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Frequently Asked Questions

WHO REGULATES MEDICINE ADVERTISING IN AUSTRALIA?

 

 QUESTIONS RELATING TO SPECIFIC SECTIONS OF THE CODE

WHO REGULATES MEDICINE ADVERTISING IN AUSTRALIA?
What are the government regulations relating to advertising medicines?

Information on the regulation of medicines in Australia is available from the TGA website: http://www.tga.gov.au/docs/html/advreg.htm

 

Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989 ("the Act") and Regulations, the Trade Practices Act 1974 and other relevant laws. Additionally, advertisements directed to consumers for therapeutic goods must comply with the Therapeutic Goods Advertising Code (TGAC).

Prescription only medicines

  • Advertising directly to consumers is not permitted (prohibited by the Act).
  • Advertising to healthcare professionals is permitted and is regulated by a self-regulatory Code administered by Medicines Australia.
  • Prior approval of advertisements is not required.
  • Complaints about advertisements for prescription medicines directed to healthcare professionals are referred by Medicines Australia to the independent Code of Conduct Committee
  • TGA's marketing approval letter requires the promotion of all prescription products (whether by a Medicines Australia member or non-member) to comply with the requirements of the Medicines Australia Code of Conduct
  • If a complaint is made about the advertising activities of a non-member company, the complaint is forwarded to the non-member with an invitation to have the complaint adjudicated by the Medicines Australia Code of Conduct Committee. If the non-member declines the invitation for adjudication, the Medicines Australia may forward the complaint to the Therapeutic Goods Administration (TGA) or the Australian Competition and Consumer Commission.
  • Where it has been determined that a breach of the Code has occurred, the Committee may impose a range of sanctions, depending on the nature of the breach.   These sanctions may include fines, corrective statements and the withdrawal of the materials found in breach.   

Non-prescription medicines

  • Non-prescription medicines include over-the-counter (OTC) medicines and complementary medicines. 
  • Generally, advertisements for non-prescription medicines may be directed both to consumers and to healthcare professionals. However, the Regulations also prohibit the advertising to consumers of certain medicines included in Schedule 3 of the Standard for the Uniform Scheduling of Drugs and Poisons (pharmacist only medicines).
  • Advertisements for non-prescription medicines are regulated by both co-regulatory and self-regulatory arrangements operated by the TGA, the Therapeutic Goods Advertising Code Council, the Australian Self-Medication Industry (ASMI) and the Complementary Healthcare Council (CHC).
  • Certain types of advertisements directed to consumers require prior approval by a Delegate of the Secretary of the Department of Health and Ageing.
 What is the Medicines Australia Code of Conduct?

The Code of Conduct sets the standards for the ethical marketing and promotion of prescription medicines in Australia. It complements the legislative requirements of the Therapeutic Goods Regulations. 

The Code provisions include standards for appropriate advertising, the behaviour of medical and company representatives and relationships with healthcare professionals and the general public.

The Code was established in 1960 and has been revised on a regular basis.

The current Code of Conduct Edition 15 and the supporting Code of Conduct Guidelines can be found on this website.

 
Does the Medicines Australia Code of Conduct apply to the promotion and marketing of generic medicines?

The Code applies to all pharmaceutical companies marketing prescription medicines in Australia, whether a Medicines Australia member or non member company.

Adherence to the Code of Conduct is a condition of marketing approval for all pharmaceutical companies.

 
Does the Medicines Australia Code apply to over the counter, pharmacy only or complementary medicines?

Non prescription medicines are not covered by the Medicines Australia Code.  Advertisements for non-prescription medicines are regulated by both co-regulatory and self-regulatory arrangements operated by the TGA, the Therapeutic Goods Advertising Code Council, the Australian Self-Medication Industry (ASMI) and the Complementary Healthcare Council (CHC).


Does the Medicines Australia Code of Conduct cover price lists that pharmacists may produce?

The Code does not apply to pharmacists publishing a list of medicines and their prices.

The TGA has intorduced a Pricing Code which will remain in place on a voluntary basis until it is given legal underpinning through legislation developed as part of the Australian New Zealand Therapeutic Products Authority, to be implemented in full at the commencement of the joint regulatory scheme.

For further information please refer to the Code which can be found at http://www.tga.gov.au/meds/vipicop.htm


What sort of standing does the Medicines Australia Code of Conduct have?

The Code is recognised by the Commonwealth Department of Health and Ageing, including the Therapeutic Goods Administration (TGA) which is the regulator of medicines in Australia, as appropriate standards for marketing and promotion by the prescription medicines industry. The TGA supports the long-established system of self regulation as being consistent with and supporting the Therapeutic Goods Regulations.


How does the Medicines Australia Code of Conduct work?

The Code has two arms, firstly the adjudication of complaints which is undertaken by the Code of Conduct Committee and secondly the proactive monitoring of promotional activities undertaken by the Monitoring Committee.


How can a complaint be lodged with Medicines Australia?

If you have any concerns in relation to the marketing activities of a prescription medicine company you may contact Medicines Australia in a variety of ways for assistance or to obtain a copy of the Complaints Submission Form.

Phone: Secretary, Code of Conduct Committee
              02 6282 6888
              Monday – Friday 9.00am – 5.00pm

Email:  secretarycodecommittee@medicinesaustralia.com.au

Online: A Complaints Submission Form can be downloaded as a PDF document, completed and faxed or mailed to Medicines Australia. 

For further information about making complaints please refer the document ‘Lodging and responding to a Code of Conduct Complaint.'

Section 11 and Appendix 1 of the Code also contain information about the complaints process.


How are complaints adjudicated?

Complaints are adjudicated by an independent Code of Conduct Committee.

Committee membership

Full members

  • Chairman, lawyer with Trade Practices experience
  • Representative from the Australian Medical Association (AMA)
  • Representative from the Australian Network of General Practitioners (ANGP) (formerly the Australian Divisions of General Practitioners (ADGP))
  • Representative from the Royal Australian College of General Practitioners (RACGP)
  • Representative from the Royal Australian College of Physicians (RACP)
  • Representative from the Australian Society of Clinical, Experimental Pharmacologists and Toxicologists (ASCEPT)
  • Representative from the Consumers’ Health Forum of Australia (CHF)
  • Representative from the Therapeutic Goods Administration (TGA)
  • Three Medicines Australia Association Representatives
  • Two Medicines Australia Medical or Scientific Directors

Observers

  • Two employees of Medicines Australia member companies
  • One observer nominated by Medicines Australia

No member of the Committee (full member or observer) may have a conflict of interest with either the therapeutic class of a medicine subject to complaint; or the complainant or Subject Company.

For further information please refer to Section 11 and Appendix 1 of the Code.

 

What does the Code of Conduct Committee do?

Complaints regarding promotional activities are accepted from any individual or organisation. Assistance can be provided to those individuals who are unsure of how to lodge a complaint or what a complaint should contain.

 

Complaints cannot be accepted from anonymous sources.  If an individual complainants request that their name be withheld from the pharmaceutical company, this request will be complied with. The complainant’s name will remain confidential to the members of the Medicines Australia Secretariat responsible for administering the Code of Conduct.

 

Intercompany complaints must show evidence of intercompany dialogue prior to their acceptance by the Code of Conduct Committee.

 

Once a complaint is received it is sent to the company whose promotional activities are being questioned (Subject Company) and this company is requested to provide a response to the issues raised in the complaint.

 

A company found in breach of the Code may lodge an appeal against the decision of the Code of Conduct Committee and this appeal will be heard by the independent Code Appeals Committee.

 

For further information please refer to Sections 11, 12, 13 and Appendix 1 of the Code.

Who can lodge an appeal?

Either the complainant or the Subject Company can lodge an appeal against the findings of the Code of Conduct Committee.


What does the Appeals Committee do?

The Appeals Committee has a different membership to that of the Code of Conduct Committee.

 

Committee Membership

  • Chairman, lawyer with Trade Practices experience
  • Representative from the target audience to which the activity was directed eg. AMA, RACGP, ANGP
  • Representative from the College and/or Society from the therapeutic class of the product subject to appeal
  • Representative from the Australian Society of Clinical, Experimental Pharmacologists and Toxicologists (ASCEPT)
  • Representative from the Australian Consumers' Health Forum (CHF)
  • Two Medicines Australia Association Representatives
  • One Medicines Australia Medical or Scientific Directors
 

A Subject Company must lodge a bond of $20,000 to submit an appeal.  There is no fee for a non industry appellant.

 

The Appeals Committee considers all written documentation in relation to the complaint and appeal in addition to oral presentations from the complainant and Subject Company.

The decision of the Appeals Committee is final.  There are no other avenues of appeal.

 

For further information please refer to Section 13 of the Code.


What type of sanctions can be imposed by the Code of Conduct or Appeals Committees?

The Code of Conduct contains a variety of sanctions for promotional activities found to be in breach of the Code. These sanctions include the immediate withdrawal or cessation of the promotional activity, the publication of corrective advertising, corrective letters to GPs, specialists or pharmacists, fines up to $200,000 and suspension and expulsion from Medicines Australia membership.

For further information please refer to Section 12 of the Code.


Are the outcomes of the Code of Conduct and Appeals Committee meetings made public?

Medicines Australia publishes an annual report on all complaints received during the year on the Medicines Australia website. In addition quarterly reports on all finalised complaints are also made available on the website.

 

Information about complaints where the activity was directed towards the general public are published on the Medicines Australia website within one month of the finalisation of the complaint.


What does the Monitoring Committee do?

The Monitoring Committee reviews promotional material to ensure compliance with the provisions of the Code, provides relevant advice on current marketing practices and trends to Medicines Australia and, if deemed necessary, will submit any complaint as a result of its findings to the Code of Conduct Committee.

The Monitoring Committee meets once a month to review promotional material submitted by companies.

Medicines Australia member companies are required to submit to the Monitoring Committee selected types of promotional materials used during a three month period for the therapeutic class under review.  For example, one month the Committee might review all printed promotional material in the cardiovascular therapeutic class, the following month all company websites (not therapeutic class specific), and the next invitations to company-sponsored educational meetings (not therapeutic class specific).


Committee Membership

Permanent Membership

  • Chairman, consultant with industry experience in marketing and knowledge of the Code of Conduct
  • Representative from the Australian Medical Association (AMA)
  • Representative from the Royal Australian College of General Practitioners (RACGP)
  • Representative from the Australian Consumers' Health Forum (CHF)

 Rotating Membership

  • Representative from the College and/or Society from the therapeutic class subject to review
  • One Medicines Australia Marketing Director
  • One Medicines Australia Medical or Scientific Directors

How do I find out more about the Medicines Australia Code of Conduct?

The full text of the Code of Conduct is available from the Medicines Australia website. 

 

QUESTIONS ON SPECIFIC SECTIONS OF THE CODE
GENERAL PUBLIC
Can a pharmaceutical company provide information about prescription medicines to the general public?

The Therapeutics Goods Regulations (Commonwealth) prohibit the advertising of prescription medicines to the general public. The Code acknowledges this regulation and provides additional information on the type information that a pharmaceutical company can provide to members of the general public as long as it does not promote a particular medicine.

 

Items of patient education provided to consumers must be educational and must not be promotional or focus on a particular medicine.

 

Once a patient has been prescribed a prescription medicine they may be provided with patient support materials (such as a leaflet or brochure) that are specific to the medicine they have been prescribed. This material may include the name of the medicine and information which is designed to aid compliance, clarify the method of administration, precautions and any special instructions. This material must not be promotional or compare different medicines.

 

For further information please refer to Section 9 of the Code.


What information can be provided in a media release about a prescription medicine to the general public media?

A company may issue one media release advising members of the general public that a specific medicine has been approved for use in Australia or has been listed on the Pharmaceutical Benefits Scheme (PBS). The media release must be educational and must not promote particular medicines to the general public.

 

For further information please refer to Section 9 of the Code.


INTERNET
Can a pharmaceutical company provide information on the Internet about prescription medicines?

Companies may provide medically and scientifically valid information about medicines on websites, however the information must not promote prescription medicines to the general public.

 

A brief non-promotional summary of a company’s medicines available in Australia can be included on a company website.

 

Companies may provide information to patients already prescribed a prescription medicine via a password protected website.

 

Companies may provide information intended for healthcare professionals via the Internet, however if this information should be via password protected website.

 

For further information please refer to Sections 3 (healthcare professionals) and 9 (general public) of the Code.


HEALTHCARE PROFESSIONALS
Who are healthcare professionals?

Healthcare professionals are defined in the Code as members of the medical, dental, pharmacy or nursing professions and other persons who in the course of their professional activities may prescribe, supply or administer a medicine.


Does the Code apply to consultants and members of Advisory Boards?

Section 10 of the Code applies to how pharmaceutical companies should interact with healthcare professionals, including consultants and Advisory Board members. 

 

Companies must be able to demonstrate a legitimate need for forming an Advisory Board to provide advice on issues pertaining to a specific medicine.


GIFTS OR OFFERS TO HEALTHCARE PROFESSIONALS
What can a pharmaceutical company give to a healthcare professional?

It is acceptable for companies to offer or give the following items to healthcare professionals:

Brand name reminders (Section 3.12)
Items of token value that are relevant to the working environment of a healthcare professional. These items must not contain any promotional claims – medicine brand name and approved name only. Items such as pens, notepads, desk sets would be acceptable.  Items of sporting equipment such as golf balls are not acceptable.


Competitions (Section 3.13)
Competitions must test medical knowledge. Prizes must be directly relevant to the practice of medicine or pharmacy such as an item of medical equipment or education.

 

Involvement in educational symposia, congresses or meetings (Section 6)

The primary objective of these meetings must be the enhancement of medical knowledge and the quality use of medicines in Australia.

 

Sponsorship (Section 7)
Companies may sponsor healthcare professionals to attend educational symposia, congresses or meetings. No sponsorship should be conditional upon any obligation to prescribe a particular medicine.

 

Hospitality (Sections 6 and 10)
Any hospitality provided by companies either directly or indirectly by sponsorship or assistance to organizers of educational meetings, must be secondary to the educational purpose. Hospitality must be consistent with the professional standing of the audience, but meals should not be extravagant or exceed standards which would meet professional and community scrutiny.

 

Medical Education Material (Section 10)
Companies may provide items of medical education to healthcare professionals. This material should not include promotional claims.


Under the Code, may golf balls and sports bags be provided to healthcare professionals?

No items of sporting or recreational equipment can be provided to a healthcare professional. This includes brand name reminders or competition prizes.

 

For further information please refer to Section 3 of the Code.


Under the Code, may healthcare professionals be provided with petrol for their cars if they are provided with product information at the same time?

A pharmaceutical company could not supply a healthcare professional with petrol, irrespective of whether they are providing medical education or product information.

 

For further information please refer to Sections 4 and 10 of the Code.

 
Under the Code, may items such as stethoscopes be offered to healthcare professionals?

A stethoscope could be offered as a prize in a competition for healthcare professionals.  As stethoscopes are usually items of more than token value, they would not be acceptable as brand name reminders.

 

For further information please refer to Section 3 of the Code.


HOSPITALITY/ENTERTAINMENT
Does the Medicines Australia Code of Conduct allow for entertainment of healthcare professionals?

Interactions between pharmaceutical companies and healthcare professionals must not include entertainment such as attendance at the movies, theatre, sporting events etc.

 

Hospitality (provision of a meal) is not regarded as entertainment and cannot be provided to healthcare professionals unless it is associated with providing education. Hospitality must always be secondary to education and must not be extravagant.

 

For further information please refer to Sections 6 and 10 of the Code.

 

ADVERTISING TO HEALTHCARE PROFESSIONALS
What level of evidence does a pharmaceutical company need to support claims made about a prescription medicine?

It is fundamental that any claim about a prescription medicine must be consistent with the Australian Product Information, irrespective of the source on which the claim is based.

 

It is the responsibility of companies to ensure that the content of all material is current, accurate and balanced.

 

Evidence to support claims must be unequivocal and the highest quality and must not solely rely on sources such as abstracts or poster presentations.

 

For further information please refer to Section 1 of the Code.

 
Can a company publish promotional materials that appear to be independent editorial content?

Companies may publish advertorials but these must clearly identified as such and must include the name of the sponsoring company.


Does the Medicines Australia Code of Conduct allow for comparisons between different medicines to be included in promotional materials?

A company may compare medicines used to treat the same condition, for example, a comparison of different medicines to treat Alzheimer’s disease. However any comparison must be factual, fair and have a high level of evidence to support it and any claims made about the medicines. The comparison must not be misleading.  The Code expects a higher standard of evidence when comparing medicines.


Are there mandatory requirements for advertising and promotion of prescription medicines to healthcare professionals?

Section 3 of the Code outlines all the mandatory requirements for advertisements or items of printed promotional material.

 

These provisions state that an advertisement must include the:

  • Medicine brand name
  • Australian approved name
  • PBS disclosure information
  • PBS price
  • Company name and address
  • References supporting promotional claims
  • Product Information
  • A statement to review the Product Information before prescribing

SPONSORSHIP
Can a pharmaceutical company sponsor healthcare professionals and their family to attend educational and scientific meetings?

Companies may sponsor healthcare professionals to attend genuine educational meetings. Companies must not pay for partners or family members to travel with the healthcare professional.  Family members may travel with the healthcare professional, but at their own cost.

 

For further information please refer to Sections 6 and 7 of the Code.


Under the Code, may a company make a charitable contribution such as purchasing a table at a fundraising dinner or a foursome slot at a fundraising golf tournament?

If a company is asked to sponsor a golf day or take a table at a fundraising dinner which has been designed to raise funds for a hospital, it should begin by asking whether this is a bona fide charity, assuring itself that the reason for involvement is not promotional and that the activity could withstand public and professional scrutiny and conform to professional and community standards of ethics and good taste.  The company would then have to examine any benefits it might derive from this sponsorship and whether these are acceptable under the Code.  Discreet signage and recognition of the company name would be acceptable. However, for events that involve members of the general public, or where signage might be seen by members of the general public, the use of a product name would not be acceptable as it would be regarded as promotion to the general public. 

 

If the benefits offered to a company sponsor include a number of rounds of golf, these cannot be offered to members of the healthcare professions as this would contravene the requirement of the Code that prohibits the provision of entertainment to healthcare professionals.  Similarly, the company could not offer the seats at their table at a dinner to healthcare professionals, as this would be regarded as providing hospitality without any educational purpose.

 

For further information please refer to Sections 6 and 7 of the Code.


Does the Medicines Australia Code of Conduct cover sponsorship of healthcare professionals outside Australia?

The Code covers the sponsorship of healthcare professionals both in Australia and overseas where this is provided by the Australian company.  The Code does not apply to activities with Australian healthcare professionals initiated by, and under the control of, the company’s head office or affiliate in another country.  However, this should not be used by companies as a means of avoiding compliance with the Code.  Companies are expected to liaise with their head offices and other affiliates to ensure that any activities undertaken in Australia comply with Australian standards set by the Code of Conduct.


PRODUCT INFORMATION
What are the documents that detail all the information about a medicine approved for use in Australia?

In Australia the Therapeutic Goods Administration (TGA) approves a document known as the ‘Product Information’ (PI) at the time of registering a prescription medicine for use in Australia. Companies cannot promote outside the approved indications listed in the Product Information.

 

Patient information, known as a ‘Consumer Medicine Information’ (CMI), is prepared by the company based on the PI.  CMI is designed to inform consumers about prescription and pharmacist-only medicines. CMI leaflets are produced by the pharmaceutical company that makes the particular medicine. They may be provided by the pharmacist when the medicine is dispensed or sold, or may be included in the medicine package.  CMIs for most prescription medicines can always be requested from the pharmacist or doctor.

 

More information about CMIs can be found on the National Prescribing Service website at:  http://www.nps.org.au/site.php?content=/resources/content/cons_med_info.html


MEDICAL REPRESENTATIVES
Do medical and company representatives undergo any training?

The majority of medical representatives in Australia have a university degree in fields such as science, nursing, pharmacy and pharmacology.  It is also compulsory for all medical representatives to undertake the Medicines Australia endorsed education program. This program is undertaken through Health Insitu at the University of Queensland.


The program comprises of five online modules:

  • Code of Conduct
  • Pharmaceutical Industry
  • Pharmacology
  • Understanding the Product Information
  • Understanding the Clinical evidence

Further information on the education program can be found at http://www.ma.healthinsitu.uq.edu.au.


Can a medical representative provide food for the staff of a medical centre?

Hospitality may be provided to healthcare professionals in association with education. A medical representative may not provide food to non-healthcare professional medical centre staff.

 

For further information please refer to Sections 4, 6 and 10 of the Code.


Can a medical representative of a prescription medicine company invite physicians to hear a scientific and educational presentation about a new medicine at a café near a bookstore and then provide coffee, cake and a gift certificate for books to the amount of $30?

A medical representative may provide hospitality in association with education.  However it would not be appropriate to also provide them with gift vouchers to a book store.  This would be regarded as a gift that does not comply with the Code.

 

For further information please refer to Sections 3 and 10 of the Code.


Can a medical representative or company invite 30 physicians to a corporate suite at the Australia Open for a 45 minutes educational presentation followed by a buffet lunch and the afternoon at the tennis?

Companies cannot provide entertainment to healthcare professionals either in association with or without education. Entertainment includes sporting, cultural or leisure activities – tennis, golf, movies, theatre, opera, comedy shows.

 

For further information please refer to Sections 6 and 10 of the Code.


Can a medical representative invite a physician out for a round of golf and lunch following the golf?

Companies cannot provide entertainment to healthcare professionals either in association with or without education. Entertainment includes sporting, cultural or leisure activities – tennis, golf, movies, theatre, opera, comedy shows.

For further information please refer to Sections 6 and 10 of the Code.


Does the Code apply to interactions with practice managers, receptionists and other medical centre staff who are not healthcare professionals?

No gifts or services, including hospitality, can be offered or given to family members or employees of healthcare professionals.  Promotion of prescription medicines to the general public is prohibited by the therapeutic goods legislation and the Code.  Non-healthcare professional practice staff should not attend a meeting which includes any promotion of a prescription medicine.

 

Medical representatives are required to maintain a high standard of ethical conduct and professionalism with whomever they interact with in their daily work.

 

For further information please refer to Section 3 and 4 of the Code.


SAMPLES AND STARTER PACKS
Does the Code cover the use of samples or starter packs?

Under Commonwealth, State and Territory regulations companies may supply clinical samples or starter packs to healthcare professionals.  Starter packs may be supplied to healthcare professionals for the following reasons:

• Immediate use in surgery for relief of symptoms
• Use of alternative treatments prior to a prescription being written
• After hours use
• Gaining familiarisation with new products

 

Section 5 of the Code of Conduct includes provisions relating to the supply of starter packs.

 

A summary of current State and Territory regulations can be found on the Medicines Australia website at www.medicinesaustralia.com.au.


EDUCATIONAL MEETINGS
Under the Code, may a healthcare professional be provided with hospitality without education?

Hospitality cannot be provided to healthcare professionals without education. Hospitality must always be secondary to education and must not be extravagant.

For further information please refer to Sections 6 and 10 of the Code.


Can a company pay for travel or associated costs for the partner or family members of a healthcare professional attending an educational meeting?

Companies must not pay for travel costs or any other associated costs (eg meals) for the partner or family members of a healthcare professional attending an educational meeting

For further information please refer to Sections 6 and 10 of the Code.


Can a company sponsor a third party educational conference and meeting?

Companies may assist and make financial contributions to educational meetings organised by third parties and may sponsor the attendance of healthcare professionals at these meetings.

 

Companies may work with organisers and provide sponsorship to ensure third party educational meetings are a success and provide a forum for the dissemination of information that enhances the quality use of medicines.  However companies should be fully cognisant of the activities that their sponsorship is supporting and must critically examine these activities to ensure they:

  • enhance medical knowledge;
  • enhance the quality use of medicines;
  • do not bring discredit on the industry;
  • could successfully withstand public, professional and community scrutiny; and
  • conform to professional and community standards

A company may not sponsor a lavish dinner at a conference or educational meeting that includes entertainment such as a feature band or entertainer, even if the company has no control over the planning or conduct of the event.  However, it could sponsor a modest conference dinner at which a medically related keynote address was given.

 

For further information please refer to Sections 6 and 7 of the Code.


Does the Medicines Australia Code of Conduct cover reprints of scientific and medical articles?

The Code allows companies to provide healthcare professionals with copies of published studies, journal articles or proceedings of symposia about medicines approved for use in Australia.

 

Healthcare professionals can request and be provided with literature from pharmaceutical companies on medicines or indications for medicines not approved for use in Australia.  However, the company must not proactively offer information about unapproved medicines or unapproved uses of registered medicines.

 
Under the Code, may a company compensate a consultant for bona fide services by providing an item with a legitimate patient benefit in lieu of paying an honorarium or fee?

Any remuneration for services should not exceed that which is commensurate with the services provided.  A company could purchase an item for use in direct patient care in lieu of direct payment to the healthcare professional as long as the cost of the item was equivalent to the remuneration that would otherwise have been paid.


Does the Medicines Australia Code of Conduct cover the compassionate use of medicines?

The Code does not cover the supply of medicines under clinical trial or for compassionate use. The focus of the Code is on activities associated with marketing and promotion of approved prescription medicines. 

 

Guidance about supply of unapproved medicines may be found on the TGA website at http://www.tga.gov.au/unapp/index.htm.