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 …