Brexit Offers No Advantages For Australia's Dental Industry
22nd Oct 18
A parliamentary committee reviewing the Australia – United Kingdom trade relationship has accepted advice that Brexit offers no new opportunities for enhanced trade and investment between Australia and the European Union.
Key Issues For The Dental Industry —
The Australian parliament’s joint standing committee of foreign affairs, defence and trade is undertaking an inquiry into Australia’s trade and investment relationship with the United Kingdom. This inquiry has a particular focus on the possible implications for Australia’s trade and investment relationships with the United Kingdom and the European Union consequent to the United Kingdom’s exit from the European Union.
In response to a request from the committee to provide advice, the Australian Dental Industry Association (ADIA) and the British Dental Industry Association (BDIA) made a joint submission reviewing the trade in dental products between Australia and the United Kingdom. The parliamentary committee has accepted the advice tendered by ADIA and BDIA to the committee.
The parliamentary committee’s interim report notes that as the medical devices sector is highly regulated the possible implications for Australia’s trade and investment relationships with the UK following the latter’s departure from the European Union will rely upon the development of the United Kingdom’s medical device regulatory system.
In Australia, the Therapeutic Goods Administration (TGA) carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances. The TGA’s subordinate regulations are to a large extent based upon the European Union’s regulatory arrangements but Australia has complete jurisdictional autonomy over the regulatory standards that govern design, safety, supply and conformance testing of medical devices.
Although there are attempts to align, to the maximum extent possible, Australia’s regulatory standards with those of the European Union this doesn’t always occur. Australia accepts attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations issued by certification bodies designated (in the context of the European Union’s regulatory framework) in the European Union. In the United Kingdom it is the Medicines and Healthcare products Regulatory Agency (MHRA) that regulates medicines, medical devices and blood components for transfusion. At this point in time, the UK’s regulatory system is fully integrated with that of the EU with the MHRA presently obligated to adopt EU Medical Device Directives.
As a result of the United Kingdom's regulatory system being fully integrated within the European Union’s, and Australia’s regulatory system and conformity assessment system being based upon that of the European Union, trade in dental products between Australia and the UK is relatively straight-forward. If there is a hard Brexit, this will be jeopardised as Australian market access to the UK may be made difficult as a result of potential differences between the medical device regulatory frameworks in Australia, the United Kingdom and the European Union.
The parliamentary committee noted that a scenario where the United Kingdom developed its own medical device regulatory framework post-Brexit would be the worst-case scenario for Australia – United Kingdom trade. It would require Australian manufacturers to meet United Kingdom regulatory requirements without gaining access to the European Union; however, this risk for United Kingdom dental product manufacturers is likely to be mitigated as it is believed they will seek to meet European Union regulatory frameworks.
In its interim report, the parliamentary committee has concluded that there is the very real risk for there to be an increase in the technical barriers to trade that a future United Kingdom – Australia Free Trade Agreement may not be able to mitigate.
Further Information —
The ADIA Policy Team negotiating with the Australian Government on matters of international trade in dental products receives advice and guidance from members serving on the ADIA-TCPC Trade & Commercial Policy Committee.
Further Information —
To keep up to date with all matters associated with dental product regulation follow ADIA on Facebook at www.facebook.com/dental.industry or the Twitter feed @AusDental. For further information on ADIA's engagement with the TGA on fees and charges send an email to firstname.lastname@example.org or telephone 1300 943 093.
Currency & Disclaimer —
This update was issued on 22 October 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
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8th Nov 18
The Therapeutic Goods Administration (TGA) has issued new guidance material setting out requirements on businesses that advertise medical devices direct to the public.
10th Dec 18
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