Experts question vax industry's special legal status

The vaccine industry has boomed in recent years, at least in part because of a legal shield that was erected in the mid-80s to protect vaccine makers from a spate of lawsuits that had driven many companies out of the business. Now, with vaccine makers reaping a $21.5 billion bonanza each year from the biologics they make, some are beginning to question whether they should still get special liability protection from the Office of Special Masters at the U.S. Court of Federal Claims.

The same special court that ruled recently that there is no credible proof that vaccines trigger autism also limits compensation in death cases to $250,000, a pittance compared to the type of awards that can be handed down by a civil court. And that protection is one reason why Pfizer is willing to pay $68 billion to buy Wyeth, which is very active in the burgeoning vaccine business.

"When you've got a monopoly and can dictate price in a way that you couldn't before, I'm not sure you need the liability protection," Lars Noah, a specialist in medical technology at the University of Florida's law school, tells the Wall Street Journal.

Don't look for anyone in the vaccine business to agree with that assessment. These legal safeguards are also partly responsible for an explosion of new vaccine R&D that has saved the lives of millions of people. If the world wants to see millions more saved, the developers will expect the same special status.

"Today, there are a number of important infectious diseases that don't have vaccines," says Merck's Mark Feinberg. "The program does provide clarity for manufacturers as they go forward with new development."

- read the article from the Wall Street Journal

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