Distribution and marketing of drugs in Australia

A Q&A guide to distribution and marketing of drugs law in Australia.

The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.

To compare answers across multiple jurisdictions, visit the Distribution and Marketing of Drugs Country Q&A Tool.

This Q&A is part of the global guide to Distribution and Marketing of Drugs.

Contents

Distribution

Pre-conditions for distribution

1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

Marketing applications for drugs must be made to and approved by the Therapeutic Goods Administration (TGA). The TGA is part of the Australian Government's Department of Health and regulates the import and supply of drugs in Australia in accordance with the Therapeutic Goods Act 1989 (Cth) (TG Act) and the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations). Subject to some exceptions, a product cannot be marketed in Australia before it is listed on the Australian Register of Therapeutic Goods (ARTG).

Authorisation conditions

Before approving a medicine, the TGA must be satisfied that it complies with all legislative requirements in force in Australia. Statutory standards under the TG Act include the:

  • Therapeutic Goods Orders (TGO).

  • British Pharmacopoeia (BP).

  • European Pharmacopoeia (Ph Eur).

  • US Pharmacopoeia-National Formulary (USP).

The BP, Ph Eur and the USP are defined under the TG Act as default standards. Therefore, if no relevant standard is specified in a TGO, any of the pharmacopoeias apply.

An exemption can be sought from the requirements of the TG Act with the consent of the Secretary of the Department of Health and Ageing.

Offences and civil penalties apply if drugs that do not comply with the relevant standards are imported into, exported from, or supplied in Australia (sections 14 and 14A, TG Act).

Exceptions

Schedules 5, 5A and 7 of the TG Regulations provide a detailed list of exemptions to the requirement that drugs must be listed on the ARTG. In addition, Schedule 8 sets out the persons that are exempt from the requirement to obtain ARTG listing.

 
2. Do any types of named patient and/or compassionate use programmes operate? If so, what are the requirements for pre-launch access?

There are a number of ways that patients can gain access to drugs that have not been approved by the Therapeutic Goods Administration (TGA).

Authorised prescribers

An authorised prescriber can prescribe a drug that has not been approved by the TGA to an individual patient in their care. A medical practitioner who has been granted authority by the TGA to become an authorised prescriber can prescribe specified unapproved drugs (or a class of unapproved drugs) to specified patients (or a class of recipients) with a particular medical condition.

To become an authorised prescriber, the medical practitioner must:

  • Have the necessary training and expertise for the condition being treated and the proposed use of the product.

  • Be able to best determine the needs of the patient.

  • Have the ability to monitor the outcome of the therapy.

Special Access Scheme

The Special Access Scheme is a scheme that provides for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Applications for access to unapproved drugs under the special access scheme are made to the TGA by registered medical practitioners. For the purposes of administering the Special Access Scheme, the TGA places patients into two categories depending on whether their condition is terminal or not. Terminally ill patients are given greater access to unapproved drugs.

Clinical trials

Limited access is provided to unapproved drugs for the purposes of clinical trials in Australia that are conducted under either the:

  • Clinical Trial Exemption Scheme (CTX Scheme).

  • Clinical Trial Notification Scheme (CTN Scheme).

All CTN and CTX trials must have an Australian sponsor who is responsible for the conduct of the trial. In addition, before commencing a clinical trial, there must be legal and financial agreements in place between all relevant parties. This must include, in particular:

  • Indemnities.

  • The procedure for the compensation and treatment of trial participants.

The relevant insurances must be obtained and all documents required by the Note for Guidance on Good Clinical Practice must be filed.

The Note for Guidance on for Good Clinical Practice also sets out the various procedural requirements for running a clinical trial. These are significant and include the maintenance of quality assurance and quality control systems with standard operating procedures for the conduct of the trial. In addition, the trial must also be monitored and any adverse events reported. A number of documents are required to be filed both during and after the clinical trial.

Personal import scheme

Unapproved drugs can also be imported by an individual in circumstances where the drug:

  • Is for use by the individual or their immediate family.

  • Is not a controlled substance under any of the Commonwealth, State or Territory legislation.

  • Complies with the relevant Commonwealth, State or Territory quarantine laws.

  • The quantity does not exceed three months' supply per importation and the total quantity per year does not exceed 15 months' supply at the manufacturer's recommended maximum dosage.

  • Is a prescription medicine and the importer has a prescription issued by an Australian registered medical practitioner.

Licensing

3. What is the procedural structure regarding licensing a drug for distribution?

Structure

In general, a drug must be entered on the Australian Register of Therapeutic Goods (ARTG) prior to distributing it in Australia.

Australia has a two-tiered system for the regulation of drugs:

  • Higher risk drugs (which include all prescription products, most over-the-counter (OTC) medicines and some complementary medicines) must be registered on the ARTG. This involves individually evaluating the quality, safety and effectiveness of the product.

  • Lower risk drugs (which include some over-the-counter medicines and most complementary medicines) that contain pre-approved, low risk ingredients and make limited claims can be listed on the ARTG.

Key stages and timing

Prescription products and many OTC medicines are subject to registration requirements. The registration process involves a detailed review by the Therapeutic Goods Administration (TGA) of the quality, safety and efficacy of the medicinal products in question.

Registration requires a sponsor to apply to the TGA, providing data supporting the quality, safety and efficacy of the product for its intended use. The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assists sponsors in preparing applications to register new prescriptions or other high risk medicines for human use in Australia.

The timeline for processing an application for registration is set down by the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations). The TGA must:

  • Accept or reject an application for evaluation within 20 working days if the requirements for the expedited application process are satisfied (see Question 4), or otherwise within 40 working days.

  • Evaluate the application within a further 255 working days (if the application is accepted).

Some OTC products are subject to listing requirements. Listed goods are classified as low risk medicines and only contain ingredients that have been pre-approved by the TGA (that is, the TGA has assessed the safety and quality of the ingredients). The TGA does not assess the final product (as opposed to the ingredient), the label or the efficacy of the product for its intended use. However, the applicant must hold relevant evidence, including evidence that supports any claim they make about the product.

 
4. Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisidiction?

There is an expedited application process available for drugs that have been previously approved in two acceptable countries. The countries currently identified by the Minister as acceptable are Canada, Sweden, The Netherlands, the UK and the US. The application process is provided under subregulations 16C(3)(a) and 16D(3)(a) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations).

For the applications, two independent evaluation reports from acceptable countries, (where the product is already approved) are required to be provided at the time of application. The evaluation reports must be independent (subregulations 16C (4) and (5) and 16D (4) and (5), TG Regulations) and the product proposed to be registered in Australia must be identical to that registered in the acceptable countries in relation to formulation, directions for use and indications.

 
5. Is virtual drug distribution possible from your jurisdiction?

There is currently no Australian jurisprudence on virtual drug distribution.

The Therapeutic Goods Act 1989 (Cth) (TG Act) provides for a number of offences that is likely to make virtual drug distribution in Australia unlawful, but the limits of the provisions have not yet been tested in the context of virtual drug distribution networks.

In addition, both wholesalers and pharmacies are highly regulated in Australia and are required to hold relevant licences. This regulatory regime helps to maintain the integrity of the drug distribution system.

 
6. What is the procedure to appeal (legal remedy) a licensing decision?

Under section 60 of the Therapeutic Goods Act 1989 (Cth) (TG Act) a person can seek a review of a licensing decision to the relevant minister. An appeal can be lodged by any person whose interests are affected by the decision. Appeals to the minister must be lodged within 90 days of the notice of the decision.

The process for appeal is by way of letter. The letter must contain all supporting information for the minister to consider as there is no opportunity for an aggrieved party to present additional information under this process. Supporting information must include the following as a minimum:

  • The reason why part of the original decision is incorrect or objectionable.

  • How the aggrieved parties interests are affected by the original decision.

  • A copy of the original decision.

If an aggrieved party is not satisfied with the minister's review under a section 60 appeal, it can apply to the Administrative Appeals Tribunal (AAT) for a further review. The timeframe for lodging an application with the AAT is within 28 days of the minister's decision.

The AAT will review the merits of the case, that is, reconsider the application on its merits and not on a question of law. If an aggrieved party wishes to review the decision on legal grounds, it can seek judicial review in the Federal Court of Australia on the grounds of the legality of the original decision.

 
7. What are the costs of obtaining licensing?

The costs of obtaining licensing as at 24 November 2016 is as follows:

  • For a new chemical entity classified as a prescription medicine there is an application fee of A$46,100 and an evaluation fee of A$185,100. In order to maintain registration of the product, an annual charge of between A$3,180 and A$6,875 (depending on whether the drug is biological and how long it has been registered for) will apply.

  • For a new chemical entity classified as a non-prescription medicine there is an evaluation fee of between A$10,100 and A$70,600 (depending on the length of the clinical or toxicological data to be evaluated). Application fees for listed complementary medicines are A$790 and registered complementary medicines are A$1,510. In order to maintain registration of the product, annual charges of up to A$1,410 will apply.

A summary of fees can be found at https://www.tga.gov.au/sites/default/files/fees-and-charges-summary-1-july-2016.pdf.

These fees can be waived if the drug is not commercially viable or intended to treat, prevent or diagnose a rare disease. To obtain a waiver, an application to have the drug designated as an "orphan drug" must be made to the Therapeutic Goods Administration before an application to register the drug on the Australian Register of Therapeutic Goods is made.

Distribution to consumers

8. What are the different categories of drugs for distribution?

Australia has a national classification system that controls how drugs are made available to the public. Legally, the scheduling of drugs is a matter for the States and Territories, but all States and Territories adhere either closely or exactly to the national standard. Drugs are classified into different schedules of the Poison Standard 2016 according to the level of regulatory control required in the interests of public health and safety.

The categories are as follows:

  • Schedule 2 (pharmacy medicine). These drugs are considered safe to use and made available to the public with minimal regulatory requirements.

  • Schedule 3 (pharmacist only medicine). These drugs require the professional advice of a pharmacist for safe use but are available to the public without a prescription.

  • Schedule 4 (prescription only medicine). These drugs require a prescription from a registered health care practitioner or other authorised medical personnel.

  • Schedule 8 (controlled drug). These drugs have a high potential for addiction or abuse.

 
9. Who is authorised to distribute prescription drugs and over-the-counter drugs to consumers?

Authorisation for distributing drugs to consumers will be granted depending on the schedule in which the drug is classified and the State or Territory in which the drug is being distributed.

Over-the-counter drugs

Pharmacy medicine (Schedule 2) does not require an authorised person to dispense the drugs. However, the drugs must be supplied to consumers at a pharmacy as they typically require advice from a pharmacist. However, in most States and Territories a person can obtain a licence to supply Schedule 2 drugs where they operate a country (remote) store that is located a prescribed distance away from a retail pharmacist.

Pharmacist only medicine (Schedule 3) can only be distributed by pharmacists.

In addition, some drugs (such as small packs of paracetamol) are unscheduled which means that as long as certain conditions are met, they are available from any retailer that wishes to stock them.

Prescription drugs

Prescription only medicine (Schedule 4) can only be distributed by pharmacists and if the buyer has a valid prescription for the drug.

Controlled drugs (Schedule 8) can only be distributed by pharmacists and if the buyer has a valid prescription. The regulations regarding who can write a valid prescription differ between States and Territories but in general are limited to specialists in the relevant field, or health care practitioners who have applied for, and been granted, a licence to prescribe Schedule 8 drugs.

 
10. What drugs can an attending physician distribute and under what circumstances?

The distribution and prescription of drugs is regulated by each of the States and Territories. Each jurisdiction's laws are relatively consistent and generally allow healthcare practitioners to prescribe drugs (including controlled drugs with authorisation) in the course of their profession.

In addition, physicians are generally permitted to distribute drugs for emergency use by patients.

 
11. Who is authorised to prescribe prescription drugs to consumers?

Authorisation to prescribe prescription drugs is based on individual State and Territory legislation and therefore differs between each State and Territory.

Prescription of a Schedule 4 (prescription only medicine)

The following professions are able to prescribe prescription drugs for the purpose of practicing in their respective professions (provided they have the valid State or Territory authorisation):

  • Medical practitioners.

  • Dentists.

  • Veterinary surgeons.

  • Optometrists.

  • Podiatrists.

  • Nurse practitioners.

  • Midwife practitioners.

The requirements and extent of the authority to prescribe for each profession varies between States and Territories. For example, in New South Wales a person must be an authorised practitioner to issue a valid prescription. Authorised practitioners include medical practitioners, dentists, veterinary surgeons, optometrists and podiatrists. Nurse and midwife practitioners are also considered authorised practitioners provided they have obtained authorisation in writing by the Director-General. The authorisation to prescribe drugs is limited to the purpose of practising their respective professions.

Prescription for a Schedule 8 (controlled drug)

Individual State and Territory laws vary, but generally in order to prescribe controlled drugs, a medical practitioner must obtain authorisation. In addition, some Schedule 8 drugs are limited to use by specific specialists.

 
12. Is direct mailing/distance selling of drugs permitted in your jurisdiction?

Distance selling of drugs via direct mailing or other means is generally legal within Australia, subject to the conditions imposed depending on the classification of the drug being sold.

In practice, some of these conditions make it difficult or impossible to direct mail or distance sell some classes of drugs. These conditions differ depending on which State or Territory the drug is being sold from and to, as each of the States and Territories have their own conditions imposed through their laws and regulations.

Selling intrastate requires adherence to the conditions imposed in the State or Territory where the sale takes place, whereas selling interstate can require adherence with the conditions imposed in both the State or Territory of the supplier and of the recipient.

Conditions

Pharmacy Medicines (Schedule 2). There is no specific regulation in any State or Territory that deals with direct mailing or distance selling of Schedule 2 drugs. The only conditions imposed are the applicable quarantine, drug and trade regulations.

Pharmacist Only Medicines (Schedule 3), Prescription Only Medicines (Schedule 4) and Controlled Drug (Schedule 8). Indirect sales, including distance selling, is effectively prohibited in all the States and Territories. Each have various requirements including that the pharmacist:

  • Directly and personally sells to the person (Western Australia).

  • Personally supervises the person (Victoria).

  • Sells only at a dispensary to the person (Queensland).

  • Personally hands the substance to the person (New South Wales and the Australian Capital Territory).

There are exceptions to this prohibition. For example, in New South Wales there is an exemption where the buyer has a prescription for the drug being sold. Further, the Victorian law on what constitutes personal supervision is also unclear, and it may be possible to discharge the duty by means of remote supervisions (such as Skype or a telephone conversation).

Cross-border sales

For commercial export of medicines, Australia requires that the drug:

  • Is listed or registered in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia or export.

  • Has been granted an exemption by the Therapeutic Goods Administration from the need to register on the ARTG.

If the drug is not listed, a company wishing to export can either apply to become the sponsor of the drug or, if the drug is already listed, arrange to export the drug on behalf of the listed sponsor.

In addition, exporters must comply with the relevant State, Territory and Commonwealth laws regarding the procurement and storage of medicines and other relevant legislation including quarantine, customs, wildlife protection, patents and trade marks.

Additional regulations exist on exporting certain drugs such as narcotics, psychotropic substances or their precursors as listed in the Customs (Prohibited Exports) Regulations 1958 (Cth).

 
13. What regulatory authority is responsible for supervising distribution activities?

Dispensing over-the-counter and prescription drugs is controlled under State and Territory drugs and controlled substances legislation. The supervisory role is performed by the relevant government agency of each State and Territory.

In addition, pharmacists are regulated at a national level by the Pharmacy Board of Australia (PBA). All pharmacists must comply with the PBA's Code of Conduct for Pharmacists and Guidelines for the Dispensing of Medicines. Failure to comply can lead to a suspension or surrender of the pharmacist's registration, which is required in order to legally dispense drugs.

 
14. What is the procedure to appeal (legal remedy) a distribution decision?

Any decision regarding a company or person breaching the relevant State or Territory legislation is subject to judicial appeal in the Australian courts.

The Australian Health Practitioner Regulation Agency (the entity responsible for enforcing the Pharmacy Board of Australia's codes) allows appeals for decisions that:

  • Impose or change a condition on a person's registration.

  • Refuse to change or remove a condition imposed on the person's registration.

  • Refuse to change or revoke an undertaking given by the person to the board.

  • Suspend the person's registration.

The decisions can be appealed to the following tribunal in the relevant State or Territory:

  • Civil and Administrative Tribunal (New South Wales).

  • Civil and Administrative Tribunal (Australian Capital Territory).

  • Civil and Administrative Tribunal (Northern Territory).

  • Civil and Administrative Tribunal (Queensland).

  • Health Practitioners Tribunal (South Australia).

  • Health Practitioners Tribunal (Tasmania).

  • Civil and Administrative Tribunal (Victoria).

  • State Administrative Tribunal (Western Australia).

 
15. What are the legal consequences of non-compliance with consumer distribution laws?

The States and Territories each have their own consumer distribution laws. The penalty for breach of these consumer laws differs between each State and Territory. The penalties range from small fines to lengthy imprisonment terms depending on the severity of the breach.

See Question 13 for the penalties for breaching the Pharmacy Board of Australia's codes.

Wholesale distribution

16. What is the legal regime regarding wholesale distribution of drugs?

Under the various State and Territory poisons and controlled substances legislation, a person who supplies drugs by way of wholesale is required to hold a wholesaler's licence. A licence must be obtained from the relevant State or Territory department. In general, an applicant for a wholesale licence must meet certain requirements, including being able to demonstrate that they are a fit and proper person to hold the licence and that the premises are appropriate for the supply of the drugs.

In addition, the Therapeutic Goods Administration publishes the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 (Wholesale Code) that is implemented through applicable State and Territory legislation and licensing arrangements, making the Wholesale Code mandatory.

The Wholesale Code is applicable to persons or organisations, including manufacturers, wholesalers, manufacturer's agents, importers and distributors who store and/or supply by wholesale substances and preparations included in Schedules 2, 3, 4 and 8 of the Poisons Standard.

The Wholesale Code is in addition to, and in no way diminishes, the wholesaler's other obligations under relevant state and federal legislation in relevant areas including:

  • Occupational health and safety.

  • Customs and excise.

  • Poisons (including narcotics).

  • Dangerous goods.

  • Australian Consumer Law.

The Wholesale Code contains a number of obligations, including in relation to the following:

  • Building and Grounds. Properties that store medicine need to be safe and secure with good housekeeping and adequate protection.

  • Storage facilities. Proper policies and procedures need to be in place regarding the storage conditions of the drug to ensure that the quality and safety of the drug is preserved.

  • Personnel. Staff involved in the process must have the necessary skills and knowledge to ensure the safe handling and maintenance of drug quality.

  • Stock handling and stock control. Policies and procedures must be in place to provide for stock handling and stock control.

  • Transport. Transport of drugs must be safe, secure and provide for a timely delivery of all medicines to the destination.

  • Management of complaints, return of unused and/or damaged goods and product recalls. A comprehensive complaints system must be in effect to provide for the receipt, handling, measuring, evaluating and resolution of complaints in order to prevent recurrence.

  • Policies and procedures. Certain policies and procedures need to be in place to ensure that:

    • damaged medication that is unsuitable for sale is quarantined and accounted for;

    • all returned unused or damaged medicine is accounted for through the Return of Unwanted Medicines Program until disposal occurs;

    • appropriate actions are taken in the event of a recall of medicines held in stock;

    • appropriate actions are taken in the event of recalling medicines on behalf of a sponsor;

    • records are able to be generated of recalled medicines.

  • Management of records, documentation and standard operating procedures. Records must be kept in accordance with legislative requirements and documentation must be adequate to achieve the requisite standard of recording and control, including documents relating to quarantined stock.

  • Cold chain medicines. Special policies must be implemented to ensure that the integrity of cold chain medicines is maintained according to the sponsor's recommendations as set out in on the Therapeutic Goods Administration approved product packaging.

  • Security arrangements and procedures. Policies and procedures must be in place for an appropriate level of protection of stored medicines to prevent theft, pilferage, diversion, misuse and illegal distribution. This includes the security and management of the facility and a reporting regime for missing or stolen drugs.

Additional security measures exist for the wholesale supply of a controlled drug or other drug with high illicit value.

 
17. What regulatory authority is responsible for supervising wholesale distribution activities?

Regulatory authority

The supervision of wholesale distribution activities lies with each of the relevant State and Territory departments as follows:

  • NSW Health (New South Wales)

  • Department for Health and Ageing (South Australia).

  • Queensland Health (Queensland).

  • Department of Health (Northern Territory).

  • Department of Health (Western Australia).

  • ACT Health (Australian Capital Territory).

  • Department of Health and Human Services (Tasmania).

  • Department of Health and Human Services (Victoria).

Rights of appeal

The appeal rights in respect of decisions relating to wholesale distribution are subject to the applicable State or Territory legislation. However, generally a decision by the relevant minister to suspend or revoke a licence can be appealed to the administrative tribunal of the relevant State or Territory.

 
18. What are the legal consequences of non-compliance with wholesale distribution laws?

The legal consequences of non-compliance with wholesale distribution laws are determined by the relevant legislation in each State and Territory. For example, in New South Wales the penalty for supplying without or not in accordance with a wholesale licence is A$1650 and/or imprisonment for six months.

 

Marketing

Promotion

19. What is the general legal regime for the marketing of drugs?

Legal regime

Marketing activities must comply with:

  • Therapeutic Goods Act 1989 (Cth).

  • Therapeutic Goods Regulations 1990 (Cth).

  • Competition and Consumer Act 2010 (Cth) (CC Act).

  • Other relevant state and territory legislation.

In addition, the industry is self-regulated or co-regulated, with a number of bodies administering various codes relevant to the marketing of drugs, including:

  • Therapeutic Goods Advertising Code 2015.

  • Medicines Australia Code of Conduct.

  • Generic Medicines Industry Association Code of Practice.

  • Australian Self Medication Industry Code of Practice.

  • Complementary Healthcare Council of Australia's Code of Practice for the Marketing of Complementary Healthcare and Healthfood Products.

Limits to marketing activities

The advertising of prescription drugs and certain over-the-counter products directly to consumers is prohibited.

Off-label marketing is also prohibited. An advertisement for a drug can only refer to the indications that have been included in the Australian Register of Therapeutic Goods for that specific product.

The CC Act regulates all types of advertising in Australia. Under the CC Act, representations made in advertisements must be documented, genuine and not misleading.

The marketing of drugs to healthcare practitioners is largely carried out though a self-regulated scheme operated by industry bodies such as Medicines Australia (which is the peak industry body representing discovery-driven pharmaceutical companies in Australia).

 
20. Are there other codes of conduct for the marketing of drugs (for example, by professional or industrial organisations)?

The advertisement of prescription drugs is regulated through a self-regulatory arrangement described (see Question 19).

 

Marketing to consumers

21. What is the legal regime for marketing to consumers?

Legal regime

Marketing activities directed at consumers must comply with:

  • Therapeutic Goods Act 1989 (TG Act).

  • Therapeutic Goods Regulations 1990 (Cth) (TG Regulations).

  • Competition and Consumer Act 2010 (Cth) (CC Act).

  • Therapeutic Goods Advertising Code 2015.

  • Other relevant state and territory legislation.

Products

The advertising of prescription medicines to consumers is strictly prohibited. The TG Act defines promotion and advertising broadly to include any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Generally, advertisements for over-the-counter (OTC) medicines can be directed to consumers. However, the TG Regulations prohibit the advertising of certain OTC medicines to consumers, including medicines that are included in Schedule 3 (pharmacist-only medicine).

Where direct to consumer advertising is permitted, prior approval is required for certain types of advertisements. Approval will be assessed based on whether the advertisement complies with the relevant legislation and codes.

 
22. What kinds of marketing activities are permitted in relation to consumers and the products which may be advertised to them?

There is no exhaustive list of specific restrictions placed on marketing activities but the Therapeutic Goods Advertising Code (TGAC) provides that advertisements must not:

  • Offer free samples.

  • Offer any personal incentive to a pharmacy assistant, or other non-healthcare professional sales person, to recommend or supply the good.

  • Be directed at minors.

  • Encourage inappropriate or excessive use.

  • Abuse the trust or exploit the lack of knowledge of consumers.

  • Be likely to provoke unwarranted and unrealistic expectations of product effectiveness.

The promotion of prescription products to the general public is strictly prohibited. The only information that can be provided to the public regarding prescription products is educational information. Educational messages must never be designed with the purpose of encouraging consumers to request a specific prescription product from their doctor.

 
23. Is it permitted to provide consumers with free samples? Are there particular restrictions on special offers (for example, "buy-one-get-one-free")?

For prescription products, all advertising to the general public (including giving free samples) is prohibited. For over-the-counter products, the Therapeutic Goods Advertising Code provides that advertisements for therapeutic goods must not contain an offer of a sample.

 
24. Are there particular rules of practice on the use of the internet/social media regarding drugs and their advertising?

In general, the relevant laws, regulations and codes do not distinguish between different types of media. Consequently, as there is a complete prohibition on the promotion of prescription drugs to consumers, advertisements for such products cannot appear on websites directed to Australian consumers.

The internet can be used to promote prescription pharmaceutical products to healthcare professionals, provided that the:

  • Advertisement complies with the regulatory regime.

  • Website can only be accessed through a secure system for healthcare professionals designed to prevent access by members of the general public.

Certain over-the-counter drugs can be promoted to consumers. If promotion direct to consumers is allowed, the promotion must comply with the Therapeutic Goods Advertising Code.

Social media can be a useful tool for the marketing of drugs and the provision of non-promotional information to consumers. However, companies can be held responsible for content posted by third parties on social media pages and therefore companies need to continuously monitor and moderate any social media content. A number of guidelines and codes require that any misleading or inappropriate content be taken down from social media sites within 24 hours.

 
25. What regulatory authority is responsible for supervising marketing activities to consumers?

Regulatory authority

The regulatory authorities responsible for supervising marketing activities to consumers are the:

  • Therapeutic Goods Administration.

  • Australian Competition and Consumer Commission.

In addition to the responsible government bodies, the industry is self-regulated or co-regulated, with the following bodies administering various codes relevant to the marketing of drugs to consumers:

  • Therapeutic Goods Advertising Code Council.

  • Medicines Australia.

  • Generic Medicines Industry Association.

  • Australian Self Medication Industry.

  • Complementary Healthcare Council of Australia.

Rights of appeal

The various laws and codes provide for their own unique avenues of appeal. For example, any decision made by a lower court in relation to breaches of the Competition and Consumer Act 2010 (Cth) can be appealed.

 
26. What are the legal consequences of non-compliance with consumer marketing laws?

Therapeutic Goods Act (TG Act)

Advertising offences under the TG Act including not complying with the Therapeutic Goods Advertising Code, carry a penalty of 60 penalty units (A$10,800) per offence.

Therapeutic Goods Advertising Code (TGAC)

Breaches of the TGAC are assessed by the Complaints Resolution Panel (CRP). If the CRP determines that an advertisement has breached the Code, it can make a request of the advertiser/sponsor but has no power to impose any penalties. If the request is not complied with, the CRP can make recommendations to the Secretary who can order the withdrawal of the advertisement or the publication of a retraction or correction. The CRP can also recommend that the secretary order that an advertiser does not repeat misrepresentations. In extreme cases, regulatory action to remove the product from the market may be necessary.

Self-regulated codes

Sanctions for breaching the various codes vary depending on the code and the severity of the breach. For example, where breaches of the Medicines Australia Code of Conduct have been found, sanctions can include:

  • A requirement to immediately cease the conduct that breaches the code, including withdrawal of the advertisement in issue.

  • Corrective action.

  • Monetary fines of up to A$300,000 per complaint.

Australian Competition and Consumer Commission (ACCC)

Contravention of the Australian Consumer Law (schedule 2 of the Competition and Consumer Act 2010 (Cth)) is subject to remedies including injunctions, damages and compensatory orders. In addition, monetary penalties of up to A$1.1 million for corporations and A$220,000 for individuals can also be ordered.

 

Marketing to professionals

27. What kinds of marketing activities are permitted in relation to professionals?

The types of marketing activities that can be directed to healthcare professionals will largely depend on the type of product (that is, whether it is a prescription or over-the-counter medicine).

Despite the broad powers of the Therapeutic Goods Administration (TGA) in relation to advertising, in practice much of the regulation of the advertising of drugs, particularly advertising directed to healthcare professionals, is through self-regulatory schemes. The most prescriptive requirements are set out in the Medicines Australia Code of Conduct that prescribes standards for the advertising of prescription products to healthcare professionals.

The TGA, in its marketing approval, requires the promotion of all prescription products to comply with the Medicines Australia Code of Conduct. The current edition of the Medicines Code of Conduct is Edition 18 (Edition 18). Updates on the can be found at https://medicinesaustralia.com.au/code-of-conduct/.

 
28. Are there any restrictions on marketing to professionals?

The types of marketing activities that can be directed to healthcare professionals will largely depend on the type of product (that is, whether it is a prescription or OTC drug). Most of the restrictions relating to marketing directed at healthcare professionals are contained within the Medicines Australia Code of Conduct (Code of Conduct), which regulates the marketing of prescription medicines.

The Code of Conduct requires that no financial or material benefit be conditional on any obligation by the healthcare professionals to recommend, prescribe, dispense or administer a company's prescription product(s).

In addition, the Code of Conduct expressly prohibits some form of marketing to professionals, including:

  • The giving of items or offers to healthcare professionals, except educational items that do not bear the name of any medicine or product. Consequently, brand name reminders are prohibited.

  • Hospitality offered to professionals must be simple, modest, secondary to the educational content and provided in an environment that enhances education and learning.

  • The travel costs of professionals can be provided if it is justifiable in the context of the educational content or origin of the delegates. If this includes air travel, tickets are restricted to economy class only. Travel arrangements cannot include any additional time over what is reasonable for the professional to attend the event and must be the most practical direct route.

  • Reasonable levels of accommodation can be provided to a professional if it is justified by the arrangements of the meeting.

  • Companies are forbidden from providing entertainment, remuneration for their attendance and subsidies to professionals' families or travel companion(s).

 
29. What information is it legally required to include in advertising to professionals?

The information required to be included in an advertisement will depend on the type of product as well as the length of time it has been on the market. For example, for advertisements placed in print for a prescription medicine which has been entered on the Australian Register of Therapeutic Goods for less than 24 months, the Medicines Australia Code of Conduct requires that the following information be included:

  • The product's brand name.

  • The Australian Approved Name of the active ingredient(s).

  • All Pharmaceutical Benefit Scheme (PBS) listings, including any restrictions (the PBS is a government scheme which provides certain prescription drugs at a heavily-subsidised price).

  • The product information or minimum product information.

  • The name of the supplier and the city, town or locality of the registered office.

  • A clear and unambiguous statement for prescribers to review the product Information before prescribing in a form prescribed by the Code of Conduct.

Each portion of mandatory information must meet the minimum size and/or formatting requirements as prescribed by the Code of Conduct.

 
30. Are there rules on comparisons with other products that are particularly applicable to drugs?

The Medicines Australia Code of Conduct, which applies to the promotion of prescription products, prescribes a number of rules with regard to the making of comparative claims, including that:

  • Care must be taken to ensure that any comparison with another product properly reflects the body of evidence and does not mislead by distortion, by undue emphasis or in any other way. Comparisons of products must be factual, fair, capable of substantiation, referenced to its source, and must not be disparaging. "Hanging" comparatives (those that merely claim that a product is better, stronger, or more widely prescribed) must not be used.

  • Claims of comparative efficacy or safety must not be based solely on a comparison of product information documents that does not reflect the general literature, as those documents are based on different databases and are not directly comparable. This applies to Australian as well as overseas product information documents.

  • Comparative claims must be substantiated with respect to all aspects of efficacy or safety. Where a comparative claim relates to a specific parameter, any claims must be clearly identified as pertaining to that parameter. The accepted level of statistical significance is p <0.05. If comparative data that is not statistically significant is used, the data must comply with the following conditions:

    • the lack of significance must be stated explicitly, it is insufficient to state the p value;

    • the data must not be used to generalise or to indicate superiority or inferiority.

  • If comparative data is used where the relevant study does not include a statement of the significance or lack of significance of the comparative data, the lack of a p value must be explicitly stated.

  • A statement that the difference is not statistically significant or p value is not stated must be linked to the original claim by a readily identifiable symbol such as an asterisk or a similar device, and appear directly below or adjacent to the claim using a type size not less than 3 mm based on the font's lower case "e" for printed materials. Care must be taken to distinguish between mathematically determined statistical significance and clinical significance.

In addition, all comparative advertising must comply with the relevant provisions of the Competition and Consumer Act 2010 (Cth).

 
31. What other items, funding or services are permitted to be provided to professionals?

The Medicines Australia Code of Conduct (Code of Conduct) requires that no financial or material benefit be conditional on any obligation by the healthcare professional to recommend, prescribe, dispense or administer a company's prescription product.

In addition, the Code of Conduct contains the following specific requirements:

  • Starter packs can only be supplied on their request to authorised healthcare professionals, including medical practitioners, dentists, veterinarians, hospital pharmacists and nurse practitioners. They can only be supplied when required for any of the following reasons:

    • for immediate use in the surgery for relief of symptoms;

    • for the use of alternative treatments, prior to a prescription being written;

    • for after-hours use;

    • for gaining familiarisation with products.

  • Sponsoring a healthcare professional's attendance at an educational event is permitted provided the event is directly related to their area of expertise. Sponsorship must have the purpose of enhancing the quality use of medicines and be able to withstand public and professional scrutiny.

  • A company can temporarily loan a piece of equipment to a medical practice or health related organisation, provided it facilitates the quality use of medicines. If the equipment is provided as part of a loan arrangement, the company must have a mechanism for retrieval of the equipment.

  • A company can provide a grant or financial support provided that the support is made only to a medical practice, hospital, institution or health related organisation:

    • for education, training or academic purposes;

    • for medical research;

    • for activities that improve the quality use of medicines;

    • to improve the outcome for patients.

  • A company can sponsor "in-institution" educational events, such as journal clubs, grand rounds, multidisciplinary and in-service meetings held within the healthcare professional workplace. To qualify for sponsorship, the primary purpose of the event must be the provision of medical education.

 
32. What regulatory authority is responsible for supervising marketing activities regarding professionals?

Regulatory authority

The regulatory authorities responsible for supervising marketing activities regarding professionals are the:

  • Therapeutic Goods Administration.

  • Australian Competition and Consumer Commission.

In addition to the responsible government bodies, the industry is self-regulated or co-regulated, with the following bodies administering various codes relevant to the marketing of drugs to consumers:

  • Therapeutic Goods Advertising Code Council.

  • Medicines Australia.

  • Generic Medicines Industry Association.

  • Australian Self Medication Industry.

  • Complementary Healthcare Council of Australia.

Supervision and rights of appeal

The various laws and codes provide for their own unique avenues of appeal. For example, any decision made by a lower court in relation to breaches of the Competition and Consumer Act 2010 (Cth) can be appealed.

 
33. What are the legal consequences in case of non-compliance with professional marketing laws?
 

Engagement with patient organisations

34. What kinds of activities are permitted in relation to engagement with patient organisations? What are the restrictions that are imposed on relationship with patient organisations?

The Medicines Australia Code of Conduct (Code of Conduct) that applies to the promotion of prescription products, prescribes a number of obligations and prohibitions in relation to the engagement by companies of patient organisations.

The Code of Conduct encourages and supports positive and beneficial relationships between industry and patient organisations. In addition, Medicines Australia has produced a set of guidelines for relationships between patient organisations and pharmaceutical companies called "Working Together – A Guide to Relationships between Health Consumer Organisations and Pharmaceutical Companies".

The guide is an informal document addressing how the relationship can be formed in an ethical and transparent manner and to comply with the Code of Conduct. Prohibited activities include:

  • Requesting to be the sole funder.

  • Interfering with the independence of the patient organisation.

  • Using the patient organisation's logo or proprietary material without agreement.

  • Exerting influence on the text of a patient organisation's material in a manner favourable to the commercial interests of a company.

 

Reform

35. Are there any plans to reform the law on the distribution and promotion of drugs in your jurisdiction?

In December 2011, the Therapeutic Goods Administration (TGA) published A blueprint for TGA's future that contains plans that are currently underway to reform many aspects of the TGA so that it remains adaptable to community and industry expectations.

With regards to the promotion of products, the main reforms aim to achieve:

  • Consistency of therapeutic sector industry codes.

  • Accessibility to the industry codes.

  • The educating of members and non-members about requirements of the relevant codes.

  • A streamlined portal to channel complaints to the appropriate industry association.

The Australian Government is presently undertaking a review of medicines and medical devices regulation. On 15 September 2016, the Australian Government Response to the Review of Medicines and Medical Devices Regulation was released. It identifies ways to improve access to medicines and medical devices for consumers and remove unnecessary red tape for the pharmaceutical industry while ensuring the safety of medicines and medical devices in Australia.

In late 2015, the TGA implemented the Therapeutic Goods Advertising Code 2015 which replaced the earlier Therapeutic Goods Advertising Code 2007 without any significant amendments. The Therapeutic Goods Advertising Code 2015 is expected to be the subject of further consideration as part of the present review of medicines and medical devices regulation.

* The authors wish to thank Dr Simone Mitchell, Alexandra Chubb and Matthew Evans for their contributions to previous editions of this chapter.

 

Contributor profiles

Nicholas Tyacke, Partner

DLA Piper

T +61 2 9286 8502
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E nicholas.tyacke@dlapiper.com

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Professional qualifications. New South Wales, 1992; High Court of Australia, 1992; New York State Supreme Court, 1997; US District Court for the Southern District of New York, 1997; US District Court for the Eastern District of New York, 1997; US Court of Appeals for the Second Circuit, 1997; US Court of Appeals for the Federal Circuit, 1997; Supreme Court of the US, 1997; Federal Court of Australia, 2003

Areas of practice. Pharmaceutical, bioscience and medical technology patent litigation and advice; pharmaceutical and medical device regulation; intellectual property; life sciences.

Recent transactions

  • Advising pharmaceutical, bioscience and medical device companies on Australian regulatory and compliance issues.

  • Acting or has acted in a number of leading Australian and US patent cases, including cases in the Federal Court of Australia, the US Court of Appeals for the Federal Circuit and the Supreme Court of the US.

  • Advising and acting for, or has advised and acted for, many of the world's leading innovator life sciences companies in patent infringement and revocation litigation, often as a member of a global team working together to resolve complex, multi-jurisdictional patent issues and disputes.

  • Advising or has advised many Australian and international pharmaceutical, bioscience and medical technology clients in relation to patent issues, including international patent protection strategies and patent portfolio management.

Greg Bodulovic, Senior Associate

DLA Piper

T +61 2 9286 8218
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Professional qualifications. Australian Capital Territory, 2004; New South Wales, 2006; High Court of Australia, 2008; Bachelor of Laws (Hons), Australian National University, 2004; M.Phil (Biotechnology), Australian National University, 2008; Bachelor of Science, Australian National University, 2003

Areas of practice. Intellectual property and litigation; pharmaceutical and medical device regulation; life sciences.

Recent transactions

  • Advising pharmaceutical, bioscience and medical device companies on Australian regulatory and compliance issues.

  • Acting in many patent infringement and revocation proceedings before the Federal Court of Australia and patent opposition proceedings before the Australian Patent Office.

  • Advising on the intellectual property and life sciences regulatory aspects of corporate transactions.

Jessie Buchan, Senior Associate

DLA Piper

T +61 2 9286 8552
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Professional qualifications. Solicitor, Supreme Court of New South Wales, 2010; Solicitor, High Court of Australia; Bachelor of Laws (Hons), University of Sydney 2009, Bachelor of Communication, University of Newcastle, 2006

Areas of practice. Pharmaceutical and medical device regulation; intellectual property and litigation.

Recent transactions

  • Advising pharmaceutical, bioscience and medical device companies on Australian regulatory and compliance issues.

  • Acting in many patent infringement and revocation proceedings in the Federal Court of Australia, including in the life sciences field.

Brett Shandler, Solicitor

DLA Piper

T +61 2 9286 8211
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E brett.shandler@dlapiper.com

Professional qualifications. Supreme Court of Victoria, 2016; High Court of Australia, 2016; Juris Doctor, University of Melbourne, 2016; Bachelor of Biomedical Science, Monash University, 2012

Areas of practice. Intellectual property and litigation; pharmaceutical and medical device regulation; life sciences.

Recent transactions

  • Advising multinational life science companies in relation to infringement and validity of Australian patents.

  • Advising pharmaceutical, bioscience and medical device companies on Australian regulatory and compliance issues.


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