Regulatory Affairs

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."

www.efpia.org

Regulatory Help via Free CD

A free service for participants of conferences and courses organized by ECA and Concept Heidelberg has been updated for the seventh time. The latest version of the CD GMP Navigator contains more than 400 GMP guidelines, recommendations and regulations. Documents from, for example, FDA, EU, PIC/s and ICH allow the CD-ROM to navigate through the 'jungle of regulations'. Described as an important electronic tool for GMP and QA professionals, it is used by both industry and regulatory authorities personnel.

www.gmp-compliance.org/pa2.cgi?ecanews=553

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.

www.emea.eu.int