HEDLEY REES
PharmaFlow, Bridgend, Wales, United Kingdom

Abstract

Stakeholders in the pharmaceutical industry are increasingly demanding radical improvements in performance in terms of affordability, safety, efficacy and quality of medicines produced. This paper asserts that no matter how much stakeholders battle against the system, the fundamental modus operandi of the industry is not fit for purpose and requires radical reform.
This is not a new call for action, of course; many are making the case, including high-profile politicians, but little seems to be making a difference.
Here, we take a deep dive into the systemic aspects of the medicines discovery and development process, to learn that major strategic errors have been made over the last forty plus years, resulting in value chains that are overly complex, cost burdened, and patient agnostic.
We therefore turn to whole systems thinking and the people-purpose system, to deliver what we believe is a feasible solution. This involves intense focus of on end-users of medicine, tight integration in the development process and keen awareness of the value proposition to be delivered; the result being safe, better, cheaper medicines fit for the 21^st century.

IS THE SYSTEM CREATING THE PHARMA VALUE CHAIN BROKEN?

Medicines are a major intervention in healthcare. As such, they play a crucially important role in the health and wellbeing of patients around the globe, as do the companies developing and supplying them - pharmaceutical companies.

There have been important breakthroughs in medicines over the years, such as penicillin, the polio vaccine, synthetic insulin, treatments for cancer, HIV/AIDS and Hepatitis C, to list some examples.

Notwithstanding these important breakthroughs, the development of the medicines value chain has fallen well short of other more progressive industry sectors, such as the semiconductor, aerospace, electronics and automotive sectors. Those sectors have leveraged innovative approaches such as design for manufacture (DfM), quality systems meeting six-sigma performance levels (3.4 defects per million opportunities) and voice of the customer (VoC) to inform their understanding of the end-user value proposition.  

In the case of Pharma, it is generally accepted that quality levels attained are in the range 2.5 – 3 sigma (70,00 ...