Stakeholders clash over European patient information
pharmafile | January 16, 2008 | News story | Medical Communications |Â Â Â
Stakeholders have voiced fresh fears pharma is moving towards advertising prescription medicines to consumers after the European Commission continued in its bid to relax laws on patient information.
The industry has rebutted claims that direct-to-consumer advertising (DTC) is inevitable, but is backing moves that could give pharma a role in the provision of information by 2011.
Draft legislation is set to come out in October, and it could be among the most controversial in European healthcare.
Health Action International (HAI), an independent network with the aim of increasing access to medicines, is in entirely against to pharma's involvement.
Its European coordinator Teresa Leonardo Alves said: "Pharmaceutical companies have a responsibility to their shareholders to promote sales and profitability. This is inconsistent with the needs of patients and the public for independent, unbiased and comparative information."
Revisiting the current laws that ban pharma from DTC advertising or producing any promotional information for patients was prompted by the internet's rise.
A huge amount of health information is now available online and it is often unregulated and varying in quality and relevance to patients.
In 2007 the European Commission suggested using Public Private Partnerships (PPPs) from a range of stakeholders to address the problem and keep patients informed of treatment options.
A consultation on the idea, which closed in last June, showed huge and unswerving opposition from patient groups and healthcare professionals who see it as a gateway to DTC.
The Commission has now pledged to consider the response and to maintain a ban on DTC advertising, but it will press on with PPPs regardless – something European pharma industry body EFPIA supports.
Director general Brian Ager said there was no risk of DTC advertising being allowed: "Absolutely no way. It is not on the cards. We've not asked for it and there's no intention of delivering that."
He cited an example where, due to current regulation, a company was unable to provide English product instructions to a patient who instead had directions in three languages he could not understand. The patient was eventually forced to find the information online from company's US website.
He added: "This is the kind of nonsense we've got ourselves into in Europe."
"Surely it's not unreasonable to expect to be able to provide information about products., when we as patients, or members of the public want to access it. We have to be able to distinguish between wanting to go and find information and having it pushed at us.
"The situation I think we're heading for in Europe is a modest liberalisation that will allow us to go and search for something. A bit like a library, where you and search to pull out a book."
But independent healthcare researcher The Picker Institute, though less militant in its view than HAI, still has doubts over pharma's potential role in the provision of information.
Don Redding, head of communications and spokesman on the subject, said: "The private-patient partnerships are unrepresentative, and the consumer is not part of the group. The Picker Institute is concerned, as the partnership arrangements need to be representative."
The institute believes there is sufficient resistance to DTC advertising and it draws a distinction between it and the softening of guidelines for pharma.
"It's not the first time we've been round this track, although there is just reason for looking at it again, which is the new technology available. Nevertheless, it has been debated before and the G10 medicines group stood up to say no to consumer advertising. Nothing has changed, and we trust the position will remain," Redding said.
"It is more likely that enterprise and industry is looking for ways to soften what the industry sees to barriers to involvement in patient information. This is not the same as a move to direct-to-consumer advertising."
No decision has been reached on how the partnerships could be introduced or regulated, and even when decided the proposals have to be considered the European parliament and council. It could take three years before the proposal to becomes law if previous examples of European healthcare legislation are used as a benchmark, and possibly longer due to its divisive nature.
