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  1. 1

    Altakoi

    I generally agree with the point about encouraging competetive listings on the PBS, however there are a few devils in the detail.

    1. The TGA can’t ‘choose’ to list anything. The legislation is written to require a company to make a submission, and the legislation requires the company to pay a fee. Lest this be another game of hunt the bureaucrat, I think it is necessary to point out that those are absolute legal constraints.

    2. Whether or not a supportive study has been published in the literature someone actually has to critique all the available evidence and prepare it in a form the PBAC can assess. As I am sure the author knows, that kind of review is time consuming and labour intensive. That is why TGA and the PBAC require fees, because it pays for that process.

    This is, I think, essentially an argument about whether a regulatory and funding system based on a user pays fee structure supported by the industry can ever work in the public interest. I don’t think it can and the only reason it ever looked like it could was that in the ‘boom’ days of the 90s there were an awful lot ‘blockbuster’ new chemical entities coming to market which companies were willing to pay to have assessed. It doesn’t work for niche medicines, it never can.

    So the answer, I think, is to look at the funding model and either the government has to underwrite the operating costs of the evaluation system or, and this would be my preference, it has to move entirely to a non-application based impost on industry. That could take the form of a levy on sales and this would, I note, have the additional advantage that it could be applied across all sectors including the very large and lucrative OTC and complementary markets.

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