Modified proposal for a Decision of the European Parliament and of the Council on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and the developing countries, undertaken by a number of Member States and Norway
Date: 2003-04-29
Institutions: European Commission
Subjects: AIDS, developing countries, health policy, infectious disease, medical research, research programme, scientific cooperation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 29.04.2003
COM(2003) 223 final

2002/0211 (COD)

Modified proposal for a

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on Community participation in a research and development programme aimed at
developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis
through a long-term partnership between Europe and the developing countries,
undertaken by a number of Member States and Norway

(presented by the Commission)

2002/0211 (COD)

Modified proposal for a

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on Community participation in a research and development programme aimed at
developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis
through a long-term partnership between Europe and the developing countries,
undertaken by a number of Member States and Norway

1.

SUBJECT OF THE PROPOSAL

In 2001, 14 Member States  and  Norway  took  the  initiative  of  combining  their  research  and
clinical  intervention  work  to  combat  AIDS,  malaria  and  tuberculosis  in  the  developing
countries. This was the EDCTP research programme, intended to accelerate the development
and evaluation of  new  vaccines  and  medicines in  a partnership between Europe and  several
developing countries, particularly in Sub-Saharan Africa.

The Commission believed it would be in the Community's interest to be associated with this
initiative,  particularly  in  the  context  of  creating  the  European  Research  Area.  For  this  it
proposed  to  use  Article 169  of  the  Treaty,  which  provides  that,  in  implementing  the
framework programme, and in agreement with the Member States concerned, the Community
may make provision for participation in research programmes undertaken by several Member
States.

The Commission's proposal is designed to enable such Community participation, for which a
financial contribution of €  200 million is provided for within the 6th framework programme
of RTD (specific programme "Integrating and strengthening the European Research Area"). It
is worth noting that this proposal represents the first concrete use of Article 169 of the Treaty.

2.

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3.

3.1

BACKGROUND

On 28 August 2002, the Commission adopted its proposal [COM(2002) 474 final].

On  27 March  2003,  Parliament  adopted  35  amendments  at  first  reading,  reflecting
the compromise text approved following various tripartite interinstitutional contacts.

THE COMMISSION'S OPINION ON PARLIAMENT'S AMENDMENTS

General assessment

Parliament's changes are in line with the approach proposed by the Commission, and provide
useful clarifications for implementing the programme. The Commission can therefore accept
all of them.

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3.2

Examination of the amendments

Programme consistency and real partnership with the developing countries

Parliament  wants  to  emphasise  that  the  EDCTP  programme  is  consistent  with  the  various
Community activities and the Union's overall policy in this area, and to underline the wish for
a stronger partnership with  and the  genuine  involvement of the  developing  countries  in  this
initiative (recitals 8, 10, 15a, 16 and 19a). The Commission fully subscribes to this.

Taking account of co-existing infections and reference to the other "neglected" diseases

Parliament wants co-existing infections to be taken into account in the design of clinical trials
(recital 6 and Annex I), and the other "neglected" diseases linked to poverty to be taken into
account in the future initiatives to be launched (recital 14). The wording of these amendments
avoids any risk of widening the scope of the EDCTP programme, which needs to be confined
to  the  three  main  communicable  diseases  originally  targeted.  The  Commission  therefore
accepts this wording, which clarifies the text of its original proposal.

Integration of other countries into the EDCTP programme

Parliament  has  inserted  recital 11a  (new)  and  Article 5b  (new)  in  order  to  send  a  political
signal  to  the  associated  countries  and  to  third  countries  regarding  their  participation  in  the
EDCTP programme. Similarly, Article 5a (new) will enable the future Member States to join
the common structure after its creation with no procedural delay. The Commission cannot but
subscribe to these amendments.

Consolidating, reinforcing and guaranteeing the impact and success of the programme

Parliament  wants  more  explicit  incorporation  of  the  concepts  of  "promotion  of  technology
transfer"  to  the  developing  countries  and  encouragement  of  the  "participation  of  the  private
sector",  especially  industry,  as  well  as  the  concepts  of  "ethical  principles",  "best  clinical
practices" and "principles of gender" (recitals 12 and 19 and Article 2). It also specifies that a
significant part of the EDCTP budget is to be spent in the developing countries (recital 12).
The Commission considers these amendments to be relevant and acceptable.

Common structure and governance model / Intellectual property rights

The  amendment  relating  to  Article 2  further  clarifies  the  common  structure,  the  EDCTP
governance  model  and  the  real  and  effective  involvement  of  the  developing  countries.  In
addition, the reference to intellectual property rights should ensure the financial involvement
of  industry  on  favourable  terms  while  providing  the  guarantees  necessary  for  easy  and
affordable access to the results of the research activities and to the products emerging directly
from  them,  to  the  benefit  of  the  local  populations.  The  Commission  approves  of  these
clarifications. The same applies to the wording on intellectual property rights, which is well
balanced.

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Description of the governance model

Parliament  wishes  to  insert  a  new  annex  (Annex Ia)  containing  a  concise  description  of  the
model of governance of the EDCTP programme and its components. While the Commission
must  point  out  that  the  creation  of  the  common  structure,  and  in  particular  that  of  the
European  economic  interest  grouping  (EEIG),  is  a  matter  solely  for  the  Member  States  and
does not therefore constitute a precedent, it has no objection to raise regarding the substance
of the amendment, and can accept it.

Obligations to inform Parliament

With the changes to Article 5 and the insertion of Article 5c (new), Parliament wishes to draw
attention,  respectively,  to  the  additional  information  it  could  require  from  the  common
structure (Article 5) and to the reference to the need for a summary of EDCTP activities in the
annual  report  the  Commission  has  to  present  pursuant  to  Article 173  of  the  Treaty
(new  Article 5c).  The  Commission  considers  that  these  additions  and  changes  reflect
Parliament's wish to be fully informed of the progress and evaluation of EDCTP programme
activities, and it accepts them.

4.

CONCLUSION

By virtue of Article 250(2) of the EC Treaty, the Commission hereby amends its proposal as
specified above.

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