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Reconciling patient empowerment and EU regulations

To achieve true patient-centricity, regulatoryframeworks must be aligned with the real-world


Revisiting the five objectives of the Action Group on Prescription and Adherence to Medical Plans (“AG”), one of six Action Groups of the European Commission's Innovation Partnership on Active and Healthy Ageing, two deserve particular attention, namely (1) Patient centric solutions and (2) Empowerment of patients (and caregivers). 

These are crucial building blocks in helping healthcare systems in post-modern society mount the challenge of a significant change in demographics. 

Highly innovative (and award winning!) solutions have to date been implemented, many of them on the initiative of the pharmaceutical industry and their providers. This follows a clear trend from rudimentary medication adherence and compliance tools to overarching patient empowerment.

However, innovation has traditionally been hampered by the lack of a supportive regulatory framework. Here, sponsors of patient programmes are forced to navigate a minefield of rules spanning advertising, pharmacovigilance, data protection and an increasing body of self-regulation. While crucial elements, in their current form these are ill-suited to accommodate innovative patient support solutions sponsored by pharma. This is not surprising as all of them predate latest developments in patient care.

Pharmacovigilance represents a case in point. The classification of all safety information collected during the course of a patient programme as 'solicited' places a significant burden on pharma sponsors. Since the 2013 EMA workshop on this very topic no progress has been made on suggestions to define these reports as 'spontaneous', obviating the need for a resource-heavy causality assessment. Changes to GVP Module VI appear unlikely.

Effective social media tools, such as online-communities, are also affected. Not surprisingly, uptake within the industry is low. We just had the EMA's stance on reporting obligations for pharma-funded communities confirmed. 

The message is simple: In paving the way towards true patient centricity and empowerment we need to align the legal and regulatory framework with the real world and overcome the current mismatch. 

• A copy of the recent EMA communication is now available from Atlantis Healthcare. For more information email: or visit

Article by
Dirk Lenz

Director of Legal & Regulatory at Atlantis Healthcare

10th February 2015

From: Regulatory, Healthcare



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