Industry Code

Code Certification is a means by which members of Pathology Technology Australia demonstrate their commitment to the Code of Conduct. The certification form should be completed by the CEO, Divisional Manager or other senior company representative. This list of questions will help you to complete the Program. The Code is supervised by a Board appointed Code of Conduct Commissioner, who is an independent, non-member expert with strong experience in healthcare, especially in in vitro diagnostics.

Download the current Code of Conduct here

BEFORE YOU START

Some companies, particularly larger multinational companies, have internal Codes which may have provisions that are stricter than the Pathology Technology Australia Code. Companies with existing stronger codes that include mandatory training and certification provisions will be accepted without the need for further training. However, if your company code has provisions that are less stringent than the Pathology Technology Australia Code, then the stricter code will apply. In which case members will need to certify that staff have been trained and follow the PTA Code of Conduct. Where there is doubt, the Code Commissioner will assess member’s Codes and adjudicate on the need for PTA certification.

A training presentation is available on request. Please email ea@pathologytechnology.org.au if you would like copy.

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CAN YOU ANSWER “YES” TO THE FOLLOWING QUESTIONS?

Are you a Member of Pathology Technology Australia?

Have you read the Code? Do you understand how it applies to your company’s business practices?
If you have any questions about the Code, you should

Read the FAQs
Contact the Pathology Technology Australia Secretariat for guidance

Do you require all officers, employees and representatives of your company to abide by the Code of Conduct?

Is there a link on your company’s Australian website to enable site visitors to view or download the Code?

Not applicable if your company does not have an Australian website.

Does your company have procedures in place to ensure Code compliance?

Examples include a “sign-off” procedure for all new promotional activities, policies to cover the amount of expenditure permitted for entertaining and/or restrictions on the venues to be used for educational activities.

Have you appointed someone within your company to be responsible for monitoring your company’s Code compliance?

This may be the CEO, Divisional Manager, Regulatory Affairs Manager or other senior personnel.

Have you provided Code training to all those employees who may be engaged in Code related activities (eg sales & marketing personnel, representatives)?

You can access the training presentation here, to run at your next sales meeting.

Do you have policies in place for policing your company’s compliance with the Code?

Do your employees know who to ask if they have questions about the Code?
Do they know how to report suspected breaches of Company policies that are based on the Code?
Do you have a process in place for responding to suspected breaches of Company policies that are based on the Code?

If you can answer YES to all these questions, you are ready to complete the Code Certification Form. Please DOWNLOAD and complete the form, then return it to Pathology Technology Australia by email or mail. Your Certificate and Code Logo will be emailed to you and should be displayed prominently to signify your status as a Code Compliant Company (eg: in your Reception area, in your booth at trade displays).

THANK YOU FOR YOUR COMMITMENT TO PATHOLOGY TECHNOLOGY INDUSTRY CODE OF CONDUCT

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FREQUENTLY ASKED QUESTIONS - CODE CERTIFICATION PROGRAM

Does my Company need to be a Member of Pathology Technology Australia to be Code Certified?

What does the Certification require?

The Certification requires companies to self-certify that they have adopted the Pathology Technology Industry Code of Conduct and implemented the elements of an effective compliance program. Companies with strong Codes, training and certification can obtain PTA certification without the need for further intervention. Companies with weaker Codes must ensure training and understanding of the PTA Code with their staff. Where there is doubt as to the strength of a member Code, the Code Commissioner with adjudicate

Are Pathology Technology Australia Members required to certify adoption?

Who must execute the Certification?

How often must my company complete the Certification?

Is there a standard set of attributes that constitute an effective compliance program?

A company’s compliance program should be appropriately tailored, meaning it will take into account the company’s size, resources, workforce and nature of the business. The Certification form sets out the basic elements of a compliance program, such as nominating an individual responsible for compliance, training staff and establishing mechanisms for identifying and addressing suspected violations of the Code.

My company has an internal Code which we must comply with. Do we still have to comply with the Pathology Technology Australia Code?

Pathology Technology Australia understands that some companies, particularly larger multinational companies, have internal Codes which may be significantly more onerous that the Pathology Technology Industry Code. The Code states that it “…is not intended … to override the provisions of any internal code, should that mandate a higher level of performance or a stricter code of behaviour.” Therefore, companies that are bound by an internal code that is stricter than the Pathology Technology Industry Code should have no difficulty in meeting the requirements of the Program for certification. Where there is doubt about the strength of a member Code, the Code Commissioner will adjudicate.

The Code and Vendor Credentialling

The current Code revision is including further reference to Vendor Credentialing in the expectation of a growing requirement for Venders to certify the bona fides of their staff visiting healthcare facilities. Vendor Credentialing in Healthcare will require demonstrable compliance with AS 5182:2018. Our Code of Conduct will include reference to this standard. Our expectation is that when members sign up to the Code, they also sign up to AS 5182:2018 and meet the requirements of the healthcare facilities that mandate this.

FREQUENTLY ASKED QUESTIONS - GENERAL

Could you please clarify for me the Pathology Technology Australia regulations on giveaways at conferences.

For an upcoming conference, the event is having daily prize draws. Customers win these by coming to the booth and answering a question correctly. We are planning to give away iPads as the daily prize and other companies are doing similar. Is this allowed? Also, traditionally we give away branded pens and other items (like all companies do)...

There are two clauses in the Pathology Technology Australia Code of Conduct that are applicable here – 7.6 and 7.10
7.6 Gifts
Members may occasionally provide:
a.     Modest gifts to healthcare professionals but these must be of an educational nature only;
b.     Company or Branded promotional items of minimal value (eg notepads and pens) at Trade Displays or Educational and Training Events;
c.     Provision of items that may be used for both educational and non-educational purposes must not be provided directly to healthcare professionals, but must be provided to the healthcare professional's department or institute clearly stating their educational use. This type of gifting must be fully documented.
Gifts must not be in the form of cash or monetary equivalents.
The provision of product samples is not considered to be a gift and the provision of reasonable sample product or demonstration product for evaluation purposes is deemed to be an appropriate activity.

7.10 Competitions
Members may conduct competitions for Healthcare professionals directly or through a third party that comply with the following provisions:
a.     The competition must be based entirely on medical or other specialist healthcare knowledge or on the acquisition of such knowledge;
b.     All competition prizes must be directly relevant to the practice of medicine or other specialist field of healthcare and be of minimal monetary value or be an item of an educational nature;
c.     Entry to the competition must not be dependent on the ordering, recommendation, use, testing, purchase, sale or prescribing of a product; and
d.     The conduct of the competition must comply in all respects with all relevant laws and regulations

With regard to an iPad as a prize, it could be argued that, it could be used for practice and/or is of an educational nature. You should document the person to whom the prize was awarded. The question to be answered must be relevant to pathology/medicine (medical or other specialist healthcare knowledge or on the acquisition of such knowledge), it must not be about your company.
With regard to pens and other promotional items, if they are of minimal monetary value, there is no issue.

Making a complaint
Pathology Technology Australia recognises a just, accessible complaints mechanism is crucial to sustaining the integrity of the Code. The Code complaints process can be used by Pathology Technology Australia members, healthcare professionals, consumers, industry and other organisations.
Pathology Technology Australia encourages making initial contact with the company. If you are unable to lodge a complaint, please contact Pathology Technology Australia where support and advice will be given in the preparation and consideration of your complaint.
A complaint be must made in writing and should be addressed to the Code of Conduct Commissioner and sent to the secretariat at Pathology Technology Australia. resolve a matter with a member directly and wish to lodge a complaint please contact Pathology Technology Australia where support and advice will be given in the preparation and consideration of your complaint.
A complaint be must made in writing and should be addressed to the Secretariat of the Code Complaints Committee. Complaints shall outline the issues of the non-compliance with the Code and include relevant supporting documentation.

The Pathology Technology Industry Code of Practice can be downloaded here.

If you need help with a complaint, please contact us.

How to Complain about other Medical Supply Industries

Who to contact to complain about an advertisement or the conduct of a company supplying therapeutic products

The therapeutic goods industry associations each have a self-regulatory Code of Conduct or Code of Practice which sets the standards for companies when promoting a medicine or medical technology. The Codes of Practice include mechanisms for dealing with complaints about advertising and other conduct by companies. In addition there is a complaints process that deals with complaints about certain types of advertising about ALL types of therapeutic goods where the advertising appears in the mainstream media (such as TV and radio).

The therapeutic goods industry is broadly organised around the types of products its member companies supply:

Prescribed medicines (medicines that you can only get with a prescription). This sector includes both companies that are researching new medicines (innovator companies) and companies that are supplying generic medicines once all valid patents have expired

Non-prescription consumer healthcare products (including medicines you can get from a pharmacy without a script and those you can buy in a supermarket)

Complementary medicines and natural healthcare products (including vitamins, mineral and nutritional supplements, special purpose foods, herbal and homoeopathic medicines, aromatherapy products and natural cosmetics)

Medical technology (such as syringes and wound dressings, as well as high-technology implanted devices such as pacemakers, defibrillators, hip and other orthopaedic implants)

In vitro diagnostics (instruments and test reagents for pathology tests requested by doctors as well as over-the-counter tests such as blood glucose meters for diabetes testing or home pregnancy test kits).

If you would like to make a complaint about an advertisement or any other conduct by a company you will find further information about how to lodge your complaint and what you can expect from the complaints process on the websites listed below.

Where you should go to make your complaint will depend on the type of product involved and, if your complaint is about an advertisement, where you saw or heard the advertisement.

First, if your complaint is about an advertisement, where did you see or hear the advertisement? The Therapeutic Goods Administration (TGA) deals with complaints about advertisements for any therapeutic product directed to consumers in TV, radio, the internet, newspapers, magazines, displays (except inside individual shops) and in cinemas. The TGA mailbox for complaints can be found here.

Or you can discuss your concerns with the CEO at Pathology Technology Australia who, if appropriate can lodge a complaint on behalf of the members.

If your complaint is about an advertisement not covered by the TGA or is about the conduct of a particular company, you need to consider what type of product the advertisement or conduct relates to referring to the general grouping of products listed above. Your complaint can be directed to the relevant industry associations under its self-regulatory Code of Practice. If you are unsure where to go, any of the industry associations listed here will be happy to guide you to the most appropriate person to contact. Alternatively you can discuss your concerns with the CEO at Pathology Technology Australia who, if appropriate can lodge a complaint on behalf of the members

JOIN US NOW

Join PTA to get these benefits:

Consultation with TGA on the IVD Framework
Networking opportunities for you and your staff
A voice for Australian manufacturers and independent distributors
A means of influencing the development of the IVD industry in Australia

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Therapeutic product Industry Association Website Contact details

Prescribed Medicines – Innovator medicines
Medicines Australia
Medicines Australia Code
Telephone - 02 6122 8500
Email - codesecretary@medicinesaustralia.com.au

Prescribed Medicines - Generic Medicines
Generic Medicines Industry Association
Generic Medicines Code
Email - code@gmia.com.au

Non-prescription consumer healthcare products
Australian Self Medication Industry
ASMI Code
Telephone - 02 9922 5111

Complementary Medicines and Natural Healthcare Products
Complementary Medicines Australia
CMA Code
Telephone - 02 6260 4022
Email - karen.hocking@cmaustralia.org.au

Medical Technology and Devices
Medical Technology Association of Australia
MTAA Code
Telephone - (02) 9900 0650
Email - code@mtaa.org.au
In-vitro Diagnostics

Pathology Technology Australia
Pathology Technology Industry Code
Email - ea@pathologytechnology.org.au

Dental Products (Medical Devices)
Australian Dental Industry Association
ADIA Code
Telephone - 1300 943 094