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  1. General

Welcome to the Health Products Portal made available at products.health.gov.au. The Health Products Portal is an electronic platform run by the Department of Health and Aged Care (‘Health’, ‘we’ or ‘us’), on behalf of the Commonwealth of Australia (‘Commonwealth’), where industry can interact with Health to apply and pay for, and track and manage, listings of regulated and subsidised health related products and services. 

The use of the Health Products Portal is subject to:  

  1. the following terms and conditions; 
  2. the Privacy Policy; and  
  3. any additional terms and conditions and notices displayed by Health on the Health Products Portal from time to time, 

(together ‘Terms of Use’).  In the Terms of Use, ‘You’ means:  

  1. the person accessing or using the Health Products Portal, or the services provided through or in connection with the Health Products Portal; and  
  1. when applicable, also includes a reference to the Organisation and Your employer if that is not the Organisation. 

If You register for, access or use the Health Products Portal, You will be taken to have accepted that You have read, understood and agreed to be legally bound by these Terms of Use, as they may be updated from time to time.  

  1. Terminology 

In addition to any term defined elsewhere in these Terms of Use, the following words and expressions (when used in these Terms of Use and in other parts of the Health Products Portal such as in declarations) have the defined meanings set out below: 

Committee’ means a committee that has been established by or on behalf of the Commonwealth, or the Commonwealth and one or more Australian States and Territories, to make recommendations and give advice, such as the Pharmaceutical Benefits Advisory Committee, Medical Services Advisory Committee, Australian Technical Advisory Group on Immunisation or Medical Devices and Human Tissue Advisory Committee, and includes their subcommittees.   

Committee Member’ has the meaning given in paragraph 4.

Commonwealth’ means the Commonwealth of Australia.  

Evaluator’ has the meaning given in paragraph 4.  

General User’ has the meaning given in paragraph 4.  

HPP Material’ has the meaning given in paragraph 12. 

Intellectual Property Rights’ include: 

  1. all copyright (including rights in relation to phonograms and broadcasts); 
  2. all rights in relation to inventions, plant varieties, trade marks (including service marks), designs and circuit layouts; and 
  3. all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields, 

but do not include: 

  1. moral rights under Part IX of the Copyright Act 1968 (Cth); or 
  1. rights in relation to confidential information. 

lodgement’ means, as applicable: 

  1. a submission to list a product on the Pharmaceutical Benefits Scheme;  
  2. an application to list a service or technology on the Medicare Benefits Schedule or other funding sources considered by the Medical Services Advisory Committee, including any applicant developed assessment report;  
  3. an application to list a product on the Prescribed List of Benefits for Medical Devices and Human Tissue Products;   
  4. an application to have a product entered on the Australian Register of Therapeutic Goods;  
  5. a submission to list a vaccine on the National Immunisation Program Schedule, including to update the Australian Immunisation Handbook; or 
  6. any other permitted application or lodgement (including to a Committee) able to be submitted or made from time to time via the Health Products Portal.  

Material’ means any thing (including information and data): 

  1. downloaded, lodged or uploaded by a User into or from the Health Products Portal; or 
  2. communicated by Health via the Health Products Portal (including receipt confirmations, invoices, requests for further action or response on Your lodgement, and all other correspondence or documents provided by Health via the Health Products Portal,  

and includes any such thing in which Intellectual Property Rights subsist. 

Organisation’ means the industry participant or representative body that undertakes business or transacts with Health relating to products with which You are associated.  ‘Your Organisation’ has the same meaning. 

Organisation Administrator’, ‘Organisation Agent’ and ‘Organisation General User’ have the meaning given in paragraph 4.  

product’ means medicines, vaccines, medical devices, human tissue products and other medical services and health technologies that may be subsidised, reimbursed or listed on the various schedules, registers or lists with which You interact via the Health Products Portal.  

Profile’ means Your online registered account to use the Health Products Portal. 

User’ has the meaning given in paragraph 4.  

In these Terms of Use, unless expressed to the contrary:  

  • words denoting the singular include the plural and vice versa; 
  • the word 'includes' in any form is not a word of limitation; 
  • where a word or phrase is defined, another part of speech or grammatical form of that word or phrase has a corresponding meaning;  
  • headings and sub-headings are for ease of reference only and do not affect the interpretation of these Terms of Use;  
  • no rule of construction applies to our disadvantage on the basis that we prepared or put forward these Terms of Use or any part of them; 
  • any legislation (including subordinate legislation) is a reference to that legislation as amended, re-enacted or replaced and includes any subordinate legislation issued under it; 
  • any document is a reference to that document (or, if required by the context, to a part of it) as amended, substituted or supplemented at any time;  
  • writing includes writing in digital form;  
  • a person includes a firm, partnership, joint venture, association, corporation or other body corporate; and 
  • any body (‘Original Body’) which no longer exists or has been reconstituted, renamed, replaced or whose powers or functions have been removed or transferred to another body or agency, is a reference to the body that most closely serves the purposes or objects of the Original Body. 
  1. Changes to these Terms of Use 

Health may at its discretion update these Terms of Use at any time. Health will provide notice of any update to these Terms of Use when it considers it feasible to do so. 

By continuing to use the Health Products Portal, You accept the Terms of Use as they apply from time to time and acknowledge that You have an ongoing need to access the Health Products Portal. Your acceptance of these Terms of Use is not affected by any statement to the contrary, or any restriction, exclusion or additional terms or conditions of use set out in any lodgement submitted by You or Your Organisation, and You agree that such statements, restrictions, exclusions, and additional terms or conditions have no legal effect. 

Failure to comply with these Terms of Use may, at any time, result in Your Profile being suspended or terminated and any lodgement submitted by You or Your Organisation not being considered further. 

The new Terms of Use will replace any Health Products Portal Terms of Use You may have previously accepted. 

  1. Users of the Health Products Portal 

When You, or any other individual with myGovID access, successfully register with the Health Products Portal, You become a ‘User’.  

There are different types of ‘Users’ of the Health Products Portal and the functionality of the Health Products Portal will depend on the type of User as described in the table below. 

 

Type of User 

 
 
 
 
 

Description 

 
 
 
 
 

What the User can do 

 
 
 
 
 

What the User cannot do 

 
 
 
 
 

Committee Member 

 
 
 
 

A User who is a member of a Committee who is using the Health Products Portal. 

A Committee Member has the ability to:  
  • view meetings and related agenda items for which they are an attendee. This may include details from the lodgements being considered; and 

  • manage any conflicts of interest in relation to their role as a Committee Member using the Health Products Portal. 

A Committee Member cannot represent an Organisation and therefore cannot have the Organisation roles (including Organisation General User, Organisation Agent or Organisation Administrator). 

A Committee Member cannot make lodgements on behalf of an Organisation or conduct evaluations. 

Evaluator 

A User who is engaged by Health or a Committee to: 

(a) undertake an evaluation to support the decision of the relevant Committee; or 

(b) conduct data analysis or other work to support the work of the Committee or Health arising from a lodgement. 

An Evaluator has the ability to:  
  • receive lodgements made through the Health Products Portal to which they have been given access to evaluate or provide advice (in whole or in part); 

  • provide an evaluation or analysis report; and 

  • updates documents at the request of Health or a Committee. 

An Evaluator cannot represent an Organisation on the Health Products Portal and therefore cannot have the Organisation roles (including Organisation General User, Organisation Agent or Organisation Administrator). 
General User 
A User who has not yet been associated with an Organisation Profile.  
A General User has the ability to:  
  • register an Organisation Profile;  

  • send a request to be associated with an Organisation (the request is sent to the Organisation Administrator(s) of the registered Organisation Profile); and 

  • draft and submit lodgements and view Materials to which they have been assigned access by the Organisation Administrator. 

A General User is unable to commence drafting of lodgements until they have established an association with an Organisation Profile (at which point they become an Organisation General User).   
Organisation Administrator 
A User who has: 
  • registered an Organisation in the Health Products Portal and by default becomes the Organisation Administrator of that Organisation who may be, for example, an Authorised Representative or responsible person (as defined in the National Health Act 1953 (Cth)); or 

  • established an association with an already registered Organisation in the Health Products Portal (i.e. has been invited by an Organisation Administrator) and has then had their permissions updated to Organisation Administrator by another Organisation Administrator associated with that Organisation. 

Once an Organisation Administrator has a registered account, an Organisation Administrator may do any of the following:  
  • invite Users to associate with the Organisation Profile (i.e. granting access for Users to act on behalf of the Organisation which will also expose those Users to draft information related to lodgements created on behalf of that Organisation and Material communicated between Health and that Organisation); 

  • assign an Organisation Agent to a lodgement (including the ability to assign themselves); 

  • update Users’ permissions who have been associated with the Organisation to hold permissions of an Organisation Administrator (i.e. an Organisation Profile can have multiple Organisation Administrators); 

  • remove Users’ association with the Organisation Profile (which means the removed User can no longer represent that Organisation in the Health Products Portal or view any information drafted/lodged on behalf of that Organisation or Material communicated between Health and that Organisation); 

  • draft and submit lodgements on behalf of an Organisation and assign draft lodgements to an Organisation Agent; and 

  • remove an Organisation Agent’s access to draft lodgements or Material communicated between Health and that Organisation. 

In addition, an Organisation Administrator also has all access and rights assigned to a General User, an Organisation Agent and an Organisation General User. 

An Organisation Administrator cannot see: 
  • draft lodgements related to their Organisation for which they have not been granted access (unless they have granted themselves access); or 

  • lodgements of other Organisations. 

An Organisation Administrator does not have the ability to delete lodgements and other Material from within the Health Products Portal. 

Organisation Agent 
A person assigned to a lodgement by an Organisation Administrator in the Health Products Portal, who may be, for example, an Authorised Representative, individual officer, employee, contractor or consultant of an Organisation. 
Once assigned, an Organisation Agent has the ability to:  
  • act on behalf of that Organisation, though will only be able to see the draft lodgements and Material communicated between Health and that Organisation to which they have been granted access; and 

  • update and submit those lodgements to which they have been assigned access. 

An Organisation Agent cannot see all other draft lodgements related to that Organisation for which they have not been granted access. 

An Organisation Agent does not have the ability to delete lodgements and other Material from within the Health Products Portal. 

Organisation General User 
A User who has both registered a personal Profile in the Health Products Portal and established an association with an Organisation Profile. 
Upon establishing an association with an Organisation in the Health Products Portal, an Organisation General User can then:  
  • represent that Organisation in the Health Products Portal;  

  • draft/submit lodgements to Health; and  

  • view Material communicated between Health and that Organisation. 

An Organisation General User cannot send invitations to other Users to associate with the Organisation (including the ability to assign an Organisation Agent to a lodgement) as this is a function restricted to the role of an Organisation Administrator. 
  1.  

  2.  

  1. Creating a profile

If You want to create a profile to use the Health Products Portal, You or someone else in Your Organisation must register an account for Your Organisation. 

When You register to use the Health Products Portal, the following terms apply: 

  1. You must only access the Health Products Portal using a valid myGovID; 
  2. You must comply with any terms and conditions applicable to Your use of the myGovID; 
  3. You confirm that Your individual identification details submitted on the Health Products Portal registration page are true and correct and that You are not registering on behalf of any other individual; 
  4. You must not create more than one account to access the Health Products Portal;  
  5. You must only use Your name or business name when creating Your account for the Health Products Portal and You must not use any slogans, brands or marketing elements (that are not Your business name) when creating or naming Your account; 
  6. You warrant to Health that You are not misrepresenting Your identity; and  
  7. You acknowledge that giving false or misleading information to the Commonwealth is a serious offence under section 137.1 of the Schedule to the Criminal Code Act 1995 (Cth).  

If You are registering an account on behalf of an Organisation, You warrant that You are an agent of that Organisation, that You are authorised to register that account, and that the Organisation has agreed to be bound by these Terms of Use. 

Health may notify You of specific requirements in relation to account creation from time to time. 

Health is not liable or legally responsible for any of the lodgements You make using Your Profile.    

  1. Communications from Health via the Health Products Portal 

Health may communicate with Your Organisation regarding Your lodgements or actions resulting from assessment of Your lodgements via the Health Products Portal. This may include corresponding with You regarding: 

  1. the assessment of Your lodgements, including seeking clarification of any Material submitted or providing Material on the assessment of Your lodgements; and 
  2. any action or proposed action relating to Your lodgements (including the proposed form of a document or instrument to be made under a law). 
  1. Your responsibilities when using the Health Products Portal 

You agree to comply with the following rules when You register an account to use the Health Products Portal, and when You access or use the Health Products Portal.

In Your use of the Health Products Portal, You must: 

  1. only use the Health Products Portal for Your own lawful purposes, in accordance with these Terms of Use or any other conditions notified by us on the Health Products Portal, and in a manner that does not infringe the Intellectual Property Rights of, or restrict or inhibit the use of the Health Products Portal by, Health or any third party; 
  2. maintain the confidentiality of all account information including user names, logins, passwords, and security questions and answers that You use to access any page or feature of the Health Products Portal; 
  3. monitor, control and take responsibility for all activities occurring under Your Profile including taking responsibility for any activities which may result from Your negligence, carelessness, misconduct, or failure to use or maintain appropriate security measures;  
  4. access and read all notices and information provided by Health in relation to the Health Products Portal; 
  5. not access, or attempt to gain access to, any Materials or information other than those submitted by You, or to which You have been given express permission; 
  6. immediately notify us of any unauthorised use or conduct of Your Profile or any other breach of security as soon as You become aware of such conduct and take, at Your cost, all other actions that we deem necessary to maintain or enhance the security of the Health Products Portal; 
  7. immediately notify us if You have access via the Health Products Portal to, or receive, any Materials not intended for You, and You must not use or communicate such Materials except as directed by Health in writing and must treat any such Materials as confidential and delete such Materials in accordance with any direction from Health; 
  8. maintain and ensure Your Profile registration and authentication details are true, accurate, current and correct;  
  9. only use the Health Products Portal strictly in accordance with these Terms of Use, and all notices, protocols, guidelines and other instructions provided or advised to You by Health from time to time; 
  10. not impersonate any person or falsely represent Your authority or association with any person or organisation (including Health); 
  11. not attempt to modify, adapt, translate, sell, reverse engineer, decompile or disassemble any portion of the Health Products Portal, including through the use of automated tools; 
  12. not use any scripts or processes on the Health Products Portal nor use any data scraping or data mining tools; 
  13. not transmit, or input via the Health Products Portal, any: 
    1. harmful code or malware; 
    2. unlawful, defamatory, obscene, offensive or scandalous Material, or any Material that constitutes or encourages conduct that would contravene any law or which may harass or cause distress or inconvenience to any person; or 
    3. Material in violation of any Intellectual Property Rights or any laws that You do not have the right to use or transmit or input into the Health Products Portal; and 
  14. comply with all applicable legislation including the Privacy Act 1988 (Cth) and the Criminal Code Act 1995 (Cth). 

Any Material (including attachments) submitted to the Health Products Portal that does not comply with these conditions may either be destroyed by Health at its absolute discretion or their contents may not be considered or assessed for the purposes of the National Health Act 1953 (Cth), the Health Insurance Act 1973 (Cth), the Private Health Insurance Act 2007 (Cth) or other relevant laws. It is Your responsibility to ensure that any files uploaded comply with these conditions.

In any engagement with Health, Committees and Evaluators, You must conduct Yourself, and take all reasonable steps to ensure that others representing the same Organisation conduct themselves, in good faith and at all times with the promptness, professionalism, diligence, prudence and foresight which would be expected of a diligent, experienced and competent professional in the relevant field and in an equivalent professional organisation.   

You acknowledge that Your access to, and use of, the Health Products Portal is subject to applicable Commonwealth legislation (including the Crimes Act 1914 (Cth), the Criminal Code Act 1995 (Cth), the Privacy Act 1988 (Cth), the Health Insurance Act 1973 (Cth), the National Health Act 1953 (Cth)) and the Private Health Insurance Act 2007 (Cth), and that penalties may apply for misuse of information obtained from the Health Products Portal (including for purposes that are different to the purposes for which information is communicated by Health via the Health Products Portal) or disclosure of information contrary to law. 

  1. Security 

Your use of the Health Products Portal will be logged for the purpose of security and usage monitoring. 

You agree that the following security conditions will apply to Your use of the Health Products Portal: 

  1. You must not attempt to undermine the security or integrity of the Health Products Portal; 
  2. When You download Material from the Health Products Portal to a personal device (for example, mobile, tablet, computer), such Material must be stored on a secure device or file server and not an email account. You are responsible for the security and safe storage of such documents;  
  3. Any documentation that You submit to the Health Products Portal must only contain the type of information required to be contained in that particular type of documentation; 
  4. You (and not the Commonwealth) will be solely responsible for any damage to Your computer, systems or software caused by Your use of the Health Products Portal, including by any virus (irrespective of the origin of the virus) arising from Your use of the Health Products Portal; 
  5. You must not tamper with other user accounts, or commit unauthorised intrusion into any part of the Health Products Portal; 
  6. You must not use, or misuse the Health Products Portal in any way which may disrupt or impair the functionality of the Health Products Portal or other systems used for the Health Products Portal; 
  7. You must not attempt to bypass any security controls of the Health Products Portal; 
  8. You must not use the Health Products Portal in a manner that makes unnecessary use of disk space, processors or other system resources; and 
  9. You acknowledge and agree that Health may routinely log, monitor and analyse usage of the Health Products Portal for any misuse, or attempted or actual security breaches.  
  1. Use on behalf of an Organisation 

When You are using the Health Products Portal in relation to, or on behalf of, an Organisation: 

  1. You must ensure that the Organisation has appointed You to access the Health Products Portal on its behalf, and that the appointment has not been cancelled; 
  2. if Your appointment to represent the Organisation is based on You holding a certain position (for example, as that other person’s employee or agent), You must currently hold that position; 
  3. if Your appointment to represent the Organisation is based on You holding a certain qualification (for example, as a legal practitioner), You must currently hold that qualification, and that qualification must not currently be suspended or cancelled;  
  4. You must only use and communicate Materials relating to the Organisation that You represent within the limits of Your authority from that Organisation and for no other purpose; and 
  5. You agree to comply with any request made by Health for You to verify any of the matters set out above. 
  1. Terms when making a lodgement   

When making a lodgement (including a pricing offer), You: 

  1. must ensure that, to the best of Your knowledge: 
    1. the information contained in Your lodgement is true, accurate, current and correct; and  
    2. no other information that is relevant is known to either You or the Organisation; 
  2. must ensure that the information contained in Your lodgement is consistent with any other information already provided to Health, for the same product, via other applications either within or outside the Health Products Portal (or provide reasons for any inconsistencies); 
  3. must provide any information to Health that may have an impact on the assessment of the lodgement;  
  4. acknowledge that, if You make a lodgement for an Organisation without quoting an ABN, the Organisation may be requested to provide an ABN or it may be required to register for an ABN to finalise consideration of the lodgement; and 
  5. acknowledge that data and information in relation to products (including the use and Commonwealth subsidisation of products) may be made available by Health or other persons for or on behalf of the Commonwealth to third parties: 
    1. for or in relation to the delivery of Government services, to inform Government policy and programs and for research and development; and 
    2. as otherwise permitted by these Terms of Use or the law. 

Once a lodgement is made: 

  1. a copy of the Material in the lodgement will be available for download on behalf of the Organisation; 
  2. a copy of the lodgement will also be made available to the relevant Committee, Evaluators and Health;
  • In the case of applications to the Medical Services Advisory Committee, the application is only provided to the Committee if considered suitable for its consideration.
  1. a copy of the lodgement will be stored in Health’s records system (SharePoint, TRIM); and 
  2. Health or third parties acting on behalf of Health can send correspondence to You to request further information. 

Nothing in these Terms of Use or on the Health Products Portal itself gives rise to any commitment on the part of the Commonwealth, a Committee or the Australian Government to approve or take any steps to approve or recommend any product included in a lodgement.  

You, and the Organisation You represent, release and forever discharge the Commonwealth, each Committee and Evaluators from all actions, claims and demands against them in respect of or arising out of the approval or recommendation or failure to approve or recommend a product the subject of a lodgement. 

When making a lodgement (other than a pricing offer), You acknowledge and agree that Health may publish the following information on the internet in relation to the work of Committees: 

  1. meeting agenda, meeting outcomes and reasons for meeting outcomes including the evidence or other material on which those outcomes are based; and 
  2. for a product that has been the subject of a Committee meeting agenda, information in relation to the progress of the product towards inclusion on the applicable schedule, register or list. 

In addition:  

  1. if Your lodgement is an application to the Medical Services Advisory Committee that is considered suitable for that Committee’s consideration, You acknowledge and agree that following the making of redactions agreed with Health, the completed (redacted) application will: 
    1. be published on the Committee’s website; 
    2. be provided to professional bodies or organisations and consumer organisations that have been identified in the application; and 
    3. be provided to any additional groups or individuals that the Department deems appropriate or relevant for consultation; and 
  2. if Your lodgement in an application to the Medical Services Advisory Committee for a potential Highly Specialised Therapy under the National Health Reform Agreement Addendum 2020-2025 that is considered suitable for that Committee’s consideration, You acknowledge and agree that the complete unredacted application will be shared with representatives of State and Territory health agencies.  
  1. Materials on the Health Products Portal  

Health may at any time change the content, including removal, of any Materials held in the Health Products Portal, at Health’s discretion and without notice. 

You agree that Material You transmit or input via the Health Products Portal may be accessed by other Users who are permitted access to the Material by Health for the purposes of processing and assessing lodgements, or operating and administering the Health Products Portal, including a Committee, Committee Members and Evaluators. You are responsible for all risks relating to access by Users to Material You transmit or input via the Health Products Portal before using the Health Products Portal. 

The Materials communicated or made available to You on the Health Products Portal may include information relating to third parties that has been made available to You for a specific purpose with the consent of that third party. Penalties may apply for misuse or unauthorised disclosure of this information. 

The Materials on the Health Products Portal may include the views or recommendations of third parties that do not necessarily reflect the views of Health, the Commonwealth or the Australian Government, or indicate a commitment to a particular course of action. 

  1. Intellectual property and licences 

All Intellectual Property Rights comprised in or derived from the Health Products Portal and the Material available via the Health Products Portal (HPP Material), including copyright comprised in the Health Products Portal and HPP Material, are owned by the Commonwealth or another third party owner.  

All logos, icons, brand names or service names that identify Health are owned by, and remain the property of, the Commonwealth.  

All other trade marks or service marks on the Health Products Portal are the property of their respective owners.  

Subject to the rights of third parties, the Intellectual Property Rights in a lodgement made by Your Organisation through the Health Products Portal will be owned by Your Organisation. 

You must not make any unauthorised use of any HPP Material or the Health Products Portal (and must not breach the Intellectual Property Rights in respect of the HPP Material). If You do so, You may become liable for a breach of the Intellectual Property Rights of the Commonwealth or third parties. 

You are granted the right to access and use the Health Products Portal by Health for the purposes of making lodgements and as otherwise expressly permitted in these Terms of Use. 

HPP Material may be protected by Intellectual Property Rights. You must not use any HPP Material for a purpose for which You do not have express permission from the Commonwealth or other relevant Intellectual Property Rights owner. If You have any doubt as to Your right to use the Material, please contact its owner. The Commonwealth is not liable if You breach an owner’s Intellectual Property Rights. 

Without limitation to any rights of the Commonwealth arising under the Copyright Act 1968 (Cth), You grant (or will procure) a royalty-free, non-exclusive, irrevocable, non-transferrable licence (including a right to sub-license) to: 

  1. the Commonwealth, State and Territory health agencies, any bodies corporate within the Health portfolio and the Committees and their personnel (including Committee Members and Evaluators) to use the information and Material included in Your lodgement (including any associated Intellectual Property Rights) for the following purposes: 
    1. the evaluation or consideration (or both) of the relevant product(s) for inclusion on, as applicable, the Pharmaceutical Benefits Scheme, Australian Register of Therapeutic Goods, National Immunisation Program Schedule and to update the Australian Immunisation Handbook, Prescribed List of Benefits for Medical Devices and Human Tissue Products or Medicare Benefits Schedule (or as part of any consideration for other funding sources by the Medical Services Advisory Committee) and as necessary for any subsequent listing of the product(s); 
    2. the proper administration of the Pharmaceutical Benefits Scheme, Australian Register of Therapeutic Goods, National Immunisation Program Schedule including the Australian Immunisation Handbook, Prescribed List of Benefits for Medical Devices and Human Tissue Products, Medicare Benefits Schedule and other Australian Government schemes or funding arrangements generally associated with such products; and 
    3. policy development, budget and costing purposes; and 
  2. Health to publish information and Material included in Your lodgement (including exercising any associated Intellectual Property Rights as required to do so), and other information related to Your lodgement, to fully describe the product on Australian Government websites and in legislative instruments. 

Without limitation to any rights of the Commonwealth arising under the Copyright Act 1968 (Cth), to the extent that the Intellectual Property Rights in any material provided by You as part of Your lodgement are owned by You or a third party, You grant (or will procure) a royalty-free, non-exclusive, irrevocable, non-transferrable licence (including a right to sub-license) permitting Health to publish the following information on the internet in relation to the work of Committees: 

  1. meeting agenda, meeting outcomes and reasons for meeting outcomes including the evidence or other material on which those outcomes are based;  
  2. the completed (redacted) application to the Medical Services Advisory Committee; and 
  3. for a product that has been the subject of a Committee meeting agenda, information in relation to the progress of the product towards inclusion on the applicable schedule, register or list.  

You acknowledge and agree that the relevant licencees described above may exercise their licence rights without further consent from You or the Organisation that You represent and the licence granted above does not limit or exclude any rights that Health is entitled to exercise at law in relation to the Material. 

For the avoidance of doubt, ownership of all Intellectual Property Rights (if any) in data and information in relation to the use, and Commonwealth subsidisation or reimbursement of, products (including a description of the subsidised or reimbursed product, the restrictions under which it is subsidised or reimbursed, and any relevant pricing, fees or mark ups) after listing, is the property of, and vests in, the Commonwealth immediately upon creation. 

  1. Suspension and termination of access to the Health Products Portal 

If Health has determined that You have, or may have: 

  1. breached any of these Terms of Use or conditions posted by Health on the Health Products Portal; or 
  2. engaged in misleading, deceptive, fraudulent, immoral or illegal conduct, 

Health may, without limiting its rights, immediately terminate Your access to the Health Products Portal or suspend for any period of time Your use of the Health Products Portal.  

Health may suspend Your registration with, access to, or use of the Health Products Portal if Health considers it necessary to protect the interests of the Commonwealth or those of any other person, including while Health investigates any technical or operational issue, breach of security or possible breach of these Terms of Use. 

Health reserves the right to report to the proper authorities any offence that has occurred, or that Health believes may have occurred, in respect of the use of the Health Products Portal, and the right to pursue legal action. 

If connection to a system or website outside of Health’s control compromises the objectives of the Health Products Portal, Health may sever links to that website or system. 

In accordance with paragraph 18, Health will have no liability to You or Your Organisation for doing any of the things referred to in this paragraph 13. 

  1. Collection of Your personal information and privacy obligations 

Information created by the Health Products Portal about You includes: 

  1. Your username; and 
  2. records of activity in relation to Your account, such as account sign-in attempts, Your device (including device name, model, operating system and IP Address), and pages and messages accessed by You. 

Your personal information is protected by law, including the Privacy Act 1988 (Cth) and the Australian Privacy Principles. Health collects, uses and discloses personal information in order to administer and use the Health Products Portal and for the purposes of the Committees and Evaluators. This includes collecting, using and disclosing Your information to: 

  1. allow You to create and sign in to Your User Profile;  
  2. associate You with Your Organisation;  
  3. enable You/Your Organisation to apply to:  
    1. list a product on the Pharmaceutical Benefits Scheme;  
    2. list a service or technology on the Medicare Benefits Schedule or on other funding sources considered by the Medical Services Advisory Committee (including by submitting any applicant developed assessment report);  
    3. list a product on the Prescribed List of Benefits for Medical Devices and Human Tissue Products;  
    4. enter a product on the Australian Register of Therapeutic Goods;  
    5. list a vaccine on the National Immunisation Program Schedule, including to update the Australian Immunisation Handbook; or 
    6. make any other permitted application or lodgement (including to a Committee) able to be submitted or made from time to time via the Health Products Portal, (listing application); 
  4. allow You/Your Organisation to manage a listing application (including an application in progress or a new application); 
  5. allow Health and the Australian Government to make decisions regarding Your listing application; 
  6. know who is making the listing application and who to contact about such listing applications;  
  7. administer, maintain and provide You with support in relation to Your Profile; and/or 
  8. allow Health, Committees and Evaluators to assess and evaluate listing applications. 

If You are a Committee Member or an Evaluator, Health is collecting personal information about You in the performance of Your functions. 

When You sign in to the Health Products Portal using Your myGovID, the Health Products Portal collects records of activity in relation to Your myGovID. 

If You do not provide this information, You will be unable to access and use the Health Products Portal and, when applicable, You/Your Organisation will be unable to lodge, manage and progress a listing application. 

Health may also collect Your personal information from another person as part of: 

  1. registering an Organisation; 
  2. inviting You to associate with an Organisation; 
  3. nominating You as a contact person in a listing application; 
  4. You being nominated as an expert for consultation; 
  5. appointing You as an Organisation Agent;  
  6. managing Your roles and permissions for an Organisation; and/or 
  7. for the purpose of processing a listing application. 

Personal information about You collected by the Health Products Portal (including a log of Your actions within the Health Products Portal and details of lodgements that You are currently drafting or have previously made) may be disclosed to: 

  1. when You are associated with an Organisation, other Users associated with Your Organisation (including Your Organisation’s Administrator and Organisation Agents) and Health Products Portal system administrators; 
  2. the Committees (including the Pharmaceutical Benefits Advisory Committee, Medical Services Advisory Committee, Australian Technical Advisory Group on Immunisation, Medical Devices and Human Tissue Advisory Committee, and their subcommittees) or Evaluators for the purpose of processing a listing application and making associated changes to documentation published by or on behalf of the Commonwealth; and 
  3. State and Territory government authorities. 

Personal Information about You may be collected from any Committees and Evaluators for the same purpose.  

For more information about how Health will manage Your personal information, including Health’s privacy policy, see Privacy when using the Department of Health and Aged Care’s Health Products Portal (HPP)

If You disclose another person’s personal information to Health via the Health Products Portal, You warrant to Health that: 

  1. the person to whom the personal information relates has consented to Health collecting, using and disclosing their personal information as described in Health’s privacy collection notice within the Privacy Policy; and 
  2. You have drawn to that person’s attention the privacy collection notice. 

You understand that, if any other personal information is included in attachments in support of the submission/application, the personal information must be provided with the consent of the individual, and evidence of consent must be provided to Health upon request. 

  1. Confidentiality 

If You provide advice to a Committee, You acknowledge that Your attention has been drawn to the contents of section 135A of the National Health Act 1953 (Cth) and are aware that You are bound by its provisions in using the Health Products Portal. 

In particular, You acknowledge that You understand that subsection 135A(1) of the Act requires that: 

A person shall not, directly or indirectly, except in the performance of duties, or in the exercise of powers or functions, under this Act, and while the person is, or after the person ceases to be, an officer, divulge or communicate to any person, any information with respect to the affairs of a third person acquired by the first-mentioned person in the performance of duties, or in the exercise of powers or functions, under this Act. 

For the purpose of the section, You recognise that information of a third party can include information provided by a company in relation to a lodgement and can include any new information derived from this information provided by a company.   

You accept that any information provided to You, Your Organisation or to Organisation Agents about the market share information of a third party with the consent of that third party may only be used for the purpose of calculating and verifying reimbursement amounts under a joint risk share arrangement. Any such information provided to You or Your Organisation remains confidential and must not be disclosed by You or Your Organisation. 

  1. Acknowledgment 

You acknowledge and agree that Your use of the Health Products Portal is entirely at Your own risk, and You have made Your own assessment on the risk of use of the Health Products Portal and any Materials on the Health Products Portal. 

You accept and agree that You are authorised and responsible for any lodgements (including any edits or deletions to lodgements) made to the Health Products Portal using Your Profile. Health is not liable or legally responsible for any of the lodgements You make, or anybody else makes, using Your Profile. 

  1. No warranty 

Health:  

  1. does not give any warranty in connection with the Health Products Portal and its Materials; and  
  2. does not guarantee or represent that:  
  3. the use of the Health Products Portal and its Materials will not breach Intellectual Property Rights; 
  4. the use of the Health Products Portal and its Materials will be uninterrupted or error free;  
  5. defects will be corrected; or  
  6. the Health Products Portal is free of harmful code. 

The Health Products Portal is hosted in a cloud environment and has been designed to satisfy relevant requirements under the Australian Government Protective Security Policy Framework and the Information Security Manual. However, You acknowledge that Health does not give any representation or warranty that the Health Products Portal or any underlying environment or platform is secure or meets a particular security standard. 

You accept that any information provided to You or Your Organisation about the progress of any listing application, through the Health Products Portal, may be subject to change. Any such information provided to You or Your Organisation remains confidential and must not be disclosed by You or Your Organisation. 

  1. Liability  

You remain solely responsible for complying with all applicable laws in connection with Your use of the Health Products Portal. It is Your responsibility to check that storage of, transfer and access to the Materials You transmit or input via the Health Products Portal will comply with all laws applicable to You. 

You agree that, to the maximum extent permitted by law, the Commonwealth, the Committees and Evaluators are not liable to You or Your Organisation (or any other person) for any loss (including special, consequential or exemplary damages or damages for loss of information, data, profits and savings) or damage resulting, directly or indirectly, in connection with: 

  1. Your (or any other person’s) use of or reliance on the Health Products Portal (including any Material or links made available through the Health Products Portal or reliance on any opinions or recommendations made available through the Health Products Portal); and 
  2. Your use of any lodgement or documents made available through or uploaded to the Health Products Portal. 

You indemnify the Commonwealth for any loss or expense incurred by Health, any Committee Member or Evaluator in dealing with any claim against it or them, including legal costs and expenses on a solicitor/own client basis and the cost of time spent, resources used or disbursements paid by them, arising from either: 

  1. a breach by You of these Terms of Use; or 
  2. an act or omission involving fault on Your part in connection with these Terms of Use. 

Your liability to indemnify the Commonwealth under these Terms of Use will be reduced proportionately to the extent that any negligent or other tortious act or omission of Health contributed to the relevant loss or damage. 

Health holds the rights of Committee Members and Evaluators on trust for them and those rights may be exercised by Health as trustee for the Committee Members and Evaluators as beneficiaries. 

  1. Your personal devices (for example, mobile, tablet, computer) 

When You use myGovID to sign into the Health Products Portal, like with mobile phone apps, You may be asked for Your permission to access certain hardware or software features of Your device, for example, Your camera. 

Access to features on Your personal device is only for the purpose of being able to assist You with a particular service. For example, being able to take a picture of a document so that You can upload it. 

When You agree to providing access to a feature on Your personal device, that access is limited to only that feature and does not mean You have agreed to allow Health access to all features on Your device. 

  1. General 

These Terms of Use are governed by the laws of the Australian Capital Territory, Australia, and You agree to submit to the exclusive jurisdiction of the courts of the Australian Capital Territory. 

If any of these Terms of Use are held to be invalid, unenforceable or illegal for any reason, the remaining Terms of Use will continue in full force. 

If either party waives any breach of these Terms of Use, this will not constitute a waiver of any other breach. No waiver will be effective unless made in writing. 

 

 

Privacy Collection Notice  
 

NOTE: 
Referred to in the ‘Collection notice for Registration stage’ section of the Terms of Use. Currently published on https://www.pbs.gov.au/info/industry/hpp/hpp-terms-and-conditions   

 

The Australian Government Department of Health and Aged Care (Health) is bound by the Privacy Act 1988 and the Australian Privacy Principles (APPs). 

The Health Products Portal is run by Health. This privacy collection notice sets out how Health collects, holds, uses and discloses personal information in relation to the Health Products Portal. Separate privacy notices apply to Your myGovID account. 

By using the Health Products Portal, You agree that Health may collect, use and disclose Your personal information as set out in this privacy collection notice. 

By using Your myGovID to access the Health Products Portal, You also agree that Health may collect from myGov and use and disclose to myGov Your personal information, as set out in this privacy collection notice, to the extent those actions are related to myGov.  

Whenever possible, we will collect personal information directly from You including information that You directly supply when You create a profile. Such information collected includes Your name, job title and position (e.g. applicant, Evaluator, consultant or lobbyist) and, if a lobbyist, whether You are listed on the Register of Lobbyists, email address, phone number, ABN (if any) and preferred method of receiving message notifications. 

Health collects, uses and discloses personal information in order to administer and use the Health Products Portal. This includes collecting, using and disclosing Your information to: 

  • allow You to create and sign in to Your Health Products Portal user profile (User Profile);  
  • associate You with an Organisation (Your Organisation);  
  • enable You/Your Organisation to apply to: (1) list a product on the Pharmaceutical Benefits Scheme; (2) list a service or technology on the Medicare Benefits Schedule or on other funding sources considered by the Medical Services Advisory Committee (including by submitting an applicant developed assessment report);  (3) list a product on the Prescribed List of Benefits for Medical Devices and Human Tissue Products; (4) enter a product on the Australian Register of Therapeutic Goods; (5) list a vaccine on the National Immunisation Program Schedule (including to update the Australian Immunisation Handbook); or (6) make any other permitted application or lodgement (including to a Committee) able to be submitted or made from time to time via the Health Products Portal  (listing application);  
  • allow You/Your Organisation to manage a listing application (including an application in progress or a new application); 
  • allow Health and the Australian Government to make decisions regarding Your listing application; 
  • know who is making the listing application and who to contact about such listing applications;  
  • administer, maintain and provide You with support in relation to Your User Profile; and/or 
  • allow Health, Committees (as defined below) and Evaluators to assess and evaluate listing applications and make associated changes to documents published by or on behalf of the Commonwealth.  

Personal information may be collected at various stages of the listing application process, including personal information about third parties such as the applicant’s experts. 

If You are a member of the Pharmaceutical Benefits Advisory Committee, Medical Services Advisory Committee, Australian Technical Advisory Group on Immunisation, Medical Devices and Human Tissue Advisory Committee or their subcommittees (Committees) or an Evaluator, Health is collecting personal information about You in the performance of Your functions. 

If You do not provide all the personal information requested, You will be unable to access and use the Health Products Portal and, when applicable, You/Your Organisation will be unable to lodge, manage and progress a listing application.  

When You sign in to the Health Products Portal using Your myGovID, the Health Products Portal collects records of activity in relation to Your myGovID.  

Health may also collect Your personal information from another person, as part of: 

  • registering an Organisation; 
  • inviting You to associate with an Organisation; 
  • nominating You as a contact person in a listing application; 
  • You being nominated as an expert for consultation; 
  • appointing You as an Organisation Agent;
  • managing Your roles and permissions for an Organisation; and/or
  • for the purpose of processing a listing application.

If Your Organisation applies to list a product on the Pharmaceutical Benefits Scheme, Medicare Benefits Schedule, Prescribed List of Benefits for Medical Devices and Human Tissue Products, the Australian Register of Therapeutic Goods or the National Immunisation Program Schedule (including to update the Australian Immunisation Handbook)  the collection of personal information can be required by legislation or legislative instruments applying to the Scheme, List, Program or Register.  For example, in the case of the Pharmaceutical Benefits Scheme, the name and contact details of Your Organisation’s responsible person (as defined in the National Health Act 1953 (Cth)) is required by the National Health (Pharmaceuticals and Vaccines — Cost Recovery) Regulations 2022.

Personal information about You collected by the Health Products Portal (including a log of Your actions within the Health Products Portal and details of lodgements that You are currently drafting or have previously made) may be disclosed to:

  • if You are associated with an Organisation, other Users associated with the Organisation (including Your Organisation’s Administrator and the Organisation Agent) and Health Products Portal system administrators;
  • the Committees and Evaluators for the purpose of processing a listing application and making associated changes to the documents published by or on behalf of the Commonwealth; and
  • State and Territory government authorities.

Personal Information about You may be collected from the Committees and Evaluators for the same purpose.

When You are associated with an Organisation, if the Organisation is not subject to the Privacy Act 1988 (Cth), the Organisation will not be accountable under that Act for how associated users handle personal information obtained from the Health Products Portal and You will not be able to seek redress under the Privacy Act 1988 (Cth).

Health is unlikely to disclose Your personal information to overseas recipients. If Your Organisation or Organisation Agent is based overseas, Health will only disclose Your personal information to these bodies on a basis otherwise set out in this collection notice.

Health has an Australia Privacy Principle (APP) privacy policy. You can obtain a copy of the APP privacy policy by contacting Health using the contact details set out at the end of this notice.  The APP privacy policy contains information about:

  • how You may access the personal information Health holds about You and how You can seek correction of it;
  • how You may complain about a breach of the APPs or a registered APP code that binds Health; and
  • how Health will deal with such a complaint.

You can contact Health by telephone on (02) 6289 1555 or freecall 1800 020 103 or by using the online enquiries form on the Health website.

The following attachments are subject to updates, the latest copy is available via following links.