COMMISSION OF THE EUROPEAN COMMUNITIES 
C0MC94) 219 final 
Brussels, 01.06.1994 
p*t 
*JK ^s^AiAS" '••"-"Ui?--
K BIOTECHNOLOGY AND THE WHITE PAPER ON GROWTH, COMPETITIVENESS AND 
EMPLOYMENT 
PREPARING THE NEXT STAGE 
Communication from the Commission to the Council, the European 
Parliament and the Economic and Social Committee 
CONTENTS 
PAGE 
INTRODUCTION 
REGULATORY FRAMEWORK 
STRENGTHENING OF SCIENTIFIC ADVICE 
RESEARCH AND DEVELOPMENT 
BIOTECHNOLOGY AND SMES 
THE INVESTMENT CLIMATE 10 
PUBLIC UNDERSTANDING 10 
ETHICS 11 
CONCLUSIONS 13 
ANNEX : STATE OF PLAY OF THE BIOTECHNOLOGICAL 15 
REGULATORY FRAMEWORK 
A & 
INTRODUCTION 
An innovative tool 
The White Paper on Growth, Competitiveness and Employment acknowledged 
modern biotechnology as one of the fields offering the greatest 
potential for innovation and growth. Its application could be of 
particular benefit in areas such as healthcare, industrial chemicals, 
food and feeds, agriculture and environmental clean-up services. 
Moreover, the further development of biotechnology will require 
increasing investment in supplies, services and hardware. This would 
have a correspondingly positive effect on the employment situation. 
A Community role 
The European Community has been becoming increasingly involved in 
biotechnology since the mid-1970s. By funding research and developing a 
regulatory framework, it has sought to promote the competitiveness of 
bio-industries, whilst also ensuring the safety of man and the 
environment. 
The Commission recognised, in its 1991 initiative, that biotechnology 
is a key technology for the future competitive development of the 
Community. As such, it will determine the extent to which Community 
industries remain world leaders in the development of innovatory 
products. Although the main responsibility for competitiveness rests 
with the firms themselves, the Commission also took the view that 
public authorities could help to stimulate competitiveness by adopting 
a consistent and supportive approach in relevant areas. This would 
entail the provision of financial support for basic and applied 
research and related infrastructure; the drawing up of a coherent 
regulatory framework, based on a number of defined principles 
(including protection of intellectual property); a renewed emphasis on 
education and training; the stimulation of technology transfer; and 
the facilitation of public understanding and consumer choice. A 
package of priority measures was subsequently approved. 
A new impetus 
The White Paper confirmed the outstanding promise of biotechnology in 
terms of growth, competitiveness and employment. 
Taking account of the content and state of implementation of the 1991 
package, it gave new impetus to achieving a fuller realisation of the 
Community's inherent strength in biotechnology and to overcoming 
existing constraints. Reinforcing conditions at both the R&D and 
marketing stages of biotechnology would increase its potential for 
employment creation. By taking a number of specific steps, Europe's 
competitiveness in this field will be further enhanced. 
The present communication represents the Commission's response to the 
White Paper's recommendations, and its structure has been designed so 
as to follow the order in which these recommendations were listed. It 
is based on the premise that the White Paper's goals in relation to 
biotechnology can be achieved only through close cooperation between 
operators, users, Community Institutions, Member State authorities and 
interest groups. The Commission recognises the important interest of 
the European Parliament in developments in biotechnology and is ready 
to establish the necessary dialogue on biotechnological issues, in 
particular with the Parliament. It will also seek, as in the past, to 
organise round-table discussions. 
it 
REGULATORY FRAMEWORK 
Introduction 
Biotechnology involves the use of modern genetic engineering, which 
will affect many different products and processes. The Community's 
regulatory framework for biotechnology was designed, in the late 1980s, 
in order to provide the necessary legislation to ensure adequate 
protection of health and the environment, while at the same time 
creating the internal market for biotechnological products. It is based 
on a number of principles, adopted in 1991*), which still retain their 
validity (see Annex 1 for details). 
The Community is putting into place both "horizontal" and product 
legislation containing a specific environmental risk assessment of 
products containing or consisting of GMOs. (An overview of the state of 
play regarding current legislative activities is attached at Annex 1.) 
This framework has been built upon the knowledge available at that 
time, when there was still considerable uncertainty as to safety and 
the risks involved in the application of modern biotechnology. The 
Community adopted legislation aiming at a broadly preventative approach 
as regards the use of modern biotechnology. 
The White Paper concluded that the Community should be open to 
reviewing its biotechnology regulatory framework, in order that the 
full potential of modern biotechnology for jobs, investment and growth 
can be realised. 
Following this commitment, the Commission, in consultation with Member 
State authorities, undertook such a review. Its objective was to 
ensure that the safety requirements and administrative procedures are 
appropriate to the risks for human health and the environment and 
reflect acquired experience, advances in scientific knowledge and 
established international practices. It also took account of the 
existing regulatory frameworks on modern biotechnology used by its main 
competitors, in particular the United States. 
The way ahead 
In carrying out the review, the Commission paid special attention to 
the wider range of knowledge and experience currently available, which 
has increased understanding of the risks associated with genetic 
modifications and increased confidence among scientists in the safety 
of genetic engineering. 
Much use has now been made of the technology in research laboratories 
and industrial facilities worldwide. From this knowledge and 
experience, it may be concluded that the risks involved in the 
contained use of GMMs are substantially less than were once foreseen. 
For example, the potential for horizontal gene transfer resulting in 
novel and harmful properties being acquired by microorganisms has not 
1) SEC (91) 629 
been shown to present hazards to human health and the environment. 
There is a growing confidence that the GMMs used in research and in 
industrial production can be more precisely categorised, so that they 
are unable to survive except in the special environment of the 
experiment or process in which they are used. Experience has shown that 
the majority of genetic modifications in contained facilities can be 
done safely by applying good laboratory practice. 
Worldwide, there have now been many deliberate releases of GMOs, mainly 
with a number of well-known crop plants. This has led to an improved 
understanding of the behaviour of these plants and their safety in 
respect of human health and the environment. So far, such releases 
have not given cause for concern, and evidence is accumulating to the 
effect that genetically modified plants do not differ from non-modified 
plants other than in the specific character conferred by the introduced 
gene. 
As part of its broader reflections, the Commission acknowledged that 
the biotechnological regulatory framework is a factor impacting on 
industrial competitiveness, which confirms the need for balanced and 
proportionate regulatory requirements commensurate with the identified 
risks. 
It also noted the results of surveys indicating the important role that 
the regulatory framework has to play in building public confidence in 
biotechnology. This shows the need for a predictable and adaptable 
regulatory system. 
Taking these elements into account, the Commission confirms its earlier 
view that, in the future, the whole network of interrelated 
biotechnological regulations needs to ensure that oversight is always 
appropriate in relation to the risks involved, the building of public 
confidence and to the competitive development of the industries 
involved, while guaranteeing the protection of human health and the 
environment. On this basis, the Commission is of the opinion that the 
following two-track approach for the future development of the 
biotechnological regulatory framework should be applied: 
the exploitation of existing possibilities for revising 
measures/procedures/degree of oversight/requirements, through use 
of the "light" procedure of adaptation to technical progress 
(regulatory Committee procedure), (internal amendment) 
the bringing forward of amendments to existing legislation in order 
to incorporate changes which cannot be achieved by technical 
adaptation while leaving the basic structure of the framework 
intact (external amendment) 
* * 
* 
The Commission examined the application of the two-track approach in 
greater detail for specific parts of the regulatory framework, 
considering each such part on its particular merits. It came to the 
conclusions outlined below. 
Directive 90/219 /EEC on the contained use of genetically-modified 
microorganisms 
The review indicated that extensive use was made during the late 1970s 
and the 1980s of genetically-modified microorganisms in laboratories 
and industrial fermenters, from which substantial experience was 
gained. This experience, together with the recommendations made by the 
OECD, forms the scientific basis of the Directive. 
The Commission identified, on the basis of the substantially increased 
understanding of the risks associated with the use of GMMs in contained 
circumstances, as mentioned above, the following objectives for further 
action: 
i) streamlining and easing of the administrative/notification/ 
consent requirements where this does not compromise safety; 
ii) ensuring that the classification of the genetically modified 
micro-organisms and of the activities in which they are used 
are appropriate to the risks involved; 
iii) ensuring that the conditions of use are appropriate to the 
risks involved; 
iv) extension of the flexibility of the Directive so it can be more 
easily adapted to technical progress by regulatory Committee 
procedures. 
In line with these objectives, this will mean that it will continue to 
make full use of the inherent flexibility of the Directive (regulatory 
Committee procedure), i.e. by: 
preparing a Decision redefining the risk categories of GMMs through 
the revision of Annex II; 
revising the guidelines for classification as established under 
Article 4.2 of the Directive as a result of the discussion 
undertaken for amending the criteria of Annex II (see above); 
further exploiting the possibilities to adapt safety assessment 
parameters, containment measures and required information for 
technical progress. 
The increased knowledge and experience mentioned above also gives a 
clearer indication of the present administrative (notification) consent 
requirements necessary to ensure safety for the different risk 
categories of GMMs. 
Taking into account the most up to date information, it may be 
concluded that the existing administrative arrangements may be 
lightened for activities presenting low risk to human health and the 
environment, without jeopardising existing safety standards. This would 
also allow a greater focusing of attention on higher risk 
possibilities. However, as the Directive does not provide for such 
adaptations, a number of specific amendments must be introduced, as 
follows: 
replacing the consent requirements by record-keeping, or 
notification for information purposes, for certain low-risk 
activities; 
- replacing the explicit consent requirements by implicit consent for 
certain higher-risk activities; 
reduction of time periods involved in implicit/explicit consent 
procedures; 
adapting the present risk classification system for GMMs, in 
accordance with new safety considerations. 
removal of the differentiation between activities in research 
laboratories and production plants. 
The Commission will propose the possibility of adapting the definitions 
contained within the scope of the Directive via a Committee procedure, 
as is, for example, at present foreseen in the case of pharmaceutical 
legislation. 
The Commission will conduct the necessary broad consultations with 
operators, users, Member State authorities and interest groups in order 
to propose amendments before the European Council to be held in Essen 
by the end of 1994. 
Directive 90/220/EEC on the deliberate release of genetically modified 
organisms to the environment 
The Commission has made a number of technical adaptations to the 
Directive to reflect the evidence acquired from the wide number of GMO 
releases in the plant area, which were shown not to pose any specific 
risks. These measures seek to improve uniform application, streamline 
and simplify the procedures and reduce the obligations on the notifiers 
while maintaining the appropriate protection of health and the 
environment. These activities are the following : 
A Commission Decision revising the notification information 
requirements of Annex II of the Directive, reducing them 
significantly for releases of plants (95% of releases) (April 94). 
- A Commission Decision revising the Summary Notification Information 
format reducing the information required for plants (April 94). 
A Commission Decision establishing criteria for introducing 
simplified procedures under Article 6.5 (Oct. 93) for genetically 
modified plants. 
Preparation of a Commission Decision introducing specific 
simplified procedures for releases of plants (to be adopted by 
June/July 94). 
The Commission concluded, on the basis of the progress made in adapting 
aspects of the Directive, that it is flexible enough to satisfy current 
needs for adaptation to technical progress and simplification of 
procedures. In the short term, it will fully exploit the existing 
possibilities in this area. 
Biotechnology is a fast-moving and continually evolving technology, and 
the Commission recognises that there are aspects of the Directive that 
might be improved. It is not, however, possible at present to detail 
the precise nature of these improvements, as further experience is 
necessary in order to determine the right balance between the need for 
safety, public reassurance and the minimum restraint on industry and 
research work. 
Hence, on the basis of future experience and scientific knowledge, the 
Commission will carry out a further review of the Directive during the 
first half of 1995. This review will assess the need for proposals in 
relation to: 
extending the flexibility of Directive 90/220/EEC, so that its 
scope and the procedures to be followed are always appropriate to 
the risks involved, and are easily adaptable; 
- strengthening more uniform decision-taking between Member States in 
the case of research and development releases; 
introducing further opportunities for notifiers (industry and 
researchers), so that they can benefit more from the existence of a 
uniform Community system; 
facilitating the link between this Directive and product 
legislation. 
Other législation 
The Commission has noted that, to date, one specific piece of product 
legislation, namely for medicinal products of biotechnology, is in 
force. As from 1 January 1995, this will be replaced by a centralised 
procedure which will result in a Community-wide marketing 
authorisation. This new piece of legislation is the result of a 
streamlining of existing marketing authorisation procedures so that 
patients can benefit from new innovative medicinal products 
simultaneously in all Member States, while at the same time 
safeguarding maximum standards of public health. 
In respect of other product-based regulations which contain or will 
contain an environmental risk assessment similar to that in Directive 
90/220/EEC, one other such piece of legislation (namely, additives in 
feeding stuffs) has been adopted - which will enter into effect as from 
1 October 1994 - and a further two (on novel foods and seeds) are under 
discussion before the other institutions. The rapid adoption by the 
Council of this legislation, as an essential part of the overall 
framework, is seen as a matter of urgency. The Commission will continue 
to make efforts to arrive at this and to ensure its proper 
implementation, by drawing upon experience and knowledge already 
available. 
It will, as a matter of urgency, make a proposal for an amendment to 
Council Directive 91/414/EEC on the placing of plant protection 
products on the market in order to complete the environmental risk 
assessment, already provided for in the Directive, with the technical 
complements which are necessary to cover adequately plant protection 
products containing or consisting of GMMs. A fast track procedure for 
certain low risk plant protection products, including biological plant 
protection products, whether derived from GMMs or not, will also be 
proposed. 
In relation to the legislation to protect workers from the risks 
related to exposure to biological agents at work, the Commission will 
press Member States for a more rapid transposition. 
The review again demonstrated the need for adequate patent protection 
for inventions, as an important condition for attracting investments in 
biotechnology. The Commission re-emphasises therefore that Community 
legislation, which has been under discussion since 1988 and 1990 
respectively, in the area of intellectual property (patents for 
biotechnology inventions and plant variety rights) should be adopted as 
a matter of urgency. By doing so, an important gap in the regulatory 
framework will be closed. 
The same applies to the draft modification of the seed marketing 
directives aiming at integrating the environmental risk assessment in 
the established variety acceptance procedure. 
The Commission will seize opportunities - as is foreseen, at the end of 
1997, for example, in the legislation for medicinal products - as 
regards further simplification and/or streamlining of procedures of the 
biotechnology regulatory framework as part of its general policy in 
this area as stated in the White Paper. An ongoing review of the 
biotechnological regulatory framework shall be carried out as new 
scientific knowledge and the emerging regulatory practice of major 
international competitors indicates that this is necessary or 
desirable. 
STRENGTHENING OF SCIENTIFIC ADVICE 
The White Paper recognised the importance of scientific advice 
available to the Commission, which is particularly relevant in the 
field of biotechnology with applications in a broad range of areas. At 
present, it is therefore assessing whether there is a need for 
reinforced scientific input to regulations, for example, in view of an 
appropriate implementation of product legislation containing a specific 
environmental risk assessment for products consisting of or derived 
from GMOs. This assessment will also take account of the work of 
existing advisory scientific committees at Community level and that 
carried out by a number of national advisory Committees on biosafety or 
genetic modification providing advice at national level. A meeting will 
be organised between the Commission and the chairpersons of these 
scientific committees to share experiences and to identify whether 
there are further needs in the area. A European Science and Technology 
Assembly is being set up to assist the Commission in the conception and 
implementation of all Community research and technological development 
policies, including those relating to biotechnology. This will further 
strengthen the links between the Commission and the research world. 
RESEARCH AND DEVELOPMENT 
One of the greatest resources for the European biotechnology industry 
is ready access to a well-established science base and a highly-skilled 
workforce. A recent survey of some 400 new biotechnology companies 
indicated that, generally speaking, they have grown up around areas of 
academic excellence. This vital resource of innovation and skills, much 
of it funded by governments, is also readily available to Europe's 
large pharmaceutical and chemical companies, either via strategic 
partnerships or directly-funded research. Experience, however, has 
shown that, despite this, Member States need to give greater 
recognition to the importance of the science base for biotechnology, as 
has been done elsewhere. Furthermore, increased coordination is needed 
between and within Member States* research programmes to minimise 
wasteful duplication and to maximise collaboration, with the aim of 
improving the efficiency of R&D expenditure. 
Community initiatives 
To these ends, the Commission has recently proposed considerably 
expanded research programmes activity within the area of Life Sciences 
and Technologies: biotechnology (552 MECU), biomedecine and health (336 
MECU) and agriculture and fisheries (684 MECU) under the Fourth 
Framework Programme. This total proposed expenditure of 1572 MECU 
signifies an increase in budget of 741 MECU in comparison to the 
relevant programmes as included in the third Framework Programme. 
The Commission realises that the European Union as a whole is not 
matching research and development expenditure made elsewhere. However, 
it is compensating for this by focusing on the most vigorous R&D areas 
and on increasing coordination between the Member States' and the 
Community's research programmes. 
To improve these aspects, the three Specific Programmes in the Life 
Sciences and Technologies area propose three mechanisms: 
- Areas offering the highest potential returns on R&D in the short to 
medium term will receive special priority for funding (concentrated 
financial support). This will often involve a multi-disciplinary 
and integrated approach. 
- Areas which are strategically important, but where limited 
financial support is available, will be supported by the 
establishment of networks aimed at coordinating and building upon 
Member States' research programmes. 
Areas which are essential to the exploitation of the life sciences, 
but which may require special attention in respect of other factors 
such as socio-economic or ethical issues, will be addressed by 
horizontal activities. These will involve the key players and users 
in dialogue aimed at socially acceptable solutions and a well-
informed public. 
By the rapid adoption of the three specific programmes and through the 
implementation of the above mentioned mechanisms, the Commission 
expects to achieve a fuller realisation of the Community's inherent 
potential in biotechnology R&D. 
BIOTECHNOLOGY AND SMES 
As shown by previous major technological advances, small and medium 
sized enterprises play a vital role in the early stages of 
technological innovation and diffusion. This sector is growing, and a 
number of important firms have been established. In terms of numerical 
importance, SMEs specialising in modern biotechnology are located in 
the UK, France, the Netherlands, Denmark and Germany, and focus 
primarily on the therapeutic and diagnostic fields of research and 
production. 
Community support 
A recognition of the important role of small and medium sized 
enterprises has led many Member States to encourage the development of 
the SME sector. Building on this, the White Paper has set out 
guidelines for an integrated programme, whose focus is on three major 
themes: improving access to finance and credit facilities, support for 
cooperation between firms and support for improvements in management 
quality. 
These objectives respond in large measure to the needs of the small 
and medium sized biotechnology enterprises. Like other SMEs, these 
firms face difficulties in accessing private sector sources of funds, 
whether from financial intermediaries, equity market or venture 
capital. Small and medium sized biotechnology firms have a particular 
need for industrial and financial partners when starting up. 
Other specific characteristics of biotechnology SMEs are the need for 
and availability of high-tech scientific input and the need to overcome 
hurdles quickly in bringing inventions and innovations onto the market. 
In view of this, the Fourth Framework R&D Programme opens up 
opportunities: 
- for facilitating the participation of SMEs, irrespective of their 
RTD capability, in Community R&D programmes, via the implementation 
of a special procedure based on the experience of CRAFT activities; 
for encouraging the establishment of industrial platforms. These 
consist of groups of European companies associated with specific 
projects under the Community research programmes, with preferential 
access to their results; 
- for demonstrations. The application of the innovative results of 
research in the life sciences area will be addressed through well 
targeted and pre-competitive demonstration activities. This will 
enhance the attractiveness of new biotechnology applications; 
for helping SMEs to find suitable partners to carry forward 
innovative applications of biotechnology and to establish trans­
national networks for technology transfer. 
Science parks 
The characteristics that biotechnology SMEs share with other science-
based SMEs underlie the emergence of science parks at the combined 
initiative of the SMEs themselves and universities, in collaboration 
with local and regional authorities. Up to one-third of biotechnology 
SMEs in the Community are located in science parks. With the steady 
entry of new biotechnology firms, some 59 of the 250 science parks in 
the Community now contain an important biotechnology component. 
Science parks facilitate the process of technology innovation and 
diffusion and offer a number of advantages for SMEs. For example, they 
provide easy and close access to science facilities, which enables the 
SME to have a "window on the technology" and to be informed on the most 
up-to-date developments. The costs involved in seeking venture or 
investment capital partners are considerably reduced for firms and 
investors alike; sourcing of intermediates and laboratory materials is 
facilitated; and labour mobility can be encouraged between academic 
work and research applications. 
This evident trend of growth, in the Community, of science parks with 
a biotechnology component, mirrors a development already witnessed in 
the USA in the past decade, where, by 1992, there were 81 dedicated 
biotechnology centres, with some 730 firms, specialising primarily in 
applied research. 
Under the Programme for Innovation and Technology Transfer, SPRINT 
1989/93 (Council decision 89/286/EEC), modest Community funding was 
envisaged to support feasibility studies and expert assistance in 
creating science parks that serve a market need and that are able to 
attract firms. Presently the Commission is, following the 
recommendations of the Communication on Cohesion and RTD Policy , 
undertaking a study to evaluate the need to create networks, the type 
of network most conducive to the optimal functioning of science parks 
and collaboration between Technology Parks within the European Union. 
fhïë would allow M fuller eMplnitatjqn of opportunities for increased 
cooperation between firms operating on the internal market, and hence 
would contribute to realising the objectives of the integrated 
programme for SMEs. 
THE INVESTMENT CLIMATE 
The importance of the investment climate to the trnnufwr of applied 
research and product development to the commerciallnat Ion stage in 
fully recognised. In general, the allocativu mochanism in market 
economies is efficient in shifting investment flows and factors towards 
sectors experiencing, or likely to experience, high growth, aa with 
certain areas of application of biotechnology. 
While, in a number of products derived from modern biotechnology, 
market-driven growth is evident, there are others of major long-term 
potential such as bioremediation products and new ranges of biosensors, 
where growth is variable or modest. The result is that medicinal 
products of biotechnology is the target domain of over 60% of the 
current modern biotechnology firms, while bioremediation product 
development occupies less than 5% of the existing firms. Investment 
incentives in particular by Member States, within the existing 
Community framework, to improve the investment climate in these areas 
are recommended. This would cover support for R&D activities, or the 
start-up or expansion of business activities, together with the 
establishment of sound technological clusters and a business-friendly 
tax climate. In doing so, Member States would strengthen Europe's 
competitiveness in high-value added future growth markets. For its 
part, the Community will, through the implementation of a newly-
proposed specific programme on the diffusion and exploitation of R&D 
results (involving expenditure of 293 MECUs), help to overcome barriers 
preventing the conversion of scientific achievements into commercial 
successes. 
10 
PUBLIC UNDERSTANDING 
The introduction of any new technology, whether in the past or at 
present, has raised critical reactions from the general public. This is 
especially true of biotechnology, as it raises value-laden issues. 
Surveys indicate that understanding of biotechnology varies widely 
within the Community, as does the perception of the risks and benefits 
of different applications. 
The Commission has helped to bring about a number of initiatives to 
raise public awareness, although it recognises that other public and 
private bodies have primary responsibility in this area. The focus for 
the Community's activities has been the Life Sciences and Technologies 
Research Programmes. The following actions will be reinforced: 
analytical work concerning public attitudes, including the 
Eurobarometer surveys. This is necessary in order to understand the 
scale of the problem and the factors which lie behind it. Such work 
will guide future awareness activities to be undertaken by the 
Commission, Member State governments and other interested parties 
from the public and private sectors. 
raising awareness among the main players. Building upon the 
experience of analytical work, increased information will be 
provided in a balanced and impartial way to raise awareness in 
industries where the commercial potential of the emerging 
technology may not be well understood; in the public sector, 
including government institutions, where policies and strategies 
are developed; among the media communicating biotechnology to the 
public; among scientists increasing public understanding of 
science; and public interest groups and educators. 
raising awareness and providing information to the general public. 
A European Initiative in Biotechnology Education has been launched 
and will be reinforced to provide teaching materials and expertise 
to school teachers throughout the European Union. Other specialised 
materials will be prepared and workshops, conferences and meetings 
will be held to encourage dialogue and to aid openness. 
The Commission recognises that modern biotechnology comprises many 
varying applications. In view of this, it is important that all parties 
concerned develop reliable information on all aspects of these 
applications, especially as regards their potential benefits and risks. 
This involves illustrating innovative advantages as well as addressing 
issues such as safety, ethics and environmental protection. It would, 
however, like to stress that, ultimately, it is the market place which 
decides the successful commercialisation of individual biotechnological 
applications. 
ETHICS 
General 
Developments in biotechnology may raise questions of an ethical nature 
in certain areas. There is concern about tampering with nature and 
life, and the White Paper stressed the need to ensure that these 
questions arc addressed and identified properly. In response to this, 
the Coiïiiïiission has reinforced the profile of the Group of Advisers on 
the Ethical Implications of Biotechnology, thereby building on the 
results achieved during the first two year term of the Group. 
11 
This group, established in 1991, is concerned with: 
the identification and definition of ethical issues raised by 
biotechnology; 
the appraisal of the ethical aspects of Community activities in the 
field of biotechnology, and their potential impact on society and 
the individual; 
and advising the Commission as regards the ethical aspects of 
biotechnology, with a view to improving public understanding. 
So far, the group has given three opinions on the ethical 
implications of the use of performance enhancers in agriculture and 
fisheries, of medical products derived from human blood and plasma, and 
of legal protection of biotechnological inventions. These opinions have 
greatly assisted the Commission in formulating its policy in these 
areas. 
The Group's mandate has been renewed recently to increase the number of 
advisers, and hence to make available a broader range of advice. It 
consists of independent leading experts from several different branches 
of science. It is the Group's intention to step up its contacts with 
the general public and international organisations. At the same time, 
it has also intensified its work programme and its Secretariat has been 
reinforced. At present, opinions are under preparation on the ethical 
aspects related to transgenic animals, gene-therapy and pre-natal 
diagnosis, all of which will be finalised before the end of this year. 
Because of its terms of reference, the Group has a unique place in the 
European Union. It is closely involved, in a consultative capacity, in 
the elaboration of relevant Community policy, but is completely 
independent. It is also able, at its own initiative, to examine any 
topic touching on biotechnology. 
Several activities such as workshops and seminars on legal and ethical 
aspects related to biotechnological and biomedical research including 
their application in the agricultural sector are proposed under the 
Fourth Framework Programme. These activities are related to more 
general issues concerning biotechnology (patents, biodiversity, animal 
models) and the application of classical rules of medical ethics 
(informed consent, confidentiality, ethical review of research 
protocols) to new fields of biomedecine like brain research, gene 
therapy and neurotransplantation. 
Biomedical ethics 
In the past, the Commission has taken a number of initiatives to 
clarify ethical issues in relation to biomedical and health research. 
For example, the human embryo and research (HER) working group has 
monitored the legal and practical aspects of research on human embryos 
in the Member States and identified sectors where a consensus could be 
reached. Two reports, on embryos before and after implantation, have 
been published, and the state of legislation on embryo research was 
reviewed. Protection of embryos and specific issues like pre-
implantation diagnosis will be the next tasks of this working group. 
Moreover, the ESLA (Ethical, Social and Legal Aspects) working group 
under the human genome analysis research programme, has encouraged 
public discussion and made recommendations to the Commission on the 
legal or other initiatives to be taken in this field. 
12 
Research in all areas of biomedical ethics has been initiated under the 
first Biomedical and Health research programme, and the Commission has 
proposed to continue this under the new second specific Biomedical and 
Health research programme. To this end, it intends to organise working 
groups to prepare reports and surveys for the European Parliament and 
Council of Ministers on relevant biomedical ethical issues. Targeted 
workshops are to be held to identify and debate issues requiring 
clarification and debate at an international level. 
International 
An increasing number of international organisations have undertaken 
initiatives to clarify the ethical issues related to the different kind 
of applications of biotechnology. In this respect the Commission 
attaches importance to the work of the Council of Europe towards the 
preparation of a Convention on Bioethics. The Commission is preparing a 
Communication to the Council on its participation in this Convention. 
CONCLUSIONS 
The Commission considers that the application of modern biotechnology 
will have a major impact on the development of a wide range of sectors. 
Whilst naturally committed to guaranteeing maximum standards of safety 
for man and the environment, it is of the opinion that, by taking a 
number of specific steps, as a follow-up to the White Paper's 
recommendations, it will encourage the competitiveness of Europe's 
bioindustries. It counts upon the other Institutions, Member States and 
interest groups to give force to these measures. The Commission 
recognises the important interest of the European Parliament in 
developments in biotechnology and is ready to establish the necessary 
dialogue on biotechnological issues, in particular with the Parliament. 
It will also seek, as in the past, to organise round-table discussions. 
Taking account of the considerations outlined above, it has decided 
upon the following: 
to implement a two-track approach as regards the future development 
of the biotechnological regulatory framework i.e. to exploit fully, 
where they exist, the inherent possibilities to adapt to technical 
progress (via regulatory Committee procedure). At the same time, it 
will bring forward amendments in order to incorporate changes which 
cannot be achieved by technical adaptation while leaving the basic 
structure of the framework intact. In line with this approach it 
will, as regards : 
directive 90/219/EEC on the contained use of GMMs, continue to 
review Annexes II to V and conduct the necessary broad 
consultations with operators, users, Member State authorities 
and interest groups, in order to propose amendments in the 
indicated areas before the European Council at Essen so that 
the wide ranging available knowledge and experience is 
incorporated in that directive. By doing so, its functioning 
will be improved without jeopardising existing safety 
standards. 
directive 90/220/EEC on the deliberate release of GMOs, make 
full use of the possibilities to adapt to progress and in 
particular to simplify procedures. On the basis of ongoing 
13 
parience and scientific and technological developments, in 
the first half of 1995 an evaluation will take place following 
the objectives set out, whereby an assessment will be made of 
the need for bringing forward amendments. 
other parts of the regulatory framework, continue to press for 
a rapid adoption of the intellectual property protection 
legislation as well as of product legislation containing an 
environmental risk assessment similar to that of directive 
90/220/EEC. It will ensure adequate implementation of such 
legislation by preparing guidelines drawing upon already 
available expertise. The Commission, for its part, will, as a 
matter of urgency, make a proposal for an amendment to Council 
Directive 91/414/EEC, in order to complete the environmental 
risk assessment of plant protection products derived from or 
consisting of genetically modified microorganisms. A fast track 
procedure for certain low risk plant protection products, 
including biological plant protection products, whether derived 
from GMMs or not, will be proposed. 
The rapid transposition of the workers' protection legislation 
by the Member States is a matter of urgency. 
An ongoing review of the biotechnological regulatory framework 
shall be carried out as new scientific knowledge and the 
emerging regulatory practice of major international competitors 
indicates that this is necessary or desirable. 
to identify and remedy the needs for strengthening scientific 
advice at its disposal. 
to enhance the rapid adoption of, in particular, the proposed 
specific programmes for biotechnology, biomedecine, health and 
agriculture and fisheries within the Life Sciences and Technologies 
area. The concentrated financial support for areas offering the 
highest potential returns on R&D and the establishment of networks 
to build upon Member States' research programmes are guarantees of 
further developing Europe's inherent strength in the area; 
to facilitate the development of small biotechnology firms, given 
their inherent advantages for developing new ideas and products. 
The Fourth Framework R&D Programme opens up opportunities for 
facilitating the participation of SMEs and for helping them to 
carry forward innovative applications of biotechnology, both within 
and outside science parks. Currently, the Commission is evaluating 
the need to create networks, and the type of networks most 
conducive to the optimal functioning of science parks. The 
continued development of a favourable investment climate, following 
existing Community guidelines, is also essential; 
to facilitate public understanding of biotechnology through the 
reinforcement of a number of outlined initiatives; 
to reinforce the profile of the Group of Advisers on the Ethical 
Implications of Biotechnology in order to clarify further value-
laden issues related to biotechnology. Biomedical ethical issues 
will be similarly identified and debated. 
14 
ANNEX 1 
STATE OF PLAY OF THE BIOTECHNOLOGICAL REGULATORY FRAMEWORK 
The Community's regulatory framework is composed of both "horizontal" 
and product legislation (medicinal products, additives used in animal 
nutrition, plant protection products, novel foods, seeds). Legislation 
on intellectual property protection also forms part of this framework, 
which is founded upon the following underlying principles: 
- Necessity: the Commission will propose legislation in this area 
only if it is shown to be necessary by a thorough examination, on 
a case-by-case basis, of the characteristics inherent in specific 
biotechnological applications. 
Efficient interaction: biotechnologically-derived products will be 
subject to only one authorisation and assessment procedure before 
being placed on the market. 
- Evaluation criteria: product evaluation will take place in 
accordance with the three established criteria of safety, quality 
and efficacy. The Commission will normally follow scientific 
advice. In exceptional cases, however, it reserves the right to 
take a different view in the light of its general obligation to 
take into account other Community policies and objectives. 
Adaptation to progress: the regulatory framework will be kept up to 
date with scientific and technical progress. This is of particular 
importance in a rapidly developing field such as biotechnology. 
- Standards: the development and existence of standards may be used 
to complement legislation, particularly on technical details of 
good practice and safety procedures. 
International obligations: the Commission will ensure that all 
decisions in the field of biotechnology will be in conformity with 
international obligations, in particular with the provisions 
resulting from the Uruguay Round negotiations. 
The state of play regarding relevant legislation is as follows: 
A. LEGISLATION ALREADY ADOPTED 
- "Horizontal" legislation 
Council Directive 90/219/EEC of 23 April 19902) which covers any 
contained use of genetically-modified microorganisms (GMMs), both for 
research and commercial purposes; 
Council Directive 90/220/EEC of 23 April 19903) on experimental and 
marketing-related aspects of genetically-modified organisms (GMOs), 
2) OJ No L 117, 8.5.1990, p. 1 
3) OJ No L 117, 8.5.1990, p. 15 
15 
which covers any R&D release of these organisms into the environment 
and contains a specific environmental risk assessment for the placing 
of any product containing or consisting of such organisms onto the 
market; 
Council Directives 90/679/EEC of 31 December 19904) and 93/88/EEC of 
29 October 19935), which provide a minimum requirement designed to 
guarantee a better standard of safety and health as regards the 
protection of workers from the risks of exposure to biological agents. 
Member States have transposed or are at the final stages of transposing 
Directives 90/219/EEC and 90/220/EEC, and competent authorities have 
been appointed in all Member States. Legislation has yet to be adopted 
in Greece and Luxembourg, and has nearly been completed in Spain. In 
Ireland, the specific regulations putting into effect the framework 
enabling legislation have still to be adopted. Over 250 research and 
development releases have been notified under Directive 90/220/EEC to 
the Commission and have taken place, the vast majority of which 
concerned plants. These releases were in Belgium (60), Denmark (11), 
Germany (10), Spain (8), France (78), Italy (18), the Netherlands (32), 
Portugal (4) and the United Kingdom (35). 
Three products have so far been cleared under the 90/220/EEC system. 
As regards Directives 90/679/EEC and 93/88/EEC, the transposition has 
yet to be widely realised. 
- Product legislation 
In respect of the other main part of the regulatory framework, namely, 
specific product legislation, the situation is as follows: 
Council Directive 93/114/EC, amending Directive 70/524/EEC on 
additives in feeding stuffs. This amendment introduced new categories 
of additives, including, among others, additives containing or 
consisting of GMOs into the existing legislation: the amendment will 
enter into effect as of 1 October 19946); 
Council Directive 93/41/EEC, repealing Directive 87/22/EEC on the the 
approximation of national measures relating to the placing on the 
market of high-technology medicinal products, particularly those 
derived from biotechnology: the legislation will enter into effect as 
of 1 January 19957). Under the 1987 procedure about 50 medicinal 
products of biotechnology have been approved ; 
Proposal for a Directive to amend Directive 91/414/EEC®) on the 
placing on the market of plant protection products: this Directive 
provides for a specific procedure for evaluating the environmental risk 
of GMM plant protection products to be included in the Directive. The 
Commission is preparing a Proposal to that end. 
The Commission has proposed to the Council to extend, for the lifetime 
of the milk quotas, the present moratorium on the placing on the market 
4) OJ No L 374, 31.12.1990, p. 1 
5) OJ No L 268, 29.10.1993, p. 71 
6) OJ No L 334, 31.12.1993, p. 24 
7) OJ No L 214, 24.8.1993, p. 40 
8) OJ No L 230, 19.8.1991, p. 1 
16 
and administration of bovine somatotropin (BST). The Council has 
adopted a Decision extending the moratorium for one year, to allow time 
for a detailed examination of all of the available information on 
BST9). 
B. PROPOSALS NOT YET ADOPTED 
Proposal for a Council Regulation concerning novel foods and novel 
foods ingredients10); 
Proposal to modify existing seed marketing directives, and in 
particular Directives 70/457/EEC and 70/458/EEC on the acceptance of 
varieties11) ; 
Draft Council Directive on Legal Protection of Biotechnological 
Inventions12); 
Draft Council Regulation on Community Plant Variety Rights13). 
9) OJ No L 332, 31.12.93, p. 72 
10) COM (92) 295 and COM (93) 631 Final 
11) COM (93) 598 
12) OJ No C 10, 13.1.1989, p.3 and COM(92) 589 final 
13) COM(90) 347 and COM(93) 104 
17 
ISSN 0254-1475 
COM(94) 219 final 
DOCUMENTS 
EN 15 
Catalogue number : CB-CO-94-237-EN-C 
ISBN 92-77-69522-6 
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