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Revised 2008 PhRMA CODE ON INTERACTIONS WITH HEALTHCARE PROFESSIONALS
 
 
  Code on Interactions with Healthcare Professionals in PDF
 
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-based pharmaceutical and biotechnology companies. Our members develop and market new medicines to enable patients to live longer and healthier lives.
 
Ethical relationships with healthcare professionals are critical to our mission of helping patients by developing and marketing new medicines. An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines, which play an ever-increasing role in patient healthcare. This document focuses on our interactions with healthcare professionals that relate to the marketing of our products.
 
Appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit. Our relationships with healthcare professionals are critical to achieving these goals because they enable us to
 
-- inform healthcare professionals about the benefits and risks of our products to help advance appropriate patient use, provide scientific and educational information,
-- support medical research and education, and
-- obtain feedback and advice about our products through consultation with medical experts.
 
In interacting with the medical community, we are committed to following the highest ethical standards as well as all legal requirements. We are also concerned that our interactions with healthcare professionals not be perceived as inappropriate by patients or the public at large. This Code is to reinforce our intention that our interactions with healthcare professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine. The Code is based on the principle that a healthcare professional's care of patients should be based, and should be perceived as being based, solely on each patient's medical needs and the healthcare professional's medical knowledge and experience.
 
Therefore, PhRMA adopts this updated and enhanced voluntary Code on relationships with U.S. healthcare professionals. This Code reflects and builds upon the standards and principles set forth in its predecessor, the PhRMA Code on Interactions with Healthcare Professionals that took effect on July 1, 2002. Like the 2002 edition, this Code addresses interactions with respect to marketed products and related pre-launch activities. PhRMA member companies' relationships with clinical investigators and other individuals and entities as they relate to the clinical research process are addressed in the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.
 

This updated Code will take effect in January 2009.
 
Read the Revised PhRMA Code. (Code attached in pdf.)
 
PRESS RELEASE
 
PhRMA Revised Marketing Code Reinforces Commitment To Responsible Interactions With Healthcare Professionals
 
Washington, D.C. (July 10, 2008) - Reflecting the continuing commitment of America's pharmaceutical research and biotechnology companies to pursue policies and practices that best serve the needs of patients and the healthcare community, the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors has adopted measures to enhance the PhRMA Code on Interactions with Healthcare Professionals.
 
The newly revised PhRMA Code, which builds on improvements already made in the previous 2002 version, is part of an ongoing effort to ensure that pharmaceutical marketing practices comply with the highest ethical standards.
 
"Informative, ethical and professional relationships between healthcare providers and America's pharmaceutical research companies are instrumental to effective patient care," said Richard Clark, PhRMA Chairman and Chairman and CEO, Merck & Co., Inc. "We take this responsibility seriously and are constantly reexamining ways we can enhance these essential company-physician interactions and reinforce the integrity of information about our medicines."
 
"Doctors rely on accurate and appropriate information about new medicines in order to provide the best possible care to their patients. The changes to the Code demonstrate that the members of PhRMA are committed to continue enhancing how our industry serves physicians and patients," said David Norton, Chairman of the PhRMA Affordability & Access Committee spearheading the Code changes and Company Group Chairman, Pharmaceuticals Group, Johnson & Johnson.
 
The voluntary PhRMA Code on Interactions with Healthcare Professionals, which will take effect in January 2009, reaffirms that interactions between company representatives and healthcare professionals "should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education."
 
Providing physicians with up-to-date, accurate information about the medicines they prescribe clearly improves patient care and advances health care in general. Pharmaceutical research companies that discover and develop new medicines are the most knowledgeable about their products and are in the best position to inform healthcare professionals about a wide range of topics related to these medicines, including new treatment options, appropriate dosing, emerging safety developments and potential interactions with other drugs.
 
"Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policymakers, healthcare professionals and others telling us we can do better," said Billy Tauzin, President and CEO of PhRMA. "This updated Code fortifies our companies' commitment to ensure their medicines are marketed in a manner that benefits patients and enhances the practice of medicine. Simply put, it marks a renewed pledge to epractice what we preach.' We hope all companies that interact with healthcare professionals will adopt these standards."
 
Among its changes, the revised Code:
 
⋅ Prohibits distribution of non-educational items (such as pens, mugs and other "reminder" objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, "may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues."
 
⋅ Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals' offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.
 
⋅ Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice - including this Code - that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.
 
⋅ Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies' annual certifications of compliance.
 
Other additions to the Code include more detailed standards regarding the independence of continuing medical education (CME); principles on the responsible use of non-patient identified prescriber data; and additional guidance for speaking and consulting arrangements with healthcare professionals, including disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company.
 
Several of the changes to the Code, like PhRMA's recent acceptance of the revised Physician Payments Sunshine Act in the Senate, reflect PhRMA's position that appropriate transparency in relationships with healthcare professionals can help build and maintain patient trust in the healthcare system.
 
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.
 
 
 
 
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