Pharmaceutical Regulation and Litigation in Foreign Countries

• Author: Kenneth Dorsney
• Pages: 437-534

437

chapter 18

Pharmaceutical Regulation

and Litigation in Foreign

Countries

This chapter examines the regulatory approval processes for innovator and

generic drugs in Australia, Brazil, Canada, the European Union and the

United Kingdom, and Japan. Particular consideration is given to (1)the rel-

evant statutory and regulatory schemes; (2)notice and pre-filing require-

ments; (3)the litigation process; and (4)remedies. Even though there may

be some similarities in each jurisdiction to the procedures and processes of

the United States, each jurisdiction has its own unique rules and responsi-

bilities, and a complete understanding of each system is essential for any

company working within that legal system. This chapter touches on the

main principles of each jurisdiction, but it is in no way a comprehensive

review of the current law, and advice from local attorneys is essential.

I. Australia1

A. The Statutory and Regulatory Scheme

In Australia, the statutory and regulatory scheme governing pharmaceuti-

cal medicines comprises three primary components, all part of Common-

wealth (federal) law:

a. The Therapeutic Goods Act 1989 (Cth) (TG Act), its subsidiary

Therapeutic Goods Regulations 1990 (TG Regs) and associated

administrative policies;

b. The Pharmaceutical Benefits Scheme (PBS), which is governed by

provisions in Part VII of the National Health Act 1953 (Cth) (NH

1. Grant Fisher and Duncan Longstaff, Blake Dawson.

CHAPTER 18

438

Act) and its subsidiary National Health (Pharmaceutical Benefits)

Regulations 1960 (Cth) (NH Regs); and

c. The Patents Act 1990 (Cth) (Patents Act) and its subsidiary Pat-

ents Regulations 1991 (Cth) (Patents Regs).

1. Registration and Listing of Therapeutic Goods

A therapeutic good (including a pharmaceutical medicine) can only be mar-

keted in Australia after it has been evaluated and approved by the Thera-

peutic Goods Administration (TGA), the government agency responsible for

administering the TG Act and TG Regs. The TGA maintains the Australian

Register of Therapeutic Goods (ARTG) for the purpose of compiling infor-

mation in relation to, and providing for evaluation of, therapeutic goods

for use in humans (TG Act, section 9A(1)). The ARTG contains four parts:

a. Registered goods are medicines assessed as being higher risk and

therefore undergo rigorous and detailed assessment on an individ-

ual basis. Whether a medicine is deemed “high risk” and therefore

required to be registered on the ARTG is determined by assessing

whether it contains a substance included in the Standard for the

Uniform Scheduling of Drugs and Poisons (SUSDP), its dosage

form(s), promotional/therapeutic claims made, the seriousness

of the illness treated, and whether there are any significant side

effects or adverse effects from prolonged use. If these factors indi-

cate a high risk, sponsors are required to provide comprehensive

safety, quality, and efficacy data from clinical trials (or, for well-

known active ingredients, standard textbooks/guidelines) to obtain

registration in one of two subcategories:

i) Prescription (high risk) registered—all prescription medi-

cines and some specified products such as sterile inject-

ables; or

ii) Non-prescription (low risk) registered—considered to be

lower risk than prescription medicines but still worthy of

a high level of scrutiny to ensure adequate labeling and

appropriate use, such as mild analgesics, cough/cold prepa-

rations, and antifungal creams.

All registered medicines must display an “AUST R” number

on the label as proof of registration. For more information, see

the TGA Website: http: //www.tga.gov.au/consumers/regulation-

basics-medicines-registered.htm.

a. Listed goods are medicines deemed to be low risk based on the

same factors described above and that contain only ingredients

I. Australia 439

the TGA has evaluated as low risk, are manufactured by licensed

manufacturers complying with GMP (good manufacturing prac-

tice), and carry indications only for health maintenance and/or

enhancement, or certain indications for nonserious, self-limiting

conditions. Listed medicines are assessed by the TGA for quality

and safety but not efficacy. As most listed medicines are self-

selected by consumers (rather than prescribed by medical practi-

tioners), the TG Regs specify some situations in which sponsors

can assess their own products. Most complementary (i.e., “tradi-

tional” or “alternative”) medicines on the ARTG (such as vitamin,

herbal, mineral, aromatherapy, and homeopathic products) are

listed medicines; however, some are low risk registered medicines

because of their ingredients and/or claims made. All listed medi-

cines must display an “AUST L” number on the label as proof of

listing and must not contain substances that are scheduled in the

SUSDP.

b. Medical devices have a physical or mechanical effect on the body

or are used to measure or monitor functions of the body.

c. Biologicals comprise, contain, or are derived from human cells or

human tissues and are used to treat or prevent disease; diagnose

the condition of a person; influence, inhibit, or modify a physi-

ological process in persons; test the susceptibility of a person to a

disease or ailment; or replace or modify parts in the anatomy of a

person.

2. Price Subsidies for Pharmaceutical Medicines Under the PBS

While TGA approval is all that is technically required for a pharmaceutical

medicine to be marketed or supplied in Australia, most high-cost pharma-

ceutical products (such as prescription medicines) cannot be viably sold

into the Australian market without the substantial government subsidies

flowing from inclusion on the PBS. Australian consumers pay only $34.20

2

for most medicines listed on the PBS (but may pay extra where they are

prescribed a brand that costs more than the least expensive brand of that

medicine), with the Australian government paying the remaining cost

(which it negotiates with each sponsor, on a product-by-product basis). The

PBS Schedule is published on the Website of the Department of Health

and Ageing (DoHA) (http://www.pbs.gov.au) and contains information on

the conditions of use for the prescribing of PBS medicines.

2. From January 1, 2011, noting that concession card holders (students, senior

citizens, persons with disabilities, etc.) pay $5.60, and that these amounts are adjusted in

line with inflation on January 1 each year.