Why MTAA has a Code?
Medical technology companies manufacture and supply a wide range of life-saving and life-enhancing medical products. These products contribute to earlier diagnosis and less invasive intervention; they return patients to productive working lives and assist them to live independently in their own homes.
Appropriate selection of medical technology products to meet an individual patient’s needs and circumstances is a decision rightly made by the treating doctor. Patients need to be reassured that the doctor is making the decision based on the qualities of the product and the suitability for the patient, and not based on incentives or arrangements that the doctor may have with the manufacturer or supplier of the product.
An industry Code of Practice (The Code) for medical technology companies sets out the ethical framework within which they must work, in their relationships with healthcare professionals and, where relevant, with the consumer. The Code is not legislation, it is a guide provided to industry and all companies in the industry are encouraged to comply with its provisions.
The Code is part of a wider regulatory framework for ensuring appropriate behaviour by Industry. Several Industry codes apply to different therapeutic sectors. It is the intention that the Code is to apply to the supply of Medical Technology products and to interactions between Healthcare Professional and Australian Companies. Where there is another therapeutic Industry code that is more relevant in the circumstances, then that code will generally be the more appropriate code. It is complemented and supplemented by a range of training and related programs to assist awareness of the ethical responsibilities of Industry.
The MTAA Code is aligned with the principles expressed in the Consensus Statement of Shared Values and Ethical Principles for Collaboration and Interaction among Organisations in the Healthcare Sector, published by the Australian Ethical Health Alliance, of which MTAA is a member https://www.ethicalhealth.org.au/
The MTAA Code reflects the principles outlined in the Global Medical Technology Alliance (GMTA) Joint Statement on Global Harmonization of Ethical Business Principles in Medical Technology.
How the Medical Technology Industry Code of Practice Has Evolved?
The first Code for the medical technology industry was introduced in 2001. It formalized legal and ethical business practices for member companies of the Medical Technology Association of Australia (MTAA) and served to promote socially responsible conduct by the companies. The Code was significantly rewritten in 2006 to address specific areas of company activity including relationships with healthcare professionals, support for third-party conferences, advertising and competitions for consumers. Since 2006 the Code has evolved to refine the issues which are covered and to introduce guidance notes to assist companies in understanding and implementing The Code.
What Happens When There is an Alleged Breach of the Code of Practice?
The Code ensures that companies in the medical technology industry conduct their arrangements with healthcare professionals in a transparent manner so that decision-making on selection and use of products by doctors, or hospital purchasing departments, is based solely on the quality and suitability of the product, not on inducements (perceived or otherwise) paid to the doctor or other decision-maker.
Anyone who believes that the actions of a medical technology company breach The Code may bring a complaint to the Code Authority. People are encouraged to raise concerns first with the company directly, as it may have been an isolated incident that can be readily resolved.
Complaints may be referred by the Code Authority to a complaints committee chaired by an independent person and including two industry and two independent panelists representing different bodies including healthcare professionals and consumers.
What the Medical Technology Industry Code of Practice means for Healthcare Professionals?
The Code covers many areas of interaction between doctors, nurses and other healthcare professionals and the medical technology industry. These include:
Company-sponsored training and education on products. Many medical technology products require hands-on training to ensure that the product is well-understood, and the correct technique is used
Sponsorship of third-party educational events and the restrictions on financial support for healthcare professionals to attend such events
Hospitality for healthcare professionals which is only permitted in very limited circumstances during training and education events, or in conjunction with the presentation of scientific, educational or commercial information
Consulting arrangements with healthcare professionals and payment of appropriate fees for the input provided in development of a product or participation on a company advisory board
Prohibition on the giving or receiving of gifts
Research and educational grants and charitable donations. Industry is a major contributor to medical research and without the contribution much research would not be funded. However, the arrangements must be transparent and arms’ length
Provision of fellowships within the framework of accredited educational programs auspice by a medical professional association.
What the Medical Technology Industry Code of Practice means for the Medical Technology Industry?
Changes to industry practice have been considerable as a result of the development of The Code. Companies have responded by developing internal guidelines, committing their staff to participate in training on The Code (online and face-to-face), as well as independent monitoring of their compliance with The Code.
Companies take their responsibilities under The Code very seriously. Compliance with it is binding on members of MTAA. Non-member companies also encouraged to observe The Code as the recognised industry standard. A breach of The Code can result in significant financial penalties. In addition, the findings are made public on the MTAA website.
For MTAA the Medical Technology Industry Code of Practice provides a platform to educate companies, healthcare professionals and consumers about the benefits of working in an ethical, transparent, and socially responsible business environment.