Government’s hospital pass to HSE on approval for new medicines

Approval has been handed back to the HSE but without any more money for drugs

Even as the Minister for Health was making a lifelong commitment last week, his department was walking away from another one made just a year previously.

A letter from the Department of Health to the HSE said that, henceforth, final approval on new medicines rests with the HSE and there is no further requirement for it to forward requests seeking ministerial approval for medicines it wanted to use but for which it had no budget.

The problem is that the commitment was a core element of the Framework Agreement of Pricing and Supply of Medicines signed last July. It offered the Government savings of up to €785 million over four years on the price of existing drugs in exchange for an agreed route to market for new drugs.

At a time of scarce resources, the ministerial backstop was an integral part of the deal.

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Simon Harris was vocal ahead of the agreement that such decisions should not become a political football. His predecessor, Leo Varadkar was of the same view.

Logjam

And the growing logjam of medicines was, increasingly, a source of political embarrassment, and patient agitation.

In the days before the letter was sent, the Department, the HSE, the Irish Pharmaceutical Healthcare Association and the Department of Public Expenditure and Reform held a meeting to monitor progress on the agreement. It ended in stalemate. The bottom line – there was no new money.

Now, in one of the first big decisions since the changing of the guard at Government Buildings, the decision on approvals for new medicines has been firmly handed back to the HSE – without any additional budget.

The danger for the Government is twofold. One, if it can abandon elements of an accord that are inconvenient to it, what is to stop others doing the same? And, if there is no security on access for their new medicines in this market, does continued investment here become less attractive?

It takes two to tango.