Industry group calls for pharma regulation shake-up
Associations has called for the European Commission to set up a
more favourable legal framework to help the region's pharmaceutical
industry compete with its peers in the USA and elsewhere.
The European Federation of Pharmaceutical Industries and Associations has called for the European Commission to set up a more favourable legal framework to help the region's pharmaceutical industry compete with its peers in the USA and elsewhere.
"Key benchmarking indicators highlight the vulnerability of the pharmaceutical industry in Europe and its steady decline in competitiveness compared to the USA, which has increased its dominance as an attractive site for R&D and a locus of innovation," said EFPIA president and chief executive of AstraZeneca Sir Tom McKillop.
EFPIA's comments have been made head of the EU Health Council meeting, to be held 2-3 June, that will consider a range of issues including a potential revamp of the centralised drug approval procedure governed by the European Medicines Evaluation Agency.
Industry has been alarmed of late by calls to do away with the current choice of either a centralised marketing application or mutual recognition of a national approval for new medicines. At present, the requirement is that innovative drugs, notably biologicals, must go through the centralised process while companies can opt for the national route for any other product.
"Retaining the current industry choice over registration route will ensure a healthy balance between centralised and national regulatory systems," said EFPIA in a statement.Other key priorities for EFPIA which may be covered at the meeting include a 10-year exclusivity period on data, which will "be an essential driving force for research in Europe," according to the group.
The pharma industry is also seeking a strengthening of the EU market surveillance and pharmacovigilance system but is fiercely resisting the introduction of the concept of 'added therapeutic value' as a criterion for product registration, in addition to the current criteria of quality, safety and efficacy, which it believes "would have a negative impact on public health." Another long-standing issue is provision of information to patients; industry would like to be able to use some form of direct-to-consumer advertising for medicines, something that is permissible in the USA but not in Europe.
"If these points are not addressed, Europe will take a serious step backwards," declared Sir Tom.
