How we in the U.S. see global compliance challenges for MedTech companies

  • Posted on 04.05.2011

How we in the U.S. see global compliance challenges for MedTech companies

Chris White

Christopher White

General Counsel, AdvaMed


AdvaMed and Eucomed are co-organizing the upcoming International Medical Device Industry Compliance Conference, taking place on 18-20 May in London.

Both AdvaMed and Eucomed worked closely with our member companies to identify the hottest issues in medical device industry compliance today to shape a truly global, industry specific event. We also worked together to invite accomplished discussion leaders and moderators, and panel participants representing North American and European perspectives and experiences. In short, this meeting is designed by industry compliance leaders to promote global medical device industry compliance. All the sessions are designed to facilitate exchange of best practices on top industry compliance issues and to further our Associations’ joint commitment to promote global compliance. It is encouraging to see that other industry associations around the globe are committed to join AdvaMed and Eucomed, and you will be able to discover who they are during the Signing of the Global Compliance Statement taking place on 19 May afternoon.

While I look forward to each session, I would like to take this opportunity to share my thinking and highlight one issue in the upcoming discussions that challenges most compliance officers within global medical device companies: addressing third party congress support.

Within AdvaMed’s compliance working groups, we’ve spent significant time discussing best practices in this area. Recently, our Board Committee on Ethics and Health Care Compliance approved a new best practices tool to depict in a decision tree format the types of
factors companies analyze in evaluating Third Party support. This chart has been very well received both within industry, and by outside professional groups. The working group did a terrific job reducing the substantive text of our Code to a visual analysis, facilitating greater understanding and transparency into company decision making in this area. For other best practices charts, you can visit this page.

Of course the starting point for AdvaMed’s approach to Third Party Congresses support is our Code. And, the Code is shaped by the unique legal environment in the United States. So, it’s important to understand how industry support in this area is structured and how some of the issues are presented in my country.

Congresses in the U.S:
Over the past decade, many American health care professional societies have come to rely on commercial financial support for their professional education programs designed to enhance practitioner skills and provide education on new treatments, clinical research and other scientific topics. Medical education in the U.S. occurs in a complex environment that includes “certified” programs consistent
with accreditation standards, specialty society sponsored sessions, programs administered by academic medical centers, commercial providers, among others. In each case, there exists a central organizing entity capable of administering the program content, arranging faculty and facilities, managing finances and other arrangements. This is key because I understand from my discussions with Eucomed that similar support structures might not exist in Europe.

Device and diagnostics company support of bona fide (“made in good faith”) scientific and educational programs benefits patient care and enhances practitioner attendance by reducing overall conference costs. It also enables specialties society to administer sessions that require use of high-cost simulation facilities. These types of training are critical in a rapidly evolving, highly technical field like ours.

Regulator Concerns and Scrutiny:
But, recently, in the U.S., we have seen increasing calls for medical education free from commercial support altogether. Critics view industry financial support as undermining physician independence and objectivity, and potentially tarnishing public trust. The issue has attracted the interest of prominent U.S. Senators, and both the Accreditation Council for Continuing Medical Education (ACCME) and the Inspector General of the Department of Health and Human Services recommended greater independence and separation of funding from decisions about educational activities. These arrangements can also implicate certain federal statutes, such as the anti-kickback statute, prohibiting the knowing and willful offer, solicitation, or payment of anything of value to induce referrals. Some have expressed concerns regarding opportunities for off-label promotion, a separate enforcement issue in the U.S.

The AdvaMed Code:
In light of these concerns, and in recognition of the benefits of industry support of bona fide educational activities, the AdvaMed Code provides a helpful tool to ensure objectivity and independence of professional education. The Code clarifies that companies may support independent, educational, scientific, and policymaking conferences in various ways. However, support may be provided only to
organizations with a genuine educational function, and the conference sponsor should independently control and be responsible for the selection of program content, faculty, educational methods, and materials.

Many companies have developed centralized internal processes and systems to review congress support requests based on these and other standards. In addition, specialty societies and other third party congress administrators have developed some complimentary procedures and controls to administer funds to preserve independence. In the current U.S. environment, our approach ensures independence and objectivity of education, and promotes bona fide scientific and other sessions.

Companies’ Challenge:
In an increasingly globalized health care market and because innovation occurs across national boundaries, the approaches taken by the various industry associations across the globe present compliance challenges for a U.S. company following our Code. For a global company implementing compliance procedures company wide and on a globalized basis, the U.S. based scrutiny of industry support will lead many companies to apply to the AdvaMed Code, particularly given the rigor of the Foreign Corrupt Practices Act (FCPA) enforcement. Other companies have developed internal resources to carefully evaluate individual region-specific codes and make determinations based on a “Choice of Code” analysis, assessing which code applies to what conduct based on the location of the activity, and other factors. Yet other companies might select the most conservative Code applicable to the arrangement at issue.

All in all, this is an increasingly burdensome and difficult area for compliance professionals, and I look forward to learning from my industry colleagues gathering in London to discuss how they operationalize these different approaches to further industry’s commitment to support worthy conferences in a credible, ethical manner.

This should be a great discussion, and I hope you can attend and participate!

Christopher White, Executive Vice President and General Counsel, AdvaMed

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