Opinion of the European Economic and Social Committee on the Proposal for a Council Regulation setting up the Innovative Medicines Initiative Joint Undertaking COM(2007) 241 final — 2007/0089 (CNS)
Date: 2007-10-24
Institutions: European Economic and Social Committee
Subjects: innovation, intellectual property, investment, joint venture, legal status, medicinal product, patent law, pharmaceutical industry, research policy

16.2.2008

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Official Journal of the European Union

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4.7.1
Autonomy and a ‘bottom-up’ approach rather than
standardisation. This means that any efforts tending towards
excessive standardisation should be rejected. Standardisation
prevents best practice from first being empirically established
through competition — which the ‘bottom-up’ principle basi-
cally allows — between different procedures, methods and
cultural approaches, and thus also prevents the advantages of
gradual progression from being tapped. This is the only way to
identify which approach is particularly effective, deserves further
funding and can serve as an example.

4.7.2
Existing mechanisms are adequate. Existing mechan-
isms at both the policymaking and programme and project
levels already provide sufficient and reasonable scope in this
regard. Further measures and rules can also be introduced or
adapted later, if there is a well-founded specific need.

Brussels, 24 October 2007.

4.8
Existing Community instruments for promoting and
coordinating R&D. On the other hand, the Committee recom-
mends that general, clear and comprehensible rules should be
developed to manage the wide range of Community instruments
for promoting and coordinating R&D. It would be very helpful
if the Commission listed and described (i.e. provided compre-
hensible instructions for use for) all
the instruments and
measures available to it for promoting and coordinating R&D
objectives. This would also show whether, among the growing
plethora of instruments, the purpose of each one is adequately
defined and the instruments properly separated, and whether
they can be easily understood by potential users and Commis-
sion staff or need to be overhauled to make them clearer.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

Opinion of the European Economic and Social Committee on the ‘Proposal for a Council Regulation
setting up the Innovative Medicines Initiative Joint Undertaking’

COM(2007) 241 final — 2007/0089 (CNS)

(2008/C 44/02)

On 11 June 2007 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 4 October 2007. The rapporteur was Mr Dantin.

At its 439th plenary session, held on 24 and 25 October 2007 (meeting of 24 October), the European
Economic and Social Committee adopted the following opinion by 118 votes to two, with two abstentions.

1. Conclusions and recommendations

The pharmaceutical industry is quite rightly considered
1.1
as a key strategic sector, and its products are crucial to the
health and well-being of European citizens. It is also important
from the point of view of employment.

1.2
In the light of this situation, and of the decline of phar-
maceutical research in Europe, the decision to set up the IMI JU
(Innovative Medicines Initiative Joint Undertaking) is very much
justified. The Committee welcomes and supports this decision,
in particular because it involves a genuine partnership between
the public and private sectors.

The key aspects on which the role of the IMI JU should

1.3
be focused include the following:

— improving the prediction of the safety and the efficacy of
new drugs, especially in the early development phases before
clinical trials begin;

— tackling the waste of resources caused by the current dupli-
cation of research efforts, both in the private and public
sector,
jointly developed knowledge
management systems;

through the use of

— bridging skills gaps by providing training to ensure that the
skills of professionals match those required by the pharma-
ceutical research sector;

— providing a focal point for developing the required synergies
by enabling cooperation between research initiated by the
IMI JU and national and European activities, thus contri-
buting to the establishment of the European Research Area
in this sector.

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The EESC welcomes the wide-ranging consultation that
1.4
preceded the drafting of
this regulation and supports the
proposal that an annual report on the results of the IMI JU be
submitted. However, the Committee regrets the absence of a
detailed assessment of the operation and the results achieved by
the former European Technology Platforms.

Thanks to an innovative financing method,

2.5
the IMI
should help to increase private investment in R&D, speed up the
transfer of knowledge between universities and businesses, and
facilitate the participation of SMEs in European research.

In the light of the multiple financing system that has
1.5
been set up and of
the significant volume of Community
resources involved, the EESC believes that it would be appro-
priate to better define the use and allocation of the end products
of the research in question, in particular as regards intellectual
property and the issue of patents.

1.6
The EESC believes that it would be helpful to think
about mechanisms conducive to returns on European invest-
ments. Similarly, it would be desirable to provide for the profits
generated by research to be assigned to investments located
within the EU.

3. Background

3.1
Over the last ten to fifteen years, pharmaceutical research
in Europe has gradually been falling behind. Whilst investment
in R&D increased by a factor of 4,6 between 1990 and 2005 in
the USA, the equivalent factor in Europe was just 2,8. Businesses
are increasingly transferring their cutting-edge research units to
countries outside the European Union, mainly the United States
and, more recently, in Asia.

This

situation could have grave consequences

3.1.1
for
European competitiveness, as innovation and cutting-edge tech-
nologies are among the keys to long-term economic growth.
This was one of the main reasons behind the decision to create
a JTI on innovative medicines.

2. Introduction

2.1
The purpose of the proposed regulation under review is
to launch the very first public-private partnerships in the area of
R&D. It defines one of the first two Joint Technology Initiatives
(JTI). This involves innovative medicines (1).

2.2
The aim of JTIs is to allow industry, research organisa-
tions, Member States and the Commission to pool some or all
of their resources into selected research programmes.

Unlike the traditional strategy, which involves providing
2.3
public funding for projects on a case-by-case basis, JTIs involve
large-scale research programmes with shared strategic research
goals. This new approach is expected to create a critical mass
for European research and innovation, consolidate the scientific
community in key strategic areas, and harmonise the funding of
projects so that research findings can be put
to use more
quickly. JTIs are aimed at key areas where the current instru-
ments have neither the scale nor the speed to keep Europe
ahead of global competition. These are areas where national,
European and private funding of research could bring significant
added value, inter alia by stimulating an increase in private R&D
expenditure.

2.4
The JTI on the Innovative Medicines Initiative (IMI) seeks
to support the development of new knowledge, new instru-
ments and new methods that will facilitate the faster supply of
safer and more effective medicines.

(1) Another JTI involves embedded computing systems. This is covered by

opinion INT/364.

3.2 Whereas governments draw up their plans at national
level, industry has a global vision. Large countries such as the
United States and China have a unified investment strategy that
enables businesses to better plan and attract resources.
In
Europe, national governments do not coordinate their R&D
investment
expend
resources adapting their activities to local circumstances.

and pharmaceutical

companies must

3.3
A Community legislative act could establish a targeted,
coherent R&D programme that could draw on all the sources of
R&D investment (public and private) at European level and thus
create a more favourable environment for the European Union.
This is the purpose of the regulation under review.

4. The Commission's proposal

the provisions of

4.1
The proposed regulation setting up the Innovative Medi-
cines Initiative Joint Undertaking [COM(2007) 241] arises out
of
the 7th Framework Programme (FP7)
covered by Decision 1982/2006/EEC. This provides for a Com-
munity contribution towards the creation of long-term public-
private partnerships at European level in the area of research.

4.2
These partnerships take the form of Joint Technology
Initiatives (JTIs) and arise from the work of the former European
Technology Platforms (ETPs).

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4.3
The Council, in its Decision No 971/2006/EEC on the
Specific Programme ‘Cooperation’, emphasised the need to set
up public-private partnerships and identified six areas in which
the creation of joint technology initiatives is appropriate with a
view to relaunching European research. These are:

4.9
The IMI joint undertaking is to be considered as an inter-
national body with a legal personality within the meaning of
Article 2 of Directive 2004/17/EEC and Article 15 of Directive
2004/18/EEC. Its seat will be in Brussels and its activities will
cease in December 2017. This period may be extended by the
Council.

— Hydrogen and fuel cells

— Aeronautics and air transport (2)

— Innovative medicines

— Embedded computing systems (3)

— Nanoelectronics (4)

— GMES (global monitoring for environment and security).

4.4 Within the context of this general strategy, the regulation
proposed by COM(2007) 241 under review provides for the
implementation of the Joint Technology Initiative on Innova-
tive Medicines (IMI JTI) by means of the establishment of an
Innovative Medicines Initiative Joint Undertaking (IMI JU).

4.5
In accordance with the Commission's aims, the establish-
ment of an Innovative Medicines Initiative Joint Undertaking is
expected to facilitate the involvement of stakeholders who are
not currently able to carry out costly and complex research
programmes (universities, SMEs, hospitals, public authorities,
etc.).

The IMI JU will be founded as a joint undertaking, its
4.6
founder members being the European Community represented
by the Commission and the EFPIA (European Federation of
Pharmaceutical Industries and Associations), and set up as a
Community body by a Council Regulation under Treaty
Article 171. The Member States and the countries involved in
the 7th Framework Programme will be able to join it, as will
any legal entity involved in R&D, provided that it makes a finan-
cial contribution.

between

This programme will benefit

4.7
from a budget of
EUR 2 billion, to be invested over a period of seven years, split
equally
from the
7th Framework Programme in accordance with the provisions
of Article 54 of Council Regulation 1605/2002) and the busi-
nesses that belong to the EFPIA, who will provide most of the
staff, equipment, consumables, etc.

the Commission

(resources

4.8
The IMI JU will support research activities conducted in
the Member States and in the countries associated with FP7. The
entire Community contribution of one billion euro will be set
aside for small and medium-sized enterprises and universities
for applied pharmaceutical research. The participating large
enterprises will invest an equal sum by bearing the costs of their
part of the research and by involving SMEs and universities in
this.

(2) INT/369.
(3) INT/364.
(4) INT/370.

5. General comments

5.1
The pharmaceutical industry is quite rightly considered,
in the report entitled Creating an innovative Europe, as a key
strategic sector, and its products are crucial to the health and
well-being of European citizens. In essence, the effective and
proper use of pharmaceutical products helps to improve quality
of life.

The pharmaceutical industry also provides a lot of jobs
this sector employed 612 000 people,

5.2
in Europe.
103 000 of whom were highly skilled in scientific research.

In 2004,

Role of the IMI JU

5.3
The main justification for the establishment of the IMI JU
is the need to address Europe's decline in the area of pharma-
ceutical research and to reverse this trend, which was already
observed in the Commission Communication dated 1 July 2003
entitled A Stronger European-based Pharmaceutical Industry for the
Benefit of the Patient — A Call for Action.

5.4
To achieve this, changes in the traditional methods of
bilateral cooperation are necessary. A new approach at European
level is now needed, bringing about direct cooperation between
universities, relevant SMEs, public bodies and the pharmaceu-
tical industry in connection with the financial provisions set out
in the 7th Framework Programme.

The key aspects on which the role of the IMI JU should

5.5
be focused are as follows:

— improving the prediction of the safety and the efficacy of
new drugs, especially in the early development phases before
clinical trials begin;

— tackling the waste of resources caused by the current dupli-
cation of research efforts, both in the private and public
sector,
jointly developed knowledge
management systems;

through the use of

— bridging skills gaps by providing training to ensure that the
skills of professionals match those required by the pharma-
ceutical research sector;

— providing a focal point for developing the required synergies
by enabling cooperation between research initiated by the
IMI JU and national and European activities, thus contri-
buting to the establishment of the European Research Area
in this sector.

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6. Specific comments

6.1
The EESC is pleased to note the wide-ranging consulta-
tion that preceded the drafting of this regulation and supports
the implementation of appropriate training programmes aimed
at providing the necessary skills in a sector that is crucial to the
European economy and to citizens' quality of life.

As stated under point 4.2, JTIs arise out of the work of
6.2
the former European Technology Platforms (ETPs). However,
these latter rarely achieved their stated aim of strategically
relaunching research in Europe. The creation of JTIs is based on
this acknowledgement of partial failure regarding the role of the
ETPs, which was essentially to make a key contribution to
industry in the area of competitiveness.

6.2.1
In the light of this, the EESC regrets the absence from
the Commission proposal of a more detailed outline of the
work previously carried out by the European Technology Plat-
forms (ETPs);
the results are not
mentioned, and there are no bibliographical references.

there is no assessment,

6.2.2
the EESC
For this reason, with regard to the JTIs,
welcomes the proposal that an annual report, giving an assess-
ment of the results and progress achieved, be submitted.

6.3
That said, the EESC welcomes the creation of the joint
undertaking for the innovative medicines initiative. In general
terms, it has the necessary features for relaunching pharmaceu-
to a genuine partnership
tical

research in Europe thanks

Brussels, 24 October 2007.

between the public and private sectors. This initiative is consis-
tent with the aims of the Lisbon strategy, which provides for the
investment of 3 % of GDP in R&D activities, two-thirds of
which are to come from the private sector.

6.3.1
However, in the light of the multiple financing system
that has been set up and of the significant volume of Com-
munity resources involved, the EESC believes that it would be
appropriate to better define the use and allocation of the end
products of the research in question. To this end, the issue of
patents and intellectual property as defined in the regulation
and its appendix, which limits itself to setting out principles,
ought to be more precise and more explicit, lest it become a
sticking point in the smooth implementation of the IMI JI.

the large pharmaceutical companies

6.3.2 Most of
that
operate in Europe have a global dimension. Here too, because of
the significant Community funding, it would be appropriate to
think about mechanisms that promote a return on European
investment. From this perspective, whilst taking care not to
create barriers to the use of innovative medicines in non-EU
countries, the regulation could contain provisions for all of the
phases of research and the production of molecules based on
such research to take place within the EU. Similarly, it would be
desirable for these same provisions to state that the profits
generated by research funded by the IMI JI should be assigned to
investments located within the EU.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS