Clinical Trials and Other Physician-Industry Interactions in Australia
Ric Day
University of New South Wales

he representative body of the innovative, prescription medicines industry in Australia, Medicines Australia is responsible for administering the Medicines Australia Code of Conduct. This self-regulatory system, underpinned by legislation, sets the standard for the ethical promotion and marketing of prescription medicines in Australia. These standards must be adhered to by member companies. Penalties for breaches of the Code of Conduct can be considerable and are increasing in severity year after year. Breaches of the Code and the resultant fines are published on the Medicines Australia website quarterly along with the comprehensive Code of Conduct Annual Report.

Clinical Trials

The Australian Clinical Trials Alliance (ACTA) has just concluded their International Clinical Trials conference, opened by the Federal Minister for Health Greg Hunt. As an indication of the interest in the topics the conference discussed, the official Conference Twitter hashtag #ACTAconf trended at number 4 in all of Australia!

As part of his presentation, Hunt launched an upgraded version of the Clin Trial Refer app which now delivers a comprehensive listing of clinical trials that are recruiting globally. Feedback from end-users and experts incorporated in this new Version 2 includes features such as customized searches that notify individual in real-time of trials in their areas of interest. Search filters such as age, tumour type, mutation status, and telehealth options can also be applied. The phase 1 cohort feature, among many new features, should improve recruiting. Pending studies and the cohorts being sought by investigators (including inclusion and exclusion criteria) can also be viewed to give patients and doctors opportunity to consider their participation.

This important initiative fits Clin Trial Refer’s mission: Collect, Collaborate, Clin Trial Refer. It also aligns with its vision: To increase participation in clinical trials research; all patients, all trials, all doctors. Initiatives that increase the numbers of patients in important clinical trials are critical to faster development of needed medicines globally, and this initiative is a welcome step towards this end.

Physician-Industry Interactions

The Code of Conduct has evolved over its sixty years through regular, open and intensive review via submissions from stakeholders and the Australian Competition and Consumer Commission. After acceptance by the Board and Membership, each new iteration (currently the 18th edition) must be authorised by determination of the Competition and Consumer Commission. The current edition, which came into use in 2015, introduced measures to enhance transparency around payments and other benefits of value from pharmaceutical companies to healthcare professionals.

A new addition to increase transparency regarding interactions between pharmaceutical companies and health professionals has just been announced. Medicines Australia launched a Centralised Reporting System (CRS) for companies to report and consumers to access information on details of these interactions in an accessible and searchable manner. This material was previously only available on company web sites, a requirement upon member companies for several years, but consumers experienced difficulties navigating such an uncoordinated system.

“It’s all about building trust about relationships between our industry and doctors as well as other healthcare professionals,” explains Sophie Hibburd, Director of Ethics and Compliance, Medicines Australia. “Interactions that are appropriate and that add value to a prescriber’s ability to deliver the best care for their patients is our goal.”

She further notes that the initiative had been in development for a number of years with multiple workshops and consultations with key stakeholders, including doctors’ organizations and the Consumer Health Forum, conducted throughout. “A lot of IT and privacy issues had to be dealt with along the way, and we are delighted that since the CRS was launched at the end of August this year, over 6000 searches have been undertaken,” she continues. “There has been some use by companies checking on their competitor’s interactions with doctors, but this was also possible previously.” So far, the site has performed well and responses have been positive.

Medicines Australia is committed to evaluating the effectiveness and acceptability of this System for the public and improving it accordingly. Pharmaceutical companies that are not members of Medicines Australia can enter, and are already entering, their data on the site, increasing the value to consumers in particular. But an interesting question arises: Will this tool alter pharmaceutical company marketing practices to the healthcare practitioners with whom they interact? One reasonable supposition is that this will promote ethical and effective interactions that will be beneficial for patients.