Pharmaceutical Executive Europe - September 2006 - (Page 25)

Balancing Acts A smooth path for marketing generics can mean fewer tests and lower costs but it can also upset the innovators of branded drugs. Data protection legislation from the EU and US seeks to balance competing interests in this contentious area. need to recognize and protect the investment made by ne of the most important factors that must be George Pickering O innovative pharmaceutical companies in undertaking taken into account both by an innovative is a senior associate with extensive clinical studies. Furthermore, not all pharma company planning a product's life cycle and a international law firm medicinal products attract patent protection, either generic intending to launch a competitor is the rules Reed Smith. because the product is not inherently patentable or governing regulatory data protection that is, when because of difficulties in enforcing first or second cross-reference can be made to data previously filed by medical use patents. the innovator . The operation of rules, combined with Consequently, both the US and EU medicinal the date of patent expiry, will determine precisely products legislation allow a generics company to when the generic product can come onto the market. obtain a marketing authorization for a product without This article examines the regulatory data protection submitting a complete set of data demonstrating the rules in the EU and then compares them briefly with safety, quality and efficacy of the product. the US system. The generics approval mechanism EU situation The data protection rules have to be understood in The current European regulatory data protection rules their practical context, which is the approval entered force on 30 October 2005 and apply to all mechanism for generic medicinal products. The US first products authorized both before and after that date, adopted such a mechanism in 1984 with the although the old data exclusivity periods will continue Hatch

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - September 2006

European Overview: Competition Time
Growth Strategies: Survival of the Fittest
Pharma Defence Strategies: Fighting Fire with Fire
Biogenerics: The Evolution of Biosimilars
Branding and Marketing: What's in a Name?
Branding and Marketing: A New World Order
Legal: Balancing Acts
Q&A: Champion of Industry
Q&A: Courting Consolidation
Market Outlook: Top Five Trends

Pharmaceutical Executive Europe - September 2006