Sandra Goudie: More Shonky Legislation?

Right now we have 24 days to make submissions to the Therapeutics Products Bill.

On the basis of protecting us all from harmful product, the Bill will have one person appointed by the Minister as a Regulator. A public servant subject to Ministerial oversight.

That one person is supposed to “foster and maintain an independent and effective system to regulate”.

Medicines, medical devices, API’s (active pharmaceutical ingredients), and biotech products are all subject to the Regulator's oversight.

However, for no discernable reason, NHP’s (Natural Health Products) have been included.

Why? The current system for NHP’s works well under the Dietary Supplements Regulations 1985 and the Food Act 2014. Foods can be natural health products. Many OECD countries and the European Union regulate NHP’s, vitamins and mineral supplements as foods or foodstuffs.

There is no reason for change, and in spite of suggesting they would not include NHP’s in the Bill, the current government has done exactly that.

With no Regulatory Impact Statement, one can only conclude there is a move to reduce our access to NHP’s by overburdening the sector with prohibitive regulation and cost. Coupled  with prohibiting and reducing licences, permits and products, for a variety of reasons adds to that reduction.

And the sole Regulator has the power to approve, disapprove, monitor, prohibit, and to enforce. Alongside this, there is also a provision whereby the Regulator facilitates relationships with overseas organisations ‘to rely on their reports, assessments or decisions, or information received from them’.

If the government was serious about independent and competent oversight, a properly constituted committee, independent of Ministerial intervention, and able to appoint the Regulator as a member of that committee would surely work better?

There should be nothing less than peer reviewed  empirical data or as close to that as possible when considering the efficacy of a product, excluding NHP’s. Independent expertise should be called upon where necessary. We should not just rely on reports/documents provided by others because we are too lazy to read them and determine matters for ourselves.

Maintaining the integrity and incorruptibility of the Regulator is further supported by having such a committee which can also act as an appeals panel.

While an Appeals Panel is not provided for in the Bill it should be.

Just being able to ‘make comment’ doesn’t cut the mustard.

If this Bill was getting graded it would likely be a big fat ‘F’ and that is generous.

Submissions on the Bill can be made HERE - the deadline was February 15 but has now been extended to 5 March.

Postscript: 

The deadline for the Therapeutics Products Bill has now been extended.

That would appear to have been prompted largely due to maori expressions of concern.

However, what this has also highlighted is the recognition of our historic access to homoeopathy, naturopathic and other NHP’s (Natural Health Products), which have become taonga to many  – part of our cultural heritage.

As someone affected by Treaty of Waitangi implications, I expect that our taonga will be protected, in the same way that taonga is protected for maori. 

Sandra Goudie is a retired Mayor and Member of Parliament.