What if your new disease awareness leaflets had to be verified by a competent authority?
What if your website providing information to patients on POMs had to meet quality standards? And also had to be registered?
Would that be a step forward for your country or have unintended consequences?
Spoiler alert – this is a rant!
So the European commission has issued new proposals for the Information to Patients directive, as of October 2011. At first glance it looks good – in parts.
- websites with POM information must meet quality standards on accuracy, evidence-based, understandable & aimed at patients
- you can still provide information on the label (presumably the prescribing information), prices, clinical trials or instructions on use
- you can still provide some information on POMs if a patient asks you
But what about
- “A publication in general print media will not be permitted.”
- “As a general principle, information which has not been approved before needs to be verified by competent authorities prior to its dessimination (sic)”
I guess this means no more Daily Mail, Le Monde, Bild or Dagbladet articles on the new wonder drug. Whilst we in med info don’t like this approach anyway (it sets up huge expectations, clinically and financially), we all know it happens. It’s usually triggered by a press release issued by our company or patient association, or both. When health pages can dominate newspapers, surely this could be interpreted as censorship. I wonder how many European countries will object to this – certainly Sweden objected to the previous proposals on these grounds.
So it may be good that unbalanced, inaccurate information couldn’t be splashed on the front page, these newspaper articles probably trigger patients and their carers to find out more and go to see a doctor or pharmacist. Could we get the balance right? Could we find a solution to trigger patients to find out more, communicating in a clear, balanced way?
But why just print media? Once more the commission is behind the times – print media is dead, long live online media! Will the online version of the Times/Bild/Dagbladet be regarded as print or non-print? Another example of when you try to restrict practice through regulations, technology is 10 steps ahead. And consumer behaviour is even further ahead.
So POM information available to patients not already approved (like the SPC or PIL) must be verified by “competent authorities”. The cynic in me says more fees for the regulatory authorities. But someone has to ensure standards are met.
“Will new bodies be set up to help the approval? More Quangos?”
Will pharma consider it more cost effective to create great websites for promoted products but may baulk at doing the same for the full product portfolio, if they market mature products? How cost effective will it be to go beyond the PIL/SPC for prednisolone or similar generics used by millions of patients? Again, we could end up with medicine information inequality. It’d encourage patients to ask for branded products even more. I’m sure the EMA don’t want that and we in medical information certainly don’t. We love fair, balanced, accurate information for everyone, not just the technically literate.
Thankfully we have PPP initiatives hosting detailed medicines information like FASS in Sweden and Electronic Medicines Compendium in UK. The EU was encouraging more PPP initiatives like these in their 2008 supporting documents. So come on France, Italy and Spain etc; empower your patients with balanced health information. EudraPharm and the EU Health Portal give European patients access to SPCs, PILs and the Public Assessment Reports. But you have to know where to look to find them! They’re not optimised to appear on the front page of a Google search for a drug.
We all know the web is global. Would a European patient searching for information on treatments be less likely to find medicines information on how they are used in Europe but still find non-EU (mainly US) information. Again – unintended consequences?
WHAT ABOUT MEDICAL INFORMATION?
What will this mean for MI? It makes the service we provide for patients even more important. We can continue to provide quality information about our products when a patient contacts us or point them to the best sources of information (including their HCP as a first point of contact). Any smart company that works out how to do that easily, ethically and cheaply, will be greatly appreciated by patients. You only have to look at successful social media campaigns run by Boehringer Ingelheim and Janssen to see how to truly engage with patients responsibly and ethically.
THE BOTTOM LINE
I HOPE I’M WRONG!
I’m sure this was all debated by the commission so I may be misinterpreting the proposals. We all know that the devil is in the details. So I’m certainly going to go away and read, re-read and debate with my MI buddies.
More importantly it’s a topic to talk through with colleagues in legal, public affairs and marketing. But if there’s one thing I have learnt at the 2 conferences I’ve attended this month (Digipharm and DIA Clinical Forum), it’s that there are creative, ethical and responsible ways we can meet the needs of the e-patient. Check out Paul Grant’s presentation and Alex Butler’s slides or follow them on Twitter; @PaulGrant and @Alex__Butler)
Like the EU commission we want to reduce health information inequalities of access, quality and outright lies. We want patients to know more about their medicines and be empowered to make informed decisions in partnership with their healthcare team, as we know it improves health outcomes.
So is this new proposal a step forward or 2 steps back? Only time will tell.