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Medicines Australia CEO on new Code of Conduct

Health Industry Hub | February 24, 2020 |

In the lead up to the launch of Medicines Australia’s new Code of Conduct, Health Industry Hub gained closer insights from Ms Elizabeth de Somer, CEO of Medicines Australia.

Edition 19 of the Code of Conduct will come into effect on 30 March 2020.

Health Industry Hub: How has ‘compliance’ become more complex in the Pharma industry? What is driving this?

Ms de Somer: What we see is a greater focus on compliance activities and transparency, which in itself creates some complexity because you are open to much greater public scrutiny. What is driving this? It is largely consumer activity. Consumers have very high expectations of what they want from their healthcare professionals and what they want from their healthcare system. In order to give confidence to the community and prescribers, there has been a much greater focus on ensuring that we maintain appropriate ethical standards.

Health Industry Hub: Considering the existing Code, what has worked well and what has been a key challenge?

Ms de Somer: The Medicines Australia Code of Conduct is the gold standard for compliance in Australia. It is a rigorous, self regulatory Code that has gained support from all stakeholders. The fact that it is a requirement under the Therapeutic Goods Administration (TGA) regulatory framework as an expectation on registration of prescription medicines, it is testament to the high standards that the Code has as a benchmark.

The Medicine Australia Code of Conduct has provided prescribers, healthcare consumer organisations and consumers confidence to expect the highest ethical standard from the Pharmaceutical industry.

Over the years the Code provided marketing, medical and compliance professionals very clear guidance on how to deliver their promotional materials to healthcare professional. However, as technology has accelerated and the Pharma industry has matured, the format for delivering healthcare professional information and promotional materials have changed dramatically. Therefore, we have modernised the Code to keep pace with those advances in technology by which information is disseminated.

Health Industry Hub: How is the new Code different? How has it evolved?

Ms de Somer: The new Code offers a principles-based approach. The ethical standards and expectations from our members will be the same. Transparency reporting, Code committees, adjudications and sanctions will remain unchanged.

However, the Code itself is outlined as a more principles-based approach with greater permissive language and more streamlined. It aligns with the maturity of the Australian Pharma industry who understands their ethical expectations, in addition to having internal global and local compliance requirements. The new Code allows companies to keep pace with new technologies.

An example is that in the former Code, there were very detailed and prescriptive requirements on font size. The font must be three millimetres of a lower case in Times New Roman font. Due to the changes in the way that information is delivered digitally, the detailed direction on font size is meaningless. For this example the new Code is focused on legibility and readability – is the reader able to understand and read the text? The focus is on the principle of being clear, accurate, legible and not misleading or unreadable.

The new Code will work synergistically with each company’s internal compliance requirements to ensure that the ethical standards remain the heightened level they are now.

Health Industry Hub: What training and other support will be provided to Pharma companies in implementing the new Code?

Ms de Somer: Medicines Australia will be engaging with members to provide educational seminars, including group training and webinars, on how to interpret the new Code. We will also notify healthcare professionals and healthcare consumer organisations on expectations and the new guidelines.

Medicines Australia recommends the Code of Conduct Bridging Program conducted by the University of Tasmania, to provide detailed information on the application of the Code of Conduct.

Health Industry Hub: The Code has been quite rigorous – and rightly so – for many years. Yet, the general media continues to portray the Pharma industry in a negative way. What can the industry do differently to enhance its image in the community?

Ms de Somer: The value of medicines is broader than just taking a pill, having an injection or an infusion. It is about keeping people in the workforce, keeping people healthy, keeping people contributing to superannuation, out of hospital, watching their children grow up and live full lives without disability. We just have to keep pressing the value that the medicines and the pipeline of fantastic new creations are bringing to patients.

We also need to communicate more of what Medicines Australia and our members do in the corporate social responsibility areas to raise community awareness.

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