03 Apr 2012
There are a handful of digital-specific guidance documents for European pharma companies, but generally rules are written for a Web 1.0 (or, arguably, Web 0.1) world.
Where that is the case careful reading is required to translate them into a Web 2.0 environment, particularly because there is no single official source that will spell out for marketers what they can and can’t do.
So much rests on interpretation, the internal will to push the boundaries and being able to reconcile these within company, national and European rules and regulations.
“The challenges for rolling things out globally are always regulatory,” says Boehringer Ingelheim’s director of digital John Pugh.
“Different markets have different regulations and different interpretations of those regulations. Also, different regions use different platforms or prefer different forms of comms. So, when trying to plan a global campaign, it gets difficult to have a one size fits all solution.”
The starting point should be the national codes of practice produced by industry associations like the Association of the British Pharmaceutical Industry (ABPI) and the rules of the national competent authorities, bodies such as the French Agency for the Safety of Health Products (AFSAAPS).
Then there are the pharmacovigilance (PV) regulations, which exist at a national level and EU level, and finally post-marketing and clinical regulations in each of the territories.