pharmacoepidemiology individual assignment..pptx

JIMMA UNIVERSITY
COLLEGE OF MEDICINE AND HEALTH S.
SCHOOL OF PHARMACY
DEPT. OF C. PHARMACY
PHARMACO EPIDEMIOLGY IND. ASSIGNMENT
PHARMACOEPIDEMIOLOGY AND THE LAW
BY MASTEWAL S. (MSC CAND.)
SUBMITTED TO ASS. PRO. GIZACHEW T. (
BPHARM, MSC)
Jimma university
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Outline
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 introduction
 Tort law and product liability
 Contract law
 Pharmacoepidemiology and
Intellectual Property Law
 Conclusion
 Reference

Introduction
 The law describes the basic rules under which
people live in modern society.
 In their daily work, pharmacoepidemiologists
encounter many different aspects of the law.
 Perhaps the most recognizable connection
occurs when patients seek redress in tort law
for adverse effects from a medical product.
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Intro…
 In such circumstances, pharmacoepidemiologic
studies may provide the scientific underpinning for
the claim as to the association between the drug
and the claimed outcome.
 pharmacoepidemiologists must navigate contract
law when they develop research agreements with
funding sources or owners of databases.
 Pharmacoepidemiologists interface with property
law when they attempt to secure ownership rights
over their discoveries using patents (a type of
“intellectual property”).
4

Tort Law and Product
Liability Lawsuits
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 Product liability lawsuits provide an
opportunity for individuals harmed by
a drug to seek damages from its
manufacturer.
 Tort litigation brought by government
agencies and individual patients can
help uncover previously unavailable
data on adverse effects, questionable
practices by manufacturers, and
flaws in drug regulatory systems.

Liability Lawsuits…
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 The Legal Theory of Product Liability
 Product liability lawsuits provide an opportunity
for individuals harmed by a drug to seek
damages from its manufacturer.
 Tort litigation brought by government agencies
and individual patients can help uncover
previously unavailable data on adverse effects,
questionable practices by manufacturers, and
flaws in drug regulatory systems.

7
 To succeed in a claim for negligence, plaintiffs
needed to show:
 that defendants had a duty to exercise
reasonable care;
 that defendants’ conduct diverged from
customary practices that would be followed by
other manufacturers or members of the
industry;

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 That there was a causal link between the
defendants’ lack of care and the outcome at
issue; and
 that the preceding three factors led to
damages.

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 Failure‐to‐Warn Claims
 Whether based on strict liability or negligence,
a failure‐to‐warn product liability action
includes three main contentions:
 knowledge of the drug risk by the
manufacturer;
 improper warning of the drug risk; and
 causation of damages.

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Learned Intermediary Defense
 If a plaintiff successfully argues these issues
and demonstrates a prima facie case of
product liability based on a failure to warn, the
manufacturer has a few possible defenses.
 The most relevant in the field of
pharmaceutical law is the learned intermediary
defense.

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Expertise and Daubert
 Pharmacoepidemiologists often serve as
expert witnesses in product liability cases.
 Pharmacoepidemiologists can help judges and
juries understand data about drugs and help
determine whether warning information
appropriately reflects the risk posed by a drug

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 Experts are usually called on to
describe the current state of
knowledge about the adverse event
at issue, and may be asked to
perform additional
pharmacoepidemiologic analyses of
available data to present before the
court.

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However, courts can exclude some
practitioners and some analyses from
trial.
Traditionally, the judge is responsible
for evaluating whether expert
witnesses lack qualifications or
espouse scientific theories out of step
with accepted knowledge.

Pharmacoepidemiology and
Contract Law
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 Many studies in the field of
pharmacoepidemiology emerge from
collaborations among individuals at different
institutions.
 Different researchers may bring specific types
of expertise to a project or different resources.
 For example, researchers may have all the
computing power they need, but require
access to a certain external database to
address a question.

Contract Law…
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 Collaborations may occur among academic
centers, between nonprofit and for‐profit
companies, or with the government.
 Cooperative work can allow more complex
research to be performed and help advance
the field of pharmacoepidemiology in several
ways.

Intellectual Property Law…
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 One type of collaborative work of particular
public health importance is contract research.
 Contract research is undertaken by an
individual, academic, or nonprofit investigator
supported by a sponsor (usually an industry or
governmental agency).
 Most contractual research relationships are
defined by the generation of a “deliverable,”
which can be a database, a research report, or
some other product

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 The contract is the centerpiece of the
relationship and classically represents the full
outline of the agreement between the parties.
 The mutually agreed‐upon terms are used as
evidence of the parties’ intentions if the
agreement later runs into trouble and ends up
in court.

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 However, contract research may pose various
potential pitfalls as well. Concern about
contract research generally centers around
 i. trial design;
 ii. access to data and data analysis; and
 Iii. publication of results.

Intellectual Property Law
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 Patent law is a field of growing importance to
the practice of pharmacoepidemiology.
 A patent is a formal grant of market exclusivity
authorized by the federal government.
 The concept of a patent may have originated
in ancient Greece, but became a formal legal
instrument in England and Europe in the
fourteenth and fifteenth centuries.

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 In the US, the original Patent Act was passed
under authority from the Constitution, which
permits Congress to develop laws that
“promote progress of Science and the Useful
Arts”.
 Patents give inventors the right to exclude
others from making, using, offering to sell, or
selling the invention claimed in the patent for
20 years from the patent application date.

21
 In recent years, numerous patents have been
obtained on methods and techniques used in
pharmacoepidemiology, including investigating
characteristics of drug use and adverse
events.
 Inventors may have numerous justifications for
pursuing patents.
 First, patents provide an incentive for
investment in research by offering an
opportunity to recoup start‐up costs after
dissemination of a product.

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 Patents related to the practice of
pharmacoepidemiology have been obtained by
applicants ranging from individuals (e.g., a
patent covering a method for assessing the
association of genomic data with drug safety
adverse event data
 To large healthcare data collectors such as
Microsoft (e.g., a patent covering a method for
large‐scale data collection and data mining to
infer health‐related observations.

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 Pharmacoepidemiologists are likely to
continue to come across patented methods in
their daily work and be faced themselves with
the question of whether to pursue patents on
their research tools.

Conclusion
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 Legal issues intersect with the practice of
pharmacoepidemiology in many ways.
 Pharmacoepidemiologists may be involved in
product liability cases brought by individuals
against drug manufacturers, either as expert
witnesses or on the basis of academic work
theyundertake

Conclusion…
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 Pharmacoepidemiologists may also
beinvolved in contract research, but should
carefully consider contractual requirements
related to ownership of the work product and
withholding publication.
 Finally, both in the US and in Europe,
pharmacoepidemiologists may decide to try to
patent their research methods, but should
weigh up the risks and benefits of this form of
intellectual property.

Reference
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 Pharmacoepidemiology by brian-Stephen-E-
kimmel 6th edition

pharmacoepidemiology individual assignment..pptx

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