Pharmaceutical Regulation and Litigation in Foreign Countries

AuthorKenneth L. Dorsney
Pages549-661
549
chapter 23
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
relevant statutory and regulatory schemes; (2) notice and prefiling 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. Australia
A. The Statutory and Regulatory Scheme
In Australia, the statutory and regulatory scheme governing innovator
and generic drugs comprises three primary components, all part of Com-
monwealth (federal) law:
Australia: Grant Fisher and Benjamin Hopper, Ashurst, Melbourne, based on a chapter
written by Grant Fisher and Duncan Longstaff.
Brazil: Gustavo de Freitas Morais, Rodrigo Augusto Oliveira Rocci, and Caio Ribeiro
Bueno Brandão, Dannemann Siemsen Bigler & Ipanema Moreira, São Paulo.
Canada: Kelly McClellan and John Norman, Gowling WLG (Canada) LLP, Ottawa,
Ontario.
European Union and the United Kingdom: Marie Manley and Marina Vickers, Bristows,
London.
Japan: Ayako Kobayashi, Hiroshi Nemoto, and Satoshi Ogawa, TMI Associates, Tokyo.
dor54588_23_ch23_549–662.indd 549 5/5/16 4:51 PM
CHAPTER 23
550
1. The Therapeutic Goods Act 1989 (Cth) (TG Act), Therapeutic
Goods Regulations 1990 (TG Regs), and associated administrative
policies;
2. The Pharmaceutical Benefits Scheme, which is governed by the
National Health Act 1953 (Cth) (NH Act) and the National Health
(Pharmaceutical Benefits) Regulations 1960 (Cth) (NH Regs); and
3. The Patents Act 1990 (Cth) (Patents Act) and the Patents Regula-
tions 1991 (Cth) (Patents Regs).
1. Registration and Listing of Therapeutic Goods
A therapeutic good (including a pharmaceutical medicine)1 may only be
marketed, imported, manufactured, or supplied within Australia after it
has been evaluated and approved by the government agency responsible for
administering the TG Act and TG Regs—the Therapeutic Goods Adminis-
tration (TGA), which is part of the Australian Government Department of
Health (DoH). The TGA maintains the Australian Register of Therapeutic
Goods (ARTG) for the purpose of compiling information in relation to, and
providing for evaluation of, therapeutic goods for use in humans (TG Act,
section 9A(1)). The ARTG contains four parts (TG Act, section9A(3)):
1. Registered goods. These are medicines assessed as having a higher
level of risk. As a result, they undergo a detailed assessment for
safety, quality, and efficacy. Registration is given in respect of the
conditions and indications for which the clinical data supports safe
use. Whether a medicine is deemed a “higher risk,” and therefore
required to be registered on the ARTG, is determined by assess-
ing whether it contains a substance included in the Standard for
the Uniform Scheduling of Medicines and Poisons (the Poisons
Standard), its dosage form(s), the 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 indicate a high risk, sponsors are required to pro-
vide 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:
1. TG Act, s 3 defines “therapeutic goods” as including goods that are represented in any
way to be, or that are, whether because of the way in which the goods are presented or for
any other reason, likely to be taken to be:
1. for therapeutic use; or
2. for use as an ingredient or component in the manufacture of therapeutic goods; or
3. for use as a container or part of a container for goods of the kind referred to in
subparagraph(a) or (b).
dor54588_23_ch23_549–662.indd 550 5/5/16 4:51 PM
I. Australia 551
a. prescription (high risk) registered medicines—all prescription
medicines and some specified products such as sterile inject-
ables; or
b. nonprescription (low risk) registered medicines—considered to
be lower risk than prescription medicines, but still requiring a
high level of scrutiny to ensure adequate labeling and appropri-
ate use, such as mild analgesics, cough/cold preparations, and
antifungal creams.
All registered medicines must display an “AUST R” number on the
label as proof of registration.2
2. Listed goods. These are medicines assessed as being lower risk
based on the same factors described above, contain only ingredients
the TGA has evaluated as low risk, are manufactured by licensed
manufacturers complying with good manufacturing practice, and
carry indications only for health maintenance and/or enhance-
ment, 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 con-
sumers, rather than prescribed by medical practitioners, the TG
Regs specify some situations in which sponsors can assess their
own products. Most complementary medicines on the ARTG (such
as vitamin, herbal, mineral, aromatherapy, and homeopathic prod-
ucts) are listed medicines, however, some are low-risk registered
medicines because of their ingredients and/or claims made. All
listed medicines must display an “AUST L” number on the label as
proof of listing, and must not contain substances that are scheduled
in the Poisons Standard.
3. Biologicals. A biological is a thing comprising, containing, or
derived from human cells or human tissues and, among other
things, are used to
a. treat or prevent disease;
b. diagnose the condition of a person;
c. influence, inhibit, or modify a physiological process in persons;
d. test the susceptibility of a person to a disease or ailment; or
e. replace or modify parts of the anatomy of a person (see TG Act,
section 32A).
4. Medical devices. A medical device is defined under the TG Act to
include an instrument, apparatus, appliance, material, or other
article (whether used alone or in combination, and including the
2. For more information about labeling, see Dep’t of Health, Therapeutic Good Admin.,
What’s on a Medicine Label?, https://www.tga.gov.au/community-qa/whats-medicine-label
(last visited March 16, 2016).
dor54588_23_ch23_549–662.indd 551 5/5/16 4:51 PM

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT