Life Science Compliance Update

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October 11, 2017

MedTech Europe Changes Ethical Code

Playbytherules

MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations.

In 2015, MedTech Europe implemented a revised version of the 2008 Code of Ethical Business Practice to regulate interactions between members of the group and healthcare professionals. To help implement the code, in 2012, MedTech Europe created the Conference Vetting System. The Conference Vetting System attempted to address MedTech Europe members’ divergent interpretation of the Code and to reduce the risks associated to industry sponsorship of healthcare providers to third-party educational events.

The new MedTech Europe Code of Ethical Business Practice sets strict, clear and transparent rules for the industry’s relationship with Healthcare professionals (HCPs) and Healthcare Organizations (HCOs), including company-organized events, arrangements with consultants, research and financial support to medical education.

The Code of Ethical Business Practice has six big changes: (1) the phasing out of direct sponsorships; (2) transparency of educational grants; (3) creating a common chapter on general criteria for events; (4) creating a new chapter on demonstration products and samples; (5) agreed definitions; and (6) a common independent enforcement mechanism.

According to MedTech Europe, the new Code is a message from the medical technology industry to safeguard and protect the relationship with healthcare professionals by adopting clear and strict self-regulations.

The largest change coming from the new educational grant system is that it adds a significant amount of work onto the shoulders of the healthcare organization.

  1. Conferences supported by medical device companies will need to apply and be in compliance with the Ethical Vetting System;
  2. Healthcare organizations will need to write and submit grant requests to each medical device company that sponsors delegations to their medical meeting;
  3. Once awarded the grant, healthcare organizations will be responsible for choosing the healthcare providers that will receive support, following the guidelines as set forth on the grant requested;
  4. Healthcare organizations will be responsible for the management of the sponsored healthcare providers, including figuring out how to contact them, gather their information, manage their travel requirements, etc.; and
  5. Healthcare organizations and medical device companies will need to submit reconciliation and disclosure reports to MedTech Europe.

The rules will change in several ways, including: by forcing the public disclosure of grants, ensuring increased transparency of the funds allocated to medical education; by requiring conferences to comply with specific requirements and the Conference Vetting System; by allowing grants to be provided only to legal entities and never individuals, requiring a written contract and other related documentation; by allowing companies to define the types of recipients eligible for the grants; and by requiring companies to have internal and independent processes based on objective criteria to assess grant requests.

While most of the changes will affect European meetings, the most important change for the United States medical meeting industry is that MedTech Europe member companies will not be able to directly sponsor a healthcare provider, neither as a delegate nor as a speaker.

As of 2018, MedTech Europe will require all meetings to be vetted through its Conference Vetting System, and only these meetings will be eligible to receive funds from MedTech Europe member companies — and only through educational grants.

Healthcare organizations should brace themselves for an impact and will need to plan for a loss in revenue from any international delegations sponsored by Medical Technology Companies in Europe.

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