Why Does the Code Exist?
The proper selection of medical technologies to meet an individual patient’s needs and circumstances is a decision rightly made by the treating doctor. Patients (as well as the public in general) need to be assured that the doctor is making the decision based on the qualities of the product and its suitability for the patient and not based on any incentives or arrangements that the doctor may have with the manufacturer or supplier of the product.
The Code sets out the ethical framework within which MTAA member companies must work, both in their relationship with healthcare professionals and, where relevant, with consumers. The Code is not legislation, but all MTAA members are obliged, as a condition of membership, to comply with the Code.
The Code is part of a wider regulatory framework in Australia, which also includes the Competition and Consumer Act (CCA) and the Therapeutic Goods Advertising Code (TGAC). Collectively, these help to regulate interactions between companies, healthcare professionals and consumers in Australia.
The Code, which not only complies with the “Australian Consensus Framework for Ethical Collaboration in the Healthcare Sector” but requires compliance with the Australian Standard for “Vendor Credentialling for Healthcare Facilities” also, embodies amongst the strongest industry self-regulation regimes in Australia.
What is the Focus of the Code?
The key areas of focus for the Code are:
- interactions with healthcare professionals, and
- advertising and promotion of medical technologies*.
The Code is underpinned by certain overarching principles, for example:
- all interactions between medical device companies and healthcare professionals must be based on legitimate need, conducted ethically and, above all, occur in the best interest of the patients,
- hospitality must not aim to impress, but to satisfy, and
- advertising must only contain information that is accurate, independently verifiable and balanced.
Note: The Code also includes a section on interactions between medical technology companies and consumers. However, this is not an area of focus since, generally speaking, MTAA member companies develop, manufacture, and distribute highly specialised medical devices, such as artificial joints, pacemakers, and neurostimulators, which are neither designed nor intended for use without the involvement of a qualified healthcare professional. Additionally, the scope and nature of interactions between companies and consumers are more directly governed by the Therapeutic Goods Advertising Code.
Does the Code Differ from its Peers?
Even though their scopes differ, which is a function of the types of industries they apply to, the Medical Technology Industry Code of Practice shares the objectives of the codes of practice of other similar organisations. Fundamentally, each is designed to ensure interactions between companies, healthcare professionals, and consumers in Australia occur in ways that are fair, transparent and, above all, ethical.
These codes also share a common framework, in that they are typically “principles based”. In that way, the others follow the example of the Medical Technology Industry Code of Practice, which has long prioritised the enablement of ethical behaviour over prescriptions for good or acceptable conduct.
But despite these similarities, there are important differences too.
An important strength of the Medical Technology Industry Code of Practice is that it explicitly requires MTAA members to comply with the Australian Standard for “Vendor Credential Healthcare Facilities” (AS 5182: 2018). This requirement may not always be present in other similar codes.
AS 5182:2018 is an independently developed, comprehensive, and a wholly separate set of standards for appropriate conduct by company representatives entering healthcare facilities in Australia that MTAA member companies are obliged to comply with as a condition of membership; that is, in addition to the requirement to comply with the requirements of the Medical Technology Industry Code of Practice itself.
How has the Code Evolved?
The first edition of the Medical Technology Industry Code of Practice was published in 2001. It formalised, for the first time, legal and ethical business practices for MTAA member companies and served to promote socially responsible conduct by medical device companies.
The Code was significantly revised in 2006 to address specific areas of company activity, such as support for third-party conferences and advertising directed at healthcare professionals. Since then, the Code has continually evolved to:
- refine the issues which are covered,
- introduce guidance materials to assist companies in understanding and implementing the Code, and
- ensure that the Code remains fit-for-purpose and consistent with the relevant laws and regulations in Australia.
How is the Code Administered?
The MTAA Code Authority (CA) is responsible for overseeing the administration of the Code. Among other things, it:
- reviews and periodically recommends updates to the Code to ensure it remains fit-for-purpose,
- oversees the work of the Code Monitoring Committee (below), and
- oversees and facilities the investigation and resolution of complaints.
The Code Monitoring Committee (CMC) is responsible for ensuring compliance with the Code. It does this by regularly collecting and reviewing information from member companies on various aspects of their interactions with healthcare professionals and consumers to ensure these activities comply with the Code.
Please see the “Code Authority” and the “Code Monitoring Committee” sections for more information.
Why Does Compliance Matter?
Compliance with the Code, which embodies amongst the strongest industry self-regulation regimes in Australia, isn’t just a matter of pride for MTAA members. It is also a matter of great practical importance.
Compliance – especially compliance verified through regular monitoring – is a clear demonstration that all MTAA members are committed to achieving, and are constantly striving to meet, the highest ethical standards in all their dealings with healthcare professionals and consumers in Australia. This gives them a clear and widely acknowledged competitive advantage over industry peers who cannot claim similarly.
How Does MTAA Monitor Code Compliance?
The MTAA Code Monitoring Committee, which reports to the Code Authority, is responsible for ensuring compliance with the Code. It does this by regularly – at least four times a year – collecting and reviewing information from MTAA members on various aspects of their interactions with healthcare professionals and consumers to ensure these activities comply with the Code.
