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Compliance In Focus
Posted by John Lehmann on Fri, Oct 26, 2012

Affordable Care Act: Impacting America’s Leadership?

Affordable Care Act: Impacting America’s Leadership? At the Medical Device Conference 2012Affordable Care Act (MedCon), held at Xavier University, in Cincinnati, Ohio, Kem Hawkins, President and CEO of Cook Incorporated and Cook Medical, delivered a powerful keynote address. In his speech, Hawkins proposed that FDA has not demonstrated the leadership necessary for the United States to maintain its position as global forerunner in the healthcare arena. Hawkins also touched on his opposition to the medical device tax included in the Patient Protection and Affordable Care Act (ACA).

Prior to the MedCon, Hawkins suggested that the claims of the ACA may be inaccurate, as the tax has already impacted U.S. healthcare leadership and medical innovation. In an article published in MedCity News titled “ACA’s 2013 medical device tax has already killed jobs, expansion plans”, Hawkins refutes the claim that proposed tax will have little effect on medical innovation. In fact, this tax on top of existing taxes and regulatory systems will drive research, development and manufacturing out of the United States. In attempts to counterbalance the 2.3 % tax on medical device sales, companies have started to take the following actions:

  • Limit research budgets, decreasing the availability of new medical treatments to patients
  • Consider clinical research studies and development of next-generation products outside of the U.S. to growing markets like China, India and South American countries
  • Limit capital investment in new factories or expanded existing plants in the U.S.
  • Lay-off workers or outsource jobs outside the U.S.

Hawkins argues against the new tax for the negative impact it may have against U.S. patients having access to breakthrough technology. The tax may also threaten U.S. and FDA’s position as a global leader in medical device research and innovation.

Does the new tax grow or limit the global leadership role in healthcare? Are there any ways that the Act can positively effect jobs in the U.S? What are potential strategies that medical device companies can develop in the U.S. to grow leadership and innovation? Share your opinions below!

Photo Credit: PMillera4

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Topics: Medical Device Tax, Kem Hawins, Cook Medical, Affordable Care Act

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