New European rules on patient groups come into force
pharmafile | July 11, 2008 | News story | Medical Communications |Â Â ethicsÂ
Pharmaceutical marketers across Europe have a new set of rules to follow if they want to work with patient groups.
A revised code of practice on the issue was put into effect by European industry association EFPIA at the beginning of July to ensure ethical behaviour and transparency.
It is the first time that the EFPIA's 2,200 members, across 31 countries, have committed themselves to a common set of ground rules and the industry has had since October last year to prepare for the changes.
Among the raft of new requirements companies must make publicly available a list of the patient organisations to which they contribute money or other support by March 2009.
EFPIA president, and Bayer Healthcare chief executive, Arthur Higgins said: "Our work with patients is important as it helps us understand and address their needs and concerns on research and medicines.
"We want this relationship to be transparent and to be in line with the highest standards of compliance and ethics. EFPIA's Code establishes clear principles for working with patient groups that all member companies must comply with."
However, the Code's first requirement is something that is already enshrined in legislation – the prohibition of advertising of prescription-only medicines to the general public.
In a far from draconian document, other Code stipulations include:
* Companies cannot insist on being the sole means of funding for patient organisations
* They have to obtain written permission for the use of patient groups' logos
* While firms can correct factual inaccuracies, they cannot seek to influence the content of sponsored patient organisation material to favour commercial interests
But critics of self-regulation are unlikely to be impressed by the fact that acting on complaints about behaviour "shall be a matter solely for the national associations".
Moreover sanctions for companies that fall short of these standards will inevitably vary from country to country, with current punishments ranging from 'naming and shaming' of offending companies in industry publications to fines and suspension from national industry associations.
On the sometimes-vexed question of freebies, the new Code says that all forms of hospitality must be "reasonable in level and secondary to the main purpose of the event". The events themselves should be held in an "appropriate venue", avoiding those that renowned for their entertainment facilities or extravagance.
As the UK's national pharma association the ABPI, whose own new Code of Practice also came into force this month, will be tasked with implementing the EFPIA Code – including processing complaints and imposing sanctions.
The new Code will also apply to corporate members of EFPIA's specialised groups, the EBE (European Biopharmaceutical Enterprises) and EVM (European Vaccine Manufacturers).
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