Liberalizing Regulations to Allow the Freer Flow of Information To Patients Globally – A Call for Harmonization

Is a patient in Europe different from a patient in the US?   No?  Then why are they treated so differently when it comes to information flow?

I have spent the past few days in Berlin at the Second Annual Digital Pharma ExL Conference.  It was a notable get-together for a number of reasons, including presenters who were extremely knowledgeable and understanding of both the potential of social media, and of the realities that must be faced both externally and internally in its use by a highly regulated industry like the medical products industry.  

There exists a tremendous conundrum.  People who use medical products – call them patients or consumers – whatever your ilk – are turning to social media in increasing numbers on both sides of the Atlantic for news and information, particularly respecting health care.  There are differences in the patterns of uptake in the U.S. vis a vis Europe, and in the specific medium – Twitter has grown wildly in the U.S., less so in Europe, for example. 

But the biggest difference is that U.S. firms can actually respond to the people who use their products about their products while in the EU, manufacturers are much more highly proscribed from interaction.  In the U.S. they can provide resources.  They can send people to the PI for responsible information.  They can provide support.  They can provide their data.  They can engage in dialog.  In the EU, they cannot.  

I was, of course, aware of this before, but had always considered the issue from the point of view of my clients – medical product manufacturers.  Suddenly, and ironically of all places in Berlin – I thought about the matter from a patient's point of view.  Patients on one side of the Atlantic can get access to dialog and information.  Patients on the other side are not allowed to.  

That leads to the fundamental question.  Why is public dialog, especially now with the ascendancy of social media, such a bad thing?  Europe does not want Direct to Consumer advertising -fine.  But there is a wide gulf between DTC and allowing public discourse between companies and the people who use them.  Allowing companies to supply information in a regulated context isn't making the leap to DTC.  Isn't it in the patient/consumer's best interests to get information about a product that they are putting into their bodies from the manufacturer that spent time and money to develop it?  

If you go to buy any other product on either side of the Atlantic – you take into account a number of factors including talking to friends, families, professionals AND the manufacturer.  Why in the world when you are perhaps making the most important decisions of your life would you not be allowed to get information from the manufacturer of the product you are about to ingest.  It does not make sense.  If you are a patient in the US you have many options available to you in order to make an informed decision.  If you are a patient in the EU, you have one less.  It does not even make good public health.

For multinational companies, they are in a special bind.  They can produce basic information for the U.S. public, but not for the public in the EU.  That is nothing short of absurd.  

As a former AIDS activist, I finally stopped to consider this from the patient's point of view.  Don't I, as a patient, have a right to get information from where I want in order to make an informed decision? 

Why, if I were a European, could I not have the same right to seek it out from a company?

Why if I were a patient advocacy organization could I not force a public discourse with a medical product manufacturer?  

I cannot imagine if during the 1980s there had been social media present at the International AIDS Conferences and AIDS activists demanded public discourse regarding a specific treatment with medical product manufacturers and were told "Sorry – regulations don't allow engagement."    For those of you too young to remember the 1980s, let me assure you, such a feeble interjection would have been stomped on.  

And so even while the U.S. moves at its glacial pace to put some definition to the parameters of social media, social media practices among medical product manufacturers has begun to evolve, though of course behind other less regulated industries.  .

Harmonization efforts are occurring on other fronts in medicine between the US and the rest of the world – an effort at harmonization could liberalize the situation outside the US.  Even while the US inches forward on its social media policies, harmonization efforts also need to be underway to address the disparities that exist between the US and the EU in this regard.  After all, considering public health authorities are evidence-based, there is no evidence to suggest that the American public is disadvantaged by having the broader spectrum of information available to them.  In fact, to consider otherwise is frankly counter-intuitive.  And that means, a formalized effort at providing a realistic basis for some harmonization that results in allowing the consumer/patient to gain insights from a broad range of sources that includes manufacturers.  

The wall of regulatory communications interference with the rights of patients and advocates to seek  information and for companies to provide it, should come down.