Legal Research

This Week?s Biotech Highlights

By Jeremy Grushcow

This Week in Biotech was notable for the passage of comprehensive health reform legislation in the U.S.  The bill will have major ramifications for coverage, cost, and insurance markets South of the 49th.  It will also have global implications for biotech and pharma companies, shaping two major industry trends:

First, the bill includes a 12-year exclusivity period for new biologic drugs.  The EU and Canada have chosen to provide only 6 years’ protection, as discussed in a post on Health Canada’s finalized Guidance Document this week.  Because these drugs are complex to begin with, there is a high technical barrier to entry.  Add to this a long data exclusivity period and you have a potentially huge boost for those few companies that successfully develop, finance and win approval for innovative drugs. 

Second, the bill funds Comparative Effectiveness research (CER).  The idea of trying to identify some treatments as provably better than others is apparently one of the scary things to come out of Obama’s plan.  If you look more closely, though, I think the CER funding in the new legislation continues down the road of personalizing treatments.  The CER bill says it’s seeking to determine “what works best,” sure; but what works best “for which patient under what circumstances.?  A promising pronouncement for personalized medicine.

Meanwhile, a different legislative process is stirring closer to home:  keep an eye on The Cross-Border Biotech Blog this Thursday for reporting on Ontario’s 2010 budget.

Full post as published by Slaw.ca on March 23, 2010 (boomark / email).