AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
Exporting Medicines for Donation and Non- Commercial Exportation Certain medicines exported for donation or non-com- mercial purposes are exempt from ARTG inclusion, provided they are not for commercial supply, do not contain prohibited export substances and are not for clinical trials. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The ARTG inclusion requirement is the primary non- tariff barrier in Australia. Depending on the nature of the product, specific non-tariff restrictions may include: • controlled substance permits (the Customs (Pro- hibited Imports) Regulations 1956 (Cth)): for narcot- ics, psychotropics, and precursors, triggered by the substance’s scheduling status; • biosecurity requirements (the Biosecurity Act 2015) for products containing biological material, admin- istered by the Department of Agriculture at the border; and • Good Manufacturing Practice (GMP) clearances – overseas manufacturing sites must hold TGA GMP clearance before their medicines can be imported. 7.5 Trade Blocs and Free Trade Agreements Australia is a signatory to a large number of free trade agreements which concern therapeutic goods, includ- ing: • the Comprehensive and Progressive Agreement for Trans-Pacific Partnership – includes a transparency annex for pharmaceuticals and regulatory coher- ence provisions; • the Australia-United States Free Trade Agree- ment – contains a dedicated pharmaceutical annex addressing transparency in Pharmaceutical Ben- efits Scheme (PBS) pricing reimbursement, and IP protections; • the Regional Comprehensive Economic Partner- ship – Australia’s largest free trade agreement (15 Asia-Pacific nations), with tariff elimination com- mitments on pharmaceutical and medical device products; and
• bilateral free trade agreements with China, Japan, South Korea, Singapore and others, which include zero or reduced tariffs on therapeutic goods. Australia also participates in various regulatory co- operation arrangements, including the Access Con- sortium (work-sharing on medicine evaluations), the Pharmaceutical Inspection Co-operation Scheme (mutual recognition of GMP inspections) and the Med- ical Device Single Audit Program (single-audit recog- nition across the USA, Canada, Japan and Brazil). 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Australia does not directly control prices for medicines or medical devices which are for private sale. Howev- er, for medicines subsidised through the Pharmaceuti- cal Benefits Scheme (PBS), the government controls the amount that it will subsidise to the price of the medicine, which in practice sets a ceiling for the sub- sidised market. The PBS is governed by the National Health Act 1953 (Cth) and its delegated legislation. Medicines can only be listed on the PBS once the Pharmaceutical Benefits Advisory Clinic (PBAC) has made a positive recommendation for listing, on the basis of clinical and cost effectiveness. If the PBAC recommends listing, the price is then negotiated between the sponsor and the Department of Health, Disability and Ageing on behalf of the Commonwealth, which becomes an “agreed price”. The approved ex- manufacturer price (AEMP) becomes the list price for the pharmaceutical benefit. Depending on the level of competition in the market, PBS-listed medicines will be subject to statutory price reductions over time, including anniversary and other “one-off” price reductions, mandatory price cuts when generics or biosimilars enter the market, and periodic price disclosure cycles that adjust prices based on actual market transaction data. The National Health Act, the National Health (Phar- maceutical Benefits) Regulations 2017 (Cth) and other
21 CHAMBERS.COM
Powered by FlippingBook