Export life sciences to Australia

Jump to:

• Overview
• Commercial opportunities in Austrlia underpinned by the FTA
• Procurement
• Innovation
• Logistics
• Regulation
• Australian product regulations and import conditions
• Additional information for selling goods in Australia
• Case study: exporting a vascular port system to Australia

Overview

Life sciences is an economically significant industry in Australia, which the UK-Australia Free Trade Agreement (FTA) will enhance UK access to. The UK’s thriving life sciences sector, which employs over 280,000 people across the UK (Source: OLS Bioscience and health technology sector statistics 2021), will benefit from enhanced collaboration on emerging technologies in health and further regulatory co-operation.

The UK was the number one Foreign Direct Investment greenfield destination for life sciences in Europe in 2021 in capex value (Source: DIT calculations on FDI Markets data, 2022). The FTA gives businesses full and fair access to invest across the whole of the UK and Australian economies. Increased investor confidence will make it easier than ever for innovative UK life sciences companies to attract investment, which could further boost the £5 billion of Australian direct investment in the UK life sciences sector (Source: ONS Foreign direct investment involving UK companies (directional), 2021. Figure relates to ‘professional, scientific, and technical services.’).

In the other direction, the UK’s £424 million of medicines and pharmaceuticals exported to Australia in 2022 will be boosted by flexible rules of origin eliminating the need for cumulation of content from the EU, and the immediate removal of any tariffs (Source: HMRC Overseas Trade in Goods Statistics, February 2023). This will benefit a UK sector which contributed £94.2 billion in turnover in 2021 (Source: OLS (2022), Bioscience and health technology sector statistics 2021).

Commercial opportunities in Austrlia underpinned by the FTA

Cutting-edge digital trade provisions and increased collaboration on innovation will benefit more than 4,060 UK HealthTech start-ups and scale-ups, who are inventing and applying modern technologies to solve age-old medical problems (Source: ABHI (2021) Making it happen: delivering future innovation in HealthTech). The deal includes the world’s first innovation chapter, in which the UK and Australia agree that emerging technologies, including artificial intelligence and other digital technologies, are becoming increasingly important within the global economy, and offer significant social and economic benefits.

The FTA provides for a bespoke Strategic Innovation Dialogue, which will act as a cooperative forum where the UK and Australia will look to promote and facilitate innovation in their territories. Furthermore, should the FTA be updated in the future, innovation (and the work of the Strategic Innovation Dialogue) will be taken into account.

Procurement

British companies will now be able to bid for Australian government contracts worth around £10 billion per year on an equal footing with Australian companies. It is the most substantial level of access Australia has ever granted in a free trade agreement. UK medicines and medical device businesses will have the legally guaranteed opportunity to bid for contracts.

The FTA contains the list of the covered participating Australian entities.

AusTender provides a centralised publication of Australian Government procurement opportunities, annual procurement plans and contracts awarded at the Federal level. For procurement opportunities beyond the Federal level, please visit the relevant State or Local Government tender portals.

Additional guidance on procurement under the FTA can be found on great.gov.uk.

Innovation

The FTA’s innovation chapter will enhance R&D collaborations allowing the expertise of UK companies to respond to emerging health trends in the Australian market.

There are more than 30 medtech incubators and accelerators in Australia, helping to grow small and medium-sized companies. Grants, incentives and support from the Australian government in the medical innovation industry are on the rise.

Logistics

The pharmaceutical industry in Australia relies heavily on imported products. For an industry that has experienced supply chain pressures in recent years, this FTA offers certainty to manufacturers and buyers alike for importing into Australia from the UK.

The Customs Chapter will make import processes quicker and easier, with documentation and data requirements designed to accelerate the release of goods and reduce time and cost of compliance for traders.

Regulation

The FTA works alongside the existing UK and Australia Mutual Recognition Agreement (MRA).

The MRA contains the conditions under which each country will accept conformity assessment results from the other. The MRA covers, among other things, medical devices and good manufacturing practice (GMP) for pharmaceuticals.

The Technical Barriers to Trade Committee will provide a forum for discussing issues related to technical regulations, standards and conformity assessments for health technologies and pharmaceuticals.

Australian product regulations and import conditions

For regulations, the registration requirements of the Australian Register of Therapeutic Goods and import conditions applicable to goods in the medicines, medical devices and biologicals industries, please visit the therapeutic goods administration website.

Additional information for selling goods in Australia

Selling goods in Australia will require following certain rules and regulations according to the agreements you have in place with your buyer. Additional information on incoterms and import conditions in Australia can be found on great.gov.uk.

The Australian Border Force regulates all goods imported into Australia. You’ll need to provide import declarations and documents and pay all relevant duties and taxes.

In order to benefit from preferential tariff treatment under the FTA, businesses must make certain declarations that satisfy data requirements.

Goods and Services Tax (GST) is a tax on most goods and services in Australia. The current GST rate is 10%. Learn more about GST on the ATO’s website. Our e-commerce explainer provides an overview of the different applications of GST for B2B and B2C sales.

Certain goods must be correctly labelled with a trade description before they can be imported into Australia. Please note that not all imported goods need labelling.

Case study: exporting a vascular port system to Australia

Please note that this case study is illustrative only and should not be relied on as a substitute for your own research. Exporters should check on the most up to date rules and processes with the relevant customs authority.

Actions taken by the exporter before exporting

1. Agree incoterms and terms of payment with importers in Australia

"We agreed on Shipping DAP to Australian importer. This means we will be responsible for all costs and risks associated with the delivery to the final agreed place."

2. Determine the HS code(s)

Use the UK's Trade Tariff tool to find your HS code

"The HS code for our vascular port system is 61124100."

3. Check if goods are prohibited

Search the list of goods that are restricted or require a permit on the Australian Border Force website.

"Our product is not restricted."

4. Gather commercial documents and submit to transporter

• Commercial invoice (content of goods and demand for payment)

"Our product is 200 new units of vascular port systems, valued at 400 AUD (200x2AUD)."

• Packing list (weight, packaging and carton numbers of goods)
• RoO documents

"No proof of origin needed as the value is below the 1,000 AUD threshold."

The UK exporter can provide an origin declaration for the Australian importer, or the importer can make a claim for preferential tariff treatment based on Importer’s Knowledge. The Australian importer can use Importer’s Knowledge based on either having documentation demonstrating that the good is originating, or being able to reasonably rely on supporting documentation provided by the UK exporter or UK producer that the good is originating. The importer must be able to provide such documentation to Australia’s customs authorities upon request.

5. Gather shipping documents (done by the transporter)

"Air waybill or bill of landing, as the good is sent by sea."

6. Get UK customs clearance

Make a export declaration through customs declaration services.

7. Check if you need to submit an Exit Summary Declaration

"Safety and security requirements met, do not need to submit Exit Summary Declaration."

Actions taken by the importer to clear Australian customs

1. Submit an Impending Arrival Report at (air)port of entry

2. Submit an Actual Arrival Report at (air)port of entry

3. Submit a customs import declaration

Customs import declaration is required for goods worth more than 1,000 AUD, otherwise declare using self-assessed clearance declaration.

"In our example full Customs Import Declaration is not needed as value is below threshold."

For further information on exporting from the UK, use the check duties and customs procedures for exporting goods tool.

For further information on importing into Australia, use the DFAT FTA portal.