Acts of Parliament assented to - Act No. 16 to 18 of 2017

Overview

The National Health Amendment (Pharmaceutical Benefits) Act 2017, enacted by the Commonwealth Parliament, aims to address the growing need for an efficient and sustainable pharmaceutical benefits system. This Act was introduced to respond to the increasing costs of pharmaceuticals and the need to ensure equitable access to essential medicines for all Australians. The policy objective of this legislation is to provide a comprehensive framework that balances the affordability of medicines with the sustainability of the Pharmaceutical Benefits Scheme (PBS). This Act is a crucial step in adapting the PBS to meet the evolving healthcare needs of the Australian population. The Corporations Amendment (Crowd-sourced Funding) Act 2017 addresses the emerging landscape of digital innovation and entrepreneurial ventures by amending the Corporations Act 2001. This Act was introduced to address the gap in existing legislation that did not adequately cater to the unique fundraising mechanisms of crowd-sourced funding platforms. The policy objective is to foster innovation and investment by providing a regulatory framework that supports and protects both investors and businesses engaged in crowd-sourced funding activities. This Act seeks to strike a balance between encouraging entrepreneurial activities and safeguarding the interests of all stakeholders involved in these innovative funding arrangements.

Scope and Application

The National Health Amendment (Pharmaceutical Benefits) Act 2017 applies to all individuals, entities, and industries that engage in the provision, supply, or reimbursement of pharmaceutical products within Australia. The Act specifically targets the Pharmaceutical Benefits Scheme (PBS), a key component of the National Health Act 1953, by amending the legislative framework to enhance the efficiency and effectiveness of the scheme. This includes the alteration of the processes for listing new pharmaceutical products, the modification of pricing and reimbursement mechanisms, and the introduction of measures to ensure the sustainability of the scheme. Geographically, the Act applies across the Commonwealth of Australia, thereby ensuring a uniform approach to the regulation of pharmaceutical benefits throughout the nation. Exclusions and exemptions within the Act are minimal, primarily focusing on ensuring that the provisions do not unduly restrict the availability of essential medications. The Act may extend its application through subordinate instruments such as regulations or guidelines issued by relevant authorities under the legislative authority granted by the Act. The Corporations Amendment (Crowd-sourced Funding) Act 2017 applies to entities and individuals involved in the issuance and management of crowd-sourced funding within Australia. This includes companies, crowdfunding platforms, and investors who participate in equity-based crowdfunding activities. The Act seeks to provide a legal framework that supports innovation and entrepreneurship by regulating the crowd-sourced funding market. The jurisdictional reach of this Act is nationwide, impacting all states and territories within the Commonwealth of Australia. The Act includes provisions for exemptions and thresholds to cater to smaller entities and ensure that the regulatory burden does not stifle emerging businesses. The Act may also be extended through subordinate instruments such as regulations or guidelines designed to provide further clarity and operational detail on the implementation of the legislation.

Key Provisions

The National Health Amendment (Pharmaceutical Benefits) Act 2017 (section 1) amends the National Health Act 1953, specifically targeting the Pharmaceutical Benefits Scheme (PBS). The key provision of this Act (section 3) is the introduction of new criteria for the listing of pharmaceutical products on the PBS, focusing on their cost-effectiveness and therapeutic value. This means that medications must now meet higher standards to be subsidised, ensuring that resources are used efficiently and effectively. The Act also includes provisions for the review and appeal process of decisions made by the Pharmaceutical Benefits Advisory Committee (section 4). Under the Corporations Amendment (Crowd-sourced Funding) Act 2001 (section 5), entities engaged in crowd-sourced funding must adhere to stringent regulatory requirements. This includes the necessity for these entities to obtain an Australian Financial Services Licence (section 6) and to comply with ongoing disclosure and reporting obligations (section 7). Companies involved in crowd-sourced funding must ensure transparency in their operations, provide detailed information to potential investors, and maintain accurate records of all transactions. Failure to comply with these obligations can result in legal repercussions and financial penalties. The Transport Security Legislation Amendment Act 2017 (section 8) imposes strict requirements on entities responsible for transport security. These entities must implement robust security measures and conduct regular risk assessments (section 9). The Act also mandates that entities must report any security incidents to the relevant authorities within a specified timeframe (section 10). Non-compliance with these obligations can result in severe penalties, including fines and imprisonment for individuals and corporations. The maximum penalty for corporate entities under this Act is $210,000, while individuals can face fines of up to $30,000 and imprisonment for up to two years (section 11). These measures are designed to ensure the safety and security of the transport sector, thereby protecting the public and maintaining national security.