Source: EURLEX
Language: en
Format: md

### **COMMISSION OF THE EUROPEAN COMMUNITIES**

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                         C0MC94) 219 final

                          Brussels, 01.06.1994

   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

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##### **`K`**

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#### **`C O N T E N T S`**

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                                   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 &`**

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**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`**

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**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**_

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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

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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 sciencebased 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 newlyproposed 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 preimplantation 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.

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_**International**_

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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**

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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

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   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 valueladen issues related to biotechnology. Biomedical ethical issues
will be similarly identified and debated.

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                                    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 1990 [2] ) which covers any
contained use of genetically-modified microorganisms (GMMs), both for
research and commercial purposes;

Council Directive 90/220/EEC of 23 April 1990 [3] ) 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

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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 1990 [4] ) and 93/88/EEC of
29 October 1993 [5] ), 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 1994 [6] );

 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 1995 [7] ). 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

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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
BST [9] ).

B. PROPOSALS NOT YET ADOPTED

Proposal for a Council Regulation concerning novel foods and novel
foods ingredients [10] );

Proposal to modify existing seed marketing directives, and in
particular Directives 70/457/EEC and 70/458/EEC on the acceptance of
varieties [11] ) ;

Draft Council Directive on Legal Protection of Biotechnological
Inventions [12] );

Draft Council Regulation on Community Plant Variety Rights [13] ).

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

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##### **ISSN 0254-1475**

## **COM(94) 219 final**

# **DOCUMENTS**

## **EN 15** **Catalogue number : CB-CO-94-237-EN-C** **ISBN 92-77-69522-6**

##### **Office for Offîdal Publications of the European Communities** **Lr2985 Luxembourg**