Healthcare code compliance: Do you see the forest through the trees?

Patrick Wellens

Patrick Wellens

By Patrick Wellens, CCEP-I, CIA, CFE, CRMA, MBA

Patrick Wellens (patrickwellens@hotmail.com) is currently working as a Compliance Manager for a division of a multinational pharma company, based in Zurich, Switzerland. He is a Board Member of Ethics and Compliance Switzerland and co-chair of the working group “life sciences.”

Pharmaceutical and/or medical device companies have many interactions with healthcare professionals. To ensure that the highest ethical standards are followed in the interactions with healthcare professionals, with the aim to benefit patients and to enhance the practice of medicine and not to be perceived as inappropriate by patients or the public, various industry associations have each put together codes of practice (see Table 1).

The code of practice defines principles that need to be followed by medical device or pharma companies that are industry association member companies. A pharma or medical device company is free to join—or not—the industry association, but if it does, it is obliged to comply with the code of practice.

Table 1: Overview of medical device/pharmaceutical industry trade associations’ codes of practice

Industry code

Scope

Advanced Medical Technology Association (AdvaMed)

  • Specific to the medical technology industry (diagnostic and medical devices) and addresses interactions with US healthcare professionals (HCPs), whether occurring inside or outside the US.

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)

  • The IFPMA Code covers interactions with HCPs, medical institutions, and patient organizations and the promotion of pharmaceutical products (i.e., pharmaceutical or biological products that are intended to be used on the prescription of or under the supervision of an HCP and that are intended for use in the diagnosis, treatment, or prevention of disease in humans, or to affect the structure or any function of the human body).

European Federation of Pharmaceutical Industries and Associations (EFPIA)

  • Same as IFPMA, but the scope is limited to Europe.

MedTech Europe

  • Specific to the medical technology industry (i.e., diagnostics and medical devices) and addresses interactions with HCPs registered or practicing in Europe or healthcare organizations located in Europe or whenever companies support scientific events related to medical device industry in Europe.

Pharmaceutical Research and Manufacturers of America (PhRMA)

  • Specific to the pharma industry and addresses interactions with US HCPs, whether occurring inside or outside the US.

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