Healthy Skepticism Library item: 16536

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Gertskis M
Call to overhaul drug regime
Pharmacy News 2009 Sep 24
http://www.pharmacynews.com.au/article/call-to-overhaul-drug-regime/499758.aspx

Full text:

The current regulatory regime governing the drug development and marketing activities of the pharmaceutical industry is not working and is in need of an overhaul, according to a prominent pharmacy academic.

Dr Ken Harvey, senior research fellow at La Trobe University’s School of Public Health, said neither the Therapeutic Goods Administration (TGA) nor the industry’s attempt at self-regulation was keeping an adequate check on drug makers.

Dr Harvey will today take part in a forum at the Women and Children’s Hospital in Adelaide organised by medical marketing lobby group Healthy Skepticism that will examine the pharmaceutical regulatory framework.

The forum’s panel will also feature Parliamentary Secretary for Health Mark Butler and Emeritus Professor Lloyd Sansom, chairman of the Pharmaceutical Benefits Advisory Committee, as well as pharmacy administrators and other academics.

“The present system is not working,” Dr Harvey told Pharmacy News.

“It gives the appearance of doing something, which is convenient to industry and Government.”

Dr Harvey has backed the single code for governing the promotional activities of both originator and generic drug makers which is being pushed by Mr Butler.

“There is a lot of concern about the double standards of promotional codes and concerns that the sanctions, when they are applied, are weak,” Dr Harvey said.

“There is a plethora of codes and systems, they are all different and they vary in their effectiveness but none of them have sufficient sanctions. In particular, the TGA failed to do anything when it is brought to their attention.”

Dr Harvey also accused the TGA of being “missing in action” when it came to regulating drug research and called for a publicly-funded system of drug trials.

“There is a big push from industry to get drugs out there faster but clearly the faster you get them out the less they are evaluated,” he said.