All members of Parliament voted in favour of the Associate Health Minister Seymour’s Medicines Amendment Bill which aims to speed up processes for approving medicines in New Zealand.
It allows for medicines to receive approval from the Health Minister within 30 days if they have been approved by two or more overseas regulators that meet certain criteria.
Ironically, given Mr Seymour’s promotion of what he sees as good law making, he produced a late amendment to the Bill after it had come back into the House after the select committee process. This amendment included allowing for the advertising of unapproved medicines at medical conferences.
Why this was suddenly so urgent it could not have been included earlier to be considered by submitters and the select committee is unclear. It is a pity because in this instance, it appears the select committee process resulted in some sensible changes to the original Bill.
In its initial form the Bill named the overseas regulators whose approvals it would accept, but names were not included in the final Bill.
As was pointed out by submitters, if these regulators were discredited or there was reason to lose confidence in them because of political influence, a law change would be required to avoid accepting their approvals.
As former Labour health minister Dr Ayesha Verrall told Parliament, the option of specifying criteria to allow approval of overseas regulators would allow flexibility and New Zealand control over its regulatory sovereignty if it had a reason to question those regulators in future.
The criteria includes that regulators must operate in a regulatory framework similar to New Zealand’s, have a formal framework for co-operation with the Director General of Health, use international guidelines and standards consistent with ours, and conduct business and release reports in English.
The Health Minister also has the power to remove regulators if they no longer meet the criteria. However, there is no detail yet on how any monitoring of the regulators will be done, with rules which will go with the new law yet to be revealed.
It remains to be seen how effective the new law will be at speeding up the introduction of new medicines.
Dr Verrall explained since New Zealand is a small market, drug companies, who would not know at the time of their application if they would qualify for Pharmac funding, could still decide they would rather put their money into selling in bigger markets.
A widely welcomed part of the new law is the extension of what Mr Seymour described as expanding prescribing rights in a safe and sensible way.
Nurse practitioners and pharmacist prescribers will be able to prescribe unapproved medicines that are in their scope of practice just as doctors can, something Mr Seymour said was important during supply shortages.
"Authorised prescribers will be able to prescribe funded alternatives without more hoops, and it means continuity of care for patients and a better use of our health workforce," he said.
One aspect of the legislation attracting less accord was that relating to appointments to the Medical Classifications Committee, which makes recommendations to the minister on legal classification of medicines.
The new Act gives the minister the power to appoint at least seven members of the committee, but there is no criteria about what qualifications these appointees might have.
Under the old law, the committee had two appointees nominated by the now defunct New Zealand Medical Association, two from the Pharmaceutical Society, and two Ministry of Health officers, one of which would chair the committee.
The new law says the minister must not appoint a person to the committee unless they are satisfied that the person is suitably qualified to be a member, but it does not spell out what that might mean.
Some definition of what will be considered suitable qualifications would help allay any fears such appointments could exert undue influence from the pharmaceutical industry.
