Interacting appropriately with industry – how compliance laws can affect you

Mr Paris Purnell1
1Hollister Incorporated, Libertyville, United States

Working with product manufacturers and suppliers (’Industry’) should at its best be a symbiotic relationship where both the healthcare professional (HCP) and the manufacturer derive mutual, yet appropriate benefits. This relationship should be driven by improving patient outcomes. Nevertheless, this affiliation can be challenging for maintaining objectivity and compliance for Industry and the HCP.

Recent global changes of compliance laws designed to govern these affiliations can make it difficult to ensure all parties remain compliant. However, the overall trend is toward transparency by Industry on any such interactions. These same considerations are increasingly becoming the focus of employers of HCPs as well as the HCP professional bodies.

The Medical Technology Association of Australia (MTAA) is the governing body regarding compliance for the medical devices industry that includes ostomy products. In Australia, there are strict codes of conduct and laws regarding interactions between HCPs and Industry including inducements (both active and passive), and anti-corruption. Disclosure of potential conflicts of interest (COI) are becoming best practice when developing such partnerships. There are cases now where nurses have been charged with corruption leading to fines and jail.

This presentation will focus on the global and local laws, codes, and market trends in compliance to better inform and protect the HCP, in this case the Stomal Therapy Nurse (STN).  By being more aware of the compliance requirements and legal ramifications when interacting with Industry, the STN will be in a better position to navigate such complex interactions that may place them at risk.


Biography:

Paris Purnell has spoken on a variety of ostomy-related topics at international conferences and local events as well as extensively published. His main focus has been the use of convexity with the stoma patient and he was instrumental in developing new guidelines for Patient Assessment for convexity which have been validated internationally. He is also focused on developing educational programs for developing countries to develop the ET Nurse role in Asia, Middle East, and Latin America.