Breadcrumbs

Interactions with pharmaceutical, medical device and other therapeutic goods companies

SA Health is committed to ensuring that the relationship with the Therapeutics Goods Industry (Industry) is maintained to the highest professional standard so that patient care takes precedence and values of integrity, respect and accountability are upheld. 

The SA Health policy, Interaction between SA Health and the Therapeutic Goods Industry (PDF 180KB) outlines requirements for all SA Health Staff when interacting with Industry in areas such as sponsorships, payments, travel arrangements, gifts, consultancies, meetings and events. The policy also outlines the expectations of Industry when interacting with SA Health or any SA Health hospital/health service.

SA Health staff are also expected to abide by relevant codes of ethics and professional conduct. Codes of professional conduct relevant to specific health professions can be found on the Australian Health Practitioners Regulation Agency (APHRA) website.

Samples

Specific requirements regarding medicines samples (product starter packs) in South Australian public hospitals and health services are provided in the SA Health Directive on Samples (Product Starter Packs) (PDF 136KB). The policy provides that:

  • The acceptance of medicines samples by prescribers within SA Health is not permitted.  All samples should be received and dispensed/supplied by the relevant hospital Pharmacy Department or Pharmacy Service.
  • The provision and use of medicine samples not listed on the relevant hospital/health service formulary must be approved by the hospital/health service Drug and Therapeutics Committee.
  • Samples of medicines already listed on the hospital formulary require approval by the Director of Pharmacy before they may be used within that hospital/health service.

Medicines Access Programs

Specific requirements regarding participation in medicines access programs, including product familiarisation programs (PFPs) and Expanded Access Programs (EAPs) are provided in the SA Health Policy Directive, Medicines Access Programs (Expanded Access Programs and Product Familiarisation Programs).

Interactions with Suppliers

Specific requirements regarding interactions with suppliers of therapeutic goods are detailed in relevant SA Health Procurement policies.

Industry Representatives in attendance at SA public hospitals/health services

Industry representatives may attend SA public hospitals/health services by appointment only and must familiarise themselves with and abide by all hospital/health service policies, including the Directive on Interaction between SA Health and the Therapeutic Goods Industry (PDF 180KB).

In addition, Industry representatives attending SA public hospitals/health services must register with the hospital/health service and wear authorised identification and a ‘Visitors’ identification badge at all times. Details of how to obtain a visitor badge are below:

Central Adelaide Local Health Network

Representatives are required to report to the Main Entrance, produce identification and sign-in. They are then issued with a visitor’s badge. Specific locations are:

  • Royal Adelaide Hospital (RAH)  - Main Entrance (Admission Centre)
  • The Queen Elizabeth Hospital (TQEH) - Main Entrance (Reception)
  • Hampstead Rehabilitation Centre (HRC) - Main Entrance (Reception)
  • St Margaret's Rehabilitation Hospital (SMRH) - Main Entrance (Reception).

Women’s and Children’s Health Network

Representatives are required to report to the Security Office to sign in and collect a visitors badge. First time visitors to the WCH from the Pharmaceutical Goods Industry must then report to the Pharmacy Administration Office where they will need to identify themselves, the company they represent, and the product they are promoting.

Southern Adelaide Local Health Network

Visiting industry representatives are required to present to the specified location of the hospital to sign the Visitor Register and collect a visitor badge prior to attending any appointments with hospital staff.

  • Repatriation General Hospital (RGH): Reception Area, Block A (Clock Tower)
  • Flinders Medical Centre (FMC): Interpreter Coordinator Office, Northern Entrance
  • Noarlunga Hospital (NH): Enquiries Desk, Main Entrance.

Industry representatives must:

  • provide their name, contact phone number, company details, reason for attending the site, onsite staff contact and intended duration of visit on the Visitor Register
  • wear the provided visitor badge in a prominent place for the entirety of their visit to the site
  • establish directions to the appointment area in advance of the day, as staff overseeing the sign in/out register are not responsible for guiding or directing industry representatives to their appointments
  • return to the Visitor Register area at the conclusion of the appointment to return the visitor badge and sign out.

Other hospitals/health services

Details of how to obtain a visitor badge should be sought from the relevant hospital/health service as processes vary between sites.

SA Health Pharmaceutical Industry Forum

An SA Health forum for members of the pharmaceutical industry was held on 17 March 2014 at the UniSA City East Campus. The forum was facilitated by the South Australian Medicines Advisory Committee (SAMAC) and covered topics relating to medicines governance in SA Health, including:

  • interactions between pharmaceutical companies and SA Health
  • SA Medicines Formulary
  • SA High Cost Medicines Formulary
  • quality use of medicines

The presentation (PDF 119KB) is available for members of the pharmaceutical industry.

FAQ for staff

Fact sheet for staff (PDF 275KB)

When prescribing a medicine or treatment for a patient, your choice of therapy should be based solely on the medical interests of the patient. You should avoid accepting any inducement that may compromise, or that may be regarded as likely to compromise, your independent professional judgment relating to patients’ management.

What is the Therapeutic Goods Industry (Industry)?

Organisations supplying medicines, medical devices and other therapeutic goods are referred to as the Therapeutic Goods Industry (Industry).

What is a conflict of interest?

A conflict of interest is a situation where a conflict arises between a professional duty (eg duty of care to the patient) and a private interest which could influence the performance of professional duties and responsibilities (eg treatment choice).

It is sometimes the perception of a conflict of interest that may be important, whether or not such conflict actually exists, as such perceptions adversely affect relationships within and outside the organisation. For example, when a physician accepts a gift for personal use, no matter how small, it represents a conflict of interest, whether or not the physician’s judgment is affected.

All conflicts and potential conflicts relating to financial interests in Industry by you or your close family members (that you area aware of) must be declared in writing to the hospital/health service CEO or their delegate. Interests must also be declared on occasions where they may form a conflict (eg to the patient with whom the product is to be used).

Can I accept funding and payments from Industry?

Any funding or sponsorships from Industry must be provided into a special purpose fund account and only be used for approved corporate
purposes (eg support of professional visitors, research fellowships, staff continuing education or other such purposes)
and must also be declared.

You may only accept payments for your time and expertise (eg for participation in research or acting as an Industry consultant) at fair market value for the service provided. You are encouraged to pay any honoraria into a special purpose fund account managed by the hospital/health service or affiliated university and not receive these as personal payments.

What do I need to declare?

You must declare all payments and sponsorship from Industry (eg sponsorship for research or education).

Can I accept gifts from Industry?

You must not accept any gifts offered directly to you by Industry as the evidence is clear: gifts, even small ones, change behaviour. Even small gifts such as pens or calendars are designed to foster familiarity and comfort with the medicines or devices.

Can I accept gifts and payments if I don’t let them influence my judgement?

Most health professionals believe that their judgement is not affected by incentives such as gifts and sponsorships, however all incentives are designed to foster preference for a particular product or brand and are likely to influence professional judgement.

Am I able to arrange a meeting or event which is sponsored by Industry?

Industry sponsored events are not encouraged. However, if Industry sponsored events are held on any SA Health premises or in association with any SA Health entity, they must be arranged in consultation with the relevant CEO or Delegate. These events must not provide public opportunities for industry to promote their products.

Can I accept donations of equipment?

Donations may only be made to the hospital/health service and not to individual staff members.

Donations of equipment must be subject to evidence of safety, efficacy and cost-effectiveness and identified clinical need. All negotiations regarding donations must be undertaken by an approved negotiator.

Can I accept Travel Sponsorship from Industry?

You may only accept travel sponsored by Industry if it is related to the need for research and/or educational activities related to your professional speciality.

All travel must be in accordance with relevant SA Health travel policies and Industry Codes including provisions regarding acceptable standards of travel and accommodation.

Does this policy apply to gifts, payments and sponsorships accepted when I am not at SA Health?

Incentives provided to you outside of SA Health working hours are equally likely to influence professional judgement as incentives provided during working hours. Thus, all SA Health employees, regardless of hours worked, must abide by the requirements of SA Health policy on Interaction between SA Health and the Therapeutic Goods Industry.

What do I need to be aware of if I am participating in Industry sponsored research?

All research projects and clinical trials, including those sponsored by industry require Human Research Ethics Committee (HREC) approval and must adhere to HREC guidelines.

Funds must be deposited into a special purpose fund account and may only be used for direct costs associated with this research as specified in a formal contract.

Payments to staff members must be within award regulations for the time and expertise of the staff involved.

Am I allowed to act as an Industry consultant?

You must obtain approval prior to engaging in any outside employment in accordance with the SA Health (Health Care Act) Human Resources Manual or Public Sector Act 2009 (SA), whichever is applicable. This includes acting as an Industry consultant. Any potential Conflict of Interest must openly be declared as a potential conflict in any relevant forum.

Can I accept Medicines Samples?

The acceptance of samples by prescribers within SA Health is not permitted in accordance with SA Health policy on Samples (Product Starter Packs).

Samples may only be provided to the pharmacy department with the approval of the Director of Pharmacy if the medicine has been approved by the hospital’s Drug and Therapeutics Committee.

Samples should not be kept in clinics, patient care areas or elsewhere in the hospital for direct supply to hospital patients.

Can I commence SA Health patients on Product Familiarisation Programs or Expanded Access Programs?

You may only commence SA Health patients on a Product Familiarisation or Expanded Access Program in accordance with the SA Health policy on Medicines Access Programs.

Are industry representatives allowed to visit SA public hospitals and health services?

Industry representatives may attend SA public hospitals/health services by appointment only and must register with the hospital/health service before contacting individual staff members.

Industry representatives attending SA public hospitals/health services must wear authorised identification and a ‘Visitors’ identification badge at all times and must familiarise themselves with and abide by all hospital/health service policies Industry representatives are not allowed to enter patient care areas.

Can I meet with Industry representatives?

You may meet with Industry representatives where the appointment does not interfere with your usual work or patient care.

If you are in your first three postgraduate years you must gain approval from your Head of Unit for any individual appointments with an Industry representative.

What should l do if another staff member breaches SA Health requirements for Interaction with Industry?

If you are aware that a breach has been committed by another member of staff, you are required to submit a complaint to your supervisor or to your CEO or their delegate.

How do I report a breach by an Industry representative?

If you are aware of a breach of policy on Interaction between SA Health and the Therapeutic Goods Industry you are required to submit a complaint to your CEO or their delegate. You must outline the details of the breach, the company and the name of the representative.

Where can I go for more information?

For more information on the interaction with Therapeutic Goods Industry, contact SA Health's South Australian Medicines Advisory Committee.

FAQ for industry

Frequently asked questions for industry (PDF 103KB)

Who is covered by this Directive?

All SA Health Staff and incorporated hospitals and health services. This includes all South Australian public hospitals and health services.

The Therapeutic Goods Industry (Industry) refers to all companies
involved in the supply, manufacture &/or promotion of medicines,
medical devices and other therapeutic goods.

If a healthcare professional works at a mix of public and private hospitals in SA, would they be considered staff for the purposes of this Directive?

Any healthcare professional who is employed by SA Health is considered staff for the purposes of the Directive, regardless of hours worked.

Some provisions relate to activities specifically within the hospital/health service and would not apply to private practice (e.g. sponsored meetings and events, donations of equipment, supply of medicines samples).

However, provisions relating to individual staff are applicable to all SA Health employees, regardless of when these activities take place (eg 10.6-Gifts to staff members, 10.7-Travel Sponsorship, 10.9-SA Health Staff Members Acting as Industry Consultants, 10.10- Financial Interests).

Can funding/payments be provided to SA Health staff or units?

Any funding or sponsorships from Industry must be provided into a SA Health special purpose fund account and only be used for approved corporate purposes (eg support of professional visitors, research fellowships, staff continuing education or other such purposes) and must also be declared.

Payments to staff may only be made for time and expertise (eg for participation in research or acting as an Industry consultant) at fair market value for the service provided.

Can gifts be provided to SA Health Staff from Industry (10.6)?

No. SA Health staff may not accept any gifts from Industry. This includes small gifts such as pens or calendars and educational items such as medical textbooks and anatomic models which are provided directly to staff members.

Can Industry Sponsor SA Health meetings or events (10.2)?

Industry sponsored events are not encouraged. However, if Industry sponsored events are held on any SA Health premises or in association with any SA Health entity, they must be arranged in consultation with the relevant CEO or Delegate. These events must not provide public opportunities for industry to promote their products.

What is an Industry sponsored meeting or event (10.2)?

This provision relates to any Industry events conducted at SA Health sites as well as hospital-run meetings or events which include any sponsorship/funding from Industry.

Who should obtain approval for an Industry sponsored meeting or event (10.2.1)?

The SA Health staff member/unit arranging the funding should also arrange the approval. The Industry sponsor would be required to provide details of the event.

What is an Industry sponsored lunch or meal during working hours (10.2.3)?

This provision includes specific meals as well as the provision of any food or refreshments at any meetings, journal clubs, grand rounds, educational events, inservices (day-to-day product training), etc held during working
hours, including the provision of meals such as breakfast or lunch
that coincide with a break in the work day or immediately
before/after work. 

This would not apply to the provision of modest refreshment as part of the approved program of allday training sessions. 

What are “public opportunities to promote products” (10.2.2)?

Public opportunities to promote products include the promotion of products at any forum which is attended by clinical staff and/or external participants.

Is there a process for inviting SA Health staff to Industry sponsored educational events (10.2 & 10.7)?

There is no official process at this stage; however it is requested that any invitations are only sent for Industry sponsored educational events which comply with the Directive (eg no offers of
sponsorship for attendance only).

Can travel sponsorship be provided to SA Health employees for attendance at a conference for educational purposes?

Sponsorship may only be provided for active participation at a conference such as presentation or for research activities. Professional
development funding can be used to support educational activities
designed to improve patient outcomes, QUM principles, etc.

All travel must be in accordance with relevant SA Health travel policies and Industry Codes including provisions regarding acceptable standards of travel and accommodation.

Does the provision relating to ‘donations of equipment’ (10.8) apply to trials &/or samples of equipment?

Donations of equipment samples/trials must be subject to evidence of safety, efficacy and cost-effectiveness and identified clinical need. All negotiations regarding donations must be undertaken by an approved negotiator.

Donations may only be made to the hospital/health service and not to
individual staff members.

What are the requirements regarding industry representatives attending SA public hospitals and health services?

Industry representatives may attend SA public hospitals/health services by appointment only and must familiarise themselves with and abide by all hospital/health service policies. Industry representatives are not permitted to enter patient care areas (unless as specified under section 11.2.

In addition, Industry representatives attending SA public hospitals/health services must register with the hospital/health service and wear authorised identification and a ‘Visitors’ identification badge at all times. Details of how to obtain a visitor badge should be sought from the relevant hospital/health service as processes vary between sites.

Is there a process companies should be aware of before engaging SA healthcare professionals as consultants (10.9)?

It is the responsibility of SA Health employees to obtain appropriate management approval prior to engaging in any outside employment, including acting as an Industry consultant.

Where can I obtain a visitor’s badge?

The exact location to obtain a visitor’s badge varies between sites. Visitors’ badges are generally obtained at the engineering & building services reception (or similar) or at the security desk if out of hours access is required. Visitors’ badges may be obtained at the front reception desk I hospitals without an engineering & building services reception.

Can I meet with SA Health Staff?

Industry representatives must register with the hospital/health service before contacting individual staff members (ie arrangement with the relevant superior).

Appointments must not interfere with usual work or patient care.

How can patient consent be obtained for participation in a hospital procedure (11.1.1 i)?

Patient consent for attendance in theatre can be obtained by the surgeon/hospital via usual patient consent process.

How can Industry representatives obtain approval to attend surgical procedures?

For industry representatives to attend surgical procedures, they must first submit a document containing a brief outline of the service they would be providing, their background and expertise for providing the service, and the endorsement of the surgeon who will be performing the procedure. This document will require approval by the Director of Surgical Services and/or General Manager of the Hospital/Health Service. 

Will approval to attend surgical procedures be provided on a blanket basis or is approval required for every procedure (11.1.1 ii)?

Approval for representatives to routinely attend surgical procedures may be granted by the Director of Surgical Services &/or General Manager for a specific service to be provided at that hospital/health service. If any aspects of the approval change (eg service to be provided, surgeon responsible for the procedure &/or location) then a new approval would be required.

What should I do if I am aware of a breach of the Directive?

It is recommended that you report the breach to the relevant hospital/health service CEO or their delegate.

Where can I go for more information?

For more information on the interaction with Therapeutic Goods Industry, contact SA Health's South Australian Medicines Advisory Committee.

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