Questions and Answers
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 and
2008-amendment to the Medicines and Related Substances Control Act?
How does this Code relate to other Policy documents, such as the
HPCSA’s Perverse Incentives Policy or the Marketing Code for
Pharmaceuticals?
SAMED’s
Code reflects the unique interactions between medical technology
companies and HCPs. Distinguishing
features in SAMED’s Code arise primarily from the fact that Members
interact with HCPs because of the complexity of medical technology
and the importance of having HCPs understand how to use the
technology safely and effectively. In other ways, however, SAMED’s
Code reflects similarities in the interactions between HCPs and
medical technology companies as compared with other elements of the
health care industry.
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 “HCPs”? Does the term include non-clinical people who
make product-purchasing decisions? Does it include decision-makers
within Group Purchasing Organisations?
The
term “HCP” 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 “HCP”
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 HCPs, 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.
Does the Code address arrangements between a Member and an HCP
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” mean?
The Code seeks to balance an interest in civility with the desire to
avoid even the appearance that meals and refreshments may be used as
an inducement.
The code stipulates that meals and refreshments offered to HCPs 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 Inappropriatehospitality include:
-
Sporting
events: Members may not sponsor or host their own golf days or other
sporting events for HCPs. Members may not invite or pay for HCP’s
to attend sporting events such as golf days, cricket and rugby
matches etc.Members may not sponsor holes, prizes etc and advertise,
put up branding / promotional material at any golf day
-
Sporting
events at Congresses/Educational events: Members may not sponsor
sporting activities which involve HCPs or pay for HCPs to
participate in such activities at congresses or educational
functions. Members may however pay for themselves to participate in
such events, but may not promote/advertise their products/company
during the event
-
Entertainment:
Members may not entertain an individual or a Practice of HCPs and
their staff. Meals may be offered provided that they are modest in
nature, and provided that the hospitality is conducive to the
exchange of information. No “stand-alone” entertainment may be
offered.
-
Resort
functions: It is inappropriate for Members to host HCPs 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. Venues such as Game Lodges,
Dive resorts, Casino’s, Cruise ships, offshore islands and
exclusive holiday resorts are some examples of inappropriate venues
and would be viewed as a perverse incentive to HCP’s.
-
Receptions:
It is inappropriate for Members to host or sponsor meals or
receptions for large groups of HCPs that are entirely unconnected to
any Congress, Business premises or educational event. This includes
year end functions.
-
Spouses:
It is inappropriate for Members to pay for the expenses of
spouses/partners accompanying HCPs. Members should inform HCPs of
this fact in advance of an event.
-
Company
year end functions: it is inappropriate to invite HCP’s as guests
to attend member company year end functions.
Examples of Appropriatehospitality include:
-
Members
may pay for themselves to participate in a golf day, be it a
charitable golf day or other
-
Members
may play a social game of golf with an HCP provided that this is
infrequent and that the member not pay for the HCP to play.
Question 6
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 an
HCP that takes into consideration the value or volume of the business
that is or may be generated by the HCP, unless permitted by law
(e.g., appropriate discounts).
The
Corruption Act and the ethical rules binding HCPs 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.
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 HCPs 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 Member’s products?
Members
may sponsor travel to healthcare related educational sessions which
are not necessarily specific to the Member’s products.
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 HCP at a local third-party educational
conference?
No. Only HCPs in training, nurses, technicians, registrars and other
deserving persons may be sponsored.
May a Member organise the travel and accommodation arrangements of
the spouse or other guest of an HCP attending a congress or training
event, if the HCP pays for the spouse or guest?
No, unless that person qualifies as a proper delegate or participant
at the meeting in their own right, it would not be appropriate for a
member to organise the travel and/or accommodation arrangements of
the spouse or guest of the HCP, irrespective of who pays.
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?
Section
5. In all cases however, 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.
What is the current limit set for prizes that may be offered as part
of a competition promoted at a conference / congress?
R10 000
Would it be appropriate for a member to sponsor an HCP to attend a
trade show e.g. Medica Trade Show held in Dusseldorf in November each
year?
No.
SALES & PROMOTIONAL MEETINGS
Why does the Code not allow Members to extend business courtesies to
spouses/partners in connection with sales and promotional meetings?
SAMED’s Code is mindful of the desire to avoid even the
appearance that business courtesies are being given as improper
inducements to promote a Member’s 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 HCPs in connection with these types of meetings.
To balance these considerations, the Code allows Members to provide
“occasional and modest meals and refreshments for HCP attendees
that are conducive to the exchange of information.”
Under the Code, such meals and refreshments 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 an HCPs travel to the meeting for
purposes of providing product information and negotiating sales
terms?
This would be inappropriate.
Members
are encouraged to hold any sales or promotional meetings as close to
the HCPs place of business as possible.
Members
are entitled to provide “modest meals and receptions” that are
“conducive to the exchange of information.”
In
the event that HCPs 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.
ARRANGEMENTS WITH CONSULTANTS
Is a clinical investigator considered a “consultant” under
Section 8?
Yes.
Is there a limit to the number of consultants a Member may retain
under Section 8?
Members may retain only as many consultants as are legitimate and
appropriate to provide bona fide services; moreover, the
requirements of Section 8 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 8 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 Basic Conditions of Employment Act, 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 consultant’s services?
The Code contemplates that if the requirements of Section 8 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 there is a bona fide business justification for
holding the meeting
-
whether the location and venue are suitable for and conducive to
the exchange of information between Member and consultant
-
whether the value of any Member-sponsored lodging is modest,
whether any ancillary meals and refreshments are modest in value
(or alternatively, the fair market value of such meals and
refreshments are taken into consideration when determining the fair
market value of the compensation to be provided to the consulting
HCP) and are subordinate in time and focus to the business part of
the meeting; and
-
whether the overall meeting has a genuine business purpose and
tenor and does not represent improper inducement of the HCP.
Venues
such as Game Lodges, Dive resorts, Casino’s, Cruise ships, offshore
islands and exclusive holiday resorts are some examples of
inappropriate venues.
GIFTS
What is the current maximum value per annum set for gifts and what
are some examples of branded promotional items of minimal value that
are “related to an HCPs work or for the benefit of patients”?
R300 incl vat
Pens and notepads that could be used in the HCPs work environment are
examples of minimal value, branded promotional items appropriate as
gifts. Items such as branded golf balls and tee shirts would be
inappropriate, as would a gift of wine or spirits.
May a Member or its representative provide a gift to recognise a life
event for an HCP, such as a wedding, birth, anniversary, or death of
a family Member?
Yes. It
would be considered acceptable to recognise a life event by offering
a gift such as flowers, fruit basket or a card.
May
a Member provide snacks and refreshments to HCPs and their staff?
If food is
provided in connection with sales and promotional meetings,
conferences, or training and education, it is acceptable to provide
snacks and refreshments of a modest nature to only those persons
attending the event.
Is the R300 limit determined on a per-gift or per-year basis?
Members may occasionally provide modest gifts to HCPs. 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 incl vat.
The R300 limit is intended to be a per-year amount.
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 an HCP to properly
evaluate whether it is economically feasible or desirable to purchase
any particular product.
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
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 HCP?
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 Section 14. 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 HCPs to attend a
third-party educational conference?
If the HCP
is in private practice elsewhere, then No.
If
the HCP is a public employee, then 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 contribution to pay for a clinical fellow?
Yes. A
Member may make a contribution to subsidize a clinical fellow if
he/she is in a genuine fellowship program affiliated with a teaching
institution.
Public
hospital service excellence awards: it would be considered
appropriate for a member company to sponsor a public hospital service
excellence award program provided that the award is modest in nature.
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.
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
against production of original invoices 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, registry 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.
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,
in general 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.
PAYMENT FOR SHELF SPACE
Is
it acceptable to pay for shelf space?
It
is not acceptable to pay for shelf or storage space in an HCPs
practice, hospital or hospital group warehouse, excluding retail
pharmacies.
PAYING AN HCP TO USE/SELL MY PRODUCT
Is
paying an HCP not in my full time employ, to use/sell my product
considered perverse e.g. commission per product used?
Yes
Can
a HCP be reimbursed by a member for cleaning and packing a loan set
at the place of their employ ie a theatre nursing sister?
No -
This would be regarded as inappropriate to pay an HCP not in the
employ of the member – member companies must train the hospital
staff in the management of their loan sets. Movement of loan sets
must be managed by local courier companies or by the member
themselves.
EMPLOYEE ATTENDANCE IN OPERATING ROOM / CLINICAL ENVIRONMENT
May a company representative who is a registered Theatre Sister work
in a hospital after hours?
Company representatives may not work as HCP’s in their spare time.
Guidance should be sought from DENOSA or SANC and the hospital policy
will prevail. It could be a conflict of interest for the member
May company representatives take / wear their own / company branded
overshoes and / or theatre clothes into theatre?
No, this is inappropriate due to infection control policies.
What should a company representative do should a hospital group /
healthcare professional ask the representative to obtain patient
consent?
Under no circumstances may a company representative obtain consent
from patients. This is the doctor’s responsibility.
May a company representative touch a patient whilst doing product
training?
No, regardless of whether they are a registered nurse or not, a
company representative may not touch a patient under any
circumstances even if demonstrating / training a product.
CODE BINDING IN OTHER COUNTRIES
Is
the Code binding on those Members who sell products in other
countries e.g. Angola etc.
No,
however should the Member sell or engage with a South African HCP
outside of South Africa, the SAMED Code will be applicable.
HANDLING INFRINGEMENTS AND ENFORCEMENT OF THE CODE
What
is the current fee that must be paid when lodging
a complaint with regard to a possible contravention of the code?
R2500 incl vat
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 HCPs 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 the SAMED Code Advisory Committee. Note, the SAMED Code
Advisory Committee bears no responsibility for the advice provided
should the Member fail to fully disclose all details / specifics
relating to the contemplated practice.
Does the Code govern the actions of Members’ agents, distributors
and Associate Members of SAMED?
Yes. As the code states, Members will communicate the Code’s
principles to their employees, agents, dealers and distributors with
the expectation that they will adhere to the Code. It is important
that Members inform these entities of any revisions to the code and
that they are made aware of the ethical business practices reflected
in the Code’s provisions.