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Regulatory Affairs Overview:

Australia

Youssef El –Nazer and Hamid Zareian

2015

Pharmaceutical Regulatory Affairs Project Supervisor:

Professor Peivand Pirouzi, Ph.D., M.B.A., Canada

Regulatory Overview

Pricing and state funding

Manufacturing

Clinical trails

Marketing

Advertising

Packaging and Labeling

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Medicinal products in Australia, are divided into two categories:

Medicines (such as prescription drugs and vitamins)

Medical devices (such as heart valves)

The Therapeutic Goods Act 1989(TG Act) provides :

A national framework for the regulation of pharmaceutical products

A national system to control the quality, safety, efficacy of medicinal products

State and territory legislation regulates the sale and distribution of medicinal products

Medicinal products cannot be imported into, exported from, manufactured or be used in Australia unless they are included in the Australian Register of Therapeutic Goods (ARTG)

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Australia's healthcare system is called Medicare. It is financed largely from general tax revenue based on a person's taxable income.

Commonwealth national funding is mainly provided through:

Subsidies for prescribed medicines (brands and generics by PBS)

Free or subsidized treatment by medical practitioners

Substantial and specific grants to state and territory governments to public hospitals and other bodies

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Patients obtain reasonably priced medicines for most medical conditions

Small Part of the cost listed drugs ( UP TO A$ 32.90) are paid by citizen (A$5.3 )

and remaining by the government, while OTC medicines is not regulated .

Commonwealth pays for some expensive drugs to outpatients

Australians encouraged, through tax incentives, to have private health insurance.

PBS applies automatic price reduction (up 35% ) once a generic competitor enters the market

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In deciding what price to recommend, the PBPA (pharmaceutical Benefits pricing authority ) takes into account a range of factors including:

Prices of alternative brands

Prices of other drugs in the same therapeutic group

Cost data information

Overseas prices

Prescription volumes

PBAC advice on clinical and cost effectiveness

Once a drug listed under the PBS, it is included in the Schedule of Pharmaceutical Benefits and reimbursed by the government to the pharmacist.

($ AU 9.2 billion in 2012 cost of PBS medicine subsidized )

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Application

A manufacturer or sponsor must submit an application to the TGA for a license, with the relevant application fee.

Conditions

Manufacturers must comply with the TG Act

The PIC/S Guide to GMP Practice for Medicinal Products (Pharmaceutical inspection corporation scheme )

The PIC/S Guide also incorporates the ICH Harmonized Tripartite Guideline GMP for active Pharmaceuticals

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Restrictions on foreign applicants

Overseas manufacturers must provide evidence that their product is manufactured to an acceptable standard and TGA will inspect the manufacturing sites to ensure compliance

Key stages and timing

When a license is issued, The GMP codes certify that the manufacturing site has met acceptable criteria, and Compliance is checked through auditors. These takes one - up to four days

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Period of authorization and renewal

A license remains in force until suspended, cancelled or revoked

-TGA may suspend or revoke a license if annual license or

inspection fees are not paid within 28 days (written notification sent by TGA)

-New license request (might be requested )

The frequency of audits depends on:

The degree of risk to patients and consumers

The extent to which a manufacturer complied with GMP codes in the past

The type of products manufactured

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The TGA can revoke the granted manufacturing license or suspend the license for a period of time if TGA believe that risk of death serious illness or injury occurred , However the TGA must:

Give the license holder notice in writing

Give reasons for that proposed action

Give the holder an opportunity to make adjust within reasonable time

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Clinical trials in Australia are conducted under either :

A Clinical Trial Exemption Scheme (CTX Scheme) more expensive ,more preferred

or the Clinical Trial Notification Scheme (CTN Scheme) submitted to HREC

The conduct of a clinical trial in Australia (under either scheme) must comply with:

The TG Act

Therapeutic Goods Regulations

National Health and Medical Research Council (NHMRC)

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)

CTN & CTX trials must have an Australian sponsor to conduct trial

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Application

Must be made to and approved by the TGA

Conditions

The TGA must be satisfied that the medicine complies with all legislative requirements in force in Australia, include the Therapeutic Goods Orders (TGOs) determined under the Act, the BP,EP,USP

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Key stages and timing

Medicinal products are included in the ARTG as registered goods

The registration process involves a detailed review by the TGA

Compliance with GMP code is checked by an onsite audit

This process require sponsor to apply to the TGA, providing data to support the quality , safety and efficacy of the product in use

The TGA must decide to accept or reject an application for evaluation within 40 working days & evaluate it within 255 working days

Can be shortened to 20 and 175 working days if sponsor provide 2 independent reports with regulatory standards similar to Australia

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-Fees Depending on the type of application and whether its registered or listed product ( see www.tga.gov.au/docs/html/feesach.htm)

Period of authorization and renewal Medicines remain listed or registered in the ARTG until their listing or registration is cancelled , annual renewal charges apply (see www.tga.gov.au/docs/html/feesach.htm).

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Application FEES $

Listed Medicine 760

Listed Medical devices 410

Non prescriptions medicine 1,445

Inclusion n the register (ARTG) 1210

GMP License 940

GMP Inspection fees /hour per inspector ( all Therapeutic goods) Oversees Manufacturers

615 1,250

Clinical trials CTX 30 days Clinical trials CTN Clinical –pre –Bio-equivalence data

1,595 330 1,015

Obtaining marketing authorization for medicinal products:

Data needed To register a new product varies and depend on the nature & use

Generics are exempt from the requirement to provide data, provided to have a sufficiently similar bio-equivalence to a leading brand in Australia

TGA monitors the continued compliance of manufacturers with the required standards and safety levels following authorization

The TGA's impose penalties for a breach of marketing authorization under TG Act

Imprisonment for 12 months and/or a fine of 1,000 penalty units (A$110,000)

Misleading information leading to harm/ injury or death ( 5 years and /or 4000 penalty units A$ 440,000 )

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These include suspension or cancellation from the ARTG and recall of medicinal products.

Parallel Import :

Australia encourages the parallel importation of products

products must comply with relevant regulatory and labeling requirements with marketing approval from TGA

In addition, an importer must obtain a PBS listing wants his products to qualify for government reimbursement

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Patents

Australia introduced a standard 20-year patent term in 1995 (WTOA)

(World Trade Organization Agreement on trade related aspect of intellectual property)

In signing Australia –US free trade agreement further extension to patent of pharmaceutical products beyond 20 years already legislated

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The TGA, in its marketing approval, requires prescription products to comply with the Medicines Australia Code of Conduct (Code).

(Ethical competition based on medical knowledge, type of hospitality offered to HCP , educational events …)

Non compliance lead to increase in the maximum fines for breaching of the code

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All advertising of prescription products to the public is prohibited

Restrictions on marketing medicinal products on the internet, by e-mail, mail under TG Act

Non-prescription pharmaceutical products can be advertised on Australian-based internet sites with strict limitations which are contained in

the TG Act

TG Regulations

Therapeutic Goods Advertising Code (TGAC)

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Advertising prescription products directly to consumers and supplied by a pharmacist is prohibited

However some exceptions to this. OTC products , health food stores, supermarkets may be advertised to the general public subject to requirements in:

The TG Act

The TG Regulations.

Relevant state and territory legislations.

The TGAC requirements on the content of advertisements for medicinal products

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Requirements for the packaging and labeling of pharmaceutical products vary whether medicinal product , device or poison must comply with the following :

The TG Act, TG Regulations

Relevant state and territory medicinal products legislation

TGO 69 on General Requirements for Labels for Medicines

TGO 37 on General Requirements for Labels for Therapeutic Devices

The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)

The TGAC (for non-prescription medicines)

Therapeutic Goods (Medical Devices) Regulations 2002

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THANK YOU

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Traditional herbal medicines Herbal medicinal products comes to the category of Complementary medicines.

Australian Regulatory Guidelines for Complementary Medicines,(ARGCM), Can be assistance to meeting their obligations under therapeutic goods legislation because in this area regulations are usually complicated .

Herbal medicinal products can be listed or registered.

Depending on 3 Items some are required to be registered :

1-The indications granted by the TGA

2-The product’s ingredients

3-The label claims made by a sponsor.

Low risk herbal medicinal product are listed and High risk herbal medicinal product must be registered .in general most of them are low risks and are listed in TGA

The TGA Office of Complementary Medicines(OCM) regulates the manufacture and marketing of complementary medicines.

The first role of OCM is to evaluate new complementary medicinal products, undertake post –market reviews and maintain and support the Electronic Listing Facility. Version 3.0

The ELF3 system provides a browser- based electronic facilities for submit an application to list complementary medicines in the ARTG. Before an application can be submitted it must be posted on the EFL3 system. once an electronic application for listing of a complementary medicine is forwarded to EFL3 system , then The TGA makes decision to listing within 10 working days. Patents:

A patent is a right granted for a device, substance, method or process that you have invented that is new, inventive and useful when compared with what is already known.

Pharmaceutical and biotechnology products & process , medical devices and methods of medical treatment are all patentable.

All patents must be novel, inventive and useful.

In addition , they must not be commercially exploited in secret by the patentee before the priority date of patent.

Patent’s authority Applications are made to IP Australia (www.ipaustralia.gov.au)

Patents fee :

According to ip Australia:

http://www.ipaustralia.gov.au/get-the-right-ip/patents/time-and-costs/fees/

The average estimated cost of obtaining an Australian patent including attorney’s fee is between A$ 6000 to 10000 A$ (appr.5300 to 8800 US $) depending on the complexity of the application.

Patent’s process and timing:

Complete specification must be filled within 12 months. A request for examination must be filled within 6 months of receiving a direction from IP Australia and if Ip Australia does not issue a direction ,within 5 years from the filling date of the complete application.

3 months After a complete application is accepted by IP Australia , interested third parties can oppose the advertisement in the Australia Official Journal of Patents(AOJP)

Duration of Protection

• Standard patent have a term of 20 years from the date of filling unless they lapse through failure to pay renewal fees or are revoked. (can be extended to a further 5 years for pharmaceutical substances that is not method or process patents)

• Innovation patents have a non –extendable 8 years

Renewal process: Annual maintenance fees are payable from the fifth anniversary of the filling of the complete specification for standard patent(about 8000 A$ over 20 year term) and from second anniversary for an innovation patent. (2000 A$ if the term is extended)

Revocation of patent:

A standard patent can be revoked on any of the following circumstances :

• The patentee is not entitled to the patent.

• The invention is not a manufacture.

• The patent or one or more claims are not novel or lack inventive step.

• The patentee has contravened a condition in the patent.

• The patent, or an modification of it , was obtained by fraud or false.

• The specification does not comply with subsections of the patents act .

Patent Infringement :

A patent is infringed when a person exploits a patented invention or authorises another to do without the licence or authority of the patentee.( According to Section 13 of the patent act)

Exploitation to an invention includes:

• Where the invention is a product: to make , hire, sell or otherwise dispose of the product or to offer to do any of those things or to import, or keep it for the purpose of doing any of these things.

• Where the invention is the process: to use it or do anything listed above in respect of a product resulting from such use.

Patent infringement actions in respect of pharmaceutical , biotechnology products and processes are common. (related to section 117 of the patent act)

The federal court of Australia is the most common jurisdiction .there is a further right to appeal , with leave to the High Court of Australia

Treatments available to a patent holder include: Interlocutory injunction orders temporarily preventing

infringement pending trial , provided: -an arguable case of infringement can be made -damage are shown to not be an adequate remedy -the balance of convenience favours its grant

Final injunctions preventing infringement during the life

At the election of the patentee , (either of the following should be awarded)

1-damages(recompensing the patentee for the loss)

2- an account of profits

Delivery up orders( infringer will deliver up the infringing product)

Patent’s protection

Australia is a member of :

• WIPO Paris Convention for protection of Industrial property 1883

• Patent Cooperation Treaty 1970.

• WTO Agreement on trade related aspects of intellectual property rights 1994 (TRIPS)

Trade marks Definition : A sign (including any word, device , brand , aspect , shape , colour, sound or scent) must be used to distinguish goods or services deal with in the course of trade.

There are some criteria for trade mark , Trade mark must :

Be a sign used for goods or services deal with in the course of trade , by a person from those provided by any other person

Not be or become descriptive or adjective of goods and services in relation to which it is registered.

Be capable of distinguishing the goods and services of the trade mark owner.

Be original to the applicant for registration and not deceptive.

Trade marks Authority Applications are made to Ip Australia www.ipaustralia.gov.au

Trade marks fee :

According to Ip Australia :

http://www.ipaustralia.gov.au/get-the-right-ip/trade-marks/time-and-costs/fees/

The fee for filling electronically in one or more classes is 120 A$.(about 106 us $)

Process and timing Applications must be made on the prescribed form , which must specify the goods and or services in respect o which the applicant wishes to register the trade mark.

The period of time taken between filling and examination varies according to the number of applications submitted.

Once a trade mark is accepted for registration, te details are advertised in AOJTR.and any person can oppose the registration of trade mark within three months from the date of advertisement

Trade mark duration of protection :

Registration is valid for 10 years from the filling date. And can be renewed indefinitely on payment of renewal fee.

Renewal Process:

Within 12 months before or after the expiry date .(late fees apply after expiry date)

Trade mark revocation circumstances : • The mark is not distinctive.

• Use of mark would be contrary to law.

• Use of mark would be deception or confusion.

• The registered proprietor is not the owner of mark.

• The registered proprietor is not intend or not authorise to use the mark in Australia

• The application or supporting document was modified opposite to the requirements of the trade mark Act.

• The application was accepted on the basis of evidence that were false.

• The mark has become generic.

Infringement (infraction) of trade mark conditions:

The rights of registered trade mark are infringed if :

• Another person uses as a trade mark a sign which is identical or similar to the registered trade mark in relation to goods or services for which it is registered.

• The mark or one similar to it is used as a trade mark in respect of :

o Goods or services of the same description as those in respect of trade mark registered

o Services which are closely related to the trade mark registered

o Goods which are closely related to services for trade mark registered

Most trade mark infringement actions are launched in the Federal Court of Australia which is empowered to grant:

• Injunctions( including interlocutory )

• Delivery up orders at the election of the trade mark owner, either damages or an account of profits.

Trade mark Protection

Australia is a member of the following international treaties:

• Paris Convention

• WIPO Protocol to the Madrid Agreement1989 (Madrid Protocol)

• Trips

Product Liability and legal provisions

Australia product liability laws are mixture of common law and various federal , state and territory statutes.

The majority of products liability claims based on :

The common law tort of negligence, which is fault-based

Breach of legal duty

Contract.

Breach of provisions of the TPA, which includes:

o Provisions prohibiting misleading and deceptive conduct

o Legal warranties imposed on manufacturers.

o Liability for unsafe products.

Substantive Test Negligence:

is fault –base , A manufacturer has a duty of care to take reasonable steps to prevent forecastable harm to consumers.

To establish liability a claimant must prove all the following:

The loss or damage has been suffered

That the manufacturer’s breach(abjuration)conduct is in breach of the common law duty of care.

That the loss or damage was caused by the manufacturer’s breach of duty

Contract: Contractual liabilitt for harm caused by faulty goods arises where is a breach of an express contractual warranty implied under statute. Usually Related to :

o Merchantable quality

o Fitness for purpose

TPA

• If manufacturers(producers) produce a defective product ,they are directly liable to consumers(customers) for any injury or damage result of that defective product. infact they are directly liable to consumers for:

• Goods which do not correspond with their description

• Goods of unmerchantable quality

• Goods which do not confirm to sample.

• Goods unfit for a stated purpose

• Non-compliance with express warranties.

Liability

Negligence :The manufacturer of goods have a duty of care to the buyer and user to safeguard them against risks of injury .

Contract:

Contractual treat are available to parties to the contract. since , in most circumstances the retailer has a contractual relationship with the buyer, the retailer possess the liability for any defect or fault according to the express and absolute terms of the contract of sale.

TP ACT: manufacturers of goods that have liabilities under both part V Division 2A and part V A of TP act, manufacturers including any companies that :

• Hold itself out to be the manufacturer

• Applies its names or brand to the goods

• Permits someone to promote the goods as those manufactured by the company

• Imports the goods where the manufacturer has no presence in Australia.

Limitation period of Liability claim

For most jurisdictions , the limitation is 3 years.

For most jurisdictions , the 3 years start running when some tangible damage occurs.

Available Defences to product liability claims depends on :

A: Negligence :

• Voluntary assumption of risk

• Contributory negligence

B : TP Act :

• Under part V division 2 A (There are 3 defences)

• Under part V A (There are 4 defences)

Under part V division 2 A

• Goods are not reasonably fit for purpose or are not merchandisable quality because of third party or human control occurring after the goods have left the control of corporation.

• In the case of goods not reasonable fit for purpose, the customer did not rely on manufacturer.

• In the case of goods not of merchantable quality, defects were drawn to the customers attention or examines must be reveal.

Under part V A

• The defect did not exist when the goods supply by the manufacturer

• The goods were defective because of compliance with mandatory standards.

• The state of technical knowledge at the time of supply does not enable defect to be revealed

• The defect is attributable to the design of the finished product rather than a defect in the component.

What treatments are available to the claimant?

General damages, including for pain and suffering , loss of amenities and loss of expectation of life.

Special damages , including for loss of wages and earning capacity(both past and future) and medical and hospital expenses.

Class actions for product liability claims : Class actions for product liability claims are permitted (Federal court of Aust. Act 1976)

Where 7 or more persons have claims against the same person and both :

• The claims of all persons are respected , similar or related circumstances.

• The claims of all persons give rise to substantial common issue of law or fact.

If these requirments are met , any one of those persons can begin action in the federal court.

Reforms

The federal court Australia has initiated its own fast-track patent litigation procedure which aims to bring all patent cases to trial within 12 months from complaint filling.

IP Australia has proposed reforms to patent law and practice which appear to think raising the rate of registration of patent in Australia and increase harmonization of Australia law with international law.

ANZTPA

In December 2003 ,the Australia and new Zealand signed a treaty to establish a bi-national Trans-Tasman regulator , to be called the Australia New Zealand Therapeutic product Authority. It was supposed to be a joint scheme to regulate therapeutic products, including medical devices and prescriptions .

In July 2007 Australia and New Zealand agreed to suspend negotiations on ANZTPA because new Zealand parliament did not support their legislation.

Medical devices to be exempted from the operation of TG Act for use in an emergency, and improving access to information available to the public and international authorities.

The therapeutic Goods Amendment (2009 measures no 2 )Act 2009 introduced changes which create an offence for a person who inappropriately advertises a therapeutic good and allows the secretary of the department of health and ageing to state particular for which medical devices may not be included on the ARTG

Under the Australian Consumer Law (ACL) , consumers will be able to dispute unfair contract terms where they form part

of standard contract.