Utopia, you are standing in it!

Medsafe denied New Zealanders access to four drugs approved in comparable regulatory jurisdictions in the last three years. Medsafe rejected two other drugs in the last three years but these drugs were not approved in comparable jurisdictions. Doxorubicin Liposomal, chemotherapy drug, is not as yet actually refused, its application is pending. Medsafe is not involved in the funding of medicines; this is the responsibility of PHARMAC.

Source: data released 29 October 2015 pursuant to an Official Information Act request to the Ministry of Health.

What’s the point of this regulatory arm of the Ministry of Health? Is it a waste of space? Should not New Zealand automatically register any drug approved in the USA, UK, Canada, Australia or Germany? What can medical trials in New Zealand find out were not already found out overseas? Medsafe targets processing applications for the approval of new drugs in New Zealand to be done within 200 days. That’s 200 days too many.

Barriers to entry – costs ($s) of bringing new drugs to the market have risen manyfold #econ3 http://t.co/MFHTFhTLrj—
Geoff Riley (@tutor2u_econ) November 30, 2014

It should be lawful under the Medicines Act 1981 to market any drug in New Zealand which any of Australia, UK, USA, Canada or Germany has approved for prescription to patients.

SEEN & UNSEEN/ How much illness & death could be averted by limiting the FDA to safety, leaving efficacy to markets? http://t.co/4QkUuCCMDN—
Robert Graboyes (@Robert_Graboyes) March 11, 2015

If economists have a bitter drinking song, a battle cry that unites the warring schools of economic thought all, it would be “how many people has the FDA killed today”. For example, drugs became available years after they were on the market outside the USA because of drug approval lags at the FDA. The dead are many. To quote David Friedman:

In 1981… the FDA published a press release confessing to mass murder. That was not, of course, the way in which the release was worded; it was simply an announcement that the FDA had approved the use of timolol, a ß-blocker, to prevent recurrences of heart attacks. At the time timolol was approved, ß-blockers had been widely used outside the U.S. for over ten years. It was estimated that the use of timolol would save from seven thousand to ten thousand lives a year in the U.S. So the FDA, by forbidding the use of ß-blockers before 1981, was responsible for something close to a hundred thousand unnecessary deaths.

In 1962, an amended law gave the FDA authority to judge if a new drug produced the results for which it had been developed. Formerly, the FDA monitored only drug safety. It previously had only sixty days to decide this. Drug trials can now take up to 10 years.

Sam Peltzman showed in a famous paper in 1973 that these 1962 amendments reduced the introduction of new drugs in the USA from an average of forty-three annually in the decade before the 1962 amendments to sixteen annually in the ten years afterwards. No increase in drug safety was identified.

Halving every 9 years.

New approved drugs per billion dollars spent on research & development
bit.ly/1StxuV9 http://t.co/Hvx6mQ0lBa—
Max Roser (@MaxCRoser) August 01, 2015

Medsafe is a cost with no benefits to the New Zealand public. Medsafe has around 60 staff operating out of two offices, with centralised administrative functions, product approval and standard setting at the head office in Wellington.

How much of this budget of several million for Medsafe could be redirected to funding more life-saving and life changing drugs for use in New Zealand? This is rather than wasted on duplicating clinical trials already completed overseas or at the minimum duplicating regulatory approval processes, paperwork already completed overseas but not requiring a duplicate clinical trial in New Zealand.

At a minimum, the net benefits of the entire drug approval framework over the past three years in New Zealand is riding out on rejecting for approval half a dozen drugs, four of which are approved as safe in other comparable jurisdictions. That’s a pretty thin reed on which to hang a large budget that could be used by PHARMAC to fund life-saving drugs.

There should be a post box at the Ministry of Health to receive the certifications from overseas drug regulation agencies. Anything more is a deadly waste of taxpayers’ money.

My next round of Official Information Act requests will ask whether the minister and associate ministers of health were briefed on refusals of new medicines approved in other jurisdictions. Next I will ask:

1. for any evidence that a separate regulatory authority for drug approvals in New Zealand has any benefits, and
2. whether the Medsafe regime has ever been subject to a cost benefit analysis.

I have previously asked for information on drug approval lags. That was refused on the grounds I can look it up for myself on a rather complicated public database that requires knowledge of the names of medicines submitted for approval. Still mulling over what to do about that.