Section 10: Appropriate Communications with Relevant Stakeholders

Communication with stakeholders who have a role in the research, development, registration, listing or monitoring of a therapeutic good is inherent in the National Medicines Policy and in the concept of the quality use of medicines. Companies are permitted to communicate proactively or reactively with relevant stakeholders, provided that discourse is limited to information that may assist the stakeholder in their role.¹

1. This communication is to be non-promotional and balanced in nature and is not to be made with the intention to inform patient-level prescribing, or any other clinical decision-making relevant to individual patients.²
2. This communication should only be conducted by appropriately qualified and selected Company personnel.
3. It is appropriate for Companies to solicit information to assist in understanding relevant aspects of the healthcare environment relating to their products.
4. Relevant stakeholders include (but are not limited to):
   1. Members of a government or relevant government agency:
      1. any therapeutic goods regulator;
      2. any therapeutic goods reimbursor;
      3. any business regulator (ACCC, ASIC, etc.);
      4. parliamentarians and their representatives.
   2. Patient organisations and patient advocacy groups;
   3. Healthcare professional organisations;
   4. Supply chain and distribution organisations;
   5. Current users of the product (patient/consumer) and their carers; and
   6. The media.

10.1 Relationship with the Consumer Media and Product-specific Media Statements

It is appropriate for Companies to meet the information needs of the general public by providing current, accurate and balanced information about prescription products approved for use in Australia. The purpose of interactions with consumer media must be to enhance the quality use of medicines by providing appropriate, non-promotional information that is relevant to the Australian public.

1. Media organisations are wholly independent entities not bound by the provisions of this Code. As a result, while companies cannot control the final output of media coverage, Companies are responsible for ensuring that all their interactions with consumer media, including by any third-party acting on their behalf, are consistent with this Code and do not promote prescription products to the general public.^{3 4}
2. Product-specific media statements to consumer media may be issued when the information is relevant to the Australian public. Appropriate circumstances include announcement/s of a new product or new indication registration, new public funding such as a PBS listing, or a change to public funding.  In consultation with the TGA, a Company may issue a media statement about issues such as product safety, shortages, recalls or withdrawal.
3. Companies may only issue each product-specific consumer media statement once, for each appropriate circumstance as described in paragraph 10.1 b), but it is acknowledged that this may be a single, coordinated release across multiple channels such as consumer media, patient organisations and via companies’ digital channels.
4. A product-specific media statement announcing a new prescription product or new indication must not be made known to the general public until the product or indication has been registered in Australia and reasonable steps have been taken to inform healthcare professionals of its availability.⁵
5. The product-specific media statement must contain all of the following:⁶
   1. The product’s brand name;
   2. The Australian Approved Name of the active ingredients in the product;
   3. Its approved indications, relevant to the product-specific media statement;
   4. Therapeutic class;
   5. Public funding status and restrictions, or a notation if the product is not publicly funded;
   6. A summary of the side effect profile, product’s precautions, adverse effects, warnings, contraindications, and interactions; and
   7. A copy of, or a link to the product’s Consumer Medicine Information.
6. A product specific media statement may also include:
   1. a non-comparative description of the mechanism of action;
   2. price to the patient; and/or
   3. date of product/indication availability.
7. A product specific media statement must not include:
   1. promotional statements or claims;
   2. comparisons with other products;
   3. quotes from experts, opinion leaders or patients that are promotional or comparative in nature;
   4. an image of the product packaging;
   5. reference to a Company product access program; and
   6. must not be accompanied by any material which encourages or is designed to encourage the use of any prescription product.
8. No statements or comments should be initiated by a Company regarding any products that are not registered in Australia but are available in overseas countries. This does not prohibit a Company listed on the Australian Stock Exchange issuing a non-promotional product specific media statement in line with the continuous disclosure requirements of the Australian Stock Exchange.
9. It is acceptable to respond to media enquiries or provide comment to a journalist or editor if a published article contains factually incorrect information provided this is done in an educative and non-promotional manner.
10. General media articles concerning specific prescription products must not be initiated by companies. Companies should not seek to encourage the publication of general media articles or its content with the aim of promoting their products but may, on request, provide educational material or review copy to ensure accuracy.

10.2 Social Media

All activities that utilise any social media platform will be considered in the same way as more traditional media activities. The product-specific media statement must contain all of the following:⁷

1. Content that can be viewed by the general public should not advertise or include promotional claims for a prescription product.^{8 9 10}
2. Content that includes promotional claims for a prescription product must be restricted to a verified healthcare professional audience.
3. Companies are responsible for all content on Company-initiated and/or controlled social media sites and activities.¹¹
4. Content that does not conform to community standards of ethics and good taste, or which relates to unapproved products or indications, should be promptly removed.
5. It is appropriate for Companies to create content that enables its employees to appropriately engage in Company social media campaigns.
6. Companies should have policies and procedures which describe the roles and responsibility of its employees and contractors when interacting in the social media space to ensure compliance with the Code of Conduct.

1. #7: Engaging with Mainstream Media ↩︎
2. #75: We know giveaways to HCPs are off-limits — but what about other audiences? ↩︎
3. #61a: Patient stories; what to consider? ↩︎
4. #61b: Patient stories; the whole ethical package ↩︎
5. #36: Initiating a press release for an unregistered product? ↩︎
6. #85: Product-Specific Social Media: Adapting to Edition 20 ↩︎
7. #85: Product-Specific Social Media: Adapting to Edition 20 ↩︎
8. #41: Calling for PBAC comments ↩︎
9. #48: Using social media to communicate with HCP’s – what to consider? ↩︎
10. #55: What’s not to love about LIKING (especially LinkedIn posts) ↩︎
11. #42: Company names on social media posts? ↩︎