26 February, 2019
Last month, UK and Australia signed a pre-Brexit deal, which provides for reciprocal recognition of conformity assessments and certification for medicines and medical devices.
The deal is aimed at streamlining export and import processes by eliminating the need, cost and time for testing and certification in the receiving country. The broad scope of the Australia-Britain Mutual Recognition Agreement on Conformity Assessment (MRA) means that if a medicine or medical device has been certified as meeting standards in Australia it is recognised as meeting British standards – and vice versa.
This is an important development for the healthcare sector, in both the UK and Australia, as the deal covers all relevant aspects of the MRA currently in place between the EU and Australia and ensures that these arrangements continue to exist, even if the UK leaves the EU without a deal.
According to Liam Fox, Britain's Trade Secretary, "This agreement will help give UK and Australian businesses, exporters and consumers the certainty they need to continue trading in confidence as the UK leaves the EU." Australian High Commissioner George Brandis stated that the MRA "… guarantees continuity of arrangements that have long boosted trade between our two countries." The MRA, which is composed of one agreement dealing with the manufacturing sector and the other dealing specifically with wines, covers approximately one-third of British goods exports to Australia, and is of particular importance in ensuring the continued smooth flow of British-made pharmaceutical and medical products into Australia.
The MRA was signed on 18 January 2019 and now needs to be formally ratified by the British and Australian parliaments.
In 2017, Australia exported to the UK pharmaceutical products, and optical, photo, technical and medical apparatus totaling USD 290 million and imported USD 771 million in these products and apparatus from the UK. Given the benefits of the MRA to the Australian and UK healthcare industries, it will be in the interests of the industries to have it ratified prior to the looming Brexit deadline of 29 March 2019.
For further information, please contact:
Ben McLaughlin, Partner, Baker & McKenzie
Ben.McLaughlin@bakermckenzie.com
