Faces of Trade: Selling Splints to Europe

When Arthur Leman created Health Enterprises in his very own basement, he created it with one mission in mind – to “design, develop and deliver healthcare products that positively impact the lives of people throughout the world.” Almost forty years later, this Massachusetts-based company ships consumer healthcare products to over 60 countries.

Headquartered in North Attleboro, Health Enterprises has experienced massive growth since the 1970s, with its products now sold in over 25,000 domestic retail stores. Additionally, Health Enterprises is recognized for its global presence. It won “Exporter of the Year” from Commercial News USA, the “Ambassador’s Award” from the Massachusetts Alliance for International Business, and even the President’s “E-Award” for exporting. Despite this success, Health Enterprises remains a small business with less than 50 employees.

As a small business, Health Enterprises faces unique difficulties when shipping overseas. While some countries block imports with tariffs, others block imports with red tape: additional regulations, registration fees, safety tests, etc. Glenn Leman, CEO, explains why this is a problem for his company. “We do not have large legal teams or in-house regulatory departments to navigate complicated international rules for global commerce.” So Health Enterprises looks to free trade agreements (FTA) instead.

So far, the United States has 20 FTAs in force, with two large ones in the works, the Trans Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership with the European Union (TTIP)To create more sales opportunities for U.S. small business exporters, he urges Congress to renew Trade Promotion Authority (TPA).

Leman especially looks forward to TTIP. “Around 38% of our export sales are directed to EU member states,” explains Leman. “Tariffs are already relatively low, but we currently encounter issues of costly and time-consuming re-registration with our FDA-registered ‘Class 1 Medical Devices.”

To illustrate an example, take a simple finger splint from Health Enterprises. It’s registered with the FDA and anyone can buy it for a few dollars from a local pharmacy in the U.S. To sell it in Europe, Health Enterprise must register it in an E.U. state. This requires Health Enterprises to hire a “European Authorized Representative” for thousands of dollars plus hourly fees. There are also separate fees per item as well as an annual fee for the Ministry of Health to maintain a database. These requirements are for simple finger splints and don’t serve to add any health or safety benefits; complicated devices have much more complex regulations often duplicating requirements already met in the United States.

Health Enterprise thus stands to benefit greatly from a TTIP agreement that provides for improved standards and regulatory cooperation. Leman emphasizes the importance of trade agreements to Health Enterprises and other small businesses, “America's small companies are the engines of growth and jobs. Any assistance the government can provide by creating a level playing field as we complete around the world is greatly appreciated.” 



Support TPA renewal at www.uschamber.com/tpa.