Monday, 20 August 2018
Customs Tariff Amendment (Incorporation of Proposals) Bill 2018, Home Affairs Legislation Amendment (Miscellaneous Measures) Bill 2018, Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018; Second Reading
That these bills be now read a second time.
I seek leave to have the second reading speeches incorporated in Hansard.
The speeches read as follows—
CUSTOMS TARIFF AMENDMENT (INCORPORATION OF PROPOSALS) BILL 2018
The Customs Tariff Amendment (Incorporation of Proposals) Bill 2018 contains a number of amendments to the Customs Tariff Act 1995 to assist Australian businesses and consumers and further enhance the operation of the act.
Firstly, the bill will make amendments consistent with Customs Tariff Proposal (No. 1) 2018, providing a "Free" rate of duty for imports of Indonesian insecticides and herbicides under the ASEAN-Australia-New Zealand Free Trade Agreement. This proposal implements an early outcome of the Indonesian-Australia Closer Economic Partnership Agreement that commenced on 20 September 2017 as announced by the Minister for Trade, Tourism and Investment, the Honourable Steven Ciobo. This early outcome benefits Australian businesses and farmers by reducing their costs and improving access to the Indonesian market for Australian sugar exporters.
Secondly, the bill will make amendments consistent with Customs Tariff Proposal (No. 2) 2018, which will remove the duty payable on eligible blinded clinical trial kits and placebos imported for use in clinical trials. This measure was announced in the 2018-2019 budget and complements the government's efforts on making Australia an attractive destination for international clinical trials. The measure makes the importation of these goods into Australia cheaper through the removal of customs duty while also simplifying the import process and reducing red tape.
Finally, the bill will make a technical amendment to schedule 12 which covers the China-Australia Free Trade Agreement. This amendment removes a redundant item from the schedule, re-aligning it with the other schedules to the Customs Tariff Act.
HOME AFFAIRS LEGISLATION AMENDMENT (MISCELLANEOUS MEASURES) BILL 2018
The Home Affairs Legislation Amendment (Miscellaneous Measures) Bill 2018 is an omnibus bill that makes a number of amendments to the Migration Act, the Customs Act, and the Passenger Movement Charge Collection Act.
Schedule 1 of the bill will amend the Migration Act to ensure that, when an attempt is made to remove an unlawful non-citizen from our country, that non-citizen does not enter the destination country and is instead returned to Australia, the non-citizen can be returned to Australia without a visa. In addition, they will be treated as if they had never left Australia for the purposes of the visa application bars imposed by sections 48 and 48A of the Migration Act.
Currently the Migration Act allows an unlawful noncitizen who has been removed from Australia to return without a visa, if the unlawful noncitizen was refused entry into the destination country. The Migration Act does not currently allow for the return without a visa of a non-citizen who we have attempted to remove from Australia in other circumstances where it may be necessary. For example, there is no facility to return a person to Australia without a visa, if a transit country refuses to allow the removed person to transit or if the United Nations Human Rights Committee makes an interim measures request that the removal not be completed. The amendments in schedule 1 to this bill will address this inconsistency.
Similarly, the current law provides that, when a non-citizen is returned to Australia without a visa because they were refused entry to the destination country, the bars on making further applications imposed by sections 48 and 48A of the Migration Act will continue to apply as if they had never left Australia. The amendments will ensure that the same rule applies to a non-citizen who is returned to Australia without a visa in any circumstance covered by these amendments.
Schedule 2 of the bill will amend the Migration Act to make it clear that the department can provide correspondence to a person by making it available through their online account.
The bill represents another step in the government's Digital Transformation Agenda, by permitting the department to make greater use of its online facilities. Already, visa applicants can provide visa applications and additional information to the department by uploading that information into the person's online account in the department's online system. However, the current provisions in the act for giving documents to visa applicants and other persons do not clearly allow documents to be given through the department's online account system. This bill corrects that by adding this additional communication method to those already available to the department.
Schedule 3 of the bill will insert a new power into the Customs Act to enable the department to refund duty or drawback of duty in circumstances where a person has been paid a refund or drawback that they were not entitled to. This amendment is proposed in order to reduce the risk of breaching section 83 of the Commonwealth Constitution which may result from refunds and drawbacks of duty being made otherwise than in accordance with legislation.
Schedule 4 of this bill amends the Passenger Movement Charge Collection Act to introduce a new head of power that will allow the department to recover the merchant fees that it incurs where a person pays passenger movement charges with a credit card.
Schedule 5 of this bill makes minor technical amendments to sections 58A and 208DA of the Customs Act to ensure these provisions operate as originally intended.
THERAPEUTIC GOODS AMENDMENT (2018 MEASURES NO. 1) BILL 2018
This bill enables the Therapeutic Goods Administration (TGA) to implement a mandatory reporting scheme for medicines shortages, in order to better address the public health implications associated with medicines shortages in Australia. There are also a small number of minor, unrelated measures outlined in the bill, some of which support the implementation in 2017 of the Government's Response to the Expert Panel Review of Medicines and Medical Devices Regulation.
Medicines shortages have become an increasing problem in recent years, not just in Australia but around the world. A shortage of a critical medicine places patients' lives at risk. This bill responds to concerns raised by patients, their carers and health professionals as well as many representations from members of parliament on behalf of often-distressed patients seeking information about a shortage of a critical medicine. The recent shortage of EpiPen auto-injectors, which are critical in the response to severe allergic reactions in many people, including children whose lives can depend on having rapid access to this life-saving medicine, is a case in point.
The current voluntary scheme for reporting medicines shortages by medicines sponsors which has been in place since 2014 has, unfortunately, proven to be ineffective. A significant number of medicines shortages of critical patient impact have not been reported to the TGA, or not reported in a timely manner.
As these voluntary arrangements do not oblige sponsors to report, the TGA is not always able to alert the Australian public to a shortage or give them timely advice about steps for alleviating its effects or, significantly, to inform health practitioners so they can work with patients to minimise a shortage's impact.
In response to these concerns, a Medicines Shortages Working Group comprised of the Medicines Partnership of Australia, the Australian Medical Association and the Society of Hospital Pharmacists of Australia, chaired by the Department of Health, developed a revised approach to deal with medicines shortages. In particular it will be mandatory for companies to report all shortages to the TGA. The TGA will principally publish information about those shortages that are of particular impact on patients, so that prompt action can be taken to address the needs of affected patients. I would like to thank these groups for their input into this new regime and for their support of this bill.
The bill would ensure that the new mandatory reporting scheme is properly targeted to higher risk medicines - principally prescription medicines, but other non-prescription medicines that are registered in the Australian Register of Therapeutic Goods may also come within the scheme. Examples of products that may be included in this way may be EpiPens and Ventolin inhalers.
The bill stipulates timeframes by which sponsors must report. For shortages of critical patient impact, a sponsor will be required to report the shortage to the secretary as soon as possible but no later than two working days after they first know, or ought to have reasonably known, about the shortage. For shortages that are not of critical impact, sponsors must notify the secretary no later than 10 working days after knowing of the shortage.
Under the bill, a 'shortage' will exist if its supply in Australia will not, or will not likely, meet the demand for it at any time in the next 6 months, for all the patients in Australia who take it or who may need to take it. This takes a balanced approach by focussing on the overall situation for a medicine's availability in Australia, meaning instances of short supply that only occur at particular locations would not be shortages under the bill—avoiding the over-reporting of events that may turn out not to be widespread shortages.
To allow for forward planning of patient care, the bill will also require sponsors to notify the secretary of a decision to permanently discontinue the supply of a medicine in Australia. For such discontinuations of critical impact the sponsor must notify the secretary at least 12 months before the proposed discontinuation or, if this is not possible, as soon as practicable after the decision is made. For all other discontinuations, the secretary must be told at least six months before the proposed discontinuation or as soon as practicable after the decision.
For the sake of clarity, a Medicines Watch List will be established as a legislative instrument. This list will set out those medicines that, if in shortage, would have a critical impact on patient care. A shortage or permanent discontinuation of a medicine not in the Medicines Watch List may still be of critical patient impact if certain criteria in the bill are met—for example, if the shortage could have a life-threatening or serious impact on affected patients. Meeting these criteria will trigger the mandatory reporting obligations for critical impact shortages or discontinuations.
The bill introduces civil penalties for sponsors who do not comply with the requirements to notify the Secretary of a shortage or permanent discontinuation of a reportable medicine within the applicable timeframe, with maximum penalties of 100 penalty units for an individual or 1,000 penalty units for a body corporate. The details of such action, and names of non-compliant sponsors and affected products, will also be published on the TGA's website.
It is important to note, however, that the TGA would, in practice, work with sponsors to ensure awareness of the scheme and an understanding of how to comply with it, and take a graduated approach to instances of non-compliance.
The bill also includes a small number of minor measures not connected to medicines' shortages, mainly to remove inefficiencies or make minor improvements to the regulation of therapeutic goods under the legislation.
Ordered that the bills be listed on the Notice Paper as separate orders of the day.