E-drug: Book Review Medicinal Products and the Law
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E-druggers:
Richard Laing gave me a copy of the above-referenced new book by Dr. D.C.
Jayasuriya and asked me to review it. I attach the review as part of this
message. In the spirit of bringing some more attention to this book, I offer
this review. All opinions are mine and are not meant to represent those of
any other person or institution.
Warren Kaplan, Ph.D., Esq.
Boston University School of Public Health
wak22@attbi.com
[Thank you Warren! KM, moderator]
Book Review: MEDICINAL PRODUCTS AND THE LAW IN DEVELOPING COUNTRIES-
CONCEPTS, ISSUES AND APPROACHES: D.C. Jayasuriya, Ph.D., LLB.
Har-Anand Publications Pvt, Ltd. (2002) New Delhi India
This new book by Dr. D.C. Jayasuriya is intended to update a prior book by
the same author, REGULATION OF PHARMACEUTICALS IN DEVELOPING COUNTRIES,
published by the World Health Organization in 1985. Much has happened in the
area of pharmaceutical law and regulation since 1985, including among other
things, the many new regulations and revisions in the statutory law of
developing countries, the acceptance of the Essential Medicines concept, and
the development of the WHO Certification Scheme. This book is therefore
intended as, in the author's words, a "non-technical orientation to
regulatory issues of concern to all those who are interested in regulating
pharmaceuticals in developing countries." It is designed to provide a
"more in-depth and detailed analysis than that contained in the earlier
book..." with more examples from selected national policies and laws.
The text is into 3 parts. Section I provides a good general background to
legal principles. Section II summarizes the scope and content of legal
issues dealing with drug regulatory authorities, product registration,
manufacturing, exports, imports, advertising and the like. Section III deals
with special issues such as intellectual property and clinical trials
This book is an excellent overview of the many legal issues facing drug
regulatory agencies but the diffuse nature of its intended audience neither
gives the book focus nor allows any critical review that might prove useful
to policy makers working with attorneys who plan to craft new legislation.
Indeed, lawyers might find the contents too superficial and pharmaceutical
regulators might well question the lack of recommendations or guidance. Most
significantly, one wishes for even more specific examples of "best practice"
. Candidly, even if the author was ultimately wrong in making a specific
recommendation, such statements would have stimulated some discussion and at
the very least provided a platform for future debate.
Some specific points will illustrate. There is a potentially useful
discussion ( p. 54) of the structure of drug regulatory authorities and the
text clearly delineates what governments should do to provide the legal
framework to support these agencies. It would, however, have been far more
interesting, useful, and important to compare what "should" be the case with
what developing countries have actually done. Conflict of interest is an
important subject (p.59) but there is only a single decade-old statutory
example from Spain to illustrate the author's point that a "small number of
countries" have legislative mandates regarding conflicts of interest. If
there are so few countries, why not list them in an Annex and try to provide
"best practice" recommendations. The legal provisions for enforcement of
pharmaceutical legislation for several developing countries are provided
p. 128) and this is an excellent start but, again, particular examples or
recommendations of "best practice" language would have been useful.
On rare occasions, the writing style can be cryptic and would have benefited
from more editing. The author states (p.28) that "[B]ecause of the very
nature of medicinal products, additional regulatory regimes specific to them
are essential, though not very common in most developing countries." The
non-expert might wonder what is this mysterious "nature of medicinal
products". It is left until later (p.45) to explain that " . considerations
of public health demand that [medicinal products].. " be subject to special
regulatory regimes. The author (p. 57) asserts that legal regulations must
be specific and comply with principles of "natural justice" but this
latter term, if it really adds to the discussion, is nowhere defined.
It is even on rarer occasions that the book actually seems oddly outdated.
For instance, this reviewer could find no list of websites of any kind and
they would have been useful. Direct to consumer advertising is allowed in
both the United States (p. 115) and New Zealand. A ".very recent study."
(page 112: footnote 110) was cited but the study was from 1993, already
nearly a decade old.
The author has succeeded in writing a non-technical orientation to
regulatory issues but, in this reviewers' opinion, has not provided the sort
of in-depth analysis that could have broken new ground and been a major
contribution to the field. The book can be recommend to students of law and
public health and regulatory/pharmaceutical professionals looking for an
introductory overview. Others will find the book disappointing. The book
that critically reviews legislation and provides recommendations and "best
practice" language still remains to be written.
--
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