In our May 2013 newsletter, we reported on the progress of the Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013 (the Bill). The Bill sought to replace the Medicines Australia Code of Conduct (the Code) and to subject "regulated corporations" to reporting requirements. It also sought to restrict certain interactions between healthcare professionals and pharmaceutical companies.
On 17 June 2013, the Senate Finance and Public Administration Legislation Committee (the Committee) recommended that the Senate reject the Bill.
The Committee received 25 submissions from interested parties, including government, industry and the Australian Medical Association. Ultimately, the Committee recommended that continuing self-regulation was preferable to the proposed legislation. The Committee's concerns included that the proposed legislation would be of limited application, would restrict appropriate interactions between pharmaceutical companies and medical practitioners, and would lessen existing requirements under the Code.
Since then, the Transparency Working Group established by Medicines Australia has developed and published a Transparency Model Consultation and Discussion Paper with the aim of introducing greater transparency about payments and transfers of value between healthcare professionals and the pharmaceutical industry.
The Discussion Paper proposes that all payments or transfers of value provided by a company to a healthcare professional relating to prescription medicines be reported to Medicines Australia, with a view to all payments made after 1 January 2015 being disclosed on a public register.
The Discussion Paper will be considered as part of the Code review for the 18th Edition of the Medicines Australia Code of Conduct. The review commenced in July 2013 and submissions have been invited. There has already been an amount of negative commentary about the Transparency Working Group's proposals, including that the proposals are unrealistic, overly burdensome and raise unresolved privacy and taxation issues. By one estimate, the number of reports companies would have to make to Medicines Australia could exceed 500,000 per year.
The Code review is scheduled to be completed by Q3 2014 and, subject to approval by the ACCC, the 18th edition is intended to be operational from 1 January 2015.