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.
Centralised Database Working Group
Medicines Australia and the Centralised Database Working Group (CDWG), comprising personnel from Medicines Australia’s member companies, have continued to investigate the feasibility of developing and implementing a central reporting system or database.
Since the third progress report published in November 2016, the Working Group has undertaken the following work.
Preparation of a description of the requirements for a Central Reporting System
Medicines Australia engaged an external, Australian company with expertise in business ICT systems and solutions to prepare a detailed description of the requirements for a central reporting system.
In engaging an external company to develop the description of requirements, Medicines Australia was careful to appoint a company that would not have a conflicting interest in the future development of a central reporting system. Further, the appointed company was instructed that the description of requirements must not propose specific system solutions or software platforms to deliver a centralised reporting system, which could potentially limit solutions that may be considered.
The information provided to the external company to enable it to perform this work included:
- The current reporting requirements:
- The Medicines Australia Code of Conduct requirements for reporting payments and transfers of value to healthcare professionals
- The Code of Conduct Guidelines for Edition 18 in relation to the requirements for reporting payments and transfers of value to healthcare professionals
- The Reporting Template for payments and transfers of value to healthcare professionals.
- The ACCC Conditions of authorisation of the Code of Conduct Edition 18 relating to the Central Reporting System.
- The Privacy Impact Assessment (PIA) of a Central Reporting System Report commissioned by Medicines Australia, noting that the description of the requirements of a Central Reporting System must respond to the relevant recommendations in this Report to address potential privacy risks.
- The ‘flow diagram’ that describes the conceptualisation of a central reporting system, which was also included in the PIA Report.
- Directions to review the current payment and transfer of value reports published on member company websites.
The detailed description of requirements for a Central Reporting System prepared by the external company includes:
- Functional requirements – a detailed description of what a Central Reporting System would be required to do, such as how the system would manage combining member companies’ data to ensure its integrity; how companies’ data would be validated within a centralised system; how the data would be made accessible by a central system; and how data that is older than three years would be removed from the system.
- Non-functional requirements – the usability of a centralised system for member companies to enable them to check data within a centralised system; the reliability and performance parameters of the system; and ongoing supportability of a system.
In order to undertake the preparation of the description of requirements, the external company has worked closely with the Director, Ethics and Compliance and Manager, Ethics and Compliance at Medicines Australia as well as with the Central Database Working Group members. The Working Group participated in a half day workshop with the external company to prepare process maps and descriptions of the current method of reporting payments and transfers of value made to healthcare professionals on companies’ websites.
The Working Group also participated in a second workshop with the external company to advise on the process maps and descriptions for the management of healthcare professional information within a centralised reporting system. This workshop considered the processes for:
- Submission of data to a central reporting system
- Validation of the data and resolution of any data errors (this validation is not a check of the accuracy of the payment and transfer of value information. It is a systematic check of the type of data submitted within each data field)
- Checking healthcare professional identity and confirming the unique identity of each healthcare professional by matching details with data already held within the central reporting system or identifying that the healthcare professional is a new unique identity
- Data publication by the central reporting system
- Removing and archiving data where the data has been published for more than three years
The Working Group has reviewed all documentation prepared by the external company associated with this work to ensure that the description of requirements is consistent with member companies’ obligations under Australia’s Privacy legislation and the Code of Conduct requirements for transparency.
Medicines Australia has reviewed and discussed each recommendation from the PIA Report that is relevant to the design of a central reporting system with the external company. For example, the risk that a central reporting system could publish inaccurate or incorrect information about a healthcare professional has formed a key consideration in the development of the description of requirements to ensure that this risk is minimised as far as practicable and that any potential solution would need to include the facility to correct published information in a timely and responsive manner, should this be required. The work of developing the description of requirements has reinforced the considerable complexity of managing personal information collected and submitted by multiple companies, ensuring the data’s integrity as it passes through validation, matching, collation and publication.
Learning from other countries
As part of its development of the system requirements, the external company was also directed to review the “Disclosure UK” website, which is the database established by the Association of the British Pharmaceutical Industry (ABPI), as this database has considerably informed the Medicines Australia Working Group’s conceptualisation of a central reporting system. Once the external company was familiar with the Disclosure UK website, Medicines Australia facilitated a teleconference between the ABPI manager responsible for the database and external company. In the teleconference the following issues were explained and discussed:
- The rationale for engaging two third parties to establish the database and the mechanisms required to ensure the protection of proprietary information associated with data uploaded to the database
- The risks and benefits of repurposing customisable, off-the-shelf software platforms and data sources for a centralised reporting system and similarly the risks and benefits of commissioning bespoke software
- The challenges associated with the data template, developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), with respect to its utility for collecting data for submission to the database
- The mechanism for healthcare professional and healthcare organisation data matching and validation of data as it is submitted to the database
- The cost recovery model employed by ABPI for companies uploading data to the database
- Challenges that have arisen during the establishment and implementation of the Disclosure UK database.
In addition to the complexity of functional data management and integrity assurance, our further interactions with the ABPI have reinforced the associated complexities that would need to be managed in a central reporting system. These have particularly related to data ownership and data sharing. As there is no single, publicly available unique healthcare professional identifier, and each member company utilises their own contracted providers to supply information relating to individual healthcare professionals or maintains their own internal unique ID system, the exchange of this information between member companies and the two external companies engaged to deliver the Discovery UK database has necessitated multiple, complex data sharing agreements between all the parties. A similar system of data sharing agreements would likely be required for a central reporting system, which Medicines Australia will continue to investigate.
These are complex issues with respect to data ownership, liability for data accuracy and legal compliance as between member companies, the industry association and third party service providers that will need careful consideration.
The ABPI database manager also advised that new EU Data Protection laws will come into force in May 2018, which may impact on the way a central reporting system containing personal information ensures compliance with the law. This highlights that a central reporting system must be sustainable in light of any changes in the legal framework for protection of personal information both within Australia and internationally.
Our interactions with the ABPI in learning from their experience, and particularly identifying the challenges and potential risks, with establishing a central database continue to be very valuable in Medicines Australia’s considerations.
Second Transparency Reports
Considerable time and effort in the last six months has also been given to preparing the information for the second reports of information about reportable payments and transfers of value to individual healthcare professionals. The second reports, relating to activities occurring between 1 May 2016 and 31 October 2016, were published on 28 February 2017. 33 member companies published their reports on their company websites. In addition, one company that is no longer a Medicines Australia member continued to publish its report on its company website. Therefore, a hyperlink to this company’s report was retained on Medicines Australia’s website along with the hyperlinks to our member companies’ transparency reporting pages.
The second six months of reportable payments and transfers of value to healthcare professionals comprised 5 months’ data where healthcare professionals were asked for consent to have their information published and one month’s data, for October 2016, where healthcare professionals were no longer asked for their consent but had the reasonable expectation of reporting. For activities occurring between May and September 2016, where healthcare professionals were asked for their consent for their information to be published, the frequency of healthcare professionals giving consent was very consistent with the first six months of reports. On average, nearly two out of three healthcare professionals agreed to have their information published. Where consent was not provided, payments and transfers of value were published in aggregate.
The work of Medicines Australia and its members in the six months to May 2017 has demonstrated substantial further progress on consideration of the development of a central reporting system whilst delivering transparent reporting of payments and transfers of value to healthcare professionals for activities between May 2016 and October 2016.
However, the detailed examination and understanding required to develop the statement of requirements has continued to highlight the complexities and challenges of implementing a central reporting system for healthcare professionals’ receipt of payments and transfers of value.
Medicines Australia will continue to consider these important issues.
16 May 2017
Downloadable PDF is also available.