Regulatory Affairs
The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness.
Pricing Debate to be Revived
The European Commission attempts to improve pharma economics
The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness. He explained that through the creation of a new high-level pharmaceutical forum, which will meet annually to provide strategic guidance on how to improve the economic base for the pharma industry, they would focus on examining the "benefits of giving industry more flexibility in establishing prices". The EU Council and European Parliament will debate the conclusion reached by the forum and action taken forward by a steering committee, which will include industry representation. Or, at least, this is Verheugen's plan.
The proposal is a successor to the G10 group that the EU set up in 2000, but was wound up in 2004 having produced little other than a "framework for debate." Similar to the G10, the new forum will also examine wider issues such as incentives for innovation, patient information and patient safety. However, Verheugen emphasized that changes will be made without sacrificing any capacity of member states to protect their healthcare budgets.
When questions were raised among industry executives about the scope for easier pricing rules and speed of progress, Tom McKillop, CEO of AstraZeneca, sharing a platform with Verheugen, pointed out that compared with the US, Europe is lagging behind when it comes to pharmaceutical research. McKillop also said that his worry was not for the pharmaceutical industry, but for Europe and European patients. He believes that Europe suffers from complacency and claims that "it is the member states that are most to blame." With reference to Verheugen's new forum proposal, he warned, "a lot of talk and regulation may not be the right solution to boost European innovation."
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How to Implement ICH Q9 Published
Details of how to implement the ICH Guideline
ICH Q9 Quality
Risk Management
within the European legislation have now been published by EMEA. The agency emphasizes that it expects the document to be implemented together with existing quality-related regulations — it does not intend to introduce new requirements or expectations with the guideline. However, the EMEA does advise, "...it should be noted that it may be applied to all aspects of pharmaceutical quality." Once the ICH Q9 Guideline has been passed, it will become an Annex to the EU GMP Guide.
