Last night, a packed lecture theatre at the Adelaide Women’s and Children’s Hospital heard presentations by several experts — including myself — warning that self-regulation by the pharmaceutical industry was not effective.
It was argued that the current plethora of inconsistent, ineffective and inefficient self-regulatory codes and complaint systems must be replaced by a new single system, underpinned by legislation, with sanctions that bite, applicable to all therapeutic claims and promotional activities regardless of the product. This reiterated similar calls by the Consumers Health Forum, Health Action International and the World Health Assembly.
Concern was expressed about the lack of transparency of the Therapeutic Goods Administration (TGA) and its total dependence on industry funding. There was also concern about the dependence of research and continuing medical education on industry funds; this often led to activities that were not in the public interest. There was a need to look at different models of funding R&D especially for neglected diseases.
Other recommendations included more independent funding of continuing medical education to reduce the perceived need for drug company supported educational activities; public funding of clinical trials in the public interest and post-marketing pharmacovigilance studies and regular reviews and updating of product information and PBS listings when new evidence arises.
The parliamentary secretary for health, Mark Butler and emeritus professor Lloyd Sansom, chairman of the Pharmaceutical Benefits Advisory Committee were vocal participants in the forum, organised by Healthy Skepticism.
Butler emphasised that he and health minister Roxon wanted a level playing for pharmaceutical regulation. The current inconsistencies in codes and sanctions were unacceptable. Their preference was to see if self-regulation could deliver the outcomes required but they were open to other solutions.
Professor Samson noted that the TGA was moving towards greater transparency. Product information, consumer medicines information and an Australian Public Assessment Record (AusPAR) will soon be available on the TGA website. AusPAR documents will provide information about the evaluation of a therapeutic goods and the considerations that led the TGA to approve or reject an application. There was a comment that this “initiative” was only 15 years behind the European Medicines Agency.
Finally, the public debate reiterated the urgent need for eHealth and data-linkage to better evaluate the benefit-risk ratio of new drugs in the real world as distinct from clinical trials. Butler noted that this was high on the agenda of the National Medicines Policy Committee.
The speakers included associate professor Chris Doecke, director of Pharmacy Services, Royal Adelaide Hospital; Dr Agnes Vitry, senior research fellow, School of Pharmacy and Medical Sciences, Uni SA; and Ken Harvey and Peter Mansfield, GP and director, Healthy Skepticism.
The debate on pharmaceutical regulation will continue tonight on the ABC Radio program The National Interest at 6:10. Butler and Dr Harvey will be interviewed by Peter Mares.
Ken Harvey is Adjunct Senior Research Fellow in the School of Public Health at La Trobe University
This is one area ripe for reform. The TGA is not even a toothless tiger, toothless kitten would be more appropriate. This is one area of regulation which should be funded independently of industry, perhaps with a turnover tax thispaid directly to Treasury and separately allocated for this regulatory purpose. The TGA allows quack medical equipment into the country doing nothing other than verifying its electrical safety while the same equipment is banned in the United States.
The mendacity duplicity of the pharmaceutical industry is beyond question, and its practice of providing doctors with funded junkets is legend, and no action is taken.
Why stop at pharma?
Self regulation in areas such as food standards and TV content have demonstrated that leaving the crims in charge of the prison is foolish.
When did self regulation ever work? If not, then why do we persist with this model anywhere, at any time? If so, then evidence please…
There is no doubt that the title of this piece is correct.
HOWEVER, there needs to be some balance injected into this process, and quickly. Successive governments (State, Federal, Global) abrogated all meaningful responsibility (and I mean funding) for continuing medical education, research and development a long time ago. About the time the expectations of the public and the costs got too high.
Sure, pharma invests in education and research for a different set of priorities than those the government/public may have but it’s naive in the extreme to think that there is no overlap nor mutual benefit.
The worse case scenario here is that education, research and development all but close down in Australia and then we’ll just be left practicing medicine based upon what other people tell us based upon evidence derived entirely from overseas populations…and that will do no-one any good.
I’ll happily declare my conflicts that I am a practicing physician and receive research funding, some travel expense and speaking honoraria from a number of pharma sources…and you can make of that what you will.