Education And Debate

Medical paternalism and expensive unsubsidised drugs

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7524.1075 (Published 03 November 2005) Cite this as: BMJ 2005;331:1075
  1. Michael Jefford, medical oncologist (Michael.Jefford@petermac.org)1,
  2. Julian Savulescu, ethicist2,
  3. Jacqui Thomson, medical oncologist1,
  4. Penelope Schofield, behavioural scientist1,
  5. Linda Mileshkin, medical oncologist1,
  6. Emilia Agalianos, research assistant1,
  7. John Zalcberg, medical oncologist1
  1. 1Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Locked Bag 1, A'Beckett Street, Victoria 8006, Australia
  2. 2Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford
  1. Correspondence to: M Jefford
  • Accepted 2 September 2005

When discussing treatment with patients, doctors may not mention newly licensed drugs that are not yet funded by healthcare schemes. Although their motives are good, the ethics are questionable

Introduction

The development of new drugs can be a lengthy process, requiring initial laboratory and animal testing and then a course of clinical studies.1 Clinical assessment involves phase I testing, which focuses on determination of side effects and an appropriate dose for later study; phase II studies, which assess efficacy in people with a particular condition; and phase III studies, which generally compare a new, experimental treatment with an existing standard treatment. Once a therapeutic benefit has been shown, the drug company can apply for approval from the relevant regulatory body. An extensive review follows, which may take many months or years. If the drug is approved, further delays may occur before funding arrangements permit the drug to be widely available. We consider some of the ethical dilemmas surrounding this process, using the example of drugs to treat people with cancer.

Unsubsidised, expensive drugs

In Australia, the cost of most prescription medicines is subsidised by the government through the pharmaceutical benefits scheme. New drugs that have been approved by the Therapeutic Goods Administration are assessed for inclusion in the scheme by the Pharmaceutical Benefits Advisory Committee, an independent expert committee consisting of medical practitioners and pharmacists. The committee considers several issues before recommending a drug, including efficacy, safety, quality of life benefits, and cost effectiveness. The committee may apply restrictions on how drugs can be prescribed. Long delays can occur between the Therapeutic Goods Administration approving a new drug and listing on the pharmaceutical benefits scheme.

Similar delays between approval and subsidisation exists in other countries. In the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) has been accused of considerable …

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