Europe has long been considered an ideal market for the first commercial launch of innovative products, thanks to its size and a regulatory system that is perceived as more predictable, consistent, transparent, and speedy than that of the United States. But with potentially more stringent regulations on the horizon in the EU, will medtech companies reevaluate their launch strategies?
Launching innovative products in Europe first has allowed medtech companies to gain market and patient access three to five years quicker than they would in the United States, according to industry organization Eucomed. It has also enabled the collection of clinical data to support entry into other markets. Critics of FDA have even held up the EU as a system to emulate: One that fosters innovation without jeopardizing patient safety.
And then the Poly Implant Prothèse scandal happened. Breast implants fraudulently featuring industrial-grade, rather than medical-grade, silicone slipped through the cracks, endangering patients. Now, the EU is bracing for sweeping change as it awaits the final, much-delayed regulations.
These new regulations are expected to have increased clinical data requirements and other stipulations that would delay the approval process—effectively negating the primary advantage of going to market first in Europe.
Of course, Europeans are hoping that won’t be the case. “Eucomed believes all parties concerned—the European Parliament, the Council, the European Commission and industry—are convinced of the need to strengthen the system to improve patient safety without unnecessarily compromising on innovation-friendliness,” says Serge Bernasconi, Eucomed CEO. "Europe has emerged as a leader in medical technology and we are convinced that we can remain in this privileged situation with the support of a decentralised, device-specific regulation that works for patients and innovation—a regulation that works for Europe," he adds.
It’s unlikely that a mass exodus of innovation will ensue. Europe is a large enough market that many companies will continue to launch there first, despite a higher barrier to entry. That said, Europe could lose some of its launch luster.
As a result, some companies looking to launch quickly may set their sights on markets with lower barriers to entry. Asia—and China, in particular—seems to be on the radar; however, intellectual property concerns, among a number of other challenges, are red flags for some companies. Experts also cite Brazil and other Latin American countries, as well as the Middle East as attractive markets for innovative product launches.
Ultimately, though, changing market dynamics could bring innovative products stateside first.
“It used to be that certain markets could leapfrog each other because the requirements were so different; you could really get a headstart in one part of the world while preparing for entry in another part,” notes Susan Garfield, senior vice president at market research firm GfK. “I think that we’re seeing a bit of a regression with the top markets starting to look more and more like each other so that manufacturers are really having to look more at the U.S. and Europe as part of the same or similar processes as opposed to very different stages of commercialization.”
If the markets are beginning to look alike, the U.S. boasts several advantages. “[Reimbursement] requirements are much more uniform in the U.S. as compared to the EU,” according to Roz Sweeney and Ron Sills, analysts at research and advisory firm Nerac. “While the EU is a single-payer system, you are still dealing with 20-plus countries. In the U.S., you have 300 million people in the market covered by Medicare and private payers. The more level playing field could cause companies to shift their initial marketing applications to the U.S., similar to what pharmaceutical companies do right now.”
With global harmonization efforts underway and the EU regulatory framework changing, a regional fast track to market for innovative, high-tech products may soon be a thing of the past—at least in the major developed markets. But all of this speculation may be moot. As Sweeney and Sills point out: “Unless there is a specific or urgent need for a device or drug in a particular country, it may not matter where a company goes to market first.”
|Learn more about the changes to the European medical device regulatory framework at the MD&M East conference and expo in New York City, June 9-12.|
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