Following in the footsteps of the US and many parts of Europe, Australia has now become the next country to set up a system to disclose payments to doctors on an individual basis.
An update to the Australian code of conduct for the ethical marketing and promotion of prescription pharmaceutical products has now been authorised by the Australian Competition and Consumer Commission (ACCC), an independent authority responsible for enforcing legislation on competition and fair trading.
The Code of Conduct was originally created in 1960 by the industry association ‘Medicines Australia’ (who represent the ‘discovery-driven’ pharmaceutical industry in Australia and whose members supply 80% of the medicines available to Australian patients). The code has been regularly updated since then and the new revisions will form part of the ‘18th Medicines Australia Code of Conduct’.
For over a decade in Australia, as in the rest of the world, stakeholders have been requesting more transparency in the interaction between medical professionals and the pharmaceutical industry. According to Tim James, CEO of Medicines Australia, “This Code shows the leadership and integrity of the Australian pharmaceutical industry. It will also strengthen the transparency and trust which are so important in the relationship between the industry, healthcare professionals and the community.” The amendments to the 18th Code of Conduct now include a more proactive statement about the commitment to transparency and how the industry interacts with healthcare professionals.
In particular, there are new requirements in the relationship with healthcare professionals for educational events: companies must have policies and procedures in place that will ensure educational events comply with the code and, in particular, ensure that the maximum cost of a meal does not exceed $120 (including beverages). New rules also apply for travel expenses to attend an educational meeting or for a third party meeting.
Under the new Code, the following activities would be reported by pharmaceutical companies for individual healthcare professionals, by name, with the amount of the payment or transfer of value:
• Consulting fees and/or speaking fees at educational event.
• Sponsorship of a healthcare professional to attend an educational event: airfares, accommodation and/or registration fees (whether held within or outside Australia).
• Fees paid to healthcare professional consultants in Australia, or to their employers on their behalf, for specific services rendered by them: consulting fees, accommodation and airfares (whether within or outside Australia).
• Fees paid to healthcare professionals in their role as Advisory Board members: sitting fees, accommodation and airfares (whether within or outside Australia).
• Fees paid to healthcare professionals for the purpose of market research only where the identity of the healthcare professional is known to the company.
• Payment of an educational grant or sponsorship to a specific healthcare professional
Companies will be required to report transfers of value and doctor information in accordance with the template provided in the Code of Conduct Guidelines. The first report is scheduled to be published on August 31, 2016 to cover the period from October 2015 to April 2016. After this, the reporting cycle will be every six months. Like in the US and Europe, companies must provide Australian healthcare professionals the opportunity to review and submit corrections to any data concerning them during a 6-week period before the public disclosure.
The Australian requirements are similar to the US Physician Payments Sunshine Act and the various national codes of conduct recently rolled out across Europe. However, there are some differences in the policies that should be pointed out. One example is for payments to consultants in relation to research and development work, including the conduct of clinical trials, which are reported in the US but do not have to be reported in Australia. Also, in Australia, the revised Code defines transfers of value as “one made by a third party on behalf of a company for the benefit of a recipient where the identity of the company is known to, or can be identified by, the recipient.”. In the US, however the onus is on the manufacturer: an indirect payment can be excluded from reporting requirements if the manufacturer does not know the identity of the recipient.
Another interesting difference is the concept of informed consent. The Code states that “Each company must establish a means to ensure informed consent and maintenance of records which comply with Australian Privacy legislation.” So that “Where recipients of transfers of value cannot be identified for legal reasons, the amount attributable to such transfers must be reported on an aggregate basis by each company. The number of recipients involved must be stated and the aggregate amount attributable to transfers of value to such recipients.” This follows the pattern of many of the codes of conduct across Europe. However in the US, the Sunshine Act allows manufacturers to totally dismiss complaints by healthcare professionals and means that the only way to opt out of reporting is to refuse to accept a payment.
According to the new Australian code of conduct, companies will have to publish data about payments and transfers of value on their own websites. Medicines Australia will provide hyperlinks from its website to each member company’s report. The industry group hopes that disclosure will help the general public to better understand the nature and extent of programs that the industry supports in the “interest of increasing quality use of medicines, advancing patient care and supporting our local communities.”
Ruth Knowles is a freelance science writer who has written articles and press releases on a range of life science and health topics. She received her MSc in Science Communication from the University of the West of England, Bristol.