33098 
NOTICES 
applying for patent protection for re- 
combinant DNA inventions developed 
by their NIH-supported investigators, 
and asking NIH to review relevant 
DHEW policies. In view of the intense 
public interest in this research gener- 
ally. the two universities felt the need 
for a formal advisory opinion on the 
patenting of such inventions devel- 
oped under NIH grants or contracts. A 
number of other universities indicated 
similar interest in obtaining the offi- 
cial NIH view. 
Prior to making an official pro- 
nouncement of DHEW-NIH policy 
with respect to patenting of recombin- 
ant DNA research inventions. NIH de- 
cided to solicit comments from a broad 
range of individuals and institutions. 
An analysis of the comments received 
was completed in December 1976 and 
was referred to the Federal Inter- 
agency Committee on Re- comblnant 
DNA Research. 
When the guidelines were released 
in June 1976. a key public issue was 
their extension to the rest of the 
public and private sectors. Commenta- 
tors whose views were solicited agreed 
that there must be standards to 
govern recombinant DNA research 
and that the NIH Guidelines could 
provide the standards for such re- 
search nationally. They were divided, 
however, on whether to approach that 
goal through the use of patent agree- 
ments. They noted that the implemen- 
tation of the NIH Guidelines through 
licenses granted under patents would 
be awkward at best and only a partial 
solution. 
The Interagency Committee mem- 
bers reviewed the matter in April and 
May of 1977. Most members voiced 
strong support for DHEW policies gov- 
erning Institutional Patent Agree- 
ments (IPA's). and all except represen- 
tatives of the Department of Justice 
believed that recombinant DNA inven- 
tions should be considered within the 
existing terms of the IPA. The Justice 
Department opinions rested heavily on 
a draft bill originally proposed by Sen- 
ator Kennedy for the regulation of re- 
combinant DNA research activities. 
Specifically, Justice referred to the 
patent sections of this bill that were 
based on the concept of Government 
ownership of recombinant DNA re- 
search Inventions. In subsequent ver- 
sions of this bill, however, all refer- 
ences to patents were eliminated. 
On the basis of the review by the 
Interagency Committee and by the As- 
sistant Secretary for Health and the 
General Counsel for DHEW. it was de- 
cided that, at least for the present, re- 
combinant DNA research inventions 
developed under DHEW-NIH support 
should continue to be administered 
within current DHEW patent agree- 
ments with universities. Each agree- 
ment, however, will be amended to 
permit the institution to grant a li- 
cense under patents secured on any 
such invention only if the licensee pro- 
vides assurance of compliance with the 
physical and biological containment 
standards set forth in the guidelines. 
Thus, the requirements set for NIH 
grantees and contractors will thus be 
honored by licensees as well. 
Legislative Developments. The Fed- 
eral Interagency Committee on Re- 
combinant DNA Research recommend- 
ed in March 1977 that legislation be 
passed to extend the standards of the 
NIH Guidelines to all recombinant 
DNA activities in the public and pri- 
vate sectors. On the basis of the rec- 
ommendations. legislation was devel- 
oped under HEW Secretary Joseph A. 
Califano, Jr., and an Administration 
bill was introduced in the Congress. 
The bill was considered in Congres- 
sional hearings: other bills on the sub- 
ject were introduced. After several re- 
drafts by the relevant subcommittees 
during 1977. a Senate bill was reported 
to the Floor and a House bill was re- 
ported to the full Committee. 
The two bills reported out contained 
many elements of the original Admin- 
istration bill. A number of differences 
emerged, however, that would neces- 
sarily Involve a greater administrative 
burden and some further delays and 
duplication in handling the highly 
technical matters involved in stand- 
ard-setting and monitoring. 
Pending legislation introduced in 
1978 provides the most promising solu- 
tion yet available for establishing na- 
tional standards for the use of recom- 
binant DNA techniques. The bill H.R. 
11192 was reported by the Committee 
on Interstate and Foreign Commerce 
on March 24. 1978. It is an interim 2- 
year measure that provides for sensi- 
ble regulation and public oversight. It 
was referred to the Committee on Sci- 
ence and Technology, was considered 
by its Subcommittee on Science. Re- 
search and Technology for a period of 
21 days, and was reported from the 
Committee for House action on April 
21. H.R. 11192 reflects new scientific 
information and administrative devel- 
opments since the release of the NIH 
Guidelines in June 1976. The general 
administrative structure of the guide- 
lines and the standards for biological 
and physical containment are en- 
dorsed for purposes of regulation. 
Thus, flexible regulation with national 
standards is the intent of the bill. 
International activities 
During the legislative hearings on 
recombinant DNA research, a number 
of questions were raised concerning in- 
ternational activities in this field. In 
light of this interest, the Federal 
Interagency Committee, at the request 
of representatives from the State De- 
partment, undertook a review of activ- 
ities in other countries. This review 
was the basis for a Committee report 
issued in November 1977 on recombin- 
ant DNA activities throughout the 
world, with recommendations for fos- 
tering common safety standards. Sci- 
entists abroad, as in the United States, 
have played a major role in bringing 
potential hazards of recombinant DNA 
research to the attention of scientists, 
governments, and international orga- 
nizations. 
The issue of recombinant DNA re- 
search has been studied by national 
and international bodies. In many 
cases some form of control has been 
adopted, but nowhere has the research 
been totally banned. The United King- 
dom. Canada. France, the Federal Re- 
public of Germany, and the Soviet 
Union have issued guidelines that 
differ in detail but are similar concep- 
tually to the NIH Guidelines. Other 
countries are generally following the 
NIH or U.K. Guidelines, including 
Denmark, the Netherlands. Israel, 
Sweden, and Switzerland. The Europe- 
an Science Foundation (ESF) has en- 
dorsed the U.K. Guidelines: the Euro- 
pean Molecular Biology Organization 
(EMBO) has endorsed use of either 
the U.K. or the NIH Guidelines: and 
the International Council of Scientific 
Unions (ICSU) and the World Health 
Organization (WHO) have urged na- 
tions to adopt the principles that 
these two sets of guidelines embody. 
As of the summer of 1977. there 
were an estimated 150 research pro- 
jects using recombinant DNA tech- 
niques under w r ay in Europe. 300 in 
the United States, and perhaps 20-25 
altogether in Australia. Japan, and the 
Soviet Union. All appear to be con- 
ducted under some form of safety 
practices and procedures. 
A number of national and interna- 
tional activities foster the monitoring 
of recombinant DNA research for pur- 
poses of safety and health. In the 
United Kingdom, the government's 
health and safety executive will be re- 
sponsible after October 1978 for insur- 
ing that the standards of the United 
Kingdom Genetic Manipulation Advi- 
sory Group (GMAG) are followed in 
matters relating to safety of employ- 
ees and the general public. The 
GMAG. consisting of representatives 
from the scientific, public, and private 
sectors, reviews recombinant DNA re- 
search projects for conformance to ap- 
propriate safety standards and prac- 
tices. Similar advisory groups have 
also been established in other Europe- 
an countries, and efforts are underway 
to identify appropriate governmental 
bodies to insure compliance with 
GMAG standards. 
Proposed Revised Guidelines 
The RAC-proposed revisions 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
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