Ethics & Compliance Guidelines
Guidelines on Interactions with Healthcare Professionals
These guidelines are intended to provide guidance on the interactions of employees with individuals or entities (such as hospitals or group purchasing bodies) that directly or indirectly purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe medical devices (“Healthcare Professionals”).
There are many forms of interactions between employees and healthcare professionals that advance medical science or improve patient care, including:
- Advancement of medical technology
The development of innovative medical devices and the improvement of existing products require collaboration between Direct Healthcare Group and Healthcare Professionals. Innovation and creativity are essential to the development and evolution of medical devices, often occurring outside the facilities of medical device companies.
- Safe and Effective use of Medical Technology
The safe and effective use of medical technology requires members to offer Healthcare Professionals appropriate instruction, education, training, service and technical support. Regulators may also require this type of training as a condition of product approval.
- Research and Education
Support of bona fide medical research, education, and enhancement of professional skills contribute amongst others to patient safety and increase access to new technology.
Direct Healthcare Group 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. Employees must encourage ethical business practices and socially responsible industry conduct related to their interactions with Healthcare Professionals.
Employees must continue to respect the obligation of Healthcare Professionals to make independent decisions regarding treatment.
The guidelines are based on the following key principles:
The Principle of Separation: Interaction with 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 Direct Healthcare Group’ products and/or services.
The Principle of Transparency: Interaction with 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, employees 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, fully disclosing the purpose and scope of the interaction.
The Principle of Equivalence: Where Healthcare Professionals are engaged by the business to perform a service for Direct Healthcare Group, the remuneration paid must be commensurate with, and represent a fair market value for, the services performed.
It is required that any third party intermediaries, both sales intermediaries and other third party agents, including but not limited to, consultants, distributors, sales agents, marketing agents, brokers, commissionary commercial agents and independent sales representatives, who interact with Healthcare Professionals in connection with the sale, promotion or any other activity involving Direct Healthcare Group’ products, comply with standards equivalent to these guidelines. Accordingly, it is recommended that where such arrangements are entered into, the relevant contractual documentation imposes obligations upon the third party to comply with these or equivalent guidelines.
These guidelines set out the standards appropriate to various types of relationships with Healthcare Professionals. These guidelines are not intended to supplant or supersede national laws or regulations or professional codes (including company codes) that may impose more stringent requirements upon members or Healthcare Professionals who engage in certain activities in those countries.
Product Training and Education
Where appropriate, Direct Healthcare Group should make product education and training available to Healthcare Professionals to facilitate the safe and effective use of medical technology. Such education and training programmes should occur at appropriate locations taking account of the convenience of the attendees and the nature of the training. In particular: Programmes and events should be conducted in clinical, laboratory, educational, conference, or other appropriate settings, including Direct Healthcare Group own premises or commercially available meeting facilities, that are conducive to effective transmission of knowledge and any required “hands on” training.
The training staff should have the appropriate expertise to conduct such training. Direct Healthcare Group may provide attendees with reasonably priced meals in connection with the programme, and for educational programmes necessitating overnight stays, additional hospitality may be appropriate. Any hospitality should be reasonable in value, subordinate in time and focus to the educational purpose of the training and in compliance with the regulations of the country where the Healthcare Professional is licensed to practise. Direct Healthcare Group may pay for reasonable travel and accommodation costs incurred by an attending Healthcare Professional, in compliance with the regulations of the country where the Healthcare Professional is licensed to practise. Direct Healthcare Group is not permitted to facilitate or pay for meals, travel, accommodation or other expenses for spouses or guests of Healthcare Professionals, or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.
Bona fide independent, educational, scientific or policy-making conferences promote scientific knowledge, medical advancement and assist in the delivery of effective healthcare. To these ends Direct Healthcare Group may support such events provided the educational conference content promotes scientific knowledge, medical advancement and the delivery of effective healthcare and is consistent with relevant guidelines established by professional societies or organisations for such meetings. Direct Healthcare Group may support such events by the provision of financial, scientific, technical, organisational and/or logistical assistance as follows:
Healthcare Professional Sponsorship: Where permitted under national and local laws, regulations and professional codes of conduct, Direct Healthcare Group may provide financial support to cover the cost of conference attendance by individual Healthcare Professionals. Such financial support should be limited to the conference registration fee and reasonable travel, meals and accommodation costs relating to attendance at the event. Direct Healthcare Group must ensure full compliance with national and local laws with regard to the disclosure or approval requirements associated with such sponsorship and where no such requirements are prescribed, shall nevertheless maintain appropriate transparency, for example, by requiring prior written notification of the sponsorship is made to the hospital administration, the Healthcare Professional’s superior or other locally-designated competent authority.
Advertisements and Demonstrations: Direct Healthcare Group may purchase advertisements and lease booth space for company displays at conferences.
Conference Support: Direct Healthcare Group may provide financial grants directly to the conference organiser to reduce the overall cost of attendance for participants and to cover reasonable honoraria, travel, meals and accommodation expenses of Healthcare Professionals who are bona fide conference faculty members. A written request must be made by the conference organiser to Direct Healthcare Group and any sponsorship must be paid directly to the conference organiser or training institution. The conference organiser alone is responsible for the programme content and the faculty selection. Direct Healthcare Group may not have any detailed involvement in determining the content of the conference other than recommending speakers or commenting on the programme where requested to do so.
Satellite Symposia: Direct Healthcare Group may sponsor satellite symposia at third party conferences and provide presentations on subjects that are consistent with the overall content of the third party conference provided that all information presented is fair, balanced and scientifically rigorous. Direct Healthcare Group may determine the content of these events and be responsible for faculty selection. The arrangement must be documented by written contract and the support of the member must be disclosed in all materials relating to the satellite event.
Scholarships: Direct Healthcare Group may provide educational grants to training institutions, healthcare institutions or professional societies for medical education programmes by providing financial support for fellowships and similar scholarship awards. The selection of the grantee should be within the discretion of the institution at which they are enrolled or the teaching institution at which they will be trained. Grants must be provided to the teaching or professional institution, not to individual fellows, save at the prior written request of the institution. In no way should the funding be tied to an institution’s purchase of Direct Healthcare Group products, or otherwise be based on an institution’s past or potential future use of the company’s products or services.
Sales and Promotional Meetings
In the countries where it is appropriate for Direct Healthcare Group to meet with Healthcare Professionals to discuss product features, conduct contract negotiations, or discuss sales terms, these meetings should, as a general rule, occur at or close to the Healthcare Professional’s place of business. In connection with such meetings, Direct Healthcare Group may pay for reasonably priced meals for Healthcare Professional attendees in an environment that is conducive to the exchange of information. Where plant tours or demonstrations of non-portable equipment are necessary, Direct Healthcare Group may also pay for the reasonable travel and accommodation costs of Healthcare Professional attendees. However, Direct Healthcare Group is not permitted to facilitate or pay for meals, travel, accommodation or other expenses for spouses or guests of Healthcare Professionals, or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.
Direct Healthcare Group occasionally may provide inexpensive, branded or non-branded items as gifts to Healthcare Professionals, if they are modest in value and in accordance with the national and local laws, regulations and industry and professional codes of conduct of the country where the Healthcare Professional is licensed to practise. Gifts must relate to the Healthcare Professional’s practice, benefit patients or serve a genuine educational function. Gifts must not be given in the form of cash or cash equivalents. This section is not intended to address the legitimate practice of providing appropriate sample products and opportunities for product evaluation. Direct Healthcare Group should support accurate and responsible billing to reimbursement authorities. In doing so, they provide economic efficiency and reimbursement information to Healthcare Professionals and third party payors regarding members’ products. This information should be limited to identifying appropriate coverage, coding or billing of member products, or procedures using those products, or to encouraging the economically efficient delivery of member products. This section is not intended to address the legitimate practice of providing technical or other support intended to aid appropriate use or installation of the member’s products.
Donations for Charitable and Philanthropic Purposes
Direct Healthcare Group may make donations for charitable or other philanthropic purposes. Donations may be made only to charitable organisations or other non-profit entities entitled to receive them under applicable national or local laws and regulations. Donations may be made to support the general activities of a bona fide organisation or may be made to support general fund raising drives for projects undertaken by such an organisation. Charitable donations must not be tied in any way to past, present or potential future use of Direct Healthcare Group products or services. All donations to a charity or non-profit organisation should be appropriately documented. For example, a written request should be submitted by the charitable organisation, detailing the purpose of the charity and the nature of its activities. The payment should be made out in the name of the charity and paid directly to the charity. Charitable donations to a bona fide organisation should not be made in response to requests made by Healthcare Professionals unless the Healthcare Professional is an employee or officer of the organisation and submits the request on behalf of the organisation. It would not be appropriate for Direct Healthcare Group to support the favourite charity of a Healthcare Professional in response to a request by that Healthcare Professional. Direct Healthcare Group should have no control over the final use of funds provided as charitable donations to charitable and other non-profit organisations.
Direct Healthcare Group may provide funds to support genuine independent medical research, advancement of medical science or education, or patient and public education. However, it is important that support of these programmes and activities by Direct Healthcare Group is not viewed as a price concession, reward to favoured customers or inducements to recommend, prescribe or purchase Direct Healthcare Group products or services. Therefore Direct Healthcare Group should ensure that they maintain appropriate documentation in respect of all educational grants made. Educational grants must not be tied in any way to past, present or potential future use of Direct Healthcare Group products or services. Educational grants may be made only to organisations or entities entitled to receive them under applicable national and local laws and regulations and should not be made to individual Healthcare Professionals.