Bidding farewell to a significant contributor in Australian Pharma

The Australian Pharmaceutical industry bids farewell to three decades of experience and outstanding contribution. Ms Deborah Monk, pharmacist and Director, Ethics and Compliance, Medicines Australia, shares her industry insights with Health Industry Hub.

Health Industry Hub: How has Ethics and Compliance in the Australian Pharmaceutical industry evolved in the last decade? How do you see this changing in the next 3-5 years?

Ms Monk: The biggest difference in the last decade is a much greater focus and intensity on ethics and compliance amongst Medicines Australia member companies. That is not only with respect to marketing compliance under the Code of Conduct, but compliance overall.

Years ago, when I first started in the industry, the Code of Conduct responsibility within the company might have been a part of one person’s job. Now we see larger member companies like Pfizer, AstraZeneca, AbbVie, Bristol-Myers Squibb and GSK have a compliance lead and several people reporting to them to manage the ethics and compliance responsibilities.

As we have seen the Code evolve members have wanted the Code to be more detailed to guide them. Unfortunately, over time, the Code has become much longer, more specific and more prescriptive.

Currently we are going through this evolution where member companies are saying perhaps we need to move to a more principles-based approach recognising that we should be making decisions based on a sound understanding of the ethical principles rather than a prescriptive method.

Over the next three to five years, we would like to see the principles-based Code of Conduct securely embedded in our member companies. Additionally, we endeavour to have the number of complaints being raised under the Code remain at a relatively low level demonstrating a good level of compliance amongst companies.

Health Industry Hub: What can the industry do differently to enhance its image in the community? Is there an innovative approach to consider?

Ms Monk: We need sustained efforts in raising awareness of the Pharmaceutical industry’s ethical behaviour within Australia and globally. We have not been out there on the front foot explaining to all key stakeholders how our behaviour has changed over time and that we do not offer inappropriate benefits to healthcare professionals today.

Often we hear negative comments from the media or from the critics. Today, as an industry, we certainly support healthcare professionals to attend educational meetings. It is valuable to their learning, to their patients, to the community here in Australia, but it is not to benefit the healthcare professional personally.

Perhaps a focus on the use of digital media rather than traditional media channels may boost this message to the wider audience and enhance the Pharmaceutical industry’s image in the community.

Health Industry Hub: The influence of digital healthcare is significant globally. What do you see as its biggest impact for the Australian Pharmaceutical industry?

Ms Monk: International transformations in healthcare often impact Australia. The real challenge is how we want to regulate the different types of technology. The Code of Conduct is supported by and follows a regulatory framework from the government. So how is the government going to deal with those new technologies and how will the Code of Conduct reflect these changes?

Health Industry Hub: In the short to medium term, what are key opportunities for the Australian Pharmaceutical industry to navigate the complex landscape? Which barriers are relevant to overcome?

Ms Monk: In the recent five years we have seen a real blurring of the boundaries between what we traditionally regarded as a prescription medicine, over the counter medicine and a medical device.

The opportunity for Medicines Australia is to embrace the broader scope of technology in order to represent those companies from both a policy and Code perspective. We recently updated the Medicines Australia Constitution to refer to biotherapeutics rather than just prescription medicines, as well as refer to vaccines, to recognise that the landscape is changing.

One of the key barriers raised by member companies and discussed with government and other key stakeholders is the translation of the knowledge and technologies developed by start-ups and the biotechnology companies. Often smaller companies do not have that financial support or experience to be able to take that discovery through to the bedside to enhance patient outcomes.

Health Industry Hub: Considering the years at Medicines Australia, what is one of your most memorable moments?

Ms Monk: In 2010 we celebrated the Code of Conduct’s 50th birthday which was a truly memorable event. Next year, it is the 60th birthday of the Code and I am hoping for an invitation to join the celebrations.

Additionally, my role has given me the opportunity to engage with similar people around the globe who manage the Code of Conduct within their own countries. I have had the pleasure of working with passionate colleagues from the UK, Spain, US, and the Asia Pacific region. We have engaged not only through our international federation, but also through the regional forum, to encourage countries in the Asia Pacific region to raise their standards of ethical conduct in the pharmaceutical and medical devices sectors.

Health Industry Hub: What is the legacy you are aspiring to leave behind to shape the future and to inspire your industry colleagues?

Ms Monk: I would like to think that I am leaving a legacy of good collaboration, not only with our internal team at Medicines Australia but with other industry association members and key stakeholders including the government and ACCC. There will always be challenges to overcome. We need to work through the issues calmly and respectfully to arrive at a solution that is going to move us forward and move the key stakeholders forward.

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Bio: Ms Deborah Monk
BPharm Dip Hosp Pharm BA MPP
Director, Ethics and Compliance, Medicines Australia

Deborah holds a Bachelor of Pharmacy from the University of Sydney and a Diploma in Hospital Pharmacy. She also holds a Bachelor of Arts from Macquarie University and recently completed the Masters in Public Policy degree at the University of Sydney. Deborah started her working life as a clinical pharmacist in the Pharmacy Department at a major teaching hospital in Sydney. Deborah has been the Director of Ethics and Compliance at Medicines Australia. She has worked for Medicines Australia or its predecessor the Australian Pharmaceutical Manufacturers Association since mid-1989 in various roles including as Scientific and Technical Affairs Director. Deborah’s primary responsibility within Medicines Australia is to manage the Ethical Conduct Program, which includes administering the Medicines Australia Code of Conduct.