Pharmaceutical and Medical Device Manufacturer Conduct药品和医疗设备制造商的行为.pptVIP

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Pharmaceutical and Medical Device Manufacturer Conduct药品和医疗设备制造商的行为.ppt

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Pharmaceutical and Medical Device Manufacturer Conduct药品和医疗设备制造商的行为

Pharmaceutical and Medical Device Manufacturer Conduct Melissa J. Lopes, Deputy General Counsel Massachusetts Department of Public Health Massachusetts: A Robust Approach Massachusetts law is the most stringent of the existing state laws. A Marketing Code of Conduct that restricts certain marketing activities. Sets PhRMA and AdvaMed Codes as the floor. A Compliance Program that goes beyond California and Nevada law. A Disclosure Requirement that mandates public disclosure above and beyond the disclosure requirements of Vermont, Maine, Minnesota, Vermont, West Virginia and the District of Columbia. Proposed Regulations: Background Drafted pursuant to Chapter 111N, part of Chapter 305 of the Acts of 2008, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Healthcare. Signed into law August 10, 2008 Overview of the law presented to the Council in September. Proposed Regulations: Purpose Seeks to identify and minimize potential financial conflicts of interest. Seeks to balance transparency interests with the legitimate proprietary concerns of HCPs and pharmaceutical and medical device manufacturers in conjunction with genuine research and clinical trials. Seeks to place pharmaceutical and medical device manufacturers on equal footing with respect to the specific requirements of Chapter 111N Clarifies permissible activities beyond those specifically allowed in Chapter 111N. Specifically incorporates provisions from the PhRMA and AdvaMed Codes not included in Chapter 111N. Who is Subject to the Marketing Code of Conduct? Pharmaceutical or Medical Device Manufacturing Companies (“PMDMC”) that employ a person to sell or market prescription drugs or medical devices in the Commonwealth Who is Affected by the Marketing Code of Conduct? Persons who: Prescribe prescription drugs for any person, and Are licensed to provide health care in the Commonwealth Partnerships or corporations comprised of such persons, or their ag