46.3 Criminal and civil law
distinguishedGenerally speaking, law is broken down into two
separate components – criminal law and civil law.
A crime is an offence or wrongdoing against the
State and is punishable by the State. Civil law
concerns the breach of a private right or duty.
Thus, in contrast to criminal cases, most civil
actions are not brought by the State but by private
individuals or other legal entities, such as corpora-
tions. In some instances, an individual’s actions
can give rise to both a criminal offence and a
civil liability, for example, an assault can result in
a prosecution by the State and a claim by the victim
for damages for personal injury.
Another important distinction between criminal
and civil cases is the threshold ‘burden of proof’
that must be reached in order to prove the case
against the defendant. In a criminal case, the State
must prove its case ‘beyond a reasonable doubt’. In
civil actions, the plaintiff must prove his/her case
‘on a balance of probabilities’. The standard of
proof for criminal matters is higher, essentially
becauseanindividual’slifeorlibertymaybeatrisk.
46.4 Criminal law
Fortunately, instances where pharmaceutical phy-
siciansfacecriminalprosecutionarerare.Thereare
a number of specific ways, however, in which the
criminal law can affect pharmaceutical companies
and their physicians. One significant area is in the
regulatorycontext,whichmayvaryfromcountryto
country. For example, in the United Kingdom, the
Medicines Act of 1968 creates some statutory
offences, such as providing false information
when applying to license a product.
In the United States, the Food Drug and Cos-
metics Act (FDCA) also creates statutory offences
for certain actions or inactions. For example, it is
not permissible to sell a misbranded drug or device,
or onewith labeling that is false, misleading or fails
to bear adequate directions for use. In addition, an
adulterated product may not be introduced, such as
one that has been modified from its intended use.
The US Supreme Court has observed that an
offence is committed ‘by all who do have such a
responsible share in the furtherance of the transac-
tion which the statute outlaws’. Furthermore, the
Court has interpreted the FDCA as imposing ‘not
only a positive duty to seek out and remedy viola-
tions when they occur but also, and primarily, a
duty to implement measures that will insure that
violations will not occur’. The Prescription Drug
Marketing Act of 1987 (PDMA, part of the FDCA)
was enacted to address marketing practices that
contribute to a second-hand market for drugs,
such as distribution of free samples, coupons for
reduced or free drugs and deeply discounted drugs.
The PDMA, makes it a crime to knowingly sell,
purchase or trade a prescription drug sample. This
Act also prohibits the resale of any prescription
drug previously purchased by a healthcare entity.
The Anti-Kickback Statute, as the name suggests,
prohibits knowingly and wilfully offering, paying,
soliciting or receiving remuneration in order to
induce business payable by a healthcare facility
or program that is federally funded (for example,
through Medicaid).
Another area where potential criminal liability
may occasionally emerge is fraud or forgery during
the course of a clinical trial. In the United States,
the Office of Research Integrity investigates
allegations of scientific misconduct in federally
funded research. Pharmaceutical physicians, who
are involved in designing and monitoring clinical
trials will be aware of the need to build in various
safeguards to protect against the possibility of
these offences. Courts expect foresight and dili-
gence from individuals who voluntarily assume
positions of authority in enterprises that affect the
health and well-being of the public.46.5 Civil law
The two main areas of civil law that may affect the
pharmaceutical physician are the law of contract
and the law of tort. Essentially, a contract is a
legally binding agreement between individuals
(or other legal entities such as corporations),
where one of the parties assumes an obligation or
makes a promise to the other. Usually, the parties to596 CH46 PHARMACEUTICAL MEDICINE AND THE LAW