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Avoiding No Man's Land: New Deloitte Study on Follow-on Biologics Investigates Proposed Legislation and Possible Unintended Consequences
Date:4/14/2009

l. With follow-on biologics, Congress may need to consider a different set of rules to balance cost savings, patient safety, and economic incentives for future innovation. Strong patent protections will likely need to be in place to enable companies to attract the risk capital they need to continue to innovate new technologies. Smaller, venture capital-backed firms could not attract funding without strong intellectual property protection."

Unintended Consequences

The Hatch-Waxman Act succeeded in creating price competition--the Congressional Budget Office estimates that by 1994, 10 years after passage of Hatch-Waxman, U.S. consumers were saving $8 billion to $10 billion per year from the use of generics. However, the act also produced unintended consequences. The Deloitte study outlines three of these unintended effects, and explores how this experience should be considered in current legislation. The so-called "make hay effect," the "blockbuster effect," and the threat of "no man's land," not only influence research and development spending by innovator companies, but also how drugs come to market, and ultimately, the availability of new medicines for patients.

  • "Make Hay" effect: Once a drug is introduced to the market, an innovator has a short time to recoup its development costs -- upwards of $1 billion over 12 years -- before a competitor enters the market. Faced with patent protection of limited duration, innovator companies must maximize their revenues in the short period before generics are introduced. To do this, they generally raise prices and invest more in marketing the drug, tactics that run counter to Hatch-Waxman, the intent of which was to lower prices.

  • "Blockbuster" effect: Facing increased drug development costs and a limited period of time before generics can compete, innovators typically focus on
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SOURCE Deloitte
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