MTAA/MTANZ Code of Practice 5th edition now released

MTAA Code of Practice 5th Edition

At MTAA's Annual General Meeting on 24 September 2009, members unanimously adopted amendments to the MTAA/MTANZ Code of Practice. The revised Code (the 5th edition) comes into effect on 1 October 2009.

While some amendments were made to clarify the Code in relation to company sponsored training and education, consultancy arrangements and the provision of hospitality and gifts, the overarching ethical principles that govern interactions between medical technology companies and healthcare professionals remain unchanged.

Amendments that have occurred include:

Definitions
The term Member has been replaced with Company to reflect the fact that the Code of Practice is an industry-wide code.

The term Product and Medical Device has been replaced with Medical Technology which now includes medical products, technologies and related services and therapies.

The term Healthcare Professional has been made more generic and includes any individual or entity involved in the provision of healthcare services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of or prescribe medical technologies in Australia and/or New Zealand.

Other Professional and Institution Staff has been deleted as they are now captured under the amended definition for healthcare professional.

A new definition has been added for consulting arrangements.

Hospitality
There have been minor amendments to some clauses in the Code around the provision of hospitality but the principle that "any hospitality provided should be modest in value, subordinate in focus to the educative intent of the meeting and does not include entertainment" remains unchanged.

Consulting Arrangements
There are three additional items in this section of the Code

  • When a company contracts with a consultant to conduct clinical research services there should be a written research protocol.
  • Consulting arrangements should only be entered into where a legitimate need for the service is identified in advance and documented.
  • The calculation of royalties payable to a healthcare professional in exchange for intellectual property arising from the consulting arrangement should be based on factors that preserve the objectivity of medical decision-making and avoid the potential for improper influence.

Gifts to Healthcare Professionals
The amendments to this section of the Code allow for the provision of an item that serves a genuine educational function for the healthcare professional or patient and has a value of less than $100 but now prohibits non educational gifts of any type -- including all branded promotional items -- regardless of value.

This provision will be phased in over six months, expiring 1 April 2010.

Research and Educational Grants and Charitable Donations
This section of the Code has been redrafted to provide clarity but the principles surrounding the provisions of grants and charitable donations remain unchanged. Research grants should only be provided to support independent medical research with scientific merit; educational grants should only be made for the advancement of medical education with an academic affiliation or the advancement of public education for consumers; and charitable donations should only be made to genuine charitable organisations.

A company must fully document every donation made.

The purpose of the MTAA/MTANZ Code of Practice is to ensure high standards of integrity of behaviour across the medical technology industry to enable both the patient and healthcare professional confidence in dealing with industry and the technologies it provides.

A copy of the Code of Practice is available here.

A copy of the media release is available here.

For further information please email code@mtaa.org.au.