zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Ms Nicole McLay - PowerPoint PPT Presentation

Annual Charge Exemption Scheme Information session zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Ms Nicole McLay Assistant Secretary, Regulatory Business Services Branch Regulatory Support Division, TGA June 2015

Representatives from the TGA • Ms Nicole McLay – Assistant Secretary, Regulatory Business Services Branch • Mr Vinod Mahajan – Director, Regulatory Decision Review • Ms Jo Flynn – Regulatory Education Section 1 Annual Charge Exemption Scheme

Annual Charge Exemption Scheme • Background • Key features zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA • New ACE scheme components • Waivers • New rates of annual charges • Compliance program • Sponsor actions • Key dates 2 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Background 1990 • Low value turnover exemption scheme introduced 1990 – No longer meets objectives – Complex and burdened with red tape – High number of complaints – Inconsistent with government’s cost recovery policy – Unsustainable and inequitable • Consultation paper released in 2014 • New scheme commences 1 July 2015 2015 3 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Key features • Rates of annual charges will reduce for some product categories – from 5% to 23% • Self declaration - online system to make notifications and declarations • Significant reduction in administration - $3m p.a. in savings to industry • A new waiver option for annual charges 4 Annual Charge Exemption Scheme

New ACE scheme - components Sponsors will New entries from not be invoiced 1 July 2015 will zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA for ACE entries automatically qualify an d be granted exemption Annual Charge Exemption (ACE) Existing entries at 1 July Scheme 2015 pre -qualify if LVT exempt in last 2 years Begins 1 July 2015 on basis of $0 turnover ACE applies until commencement of turnover Annual self - declaration through client portal or by mail No application No TGA fee delegate decision 5 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Benefits of ACE • No application fee – additional saving of $2.4m p.a. to industry • A high number of current exemptions continue (74%) • No third party accountant certification • Only need to declare no turnover rather than the value of turnover • Annual charges are reducing for: – non-biological (chemical) prescription medicines, and – medical devices class IIa and above • Annual charge invoices only issued for non-exempt entries • Waivers available on public health/financial viability grounds 6 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Waivers new waiver option under ACE Waiver refused, annual charge Available for payable registered medicines, Waiver criteria biologicals, devices class IIa or higher and • public health risk if product IVD class 2 or higher is removed from the ARTG • product becomes financially unviable if annual charge applies Decision appealable Annual application zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Decision by a TGA delegate 7 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Chemical prescription medicines - 2 levels of annual charges zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA • Two levels of annual charges for chemical prescription medicines based on pharmacovigilance activities/costs: – Higher amount – relevant goods until 8th anniversary* – Lower amount – most generic medicines*, relevant goods past 8th anniversary • Relevant goods = new chemical entity, extension of indications, or change to intended patient group • Other major variations such as new formulation, change of strength, dosage forms – higher or lower amount depending on parent good • *goods containing certain active ingredients will always attract the higher amount – thalidomide, leflunomide, lenalidomide, mifepristone, clozapine and isotretinoin 8 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Fees and charges 2015-16 • Non-biological prescription medicines – 23% reduction in annual charge for lower amount – 5% reduction in annual charge for higher amount • Medical devices – 5% reduction in annual charges for class IIa and above • All fees and charges – 2.12% increase in fees and charges (CPI/WPI 2.5%) • Revised fees and charges schedule - TGA website 1 July 2015 9 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Audit and compliance program • Audit and compliance assurance program will commence • Uses existing information collecting provisions in the legislation • Failure to provide information in response could result in suspension/cancellation of entry • Providing incorrect declaration results in cancellation of the exemption – from year of turnover (multiple annual charges could become payable) • Criminal Code applies • Exempt and waived entries published on the website 10 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Sponsor actions • Letter sent to sponsors with pre-qualified entries 3 June – please check your list of exempt entries – new entries will be automatically exempted • Notify commencement of turnover for exempt entries at any time • Declaration of $0 turnover between 1 - 22 July each year for prior year to maintain exemption first declaration July 2016 • Payment of annual charges by 15 September each year 11 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Key dates zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA June 2015 Advice to sponsors on existing entries, information sessions, website material 1 July 2015 ACE scheme commences Between 1 July and 22 July (annually starting 2016) Sponsor self-declares that entry had $0 turnover in the previous financial year Sponsor may notify commencement of turnover at any time July (annually) Annual charge invoices issued for non-exempt entries 15 September (annually) Due date for the payment of annual charges 12 Annual Charge Exemption Scheme

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA More information TGA website - https://www.tga.gov.au/annual-charge-exemption-scheme email: ace.scheme@tga.gov.au 13 Annual Charge Exemption Scheme