At Corporate Compliance Insights, Eric McClafferty of Kelley Drye & Warren LLP has written an excellent article on the importance of export compliance to the health industry. He addresses two key questions:
- What are some fundamental export compliance keys for health industry companies?
- How should compliance professionals deal with those from a real world compliance perspective?
McClafferty goes on to address the following key issues that the health care industry faces when complying with export regulations. Below I have listed the key points, but please read the entire article to get the full details.
1. Unique Issues: Medical device and pharmaceutical companies face compliance issues that are common to all exporting companies, but they face issues that are unique to the industry. For example, medical devices and medicine are some of the few types of products that may be shipped to countries subject to U.S. economic sanctions (e.g. Cuba, Iran, Sudan) under export licenses.
2. Overly Generic Export Compliance Systems: Many compliance programs are too generic. The company issues a one paragraph policy in its corporate compliance policy indicating that it will comply with export regulations and leaves it at that.
3. How Should We Start Implementing an Effective Export Compliance System?: An effective export compliance system does not have to be overly-complicated or involve a lot of legal jargon jammed into a heavy Export Control Binder that winds up collecting dust on a shelf. In fact, an effective export management system is laser focused on specific high risk compliance issues.
4. What are Export Controls on Technology All About?: Entire sections of the classification regulations are devoted to controlling exports of certain technologies, but many companies that have compliance systems are so focused on product controls that they simply ignore the technology control issues.
5. What Risks Are Associated with “Non-Core” Exports?: By non-core exports, I mean items companies use or own that are not their day-to-day product exports. Perhaps your company makes widgets and you know what your widget product and technology classification is under the export rules.
6. Fixing Our Export Classification Compliance Gap: To respond to this classification issue and make fundamental export risks (or the lack thereof) explicit, one of the fundamental documents every exporter needs to compile is a product classification table or matrix that documents product, software, and technology classifications for core and non-core products.
Read his complete article at: Critical FCPA and Export Compliance Issues for the Health Care Industry.
Export Compliance Case Study:Leading Medical Technologies Company Automates Export Compliance
A leading medical technologies company ships products from over 145 locations and faced an increasingly complex supply chain spanning international borders, time zones and multiple regulatory environments. And with subsidiaries, suppliers, distributors, manufacturing facilities, carriers, brokers, and customers located all over the globe, operations were fragmented and difficult to manage.
By implementing an export compliance solution, the company:
- Streamlined its global trade compliance process
- Minimized fines by improving licensing accuracy and efficiency
- Reduced cycle time by preventing shipment delays
- Increased visibility and availability of data between trading partners and business units
- And, reduced risk by complying with country specific regulations
Download the case study to learn more.
