Please login to the form below

Not currently logged in
Email:
Password:

Pharma wants review of EMA pharmacovigilance fees

EFPIA among associations to call for ‘balanced and transparent’ funding
EU flag

The pharmaceutical industry has called on the European Medicines Agency (EMA) to re-assess the way it handles pharmacovigilance payments to make them more "balanced and transparent".

The European Federation of Pharmaceutical Industries and Associations (EFPIA) was one of several industry organisations to say they were concerned about the "increasing financial burden" for companies who pay into the system to assess the safety of medicines approved in the EU.

These payments apply to the marketing authorisation holder for any drug licensed by the EMA and have been in place since the EU adopted new pharmacoviglance legislation in 2010.

A joint statement from EFPIA and the European Generic medicines Association (EGA), European biotech industry (EuropaBio), Association of the European Self-Medication Industry (AESGP) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), voiced its support for the "implementation of an effective pharmacovigilance system to ensure patient safety".

The groups said they recognised "recent efforts which have been made to ensure greater fairness, proportionality and transparency", but said further revision of the payment process was needed.

This was especially pressing for procedural fees, such as for pharmacovigilance referrals, which have significantly increased compared to calculations from 2008 in a process 'without open and transparent communication'.

To remedy this the industry wants annual cost breakdowns, along with detailed information on performance indicators, to be presented for the activities covered by the fees regime.

This would tie in with EMA efforts to improve transparency in other areas, including posting minutes for its committee meetings.

These issues are likely to be discussed further during overall legislative revision of the EMA fees regime, which is expected at some point during the year.

One potential solution offered by the industry groups in their statement included sharing the cost of pharmacovigilance activities beyond drug companies due to the public health importance of medicines safety.

Article by
Thomas Meek

25th February 2014

From: Sales, Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Adelphi Research UK

Adelphi Research UK is a healthcare insight partner. We uniquely blend robust market research with a consultancy approach, to guide...

Latest intelligence

Precision medicine and the changing role of the healthcare professional
The growth of precision medicine introduces a shift away from treating the population as a whole, to treating each patient as an individual. How does this change the role of...
How will Sustainability and Transformation Plans (STPs) change the NHS commissioning landscape?
Sue Thomas and Paul Midgley, of Wilmington Healthcare, take a look at new commissioning structures and what they mean for pharma...
eyeforpharma Barcelona 2017 highlights: Industry at the brink of transformation
Hear what Anthill's delegates reported back from the biggest eyeforpharma Barcelona yet....

Infographics