S-1999-01-1999_OVE

L1ASSOCIATION MEDICALE MONDIALE, INC ASOCIACION MEDICA MUNDIAL, INC
THE WORLD MEDICAL ASSOCIATION, INC.
B.P. 63 • 01212FERNEY-VOLTAIRE Cedex, France
Centre Intemation&! de Bureaux- Immeuble A ‘Keynes’
13,chemin du Levant· 01210 FERNEY·VOLTAIRE,France
Telephone : (33) 4 50 40 75 75
Fax: (33) 4 50 40 59 37
October 1999
E-mail address:infoOwrna.net
Website : www.wma.net
17n77
Original:English
WORLD MEDICAL ASSOCIATION STATEMENT
ON
MEDICAL PROCESS PATENTS
Adopted by the sr’ World Medical AssociationGeneral Assembly
Tel Aviv, Israel, October 1999
PREAMBLE
1. Under the law of some jurisdictions medical procedures are patentable subject matter.
Patents on medical procedures are often called medical process patents. A medical
process patent or patent claim is one that only confers rights over procedural steps and
does not confer rights over any new devices. .
2. Over 80 countries prohibit medical process patents. The practice of excluding medical
procedures from patentability is consistent with the Uruguay Round of Amendments to
the General Agreements on Tariffs and Trade Agreement on Trade Related Aspects of
International Property Rights (GATT-TRIPs), which states: «Members may also exclude
from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of
humans or animals» (Article 27). The United States still allows medical process patents,
but as of July 1996 newly issued medical process patents will no longer be enforceable
against medical professionals who infringe while performing a medical or surgical
procedure. This law makes new medical process patents virtually worthless in the United
States. However, in the United States there are still numerous medical process patents
which were issued prior to 1996 and which are still enforceable.
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3. The purpose of patents is to encourage private investment in research and development.
However, physicians, particularly those who work in research institutions, already have
incentives to innovate and improve their skills. These incentives include professional
reputation, professional advancement, and ethical and legal obligations to provide
competent medical care (International Code of Medical Ethics, 17.A). Physicians are
already paid for these activities, and public funding is sometimes available for medical
research. The argument that patents are necessary to spur invention of medical
procedures, and that without process patents there would be fewer beneficial medical
procedures for patients, is not particularly persuasive when these other incentives and
financing mechanisms are available.
4. Another argument is that patents are necessary, not so much for invention but for product
development. This argument also is not persuasive in the case of medical process patents.
Unlike device development, which requires investment in engineers, production e
processes, and factories, development of medical processes consists of physicians
attaining and perfecting manual and intellectual skills. As discussed above, physicians
already have both. obligations to engage in these professional activities as well as rewards
for doing so.
,
5. Whether or not it is ethical to patent medical devices does not bear directly on whether it
is ethical for physicians to patent medical procedures. Devices are manufactured and
disseminated by companies, whereas medical processes are «produced and disseminated»
by physicians. Physicians have ethical or legal obligations to patients and professional
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by physicians. Physicians have ethical or legal obligations to patients and professional
obligations towards each other, which companies do not have. Having particular ethical
obligations is part ofwhat defines medicine as a profession.
6. There is no a priori reason to believe that those holding medical process patents would
make patented medical procedures widely available. Patentees might attempt to maximize
their profits by making the procedure widely available through nonexclusive licensing
with low fees. Alternatively, they might attempt to maximize profits by limiting..
availability ofthe procedure and charging higher prices to those for whom the procedure.
is extremely important and who have the means to pay. Competition between
organizations providing health care could provide incentives for some organizations to
negotiate exclusive licenses, or licenses which sharply limit who else could practice the
procedure. Such a license might provide the organization with an advantage in attracting
patients, if the organization could advertise that it was the only organization in a region
which could provide;a particularly desirable service. Thus, at least some of the time
patentees will probably limit access to patented medical procedures.
7. Medical process patents may negatively affect patient care. If medical process patents are
obtained, then patients’ access to necessary medical treatments might diminish and
thereby undermine the quality of medical care. Access could diminish for the following
reasons:
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7.1 the cost ofmedical practice would likely increase because of licensing and royalty
fees, and because the cost of physicians’ insurance would likely increase to cover
patent litigation expenses.
7.2 some physicians capable of performing the patented procedure might not obtain
licenses to perform it. The number of licensed physicians might be restricted
because certain physicians cannot or will not pay the licensing fees or royalties, or
because the patentee refuses to make the license widely available. Limiting the
number of licenses would, in some circumstances, limit patients’ choice of
physicians.
7.3 The presence of patents may prevent physicians from undertaking even those
procedures which do not infringe. Devices can be labeled if they are patented, but
procedures cannot, and therefore it is not immediately obvious whether what one
is doing infringes somebody else’s medical process patent. However, lack of
knowledge is no defense against patent infringement, so if a physician is uncertain
he or she may simply refrain from performingthe.procedure.
8. Enforcement of medical process patents can also result in invasion of patients’ privacy or
in the undermining of physicians’ ethical obligation to maintain the confidentiality of
patients’ medical information, Where physicians practice in small groups or as sole
practitioners, the most expedient methods for a patentee to identify instances of
~1idlfWRMt!!’Vi&ht..~S..!O !~~~~~()ugh patients’ medical records or to interview patients.
infringement might ~~ to look through patients’ ~edical ~~cords-oi1o-inrerne~i>’awe\t~
;
Removing obvious identifiers for the record review would not guarantee confidentiality,
because identity can often be «reconstructed» with very few pieces of information. This
would be particularly true in small towns or small practices.
9. Physicians have ethical obligations both to teach skills and techniques to their colleagues,
and to continuously learn and update their own skills. Medical process patents can
undermine these obligations. Once a patent has issued on a process, the process would be
fully disclosed (this is one requirement for obtaining a patent); however, those without
licenses would not be able to practice it. Limiting who can practice the procedure
undermines the spirit ofthe ethical mandate to teach and disseminate knowledge. It also
undermines the obligation to update one’s skills, because it does not do much good to
acquire skills which cannot be used legally.
10. The obligation to teach and impart skills may also be impaired if the possibility ofpatents
causes physicians to _delay publishing new results or presenting them at conferences.
Physicians may be i~clined to keep new techniques secret while waiting to complete a
patent application. J’his is because public use of a procedure, or publication of a
description ofthe profedure, prior to applying for a patent may invalidate the application.
11. Physicians also have an ethical obligation not to permit profit motives to influence their
free and independent medical judgment (International Code ofMedical Ethics, 17.A). For
physicians to pursue, obtain, or enforce medical process patents could violate this
requirement. Physicians holding patents or licenses for procedures might advocate for the
use of those procedures even when they are not indicated, or not the best procedure under
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the circumstances. Physicians who are not licensed to perform a particular procedure
might advocate against that procedure, even when it is the best procedure under the
circumstances.
12. FinaUy, physicians’ professional obligations to practice their profession with conscience
and dignity (Declaration of Geneva) might be violated by the enforcement of medical
process patents. Lawsuits are rarely dignified or respectful enterprises, and the spectacle
ofphysicians suing each other on a regular basis is unlikely to enhance the standing of the
profession.
posmON
13. The World Medical Association
13.1 states that the patenting of medical procedures poses serious risks to the effectivee
practice of medicine by potentially limiting the availability of new procedures to
patients.
13.2 considers that the patenting of medical procedures is unethical and contrary to the
values of professionalism that should guide physicians’ service to their patients
and relations with their colleagues. However, in light of the differences between
medical procedures and medical devices discussed above, the patenting of medical
devices is a~ptable~
13.3 encourages national medical associanons to make every effort to protect
physicians’ incentives to advance medical knowledge and develop new medical
procedures.
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