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Welcome to the May 2012 homepage edition of i2P-Information to Pharmacists. Rollo Manning has been having some time out having staples removed from the site of his open heart surgery.He is now at home recuperating in Darwin, having arrived home last Friday, beating a cold and hasty retreat from Canberra.We all wish him a speedy recovery and hopefully, he will be fit enough to contribute by next month.
This month, Pharmedia discusses the toll that is taken when someone complains about you to an authority without good cause. Well, the good news is that you can now take action to protect yourself if such a complaint is made, and that may even include action for defamation. Read about a recent case involving two doctors, with Mark Coleman drawing on personal experience to illustrate.

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Has Kevin lost his Rudder?

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	Garry Boyd articles by this author...
Garry has an interest in intellectual property (patents and trade marks), pharmacy automation and dispensary systems extending to workflows, layout and design within a pharmacy. He has a wide knowledge of the pharmacy industry having once worked for Sigma. He is also the inventor of Express Rx, one of the first Australian designed and built automated dispensing solutions for the local market.

The Rudd government is potentially on an intellectual property collision course that would make anything NASCAR could conjure up pale into insignificance.
In January 2003, the Pharmaceutical Research and Manufacturers vigoursly lobbied US negotiators for the Free Trade Agreement with Australia to mind its manners with regard to PBS pricing. The fear was that the Australian Government might bastardize PBS prices to a low level which would impinge on the ability of Drug Companies (presumably American) to invest in critical R&D and of course print money.
These discussions were conducted in an environment of concern on the part of the US that the combined party trick of Patent Law and the PBS might not be exactly to Uncle Sam’s liking.

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Fast forward to the present day and we find Hospira; a giant amongst generic drug companies, seeking to manufacture in Australia. Yep, this is all very nice and noble, but it will require a contentious change in Patent Law by Kev and his merry band of bean counters. Despite the fact Hospira is apparently only intending to manufacture in our backyard and not actually supply the local market with generic drugs that are still protected by patent, it is a breach to manufacture originator drugs whilst still in patent.

Kevin from Queensland will require the help of Bob from Greensland to get the change though the Senate, which is probably a given…….but you just never know.

Hospira is seeking to invest heavily in Australia and has the vision of exporting $2billion worth of drugs in the first decade of operation here………Good grief, manufacturing jobs in Australia? Just when we thought our financial future was dependent on digging the country up, teaching kids from overseas and having people pay to get a sun tan, look at penguins and climb a rock, somebody actually wants to make something……

At first glance it would be easy to suggest to Kev that if it ain’t broke, don’t fix it, but the Government has always held the right to meddle in Patent Law and will do so again if it looks good at the ballot box. However, given that Hospira is seeking establish the state of the art process known as biologics where production techniques involve the growing of drugs, which is vastly different from the technique whereby drugs are synthesised chemically, should we deny the opportunity to lead with this new technology?

A real Pandora’s Box of issues are circling all of this, nonetheless the fact that no doubt Hospira will have an army of Patent Attorney’s inspecting all live originator patents to see if any products claim the “manufacturing process” of any drugs as well as the actual composition of the drug. If a manufacturing process is claimed it might just provide Hospira with sufficient means to file a new patent for a still in patent originator drug, citing a different manufacturing process.

As us old hackers say on the Golf Course; “There’s a lot of golf left in this hole”.

All the so called “smart” people will tell you the country in which a patent originates provides well over 90% of commercial activity, and therefore profit. This is simply not true, and Hospira knows it well. Over the next six years or so, $150billion worth of drugs will slip out of patent protection. I wonder, is Kevin going to deny the opportunity for Australia to lead a new age of pharmaceutical manufacturing? It will matter not where patents originate from, and the fact is, Australia has the rare opportunity to become a pharmaceutical manufacturing monolith.

Australia changed Patent Law at the request of the originator drug companies to allow patent extensions so that patents would expire at the same time as patents in offshore domains. Now, change is again being proposed, albeit for a vastly different reason. The reduction of patent protection that would allow Hospira to manufacture here is a far more risky challenge for Kevin from Queensland than playing with a six week old kitten.

The Americans will be suitably outraged, but will probably refrain from sending troops across the Pacific in retaliation. As for Kevin and his group of intellectually brilliant bureaucrats whose task it is to deliberate over the matter, the easy decision would be to blame the Howard Government for showing such poor judgment by extending patent life and allow Hospira to wave their manufacturing wand.

This strategy is flawed on two fronts though. Firstly, the voting punters aren’t going to be too receptive to seeing little Johnny cop any blame for what was the correct decision at the time. Besides, we are all a bit sick of the blame game, aren’t we? I’m surprised that John Howard hasn’t been blamed for the limp celery at my supermarket.

The more interesting problem is that the government is required to make the decision to change Patent Law with a degree of “reasonableness”, which means anybody adversely affected by the decision may take issue on the basis the decision was lacking “reasonableness”. Very, very tricky…….

Kevin and the people steering his Rudder would be well advised to appreciate that they are not playing with the “little people” this time……..much is at stake, particularly for the image of the government, which of course appears to emotionally be the driving factor in any decision making process these days.

The weird thing about Australians is, we have great inventive minds, yet when it comes to investing in R&D and getting to market, we are about as impressive as Dame Edna Everage playing football.

I mean fair shake of the sauce bottle Kev, you were an out, proud and unashamed “economic conservative” before the election, but then swapped ideological sides and became an economic Mother Kevin Theresa by throwing money at wealthy reverse ex-pat’s living in those European countries around the Mediterranean who are still rolling around their vineyards and olive groves laughing madly…….don’t spill the sauce this time mate, the honeymoon is well and truly over.

As the late Kerry Packer once famously declared; “You only get one Alan Bond in your life”.

Will Australia only get one Hospira?

Garry Boyd.

 August 2009.

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