (including travel to and from them), ‘disguised’ promotion, distribution of marketing materials and several more, including relationships with the press, as well as the general public.
Of note is a helpful clarification of the ways in which pharma can interact directly with patients and the public regarding prescription-only medicines (POMs).
First up is advertising in journals: the new limit is two pages maximum allowed for any one particular product. The two-page limit encompasses inserts, whether loose or bound in, however it is permitted for a summary of product characteristics to be included as an insert in addition to the two bespoke pages of advertising. Ads on non-facing pages (ie, right then left) must not, when read in isolation, be ‘false or misleading’. Wrap-arounds and stick-on cards are still acceptable.
Gifts and hospitality are areas where clampdowns have occurred. The bottom line is that pharma shall not give or offer gifts, benefits in kind or pecuniary advantages to health professionals or their administrative staff as inducements to prescribe, administer, recommend, buy or sell any medicine. For instance, you wouldn’t now be allowed to deliver a CD containing medical information within a laptop computer and leave the computer behind with the CD, to be retrieved at an unconfirmed future date.
Promotional aids and items on long-term or permanent loan to doctors are acceptable, provided they are inexpensive (no more than 6 excluding VAT) and relevant to the recipient’s work. These would include desktop stationary, surgical accessories (nail brushes, gloves, tissues, tongue depressors and peak flow meters) and coffee mugs, but exclude items that are for use in the home or car (examples given are maps, umbrellas, neck cushions, lamps, teapots, coffee pots, rugs, clocks, thermos flasks, toolboxes, table mats, fire extinguishers, coasters, music CDs, desk thermometers…clause 18.2 is nothing if not specific).
Banned are competitions, quizzes etc that give prizes, as these were deemed to be ‘unacceptable methods of promotion’. It remains possible however to provide gifts to, and for use by, patients, provided the recipients are not encouraged to request the prescription of the related products.
talk to the public
Flip the coin over and the new Code brings to light that companies are able, and even encouraged in a way, to communicate directly with the general public.
No POM can be advertised directly to Joe Public, and any requests from individual members of the public for advice on personal medical matters must be refused and enquirers directed towards their health professional. Yet, needless to say while little information provided must be factual and balanced, it has been made much clearer that there are channels through which pharma is at some liberty to educate people about their POMs:
Proactive information can be released without any direct appeal for information from the public and includes disease awareness advertising, booklets on medicines and diseases, briefings, conferences, press releases, and mailings to patient organisations.
Reference information is more of a comprehensive and up-to-date library resource on medicines with marketing authorisations that is made available for the public to view primarily on company websites. Provision of this type of information is voluntary, though the ABPI looks upon it as good practice to publish product characteristic summaries, package information leaflets, public assessment records, registration and other relevant studies, plus material supplied to NICE and other health technology assessors.
The key point about reference information is that it should be a fair representation of a drug’s benefit/risk profile, based on the current body of evidence.
Reactive information can be supplied to the public in response to a direct request. It is deemed to be good practice for companies to provide a summary of product characteristics with a related press release or press pack and there’s the option to include public assessment reports. Firms should also consider pointing enquirers to other credible information sources about a medicine or condition.
The well known barriers to intervening in the patient/doctor or patient/prescriber relationship are iterated in Clause 20.4, though it is permissible to provide a factual, non-promotional leaflet to a physician who may pass it on to a patient taking the related POM.
Where caution should be heeded is in responding to inquiries about the side effects and indications, for which the recommended course of action is to direct askers to their healthcare professional.
the clear position
Of course, there is nothing essentially new with regard to these direct-to-patient communications. The previous ABPI Code also allowed companies to behave as described above, but it’s much more clearly defined than now. Companies have, in the past, been quite cautious, taking a ‘we’d better not do that’ stance, probably due to the fact that their freedoms were not spelled out quite so clearly.
With that now accomplished, one of the ABPI’s key aims for 2006 is to ensure effective implementation of the Code. The other chief priorities are based on recovering from a challenging 2005.
“It was the perfect storm for us this year”, Curl muses. “The issues were the 7 per cent price cut imposed on the industry, with no justification whatsoever, from the Pharmaceutical Price Regulation Scheme, we had the surprise Office of Fair Trading investigation, NICE delays, as well as the government select committee inquiry. It turned out that 2005 was the first year on record that we actually ended in deficit, by around 3 per cent.”
Some felt that the Health Select Committee (HSC) inquiry could have been tougher and while Curl believes that pharma did okay, he’s eager to highlight that despite the probe into the industry’s conduct, the revision of the CoP was called for and initiated before the HSC got stuck in.
“We have nothing to hide and I feel that the industry came through the HSC in a positive way. Indeed recommendations made by pharma were included, so we were delighted to see those and, infact, there were only a small amount that we had any issue with.”
Paramount for 2006, he sums up, is “to cut long-term costs related to treating chronic diseases and , of course, the continued articulation by the industry of the benefit of new drugs that improve the healthcare of the nation. Everything we do is linked in to benefits for patients, and it is a tragedy that modern medicines are not used as widely as possible”.