Sometimes a conference is just too early. Sadly the EU Commission’s Pharmaceutical Package, which was due to be published in time for the DIA conference, was delayed

So what was the significance? The package will include proposals for patient communications, as well as measures on counterfeit medicines and a directive to modernise pharmacovigilance. The earliest that any regulations changes can come about is 2010, so the sooner the package is published, the less likely the delay.

However Paul Woods, Global Compliance Policy Director at AstraZeneca and Co Chair for the EFPIA Informed Patient Task Force, gave us a flavour of what might be coming any day now. This was part of a session on Regulations, including an excellent overview of the mechanisms of regulations and legislation by Genevieve Le Visage, EMEA and an update on the EFPIA code changes by Andrew Robson, an independant consultant who advises pharma in codes of practice theory and practice. Contact Andrew Robson

We’re up for change

The time is right for change in patient communications.

  • Better information for patients leads to better health outcomes
  • There is no consistency across Europe in regulations
  • Multiple information providers leads to variable quality and reliability but industry information is good quality
  • The distinction between information and advertising is not clear

But let’s state upfront; none of the stakeholders (including the EU commission, patient associations, pharmaceutical (pharma) industry or regulators) want direct to consumer advertising (DTC).

Paul outlined pharma’s position. We believe that patients should have access to non-promotional health information in their own language. We want recognition of pharma as a partner in the interactions. Regulations must enhance not reduce the quality of health information. Harmonisation to the level of best practice is essential. Lastly, legal clarity between information and advertising is overdue. Since self-regulation can work, unnecessary bureaucracy is not wanted.

The think tank High Level Pharmaceutical Forum has already published their position ; they want practical progress in improving the quality and access to high quality, non-promotional patient focused information from multiple sources, including pharma.

An earlier report from the EU Commission and EU Ministers of Health debates gives us some hints that information from industry can be regarded by some as advertising through the back door. Check out the legal proposal for information to patients

As the legal proposal will only apply to MAH holders, it implies industry will be constrained in what we say, whereas anyone else can say what they want! Hardly desirable since pharma holds the greatest repository of information and data on their products.

Paul went on to outline the position from EFPIA with their model of 4 categories of non-promotional information based on push and pull situations.

Until the proposals are finally published, we are still in the dark. The concern is that we will continue with information inequalities and unecessary bureaucracy.

A lost opportunity, if this comes to pass.