Drug approval delays.

A change to the way new pharmaceuticals are approved for inclusion under the Pharmaceutical Benefits Scheme ( PBS ) has been quietly put in place by the Federal government.    Under the old procedure, new drug approvals passed through a price filter.   Those that would have a price impact on the scheme of ten million dollars or less were passed automatically provided they had approval from an independent expert committee.   It was only new drugs with a huge impact on costs that needed to go to cabinet for a decision. Now - each and every new drug will need to be examined - irrespective of cost - and that means extended approval delays.

With this procedure in place it will not take much time for Australia to lag behind  other civilized countries in the flow of newly developed drugs reaching citizens under the PBS.   It also introduces politics into the decision making process.  Decisions previously made by an expert committee will now be subjected to the vagaries of non-medical politicians who may question drugs in the context of patient lifestyle or specific gender usage.    Approval could become a whole new ball game.

There will also be a dramatic change to decisions on research within the drug industry.  When a new drug is developed there is a long gap between discovery and it's appearance on the pharmacy shelf.  There are years of testing and long consideration by that expert committee - and that delay cuts into the time the developing company is protected by patent.  

It costs millions of dollars to develop a new drug and the developer hopes to make a profit while the patent gives exclusive right of production.  If approval delays shorten this window - there is less incentive to spend money on research.

The PBS is a big component of the national budget and spending has to be controlled, but in this instance the decision to bring all new drugs under individual parliamentary approval destroys a practical filter that has worked well.

We will soon be seeing stories in the media of miracle drugs curing patients in other countries - but not being available here in Australia because they are caught up somewhere in the labyrinth of committees that choke the political process.

Whoever heard of politicians delivering speedy and accurate solutions to problems that involve decisions ?