Part 1: The growing scope of Medical Affairs – challenges the industry faces.
Written by Dr Niamh O’Reilly


Medical Affairs is undergoing an evolution of sorts. This is the first of a three-part series looking at three key areas where external landscape changes are impacting the Medical Affairs function.

1. Greater Consumer Empowerment

Unprecedented access to healthcare information has allowed patients to become more discerning about their health needs, which is influencing pharmaceutical and medical device companies to integrate patient centric strategies that impact across the organisation (1). Empowered consumers leverage knowledge to demand more sophisticated, convenient and personalised therapies (2).Traditionally, companies focused on satisfying the needs of regulators, payers and prescribers throughout the product life cycle, while patient insights were gathered indirectly via healthcare providers (3). However, patients have found their voice and the onus now is on industry to engage with them as key stakeholders and implement solutions that provide more considered support to patients.

Medical Affairs teams can respond to this by taking a ‘360-degree’ approach to engaging with patient communities in designing patient support programs (PSPs) that facilitate holistic disease management. This means the PSP does not simply focus on medication adherence but aims to demonstrate a deep understanding of how the disease and the therapy impact patient outcomes, which informs those services most meaningful to patients for improving their lives (3, 4). For example, PSPs developed for patients with diabetes may need to address the emotional, social and psychological impact of their condition, it’s monitoring and adhering to therapy, while a PSP for an oncology drug may require more focus on managing treatment side effects and how these impact patient lives.

2. Complex regulatory pathways

Innovative therapies, especially biological medicines, are being developed at an accelerated rate, which has created pressure on regulators to implement effective risk management solutions. In Australia, a series of reforms shown below have added to the burden of risk management activities for pharmaceutical and medical device companies (5).

Table reproduced from: https://www.tga.gov.au/sites/default/files/presentation-mmdr-consultation-strengthening-monitoring-of-medicines-in-australia-170426.pdf

These reforms include the introduction of the Black Triangle Scheme in Australia in 2017 (Figure 1), which has been in effect in the EU since 2013 (6). Black triangle notices will apply for a period of 5 years to biological medicines and therapies that contain a new active substance to indicate the medicine is subject to additional monitoring, as well as highlight the location of safety information along with details of how to report adverse reactions (5-7). These changes reflect the increasing concern of regulators and consumers about the long-term safety risk of some new medications,specifically biologicals that can cause increased risk of adverse events (7). These reforms can only benefit patient outcomes via the increased safety vigilance and risk management, however companies may be challenged by the increased workload and resource implications.

Figure 1. Example of new product labelling under the Black Triangle Scheme.

3. Informing payers about real world data

Healthcare systems globally are evolving from high cost fee-for-service based models towards value-based systems linking payment to performance and, as discussed previously, Australia has been slow to implement these changes (8). There is increasing pressure on pharmaceutical and medical device companies to demonstrate not just clinical effectiveness but the value for money their products provide. This is no longer achieved solely through traditional evidence based medicine in the form of clinical studies to prove the safety and efficacy of a therapy. In fact, companies are now facing unpredictable reimbursement decisions and are challenged to implement strategies to prove long-term, real-world clinical and cost-effectiveness outcomes in securing funding for new therapies (9, 10). Industry as a whole could therefore benefit from coming together as ‘change agents’to face this challenge by working with payers to establish the appropriate mechanism in progressing the collection and use of real world evidence to support therapy funding.

CRC’s mission is to increase our clients’ competitive edge by implementing Medical Affairs solutions to maximize commercial opportunities. Our dedicated Medical Affairs experts are well equipped to find strategic approaches for the current challenges facing industry and implement them with our clients.


  1. Taylor K, Steedman M, Sanghera A. 2017. Deloitte. Pharma and the connected patient – How digital technology is enabling patient centricity. Available at: https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-pharma-and-the-connected-patient.pdf
  2. Figgis P, Walters C. The Empowered Consumer. Available at: http://www.pwc.com/gx/en/industries/healthcare/emerging-trends-pwc-healthcare/new-entrants-healthcare-provision.html
  3. Gosling H. 2016. Patient-centricity: Ghost in the machine. Available at: http://www.pharmatimes.com/magazine/2016/may_2016/patient-centricity_ghost_in_the_machine
  4. Ocvirk A. 2016. Creating value through patient support programs. Available at: https://www.dddmag.com/article/2016/03/creating-value-through-patient-support-programs
  5. Cook J. 2017. Therapeutic Goods Administration. Strengthening monitoring of medicines in Australia. Available at: https://www.tga.gov.au/sites/default/files/presentation-mmdr-consultation-strengthening-monitoring-of-medicines-in-australia-170426.pdf
  6. European Medicines Agency. 2013. Medicines under additional monitoring. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp
  7. Scott S, Griffiths M. 2017. ABC News. Therapeutic Goods Administration considering new ‘black triangle’ warnings to make medicine safer. Available at: http://www.abc.net.au/news/2017-03-20/new-black-triangle-warnings-aim-to-make-medicine-safer/8369530
  8. O’Reilly N. 2017. From evidence based medicines to value based healthcare – is Australia ready? Available at: https://crcaustralia.com/media-releases/from-evidence-based-medicine-to-value-based-healthcare-is-australia-ready/
  9. Sackman J, Kuchenreuther M. 2015. BioPharm International. Market Access Outlook for Australia. Available at: http://www.biopharminternational.com/market-access-outlook-australia?__hstc=40333757.a7b8394010b2114973f462b41afaf8dc.1494816515259.1500334787588.1500422925924.13&__hssc=40333757.1.1500422925924&__hsfp=2974958270
  10. Loic P, Schlegel C, Gordian M. 2017. Reinventing the role of medical affairs. Available at: http://www.bain.com/publications/articles/reinventing-the-role-of-medical-affairs.aspx