New Code Of Ethics For More Transparent Medical Technology Industry

Main Category: Pharma Industry / Biotech Industry
Article Date: 29 May 2009 - 4:00 PDT

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RAJ Devices, the regulatory affairs journal published by Informa and covering the medical technology industry, has published a comprehensive feature on how companies in the US can comply with a much stricter code of ethics that medical technology industry association AdvaMed will launch on 1 July.

AdvaMed, which represents medical technology companies that produce 90% of devices and diagnostics sold in the US and 50% of those sold worldwide, is also encouraging companies that are not members to adopt its new code.

"The revised code contains completely new guidance in a number of areas," says Andrew Van Haute,associate general counsel at AdvaMed. The new rules cover, among other things, the payment of royalties to healthcare professionals who help develop medical technology; the provision of demonstration and evaluation products; and the complete prohibition on gifts, entertainment and recreation. In addition, the code provides strong encouragement and incentives to companies who certify that they will comply.

Medical technology companies and the healthcare profession are entering a new era in terms of how they deal with each other. Federal and state legislatures in the US are considering or have already passed disclosure laws affecting companies and healthcare professionals. Efforts to improve transparency outside the US are also under way by industry bodies.

Medical professionals often work in tandem with companies to invent and improve upon medical devices, Mr Van Haute explains. Both parties also collaborate to design effective clinical trials of devices and once a product is in the field, companies work closely with healthcare professionals to ensure the product is used properly.

While these interactions are clearly necessary and vital, they occasionally present the potential for conflicts of interest in that healthcare professionals might base clinical decisions on their relationship with a company rather than on the best interests of their patients. As such, the relationships between physicians and industry have come under the scrutiny of lawmakers, prosecutors and the public.

For many years, AdvaMed has made available a code of ethics to help industry ensure that all decisions made by healthcare professionals were based on the best interests of their individual patients and not on their relationship with a medical technology company. However, with the revised code, AdvaMed is helping to extend patient protection with greater transparency and clear demarcations for industry relationships.

"The new code spells out the rules in very certain terms," says Neena Brizmohun, Deputy Editor of RAJ Devices. "Training, educational conferences, entertainment, gifts, consulting arrangements, meals, royalty payments, grants and donations, and overall code compliance are all covered in detail."

Source
RAJ Devices

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