Central Database Working Group
A Centralised Reporting System for Medicines Australia Member Companies’ Payments and Transfers of Value to Health Care Professionals.
On 24 April 2015 the ACCC issued its final determination granting conditional authorisation of Edition 18 of the Medicines Australia Code of Conduct for a period of five years. The authorisation became effective on 16 May 2015.
A condition of the authorisation is that Medicines Australia must use reasonable endeavours to develop and implement a Central Reporting System which will allow the public to access information on payments and transfers of value from all companies to healthcare professionals in a single location, via the internet. This condition also requires Medicines Australia to provide regular six-monthly reports identifying the steps taken each reporting period to develop and/or implement a Central Reporting System.
This report summarises Medicines Australia’s work in the second six months following authorisation of Code Edition 18.
Centralised Database Working Group
The Centralised Database Working Group (CDWG), comprising twelve personnel from Medicines Australia’s member companies, has continued investigating the feasibility of developing and implementing a central reporting system or database. The Working Group and the Board of Medicines Australia are aware that establishing a central reporting system is a significant project, with both short and long-term challenges that must be thoroughly assessed in order for it to be fit for purpose, legally compliant, financially viable, appropriately supported by member companies and acceptable to all stakeholders.
Since the first progress report in November 2015, the Working Group has undertaken work on the following issues:
- Members of the CDWG have drafted a technical overview of a central reporting system. A central reporting system would need to enable member companies to upload and administer their data within the system. Different upload options would need to be available to companies, reflecting that different companies would have different amounts of data to be uploaded. The reported data could be made available to the public via a web-based search function that could enable a person to search the database by name and work address of a healthcare professional and display the search results for those companies that had made a reportable payment to the individual healthcare professional.
- The CDWG has further investigated options for a unique identifier for each healthcare professional that could enable data from all companies to be combined within a central reporting system. Members of the CDWG met with officers from the Office of the Australian Information Commissioner (OAIC) to request specific advice on utilisation of the Australian Healthcare Practitioner Regulation Authority (AHPRA) registration number as a unique identifier. The OAIC confirmed that a central reporting system established by Medicines Australia is unlikely to be able to meet the exceptions in Australian Privacy Principle (APP) 9.1. Therefore, the Privacy Act would prevent Medicines Australia from adopting the AHPRA registration number as a healthcare professional unique identifier within a central reporting database.
- The absence of a comprehensive, national, non-proprietary healthcare professional unique identifier significantly adds to the complexity and cost of establishing and maintaining a central reporting system that would deliver a high standard of data integrity. Having recently received the OAIC advice, alternatives to the AHPRA registration number are now being considered by the CDWG. Alternatives include establishing and maintaining a database of healthcare professional unique identifiers for a central reporting system or utilising an established proprietary healthcare professional unique identifier. The requirement to identify an alternative unique identifier increases the complexity, time required and cost of establishing and maintaining a central reporting system, which must be carefully considered.
- During consideration of Medicines Australia’s application for authorisation of Code Edition 18, the Australian Privacy Commissioner noted that storage of personal information in a centralised database, including a publicly available database, poses potential privacy risks. The Commissioner recommended that a Privacy Impact Assessment (PIA) of a central reporting system should be conducted early in the scoping and design stage. Medicines Australia has engaged an external organisation with expertise in Australia’s privacy laws to conduct a PIA to ensure that a central reporting system could comply with Australia’s privacy laws and meet all legal obligations of Medicines Australia and its member companies. The PIA is expected to be completed by mid-June 2016. The recommendations from the PIA must then be taken into account in the further evaluation of a central reporting system.
- Initial estimates of the cost of establishing and maintaining a central reporting system have been sought, to assist the CDWG and Medicines Australia to consider how a central reporting system could be funded.
- As previously reported, the CDWG has communicated with the Association of the British Pharmaceutical Industry (ABPI), which is developing a central database on behalf of its member companies for reporting payments and transfers of value to healthcare professionals. A senior manager from Medicines Australia will meet with ABPI personnel in May 2016 to gather further information about their progress in establishing the ABPI central database and learnings that may assist the CDWG and Medicines Australia in its consideration of establishing a central reporting system.
Next steps and member consultation
A number of questions and concerns have been raised by member companies in relation to establishing and maintaining a central reporting system. The CDWG and Medicines Australia will report to and further consult with member companies on the work that has been undertaken and the issues arising as described in this progress report, including consideration of:
- the outcomes of the PIA to ensure that a central reporting system would be consistent with member companies’ and Medicines Australia’s obligations under Australia’s privacy legislation
- the cost of establishing and maintaining a central reporting system and how it could be funded, also taking into consideration member companies’ internal costs and resources that would be required
- experience from central reporting systems implemented in other countries, to gain knowledge from others’ experience and avoiding problems.
16 May 2016
Downloadable PDF is also available.
The first Progress Report published on 16 November 2016 is also available.