Incoming AdvaMed chairman Jose Almeida has an international outlook, planning to focus his 2-year leadership tenure on several goals that aim to reconcile initiatives in the U.S. with efforts overseas.
In an conference call with reporters today Almeida, the president & CEO of Covidien (NYSE:COV), talked about harmonizing regulatory expectations and implementing ethical business standards internationally, while staying the course on efforts to streamline medtech review and to spur corporate tax reform in the U.S.
He committed to ongoing efforts to repeal the medical device tax, but focused on initiatives with a global reach, saying that he hopes to maintain U.S. competitiveness in medical technology while making it easier to do business abroad.
Almeida was particularly concerned about the new FDA unique device identifier (UDI) program and what it might mean if other countries take up their own different tracking systems. The FDA’s UDI rule requires most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
Large companies may do business in 80 or 90 countries and may sell products in as many as 150 countries, he noted. AdvaMed has been making headway in devising parallel UDI systems in the E.U. and in China, but there are still inklings that some governments may choose to go their own way in tracking medical devices.
Building the infrastructure to comply with new physician payment sunshine rules has also been a "huge undertaking," Almeida said.
"If you look at the amount of work and money that was put behind, by the industry, in creating databases and systems to capture that information – 1st for the state of Massachusetts and Vermont, and then other states, and then for the whole of the U.S. when the federal law came in – we’re going and feeling the same issues in France, for instance," Almeida said. "Our mandate for our international committee is to really work hard in trying to harmonize. The data to be collected is quite similar, but if you start varying by country we’re going to have a bigger issue in terms of cost."
"It becomes absolutely prohibitive to have the same system replicated in countries," Almeida said.
AdvaMed has also been working to harmonize ethical codes of conduct for industry. With his tenure, Almeida plans to extend ethics initiatives to Latin America, adding to ongoing efforts in the Asia-Pacific region, he said. Once the chair of AdvaMed’s ethics committee, Almeida reinforced his commitment to ethical business conduct, saying it’s the best thing for patients as well as for industry.
"A rigorous code of ethics allows companies of all sizes to compete fairly and advance quality patient care," he said. "By advancing our code of ethics, we will help ensure that healthcare decisions are made in the best interests of patients."
Updated April 3, 2014.
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