Rare Disorders NZ has made a submission to Parliament on the Therapeutic Products Bill.
RDNZ is concerned about the risk-proportionate approval systems to ensure New Zealanders especially those living with a rare disorder can access necessary life-saving medicines.
We ask that there are specific allowances made within the Bill for medicines for rare disorders, that takes into account the risk benefit equation for medicines for rare disorders which is different to other medicines used for wider know conditions amongst larger groups of the population.
RDNZ asks that the Bill is amended to ensure there is carve out for advertising, advocacy and communication allowed by charities, not for profits and advocacy patient groups and individuals for all therapeutic products that aren't already regulated in New Zealand.
RDNZ asks that the Bill/Act is amended to ensure there is provision for an orphan drug registration scheme similar to Australia' s TGA where Medsafe would waive fees for medicines for rare disorders.