BRUSSELS, Jan 13 (APM) - Europe's branded pharma trade body has responded enthusiastically to a European Union consultation on mobile health (m-health), including with an explicit suggestion that the anti-counterfeiting system it is developing with a consortium of healthcare players could provide a valuable hub for m-health apps too.
The European Federation of Pharmaceutical Industries and Associations sees a clear role for m-health in providing authoritative and up-to-date product information. It favours electronic dissemination linked to a data-base of regulatory authority-approved package leaflets and summaries of product characteristics .
"Currently there is a time lag of up to two years between regulatory agreement of new information and the provision of products with updated leaflets in the supply chain," EFPIA admits.
It says compiling the information under one address will create a single trusted source, providing patients and healthcare professionals with an authorised baseline against which they can compare other applications.
The approach could also permit the provision of tailor-made information, personalised to the individual user, readily accessible through a single point of entry and with access intuitive and at the right time.
Conceding that the underlying technology required for such a major database solution would be a major enterprise beyond the means of any single stakeholder, EFPIA goes on to suggest a role for the pan-European product verification system it is now developing in the context of the EU's falsified medicines directive.
"Rather than re-inventing the wheel," says EFPIA, this "provides the right infrastructure for accessing and disseminating such electronic product information", and "will enable a step change in the provision of information to patients".
The industry association, which is the principal investor in the so-called European Stakeholder Model, foresees the possibility of "a bigger initiative to develop product- or disease-specific apps, that could also be accessible through the system".
EFPIA also sees scope for making healthcare cost savings through judicious use of m-health.
"The building of trust in the provided medicine by more patient-friendly product information should support better adherence to treatments," it says.
"If medicines were taken more often and in line with the prescription the efficiency of the treatment would increase and health care costs could be lowered."
The potential of m-health in generating big data has also caught the attention of EFPIA, particularly if new analytical techniques can be developed and answers can be found to still-unresolved legal and ethical issues.
This will require significant research, says EFPIA, recommending direct European Commission engagement, both in funding the necessary technical research and in developing responses to the many broader outstanding questions.
"The private sector alone is unlikely to develop the answers here, so we rely on a co-ordinated response," says EFPIA - cautioning that "if this doesn’t happen, the potential for big data (whether powered by m-health or other technologies) will not be realised."
The industry federation is keen to explore ways of working around current constraints on medicines' advertising.
"Any information that is not approved by a regulatory agency (package leaflets, summary of product characteristics and educational material ) is often considered as advertisement," EFPIA observes.
This precludes apps relating to individual medicines, because the information would be available for the public and therefore fall foul of the law.
However, EFPIA points to arrangements in Sweden and the UK, under which it is possible for the prescriber to give a code to the patient to use an app as a patient support programme linked to the prescription of a specific medicine.
"EFPIA would be in favour of exploring possible options in order to harmonise ways of prescription throughout the European Union," it adds.
The consultation prompted more than 200 responses from industry, patients, healthcare professionals and non-governmental organisations.
Most of the responses included calls for tougher safeguards for data privacy, improved interoperability and wider promotion of standards, a clearer legal framework and certification of m-health applications to ensure patient safety.
The Commission now intends to discuss whether to legislate or to promote self-regulation or guidelines.
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