Ethical Business Practice
We are fortunate to work in an industry whose main aim is to bring hope to patients and it’s important that we do so in an ethical manner to ensure quality of care but also good business practice. We as an industry have responsibility both to patients and to the healthcare providers and system.
The long collaborative tradition between the medical technology industry and the healthcare profession has produced ground-breaking treatments which have transformed healthcare and patient quality of life. However, it is widely recognised that medical technology companies and the healthcare profession are entering a new era in terms of how they deal with each other.
The Irish Medtech Association Code of Ethical Business Practice governs all interactions between Healthcare Professionals and Industry. Members of the Irish Medtech Association are obliged to abide by the Code of Ethics.
The Irish Medtech Association has provided resources below in order to provide absolute clarity on all aspects and requirements of the Code.
MedTech Europe (the European organisation representing the medical technology industry) published the MedTech Europe Code of Ethical Business Practice which came in force on 1 January 2017.
The Irish Medtech Association, as a member association of MedTech Europe has adopted this code and over the past number of years we have been busy providing guidance and information to members about the Code. The Code is mandatory for all members of the Irish Medtech Association. It is not meant to restrict or in any way hamper how companies do business with healthcare systems, but instead sets expectations and norms concerning the conduct of business and our interaction with healthcare professionals.
The Code of Ethical Business Practice for the Irish medical technology industry is comprehensive in its commitment to high ethical standards. It governs all interactions between medical technology companies and healthcare professionals and it is supplemented by detailed guidelines which clarify and distinguish between appropriate and inappropriate activity in areas such as:
- Appropriate support of scientific and educational conferences
- Legitimate consulting agreements with HCP’s
- Provision of educational grants and charitable donations
- Provision of modest hospitality and gifts
The Irish Medtech Association is committed to this code and we look forward to working with our members and other stakeholder to oversee its continued implementation.
Separation
Interaction between industry and healthcare professionals must not be misused to influence through undue or improper advantages, purchasing decisions, nor should such interaction be contingent upon sales transactions or use or recommendation of products.
Transparency
Interaction between industry and healthcare professionals must be transparent and comply with national and local laws, regulations, or professional codes of conduct. In countries where specific provision is not made, members shall nevertheless maintain appropriate transparency by requiring prior written notification is made to the hospital administration, the healthcare professional’s superior or other locally designated competent authority, full disclosing the purpose and scope of the interaction
Equivalence
Where healthcare professionals are engaged by a member to perform a service for or on behalf of a member, the remuneration paid by the member must be commensurate with, and represent a fair market value for, the services performed by the healthcare professional.
Documentation
For interactions between a member and a healthcare professional, such as where services are performed by a healthcare professional for or on behaf of a member, there must be a written agreement setting out, inter alia, the purpose of the interaction, the services to be performed, the method for reimbursement of expenses as well as the remuneration to be paid by the member
Medical technology companies and the healthcare profession are entering a new era in terms of how they deal with each other and in order to guarantee the reputation of the industry, we want to ensure that sufficient safeguards are in place to uphold the integrity of such relationships. It is our hope that an Irish Code of Ethical Business Practice for the medtech sector will play a very important role in governing all interactions between medical technology companies and healthcare professionals, and embed ethical behaviour into routine professional collaborations.
Industry codes of ethics have been adopted in many countries as instruments of self-regulation with the purpose of defining the rules whereby the industry may operate in an equitable and transparent manner. Born out of the recognition that that adherence to high ethical standards is critical to guaranteeing access to modern, innovative and reliable medical technology, the Irish Medtech Association have developed the Code of Ethical Business Practice to protect a culture of integrity and ethical business practices across the med-tech industry in Ireland.
Our members carry out many different forms of interactions with Healthcare professionals that provide advancement in medical science or improve patient care including:
- Collaboration in innovation and improvement in the device sector
- Training and technical support
- Research and education
We recognise that adherence to ethical standards and compliance with applicable laws are critical to the medical technology/devices industry's ability to continue its collaboration with Healthcare Professionals.
The Irish Medtech Association's Code of Ethical Business Practice is mandatory for members of the Association. The Code of Ethical Business Practice is supported by a guidance document and implemented via an effective and efficient complaint handling process.
The aim is that the dispute resolution process is that enjoys the confidence of all involved stakeholders and have full member support. It is based on principles of proportionality, speed, due process, fairness and transparency.
Should a complaint be submitted, evidence, documentation and the Code will be reviewed by the Code of Ethics Panel, who will decide on the outcome (sanction or non-case).
Any complaints about the conduct of any Applicable Company under the Code or the Interactions of Industry with Healthcare Professionals in general should be submitted to the Irish Medtech Association, with the appropriate documentation (letter of complaint). who will forward to the panel for review.
Complaints Procedure and Panel Constitution
The Code of Ethical Business Practice complaints procedure and sanctions was formally ratified at the Irish Medtech Association's AGM on the 12 December 2013. Compliance with the Code and with this Complaints Procedure and Panel Constitution is mandatory for members of the Irish Medtech Association. The Code is administered by a Panel Administrator and by a panel of independent individuals and the Panel is chaired by an independent solicitor/ barrister.
The Panel is comprised of representatives from industry, clinical, legal and patient care backgrounds including a chairman who is of a legal background. The role of the panel is an independent medium which receives and prepares the complaint for review and makes a ruling on whether or not the code has been violated.
- Legal Representative: Colin Kavanagh, Partner, Arthur Cox (Chair)
- Company/Commercial Representative: Jerry Kiely, fmr. General Manager, Teleflex
- Clinical Representative: Derek O’Keeffe, Consultant Physician and Professor of Medical Devices
- Patient/Research Representative: Mr. Neil Johnson, CEO, Croí
Any complaints about the conduct of any Applicable Company under the Code or the Interactions of Industry with Healthcare Professionals in general should be submitted using this letter and submit to Eoghan Ó Faoláin, Deputy Director, Irish Medtech Association (firstname.lastname@ibec.ie), who will forward to the panel for review
Please ensure to give as much detail as possible and to attach any documentary evidence to the form.