The Medical Device Code of Ethical Marketing and Business Practice (the Code) promotes and encourages ethical principles and practices during marketing and business interactions between SAMED members and their customers. The Code is binding on all SAMED members. Including their agents and contractors working for or in conjunction with such member, as well as marketing agencies, advertising agencies, event management entities, commission agents or independent sales representatives, procurement or software entities, working for or on behalf of a SAMED member. Members should ensure that reference is made to this Code in agreements with third parties mentioned in this context.
SAMED’s Code Committee provides information and training sessions about the Code and compliance on an ongoing basis. The latest such member forum was hosted virtually on 12 August 2020 and was attended by 350 delegates. Such strong attendance indicates SAMED members’ awareness about the need to ensure their employees understand and follow the Code. It also suggests that the virtual sessions are a suitable method to conduct trainings which we will continue to use in the future.
Why the Medical Device Code?
The Code is patient-centric. Optimal quality healthcare is inseparable from ethical business and marketing practices. By adopting and driving this approach, SAMED demonstrates to healthcare stakeholders in the public and private sectors that the medtech industry is serious about self-regulation and eradicating perceived perverse practices. Medical technology suppliers – specifically SAMED members – must take a firm stance against corrupt and fraudulent activities to protect patient interests.
Awareness of what constitutes a perverse incentive and avoiding such practice safeguards patient interests and creates trust between suppliers, healthcare providers and practitioners (HCPs), policymakers, funders and the public. Close collaboration between the suppliers and users of medical technology supports innovation and facilitates choice and use of appropriate medical technology. It can also, however, provide the opportunity for inappropriate and irresponsible marketing and business practices, which can compromise patient safety and outcomes and, furthermore, damage the reputation of both the healthcare practitioner and our industry.
The Code governs the interaction between industry and HCPs and is not intended to govern HCP ethical practices which is the domain of the Health Professions Council of South Africa (HPCSA).
Principles of the Code
- The principle of image and perception: SAMED and our members are representative of the medical technology industry. It is our responsibility to protect the reputation of our industry and safeguard the trust relations between the public, HCPs and medical technologies.
- The principle of separation: We need to maintain the independence of HCPs and ensure that our relationships with them are not misused to influence their professional discretion.
- The principle of transparency: It is essential that all dealings with HCPs be conducted in a transparent manner and in a way that complies with international best practice and local guidelines and legislation.
- The principle of equivalence: Members should ensure that they are using fair market value when contracting HCPs and not use contracts to influence HCP purchasing or prescribing.
- The principle of documentation: This is a critical element of any compliance programme. All interactions, professional agreements and contracts need to be well documented with clear risk mitigation considerations.
The Medical Device Code of Ethical Marketing and Business Practice
In order to ensure that the Code is understood and consistently practiced by members and other industry role players, SAMED has developed training materials that describe and explain the key principles of the Code and their intended application. These materials are available on the SAMED website for in-house training conducted by our members and support our regular training events. Training covers the proper conduct of company events, use of promotional items, gifts and competitions, charitable donations, loaned equipment, bonusing, rebates and incentive schemes, royalty arrangements, reimbursement procedures and advertising.
Since the introduction of the CPD-accredited Code online certification programme in 2018, 7037 company representatives and 1389 healthcare practitioners have been certified.
The anonymous Medical Device Code ethics hotline
Whistleblowing is recognised as the most effective measure to guard against fraudulent or unethical activity within organisations. The Medical Device Code whistleblowing hotline is an anonymous tip-off mechanism available to any member of the public wishing to report contraventions of the Code. The hotline is independently managed and available 24/7. Freecall the Medical Device Code Ethics hotline on 0800 00 04 68.
Ending corruption requires a partnership. We need your support. This is a call to action for you to take a stand against unethical conduct. We urge you to call our hotline should you be witness or become aware of Code transgressions by signatories.
SAMED’s complaint process is handled through an independent ethics chair who assesses the complaint – which is either received through receipt of a formal written complaint or through the Medical Device Code Ethics hotline. The independent chair decides on course of action, either with further investigations or a hearing which may result in sanctions. Should the matter be criminal in nature the independent chair forwards the report and findings to the relevant authorities.
To date, SAMED has received six reports through the Medical Device Code hotline. Cases that are of a medical device regulatory nature are referred to SAHPRA for investigation and management. Currently, there is one active case.