Pharmaceutical free trade - will it be fair?

Editor, – What has happened to your HON code? Your editorial (Aust Prescr 2004;27:54-5) on the US Free Trade Agreement fails to meet the requirement of honest informed reliable advice that your magazine purports to hold dear. Your editorial is not only a farrago of unsubstantiated and false claims on what is a contentious political issue, it reveals an abysmal lack of knowledge of the agreement itself. It is insulting to your professional colleagues in the Department of Health whose fully-informed public statements correcting the falsehoods you have regurgitated have been ignored by you - if you ever bothered to inform yourself of them.

It is now possible for you to discover reality, and inform your readers of it, by reading the 18 recommendations in the recent report on the FTA of the Joint Standing Committee on Treaties, chaired by your professional colleague, Dr Andrew Southcott MP. All but one of these 18 were supported by the three Labor members of the committee; this report demolishes your stand.

As a former federal Shadow Minister for Health and subsequently Consul-General in New York, I have closely studied the US Free Trade Agreement. I challenge you to point to any section of the agreement that supports the thrust of your claims. You appear to have confused the terms of the agreement which are clear and self-evident with the inevitable uncertainty of the exact nature of the Australian government's measures to implement it - measures that are entirely up to an elected Australian government and subject to the democratic political process - and which could be introduced whether there was an FTA or not. The US has no power to require action otherwise than in the strict wording of the agreement and attached side letters, reflecting the same right we have at their end. In no instance does that right establish a US position that justifies your scare-mongering.

This is how your nonsensical claims fall down:

• There is nothing in the agreement that empowers the Medicines Working Group, which has a specified advisory-only role (giving us access to the world's most dynamic innovative pharmaceutical knowledge) to determine 'details of the agreement'. You are just plain wrong in claiming it 'probably' will do so; you cannot provide any evidence to support this.
• It does not 'remain to be seen' whether an Australian decision not to approve a drug or not to list it on the PBS 'could be construed as a breach' of the FTA; the agreement guarantees the basic architecture of the PBS and you cannot point to any section of it that leaves this issue otherwise than totally in the hands of the Australian government; even the nature of the independent review process for PBS listing is entirely up to the Australian government.
• There is nothing in the agreement that requires or empowers the independent review process to overturn a listing decision; the Minister remains the only instrument of approval and can only act on the recommendation of the PBAC. The FTA does nothing to change this and the government has already said it has no intention to do so.
• No trade deal can dictate how much the Australian government spends on medicines or what they cost and you cannot point to anything in the US FTA that has the capacity to do so.
• The FTA specifies that any marketing and advertising to consumers must comply with Australian laws (such as prohibiting industry advertising direct to consumers) and there is nothing in the agreement requiring the government to change them.
• The agreement reinforces Australia's existing intellectual property protection of pharmaceuticals, ensuring that generics cannot enter the market until a patent has expired. What on earth is your objection to that - or do you favour us joining the patent-pirates and getting excluded from western commerce?
• Most rational people think greater transparency of governmental agency decisions (and a formal appeal mechanism) represents a more democratic approach. Why don't you?

Your editorial demeans you and your journal. Like most quack medicines, it should be marked 'harmful if swallowed'.

Michael Baume
Mosman, NSW

The Editorial Executive Committee comments:

The controversy surrounding the editorial is ironic, as the Editorial Executive Committee's intention was to bring to readers' attention some of the issues that have been raised concerning the pharmaceutical part of the Free Trade Agreement. As pharmaceutical policy influences prescribing it was appropriate for Australian Prescriber to comment.

While the wording of parts of the agreement seemed ambiguous this may have been to allow flexibility in implementing the agreement.¹ Although the Editorial Executive Committee is grateful for Mr Baume's insight into the arcane language of international treaties, some questions remain. They will only be answered with the passage of time. It is therefore appropriate that the first of the 23 recommendations made by the Joint Standing Committee on Treaties was to have a review of the impact of the agreement after five years.