Are Medtech Ethics Codes Up to Snuff?

The rapid evolution of medtech has left many aspects of the industry scrambling to keep up, including its business ethics.

The rapid evolution of medtech has left many aspects of the industry scrambling to keep up, including its business ethics.

The scramble is evident worldwide and in the United States. At the recent Global MedTech Compliance Conference in Paris, 26 international and regional medtech associations that make up the Global Medical Technology Alliance announced they had adopted “globally harmonized ethical business principles across their respective member associations.”

The principles cover:

  • Consulting arrangements;
  • Company support for third-party educational programs;
  • Company-organized training and educational events;
  • Sales and promotional meetings;
  • Educational and promotional items;
  • Entertainment;
  • Charitable donations;
  • Demonstration and evaluation products;
  • Ensuring effective implementation; and
  • Third-party sales and marketing intermediaries.

Alliance member AdvaMed had a hand in developing guidance for ethical third-party intermediary relationships in the Asia-Pacific region and the phase-out of companies in China directly sponsoring healthcare professionals’ attendance at third-party educational events. Other medtech associations that phased out direct sponsorship this year include MEDEC (Canada), MedTech Europe, the Asia-Pacific Medical Technology Association, the Middle East & North Africa Medical Technology Association, and the Mexican Association of Innovative Medical Devices and ABIMED (Brazil).

Such efforts facilitate fair competition and open markets, and far more importantly, help ensure the best possible care for patients,” AdvaMed said in a statement.

Unethical business practices by companies worldwide can yield the equivalent of a tariff on U.S. competitors, explained Nancy Travis, vice president for international compliance and governance for AdvaMed. The Foreign Practices Act requires American companies to adhere to high ethical principles and that costs money that companies in other countries might not have to spend, Travis said.

We’re very pleased that the GMTA signed onto those principles,” she added.

AdvaMed has also begun work on updating its nine-year-old code of ethics. The code, which was considered the gold standard when it was adopted, has begun to look a little rusty, Travis said. The updates will be based on more than 50 questions that AdvaMed members have posed regarding the code over the years as well as changes in payment models stemming from the Affordable Care Act.

The trend toward payers requiring value-based care can change relationships between medtech companies and the hospitals that purchase their products, or with those who recommend medtech purchases. AdvaMed wants to make sure those relationships are free of inappropriate transactions, Travis said.

The group’s new code will also address the rapid development of digital health technology, which has led to companies increasingly communicating directly with patients and interacting with healthcare providers via smartphone apps. Patient data privacy will also get a closer look.

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