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OCR for page 228
Medical Technology Assessment in
~ Developec! Countries Trends and
JO Opportunities for Collaboration
Health technology increasingly is the ob-
ject of public concern not only in the
United States but also in other industrial-
ized countries. For years these govern-
ments have directed their health care ex-
penditures toward safety, efficacy, and
equitable access to care. But in the early
1970s health care costs increased steadily,
approaching 7-10 percent of the gross na-
tional product (GNP) in many countries
(Table 6-1) (Department of Health and
Human Services iDHHS], 1982; Groot,
1982~. For example, in 1970 West Ger-
many spent 3.7* percent of its GNP on
sickness funds (the insurance that covers 99
percent of the population with virtually
full benefits) and 8.0 percent in 1980; costs
in the Netherlands increased from 7.2 per-
cent of GNP in 1971 to 8.6 percent in 1980
This chapter was prepared by Enriqueta Bond, in
part based on materials contributed by David Banta,
Seymour Perry, and Duncan Neuhauser.
* There are other sources of data that estimate that
Germany spends a far higher proportion of its GNP on
health care than these data from sickness funds indi-
cate. The important point is the percent difference in
expenditures over the years.
228
(Office of Technology Assessment [OTA],
1980; Shepard and Durch, 1984). As a
result, a number of countries have begun
cost-containment efforts that relate costs to
effectiveness. These efforts have rekindled
interest in international collaboration on
technology assessment for new purposes.
The needs of industrialized and develop-
ing countries for medical technology as-
sessment differ. Developing countries try
to emphasize simple and effective technol-
ogies that the countries can afford, but in-
dustrialized countries ask whether the
rapid development of highly sophisticated
technology overshoots the target, serves the
medical professions more than the pa-
tients, and drives health care costs too
high. This latter concern, the interest of in-
dustrialized countries in technology assess-
ment and how better to foster interna-
tional collaboration, is the subject of this
chapter.
This chapter begins by reviewing the ap-
proaches and policies of various developed
countries for medical technology assess-
ment. The trend is toward more efforts in
medical technology assessment, and a few
countries are trying to develop a coherent
OCR for page 229
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
TABLE 6-1 Health Care Costs in Selected
Countries as Percentage of GNP, 1980
Countries
Health Care Costs
as Percentage of GNP, 1980
(unless otherwise noted)
7.5
6.7 (1978)
3.7
8.0
7.8
8.4 (1978)
6.4
10.4 (1977)
8.6
5.6
9 5b
10.0 (1982-1983)
Belgium
Denmark
Greece
West Germany
France
Ireland
Italy
Luxembourg
The Netherlands
United Kingdom
United Statesa
Sweden
a U.s. data from U.S. DHHS (1982~.
b United States in 1982: 10.5 percent GNP, according
to Fall 1983 Health Care Financing Review.
SOURCE: Groot (1982~.
system for such assessment. Next the chap-
ter describes case studies of medical tech-
nology assessment for specific technologies
in different countries. The case studies il-
lustrate the differences in approaches to
medical technology assessment and the
needs of different countries. Finally, the
efforts of international organizations to es-
tablish collaboration in technology assess-
ment are examined for their applicability
as models for an international system of
technology assessment.
TRENDS IN ASSESSMENT AND
REGULATION
A review of the current approaches and
policies of different countries for assessing
drugs and devices and controlling equip-
ment purchases finds that there is increas-
ing concern for safety, efficacy, costs, and
social and ethical issues. This has catalyzed
new institutional mechanisms for technol-
ogy assessment. However, the institutional
arrangements that exist to regulate medi-
cal technology and to carry out assessments
229
vary substantially from country to coun-
try.
Most industrialized countries have con-
sistent national policies and institutional
arrangements for evaluating the safety and
efficacy of drugs. These appear to have
been strengthened in recent years, influ-
enced to some extent by the United States
Food and Drug Administration's example
and assistance to other countries. The cur-
rent World Health Organization program
on effective drugs to assist countries that
want to improve their drug regulatory sys-
tems reinforces this trend.
However, systematic regulation of de-
vices has been established only in the
United States, Sweden, Japan, and Can-
ada; most assessment of devices elsewhere
proceeds on an ad hoc basis. Even in coun-
tries with policies for assessment of devices,
these mechanisms are of more recent origin
and less systematic than for drugs.
Sweden is one of the few countries to de-
velop a national policy or institutional ar-
rangement for the assessment of devices,
equipment, and procedures used in medi-
cal care. The Swedish Planning and Ra-
tionalization Institute of Health Services
(SPRI) was established in 1968 by the
Swedish government and the Federation of
County Councils (the health care authori-
ties), and has been involved in the conduct
of technology assessment since 1980 (SPRI,
1981~. The organization has a mandate to
solve problems confronting those who
work in the health care sectors and to pro-
mote better use of existing health services
resources. Additional tasks include infor-
mation dissemination, establishment of
standard specifications for hospital equip-
ment, and planning. In 1981 the SPRI
budget was $8 million (total health service
expenditures that year were $11 billion). A
15-member board oversees the work of the
organization, whose central task is to pro-
vide advice that promotes a cost-effective
health service. An example of one of their
activities was the consensus conference on
OCR for page 230
230
hip joint replacement discussed later in this
report. In contrast to Sweden, professional
organizations in other countries, i.e., pri-
vate groups, have shouldered what assess-
ment exists of medical practice.
RESEARCH AND DEVELOPMENT
All developed countries have policies to-
ward scientific research and technologic
development (R&D). Since World War II,
governments of the industrialized world
have become deeply involved in support-
ing R&D in many different fields. Increas-
ingly, R&D for health has been seen as an
appropriate investment. Across all indus-
trialized countries, health R&D probably
accounts for about 10 percent of all R&D
expenditures by government (OTA, 1980~.
Nevertheless, different countries take very
different approaches to planning and sup-
porting biomedical research. They vary
greatly in the total amount of support the
government provides, in the proportions of
that support given to different fields and
kinds of research, in the role of the private
sector in research support, in the mecha-
nisms used to set priorities and choose re-
search projects, and in the institutions and
individuals that carry out the work (Shep-
ard and Durch, 1984~.
Table 6-2 shows the estimated spending
of both public and private dollars in 1980
on biomedical research and development
in 19 countries that are members of the Or-
ganization for Economic Cooperation and
Development (OECD). Support for R&D
is highly concentrated in only a few coun-
tries, with the United States accounting for
nearly half of the total support for research
among them. Japan, West Germany,
France, and the United Kingdom, together
with the United States, make up almost 85
percent (Shepard and Durch, 1984~.
Therefore, it is likely these countries will
provide the bulk of the primary data infor-
mation available for technology assessment
or at least are potentially the major sup-
ASSESSING MEDICAL TECHNOLOGY
TABLE 6-2 Amount and Distribution of
Total Biomedical Research and Develop-
ment (BAIRD) Funding, 1980 (in millions
of 1975 U. S. dollars
Country
BMRD
Funding
5,256
1,523
1,271
712
495
299
257
251
229
176
122
94
69
52
41
32
Percentage of
Total BMRD in
all Countries
4g.18
13.96
11.65
6.53
4.54
2.74
2.37
2.30
2.10
1.62
1.13
0.86
0.63
0.48
0.37
0.29
14 0.13
10 0.09
6 0.05
United States
Japan
West Germany
France
United Kingdom
Italy
The Netherlands
Sweden
Switzerland
Canada
Belgium
Denmark
Australia
Spain
Norway
Finland
New Zealand
Portugal
Ireland
a Includes public and private funds.
SOURCE: Shepard and Durch (1984~.
porters of technology assessment. Estab-
lishment of technology assessment efforts
are not necessarily dependent upon the
generation of biomedical data by the coun-
try involved. Sweden and Canada, two of
the leading countries engaged in technol-
ogy assessment, are not among the highest
supporters of biomedical research and de-
velopment.
Other countries may provide special op-
portunities for technology assessment be-
cause of unique data collection systems or
populations at high risk for the condition of
study. For example, Sweden has a Na-
tional Bureau of Statistics that assembles
data concerning all Swedish patients, iden-
tified by their social security numbers. Be-
cause social security numbers are used for
medical record identification, all medical
services rendered to a given individual can
OCR for page 231
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
be accounted for and used in tabulating
national health statistics. A country with a
high prevalence of a particular disease, for
example pertussis in England, may offer an
opportunity for testing a new vaccine from
somewhere else.
How much of the total amount of sup-
port for R&D is devoted to technology as-
sessment in different countries is difficult
to determine. The R&D system in most
countries is largely decentralized, has a
large private involvement, and often takes
place in academic settings or in research
centers. Academics in some countries, such
as England and the United States, play a
large role in shaping biomedical research
priorities. However, since the 1960s more
governmental efforts have gone into influ-
encing research priorities in order to fur-
ther social goals. The United States' "war
on cancer" is one example.
Many countries now evaluate the bene-
fits, risks, and costs of medical technology
(Council of Science and Society, 1983,
Groot, 1982; OTA, 1980; SPRI, 1979; U.S.
DHHS, 1981~. The Swedish program has
been described. Canada has established a
special activity in the federal government
to develop guidelines for use of technology
based on the best available scientific data.
Australia has funded a special program to
evaluate medical technology. Such pro-
grams are being discussed in France, West
Germany, and the Netherlands, among
others. These programs develop informa-
tion as an aid to making decisions.
Governments increasingly want answers
to such questions as which technologies
should be covered by national health insur-
ance. Although rising health care costs
have fueled much of this increased interest,
the improvement of medical practice still is
an underlying rationale for technology as-
sessment (U. S. DHHS, 1981) . The interna-
tional exchange of data would facilitate
the assessment of programs of many coun-
tries, but only if some agreement on com-
mon methodology is reached.
231
Assessment of technologies can be di-
vided into two broad categories:
1. assessment of safety, quality, efficacy,
and effectiveness; and
2. assessment of the effects of technology
on the organization, law, economics, and
ethics of health care and on society.
Because most countries define safety simi-
larly, the greatest benefits of sharing data
probably would be gained in assessment of
safety and efficacy of drugs, devices, or
techniques. Cultural differences and dif-
ferences among health care systems could
make economic, ethical, and social consid-
erations less comparable. Nevertheless, ex-
change of information on these matters of
less commonality could provide new in-
sights or approaches to problems and aid
establishment of compatible policies for as-
sessment.
Clinical Trials
Clinical trials often are the preferred
method for assessment of safety and effi-
cacy. Because their results are often used in
countries other than the country of origin,
controlled clinical trials have international
implications. Britain invests more per cap-
ita than any other country in clinical trials
because the total costs of patient care al-
ready are borne by the National Health
Service (OTA, 1980~. The apparent costs
are low in comparison with the cost of
trials in the United States, where some pa-
tient care costs must come from research
funding. Smaller countries might have
problems in carrying out clinical trials,
particularly if they lacked an adequate re-
search establishment or imported most of
the technology to be assessed. They might
make financial contributions to help en-
sure that technologies of interest to them
are studied. However, mechanisms for
such collaboration would have to be estab-
lished before this could occur in a system-
atic manner. First, for example, the coun-
OCR for page 232
232
try would need to develop ways of
identifying those technologies it wishes to
have assessed and then find a way of sup-
porting the appropriate studies. Alterna-
tively, a group of countries could get to-
gether on a clinical trial and divide up the
work.
Consensus Activities
In 1982 two consensus conferences on
safety and efficacy issues related to hip
joint replacement were held, one in the
United States by the National Institutes of
Health (NIH) Office for Medical Applica-
tions of Research (OMAR), the second by
the Swedish Medical Research Council and
SPRI (NIH, 1982; Rogers, 1982; SPRI,
1982~. The two conferences were intended
to be as similar as possible, employing the
same formats and questions, but the Swed-
ish conference went beyond the consider-
ations of safety and efficacy by also consid-
ering the need for and the costs of hip joint
replacement. While similar in their con-
clusions, the evaluation of safety and effi-
cacy data in the NIH conference was more
extensive in that more data were provided
on indications, complications, etc. Fur-
thermore, it is unlikely that results of eco-
nomic and social considerations of the con-
sensus conference in Sweden would be
easily transferable for use by the United
States because of the large differences in
the financing and organization of health
care. Despite these disparities, the similari-
ties in the exercise open the way for further
collaboration and indicate that informa-
tion from such consensus conferences may
be useful across countries. Perhaps more
useful for exchange among countries
would be the primary data used for such
evaluations. The addition of economic and
social considerations on the Swedish con-
sensus exercise provides an interesting
model for other countries.
More recently, Britain sponsored a con-
sensus development conference on its coro-
ASSESSING MEDICAL TECHNOLOGY
nary artery bypass surgery (Coronary Ar-
tery Bypass Surgery: A Consensus, 1984;
Stocking and Jennett, 1984~. Coronary ar-
tery bypass surgery is of great interest be-
cause of the wide difference in its fre-
quency in different countries. If regular
consensus programs develop in a number
of different countries, a system for cross-
national comparisons and data analysis
may enhance their value in other coun-
tries. Since several countries in Europe are
considering establishing consensus confer-
ences, this option may be realizable.
Technology transfer often is aided by
marketing efforts of the multinational
companies or by organizations such as the
U.S. Alliance for Engineering in Medicine
and Biology. In 1973, a series of interna-
tional workshops was held by the alliance,
to aid governments, administrators, and
executives in (1) formulating policies for
planning, manufacturing, and medical
and technical education and training, (2)
coordinating the professional activities of
physicians, life scientists, and biomedical
engineers; and (3) developing facilities and
personnel policies to open channels of com-
munications among biomedical engineers
and between biomedical engineers and
health care professionals. Forums such as
these provide opportunities for collabora-
tion in the development of methodologies
for appropriate assessment of technologies
at the same time as assisting in technology
transfer (American Institute of Biological
Sciences, 1973~. Since technology transfer
and assessment is fostered by programs of
this sort, consideration should be given to
enlarging such assessment efforts, espe-
cially as related to technology transfer to
developing countries.
USE OF TECHNOLOGY IN DIFFERENT
COUNTRIES
Comparison of information on the use of
medical technologies in different countries
may indicate where costs may be saved by
OCR for page 233
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
changing patterns of use. Rasmussen
(1981) has collected information on pace-
makers in 13 different countries. A closer
look at pacemaker utilization in four En-
glish-speaking countries by Selzer (1983)
reveals striking differences, with the
United States leading by a substantial mar-
gin (Table 6-3~. Such data suggest overuse
of this technology in the United States or
underutilization elsewhere.
Similarly, a survey carried out by Groot
(1982) in countries of the European Com-
mon Market showed differences in num-
bers of coronary bypass operations, com-
puted tomography (CT) scanners, kidney
transplants, and radiation units (Table
6-4~.
There appear to be substantial differ-
ences from country to country in both the
numbers of operations and the numbers of
233
TABLE 6-3 Use of Pacemakers in Selected
Countries in 1978
Country
United States
Canada
Australia
United Kingdom
SOURCE: Seizer (1983).
Number of Pacemakers per
Million Population
Use in Sinus-
All Uses Node Disease
125
42
20
15
309
145
82
75
diagnostic equipment. Explanations for
the striking national differences in use of
different technologies may lie in differ-
ences in economic capacities, differences in
practice patterns, differences in health
care delivery systems, and differences of
need in the respective populations. Figure
TABLE 6-4 Use of Technologies in Selected Countries per Million Population in 1981a
Heart Operations Kidney CT Radiation
Country All Coronary Bypass Transplants Scanners Units
Belgium 202 [355] 29 12.60 3.7 [3-4] 4.55 [6]
Denmark 160 [120] 27 2.4 [3.4] 5.50
Germany
Federal
Republic
North-
Rhine
Westphalia
Bremen
Greece
France
Ireland
Italy
Luxembourg
The Netherlands
United
Kingdom
United
States
190 [259] 106 [176]
72 18 [103]
131 [348]
154 [210]
397 [460]
66 [174]b
89 72 [90-100]
7,608 740
7.8
4.2
8.19
22.1
o
15.3
16.6
22 7
.
0.71
9.lc
3.4
6.7
1.23
0.98 [1.1-1.7]
1.45
2.05
8.45
2.8
[4]
[5~7]
[2.97]
[1~1-2.35]
1.76 [3.62]
3.08 [6.15]
7.37 [6.45]
1.45 [2.91]
2.97 [8.91]
3.47 [5.66]
3.66
a Numbers in brackets indicate national planning/desirable guidelines. Data were not available for the spaces left
blank.
b Taken as half the total number of heart operations.
c This value is for 1983.
OCR for page 234
234
ASSESSING MEDICAL TECHNOLOGY
-
~ 300
Cal
co
o
o
. _
Q 200
o
Q
o
. _
. _
a'
Q
-
100
At
LL
he
>
O
r=0.766, n=35 Japan U.S.A.
p = 0.0000001
Australia >~.
~ France ~ Denmark
Israel ~
Italy .,
.
New Zealand ~ / Netherlands
Spain ~ U.K~/
Greece ~ /
South Africa
/ ~ G.[).R.
I I ~ 1 1 , , I 1 1 1 , , , 1
F.R.G.
Sweden
Switzerland
.
o
5,000 10,000 15,000
G.N.P. (per capita in U.S. $ in 1979)
FIGURE 6-1 Correlation between number of patients treated for ESRD and GNP in 1979.
SOURCE: Groot (1982~.
6-1, from the report issued for the 11th
Congress of the European Dialysis and
Transplant Association, supports a hypoth-
esis of economic capacity influencing use of
technology by indicating that countries
with larger GNPs treat a greater percent-
age of patients diagnosed as having end-
stage renal disease (ESRD). Recent analy-
sis of the treatment of ESRD in Britain
shows that despite the fact that there are
no special rules about which patients may
or may not be treated, access to renal dial-
ysis is limited (Aaron and Schwartz, 1984,
Wing, 1983~. Physicians functioning with
a recognition of limited resources act as
gatekeepers to limit dialysis.
ASSESSMENT OF DRUGS IN
DIFFERENT COUNTRIES
Most European countries have regula-
tions governing the safety and efficacy of
drugs modeled on the Food, Drug, and
Cosmetic Act of the United States, but the
state of harmonization necessary for the
acceptance by one country of a drug evalu-
ated by another has not nearly been
reached either among European countries
or between the United States and any other
developed country. For example, despite
the desire in the United States for an im-
proved pertussis vaccine such as the one
made and accepted for use in Japan, the
vaccine must undergo clinical trials with a
possible delay of 4 years before licensure in
the United States. Nevertheless, efforts are
under way by the European Free Trade
Association, the European Economic
Community, and the World Health Orga-
nization (WHO) to establish uniform stan-
dards for-drugs and biologicals, and it
might be supported by governments to pro-
mote more international collaboration in
the assessment of pharmaceuticals. As data
OCR for page 235
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
developed in one country already are used
for assessment of drugs by the relevant in-
stitution in another country, harmoniza-
tion of requirements for regulatory nur-
poses has the potential of saving costs and
accelerating the marketing of useful drugs.
Barriers to collaboration are raised by
factors such as differences in the drug regu-
latory agencies' organization and staff and
differences in requirements for demon-
strating safety and efficacy. Not only are
the regulatory agencies different but also
the industry differs from country to coun-
try. The German pharmaceutical industry
was developed primarily from chemical
companies, the British pharmaceutical in-
dustry has strong university roots, and the
French pharmaceutical industry arose pri-
marily from independent pharmacists
working in the community compounding
prescriptions. Furthermore, cultural dif-
ferences in attitudes toward ill health, to-
ward dying, and toward use of medication
and differences in disease risks may affect
the definition of safety and efficacy in dif-
ferent countries. Political differences in the
developed countries are reflected in the
regulation of drugs, the activities of na-
tional drug agencies, their communica-
tions with each other, and the conse-
quences that decisions made in one country
have for another. So far, there are few offi-
cial contacts among the drug regulatory
agencies of the member states of the Euro-
pean Economic Community, much less
with the United States, nor is there mutual
acceptance of drug applications, licensure,
or a uniform policy on withdrawing drugs
(Gross, 1980~.
There are, however, many informal
contacts and a few bilateral agreements
between countries; for example, the
United States has a memorandum of un-
derstanding with Sweden and Canada
concerning inspection of foreign manufac-
turers. Bilateral agreement may offer spe-
cial opportunities for collaboration be-
tween two similar countries, for example,
the United States and Canada. Further-
235
more, there are informal contacts fostered
largely by WHO and by the desire of coun-
tries to improve their regulatory processes.
A closer look at some aspects of drug ap-
proval in France and in West Germany re-
veals some problems faced in information
exchange. However, it also is apparent
that similar information is required in both
countries for determining safety and effi-
cacy and that great benefits would occur
from efforts to systematize collection and
exchange of such data. Although decisions
in one country may not be easily transfer-
able, the information base for the decisions
is transferable.
France
In 1978 the French Ministry of Health
created the Commission d'Autorisation de
Mise sur le Marche (CAMM) to advise it on
drug marketing and authorization of new
and old drugs (Weintraub, 1982~. The
commission considers safety and efficacy,
therapeutic indications, and information
about medications to be provided to physi-
cians and patients. CAMM is staffed by the
Office of Pharmacy and Medications in the
Ministry of Health. Members of CAMM
are of two types. The first group is com-
posed of physicians and pharmacists; the
second group includes academicians, med-
ical practitioners, and a hospital pharma-
cist. Liaison members come from the Na-
tional Institute of Health and Medical
Research, the National Laboratory for
Health, and the Office of Pharmacy and
Medications. Observers from industry at-
tend meetings and provide information.
In 1980 CAMM reviewed 400 applica-
tions of which 40 were for new drugs and
10 for new chemical entities (the rest were
for combinations of already approved
drugs). Decisions are based on reports pro-
vided to CAMM on biopharmaceutical,
pharmacologic, toxicologic, and clinical
data. Some U.S. companies submit their
data for these reports with an addendum
specifically prepared by a French expert.
OCR for page 236
236
In addition to considerations of safety and
efficacy, the economic impact of drug ap-
provals on the government, the pharma-
ceutical industry, and society comes into
every debate, even though CAMM neither
approves reimbursement through social se-
curity nor advises the government on set-
· . .
tong prices.
Once a drug has been approved for sale
in France, there are no restrictions on ad-
vertising or price. However, unless the
drug is included on the reimbursable list of
the social security system (which pays for
medical care) there will not be a large mar-
ket for it. In order to be placed on this list,
the new drug must be shown to be more ef-
ficacious, have fewer side effects, or cost
less than a similar drug already on the list.
Once placed on the list, the drug's price is
set by the ministry and advertising is re-
stricted.
West Germany
Drug regulation in West Germany was
strengthened with the implementation in
1978 of a law (enacted in 1976) requiring
approval of drugs for marketing (Gross,
1980~. The law gives more power to the
Federal Health Office (Bundesgesundheit-
samt) regarding acceptance, surveillance,
quality control, distribution, and promo-
tion of drugs. The new law also forces the
agency to process drug applications within
4 months. From January 1978 to June
1980, about 850 applications for new drugs
were submitted; 26 were rejected, 75 were
withdrawn by manufacturers, and more
data were requested for most of the rest.
Pharmacologic, toxicologic, and clinical
data, and expert assessment of these, must
be submitted to a special committee before
the agency accepts a drug. This committee
consists of representatives from the medi-
cal profession, dentistry, veterinary medi-
cine, pharmacy, nonorthodox medicine,
and the pharmaceutical industry. One ma-
jor objection to the current law is its inade-
ASSESSING MEDICAL TECHNOLOGY
quate guarantee of efficacy. Comparative
trials are not required. The agency may
not refuse acceptance of a new drug if ther-
apeutic results have been obtained in even
a limited number of cases.
It is easy to see from these two descrip-
tions that both France and West Germany
require similar information when assessing
the safety and efficacy of a drug. However,
the regulations for licensing drugs in the
two countries are not identical. For exam-
ple, in West Germany a drug must be li-
censed if therapeutic results have been ob-
tained in even a few cases. Therefore, the
French authorities would not automati-
cally accept a drug for marketing in France
on the basis of its approval in West Ger-
many. Efforts to collaborate on technology
assessment then may need to be focused on
the information-gathering level rather
than on the policies for licensure resulting
from the use of the information.
Because West Germany does not require
permission from the drug regulatory
agency before clinical trials can begin,
manufacturers from other countries sub-
mit new drugs to first clinical studies in
West Germany. However, language differ-
ences and differences in attitudes about as-
pects of the methodology or ethics of clini-
cal trials may raise barriers to the conduct
of trials in West Germany under protocols
acceptable to France or other countries.
Despite efforts for harmonization, drug
regulation in Europe is still far from being
coordinated, and the auspices for mutual
agreement regarding the acceptance of
new drugs or the acknowledgment of data
are still rather poor (Gross, 1980~. Coordi-
native assessment and regulatory efforts
could be enhanced if the national institu-
tions for drug assessment worked toward
mutually acceptable standards. WHO has
organized yearly workshops in Europe on
clinical pharmacologic evaluation in drug
control. From 1972 to 1978, seven of these
workshops have taken place with partici-
pation of agency representatives from 25
OCR for page 237
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
European countries. In the United States,
recent revision of FDA regulations permits
approval of drugs for domestic marketing
solely on the basis of foreign data if certain
criteria are met. However, acceptance of
data from a country is not the same as ac-
cepting licensure by one country as licen-
sure to market in a second. Gross (1980)
suggests that supranational regulations
will be composed of the strictest national
regulations, and that these guidelines will
not facilitate either preclinical or clinical
studies.
HEALTH CARE SYSTEMS IN
DIFFERENT COUNTRIES
Technology assessment needs vary
among nations according to differences in
organization and resources of the various
health care systems. Some may see a larger
role for technology assessment to control
cost of care, while others use budget allo-
cations as the main device for cost control.
These variations do not alter the need for
technology assessment but they will affect
the nature of assessments, the responsible
institutions, and the user of the assessment
information. These variations have to be
accommodated in international collabora-
tion. Countries can nevertheless learn from
one another and apply selected approaches
and findings of others. The following ex-
amples illustrate how differing approaches
to cost-containment affect the nature of
technology assessment in different coun-
tries.
Britain
In Britain the National Health Service
(NHS) operates on a budget set by Parlia-
ment (OTA, 1980~. Health care is provided
to patients without charge at the point of
service delivery. The district management
is responsible for all hospital and commu-
nity services. In turn, the district is part of
237
a larger area, overseen by regional authori-
ties responsible to the Department of
Health and Social Security (DHSS). While
NHS funds are distributed to regions ac-
cording to a complex formula based on
population and modified by factors that
indicate the need for health care, the re-
gions and areas have the authority to allo-
cate resources as they see fit.
Regional and area health authorities de-
cide how money is to be spent, what equip-
ment is needed, and which should be pur-
chased. Therefore, funds for equipment
are in direct competition with other health
capital needs. There are no formal proce-
dures for the evaluation of medical de-
vices; assessments proceed on an ad hoc ba-
sis. Request for the evaluation of a
particular procedure or piece of equipment
may originate in a committee, unit, or
council of the Medical Research Council,
may be suggested independently by a re-
searcher in a grant application, or may be
requested by DHSS. Existing assessments
are based almost entirely on clinical per-
formance (safety and efficacy consider-
ations) with little or no attention to gen-
eral, social, or economic impacts of
innovations. A recent report by the Coun-
cil of Science and Society (1983) pointed
out the haphazard manner in which expen-
sive techniques are introduced into routine
service. Criteria used for evaluation were
deemed too narrow and too inattentive to
patient reactions or to the social and psy-
chological consequences of innovation.
The report favored establishment of a na-
tional institute of health services research
to coordinate and commission research on
important technologies including clinical
trials; the analysis of costs; and epidemio-
logical, psychosocial, and policy studies.
Another of the institute's functions would
be to disseminate information.
The report urged the Secretary of State
for Social Services to begin development of
the institute by appointing an advisory
group on expensive medical technologies
OCR for page 238
238
responsible for ensuring that such technol-
ogies are properly evaluated clinically.
Because capital needs in Britain must
compete with operating expenses for a to-
tal annual allocation of funds that is se-
verely limited in virtually every region,
costly technologies tend to spread there
much more slowly than in the United
States. For example, there was one com-
puted tomographic scanner per 1,400,000
population in the United Kingdom in 1981
(Groot, 1982), in contrast to one per
110,000 population in the United States in
1980 (ECRI, 1983~.
Japan
Medical care in Japan is delivered
largely by solo general practitioners in
clinic settings (OTA, 1980~. The clinics
generally possess 20 or fewer short-term
(72 hours or less) beds. Hospitals are
owned and managed by private physi-
cians, unions, insurance plans, churches,
and various levels of government. Tradi-
tional public health and environmental
health programs screening, immuniza-
tion, physical exams for infants and school
age children, etc. are administered in lo-
cal health centers.
Nearly all of the population is covered
by health insurance that has evolved over
40 years from a broad law covering the
working population. Patients in Japan
have the right to seek care from any pro-
vider, and the provider in turn is able to
bill any of the patient's appropriate health
insurance plans for the services rendered.
Fees for each service are negotiated on an
annual basis within the Central Social In-
surance Medical Council, an advisory
body to the Ministry of Health and Wel-
fare made up of representatives from medi-
cine, dentistry, insurance plans, and other
relevant groups.
Because of the rapid development and
dissemination of new medical technology
in Japan, evaluation has been ignored in
ASSESSING MEDICAL TECHNOLOGY
many instances or set aside for future
action. Drugs and medical devices are cur-
rently regulated in Japan under the Phar-
maceutical Affairs Law passed in 1960.
Whenever a new drug is proposed for mar-
keting, data concerning its safety and effi-
cacy must be submitted to the Bureau of
Pharmaceutical Affairs. The Bureau of
Pharmaceutical Affairs is assisted in imple-
menting the Pharmaceutical Affairs Law
by the Pharmaceutical Affairs Council, an
advisory group with a number of commit-
tees. These committees deal with such
matters as the approval of manufacture
and import of new drugs, the establish-
ment of quality standards for medical de-
vices, measures to ensure the safety of
drugs, and review of drugs already on the
market for safety and effectiveness. The
Pharmaceutical Affairs Council makes rec-
ommendations based on safety and effi-
cacy, but final market approval is granted
by the bureau. Evaluation of medical de-
vices is based on an industrial standard
law, largely focused on safety. However,
escalating medical costs have led to greater
interest in technology assessment for cost
containment and cost-effectiveness.
Controls on investment in health care
and use of technologies appear to be much
greater in a country such as Britain with a
national health care system and strict
budgetary control than in countries such as
Japan or the United States with a system of
fee for service. Setting of fees and condi-
tions of reimbursement would provide lev-
erage for influencing technology diffusion
in a country such as Japan, but not in the
United Kingdom where few physicians or
hospitals are paid fees. Technology assess-
ment in Britain can be most useful in aid-
ing the regions or areas to make good
resource allocations, and in Japan assess-
ments may be most useful for setting reim-
bursement schedules.
Differences among health care systems,
perspectives, etc., would make it unlikely
that decisions about or assessments for spe-
OCR for page 239
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
cific allocation purposes would be easily
transferable; nevertheless, safety and effi-
cacy assessments used by national bodies
for marketing approval of drugs and de-
vices would be transferable.
INTERNATIONAL ORGANIZATIONS
What roles can international organiza-
tions play in medical technology assess-
ment? The following few categories give
some indications of functions.
International Pharmaceutical Firms
Many companies have developed mar-
kets and production facilities for drugs and
devices that are worldwide.
According to Fudenberg (1983) the ma-
jor pharmaceutical firms in the United
States spend about 5 to 10 percent of their
total dollars on research. However current
estimates range up to 12 percent (see Chap-
ter 2~. More than 15 percent of U.S. drug
industry R&D expenditures are made
abroad. The amount of R&D money that
U.S. firms are spending abroad is increas-
ing at 20 percent a year and will exceed
$500 million in 1983 (Standard & Poor's
Corporation, 1983~.
SmithKline Beckman markets about 15
prescription pharmaceutical products, ac-
counting in 1982 for $1.34 billion in sales.
Its cimetidine was the world's largest-sell-
ing drug in 1983. Worldwide sales of ci-
metidine amounted to $857 million in
1982, when U.S. sales were about $450
million. SmithKline Beckman had to de-
velop the information needed to get cimeti-
dine licensed in the various countries. Such
multinational pharmaceutical companies
can become well positioned to foster inter-
national collaboration in assessing the
safety and efficacy of drugs.
International Health Information
One of the largest repositories of bio-
rnedical information useful for technology
239
assessment is the National Library of Medi-
cine (NLM) of the U.S. National Institutes
of Health. Since its inception in 1956,
NLM activities have included acquiring
and preserving information from around
the world. Fully two-thirds of the journals
cited in Index Medicus are published
abroad. NLM currently has quid pro quo
agreements with 13 countries and the Pan
American Health Organization (Table 6-5)
(OTA, 1982a). In exchange for indexing
and other services, the foreign centers are
allowed access to the MEDLARS (Medical
Literature Analysis and Retrieval System,
the NLM's computerized index of biomedi-
cal publications) data base.
Although MEDLARS provides a core of
information useful for collaborative tech-
nology assessment efforts among countries,
it is not sufficient. MEDLARS is primarily
oriented toward the information needs of
U.S. biomedical communities and makes
no selection of the substantive literature for
technology assessment as such. The ability
to access MEDLARS in Europe is growing
because of the expansion in specialized
data telecommunications networks, but
there may be price barriers to access for the
diverse users represented by the technology
assessment community. Perhaps, as part of
the regional network being set up by WHO
described below, consideration could be
given to a literature collection valuable for
these endeavors.
TABLE 6-5
MEDLARS
Foreign Centers' Access to
Tapes
Tapes/Software
On-Line NEM
West
Germany
Japan
Sweden
United Kingdom
Australia
France
South Africa
Canada
Pan American Health Mexico
Organization Colombia
Kuwait
Italy
Switzerland
SOURCE: OTA, 1982a.
OCR for page 240
240
World Health Organization Network
on Technology Assessment
Increased interest in technology assess-
ment has led the World Health Organiza-
tion to establish a network for information
exchange on technology assessment (U.S.
DHHS, 1981; WHO, 1977~.
The European Regional Office of WHO
has:
· a program on appropriate technology
for health, including development of
appropriate technology in laboratory
services, radiology/radiotherapy/nuclear
medicine, and biotechnology for health in
member states;
· a program to promote the develop-
ment of standard health technologies and
identify, develop, and promote models for
the systematic development of all major
health care programs at the national level,
including introduction of new health care
technologies;
· a program to develop a health care
technology assessment network, the hope
being to link selected national institutes ca-
pable of ensuring technical and economic
assessments of new equipment and tech-
nologies.
As information is gathered it will be dis-
seminated to member states. Six European
countries have provisionally agreed to par-
ticipate in the first phase of the assessment
network.
In November 1983 WHO held a meeting
to permit member states to formulate
guidelines for medical technology assess-
ment and appropriate utilization (WHO,
1983~. Principles for drafting national
guidelines were drawn up outlining possi-
ble strategies such as research and develop-
ment policies, assessment priorities and
methodologies, market entry, and deploy-
ment and use. Future programs will be
held on economic incentives for the appro-
priate and rational use of medical technol-
ogies in different member states; coordina-
ASSESSING MEDICAL TECHNOLOGY
tion of national standards for health care
facilities, equipment and procedures; tech-
nology at the primary health care level;
and geographic variation in use of health
services.
The establishment in 1984 of a new jour-
nal, The International journal of Technol-
ogy Assessment in Health Care (Reiser,
1983), is evidence of the interest and fer-
ment around this topic. The journal's scope
of interest is in the generation, assessment,
diffusion, and use of health care technol-
ogy. It will examine the effects of technol-
ogy as perceived by policymakers, differ-
ent academic disciplines, and different
countries, and examine methods to con-
duct studies and evaluations of technology.
The journal will provide a vehicle for es-
tablishing ties with scholars, governments,
and private institutions concerned with
health care technology, and facilitating
outreach and interaction on matters of
technology assessment. The journal may
also play a key role in identifying the most
useful literature for purposes of technology
assessment. Also, plans are developing for
the creation of a New International Society
for Technology Assessment in Health Care,
which is designed to facilitate the exchange
of ideas on technology assessment.
Postmarketing Surveillance of Drugs
Postmarketing surveillance* of drugs
may offer a special opportunity for inter-
national collaboration. Postmarketir~o sur-
veillance is generally used to determine a
drug's beneficial and harmful effects, espe-
cially over longer periods of observation
than are used in premarketing clinical
trials. It would provide information that
could be transferred across national
boundaries for regulatory purposes. The
* The systematic collection and analysis of infor-
mation from the normal therapeutic use of drugs,
with the object of acquiring evidence on adverse ef-
fects or other phenomena associated with their use.
OCR for page 241
MEDICAL TECHNOLOGY ASSESSMENT IN DEVELOPED COUNTRIES
accelerated discovery and development of
new drugs and the crippling consequences
of thalidomide use during pregnancy have
focused world attention on drug safety and
the significance of shared information.
Benefits of such an international effort
could be large (Finney, 1964~. The public
would gain in protection and physicians
might gain in assurance if decisions could
be based on experience in more than one
country. Manufacturers might economize
and expedite new testing if certified evi-
dence on the efficacy and safety of a drug
in one country can be used in support of its
introduction into another.
Twenty-three countries participate in
the World Health Organization's Program
for International Monitoring of Adverse
Reactions (OTA, 1982b). Each participat-
ing country provides to WHO reports sum-
marizing adverse drug reactions that oc-
curred during the past year. The purpose
of the WHO program is to increase the
probability of detecting effects that might
be overlooked by individual countries.
However, the program does not appear to
be widely used for regulatory purposes.
Problems exist with the timeliness, reliabil-
ity, and completeness of the information
available. The use of the information is still
in a rudimentary phase, and a good con-
ceptual framework for its application and
development is lacking.
Nevertheless, the program could be de-
veloped into a useful component for inter-
national technology assessment of the
safety and efficacy of drugs. New possibili-
ties are opened by the capability of com-
puterizing the system so that data can be
entered promptly from one corner of the
world and be accessible to others almost
immediately.
CONCLUSIONS AND
RECOMMENDATIONS
The information collected in the prepa-
ration of this chapter prompts the study
241
committee to make the following recom-
mendations (in italics).
· International collaboration among
the industrialized nations is necessary to
the fullest establishment of a comprehen-
s?ve system of medical technology assess-
ment in any one of them. A first step should
be collaboration in gathering data on such
technologies and on research concerning
their assessment.
Developed countries increasingly are in-
terested in technology assessment, particu-
larly as related to devices, equipment, and
medical practice. Such assessment typi-
cally is hoped to help in improving patient
care, controlling costs, and diffusion of ex-
pensive technologies. As in the United
States, many different groups and agencies
in each country carry out and use the
results of technology assessment. Most
countries do not yet have a coordinated co-
herent system for medical technology as-
sessment, with one possible exception be-
ing Sweden. Until coordinated systems are
developed within countries, it will be very
difficult if not impossible to develop any
international system of medical technology
assessment.
However, most countries do appear to
have a system for determining the safety
and efficacy of drugs. Therefore, it is not
surprising that more progress appears to
have been made toward international col-
laboration in the assessment of drugs than
in the assessment of devices or medical
practices. The presence of national organi-
zations charged with drug evaluation pro-
vides a focus for these activities and facili-
tates international collaboration. The
presence of formal mechanisms for assess-
ment of drugs in the developed countries is
evidence of international interest in tech-
nology assessment that may be extended to
devices and procedures. This shared inter-
est may prompt standardization of meth-
ods, data exchange, and other forms of
collaboration especially if it leads to devel-
opment of formal systems for such efforts.
OCR for page 242
242
Several international organizations,
most particularly OECD and WHO, have
made an important beginning to system-
atic approaches to the international assess-
ment of drugs. These efforts must continue
to be supported by the governments of dif-
ferent countries and by the pharmaceutical
industry. Such programs may provide
models for systematic collaborative efforts
for assessing devices or medical proce-
dures.
· Aninternationalclearinghouse should
be established to serve as an information
pool of data gathered on medical technolo-
gies and research concerning their assess-
ment. Much can be done short of establish-
ing an international system for technology
assessment. An international clearinghouse
for technology assessment would facilitate
information dissemination, lessen duplica-
tive efforts, and foster international collab-
oration. The WHO network is a begin-
ning. In the United States the proposed a a
Institute of Medicine (1983) consortium re .
whose primary function could be to act as
a clearinghouse would be part of an inter-
national clearinghouse for medical tech-
nology assessment.
Investigators from different countries al-
ready collaborate in developing informa-
tion for technology assessment. More sup-
port should be made available to extend
such research. For example, the Scandina-
vian countries have excellent routine data
collection that could be used to gather in-
formation on safety and (in some cases) ef-
ficacy. Some of this is done at present, but
much more could be done.
· An international clearinghouse should
be established for information about clini-
cal trials. A possible model is the British
National Perinatal Epidemiology Unit at
Oxford, which promotes clinical trials and
conducts research on their effect on medi-
cal practice.
Much can be learned from other coun-
tries' experience with medical technology
ASSESSING MEDICAL TECHNOLOGY
assessment. Although U.S. medical tech-
nology assessment is methodologically ad-
vanced, there is much to be learned about
adoption of assessment findings by physi-
cians and hospitals.
In this respect, a Swedish experience
with a hip joint consensus meeting may be
illuminating. The consensus format ap-
proach began in the United States at NIH,
but it is was limited to considerations of
safety and efficacy. In contrast, when the
first European consensus meeting was held
in 1982 in Sweden on hip surgery, costs and
use were also on the agenda. In addition,
there was extensive newspaper coverage
throughout the country discussing the is-
sues in lay terms, every medical opinion
leader relevant to hip surgery attended the
meeting (Sweden's population is eight mil-
lion), and the jury panel included not only
medical experts but politicians.
The immediate result was a major reor-
ganization of hip surgery in the Stockholm
The U.S. Office for Medical Applica-
tions of Research responsible for the con-
sensus conferences is currently funding re-
search both to formalize and improve the
consensus process and to find out how to
enhance their impacts.
· Industrialized nations with compe-
tence in medical technology assessment
should work with less-developed countries
to help them fill their special needs for in-
formation. For example, fellowships to
train individuals from less-developed
countries in methods of technology assess-
ment should be established in the United
States and elsewhere.
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Representative terms from entire chapter:
west germany
