Cabinet paves way for updated medicines regulationsHealth Regulatory Reform
Fluoride toothpastes, anti-dandruff shampoos and anti-pimple creams commonly sold in supermarkets will no longer be treated like medicines once new regulations have been drafted and approved.
Health Minister Tony Ryall says, "Cabinet has approved policy changes that pave the way for the drafting of amendments to the Medicines Regulations 1984 and the Medicines (Standing Order) Regulations 2002.
"The new regulations will remove many requirements that are unnecessary, ineffective or excessively costly, and they will better align the law with modern practice. They are expected to come into effect by middle of next year.
"One of the policy changes will allow pharmacists to substitute an alternative brand of a medicine in certain circumstances, where clinically appropriate. Electronic prescribing will also be advanced.
"Other changes align medicine labelling requirements with those of Australia, reducing the need for re-labelling and repackaging," Mr Ryall says.
Minister of Regulatory Reform, Rodney Hide says "The current regime is onerous for business, restricts consumer choice, and is costly and expensive to individuals, without creating significant safety benefits.
"The new regulations will continue to protect consumers, while giving them easier access to key medicines and related products.
"This is a good outcome for all New Zealanders and is a great example of exactly what the Government's Regulatory Reform agenda is designed to achieve," Mr Hide said.
Detailed information on the outcome of those consultations is available from the Report of the Analysis of Submissions and Final Decisions on Proposed Amendments to Regulations under the Medicines Act 1981 is available at:
Questions and Answers:
1. What other changes to the Medicines Regulations 1984 and the Medicines (Standing Order) Regulations 2002 have been approved by Cabinet:
The updated regulations:
- include changes to the labelling and advertising requirements for medicines and related products to bring them into line with those of other countries, particularly Australia
- align prescribing rights for doctors, dentists and midwives by restricting prescribing to their respective scope of practice
- allow prescribers to use their discretion to extend the period of supply on a prescription from 6 to 12 months for oral contraceptives, and from 3 to 6 months for other prescription medicines
- allow pharmacists to substitute an alternative brand of a medicine in certain circumstances
- update technical requirements (including how data sheets are prepared and distributed, and how prescriptions are dispensed)
- remove some of the barriers to allow electronic prescribing
- allow the sale of "general sales" medicines including some cough and cold remedies and medicines to treat travel sickness, which are already sold by a wide range of shops such as supermarkets, dairies, patrol stations and mixed-merchandise stores, through vending machines.
2. Will some toothpastes and anti-dandruff shampoos still be regulated under the medicines legislation?
Yes. The changes recently approved by Cabinet will affect most fluoride toothpastes and those anti-dandruff products already 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.
3. How will toothpaste products that would no longer be regulated under the medicines legislation be ensured they don't pose any risk of harm to consumers?
The safety of these products would be regulated under the Cosmetic Products Group Standard issued by the Environmental Risk Management Authority in accordance with the Hazardous Substances and New Organisms Act 1996.
4. Why is it desirable to bring New Zealand's labelling rules in line with those in other countries?
Most of the medicines supplied in New Zealand are manufactured in other countries. Since 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.
5. What controls will be placed on vending machine operators to ensure that general sales medicines are sold appropriately through these machines?
Controls will be placed to ensure "general sales" medicines are sold appropriately through these machines and to safeguard against inappropriate access. These controls include limitations on pack sizes, the placement of the machines out of the reach of children or in locations which provide adult supervision, and temperature controls.
6. Under what circumstances can a pharmacist dispense a different brand of medicine from that prescribed?
The updated regulations will allow a pharmacist to substitute an alternative brand of a prescribed medicine (but not a different medicine) provided:
- there are no clinical reasons why substitution should not occur
- the prescriber has not marked the prescription with a statement such as "no brand substitution permitted"; and
- the pharmacist records details of the brand substitution on the prescription and informs the patient of the change of brand.