Therapeutic Products Regulatory Scheme
A Therapeutic Products Bill is being developed to replace the Medicine Act 1981 and establish a new regulatory scheme for therapeutic products.
As part of this draft Bill, personal importation of medicines would be restricted: Section 76 would not allow consumers to order prescription medicines from an overseas supplier.
The only way to access off-label medicines (used for a purpose other than what it was developed for) from overseas would be through a doctor who will use a special clinical needs supply authority, and the issuer will have to be a pharmacist or wholesaler - they would then import the medicine for the patient.
There is a consultation paper and discussion forums to seek feedback before it is introduced to Parliament. NZORD’s Lisa Foster attended the Wellington forum on 21 March during which there was an explanation that there is always a trade off between access and safety relating to barriers and increasing costs. The hope from the Ministry of Health is to ensure all perspectives are heard so the Therapeutic Products Bill can be balanced.
Some issues that were raised included:
· Medicines for rare disorders are often in the unapproved medicine bracket and introducing stricter conditions and limitations may make them more challenging to access.
· For many rare disease patients’ medicines that can be approved through Medsafe are still not available due to lack of funding by PHARMAC.
· Some off-label medicines (used for a purpose other than what it was developed for) accessed from overseas for mental health meant that the harmful impacts are not being explained adequately to people. The hope was for pharmaceutical companies to supply consumer medicine information and perhaps also to require companies to gain informed consent from the patient.
Questions you may wish to offer feedback on:
· What are your thoughts about the fact that only medical practitioners would be able to issue a special needs supply authority for unapproved and off-label medicines?
· What do you think of the approach to curtail the personal importation of prescription medicines via the post and courier?
· It will continue to be an offence to advertise an unapproved product, however, direct to consumer advertising is still occurring. Do you agree with this?
Feedback can be provided by using the online tool at https://consult.health.govt.nz/medsafe/therapeutic-products-exposure-draft-consultation
Or send an email to email@example.com