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  GUIDING PRINCIPLES FOR COLLABORATION
BETWEEN DEPUY SPINE AND THE MEDICAL COMMUNITYCollaboration between DePuy Spine and health care professionals is fundamental to advancing the treatment of spinal disorders. It is important that this collaboration be based on principles to ensure a relationship built on trust, respect and common goals. With this in mind, DePuy Spine has developed these Principles of Collaboration to help guide our process. Patient safety is our first priority
DePuy Spine believes that its first priority is to patient safety and public health. It guides all our actions and informs all our decisions. We collaborate and seek to collaborate with those who hold this same belief. Collaboration with
surgeons is essential to developing innovative spine treatments and
procedures that advance patient care DePuy Spine, working closely with surgeons and other health professionals and experts, has pioneered important advances and innovations in the treatment of spinal disorders that have helped millions of people suffering from scoliosis, degenerative disc disease, spinal deformity, malignancy and trauma. DePuy Spine will continue these collaborations to develop the technologies of tomorrow that will transform the diagnosis and treatment of spinal disorders. Comprehensive planning and needs
assessments are conducted to identify current and future needs for
collaborations with health care professionals DePuy Spine goes through a thorough planning and needs assessment process to determine our clinical, educational, research and training requirements. This process helps to guide the funding for the year and the projects we initiate and support. DePuy Spine is committed to conducting its
business in accordance with all applicable Health Care Compliance laws,
regulations, industry standards, and Johnson & Johnson
policies The company has implemented a comprehensive Health Care Compliance program to promote adherence to applicable laws governing DePuy Spine's interactions with the medical community. The company has adopted the OIG's "Seven Elements of an Effective Compliance Program," the AdvaMed Code of Ethics on Interactions with Health Care Professionals, as well as the guidelines of the Accreditation Council for Continuing Medical Education ("ACCME") which governs the execution of CME-accredited educational meetings. All employees, contractors, and independent sales professionals are required to abide by the DePuy Spine Health Care Compliance policies. Questions about the company’s Health Care Compliance program may be directed to the Director of Health Care Compliance. Fair compensation is provided based on
contributions and expertise
DePuy Spine works with leading spine surgeons, institutions and surgical and medical societies in a variety of ways, including product development, professional education, sales representative training, and product testing. For this work, DePuy Spine provides remuneration or an honorarium that is consistent with fair market value which DePuy Spine endeavors to objectively determine. In some cases, surgeons have contributed intellectual property to help develop implants and instrumentation for which they receive royalty payments on sales. The payment of royalties in consideration of intellectual property contributions is a well-established practice. However, it is our policy that royalties are not payable to a surgeon designer for his/her own purchases of the royalty-bearing products, nor for products purchased by colleagues at the same institution or surgical practice. Evidence-based medicine plays a critical
role in the safe and appropriate use of medical technology, and surgeons
are critical to gathering this data DePuy Spine supports the role of evidence-based medicine in the development of new technologies and in support of existing technologies. We fund FDA-regulated clinical trials aimed at developing safety and effectiveness data to support our FDA applications for new products. We fund research efforts proposed by clinicians seeking to develop data on our already-marketed products, and we fund long-term follow-up studies to confirm and monitor the performance of our products beyond the usual two years required by regulatory authorities. DePuy Spine relies on health care professionals to provide important information about the use of our products to regulatory bodies and to the company. Use of our products should primarily be
based on clinical value followed by other considerations
Physicians’ decisions about the choice of products in patient care should first and foremost be based on its clinical value and safety followed by its cost effectiveness and economic value to the health care system, as well as other factors. Our products are developed based on solid clinical research that establishes its safety and effectiveness. We strive to also determine the cost effectiveness of our products by undertaking cost effectiveness and outcomes studies, as appropriate. We regularly support publication of our research in peer-reviewed journals and through presentations at scientific meetings. We Believe in Open Dialogue and Ongoing
Evaluation We are open to working with all stakeholders including medical societies, regulatory bodies, patient advocates and others to evaluate and determine the best ways to ensure collaboration that is in the best interest of the public health. Our Mission - Trust and Respect
DePuy Spine is committed to being the most trusted and respected spine company in the world. We do this with integrity, social and environmental responsibility, and respect for our customers and the patients they care for. We remain committed to innovation with purpose, world-class education, exceptional customer service, major investments in research and development and support of various charitable organizations. We will continue to partner with those who care most about advancing spinal technology and improving the lives of spinal patients all over the world. |
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