35 EU research and development programmes
| (a)
(35196)
12336/13
+ ADDs 1-2
COM(13) 493
(b)
(35201)
12367/13
+ ADDs 1-2
COM(13) 500
(c)
(35205)
12369/13
+ ADDs 1-2
COM(13) 498
(d)
(35206)
12370/13
+ ADDs 1-2
COM(13) 495
|
Draft Decision on the participation of the Union in a Research and Development Programme jointly undertaken by several Member States aimed at supporting research performing small and medium-sized enterprises
Draft Decision on the participation of the Union in the Active and Assisted Living Research and Development Programme jointly undertaken by several Member States
Draft Decision on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several member States
Draft Council Regulation on the Innovative Medicines Initiative 2 Joint Undertaking
|
| Legal base | (a) to (c) Articles 185 and 188 TFEU; co-decision; QMV
(d) Articles 187 and 188 TFEU; consultation; QMV
|
| Documents originated | (All) 10 July 2013
|
| Documents deposited | (a) 18 July 2013
(b) to (d) 19 July 2013
|
| Department | Business, Innovation and Skills
|
| Basis of consideration | (a) EM of 29 July 2013
(b) and (d) EMs of 31 July 2013
(c) EM of 1 August 2013
|
| Previous Committee Report | None
|
| Discussion in Council | No date set
|
| Committee's assessment | Politically important
|
| Committee's decision | Cleared
|
Background
35.1 Title XIX of Part Three of the Treaty on the Functioning
of the European Union (TFEU) provides the EU with a broad competence
to act in the field of research and technological development
with a view to:
- strengthening the EU's scientific and technological bases;
- creating a European research area within which
researchers, scientific knowledge and technology circulate freely;
- enhancing competitiveness within the EU, including
in industry; and
- promoting research activities where needed to
achieve policy objectives in other areas covered by the EU Treaties.
35.2 The objectives of EU action in the field of
research and development (R&D) are set periodically in multiannual
Framework Programmes. These Programmes are the EU's main instrument
for funding research. The Seventh Framework Programme for Research
and Technological Development will expire at the end of 2013 and
negotiations are drawing to a conclusion on a successor programme
— Horizon 2020 — which will establish the legal framework
and budget for EU expenditure on research and innovation for the
period 2014-20. Horizon 2020 identifies three priority areas
for EU funding — excellence in science, industrial leadership,
and societal challenges — which are intended to complement
and support the jobs and growth objectives set out in the Europe
2020 Strategy.[116]
35.3 All EU funding for research and innovation programmes
must be consistent with the objectives set in the overarching
Framework Programme, but EU support can take a number of different
forms. The EU may, for example, participate in collaborative
R&D programmes undertaken by several Member States (Article
185 TFEU) or establish joint undertakings (Article 187 TFEU).
Documents (a) to (c) — draft Decisions providing
for EU participation in collaborative R&D programmes
35.4 These draft Decisions are based on Article 185
TFEU and establish the rules governing EU participation in collaborative
research programmes involving several Member States as well as
the maximum amount of EU funding that may be made available from
the Horizon 2020 budget.
35.5 The first — document (a) — concerns
EU participation in the Eurostars Joint Programme. This Programme,
which was established in 2008, provides support for market-oriented
cross-border research projects carried out by partnerships involving
research-performing SMEs — those whose R&D activities
account for at least 10% of their turnover or occupy more than
10% of their full-time workforce. All EU Member States and five
associated countries (Iceland, Israel, Norway, Switzerland and
Turkey) take part in the current Eurostars Joint Programme which
is funded by a contribution from the participating countries and
a contribution from the EU capped at €100 million for the
period 2008-13.
35.6 The purpose of the draft Decision is to set
out the objectives for the successor to the Eurostars Joint Programme
— Eurostars 2 — and to authorise the EU to make
a financial contribution. The Programme will continue to support
SMEs pursuing cross-border research activities (although the partnership
may also include universities and research organisations) with
a view to accelerating the time taken to bring innovative technologies,
products or services to the market. The draft Decision specifies
that EU funding shall be equal to one third of the financial contribution
made by the participating countries and shall be capped at €287
million for the period 2014-20.
35.7 The Commission notes that Eurostars 2 will support
the specific objective on "Innovation in SMEs" under
the Industrial Leadership heading of the Horizon 2020 Framework
Programme and is the only programme specifically dedicated to
supporting the cross-border activities of research-performing
SMEs.
35.8 The second draft Decision — document (b)
— provides for EU participation in the Active and Assisted
Living Research and Development Programme. This Programme is
intended to build on the Ambient Assisted Living Joint Programme,
established in 2008 to provide research funding to develop and
bring to the market ICT-based products and services which enable
older people to remain active and independent for longer and enhance
their quality of life. The current Programme has a budget of
€600 million, of which up to €150 million is provided
from the EU budget and a similar amount from participating Member
States (including the UK). The remaining funding comes from private
sector participants.
35.9 The draft Decision authorises the EU to make
a financial contribution to the successor programme — the
Active and Assisted Living Research and Development Programme
— of no more than €175 million for the period 2014-20
and specifies that the EU's annual financial commitment to the
Programme shall not exceed the annual commitments made by the
participating States. The EU contribution will come from that
part of the Horizon 2020 Framework Programme addressing societal
challenges. The Programme will continue to focus on enhancing
the availability of ICT-based products and services to promote
active and healthy ageing and is intended to support market-oriented
research and innovation projects, particularly those involving
SMEs.
35.10 The third draft Decision — document (c)
— provides for EU participation in the successor to the
European and Developing Countries Clinical Trials Partnership
(EDCTP). The Partnership was first established in 2003 to help
defray the significant costs involved in the clinical development
and testing of new drugs and vaccines to combat the three main
poverty-related diseases — HIV/AIDS, malaria and tuberculosis.
Active funding for the Partnership ceased in 2012. An interim
evaluation carried out by independent experts in 2009 concluded
that the Partnership had helped to develop improved medical treatments
and research capacities in developing countries, provided training
opportunities for more than 400 African clinical researchers,
and contributed to the establishment of the Pan-African Clinical
Trials Registry and the African Vaccine Regulators Forum.
35.11 Notwithstanding these achievements, poverty-related
diseases still constitute a major obstacle to sustainable development
because of the absence of effective, safe and affordable medical
treatments, and investment in clinical research remains inadequate.
The Commission estimates that more than one billion people, including
400 million children, suffer from one or more poverty-related
diseases. HIV/AIDS alone kills an estimated two million people,
while malaria and tuberculosis together kill an estimated 2.2
million annually. The draft Decision authorises the EU to make
a financial contribution to a second Partnership Programme —
EDCTP2 — of no more than €683 million for the period
2014-20 and specifies that EU funding is intended to match the
financial contributions made by participating Member States.
The EU contribution will come from that part of the Horizon 2020
Framework Programme addressing health, demographic change and
wellbeing which comes under the heading of societal challenges.
The Partnership Programme will continue to focus on the development
of new medical interventions for HIV/AIDS, malaria, tuberculosis
and other poverty-related diseases and on building the capacity
of sub-Saharan African countries to conduct clinical trials.
Document (d) — draft Regulation establishing
the Innovative Medicines Initiative 2 Joint Undertaking
35.12 The draft Regulation is based on Article 187
TFEU and establishes a Joint Undertaking to implement the Joint
Technology Initiative on Innovative Medicines for the period 2014-24.
Joint Technology Initiatives ("JTIs") are public-private
partnerships which bring together a range of stakeholders to pursue
research activities in particular sectors. The JTI on Innovative
Medicines was first established in 2008 to strengthen collaboration
within the pharmaceutical sector and promote innovative research
into new medicines. The draft Regulation would continue the work
of the Innovative Medicines JTI, but would involve a broader range
of partners (including, for example, medical imaging and IT industries)
and seek to enhance cross-industry collaboration in achieving
the following objectives:
- increasing the success rate
for clinical trials on priority medicines identified by the World
Health Organisation;
- reducing the time needed to reach clinical proof
of concept in the development of medicines for immunological,
respiratory, neurological and neurodegenerative diseases;
- developing new therapies for diseases for which
there is a high unmet need (such as Alzheimer's disease) and limited
market incentives (such as antimicrobial resistance);
- developing diagnostic and treatment biomarkers
for diseases clearly linked to clinical relevance and approved
by regulators;
- reducing the failure rate of potential vaccines
through new biomarkers for initial efficacy and safety checks;
and
- improving the current drug development process
by providing support for the development of tools, standards and
approaches to assess efficacy, safety and quality of regulated
health products.
35.13 The Joint Undertaking would continue to be
funded by contributions from the European Federation of Pharmaceutical
Industries and Associations (representing the research-based pharmaceutical
industry), other members or associated partners supporting the
objectives of the JTI, and the EU. The EU contribution is capped
at a maximum of €1.7 billion and is intended to match the
funding provided by other participants in the Joint Undertaking.
The Government's view
35.14 The Minister for Universities and Science (Mr
David Willetts) strongly supports the continuation of the Eurostars
Joint Programme, adding that participation in collaborative projects
enables SMEs to access expertise which cannot be efficiently generated
in-house, reduce and share costs, improve their access to export
markets, and increase the speed at which they are able to respond
to rapidly evolving markets and technologies. He continues:
"The Government believes that
participation in Eurostars will benefit UK industry (especially
R&D performing SMEs) and researchers through increased European
collaboration in cutting-edge research and innovation. Eurostars
is the Technology Strategy Board's (TSB) preferred mechanism for
supporting UK SMEs in cross border collaborative research projects.
The TSB committed £12.5M to Eurostars between 2008-2013 and
subject to funding settlements have outlined an indicative budget
of £52.5M funding for Eurostars-2 between 2014-2020. The
Government would expect successful Eurostars projects to be in
a strong position to access the dedicated SME instrument proposed
in Horizon 2020, which includes support in accessing finance."[117]
35.15 The Minister also supports the Active and Assisted
Living Research and Development Programme which, he suggests,
will form a valuable part of the Health and Demographic Wellbeing
and ICT elements of the Horizon 2020 Programme. He highlights
parallels with the UK's Assisted Living Innovation Platform which
seeks to encourage technological, business and social innovation
to enable people to continue to live independent and healthy lives.
35.16 The Minister notes that clinical trials of
drugs and preventive vaccines against HIV, tuberculosis, malaria
and other neglected infectious diseases associated with poverty
are expensive and scientifically complex. He considers that the
second European and Developing Countries Clinical Trials Partnership
Programme will ensure "strategic coordination of research
activity that takes account of the global pipeline for new products,
and which will leverage the additional resources to make a significant
impact on the field."[118]
He adds that the Programme will be the main vehicle supported
by the UK's Medical Research Council and Department for International
Development for delivering large-scale, multi-centre intervention
trials for these types of diseases.
35.17 The Minister highlights the importance of the
UK biopharmaceutical industry and notes that many companies have
significant R&D and manufacturing operations in the UK. He
considers that JTIs can make an important contribution to the
implementation of the Horizon 2020 Framework Programme and that
the second Innovative Medicines Initiative is well aligned with
the Strategy for UK Life Sciences. He adds that UK-based pharmaceutical
companies, SMEs and universities have a high rate of participation
in the current JTI on Innovative Medicines and that awards received
by UK participants account for almost 30% of available funding.
35.18 Notwithstanding the Minister's support for
all four proposals, he makes clear that he will not agree to their
adoption until a formal agreement has been reached on the EU's
Multiannual Financial Framework for 2014-20.
Conclusion
35.19 The Horizon 2020 Programme will account
for a substantial proportion of the EU budget for 2014-20. These
proposals provide a useful initial indication of how elements
of the Programme will be implemented and the scale of the financial
contribution which the EU proposes to make. We note that all
of the proposals build on existing initiatives and programmes
and that the Government strongly supports their continuation.
We are therefore content to clear them from scrutiny.
116 See (33492) 17932/11, (33493) 17933/11 and (33495)
17935/11, HC 428-xlvii (2010-12), chapter 5 (18 January 2012). Back
117
See para 15 of the Minister's Explanatory Memorandum. Back
118
See para 21 of the Minister's Explanatory Memorandum. Back
| 
