The Commission proposal for a revised ‘Transparency Directive’ will improve Member States’ procedural framework for pricing and reimbursement of medicines to accelerate patient access to innovation, says the European Federation of Pharmaceutical Institutions and Associations (EFPIA).
In the current difficult economic context in Europe, however, more needs to be done to ensure fair access for all EU patients to pharmaceutical treatment.
EFPIA Director General Richard Bergström says: “This proposal is a welcome step in the right direction to address some of the procedural shortcomings in national pricing and reimbursement systems. It respects Member States’ competence in healthcare.
“Further steps are needed to tackle the challenges to patient access to medicines”.
The proposal maintains the core principles of the existing Directive and adapts it to reflect judgements by the Court of Justice of the European Union.
In particular, EFPIA welcomes the following steps toward faster patient access to the medicines they need:
· Shorter maximum time limits for completing and publishing pricing and reimbursement decisions.
· The transparency requirements to include all measures that control or promote the prescription of specific medicines.
· No re-assessment of any regulatory approval data which may have caused delays in the past.
· Improved enforcement through creation of a remedies procedure in case of non-compliance with the time-limits, dialogue with stakeholders and regular monitoring of implementation.
Richard Bergström adds: “Improving access to medicines is a complex challenge requiring a joint response from the Commission, Member States and industry. Europe must continue to incentivise and reward innovation.
Industry wants to make sure that products are available, but this requires solidarity among Member States. The practice of international price referencing prevents differential pricing between markets – something that is standard in other parts of the world where it is not only accepted but indeed welcomed that companies charge lower prices in low- and middle-income countries.
“In Europe too, access to medicines could be improved for patients if governments embraced differential pricing”.
“Especially in times of economic crisis, the focus of Member States on pricing measures such as international or therapeutic reference pricing poses a threat to the long-term innovative capability of Europe and hinders access to medicines.
“This is even more worrying if emergency price cuts under exceptional circumstances such as in Greece lead to automatic and arbitrary price cuts in 15 other Member States”, Richard Bergström concludes.
The pharmaceutical industry across Europe is working with the European Commission, Member States and international institutions to ensure that pharmaceuticals support patient needs in countries in difficult economic times.