Interactions with the medical industry (2021)

Interactions between medical practitioners and the medical industry are subject to greater scrutiny by government, the media and society than ever before. Patients rely on the independence and trustworthiness of their surgeon, in particular any advice or treatment they recommend or prescribe.

Introduction

Interactions between surgeons and the medical industry can be beneficial to surgeons, patients and the industry. These interactions facilitate new opportunities for collaboration in research and to develop innovative technology, products and services to improve the medical treatment of patients. Interactions between the medical industry and surgeons have evolved to include conducting of clinical trials, serving on scientific advisory boards and monitoring the introduction of new technology. The medical industry has provided many genuine educational opportunities that arguably would not have been accessible to medical practitioners without the industry support.

Certain interactions between Fellows, Trainees or Specialist International Medical Graduates (SIMGs) and the medical industry have the potential to become a conflict of interest. A conflict of interest in medical practice arises when a medical practitioner, entrusted with acting in the best interests of a patient, also has a pecuniary, professional or personal interest/s or relationship/s with third parties, which may affect their care of the patient. This may be a perceived, potential or an actual conflict of interest, all of which require judicious consideration. The key issue is that surgeons, Trainees and SIMGs recognise and acknowledge when a conflict may exist and try to mitigate these factors to reduce any bias.

Key issues

RACS advises that interactions between surgeons, Trainees and Specialist International Medical Graduates (SIMGs) with the medical industry be governed by three key principles:

That the best interest of the patient is the first and foremost consideration.
That surgeons, Trainees and SIMGs conduct themselves with accountability and transparency.
That perceived, potential and actual conflict of interest are acknowledged and require judicious consideration.

RACS position

A surgeon, Trainee or SIMG must not accept any benefit, pecuniary remuneration or financial advantage, either by way of money or goods or services, based solely or partly on the use, or expectation of use of products, devices, prostheses, implants, medication, technology or services.

RECOMMENDATIONS

RACS supports key medical industry code of practice in Australia and Aotearoa New Zealand*[1] and has developed the following recommendations for surgeons, Trainees and SIMGs:

A surgeon must ensure that any relationship with the medical industry is transparent and publicly acknowledged if a medical product or service is, either directly or indirectly, endorsed.
A surgeon must declare to the patient or their legal guardian, any arrangement they have with medical industry that results in benefit, financial or non-financial, before any recommendations or decisions with respect to any of products, devices, prostheses, implants, medication, technology or services, on behalf of patients are made.
A surgeon must disclose to the patient any possible self-interest and must make such issues available for comprehensive review - particularly by patients, but also by colleagues, professional bodies and the general public.
A surgeon must not approach the medical industry as an individual for payments, either direct or indirect for a product, device, prosthesis, implant, medication, technology or service.
A surgeon must not enter into any financial arrangement that could influence, or be reasonably perceived to influence, the decisions they make on behalf of their patients (subject to 6).
Except where he or she has been involved in the creation or development of a medical product or service, a surgeon shall not promote or endorse that product or service other than (whether or not for remuneration) by demonstrating or training others in the use of that product or service.
A surgeon must distance themselves from financial grants obtained from medical industry e.g., educational grants should be directed to organising bodies or other third parties, payment for specific Fellowship training should be by way of the specialist organisations.
Surgical organisations must not accept grants from medical industry if there are any conditions stipulating that the funds be directed towards a specific individual or individuals.
A surgeon should not permit any member of their family or close associates, to accept benefits from the medical industry.
Potential conflicts of interest, or even the possibility of a perceived conflict of interest that cannot be resolved, should be addressed by consultation with relevant institutional authorities or with RACS.
A surgeon should not accept any gifts from the medical industry, except if the gift may directly benefit patient care, e.g. medical textbooks or anatomical models.
Hospitality offered by the medical industry should not be accepted in the circumstances that is deemed to be excessive or extravagant- hospitality should be able to withstand public and professional scrutiny.
A surgeon, Trainee or SIMG should provide a written declaration of any conflict of interest prior to an engagement related to an educational event, training session, or meeting.
A surgeon, Trainee or SIMG should be diligent in upholding professional standards when advertising on social media platforms. If referencing a product, device, prosthesis, implant, medication, technology or service, one should avoid bias and where possible, generic names should be used rather than trade names.

RACS acknowledges that there are many scenarios that have the potential to expose surgeons, Trainees and SIMGs to conflicts of interest - whether they be perceived, potential or actual conflicts of interest. Examples to ensure absolute clarity of RACS’ expectation of conduct include:

Clinical settings - consulting rooms
Meetings with medical industry representatives are acceptable for the purposes of education and obtaining information. A fee must not be charged for such meetings nor should gifts be accepted.

Clinical settings - operating theatres

While the attendance of medical industry representatives during procedures can be useful, the overall responsibility for the treatment of the patient resides with the surgeon and decisions regarding the patient must be made by the surgeon.

Educational events
Educational development should, whenever possible, be through third parties such as specialist groups/ training boards that are independent and accountable to the profession. Content presented should be scientifically accurate and ideally be referenced with evidence based recommendations. Education should be free of commercial bias for or against any company, product, device, prosthesis, implant, medication, technology or service. If an activity contains reference to commercial products and/or services, objective information based on generally accepted scientific methods must be presented. It is preferable that such products and services are referred to by their generic name rather than trade names.

The educational content, faculty, venue and format should be determined by the convening body and not compromised or necessarily constrained by an industry’s brand or product. The venue should be selected as an appropriate educational space, not because of its entertainment facilities.

If medical industry has convened an educational meeting, the venue should not be excessive or extravagant.

Surgeons, Trainees and SIMGs should enter into a written agreement with the company/supplier that sets out the nature of the program and the services to be provided by or on behalf of the company.

Attending educational meetings
Surgeons, Trainee and SIMGs must not accept any financial support, direct or indirect, from medical industry for attending educational meetings. Any such support from industry must be directed to the organisers of the meeting to disseminate payments as deemed appropriate.
Presenting at educational meetings
Any payment for presenting at surgical meetings should be made to individuals by the organising committee of the meeting, not directly by industry. If organisers accept a grant from industry for payment of a speaker, this must not be dependent upon a specified speaker. The organising committee must retain autonomy for the arrangements of the meeting.
Any travel or accommodation expenses met by industry should be declared at the beginning of any presentation or demonstration. Any such expenses or reimbursement should be reasonable and not excessive.
Intermittently, a surgeon is paid by a medical industry company to attend a meeting in order to represent that company. In this situation, a surgeon must disclose that he or she is a paid consultant or advisor to, or an employee of, the company during any discussions involving that company or its products, formal or informal. Subsequently, a surgeon must disclose to a patient or their legal guardian that he or she is or has been a paid representative of the company before making any recommendation about the use of that company’s products for the patient.
Arranging educational meetings
A surgeon must not approach industry directly as an individual for support for meetings. Any approach should be clearly understood to be on behalf of the organising committee. A surgeon acting on behalf of, or as a representative of RACS, should have the expressed permission to do so. A meeting should always have the primary focus as education, rather than entertainment or hospitality being the main enticement.

Training sessions for new technology
Learning new techniques or becoming familiar with new technology, devices or prostheses may require training. Such training may require travel and accommodation. Reimbursement for reasonable expenses is appropriate but compensation for lost income is not. A surgeon must not accept any financial support, direct or indirect, in excess of reasonable travel and accommodation expenses from medical industry for such sessions.

Demonstrations and endorsements
A surgeon demonstrating a technique or the use of prosthesis, device or other technology to colleagues must be aware that they are in fact endorsing the technique, prosthesis or device. Any direct or indirect payment from medical industry indicates that the surgeon is a paid consultant, advisor or an employee of the company involved. This must be disclosed prior to the start of the demonstration and subsequently to patients prior to recommending the company’s devices and prostheses.

Fellowships
Industry funded Fellowships should be organised through and approved by RACS or the relevant surgical specialty board rather than directly by individual surgeons. A surgeon must not accept financial support directly from medical industry for the purpose of funding their own personal fellowship.

Research and publications
Any industry arrangement or involvement pertaining to a submitted paper for consideration for publication should be accompanied by an appropriate declaration of interest. In addition, any reviewer for a journal should declare any potential conflict of interest with respect to a paper to the editor of the journal. A surgeon may publish (or present) their experience with a device, prostheses or technique in a peer reviewed journal (or meeting).

Sponsorship
Sponsorship of educational meetings and events should be directed through the relevant organising committee (RACS, specialty organisation or training board) and be in accordance with professional and community standards and expectations. Venues and hospitality should be conducive to education and not excessive or extravagant. The primary focus of the event should be on education, not the entertainment or hospitality.

[1] Medical Technology Association of Australia; Medical Technology Association of New Zealand; Medicines Australia; Medicines New Zealand

A Surgeon's Responsibility

The community has entrusted medical practitioners with certain rights and privileges; one of these is to recommend products, devices, prostheses, implants, medications, technology or services that best meet the requirements of the patient. Surgeons who recommend products, devices, prostheses, implants, medications, technology or services to increase personal financial remuneration either by way of money or goods or services are in breach of the Medical Board of Australia (MBA) Code of Conduct, Medical Council of New Zealand (MCNZ) Code of Conduct and the Royal Australasian College of Surgeons (RACS) Code of Conduct.

Interactions and possible conflict of interests require identification, consideration, appropriate disclosure and accountability.