Monday, March 2, 2009

AdvaMed and PhRMA Take Similar Approaches to Health Care Providers

By: Justin Will, Esq., CIS Compliance Manager
justinwill@cis-partners.com

The Advanced Medical Technology Association (AdvaMed) recently joined the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Commonwealth of Massachusetts[1] in denouncing the giving of promotional products to physicians to advertise drugs or other medical related services. On December 18, 2008, AdvaMed released a revised “Code of Ethics on Interactions with Health Care Professionals”[2] which is effective beginning on July 1, 2009. The revised code further restricts allowable conduct between healthcare professionals, and reflects the ongoing government and industry focus on transparency in the healthcare industry. As stated by Michael A. Mussallem, Chairman of AdvaMed, “This updated and more rigorous Code of Ethics reflects the medical technology industry’s ongoing commitment to openness, transparency and high ethical standards.”[3]

The revised code includes new or additional provisions including:

1. A Code Compliance section of the AdvaMed website for companies to certify that they are members of AdvaMed.

2. A prohibition on providing entertainment, recreation or gifts of any kind (regardless of value) to Health Care Professionals.

3. Guidelines regarding royalty arrangements with HCPs.

4. A new section addressing Evaluation and Demonstration Products.

5. An expanded section addressing the provision of research grants.

Similar to the PhRMA “Code on Interactions with Healthcare Providers”[4] which went into effect January 1, 2009, the revised AdvaMed Code includes limitations regarding the provision of gifts and entertainment or recreational events to HCPs. Some of the similarities between the revised AdvaMed and PhRMA codes include: the prohibitions of non-educational branded material, the prohibition on entertainment or recreational events, provisions for certification, and the provision of company compliance program contact information.[5]

This is yet another development in the push for transparency that is changing the face of the pharmaceutical and medical device industries. For more background on transparency and how it affects you, see these recent posts:

1. Transparency and Its Implications for Pharmaceutical and Medical Device Manufacturers
2. Health Care Reform, Economic Stimulus, and Transparency
3. The Sunshine Act... It's Only a Matter of Time
4. Transparency Articles of the Week


Sources:
[1] See February PCX Newsletter article by CIS Consultant Judy Fox for more information regarding the Massachusetts reglation.
[2] See http://www.advamed.org/MemberPortal/About/code/ for the revised AdvaMed Code.
[3] See http://www.advamed.org/MemberPortal/About/code/ for the December 18, 2008 AdvaMed Press Release.
[4] See http://www.phrma.org/code_on_interactions_with_healthcare_professionals/ for the revised PhRMA Code.
[5] For a complete breakdown of the differences and similarities between the new AdvaMed and PhRMA codes see http://www.advamed.org/NR/rdonlyres/36342E58-E037-45CA-9FFA-9B4947346691/0/ADVAMEDCOMPARISONCHART.pdf.

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