Red Tape Taken Off Shampoos and Toothpaste – Plans
Cuts to red tape covering some fluoride toothpastes and anti-dandruff shampoos is possible under an update to medicine regulations proposed in a paper released by the Ministry of Health today.
Fluoride toothpastes and anti-dandruff shampoos currently have to be approved before they can be marketed. The changes would mean that the sorts of toothpastes and anti-dandruff products commonly sold in supermarkets would no longer be regulated under medicines legislation. This would bring New Zealand into line with most other countries, including Australia. Costs would be reduced and products could reach retailers’ shelves sooner.
A number of other changes are also being considered with the aim of improving efficiency, removing barriers to innovation, and achieving better alignment between the law and modern practice.
The Ministry is accepting submissions on the proposals until 26 March 2010. The consultation document and submission form can be found on the Ministry’s website at www.moh.govt.nz
Please attribute these comments to Principal Advisor Regulation Susan Martindale.
BACKGROUND
What legislation would be affected by the proposed changes?
The proposed changes affect two sets of regulations made under the Medicines Act 1981 – the Medicines Regulations 1984 and the Medicines (Standing Order) Regulations 2002.
What is the process and timing for bringing the changes into effect?
Submissions on the discussion paper will close on 26 March 2010. Final decisions on changes to the regulations will then be made in light of comments received through the submission process. It is expected that amended regulations could come into effect in late 2010.
How are fluoride toothpastes and anti-dandruff shampoos currently regulated?
In New Zealand, fluoride toothpastes and anti-dandruff shampoos and conditioners are regulated under the Medicines Act 1981. Pre-market approval is required for new products, and changes to existing products (such as new flavours or colours) must also be approved. This means that suppliers must prepare and submit an application, pay a regulatory fee and obtain an approval before they can place a product on the market here. In contrast, many such products are treated as cosmetics in most other countries and pre-market approval of products is not required.
Will some toothpastes and anti-dandruff products still be regulated under medicines legislation?
Yes. The proposed change will affect most fluoride toothpastes and those anti-dandruff products already able to be sold through supermarkets and other general retail outlets. Toothpastes containing high levels of fluoride, or containing other substances used to treat tooth sensitivity, will continue to be regulated under medicines legislation. Anti-dandruff products that are only permitted to be sold through pharmacies, and products that are used for dandruff but are also intended to treat conditions such as psoriasis of the scalp, will also continue to be regulated under medicines legislation.
What other changes are being proposed?
Other proposals that are designed to reduce unnecessary costs, remove barriers to innovation and improve access to medicines include:
Changing some labelling and advertising requirements to bring them more into line with those of other countries, particularly Australia
Ensuring that the regulations do not stand in the way of progress towards electronic prescribing
Removing some limitations on prescribing (e.g. allowing all prescribers to write a prescription for up to 3 months of treatment)
Limiting prescribing for people who are not in New Zealand
Allowing pharmacists to substitute a different brand of a medicine in certain circumstances
Making the requirements for counter-signing of standing orders more flexible
Allowing certain medicine to be sold by vending machine
In addition, there are a number of planned updates to technical requirements (e.g. how data sheets are prepared and distributed; how prescriptions are dispensed).
Why is it desirable to bring New Zealand’s labelling rules into line with the requirements in other countries?
Most of the medicines supplied in New Zealand are manufactured in other countries. Because the New Zealand market is small, it can become difficult to obtain products that meet our requirements if they are different from those in most other countries. The result can be higher costs or reduced access to medicines.
Why does prescribing need to be restricted in relation to overseas patients?
Some New Zealand doctors have become involved in issuing prescriptions for people in other countries who have submitted treatment requests via the internet. The medicine is then ‘prescribed’ for the patient by the doctor in New Zealand, dispensed and sent to the patient. Sourcing medicines through New Zealand is an attractive proposition for patients in other countries because in many cases prices are lower here. This activity causes a potential loss of supply of certain medicines in New Zealand and could cause pharmaceutical companies to withdraw their products from the New Zealand market to avoid a situation where they are supplying products in New Zealand at a lower price and then seeing them resold at a higher price to patients overseas. The proposal will permit prescribing to New Zealanders who are abroad but remain under the care of a New Zealand prescriber (e.g. those temporarily overseas), but would avoid prescribing to foreign citizens who are not under the care of the New Zealand-based prescriber.
When can a pharmacist dispense a different brand of medicine from that prescribed?
Currently, a pharmacist can only supply a different brand of a medicine from that prescribed if they obtain the authority of the prescriber to do so. This applies even in situations where a discontinued brand has been prescribed inadvertently, or where the prescriber has not realised that the patient will have to pay for the prescribed brand. Requiring the pharmacist to contact the prescriber in such situations is time-consuming and costly for all concerned.
What sort of medicines would be allowed to be sold by vending machine?
It is proposed that ‘general sale medicines’ (i.e. those that can already be sold by any retailer) should be allowed to be sold by vending machine. Such medicines would include nicotine replacement therapies, some cough and cold treatments, and medicines to treat pain and travel sickness.