irish medical technology industry code of ethics … · the irish med tech industry code of ethics...
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January 2012
IRISH MEDICAL TECHNOLOGY INDUSTRYCODE OF ETHICS
Applying the Code of EthicsEthical Collaboration with Healthcare Professionals
The long collaborative tradition between the medical technology industry and the healthcareprofession has produced groundbreaking treatments which have transformed healthcare in general and patient quality of life more specifically. The Irish medical technology industryis truly committed to ensuring that this vital cooperation adheres to the highest ethical standards. The Irish Med Tech Industry Code of Ethics is an essential component in guaranteeing access to modern, innovative and reliable medical technology.
Collaboration with healthcare professionals is a fundamental part of medical technology
Healthcare professionals (HCP’s) and the medical technology sectorhave a symbiotic relationship which advances medical science, improves patient care and increases access to new technology:
• HCP’s are an integral part of the research and developmentprocess and a source of innovation and creativity during the development and evolution of medical devices;
• As prime users of new technology, HCP’s play an instrumental role in the successful diffusion of innovative medical devices.
• The safe and effective use of new medical technology often requires that companies provide appropriate instruction, education, training, technical and clinical support.
Safeguarding independence of HCP’s
It is important that sufficient safeguards are in place to uphold theintegrity of such relationships. The Irish Med Tech Industry Code of Ethics, which is based on four key principles, (i.e. transparency,equivalence, separation and documentation) is supplemented by detailed practical guidance. These recommendations aim at facilitating the compliance with applicable rules by member companies. Moreover, it should provide the necessary reassurance to all healthcare stakeholders that the independenceof treatment decision-making is not potentially threatened by collaboration.
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
Introduction and background: Integrity and Collaboration
The Irish Med Tech Industry Code of Ethics is comprehensive in its commitment to high ethicalstandards. It governs all interactions betweenmedical technology companies and healthcareprofessionals and it is supplemented by detailedguidelines which embed ethical behaviour intoroutine professional collaborations. However, theCode is not intended to supplant or supersede national laws or regulations which will have to berespected as well.
Scope of the Code
Who is subject to the Code?The Code covers IMSTA and IMDA members, and ideally all medicaltechnology companies, and their relationships with HCP’s.
HCP’s are defined as individuals or entities that directly or indirectly purchase, lease, recommend, use, purchase or prescribemedical devices. Third-party intermediaries include both sales intermediaries and other agents who interact with HCP’s during the sale, promotion or any other product-related activity.
What types of interactions are covered by the Code?The Code of Ethics regulates a number of aspects of the professional collaboration between the medical technology industry and healthcare professionals, including:
EventsSpecific guidance is provided regarding appropriateness of a number of events (i.e. scientific, educational, promotional or product-related training event) including criteria to assess and decide on elements such as locations and venues, reasonable traveland hospitality arrangements.
RemunerationBe it for consultancy work, speaker fees or participation in researchor clinical trials – all financial arrangements need to be fully transparent and legitimate. Therefore some specific requirementsare set out in the guidelines, such as HCP compensation has to beset at a fair market value and specific notifications and clear documentation are also required.
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
A Transparent Compliance Framework
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
A Transparent Compliance Framework
DonationsDonations can be in the form of financial or in-kind support.Whereas the type of support can vary – from a research project to ascholarship to the sponsorship of a fund-raising event to the provision of equipment – there are precise requirements in place,such as the obligation of documentation.
Gifts, meals & accommodationTo ensure that the tone of the collaborative relationship remains professional, the Code outlines the limited contexts inwhich gifts to HCP’s can be considered appropriate. Likewise, thereare guidelines for hotels, meals and other related expenses.
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
Ethical Collaboration: Examples and Best Practices
The Code of Ethics clearly illustrates the ‘rules of engagement’. Professional collaboration between medical technology companies andHCP’s includes:
Support of scientific and educational conferences• Support is permissible only for bona fide – third-party-
independently-run conferences that promote scientific knowledge, medical advancement or assist in the delivery of effective healthcare. Financial, scientific, technical, organisational and/or logistical assistance may be provided.
• Members may sponsor HCP’s attendance to such third-party conferences and congresses, in compliance with the relevant laws, regulations and professional codes or conduct. If no such requirements are prescribed, transparency should be maintained via prior notification of the relevant hospital administration or competent authority.
Entering into legitimate consulting agreements with HCP’s• Agreements must have a valid purpose and represent a fair
market value for the services provided. Consultants are to be selected based on objective criteria (e.g. on the basis of their expertise or qualification). If no consents and approvals are required by the relevant laws, regulations and professional codes of conduct, prior notification should be made to the relevant competent authority.
Provision of educational grants and charitable donations• Grants may be for independent medical research,
advancement of medical science or patient and public education programmes. Grants can only be made to legitimate entities and not to individual HCP’s.
• All charitable donations should be appropriately documented and detail the purpose of the charity and the nature of its activities. Payments should be made directly to the charity.
Provision of modest hospitality and gifts• Hospitality should be reasonable in value, subordinate in time
to the primary purpose of the professional collaboration being undertaken and in compliance with the relevant laws, regulations and professional codes of conduct.
• Gifts must relate to the HCP’s practice, benefit patients or serve a genuine educational function.
The Irish Med Tech Industry Code of Ethics alsooutlines some behaviours that are to be considered as unethical and unprofessional.Members of IMSTA and IMDA, but ideally all medical technology companies, should not:
Provide inappropriate support for conference events such as:• Covering the cost of travel or hospitality for partners or family
members of HCP’s.
• Offering to organise to pay for any entertainment, sporting or recreational activities for HCP’s.
• Sponsoring HCP’s participation at third-party conferences and/or other meetings taking place in inappropriate locations as defined by the Guidance Document (e.g. beach, ski, golf resort).
Enter into questionable consulting agreements with HCP’s• The compensation paid to HCP’s must not be tied in any way
to the volume of medical devices used or ordered by the HCP in the healthcare setting in which he/she works.
• Under no circumstances may HCP’s receive any financial compensation in respect of medical devices he/she has prescribed in the past or may prescribe in the future.
Provide grants or charitable donations with strings attached• Educational grants must not be indicative of a price
concession, reward to favoured customers or inducements to recommend, prescribe or purchase certain products or services.
• The choice of grant recipients must be at the sole discretion of the educational institution without interference of the company.
• Charitable donations cannot be tied to the use of certain medical products and if a financial contribution is made, it must be paid directly to the institution concerned and not to an individual.
• It is not appropriate to support a particular charity in response to a request from HCP.
Provide excessive hospitality or lavish gifts• Gifts should not be expensive or unrelated to a healthcare
professional’s practice (e.g. iPad) and gifts must never be given in the form of cash or cash equivalents.
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
Unethical collaboration undermines credibility
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
Unethical collaboration undermines credibility
The Irish Med Tech Industry Code of Ethics is composed of the following documents:
• The Guidelines on the Interactions with Healthcare Professionals
• The Q&A on the Irish Med Tech Industry Code of Ethics Guidelines on the Interactions with Healthcare Professionals
• Competition Authority’s Notice 09/002 on Activities of Trade Associations and Compliance with Competition Law
• Code of Ethical Business Practice: Procedural Framework
The full text of the Code of Ethics is available at www.medtechethics.ie. The Code is available from IMSTA [email protected] or IMDA on [email protected]
To implement the Code of Ethics please refer to the Code of Ethicswebsite above or contact IMSTA or IMDA to learn more about programmes which offer member and non-member companies an opportunity to certify their compliance with the Irish Med Tech Industry Code. Additional copies of this brochure are available by contacting IMSTA on www.imsta.ie
About IMSTA
IMSTA represents the medical technology supply industry in Ireland.IMSTA’s member companies produce and market medical devices, diagnostic products and health information systems that are transforming healthcare through earlier disease detection, less invasive procedures and more effective treatment.
About IMDA
The Irish Medical Devices Association (IMDA) is the association withinIBEC representing the medical device and diagnostics industry in Ireland. IMDA promotes and supports an environment - nationally andinternationally - that encourages the sustainable development andprofitable growth of Ireland’s multinational and indigenous medicaldevice and diagnostic companies.
Contacts
IMSTA Kandoy House, 2 Fairview Strand, Dublin 3Tel: +353 1 4847828 Email: [email protected]
IMDA Confederation House, 84/86 Lower Baggot Street, Dublin 2Tel: +353 1 6051500 Email: [email protected]
Irish Medical Devices Association is a business sector within IBEC.
IRISH MEDICAL TECHNOLOGY INDUSTRY CODE OF ETHICS
The Irish Med Tech Industry Code of Ethics