Records Authority 2014/00243899

Department of Health

Pharmaceutical Benefits and Access

2014

This is an accurate reproduction of the authorised records authority content, created for accessibility purposes

Introduction

The Department of Health and the National Archives of Australia have developed this Records Authority to set out the requirements for keeping or destroying records for the core business area of Pharmaceutical Benefits and Access. It represents a significant commitment on behalf of the Department to understand, create and manage the records of its activities.

This Authority is based on the identification and analysis of the business of the Department. It takes into account the agency's legal and organisational records management requirements, and the interests of stakeholders, the agency and the National Archives of Australia.

The Authority sets out those records that need to be retained as national archives and specifies the minimum length of time that temporary records need to be kept. This Authority gives the Department permission under the Archives Act 1983, for the destruction of the temporary records described after the minimum retention period has expired. Retention periods for these temporary records are based on: an assessment of business needs; broader organisational accountability requirements; and community expectations, and are approved by the National Archives of Australia on the basis of information provided by the agency.

As changes in circumstances may affect future records management requirements, the periodic review of this Authority is recommended. All amendments must be approved by the National Archives.

Application of this Authority

  1. This Authority is to be used to determine how long records must be kept. Records are matched to the relevant core business and records class in the Authority:
    • where the minimum retention period has expired and the records are not needed for agency business they should be destroyed as authorised in this Authority;
    • records that have not reached the minimum retention period must be kept until they do; and
    • records that are identified as Retain as National Archives (RNA) are to be transferred to the National Archives of Australia for preservation.
  2. This Authority should be used in conjunction with general records authorities such as:
    • the Administrative Functions Disposal Authority (AFDA) and/or AFDA Express issued by the National Archives to cover business processes and records common to Australian Government agencies;
    • General Records Authority 24 – Records Relating to Data Matching Exercises; and
    • General Records Authority 31 for source (including original) records that have been copied, converted or migrated.
  3. The Normal Administrative Practice (NAP) provision of the Archives Act 1983 gives agencies permission to destroy certain records without formal authorisation. This usually occurs where records are duplicated, facilitative or for short-term use only. NAP does not replace arrangements agreed to in this Authority but can be used as a tool to assist in identifying records for destruction together with an agency's Records Authority or Authorities, and with AFDA and AFDA Express. The National Archives recommends that agencies develop and implement a Normal Administrative Practice policy. Advice and guidance on destroying records as a normal administrative practice and on how to develop an agency NAP policy is available from the National Archives' website at www.naa.gov.au.
  4. Records that are reasonably likely to be needed as evidence in a current or future judicial proceeding or are subject to a request for access under the Archives Act 1983, the Freedom of Information Act 1982 or any other relevant Act must not be destroyed until the action has been completed.
  5. Records subject to a disposal freeze must not be destroyed until the freeze has been lifted. Further information about disposal freezes and whether they affect the application of this Authority is available from the National Archives website at www.naa.gov.au.
  6. Where the method of recording information changes (for example from a manual system to an electronic system, or when information is migrated from one system to a new system) this Authority can still be applied, providing the records document the same core business. The information must be accessible for the period of time prescribed in this Authority. The agency will need to maintain continuing access to the information, including digital information, for the periods prescribed in this records authority or until the information is transferred into the custody of the National Archives.
  7. In general, retention requirements indicate a minimum period for retention. The Department may extend minimum retention periods if it considers that there is an administrative need to do so, without further reference to the National Archives. Where the Department believes that its accountability will be substantially compromised because a retention period or periods are not adequate, it should contact the National Archives for review of the retention period.
  8. Records coming within the 'Retain as national archives' class in this Authority have been determined to be part of the archival resources of the Commonwealth under Section 3C of the Archives Act 1983. The determination of Commonwealth records as archival resources of the Commonwealth obliges agencies to transfer the records to the National Archives when they cease to be current and, in any event, within 15 years of the records coming into existence, under Section 27 of the Archives Act 1983.
  9. Records in the care of agencies should be appropriately stored, managed and preserved. Agencies need to meet this obligation to ensure that the records remain authentic and accessible over time. Under Section 31 of the Archives Act 1983, access arrangements are required for records that become available for public access including those records that remain in agency custody.
  10. Appropriate arrangements should be made with the National Archives when records are to be transferred into custody. The National Archives accepts for transfer only those records designated as national archives.
  11. Advice on how to use this Authority is available from the Department's records manager. If there are problems with the application of the Authority that cannot be resolved, please contact the National Archives.

Contact Information

For assistance with this authority or for advice on other records management matters, please contact National Archives' Agency Service Centre.

Queen Victoria Terrace
Parkes ACT 2600

PO Box 7425
Canberra Mail Centre ACT 2610

Email: recordkeeping@naa.gov.au
Website: www.naa.gov.au

Authorisation

Person to whom notice of authorisation is given:

Mr David Learmonth
Acting Secretary
Department of Health
GPO Box 9848
Canberra ACT 2601

Purpose:

Authorises arrangements for the disposal of records in accordance with Section 24(2)(b) of the Archives Act 1983

Determines records classed as 'Retain as national archives' in this Records Authority to be part of the archival resources of the Commonwealth under section 3C of the Archives Act 1983.

Application:

All core business records relating to Pharmaceutical Benefits and Access.

This authority gives permission for the alteration of the records described. This authority will apply only with the consent of the agency currently responsible for the business documented in the records described.

Authorised by:

Anne Lyons
Acting Director-General
National Archives of Australia

10 October 2014

Classes

Pharmaceutical Benefits and Access

The core business of facilitating public access to pharmaceutical benefits and regulating the use of medicines by the public. Includes providing access to life saving and high cost drugs, and targeted assistance through measures designed to increase the affordability of pharmaceutical aids and appliances or providing pharmaceutical products at no cost to eligible individuals.

The core tasks associated with pharmaceutical benefits and access include:

  • developing, implementing, and reviewing policies, strategies, plans, and programs;
  • developing, maintaining and updating the listing of pharmaceutical benefits;
  • managing applications for inclusion on, or modifications to, the listing of pharmaceutical benefits;
  • pricing pharmaceutical benefits;
  • negotiating, establishing and implementing agreements, including agreements with pharmaceutical companies and drug manufacturers;
  • assessing the eligibility of individuals for access to certain subsidised pharmaceutical benefits or items;
  • approving suppliers of pharmaceuticals; 
  • providing funding and subsidies to support the supply of pharmaceuticals;
  • providing advice and other forms of information to stakeholders, including on the quality use of medicines;
  • managing appeals and reviews arising from unsuccessful applications for programs and other administrative activities; and
  • conducting research.

The performance of the core business is supported by general administrative tasks such as:

  • liaising and consulting with internal and external stakeholders;
  • developing, implementing, and reviewing internal processes, systems and procedures;           
  • developing reports and submissions; 
  • managing and participating in internal and external meetings and committees;
  • preparing and presenting speeches and addresses; 
  • managing and monitoring public reaction, feedback and enquiries;
  • arranging and attending conferences; 
  • planning, conducting and facilitating audits; and
  • identifying, assessing and managing risks.

Cross references to AFDA Express Records Authority

  • For advice to the portfolio Minister and ministerial and cabinet submissions, use GOVERNMENT RELATIONS.
  • For development of legislation, including liaising with relevant stakeholders, use GOVERNMENT RELATIONS and/or STRATEGIC MANAGEMENT.
  • For acquisition of goods and services, use PROCUREMENT.
  • For the preparation of budget estimates, budget proposals, cost modelling, and making financial transactions, use FINANCIAL MANAGEMENT.
  • For the production and distribution of agency publications, use PUBLICATION.

Cross references to other records authorities

  • For statutory and non-statutory advisory bodies supporting pharmaceutical benefits and access, such as the Pharmaceutical Benefits Advisory Committee (PBAC) and the Pharmaceutical Benefits Pricing Authority (PBPA), use ADVISORY BODIES.
  • For the application, awarding and management of grants, including grant funding agreements, use GRANT MANAGEMENT.
  • For public access to medical and health care services and systems relating to the delivery of community, primary and acute care, use MEDICAL AND HEALTH CARE ACCESS.
Class no Description of records Disposal action
61525

The following significant records documenting:

  • developing, implementing and reviewing national and high-level policies, plans, strategies, schemes, frameworks, programs and services supporting the core business. Includes the Pharmaceutical Benefits Scheme, Life Saving Drugs Program and programs under the Community Pharmacy Agreements. Includes final versions, proposals, briefs, submissions, records of stakeholder consultation, major drafts and supporting research;
  • high-level advice given to or received by major stakeholders in support of the core business. Includes final versions of formal advice, submissions, supporting research and briefs;
  • high-level internal and external committees and other bodies where the agency provides the Secretariat, is the Australian Government's main representative, or plays a prominent or central role (eg Subcommittees of the Pharmaceutical Benefits Advisory Committee including the Drug Utilisation Sub-Committee and the Economic Sub-Committee). Includes establishment documentation, agenda, final versions of minutes, reports, briefing notes and tabled papers;
  • master version of the listing of pharmaceutical items that are subsidised by the Australian Government through the pharmaceutical benefits scheme. Includes final published versions and datasets and associated information about the data fields (eg data dictionaries and data repositories);
  • application decisions referred to Cabinet in relation to the core business, including proposed listings and amendments to the Pharmaceutical Benefits Scheme Schedule, Life Saving Drugs Program, Immunise Australia Program, and products and appliances;
  • summary records (such as registers) of applications received in relation to the pharmaceutical benefits scheme (eg Pharmaceutical Evaluation Branch Database, Pharmaceutical Benefits Advisory Committee Database). Includes datasets and associated information about the data fields (eg data dictionaries and data repositories);
  • final versions of significant agreements and contracts (including contracts under seal) and supporting documents, where the contracts and agreements: relate to substantial pharmaceutical benefits funding arrangements with States and Territories and other organisations; are controversial, of public interest or ground-breaking in nature; or will substantially impact upon the provision of pharmaceutical benefits in Australia (eg Community Pharmacy Agreements). Includes joint venture agreements, Memorandums of Understanding and Deeds of Standing Offer;

For National Partnership Agreements, National Partnership on Improving Public Hospital Services, and Special Pricing Arrangements, use Medical and Health Care Access

  • outcomes of research undertaken to support the core business, including trend analysis. Includes final research reports, research findings, statistical analysis, and data models;
  • developing national and high-level internal and external reports supporting the core business. Includes final versions, stakeholder consultation and supporting research;
  • national and high-level reviews relating to the core business, including major internal reviews, that: relate to matters which are controversial or of public interest; will have a substantial social, economic, or political impact; result in substantial changes to agency policy and programs; or have far reaching implications for the provision of pharmaceutical benefits. Includes final reports, major drafts and submissions;
  • master versions of agency publications produced to support the core business (eg Australian Statistics on Medicines);
  • final versions of unpublished proceedings, reports and papers from pharmaceutical benefits and access related conferences, seminars and workshops hosted by the agency;
  • final versions of speeches and addresses presented by the portfolio Minister or senior agency staff in support of the core business, including addresses presented at conferences; and
  • appeals and reviews of decisions made by the agency under health care legislation that are precedent setting, related to issues that are controversial or of public interest, or result in significant changes to agency policy or programs. Includes reports for legal counsel and supporting application case files.
Retain as national archives
61526

Records documenting:

  • processes associated with maintaining and updating the listing of pharmaceutical items that are subsidised by the Australian Government through the pharmaceutical benefits scheme, other than those covered in 61525, including:
    • development of advice and general information for the prescribing of pharmaceutical benefits by medical practitioners and participating dental practitioners, and the supply of pharmaceutical benefits by approved pharmacists, approved medical practitioners and approved hospital authorities;
    • receipt and processing of applications from pharmaceutical companies and drug manufacturers to be included in the schedule, or for an existing listing to be modified. Includes the granting of approvals and restricted approval, the receipt and processing of information requested and provided after an application has been granted, correspondence, case files on each supplier, and the withdrawal, lapsing, or revocation of approvals;
    • liaison, consultation, negotiation and correspondence with pharmaceutical companies and drug manufacturers seeking to be included in the listing, or the listing to be modified, and other relevant stakeholders; 
    • collection and collation of information in support of applications or proposed changes;
    • development or receipt of impact assessments or legal advice, and recommendations resulting from these activities; and
    • formal approval by the delegate for inclusion in the listing.

For the master version of the listing of subsidised pharmaceutical items and for application decisions referred to Cabinet, use class 61525.

For legal advice relating to the interpretation of agency legislation, use AFDA/AFDA Express – LEGAL SERVICES.

  • receipt, assessment, determination of eligibility, and processing of applications from individuals for access to certain eligible subsidised pharmaceutical benefits or items, including aids and appliances. Includes applications, minutes, briefs, correspondence, legislative instruments and notification of assessment outcome; and

For policies establishing eligibility criteria for the assessment of applications from individuals for access to subsidised pharmaceutical benefits and items, use class 61525

  • independent reviews of decisions made by the agency under healthcare legislation.

For other reviews of decisions, use class 61525 or 61529

Destroy 100 years after last action
61527

Records documenting:

  • pricing of pharmaceutical benefits. Includes liaison, consultation and correspondence between the Department and pharmaceutical companies or drug manufacturers. Includes company files, records of negotiations, correspondence, minutes, briefs, submissions, and applications; and
  • developing, implementing and reviewing programs and services supporting the core business, other than those covered in class 61525. Includes stakeholder consultation, communication and change management strategies, supporting research, funding arrangements and budget papers, correspondence, minutes, and briefs.
Destroy 20 years after last action
61528 Signed agreements or contracts executed under seal with individuals, government agencies, non-government organisations and companies (including pharmaceutical companies), relating to the core business, and supporting records. Includes joint venture agreements, Memorandums of Understanding and Deeds of Standing Offer. Excludes agreements and contracts under seal covered in class 61525. Destroy 21 years after completion or other termination of agreement
61529

Records documenting:

  • routine operational administrative tasks supporting the core business; and
  • pharmaceutical benefits and access activities, other than those covered in classes 61525 to 61528.
Destroy 10 years after action completed
Copyright National Archives of Australia 2017