COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 29.08.1997 
COM(97) 446 final 
95/ 0350 (COD) 
Amended proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 
on the legal protection of biotechnological inventions 
(presented by the Commission pursuant to Article 189 a (2) 
of the EC-Treaty) 

EXPLANATORY MEMORANDUM 
GENERAL COMMENTS 
In February 1996, the Commission presented to European Parliament and the Council a 
new proposal for a Directive on the legal protection of biotechnological inventions.1 
The Economic and Social Committee adopted its opinion regarding this proposal on 
11 July 1996.2 
European Parliament adopted 66 amendments at its first reading of the proposal during 
its plenary part-session of 14-18 July 1997.3 
These amendments reflect European Parliament's concerns regarding the need (a) to 
clarify the difference between discoveries and inventions where the patentability of 
elements of human origin is concerned and (b) to introduce an ethical dimension into the 
proposal for a Directive. 
In this respect, this amended proposal takes account of all of European Parliament's 
amendments. 
There is only one amendment, amendment 76, which the Commission is unable to accept. 
This proposed the introduction of an Article 8a. The first paragraph of this amendment 
required a patent application for an invention consisting of biological material of animal 
or plant origin to indicate the geographical place of origin of the material in question and 
to provide evidence that the material had been used in accordance with the legal access 
and export provisions in force in the place of origin. The second paragraph required that, 
if the biological material was of human origin, the patent application should publish the 
name and address of the person of origin or his or her legal representative and also 
provide evidence that the material had been used and the patent applied for with the 
agreement of the person of origin or of his or her legal representative. 
The first paragraph of this amendment goes beyond the international commitments which 
the Community and its Member States have entered into in approving and ratifying the 
Convention on Biological Diversity of 5 June 1992.4 Moreover, the second paragraph 
does not meet the requirements governing the protection of personal data.5 
1 OJ No C 296, 8.10.1996, p. 4. 
2 OJ NO C 295, 7.10.1996, p. 11. 
3 Not yet published. 
4 Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological 
Diversity, OJNo L 309, 13.12.1993, p. 1. 
5 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the 
protection of individuals with regard to the processing of personal data and on the free movement of 
such data, OJ No L 281, 23.11.1995. 
COMMENTS ON THE RECITALS 
From a general point of view 
The table below indicates the numbers of the recitals into which the amendments adopted 
by Parliament have been incorporated. 
Recitals Amendments 
3 
4 
8a 
9a 
9b 
9c 
11 
13 
14 
14a 
14b 
15 
16 
16a-e 
16f 
16g 
17 
17a 
17b 
17c 
18 
19 
19a 
19b-c 
20 
22 
23 
24 
24a 
24b 
25 
30 
32 
33 
34 
35 
36 
37 
38 2 
3 
5 
6 
7 
8 
9 
11 
12 
13 
1 
14 
15 
16 
17 
99 and 79 
18 
19 
20 
21 
22 
23 
24 
26 
27 
80 
30 
31 
new 
10 and 33 
34 
35 
new 
36 
37 
38 
39 
40,41,42,43,68,77 
44 
From an individual point of view 
All the amendments to the recitals have been incorporated in full, except as far as the 
following aspects are concerned: 
Recital 13 incorporates amendment 11. Its middle section has been slightly reworded in 
order to align it on the wording of Article 5(1). 
Recital 14a incorporates amendment 13. The beginning has been slightly reworded in 
order to take better account of the need to finance research against rare or so-called 
orphan diseases. 
Recital 15 incorporates amendment 14. It has been slightly reworded at the end because 
it is the rights conferred by a patent and not the patent itself which are concerned. 
Recital 16b incorporates amendment 16b. It has been slightly reworded in order to make 
it clearer that it is a DNA sequence's lack of biological function which makes it 
unpatentable. 
Recital 16f incorporates amendment 17. It has been slightly reworded in order to align it 
on point 2.4. of Opinion No 8 of the Group of Advisers on the Ethical Implications of 
Biotechnology. 
Recital 16g summarises amendments 79 and 99 in the light of the consequences of 
Article 28(1 )(a) of the TRIPs Agreement. 
Recital 17 incorporates amendment 18, with one slight change: the word "practicability" 
has been replaced by "application". 
Recital 19 incorporates amendment 23. Its wording has been amended to make it legally 
more certain. 
Recital 19c incorporates the second part of amendment 26. The final clause has been left 
out because there is nothing to prevent the patent on a product, e.g. a medicinal product, 
whose commercial exploitation has been authorised from being annulled if a judge finds 
that one of the conditions for its patentability is not met. Annulment of the patent does 
not involve withdrawal of the authorisation to exploit the product commercially. The 
two procedures are independent of each other. 
Recital 22 incorporates amendment 80. The end has been slightly reworded in order to 
avoid any incorrect scientific interpretation which would be inconsistent with the 
amendment's purpose. 
Recital 23 incorporates amendment 30. The wording has been amended following the 
deletion of recital 21 by amendment 28 because recital 23 is linked to it. 
Recital 24a is new. It refers to the definition of human reproductive cloning contained in 
Opinion No 9 of the Group of Advisers on the Ethical Implications of Biotechnology. At 
the same time, it incorporates what was intended by amendment 55, paragraph 2(bb). 
This subparagraph better explains why the patentability of human reproductive cloning is 
to be ruled out. In view of the need for proper drafting, any redundant information 
should be avoided in the operative part of the Directive and the explanation should be 
incorporated into the recitals. 
Recital 24b is a summary of amendments 10 and 33. 
Recital 32 has been given a new wording. It is aligned on the wording of Article 31(l)(i) 
of the TRIPs Agreement in view of the fact that amendment 67 expressly introduces a 
reference to the rights and obligations arising out of that agreement, inter alia, in Article 
1 (2) of the proposal for a Directive. 
Recital 35 incorporates amendment 38. The words "because otherwise patenting would 
be precluded on the grounds of lack of novelty of the invention" have been left out for the 
sake of clarity and in order to avoid any incorrect technical interpretation. 
Recital 37 summarises amendments 40, 41, 42, 43, 68 and 77. Some of these 
amendments proposed introducing complete quotations of articles from the Convention 
on Biological Diversity. It would appear more appropriate, in view of the fact that recital 
40 states that this Directive does not affect the rights and obligations of Member States 
arising from international agreements, and that amendment 67, cited above, also refers to 
this Convention, to refer globally to the Council Decision of 25 October 1993 concerning 
the conclusion of the Convention on Biological Diversity. 
COMMENTS ON THE INDIVIDUAL ARTICLES 
Article 1(2) incorporates amendment 67. 
Article 2 incorporates amendment 48, paragraphs 2, 4, 5 and 6. 
Article 3 incorporates amendment 48, paragraphs 1 and 3. 
Amendment 48 has been divided into two articles for the sake of clarity. 
Article 4 incorporates amendment 47. Paragraph 2 of this Article has been amended in 
the same way as recital 17, amended by amendment 18. The word "practicability" is 
replaced by "application". 
Article 5 incorporates amendments 100 and 49. It corresponds to the former Article 3 
Articles 4, 5, 6, 7 and 8 have been deleted in accordance with amendments 50. 51. 52. 5"* 
and 54 respectively. This is basically because they have been incorporated into Article 2, 
3 and 4 of the amended proposal. 
Article 6 incorporates amendment 55. It corresponds to the former Article 9. 
It should be noted that the word "publication" bus not been included in paragraph 1. The 
paragraph is thus consistent with Article 27(2) of the TRIPs Agreement. 
Paragraph 2(bb) of the amendment is not incorporated as such into Article 6. See the 
explanation given regarding the new recital 24a. 
Article 7 incorporates amendment 78. As the Commission announced during the plenary 
debate, it considers that, in the context of the request for proposals to be formulated on 
the composition and terms of reference of an ethics committee before the Directive enters 
into force, its Group of Advisers on the Ethical Implications of Biotechnology should be 
made competent. In so doing, the Commission will take account of Parliaments 
Resolution B4-0484/97 of 13 June 1997 on the terms of reference of the Group of 
Advisers on the Ethical Implications of Biotechnology. 
Article 8(1) is unchanged. It corresponds to the former Article 10. 
Article 8(2) incorporates amendment 57. 
Article 9 is inspired by amendment 58. It corresponds to the former Article 11. 
However, the reference in this amendment to Article 2a(l) (i.e. Article 4(1) of the 
amended proposal) is technically and legally incomprehensible in the light of Article 11 
of the proposal, which introduces a derogation for farmers, and Article 12, which 
provides for a system of compulsory cross-licensing where a patent dominates a plant 
variety. It would therefore not be appropriate to include this reference because, in 
practice, this would limit the scope of protection conferred by a patent in such a way as to 
go against current practice under patent law. 
Article 10 is unchanged. It corresponds to the former Article 12. 
Article 11 incorporates amendment 59. It corresponds to the former Article 13. 
It should be noted that amendment 95, which aimed to amend paragraph 2 of this Article, 
gives rise to a number of practical difficulties. The reference to Article 14(1) and (3) of 
Regulation No 2100/94 is incomplete. Those two paragraphs cannot function without 
paragraph 2 because it that would render meaningless the idea that the derogation 
provided for in Article 11 is in accordance with the provisions on plant varieties. 
Moreover, farmers might be confronted with different legal situations. This would not be 
desirable. 
The final sentence of amendment 95 repeats the final sentence of amendment 59. 
However, this applies to plants what is specifically laid down for animals, which would 
not be appropriate. 
Article 12(1) and (2) remain unchanged. They correspond to the former Article 14. 
Article 12(3)(b) incorporates amendment 60, in accordance with Article 31(l)(i) of the 
TRIPs Agreement. 
Article 12(4) incorporates amendment 61. 
Article 13 is unchanged. It corresponds to the former Article Î5. 
Article 14 is unchanged. It corresponds to the former Article 16. 
Article 17 of the initial proposal is deleted in accordance with amendment 62. 
Article 15(1) incorporates amendment 63. It corresponds to the former Article 18. 
Article 16 is new. It corresponds to amendment 64. 
Articles 17 and 18 are unchanged. They correspond to the former Articles 19 and 20 
respectively. 
Amended proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 
on the legal protection of biotcchnological inventions 
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN 
UNION, 
Initial proposal 
Having regard to the Treaty establishing Unchanged 
the European Community, and in particular 
Article 100a thereof, 
Having regard to the proposal from the Unchanged 
Commission,1 
Having regard to the Opinion of the Unchanged 
Economic and Social Committee,2 
Acting in accordance with the procedure Unchanged 
laid down in Article 189b of the Treaty,3 Amended proposal 
(1) Whereas biotechnology and genetic 
engineering arc playing an 
increasingly important role in a 
broad range of industries and the 
protection of biotechnological 
inventions will certainly be of 
fundamental importance for the 
Community's industrial 
development; 
(2) Whereas the investments required 
in research and development, 
particularly for genetic engineering, 
are especially high and especially 
risky and the possibility of 
recouping that investment can only 
be guaranteed effectively through 
adequate legal protection; 
(3) Whereas without effective and (3) 
harmonised protection throughout 
the Member States such 
investments might well not be 
made; (1) Unchanged 
(2) Unchanged 
Whereas effective and harmonised 
protection throughout the Member 
States is essential in order to 
maintain and encourage investment 
in the field of biotechnology; 
1 OJ No C 296, 8.10.1996, p. 4. 
2 OJ No C 295, 7.10.1996, p. 11. 
3 European Parliament Opinion of 
Initial proposal Amended proposal 
(4) Whereas following the European (4.) 
Parliament's rejection of the joint 
text, approved by the Conciliation 
Committee, for a European 
Parliament and Council Directive 
on the legal protection of 
biotechnological inventions,1 the 
European Parliament and the 
Council have determined that the 
legal protection of biotechnological 
inventions cannot be left as it 
currently stands; Whereas following the European 
Parliament's rejection of the joint 
text, approved by the Conciliation 
Committee, for a European 
Parliament and Council Directive on 
the Êegai protection of 
biotechnological inventions, the 
European Parliament and the 
Council have determined that the 
legal protection of biotechnological 
inventions requires clarification: 
(5) Unchanged 
(6) Unchanged (5) Whereas differences exist in the 
legal protection of biotechnological 
inventions offered by the laws and 
practices of the Member States; 
whereas such differences could 
create barriers to trade and to the 
creation and proper functioning of 
the internal market; 
(6) Whereas such differences in legal 
protection could well become 
greater as Member States adopt new 
and different legislation and 
administrative practices, or as 
national case-law interpreting such 
legislation develops differently; 
(7) Whereas the uncoordinated (7) Unchanged 
development of national laws on 
the legal protection of 
biotechnological inventions in the 
Community could result in the 
creation of new disincentives to 
trade, to the detriment of the 
industrial development of such 
inventions and of the smooth 
operation of the internal market; 
OJ No C 68, 20.3.1995, p. 26. 
Initial proposal Amended proposal 
(8) Whereas the legal protection of 
biotechnological inventions does 
not necessitate the creation of a 
separate body of law in place of the 
rules of national patent law; 
whereas the rules of national patent 
law remain the essential basis for 
the legal protection of 
biotechnological inventions; 
whereas, however, they must be 
adapted or added to in certain 
specific respects in order to take 
full account of technological 
developments involving biological 
material which also fulfil the 
requirements for patentability; (8) Unchanged 
(8a) Whereas in such cases as the 
exclusion from patentability of 
plant and animal varieties and of 
essentially biological processes for 
the production of plants and 
animals, certain concepts in 
national laws based upon 
international patent and plant 
variety conventions have created 
uncertainty regarding the protection 
of biotechnological and certain 
microbiological inventions; 
whereas harmonisation is necessary 
to clarify the said uncertainty; 
Initial proposai 
(9) Whereas harmonisation of the laws 
of the Member States is necessary to clarify 
certain concepts in national laws 
originating in certain international patent 
and plant variety conventions which have 
led to some uncertainty as to the possibility 
of protecting biotechnological inventions 
concerning plant matter and certain 
microbiological inventions, concepts such 
as the exclusion from patentability of plant 
and animal varieties and of essentially 
biological processes for the production of 
plants and animals; (9) 
(9a) Amended proposal 
Deleted 
Having regard to the potential of 
the development of biotechnology 
for the environment and in 
particular the utility of this 
technology for the development of 
methods of cultivation which are 
less polluting and more economical 
in their use of land; whereas the 
patent system should be used to 
encourage research into, and the 
application of, such procedures; 
10 
Initial proposal Amended proposal 
(9b) Having regard to the importance of 
the development of biotechnology 
to developing countries, both in the 
field of health and combating major 
epidemics and endemic diseases 
and in that of combating hunger in 
the world; whereas the patent 
system should likewise be used to 
encourage research in these fields; 
whereas international procedures 
for the dissemination of such 
technology in the Third World and 
to the benefit of the population 
groups concerned should be 
promoted; 
(9c) Whereas the TRIPs Agreement 
signed by the European Community 
and the Member States has entered 
into force and provides that patent 
protection shall be guaranteed for 
products and processes in all areas 
of technology; 
11 
Initial proposal Amended proposal 
(10) Whereas the Community's legal 
framework for the protection of 
biotechnological inventions can be 
limited to laying down certain 
principles as they apply to the 
patentability of biological material 
as such - such principles being 
intended, in particular, to determine 
the difference between inventions 
and discoveries with regard to the 
patentability of certain elements of 
human origin - and can be further 
limited to defining the scope of the 
protection accorded by a patent on a 
biotechnological invention, to the 
right to use a deposit mechanism in 
addition to written descriptions, to a 
reversal of the burden of proof and 
to the option of obtaining 
non-exclusive compulsory licences 
in respect of interdependence 
between plant varieties and 
inventions; (10) Unchanged 
(11) Whereas a patent for invention does 
not authorise the holder to 
implement that invention, but 
merely entitles him to prohibit third 
parties from exploiting it for 
industrial and commercial 
purposes; whereas, consequently, 
substantive patent law cannot serve 
to call into question national and 
Community law on the monitoring 
of research and of the use or 
commercialisation of its results, 
notably from the point of view of 
the requirements of public health, 
safety, environmental protection, 
animal welfare, the preservation of 
genetic diversity and compliance 
with certain ethical standards; (11) Whereas a patent for invention does 
not authorise the holder to 
implement that invention, but 
merely entities him to prohibit third 
parties from exploiting it for 
industrial and commercial 
puiposes; whereas, consequently, 
substantive patent law cannot serve 
to replace or render superfluous 
nationals European or international 
law which may impose restrictions 
or prohibitions or which concerns 
the monitoring of research and of 
the use or commercialisation of its 
results, notably from the point of 
view of the requirements of public 
health, safety, animal welfare, the 
preservation of genetic diversity 
and compliance with certain ethical 
standards; 
12 
(12) 
(13) 
(14) Initial proposal 
Whereas no prohibition or 
exclusion exists in national or 
European patent law (Munich 
Convention) which precludes 
a priori the patentability of 
biological matter; 
Whereas it should be specified that 
knowledge relating to the human 
body and to its elements in their 
natural state falls within the realm 
of scientific discovery and may not, 
therefore, be regarded as patentable 
inventions; whereas it follows from 
this that substantive patent law is 
not capable of prejudicing the basic 
ethical principle excluding all 
ownership of human beings; (12) 
Whereas significant progress in the 
treatment of diseases has already 
been made thanks to medicinal 
products derived or otherwise 
produced from elements isolated 
from the human body, and 
medicinal products resulting from a 
technical process aimed at 
obtaining elements similar in 
structure to those existing naturally 
in the human body and whereas, 
consequently, the patent system 
should promote research aimed at 
obtaining such elements; (13) 
(14) Amended proposal 
Unchanged 
Whereas patent law must respect 
the fundamental principles 
safeguarding the dignity and 
integrity of the person; whereas it is 
important to assert the principle that 
the human body, at any stage in its 
formation or development, 
including germ cells, and the simple 
discovery of one of its elements or 
one of its products, including the 
sequence or partial sequence of a 
human gene, cannot be patented: 
whereas these principles are in line 
with the criteria of patentability 
proper to patent law, whereby a 
mere discovery cannot be patented; 
Whereas significant progress in the 
treatment of diseases has already 
been made thanks to medicinal 
products derived and/or otherwise 
produced from elements isolated 
from the human body, and 
medicinal products resulting from 
technical processes aimed at 
obtaining elements similar in 
structure to those existing naturally 
in the human body and whereas, 
consequently, the patent system 
should promote research aimed at 
obtaining and isolating such 
elements valuable to medicinal 
production; 
13 
Initial proposal 
(15) Whereas, therefore, it should be 
made clear that an invention 
capable of industrial application 
and based on an element isolated 
from the human body or otherwise 
produced by means of a technical 
process is patentable, even where 
the structure of that element is 
identical to that of a natural 
element, since no patent may be 
interpreted as covering an element 
of the human body in its natural 
environment forming the basic 
subject of the invention. Amended proposal 
(14a) Whereas, since the patent system 
provides insufficient incentive for 
financing research into and 
production of biotechnological 
medicines which are needed to 
combat rare or 'orphan' diseases, the 
Community and the Member States 
have a duty to respond adequately 
to this problem; 
(14b) Having regard to Opinion No 8 by 
the Group of Advisers on the 
Ethical Implications of 
Biotechnology to the European 
Commission; 
(15) Whereas, therefore, it should be 
made clear that an invention based 
on an element isolated from the 
human body or otherwise produced 
by means of a technical process, 
which is capable of industrial 
application, is not excluded from 
patentability, even where the 
structure of that element is identical 
to that of a natural element, while 
the rights conferred by the patent do 
not extend to the human body and 
its elements in their natural 
environment; 
14 
Initial proposal Amended proposal 
(16) Whereas such an element isolated 
from the human body or otherwise 
produced may not be regarded as 
unpatentable in the same way as an 
element of the human body in its 
natural state, that is to say, may not. 
be equated with a discovery, since 
the element isolated is the result of 
the technical processes used to 
identify, purify and classify it and 
to reproduce it outside the human 
body, techniques which human 
beings alone are capable of putting 
into practice and which Nature is 
incapable of accomplishing by 
itself; (16) 
(16a) 
(16b) 
(16c) Whereas such an element isolated 
from the human body or otherwise 
produced is not excluded from 
patentability as it is, for example, 
the result of the technical process 
used to identify, purify and classify 
it and to reproduce it outside the 
human body, techniques which 
human beings alone are capable of 
putting into practice and which 
Nature is incapable of 
accomplishing by itself; 
Whereas the discussion on the 
patentability of sequences or partial 
sequences of genes is controversial; 
whereas, according to this 
Directive, the granting of a patent 
for inventions which concern such 
sequences or partial sequences 
require the same criteria to be 
applied as in all other areas of 
technology; 
Whereas a mere sequence of DNA 
segments without indication of a 
biological function does not contain 
a technical teaching and is therefore 
not a patentable invention; 
Whereas a sequence or partial 
sequence can be the subject of a 
patentable invention when all the 
necessary conditions for a patent 
are satisfied: novelty, level of 
invention and industrial application; 
15 
Initial proposal Amended proposal 
(16d) Whereas for the criterion of 
industrial application to be 
complied with, the genetic sequence 
or partial sequence and thus also the 
protein for which a DNA sequence 
codes must be determined; whereas 
for sequences which overlap, each 
sequence will be considered as an 
independent sequence in patent law 
terms; 
(16e) Whereas the requirements for 
disclosure of the industrial 
application of the sequences or 
partial sequences do not differ from 
those in other areas of technology; 
whereas at least an industrial 
application must be actually 
disclosed in the patent application; 
(16f) Whereas the free and informed 
consent of the person from whose 
body material is taken is required in 
order for an application to be made 
for a patent in respect of the use of 
that material; 
(16g) Whereas this Directive in no way 
affects the basis of current patent 
law, according to which a patent 
may be granted for any new 
application of a patented product; 
16 
Initial proposal 
(17) Whereas, in order to determine the 
extent to which piant and animr.1 
varieties are to be excluded from 
patentability, it should be specified 
that the exclusion concerns those 
varieties as such and that, 
consequently, it does not prejudice the 
patentability of plants or animals 
obtained by means of a process at 
least one stage of which is essentially 
microbiological, irrespective of the 
basic biological material to which that 
process is applied; Amended proposal 
(17) Whereas this Directive shall be 
without prejudice to the exclusion 
of plant and animal varieties from 
patentability; whereas on the other 
hand inventions which concern 
plants or animals are in general 
patentable ppovided that the 
application of the invention is not 
technically confined to a single 
plant or animal variety; 
(17a) Whereas the concept 'plant variety' 
is defined by the law protecting 
new varieties, pursuant to which a 
variety is defined by its whole 
genome and therefore possesses 
individuality; whereas it is clearly 
distinguishable from other varieties; 
(17b) Whereas a plant totality which is 
characterised by a particular gene 
(and not its whole genome) is not 
covered by the protection of new 
varieties and is therefore not 
excluded from patentability even if 
it comprises plant varieties; 
17 
Initial proposa! Amended proposal 
(17c) 
(18) Whereas, for the purposes of 
determining whether or not it is 
possible to patent essentially 
biological processes for obtaining 
plants or animals, human intervention 
and the effects of that intervention on 
the result obtained must be taken into 
account; (18) Whereas, however, if an invention 
consists only in genetically 
modifying a particular plant variety, 
it shall be excluded from 
patentability even if the genetic 
modification is the result not of 
breeding but of a genetic 
engineering procedure; 
Whereas a procedure for the 
breeding of plants and animals is 
essentially biological if it is based 
on crossing whole genomes (with 
subsequent selection and perhaps 
further crossing of whole genomes); 
(19) Whereas national patent laws for (19) Whereas this Directive shall be 
inventions contain provisions as to the 
criteria for allowing or excluding 
patentability, including provisions to 
the effect that a patent may not be 
granted in respect of inventions 
whose publication or exploitation 
would be contrary to public policy or 
morality; without prejudice to concepts of 
invention and discovery, as 
developed by national, European or 
international patent laws; 
(19a) Whereas this Directive shall be 
without prejudice to the provisions 
of national patent law whereby 
surgical or therapeutic treatment 
procedures applicable to the human 
body or the bodies of animals and 
diagnostic procedures which are 
carried out on the human body or 
the bodies of animals are excluded 
from patentability; 
18 
Initial proposal Amended proposal 
(19b) Whereas the TRIPs Agreement 
provides for the possibility that 
members of the World Trade 
Organisation may exclude from 
patentability inventions whose 
commercial exploitation within 
their territory must be prevented in 
order to protect public policy or 
morality, including to protect 
human or animal life or health, to 
preserve plants or to prevent serious 
harm to the environment, provided 
that such an exclusion is not 
undertaken solely because 
exploitation is prohibited by their 
legislation; 
(19c) Whereas other prohibitions on 
exploitation under national law are 
not sufficient to exclude 
patentability; whereas such an 
exclusion presupposes that the 
commercial exploitation of the 
invention is prohibited in the 
Member State in question; 
(20) Whereas such a reference to public 
policy and morality should be 
included in the operative part of this 
Directive in order to bring out the fact 
that some applications of 
biotechnological inventions, by virtue 
of some of their consequences or 
effects, are capable of offending 
against them; (20) W7hereas the principle whereby 
inventions must be excluded from 
patentability where their 
commercial exploitation offends 
against public policy or morality 
must also be stressed in this 
Directive; 
19 
Initial proposai 
(21) Whereas it must be determined 
whether applications offend against 
public policy and morality in each 
specific case, by means of an 
appraisal of the values involved, 
whereby the benefit to be derived 
from the invention, on the one 
hand, is weighed and evaluated 
against any risks associated 
therewith, and any objections based 
on fundamental principles of law, 
on the other hand; 
(22) Whereas the operative part of this 
Directive should also include an 
illustrative list of inventions 
excluded from patentability so as to 
provide national courts and patent 
offices with a general guide to 
inteqsreting the reference to public 
policy or morality; Amended proposal 
(21) Deleted 
(22) Whereas the operative part of this 
Directive should also include an 
illustrative list of inventions 
excluded from patentability so as to 
provide national courts and patent 
offices with a general guide to 
interpreting the reference to public 
policy and morality; whereas this 
list cannot presume to be 
exhaustive; whereas processes the 
use of which offend against human 
dignity, such as processes to 
produce chimeras from a mixture of 
human and animal genomes, are 
also excluded from patentability; 
20 
Initial proposal Amended proposal 
(23) Whereas such moral considerations (23) 
must be given greater weight in 
appraising the patentability of 
biotechnological inventions, both 
on account of the subject-matter of 
this branch of science, namely 
living matter, and because of the 
often far-reaching implications of 
the inventions to be examined; 
whereas these considerations do 
not, however, change the nature of 
patent law as a primarily technical 
body of law and are no substitute 
for the other legal checks which 
biotechnological inventions are 
required to undergo from the start 
of their development or at the 
marketing stage, particularly with 
regard to safety; 
(24) Whereas, in view of the importance (24) 
and the controversial nature of the 
unprecedented questions raised by 
germ line gene therapy, it is 
important to exclude unequivocally 
from patentability methods of 
treatment of human beings based on 
it; Whereas morality represents the 
ethical or moral principles generally 
observed in a Member State or 
accepted by the scientific or 
professional circles concerned; 
whereas it is particularly important 
that these principles be respected in 
the field of biotechnology in view 
of the potential scope of inventions 
in this field and their inherent 
relationship to living matter; 
whereas such ethical or moral 
principles supplement the standard 
legal checks of patent law 
regardless of the technical field of 
the invention; 
Whereas in the European Union 
there is a consensus that 
interventions in the human germ 
line and the cloning of human 
beings offends against public policy 
and morality; whereas it is therefore 
important to exclude unequivocally 
from patentability methods for 
intervention in the germ line of 
human beings and processes for 
cloning human beings; 
21 
Initial proposal Amended proposai 
(24a) Whereas in the European Union 
there is a consensus that 
interventions in the human germ 
line and the cloning of human 
beings offends against public policy 
and morality; whereas it is therefore 
important to exclude unequivocally 
from patentability methods for 
intervention in the germ line of 
human beings and processes for 
cloning human beings; 
22 
Initial proposal Amended proposal 
(24b) Whereas this Directive does not 
affect the application of the 
Convention on Human Rights and 
Fundamental Freedoms of 4 
November 1950, the Convention 
for the protection of human rights 
and the dignity of the human person 
with respect to applications of 
biology and medicine: Convention 
on human rights and biomedicine of 
19 November 1996, or any other 
international instrument concerning 
the protection of human rights on 
which the Member States have 
cooperated or to which they have 
acceded; 
(25) Whereas processes for modifying 
the genetic identity of animals 
which are likely to cause them 
suffering or physical handicaps 
without any substantial benefit to 
man or animal, and also animals 
resulting from such processes must 
be excluded from patentability 
insofar as the suffering or physical 
handicaps inflicted on the animals 
concerned are out of proportion to 
the objective pursued; (25) Whereas processes for modifying 
the genetic identity of animals 
which are likely to cause them 
suffering without any substantial 
medical (diagnostic or therapeutic) 
benefit to man or animal, and also 
animals resulting from such 
processes, must be excluded from 
patentability; 
23 
Initial proposal 
(26) Whereas, in view of the fact that the 
function of a patent is to reward the 
inventor for his creative efforts by 
granting an exclusive but 
time-bound right, and thereby 
encourage inventive activities, the 
holder of the patent should be 
entitled to prohibit the use of 
patented self-reproducible material 
in situations analogous to those 
where it would be permitted to 
prohibit such use of patented, 
non-self-reproducible products, 
namely in respect of the production 
of the patented product itself; 
(27) Whereas it is necessary to provide 
for a first derogation from the rights 
of the holder of the patent when the 
propagating material incorporating 
the protected invention is sold to a 
farmer for farming purposes by the 
holder of the patent or with his 
consent; whereas that initial 
derogation must authorise the 
farmer to use the product of his 
harvest for further multiplication or 
propagation on his own farm; 
whereas the extent and the 
conditions of that derogation must 
be limited in accordance with the 
extent and conditions set out in 
Council Regulation (EC) 
No 2100/94;i Amended proposal 
(26) Unchanged 
(27) Unchanged 
(28) Whereas only the fee envisaged 
under Community plant variety 
rights as a condition for applying 
the derogation from Community 
plant variety rights can be required 
of the farmer; (28) Unchanged 
OJNoL227, 1.9.1994, p. 1. 
24 
Initial proposal 
(29) Whereas, however, the holder of the (29) 
patent may defend his rights against 
a farmer abusing the derogation or 
against the breeder who has 
developed the plant variety 
incorporating the protected 
invention if the latter fails to adhere 
to his commitments; 
(30) Whereas a second derogation from (30) 
the rights of the holder of the patent 
must authorise the farmer to use the 
protected livestock for breeding 
purposes on his own farm, in order 
to replenish their numbers; 
(31) Whereas the extent and the 
conditions of that second 
derogation may be determined by 
national laws, regulations and 
practices, since there is no 
Community legislation on animal 
variety rights; 
(32) Whereas, in the field of exploitation (32) 
of new plant characteristics 
resulting from genetic engineering, 
guaranteed access must, on 
payment of a fee, be granted in a 
Member State in the form of a 
compulsory licence where, in 
relation to the genus or species 
concerned, public interest demands 
the exploitation of the plant variety 
for which the licence is requested 
and the plant variety represents 
significant technical progress; Amended proposal 
Unchanged 
Whereas a second derogation from 
the rights of the holder of the patent 
must authorise the farmer to use the 
protected livestock for agricultural 
purposes; 
(31 ) Unchanged 
Whereas, in the field of exploitation 
of new plant characteristics 
resulting from genetic engineering, 
guaranteed access must, on 
payment of a fee, be granted in the 
form of a compulsory licence 
where, in relation to the genus or 
species concerned, the plant variety 
represents significant technical 
progress of considerable economic 
interest compared to the invention 
claimed in the patent; 
25 
Initial proposal 
(33) Whereas, in the field of the use of 
new plant characteristics resulting 
from new plant varieties in genetic 
engineering, guaranteed access 
against a fee must be granted in the 
form of a compulsory licence where 
public interest demands the 
exploitation of the invention for 
which the licence is requested and 
where the invention represents 
significant technical progress, Amended proposal 
(33) Whereas, in the field of the use of 
new plant characteristics resulting 
from new plant varieties in genetic 
engineering, guaranteed access 
against a fee must be granted in the 
form of a compulsory licence where 
the invention represents significant 
technical progress of considerable 
economic interest; 
(34) Whereas the TRIPs Agreement 
contains detailed provisions on the 
burden of proof which are binding 
on all Member States; whereas, 
therefore, a provision in this 
Directive is not necessary; 
(35) Whereas the Commission will 
investigate whether, in the field of 
basic genetic engineering research, 
free and unimpeded scientific 
exchanges are hampered because 
publications containing information 
which might be patentable are 
delayed or not undertaken, as a 
result of which patentability would 
be excluded because of the lack of 
novelty on the part of the inventor; 
whereas the Commission will carry 
out a comparison with the patent 
law of the United States and Japan 
in this respect and report to the 
European Parliament and the 
Council two years after the entry 
into force of this Directive; 
26 
Initial proposal Amended proposal 
(36) Whereas the Commission will 
report [annually] to the European 
Parliament on the development of 
patent law in the field of 
biotechnology and genetic 
engineering; 
(37) Whereas the rights and obligations 
of the Member States derived from 
international agreements, 
particularly further to the Council 
Decision of 25 October 1993 on the 
conclusion of the Convention on 
Biological Diversity,1 and Articles 
3, 8(j), 16(2), second sentence, and 
16(5) of the Convention on 
Biological Diversity of 
5 June 1992, are not affected by this 
Directive; 
1 OJ No L 309,13.12.1993, p. 1. 
27 
Initial proposal Amended proposal 
(38) Whereas the Third Conference of 
the Parties of the Biodiversity 
Convention , which took place in 
November 1996, noted in Decision 
HI/17 that 'further work is required 
to help develop a common 
appreciation of the relationship 
between intellectual property rights 
and the relevant provisions of the 
TRIPs Agreement and the 
Convention on Biological 
Diversity, in particular on issues 
relating to technology transfer and 
conservation and sustainable use of 
biological diversity and the fair and 
equitable sharing of benefits arising 
out of the use of genetic resources, 
including the protection of 
knowledge, innovations and 
practices of indigenous and local 
communities embodying traditional 
lifestyles relevant for the 
conservation and sustainable use of 
biological diversity'; 
28 
Initial proposal Amended proposal 
HAVE ADOPTED THIS DIRECTIVE: HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Patentability 
Article 1 
1. Member States shall protect 
biotechnological inventions under national 
patent law. Member States shall, if 
necessary, adjust their national patent law 
to take account of the provisions of this 
Directive. 
2. This Directive shall be without prejudice 
to national and Community laws on the 
monitoring of research and of the use or 
commercialisation of its results. 
Article 2 
For the purposes of this Directive, CHAPTER I 
Patentability 
Article 1 
1. Unchanged 
2. This Directive shall be without prejudice 
to the obligations of the Member States 
pursuant to international agreements, and 
in particular the Convention on Biological 
Diversity and the TRIPs Agreement. 
Article 2 
1. For the purposes of this Directive, 
Biological material means any (a) 
material containing genetic 
information and capable of 
self-reproduction or of being 
reproduced in a biological system; 
Microbiological process means any (b) 
process involving or performed 
upon or resulting in microbiological 
material; a process consisting of a 
succession of steps shall be treated 
as a microbiological process if at 
least one essential step of the 
process is microbiological; Biological material means any 
material containing genetic 
information and capable of 
reproducing itself or being 
reproduced in a biological system; 
Microbiological process means any 
process involving or performed 
upon or resulting in microbiological 
material. 
29 
Initial proposai 
Essentially biological process for 
the production of plants or animals 
means any process which, taken as 
a whole, exists in nature or is not 
more than a natural plant-breeding 
or animal-breeding process. Amended proposa! 
2. A procedure for the breeding of plants or 
animals shall be defined as essentially 
biological if it is based on crossing and 
selection. 
3. The concept plant variety is defined by 
Article 5 of Regulation (EC) No 2100/94. 
Article 3 
1. For the purposes of this Directive, 
inventions which are novel, imply 
inventive activity and are capable of 
industrial application shall be patentable 
even if they concern a product consisting of 
or containing biological material or a 
procedure by means of which biological 
material is produced, processed or used. 
2. Biological material which is isolated 
from its natural environment or processed 
by means of a technical process may be the 
subject of an invention even if it already 
occurred in nature. 
Article 4 
1. The following shall not be patentable: 
(a) plant and animal varieties, 
(b) essentially biological procedures for 
the breeding of plants and animals. 
2. Inventions which concern plants or 
animals may be patented if the application 
of the invention is not technically confined 
to a particular plant or animal variety. 
30 
Initial proposal Amended proposal 
3. Paragraph 1(b) shall be without 
prejudice to the patentability of inventions 
which concern a microbiological or other 
technical procedure or a product obtained 
by means of such a procedure. 
31 
Initial proposal 
Article 3 
I. The human body and its elements in 
their natural state shall not be considered 
patentable inventions. 
2. Notwithstanding paragraph 1, the subject 
of an invention capable of industrial 
application which relates to an element 
isolated from the human body or otherwise 
produced by means of a technical process 
shall be patentable, even if the structure of 
that element is identical to that of a natural 
element. Amended proposal 
Article 5 
1. The human body, at the various stages of 
its formation and development, and the 
simple discovery of one of its elements 
including the sequence or partial sequence 
of a gene, cannot constitute patentable 
inventions. 
2. An element isolated from the human 
body or otherwise produced by means of a 
technical process including the sequence or 
partial sequence of a gene may constitute a 
patentable invention, even if the structure 
of that element is identical to that of a 
natural element 
Article 4 
1. The subject of an invention shall not be 
considered unpatentable merely on the 
grounds that it is composed of, uses, or is 
applied to biological material. 
2. Biological material, including plants and 
animals, as well as elements of plants and 
animals obtained by means of a process not 
essentially biological, except plant and 
animal varieties as such, shall be 
patentable. 
Article 5 
Microbiological processes and products 
obtained by means of such processes shall 
be patentable. 3. The function of a sequence or a partial 
sequence of a gene must be disclosed in the 
patent application. 
Deleted 
Deleted 
32 
Initial proposal 
Article 6 Deleted 
Essentially biological processes for the 
production of plants or animals shall not be 
patentable. 
Article 7 Deleted 
Uses of plant or animal varieties and 
processes for their production, other than 
essentially biological processes for the 
production of plants or animals, shall be 
patentable. 
Article 8 Deleted 
The subject of an invention concerning a 
biological material shall not be considered 
a discovery or lacking in novelty merely on 
the grounds that it already formed part of 
the natural world. 
Article 9 Amended proposal 
1. Inventions shall be considered 
unpatentable where exploitation would be 
contrary to public policy or morality; 
however, exploitation shall not be deemed 
contrary merely because it is prohibited by 
law or regulation. 
2. On the basis of paragraph 1, the 
following shall be considered unpatentable: Article 6 
1. Inventions shall be considered 
unpatentable where their commercial 
exploitation would be contrary to public 
policy or morality; however, exploitation 
shall not be deemed to be so contrary 
merely because it is prohibited by law or 
regulation. 
2. On the basis of paragraph 1, the 
following shall be considered unpatentable: 
(a) methods of human treatment (a) 
involving germ line gene therapy; procedures for human reproductive 
cloning; 
33 
Initial proposal 
(b) processes for modifying the genetic 
identity of animals which arc likely to 
cause them suffering or physical 
handicaps without any substantial 
benefit to man or animal, and also 
animals resulting from such 
processes, whenever the suffering or 
physical handicaps inflicted on the 
animals concerned are 
disproportionate to the objective 
pursued. Amended proposal 
(b) processes for modifying the germ 
line genetic identity of human 
beings; 
(c) methods in which human embryos 
are used; 
(d) processes for modifying the genetic 
identity of animals which are likely 
to cause them suffering without any 
substantial medical benefit to man 
or animal and also animals resulting 
from such processes; 
Article 7 
The Commission's Group of Advisers on 
the Ethical Implications of Biotechnology 
shall assess all ethical aspects of 
biotechnology. 
34 
Initial proposal 
CHAPTER II 
Scope of protection 
Article 10 
1. The protection conferred by a patent on a 
biological material possessing specific 
characteristics as a result of the invention 
shall extend to any biological material 
derived from that biological material 
through multiplication or propagation in an 
identical or divergent form and possessing 
those same characteristics. 
2. The protection conferred by a patent on a 
process that enables a biological material to 
be produced possessing specific 
characteristics as a result of the invention 
shall extend to biological material directly 
obtained using that process and to any 
other biological material derived from the 
biological material directly obtained 
through multiplication or propagation in an 
identical or divergent form and possessing 
those same characteristics. That protection 
shall not affect the exclusion from 
patentability of plant and animal varieties 
as such, pursuant to Article 4(2). 
Article 11 
The protection conferred by a patent on a 
product containing or consisting of genetic 
information shall extend to all material, 
save as provided in Article 3(1), in which 
the product is incorporated and in which 
the genetic information is contained and 
expressed. Amended proposal 
CHAPTER II 
Scope of protection 
Article 8 
1. Unchanged 
2. The protection conferred by a patent on a 
process that enables a biological material to 
be produced possessing specific 
characteristics as a result of the invention 
shall extend to biological material directly 
obtained through that process and to any 
other biological material derived from the 
biological material directly obtained 
through multiplication or propagation in an 
identical or divergent form and possessing 
those same characteristics. 
Article 9 
The protection conferred by a patent on a 
product containing or consisting of genetic 
information shall extend to all material, 
save as provided in Article 5(1), in which 
the product is incorporated and in which 
the genetic information is contained and 
expressed. 
35 
Initial proposal 
Article 12 
The protection referred to in Articles 10 
and 11 shall not extend to biological 
material obtained from the multiplication 
or propagation of biological material 
marketed in the territory of a Member State 
by the holder of the patent or with his 
consent, if the multiplication or 
propagation necessarily results from the 
application for which the biological 
material was marketed, provided that the 
obtained material is not subsequently used 
for other multiplication or propagation. 
Article 13 
1. By way of derogation from Articles 10 
and 11, the sale of propagating material to 
a farmer by the holder of the patent or with 
his consent for agricultural use implies 
authorisation for the farmer to use the 
product of his harvest for reproduction or 
propagation by him on his own farm, the 
scope of and procedure for this derogation 
corresponding to those under Article 14 of 
Regulation (EC) No 2100/94. 
2. By way of derogation from Articles 10 
and 11, the sale of breeding stock to a 
farmer by the holder of the patent or with 
his consent implies authorisation for the 
farmer to use the protected livestock for 
breeding purposes on his own farm, in 
order to replenish their numbers. Amended proposal 
Article 10 
The protection referred to in Articles 8 and 
9 shall not extend to biological material 
obtained from the multiplication or 
propagation of biological material 
marketed in the territory of a Member State 
by the holder of the patent or with his 
consent, if the multiplication or 
propagation necessarily results from the 
application for which the biological 
material was marketed, provided that the 
obtained material is not subsequently used 
for other multiplication or propagation. 
Article 11 
1. By way of derogation from Articles 8 
and 9, the sale of propagating material to a 
farmer by the holder of the patent or with 
his consent for agricultural use implies 
authorisation for the farmer to use the 
product of his harvest for reproduction or 
propagation by him on his own farm., the 
scope of and procedure for this derogation 
coiTesponding to those under Article 4 of 
Regulation (EC) No 2100/94. 
2. By way of derogation from Articles 8 
and 9, the sale of breeding stock or other 
reproductive material to a farmer by the 
holder of the patent or with his consent 
implies authorisation for the farmer to use 
the protected livestock for an agricultural 
purpose. This includes the sate for the 
purposes of pursuing agricultural activities 
but not the sale within the framework, or for 
the purpose of a commercial breeding 
activity. 
36 
Initial proposal Amended proposal 
3. The extent and the conditions of the 3. Unchanged 
derogation provided for in paragraph 2 
shall be determined by national laws, 
regulations and practices. 
CHAPTER III 
Compulsory cross-licensing 
Article 14 
1. Where a breeder cannot acquire or 
exploit a plant variety right without 
infringing a prior patent, he may apply for 
a compulsory licence for non-exclusive use 
of the invention protected by the patent 
inasmuch as the licence is necessary for the 
exploitation of the plant variety to be 
protected, subject to payment of an 
appropriate royalty. Member States shall 
provide that where such a licence is 
granted, the holder of the patent will be 
entitled to a cross-licence on reasonable 
terms to use the protected variety. 
2. Where the holder of a patent on a 
biotechnological invention cannot exploit it 
without infringing a prior plant variety 
right, he may apply for a compulsory 
licence for non-exclusive use of the plant 
variety protected by that right, subject to 
payment of an appropriate royalty. 
Member States shall provide that where 
such a licence is granted, the holder of the 
variety right will be entitled to a 
cross-licence on reasonable terms to use 
the protected invention. CHAPTER III 
Compulsory cross-licensing 
Article 12 
1. Unchanged 
2. Unchanged 
37 
Initial proposal 
3. Applicants for the licences referred to in 
paragraphs 1 and 2 above must 
demonstrate that: 
(a) they have applied unsuccessfully to 
the holder of the patent or of the 
plant variety right to obtain a 
contractual licence; 
(b) exploitation of the plant variety or 
the invention for which the licence 
is requested is dictated by the 
public interest and the plant variety 
or the invention constitutes 
significant technical progress. 
4. Each Member State shall designate the 
authority or authorities responsible for 
granting the licence. The licence shall be 
granted principally for the supply of the 
domestic market of the Member State 
which has granted the licence. 
CHAPTER IV 
Deposit, access and re-deposit of a 
biological material 
Article 15 
1. Where an invention involves the use of 
or concerns a biological material which is 
not available to the public and which 
cannot be described in a patent application 
in such a manner as to enable the invention 
to be reproduced by a person skilled in the 
art, the description shall be considered 
inadequate for the purposes of patent law 
unless: Amended proposal 
3. Unchanged 
(a) Unchanged 
(b) the plant variety or the invention 
constitutes significant technical 
progress of considerable economic 
interest. 
4. Each Member State shall designate the 
authority or authorities responsible for 
granting the licence. 
CHAPTER IV 
Deposit, access and re-deposit of a 
biological material 
Article 13 
1. Unchanged 
38 
Initial proposal 
(a) the biological material has been 
deposited, no later than the date 
on which the patent application 
was filed, with a recognised 
depositary institution. At least 
the international depositary 
authorities which acquired this 
status by virtue of Article 7 of 
the Budapest Treaty of 
2SAprill977 on the 
International Recognition of the 
deposit of micro-organisms for 
the purposes of patent procedure, 
hereinafter referred to as the 
"Budapest Treaty", shall be 
recognised; 
(b) the application as filed contains 
such relevant information as is 
available to the applicant on the 
characteristics of the biological 
material deposited; 
(c) the patent application states the 
name of the depository 
institution and the accession 
number. Amended proposal 
2. Access to the deposited biological 2. Unchanged 
material shall be provided through the 
supply of a sample: 
(a) up to the first publication of the 
patent application, only to those 
persons who are authorised under 
national patent law; 
(b) between the first publication of 
the application and the granting 
of the patent, to anyone 
requesting it or, if the applicant 
so requests, only to an 
independent expert; 
(c) after the patent has been granted, 
and notwithstanding revocation 
or cancellation of the patent, to 
anyone requesting it. 
39 
Initia! proposal 
3. The sample shall be supplied only if the 
person requesting it undertakes, for the 
term during which the patent is in force: 
(a) not to make it or any matter 
derived from it available to third 
parties and 
(b) not to use it or any matter 
derived from it except for 
experimental purposes, 
unless the patent holder or 
applicant, as applicable, expressly 
waives such an undertaking. 
4. At the applicant's request, where an 4. Unchanged 
application is refused or withdrawn, access 
to the deposited material shall be limited to 
an independent expert for twenty years 
from the date on which the patent 
application was filed. In that case, 
paragraph 3 shall apply. 
5. The applicant's requests referred to in 5. Unchanged 
point (b) of paragraph 2 and in paragraph 4 
may only be made up to the date on which 
the technical preparations for publishing 
the patent application are deemed to have 
been completed. 
Article 16 
1. If the biological material deposited in 1. Unchanged 
accordance with Article 15 ceases to be 
available from the recognised depositary 
institutions, a new deposit of the material 
shall be permitted on the same terms as 
those laid down in the Budapest Treaty. Amended proposal 
3. Unchanged 
Article 14 
40 
Initial proposal 
2. Any new deposit shall be accompanied 
by a statement signed by the applicant 
certifying that the newly deposited 
biological material is the same as that 
originally deposited. 
CHAPTER V 
Burden of proof 
Article 17 
l.If the subject-matter of a patent is a 
process for obtaining a new product, then, 
when the same product is produced by any 
other party, it shall, in the absence of proof 
to the contrary, be deemed to have been 
obtained by the patented process. 
2. In the adduction of proof to the contrary, 
the legitimate interests of the defendant in 
protecting his manufacturing and business 
secrets shall be taken into account. 
CHAPTER VI 
Final provisions 
Article 18 
1. Member States shall bring into force the 
laws, regulations and administrative 
provisions necessary to comply with this 
Directive not later than 1 January 2000. 
They shall immediately inform the 
Commission thereof Amended proposal 
Unchanged 
Deleted 
CHAPTER VI 
Final provisions 
Article 15 
1. Member States shall bring into force the 
laws, regulations and administrative 
provisions necessary to comply with this 
Directive not later than 1 January 1999. 
They shall immediately inform the 
Commission thereof. 
41 
Initial proposal 
When Member States adopt these 
measures, these shall contain a reference to 
this Directive or shall be accompanied by 
such reference at the time of their official 
publication. The procedure for such 
reference shall be adopted by 
Member States. Amended proposal 
Unchanged 
2. Member States shall communicate to the 2. Unchanged 
Commission the text of the main 
provisions of national law which they 
adopt in the field covered by this Directive. 
Article 16 
Every five years after the transposition of 
this Directive the Commission shall 
publish a report on any problems 
encountered with regard to the relationship 
between this Directive and international 
agreements on the protection of human 
rights to which the Member States have 
acceded or on which they have cooperated. 
The report shall be forwarded to European 
Parliament and the Council. 
Article 19 Article 17 
This Directive shall enter into force on the Unchanged 
20th day following that of its publication in 
the Official Journal of the European 
Communities. 
Article 20 Article 18 
This Directive is addressed to the Unchanged 
Member States. 
42 

ISSN 0254-1475 
COM(97) 446 final 
DOCUMENTS 
EN 05 06 08 15 
Catalogue number : CB-CO-97-455-EN-C 
ISBN 92-78-24376-0 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
43