B3 Individualised medicines: An ethical approach

Thursday 14 September 2017
COEX Convention & Exhibition Center : Grand Ballroom 105 3 hours

Organised by the FIP Social and Administrative Pharmacy Section, the FIP Industrial Pharmacy Section and the FIP Expert Group on Ethics

Chairs: Cody Midlam (MedImpact Healthcare Systems Inc., USA) and Gaby Wiederkehr (ACCESS Regulatory Consulting GmbH, Switzerland) 


With the rapidly evolving pharmaceutical sector in individualised medicines, the overall impact/benefit to all populations must be considered. This form of medicine is much specialised, may be highly effective and is often extremely expensive. Considering this, can we be sure that these individualised medicines are regulated appropriately, compared with the other medicines on the market? How can we ensure that those who need access to these medicines will not be detrimentally affected by location, wealth, obscurity of disease and how the drugs are provided? As these medicines are created based on an individual’s genetic make-up, is there a risk that other diseases coded for in the genome will not be recorded against a person’s insurance, thus making this a pre-existing condition for any future claims? Are there other ethical dimensions in individualised medicine? And are there implications for big data to assist in finding genetic patterns in populations, highlighting those with either higher risk of disease or better expected outcomes based on their genome?

Balancing therapeutic prospects introduced by scientific and technological advances with regulation to address emerging socio-ethical concerns is the ultimate challenge in dealing with application of such advances in health care. This presentation will highlight the many challenges that pharmacogenetics pose to ethicists, government bodies and practitioners alike. These challenges include such issues as reliability of personalised medicines; availability, affordability and equitable access to medicines, among many others.  

Learning objectives

At the conclusion of this knowledge-based session, participants will be able to:

  1. Identify regulatory resources and systems for pharmacists to guide the right patient to the correct individualised medicine.  
  2. Identify current challenges for regulators and payers globally to fund this practice change.
  3. Outline the ethical dimensions of pharmacogenetics and individualised medicine.
  4. Describe use of big data to study and benefit from individualised medicines. 


14:30 – 14:40
1. Introduction by the chairs

14:40 – 15:15

2. Implementing personalised healthcare — Examples around the world

Junghee Suh (Roche Products Limited, Reublic of Korea)

15:15 – 15:50

3. Payment models for individualised medicines

Hae Mi Choe (University of Michigan, USA)

15:50 – 16:10 Coffee/tea break

16:10 – 16:45
4. Ethical dimensions of pharmacogenetics and individualised medicine

Betty Chaar (The University of Sydney, Australia)

16:45 – 17:20
5. How to use big data to maximise benefit from individualised medicines

Michael Sorich (Flinders University, Australia)

17:20 – 17:30
6. Conclusions