Questions and Answers
SAMED CODE OF BUSINESS PRACTICE
FREQUENTLY ASKED QUESTIONS AND ANSWERS
1. PREAMBLE & GENERAL QUESTIONS
Why did SAMED develop a code of business practice? How does this Code relate to the Code promulgated in terms of the 1997 amendment to the Medicines and Related Substances Control Act? How does this Code relate to other Policy documents, such as the HPCSAs Perverse Incentives Policy?
SAMEDs Code reflects the unique interactions between medical technology companies and Healthcare Professionals.
SAMEDs Code arose primarily due to the complexity of interactions between Members and Healthcare Professionals, because of the complexity of medical technology and because of the importance of having Healthcare Professionals understand how to use the technology safely and effectively.
The SAMED Code aims to be in line with other applicable Policy documents that bind health professionals, such as the Guidelines and Ethical Rules of Conduct for Practitioners Registered under the Health Professions Act and the HPCSA Policy on Undesirable Business Practices. See www.hpcsa.co.za
Who are Healthcare Professionals? Does the term include non-clinical people who make product-purchasing decisions? Does it include decision-makers within Group Purchasing Organisations?
The term Healthcare Professional includes: individuals, entities, their employees or employers, their agents or other delegates, and includes, but is not limited to persons registered with the Health Professionals Council, Allied Health Professions Council, the Nursing Council, the Pharmacy Council or, an institution registered at the Department of Health or other regulatory or organisational body, such as a health facility, and who purchase, lease, recommend, use, maintain, arrange for the purchase or lease of, Members medical technology products in South Africa.
This includes both clinical and non-clinical people who make product-related decisions. It also includes decision-makers within group purchasing organisations (GPOs). This is a broad definition, intended to encompass anyone with material influence over purchasing, utilisation and similar decisions. Other examples of entities that fall within the definition of Healthcare Professional are: The Board of Healthcare Funders, Private and Public Hospitals, Medical Schemes or Funders, Council for Medical Schemes, Laboratory and Pathology technicians.
Note that there may be laws and other codes applicable to relationships with Healthcare Professionals, including relationships with government employees e.g. The Foreign Corrupt Practices Act.
Are combination products covered by the Code?
Yes, interactions related to combination products (e.g. devices containing medicines) are covered by the Code.
In addition, if a device is classified as a medicine due to the lack of regulations for devices, members may wish to refer to the code of practice for the Marketing of Medicines in SA. To summarize, a device that is classified as a medicine will be also be subject to medicine regulations and applicable codes.
Does the Code address arrangements between a Member and a Healthcare Professional relating to licensing a new medical technology to the Member?
Interactions relating to product development and intellectual property would be subject to the general principle that Members shall encourage ethical business practices and socially responsible industry conduct and shall not use any unlawful or unethical inducement in order to sell, lease, recommend, use, maintain or arrange for the sale, lease, or prescription of, their products.
What do the terms modest, occasional, and hospitality mean?
The Code seeks to balance an interest in civility with the desire to avoid even the appearance that hospitality may be used as an inducement.
The code stipulates that meals and hospitality offered to Healthcare Professionals must in all circumstances be modest in nature and subordinate to the purpose of the meeting.
Modest means moderate or low value and occasional means infrequent.
Examples of Appropriate hospitality include:
-
Sporting events: Members may invite individuals or small groups of Healthcare Professionals to sporting events such as cricket and rugby matches. When these are local in nature they should not involve travel and accommodation expense. Such hospitality may include meals and receptions that are modest in nature.
-
Sports: Members may from time to time engage in sporting activities with Healthcare Professionals.
-
Sporting events at Congresses/Educational events: Members may engage in sporting activities with Healthcare professionals at congresses or educational functions, where such activity is subordinate to the main purpose of the congress or function.
-
Meals: Members may entertain an individual or a Practice of Healthcare Professionals and their staff from time to time, provided that, where local in nature, such activity occurs in reasonable proximity to where the Healthcare Professional practices.
Examples of Inappropriate hospitality include:
-
Sporting events: Members may not sponsor or host stand-alone golf days or other sporting events for large groups of Healthcare Professionals.
-
Congresses: Members may not engage in sport with Healthcare Professionals where such activity conflicts with the main program organised for that meeting.
-
Resort functions: It is inappropriate for members to host Healthcare Professionals at venues that would exclusively be considered as holiday destinations and which are distant from their normal place of practice, unless it is a bona fide educational meeting, conference or congress, endorsed by a Professional Healthcare Association.
-
Receptions: It is inappropriate for members to host meals or receptions for large groups of Healthcare Professionals that are entirely unconnected to any Congress or educational event.
-
Spouses: It is inappropriate for Members to pay for the expenses of spouses/partners accompanying Healthcare Professionals.
May a Member offer to provide laptop computers with independent value to a purchasing manager whose hospital purchases medical devices and technology that the Member has just introduced?
No. It is not appropriate for a Member to provide any item of value to a Healthcare Professional that takes into consideration the value or volume of the business that is or may be generated by the Healthcare Professional, unless permitted by law (e.g., appropriate discounts).
The Corruption Act and the ethical rules binding Health Professionals and managers in such situations (including but not limited to the obligatory disclosure of all gifts and support in terms of the Public Service Act and Regulations) have to be borne in mind.
These laws and rules prohibit the offering or acceptance of any object of value in return for an action (in this case an order), that the recipient is empowered to make, irrespective of whether the object did indeed influence the particular decision to purchase, lease, maintain or use.
2. MEMBER-SPONSORED TRAINING AND EDUCATION
Why may it be appropriate under the Code for Members to pay for travel to training and education sessions?
In order to efficiently deliver training at appropriate facilities, the Code contemplates that Members may bring Healthcare Professionals together at a central location, which may make out-of-town travel necessary. Note that this section deals only with meetings focused on training and education on Member products, and only for persons who could legitimately benefit from the training.
Meetings focused on sales and promotion may not be sponsored under the Code, unless an educational aspect is central to the meeting.
May a Member pay for travel to a Member-sponsored general educational program not specific to the Members products?
Members may sponsor travel to healthcare related educational sessions which are not necessarily specific to the members products.
3. SUPPORTING THIRD PARTY EDUCATIONAL CONFERENCES
May a Member designate attendees or faculty who will speak at third-party educational conferences?
No. The Code contemplates that an independent third party will select faculty and attendees. The Code does not preclude a Member from recommending a knowledgeable faculty member. The conference sponsor or a professional association should make the ultimate selection.
Can a Member provide an educational grant to support the attendance of a Qualified Healthcare Professional at a third-party educational conference?
Yes.
What section of the Code applies to Member-sponsored off-agenda activities (e.g. sales and promotional meetings or educational programs) that are ancillary to a conference sponsored by a third party?
Sales and promotional meetings should be evaluated under Section 6. However, Member sponsored product-related educational programs should be evaluated under Section 4.
In either case, it should be determined whether the conference sponsor has guidelines that cover that type of off-agenda activity, and if so, the sponsor's guidelines should also be honored.
4. SALES & PROMOTIONAL MEETINGS
Why does the Code not allow Members to extend business courtesies to spouses/partners in connection with sales and promotional meetings?
SAMEDs Code is mindful of the desire to avoid even the appearance that business courtesies are being given as improper inducements to promote a Members products. On the other hand, it is appropriate for Members, as a matter of common courtesy and civility, to provide modest meals and receptions for Healthcare Professionals in connection with these types of meetings.
To balance these considerations, the Code allows Members to provide occasional hospitality only in the form of modest meals and receptions for Healthcare Professional attendees that are conducive to the exchange of information.
Under the Code, such meals and hospitality are to be incidental and conducive to the underlying business purpose. The Code precludes the extension of these courtesies to persons, such as spouses/partners, without a bona fide professional interest in the meeting.
May a Member conduct a product sales or promotional meeting at a resort location and pay for a Healthcare Professionals travel to the meeting for purposes of providing product information and negotiating sales terms?
Generally, this would not be appropriate.
Members are encouraged to hold any sales or promotional meetings as close to the Healthcare Professionals place of business as possible.
Members are entitled to provide hospitality only in the form of modest meals and receptions and conducive to the exchange of information.
In the event that Healthcare Professionals need to travel to such sales or promotional meetings, the cost of travel shall not be borne by the Member.
The Code does provide for limited special circumstances of plant tours and demonstrations of non-portable equipment as specific examples of when travel might be necessary.
5. ARRANGEMENTS WITH CONSULTANTS
Is a clinical investigator considered a consultant under Section 7?
Yes.
Is there a limit to the number of consultants a Member may retain under Section 7?
Members may retain only as many consultants as are legitimate and appropriate to provide bona fide services; moreover, the requirements of Section 7 must be satisfied for each consultant and the contracts should be similar in terms of remuneration, i.e. may not be scaled up or down depending on the relative support of the consultant for the members products or events.
May a consultant be placed under retainer with services provided as requested?
Yes, provided the requirements of Section 7 are met. One should be mindful of labour legislation that currently takes a practical (and not a legal) view of employment, i.e. a person who works continuously and under the direction of the member may be regarded as an employee in terms of the BCEA, but which violates the Health Professions Act of 1974, that prohibits institutions and people not registered at the HPCSA from employing health professionals that are registered at the HPCSA.
What happens if a consultant is engaged but the project is cancelled or modified without using the consultants services?
The Code contemplates that if the requirements of Section 7 were met when the consultant was engaged and then unanticipated circumstances prevented performance, then the question of whether or how much payment is made to a consultant would be a matter determined by the underlying agreement.
What factors should a Member consider when evaluating the venues and circumstances for meetings with consultants?
A Member should assess:
-
whether the value of any member-sponsored lodging is modest, whether any ancillary meals and hospitality are modest in value (or alternatively, the fair market value of such meals and hospitality are taken into consideration when determining the fair market value of the compensation to be provided to the consulting Healthcare Professional) and are subordinate in time and focus to the business part of the meeting; and
6. GIFTS
What are some examples of branded promotional items of minimal value that are related to a Healthcare Professionals work or for the benefit of patients?
Pens and notepads that could be used in the Healthcare Professionals work environment are examples of minimal value, branded promotional items appropriate as gifts. However, other promotional items such as golf balls and tee shirts would be allowed, as long as they are modest in value and do not exceed a value of R300.
May a Member provide a gift such as flowers, gift baskets, meals, snacks, wine, or other refreshments to a Healthcare Professional or a Healthcare Professionals office or staff?
Yes. It is recognised that it is at times appropriate to entertain a Healthcare Professional and /or his staff. In the case of gifts, it is appropriate for members to give occasional gifts, as provided for above.
However if food is provided in connection with either sales and promotional meetings, conferences, or training and education, see sections 4, 5 and 6 to evaluate when meals and receptions may be appropriate.
Is the R300 limit determined on a per-gift or per-year basis?
Members may occasionally provide modest gifts to Healthcare Professionals. Other than the gift of medical text books or anatomical models used for educational purposes, any gift from a Member should have a fair market value of no more than R300.
The R300 limit is intended to be a per-gift amount; however consideration should be given to the frequency of providing gifts to any one individual (note the requirement that gifts be only occasional). Repeated gifts to the same person each with a value below the R300 threshold could violate the spirit of the Code, the purpose of which is set forth in the Preamble.
7. REIMBURSEMENT SUPPORT PROGRAMS
Is it appropriate to demonstrate that a product can be used in an economically efficient manner?
It may be appropriate for Members to provide accurate information relating to the costs, savings and revenues associated with the use of a particular product.
Without this information, it may be difficult for a Healthcare Professional to properly evaluate whether it is economically feasible or desirable to purchase any particular product.
8. GRANTS & OTHER CHARITABLE DONATIONS
What is an example of a grant or donation to individuals engaged in genuine charitable missions for the support of that mission?
One example is providing medical devices to individuals who perform volunteer disaster relief abroad. Supporting disaster relief work may be appropriate under the Code, notwithstanding that the individuals or group are acting as independent volunteers and not under the umbrella of a not-for-profit, charitable organisation, registered as such in terms of applicable legislation.
Donations in cash or supplies may also be made to organisations, foundations and other institutions dedicated to a specific charitable cause.
Corporate Social Investment donations may also be made in keeping with the principles of the BBBEE Act and the Healthcare Charter.
May grants be given to a for-profit organisation, such as a legitimately sponsored research grant to a for-profit hospital? What about a research grant to an individual Healthcare Professional?
This section of the Code addresses charitable giving. Funding a research project at a for-profit institution, or paying an individual researcher, would not qualify as a charitable gift. However, that does not, by itself, mean that the funding would violate the Code. For example, if the funding constituted payment for a legitimate service, it could be appropriate under Section7. Equally, donations made to for-profit organisations in terms of corporate social investment are legitimate.
May a Member make a charitable contribution to a not-for-profit institution to pay the registration or seminar fees and travel expenses for one or more of its affiliated Healthcare Professionals to attend a third-party educational conference?
Yes.
May a Member make a charitable contribution to a not-for-profit or state hospital for construction of a new wing?
Yes. Members have historically supported the delivery of healthcare services through charitable contributions. As with any other contribution, this type of contribution may be appropriate if (a) the recipient of the contribution is a charity; (b) the purpose of the donation is charitable in nature and (c) it is not offered with the intent of providing an inducement to order, sell, lease, recommend, arrange for the sale or lease of, or prescribe Members products.
Many factors would be involved in considering whether such a contribution is appropriate, including ensuring that the amount of the donation is not dependent upon the volume of business or anticipated business conducted with or referred to the Member. Legislative and policy provisions have to be considered as well, particularly in the context of state facilities.
May a Member make a charitable contribution to pay for a clinical fellow?
Yes. A Member may make a charitable contribution to subsidize a clinical fellow if he/she is in a genuine fellowship program affiliated with a teaching institution.
Does the SAMED Code offer legal advice?
No. The Code is intended to facilitate ethical behavior, and is not intended to be, nor should it be, construed as legal advice. All Members have an independent obligation to ascertain that their interactions with Healthcare Professionals comply with all current laws and regulations.
Will SAMED provide advice on how specific provisions of the Code would apply to specific practices that a Member is contemplating?
Yes. Members are at liberty to address any questions about specific practices to SAMED.
Does the Code govern the actions of Members agents, distributors and Associate members of SAMED?
Yes. As the Note to the Code states, Members will communicate the Codes principles to their employees, agents, dealers and distributors with the expectation that they will adhere to the Code. It is important that these entities be informed that SAMED has a revised Code of Business Practice and that these entities be made aware of the ethical business practices reflected in the Codes provisions.
9. CLINICAL TRIALS AND PRODUCT EVALUATIONS
Must the patient consent to the Trial or Evaluation?
Yes - in the case of a Clinical Trial. No - in the case of an Evaluation.
Can payment be made to a patient for participation in a Trial or Evaluation?
Certain patient expenses may be reimbursed, as provided for in the Trial protocol. Small gifts given to child participants after completion of a research project shall be allowed. Any payments to be made should be declared to and scrutinized by the appropriate Research Ethics Committee (see Addendum for details).
Is the practice of offering inducements directed towards the investigators acceptable or perverse?
Expenses
Where researchers incur personal expense as a direct consequent of undertaking research, it is quite proper that they be reimbursed for that expenditure by the sponsor of the research. Expenses should be moderate and reasonable and where a healthcare practitioner is reimbursed by a Funder or patient for the procedure, it would be inappropriate to enrich the healthcare practitioner further for his/her skill.
Fees
Sponsors of research involving patients may properly engage healthcare practitioners to assist in that research, and it is proper for these healthcare practitioners to be paid a fee for their services. It is inappropriate that a healthcare practitioner should be paid a fee for carrying out research work in sessions for which he or she is already being paid from another source. Sponsorship must be declared in a participant information sheet.
Again, the rates should be moderate and in line with the time, not for the procedure, but for actual time taken for conducting the research.
Can healthcare practitioners be reimbursed for evaluating a product not conducting a formal trial?
No. It is not appropriate to reimburse a healthcare practitioner for time spent evaluating a product not under the scope of an ethics committee, or without appropriate acknowledgement.
What about products developed in South Africa?
Currently no Medical Device regulation exists in South Africa, with the exception of electro-medical devices. There is nothing to stop a manufacturer from releasing untried products into the market. However, the rules for Clinical Trials and Product Evaluations apply equally to such products.
[Addition]10. FREE EQUIPMENT, PAYMENT FOR CONSUMABLES / DISPOSABLES
Is it acceptable that one enter into a contract with a provider that associates the placement/loan of equipment with the purchase of a finite or minimum number of consumables?
No, this would be considered unacceptable and unethical since the stipulation that a finite number of consumables must be purchased has the potential to result in over-servicing.
[Addition]11. PAYMENT FOR SHELF SPACE
Is it acceptable to pay for shelf space?
It is not acceptable to pay for shelf or storage space in a healthcare professionals practice, hospital or hospital group warehouse, excluding retail pharmacies.