EU divided over patient information proposals
pharmafile | September 1, 2009 | News story | Sales and Marketing | EFPIA, Europe, patient information
Europe’s member states are at loggerheads over plans to relax current restrictions on pharma communicating with patients.
The plans tabled by Commissioner Verheugen would allow pharma to communicate directly with patients via mediums like the internet, though through a strict vetting system. This would end current rules which outlaw any communication with patients, but Europe is deeply divided on the issue.
The various governments divide into two broad camps those who favour a more liberal approach to regulating pharmas communications, and those who demand more restrictions.
The UK, Sweden, and Denmark are among the most prominent countries who want a more liberal approach, while Germany, France and Spain take a more conservative approach.
The pharma industry’s European body EFPIA is keen to see a change to the status quo, but spokesman Colin Mackay is not optimistic of a breakthrough any time soon: “We probably wont see much happening this or next year,” he said.
Mackay says the trade bodies in Germany, France and Spain have lobbied for a role for the industry, but without much success, mainly because the national authorities are concerned that providing more information to patients will increase drug budgets.
“There is also concern about the role of the industry, and this is supported by physicians, pharmacists and consumer organisations, who all think they are better placed to do it, with less vested interest,” he said.
Despite the opposition, the Commission is keen to push through the proposals. Now that feedback has been given by the EU member states, parliament will begin its debate, a process that could take between 6-9 months.
But Mackay said it could take around two years for a reform – if any – to be finalised by the Commission.
Divided opinion
EFPIA is broadly in favour the Commissions proposals to improve patient information.
“We are in favour of more information being available to patients, and for pharmaceutical companies to be able to participate in discussions about medicines,” said Mackay.
The industry group makes it clear it is opposed to direct-to-consumer advertising, which is permitted in the US but banned throughout the EU.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has just closed a public consultation on the plans.
The MHRA seems to support the principle of allowing the industry to give patients more information about medicines and has suggested companies could potentially self-regulate the information they provide to patients.
But the EU’s proposals have been attacked by groups who fear that pharma would exploit the rules and promote branded medicines to consumers.
In a recent editorial, the Drug and Therapeutics Bulletin (DTB) published by the BMJ Group said: “We believe that acceptance of the ECs proposals would permit public dissemination of promotional information about prescription-only medicines, masquerading as information provision.”
DTB also warned that experience in the US has shown that infringements of rules on information provision have tended to be detected only after they have been made.
However, despite wanting to see change, even those who favour a more liberal approach are not in favour of the EC plans.
Countries like the UK and Sweden are concerned that the EU-wide plans, which are already angled towards compromise, will actually mean a reduction in what is permissible compared to current regulations.
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