IVD Australia

pageImage-microscopePipette.jpg

Code FAQs

Frequently Asked Questions - GENERAL

 

Could you please clarify for me the IVD 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 IVD 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.

Hope this helps, if not, let us know ea(at)ivd.org.au.



Frequently Asked Questions - CODE CERTIFICATION PROGRAM

Q: What does the Certification require?

A: The Certification requires companies to self-certify that they have adopted the IVD Australia Code of Conduct and implemented the elements of an effective compliance program.

 

Q: Are IVD Australia Members required to certify adoption?

A: Compliance with the Code is a requirement of membership of IVD Australia. Therefore while the Code Certification Program is not mandatory, members are strongly encouraged to adopt the Program to confirm their commitment to effective self-regulation.

 

Q: Who must execute the Certification?

A: The nominated IVD Australia Member Representative of the company seeking Certification must sign and date the form.

 

Q: How often must my company complete the Certification?

A: The certification must be renewed annually.  Annual renewal is an opportunity to reconfirm your adherence to the Code.

 

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

A: 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.   

 

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

A: IVD Australia understands that some companies, particularly larger multinational companies, have internal Codes which may be significantly more onerous that the IVD Australia 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 IVD Australia Code should have no difficulty in meeting the requirements of the Program.