New guidelines for industry ‘disease awareness’ campaigns
pharmafile | October 28, 2003 | News story | |
Pharmaceutical industry 'disease awareness campaigns' aimed at UK consumers are to be governed by new guidelines to formalise the practice and clear up grey areas.
The campaigns, such as the Impotence Association's press and TV adverts (sponsored by Pfizer, manufacturer of Viagra), have always been governed by industry advertising guidelines, but have frequently fallen foul of regulators the Code of Practice Authority (CPA).
The campaigns are also governed by European and UK laws, which the Medicines and Healthcare Regulatory Agency (formerly the MCA) has now clarified with the new guidelines.
The MHRA says disease awareness campaigns are "a valuable source of information" to the public, helping patients recognise symptoms and where to seek further advice.
Restating general principles, the MHRA says campaigns should not promote products, and anything that aimed to stimulate demand would likely be considered promotional and therefore illegal.
Most recently, the CPA ruled that the prominence of Pfizer's logo on an Impotence Association advert would prompt patients to ask doctors for its product. This grey area of where education ends and where promotion begins has now been specifically addressed by the MHRA.
The new guidelines say a campaign "should not be of such a nature that an individual would be encouraged to approach a prescriber to request a particular medicinal option".
"The emphasis of the material should be on the condition and its recognition rather than on the treatment options. The appropriate treatment for each disease is for the health care professional to decide in consultation with the patient".
It adds that particular care should be taken where one product stands to gain directly, either because it is the only treatment available or for other reasons. "It is particularly important that these campaigns focus on health and disease education, with details of where to get appropriate advice".
The new guidelines were first requested as part of the industry-Government taskforce, the Pharmaceutical industry Competitiveness Taskforce, and have been welcomed by the ABPI.
Director General Dr Trevor Jones said: "I am delighted that the MHRA guidelines finally remove areas of doubt so that pharmaceutical companies are quite clear what is permitted and what is not".
He emphasised that the new guidelines do not affect the current ban on direct to consumer advertising, but that they would only encourage companies to consider taking part in such campaigns.
"The UK is a leader in Europe in producing guidelines for disease awareness campaigns, which are not permitted in some other countries, and I am delighted that patients in the UK will benefit from the clarification they bring to this area".
The ABPI remains concerned that current proposals to liberalise EU laws governing industry-patient communications will actually have the effect of banning disease awareness campaigns, which are little known in the rest of Europe.
Nevertheless, it has been over a year since the last new disease awareness campaign was launched, although it is unclear why the innovative marketing campaigns have not continued to proliferate.
It is unknown whether the new rules will indeed encourage more companies to launch new campaigns even with clearer UK guidelines, the uncertainty surrounding the EU reform process may have deterred companies.
But many industry marketers believe few products would benefit from such a campaign, with proof that they deliver return on investment relatively scarce.
