Dr Narcyz Ghinea

Postdoctoral Researcher
Sydney Health Ethics
School of Public Health


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Biographical details

I am a pharmaceutical policy analyst and empirical bioethicist with a background in applied mathematics. In my early career I developed predictive clinical decision support tools at the Department of Neurosurgery at Liverpool Hospital. In 2004 I was awarded a Phd scholarship to pursue this work by the Ingham Institute, but instead sought real-world experience of policy development and decision making processes. I worked in health administration with positions at the Clinical Governance Unit of the South Western Sydney Area Health Service, NSW Department of Health (now Ministry of Health), and the Clinical Excellence Commission.

In 2015 I returned to academia, becaming a full-time academic atSydney Health Ethics (formerly the Centre for Values, Ethics and the Law in Medicine) working on an NHMRC project investigating issues around the funding of high-cost cancer medicines. I completed my doctorate in 2017, atSt Vincent's Clinical Schooland theAustralian Institute of Health Innovation, UNSW. This project investigated the ethical and epistemic implications of off-label drug prescribing. To date, my research has been entirely funded by the National Health and Medical Research Council.

My work has been published in high-impact journals including first author articles in the Lancet and BMJ. For a current list of research articles and projects refer to my ResearchGate profile.

Research interests

I investigate the interface between clinical decision-making, ethics, evidence and health technology assessment of novel medicines, recognising that for meaningful policy solutions none of these facets can be analysed alone. Some current interests I have in this area include:

  • The blurring boundary between clinical research and clinical practice, and ambiguity around responsibility.
  • Impact of globalisation on health technology assessment and medicine access patterns.
  • The appropriate role of consumers in health technology assessment.
  • Application of decision sciences in health care.
  • The warrants that underpin clinical decision making in the real-world.

Teaching and supervision

Medicines policy, economics and ethics (BETH5209) (unit coordinator with Wendy Lipworth).

Topic Leader for the Public Health Capstone (PUBH5034).

Current projects

Improving funding of high-cost cancer medicines in Australia (NHMRC Project Grant).

An empirical and normative critique of off-label prescribing (funded through the NHMRC Patient Safety Program Grant).

In the media

I have been interviewed about my research by the New York Times, Fairfax, Radio National News, ABC Radio, ABC News, and the Medical Observer. I also regularly write for the Conversation. Some recent pieces I've written or co-authored include:

Articles that I have recently been interviewed for and quoted in include:

  • Cousins S. The Tasmanian Hep C buyers' club. The New York Times, July 25, 2017.
  • Pain C. 'Dallas buyers club' for cancer drugs presents a dilemma for patients and doctors. Medical Observer, March 3, 2017.
  • Lee J. 'Hundreds of cancer drugs' to enter market in next five years: report. Sydney Morning Herald, April 4, 2016.

Selected publications

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Journals

  • Ghinea, N., Kerridge, I., Lipworth, W., Pace, J. (2018). An ethical framework for the creation, governance and evaluation of accelerated access programs. Health Policy, 122(9), 984-990. [More Information]
  • Pace, J., Ghinea, N., Kerridge, I., Lipworth, W. (2017). Accelerated Access to Medicines: An Ethical Analysis. Therapeutic Innovation and Regulatory Science, 51(2), 157-163. [More Information]
  • Ghinea, N., Little, M., Lipworth, W. (2017). Access to High Cost Cancer Medicines Through the Lens of an Australian Senate Inquiry-Defining the "Goods" at Stake. Journal of Bioethical Inquiry, 14(3), 401-410. [More Information]
  • Pace, J., Ghinea, N., Kerridge, I., Lipworth, W. (2017). Caution needed in introduction of provisional approvals for medicines. Internal Medicine Journal, 47(11), 1321-1324. [More Information]
  • Ghinea, N., Kerridge, I., Little, M., Lipworth, W. (2017). Challenges to the validity of using medicine labels to categorize clinical behavior: An empirical and normative critique of "off-label" prescribing. Journal of Evaluation in Clinical Practice, 23(3), 574-581. [More Information]
  • Pace, J., Ghinea, N., Kerridge, I., Lipworth, W. (2017). Demands for access to new therapies: Are there alternatives to accelerated access? BMJ, 359, 1-4. [More Information]
  • Ghinea, N., Lipworth, W., Day, R., Hill, A., Dore, G., Danta, M. (2017). Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries. The Lancet, 389(10075), 1268-1272. [More Information]
  • Danta, M., Ghinea, N. (2017). The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study. Journal of Virus Eradication, 3(2), 77-81.
  • Harper, C., Ghinea, N., Lipworth, W. (2017). The Right to Health: Implications for the Funding of Medicines in Australia. Journal of Law and Medicine, 24(3), 640-655.
  • Ghinea, N., Lipworth, W. (2016). Affordable access to innovative cancer medicines - don't forget the prices. Medical Journal of Australia, 204(6), 214-215.e1. [More Information]
  • Lipworth, W., Ghinea, N., Kerridge, I. (2016). Negotiating limits to the funding of high cost cancer medicines. Cancer Forum, 40(2), 93-96.
  • Ghinea, N., Lipworth, W., Kerridge, I. (2016). Propaganda or the cost of innovation? Challenging the high price of new drugs. BMJ, 352, 1-4. [More Information]
  • Ghinea, N., Lipworth, W., Kerridge, I. (2015). Evidence, regulation and 'rational' prescribing: The case of gabapentin for neuropathic pain. Journal of Evaluation in Clinical Practice, 21(1), 28-33. [More Information]
  • Ghinea, N., Lipworth, W., Kerridge, I. (2015). Off-Label Promotion of Prescription Medicine: Is It Ever Justifiable? Therapeutic Innovation and Regulatory Science, 49(3), 359-363. [More Information]
  • Ghinea, N., Lipworth, W., Little, J., Kerridge, I., Day, R. (2015). Overcoming Entrenched Disagreements: the Case of Misoprostol for Post-Partum Haemorrhage. Developing World Bioethics, 15(1), 48-54. [More Information]
  • Day, R., Lipworth, W., Ghinea, N. (2015). The Ethics Around Drug Labels and Generic Medicines. Therapeutic Innovation and Regulatory Science, 49(3), 348-351. [More Information]
  • Ghinea, N., Lipworth, W., Kerridge, I., Little, J., Day, R. (2014). Ethics & Evidence in Medical Debates: The Case of Recombinant Activated Factor VII. The Hastings Center Report, 44(2), 38-45. [More Information]
  • Ghinea, N., Ghinea, N., Lipworth, W., Lipworth, W., Kerridge, I., Kerridge, I., Day, R., Day, R. (2012). No evidence or no alternative? Taking responsibility for off-label prescribing. Internal Medicine Journal, 42(3), 247-251. [More Information]

2018

  • Ghinea, N., Kerridge, I., Lipworth, W., Pace, J. (2018). An ethical framework for the creation, governance and evaluation of accelerated access programs. Health Policy, 122(9), 984-990. [More Information]

2017

  • Pace, J., Ghinea, N., Kerridge, I., Lipworth, W. (2017). Accelerated Access to Medicines: An Ethical Analysis. Therapeutic Innovation and Regulatory Science, 51(2), 157-163. [More Information]
  • Ghinea, N., Little, M., Lipworth, W. (2017). Access to High Cost Cancer Medicines Through the Lens of an Australian Senate Inquiry-Defining the "Goods" at Stake. Journal of Bioethical Inquiry, 14(3), 401-410. [More Information]
  • Pace, J., Ghinea, N., Kerridge, I., Lipworth, W. (2017). Caution needed in introduction of provisional approvals for medicines. Internal Medicine Journal, 47(11), 1321-1324. [More Information]
  • Ghinea, N., Kerridge, I., Little, M., Lipworth, W. (2017). Challenges to the validity of using medicine labels to categorize clinical behavior: An empirical and normative critique of "off-label" prescribing. Journal of Evaluation in Clinical Practice, 23(3), 574-581. [More Information]
  • Pace, J., Ghinea, N., Kerridge, I., Lipworth, W. (2017). Demands for access to new therapies: Are there alternatives to accelerated access? BMJ, 359, 1-4. [More Information]
  • Ghinea, N., Lipworth, W., Day, R., Hill, A., Dore, G., Danta, M. (2017). Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries. The Lancet, 389(10075), 1268-1272. [More Information]
  • Danta, M., Ghinea, N. (2017). The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study. Journal of Virus Eradication, 3(2), 77-81.
  • Harper, C., Ghinea, N., Lipworth, W. (2017). The Right to Health: Implications for the Funding of Medicines in Australia. Journal of Law and Medicine, 24(3), 640-655.

2016

  • Ghinea, N., Lipworth, W. (2016). Affordable access to innovative cancer medicines - don't forget the prices. Medical Journal of Australia, 204(6), 214-215.e1. [More Information]
  • Lipworth, W., Ghinea, N., Kerridge, I. (2016). Negotiating limits to the funding of high cost cancer medicines. Cancer Forum, 40(2), 93-96.
  • Ghinea, N., Lipworth, W., Kerridge, I. (2016). Propaganda or the cost of innovation? Challenging the high price of new drugs. BMJ, 352, 1-4. [More Information]

2015

  • Ghinea, N., Lipworth, W., Kerridge, I. (2015). Evidence, regulation and 'rational' prescribing: The case of gabapentin for neuropathic pain. Journal of Evaluation in Clinical Practice, 21(1), 28-33. [More Information]
  • Ghinea, N., Lipworth, W., Kerridge, I. (2015). Off-Label Promotion of Prescription Medicine: Is It Ever Justifiable? Therapeutic Innovation and Regulatory Science, 49(3), 359-363. [More Information]
  • Ghinea, N., Lipworth, W., Little, J., Kerridge, I., Day, R. (2015). Overcoming Entrenched Disagreements: the Case of Misoprostol for Post-Partum Haemorrhage. Developing World Bioethics, 15(1), 48-54. [More Information]
  • Day, R., Lipworth, W., Ghinea, N. (2015). The Ethics Around Drug Labels and Generic Medicines. Therapeutic Innovation and Regulatory Science, 49(3), 348-351. [More Information]

2014

  • Ghinea, N., Lipworth, W., Kerridge, I., Little, J., Day, R. (2014). Ethics & Evidence in Medical Debates: The Case of Recombinant Activated Factor VII. The Hastings Center Report, 44(2), 38-45. [More Information]

2012

  • Ghinea, N., Ghinea, N., Lipworth, W., Lipworth, W., Kerridge, I., Kerridge, I., Day, R., Day, R. (2012). No evidence or no alternative? Taking responsibility for off-label prescribing. Internal Medicine Journal, 42(3), 247-251. [More Information]

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