This October, the European Parliament will take its position on direct to consumer (DTC) communication about prescription drugs after a year-long review period.
When draft EC proposals on DTC were published in July 2001 they were greeted with some optimism and a great deal of confusion.
Initial excited media coverage of the proposals reported that DTC advertising was to be piloted in Europe. It then materialised that this appeared to be a translation error and what was in fact being piloted was DTC information.
'My take on the issue is that people are horribly confused about what the proposals mean,' says Sarah Matthew, MD of DTC specialist agency Sugar Consulting. 'Do they mean promotion, or provision of information, and is provision directly linked to solicited requests, and is that linked to the internet?'
In the year since the proposals were launched, all sides of the debate have been trying to come to terms with what they mean, and to put their side of the argument.
'We welcome the fact the EC recognises it needs to do something about the provision of information to patients, but we don't feel this goes anywhere near far enough,' says Association of the British Pharmaceutical Industry (ABPI) public affairs executive Marjorie Syddall. 'We're not in any way asking for advertising, but we would like patients to be able to approach the industry and ask for information, perhaps via a website or in printed form, and within certain quality standards.'
As legislation stands, pharma companies in Europe are not allowed to provide product information for consumers on their website. But patients with access to the internet can look up information about their prescription medicine on the website of US-based pharma companies.
It is this anomaly that Ralph Sutton, MD of Burson-Marsteller's European healthcare practice, feels the EC proposals have been drawn up to address: 'I sense the proposals are very conservative, and are really only playing catch-up.'
While there is relief on all sides that the EC has realised the need to address the issue of patient information, there is real concern that the proposals as they stand in draft form may be even more restrictive.
One of the items in the proposals causing the hottest debate is the definition of advertising. This has been amended to include 'any activity designed to promote awareness of the availability of medicinal products'.
A joint statement from European patient groups has branded the new definition as 'flawed', claiming it 'undermines efforts to distinguish between advertisements and other forms of information and will undermine information and education programmes produced by patient organisations and other external independent sources'.
Draft reports prepared by the European Parliament Committees charged with examining the EC proposals, published online in recent weeks, suggest that concerns about the definition of advertising being extended may, however, be unfounded.
The Environment, Public Health and Consumer Policy Committee's report calls for 'information' to be amended to 'marketing', explaining 'For the sake of clarity, the word "information" should be deleted from the definition of advertising'.
The Committee on Industry, External Trade, Research and Energy also calls for the EC to reconsider its proposal on advertising. 'There is a need for access to accurate, understandable and reliable information on the range of treatments, including medicines. But moves towards direct to consumer advertising should be resisted. The Commission, as an alternative, should look at how internet information could be validated, addressing issues concerning liability.'
The issue becomes even more confused when the EC proposals are compared to the system in the UK.
The Government's position on advertising and information has been stated by the Medicines Control Agency (MCA): 'The UK Government does not support direct to consumer advertising of prescription medicines but is supportive of the provision of information to patients.'
However, the current MCA Advertising Regulations, which prohibit advertising to the public likely to lead to the use of a prescription medicine, 'apply to all forms of advertising including the Internet'.
So there is still a great deal of uncertainty and many grey areas. Paul Woods, AstraZeneca global promotional consultant, has been working with ABPI and European pharmaceutical trade body ESPIA to formulate their response to the EC proposals. 'The proposals are unclear about what information would be allowed which has not previously been allowed,' he says.
Woods feels that the existing ABPI code of practice already provides detailed guidance on what is and isn't considered advertising. However, it is different attitudes to advertising around Europe that could have a real impact on DTC communication in the UK.
'In some countries the regulatory authorities have a different attitude about where the line between advertising and non-promotional communication lies,' says Woods. 'One of the aims of the EC proposals must have been to try to normalise the position in member states. The danger is that this could mean even more restrictions are placed on UK pharmaceutical companies.'
Matthew has the same concern. 'If the EC proposal to amend the definition of advertising is adopted it will include all the activities under the auspices of PR.' The question facing the PR industry is what will be the EC's position on activities such as branded work around the launch of a drug?
Even if the right to provide information is won, a further hurdle could be put in place which is causing great concern to the pharmaceutical industry and PR practitioners.
The other issue provoking heated debate is the EC's proposal to pilot DTC communication for a five-year period in only three disease areas - asthma, diabetes, and HIV.
A joint statement from European patient groups has drawn attention to the inherent unfairness in the proposals: 'Restricting the information pilot study to only three disease areas is inequitable because patients suffering from other diseases have exactly the same need for information as patients suffering from the three disease areas in the proposal'.
The statement also sends out a dire warning about the consequences of the proposal being adopted: 'patients excluded from the pilot will have to wait at least ten years before they too may be entitled to information (five years for adoption and implementation of the proposal, and five more years for an evaluation report of the pilot)'.
Opinions about whether the number of disease areas will be expanded vary. 'If there is debate around expanding the disease areas it would delay matters even more. In the short term I think the three disease areas will go through and it will be restricted to that, but I would hope that shortly after the disease areas would be expanded,' says Sutton.
Manning Selvage & Lee director of consumer health Sally Bradford is more optimistic: 'Based on the disease areas already highlighted we do think there is a likelihood that others will be considered - other chronic patient managed conditions such as MS, CVD, prostate and some forms of breast cancer. The other possible area is preventative management such as HRT, Obesity and Glaucoma for example'.
Based on responses to the lobbying activities being carried out by the ABPI, Eadie feels there is a good chance that other disease areas will be added. 'The inherent unfairness of selecting three disease areas is increasingly recognised and I think the Commission will respond to that,' he says.
Matthew agrees there is a need for change: 'We have to see better provision of information, and I think that will happen. Companies will be able to provide product specific information on their website, provided it is not promotion and it complies with regulations.
'I would hope the proposals will make our job easier, and it would certainly be useful to have the opportunity to make information available across a wider range of media,' she says.
All those affected are now waiting with baited breath to see what the final EC proposals will look like. While there are genuine concerns that a more restrictive regime will hamper DTC communication there is still room for optimism.