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Contents
EU Health Research Policies
a. MEPs formally oppose cuts in Horizon 2020
b. Outcomes of Seminar ‘Business for research’
c. Update Commission working group on disruptive innovation in health
d. Scientific advisor post could still disappear
e. Call for proposals on Diagnostics and intervention in chronic non-communicable diseases
f. WHO calls for increased transparency in medical research
g. Consultation on the Role of Research in Global Food and Nutrition Security
EU Public Health Policies
a. Update on TTIP negotiations-medical devices
b. MEPs want certain health areas to be excluded from TTIP
c. Update HTA network
d. Call for papers on inter-sectorial action for Public Health Panorama publication
e. Parliamentary question on Health cards and information on blood type and allergies
Environmental Health
a. European Parliament update on air pollution
b. Commission public consultation on the effort of Member States to reduce their greenhouse gas
emissions
c. Update Atopica project: allergy to ambrosia, a significant public health problem
Annexes
a. Parliamentary questions
b. EU events tracker
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EAACI
EU Affairs Monitoring Report
Volume 11 – April 2015

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EU Health Research Policies
a. MEPs formally oppose cuts in
Horizon 2020
On 20 April, the ITRE Committee of the European
Parliament adopted its position on Juncker’s
investment plan EFSI, which foresees to use 2.7
billion euro from Horizon 2020, the EU research
programme.
The ITRE Committee is in charge of research
policies within the Parliament and it was given
exclusive competence on the matter of the
relocation of funds from Horizon 2020 to EFSI. The
Committee members formally opposed this move,
backing instead an alternative scheme to provide
EFSI with funds.
EARTO, representing 350 European Research &
Technology Organisations, sent an open letter to
the Parliament to “fully support” its position and
encouraging MEPs to continue to protect Horizon
2020 during the inter-institutional negotiations.
The Parliament has now to convince the
Commission and the Council that this is the right
way forward. However, Commission Vice President
Jyrki Katainen has already declared that there is
not much room to fund EFSI other than the one
proposed by the Commission
b. Outcomes of Seminar ‘Business
for research’
The outcomes of the Seminar ‘The Business for
research: Enabling policies for the medicines of
tomorrow’ were released in April in the form of a
White Paper.
The seminar took place in Brussels on March 3rd,
hosted by MEPs Philippe De Backer and Sirpa
Pietikäinen.
This paper has a special focus on neurological
diseases but also makes the case for continued
investment in medical R&D, and patient access to
state-of-the-art therapies, while maintaining
sustainable healthcare budgets.
c. Update Commission working
group on disruptive innovation in
health
The Commission published in April the minutes of
the 2nd Working Group meeting on ‘Disruptive
Innovation in Health Care. Considerations for the
future.’ The group works within the frame of the
Expert Panel on Effective Ways of Investing in
Health. The meeting was held end of March.
The main outcome of the meeting was the change
of terms: instead of using Disruptive Innovation
(DI) in its opinion, the experts agreed to introduce
the term High Value Innovation (HVI). The
definition and taxonomy will be further developed.
 Members of the working group are:
 Pedro Barros (Chair)
 Walter Ricciardi (Rapporteur)
 Margaret Barry
 Werner Brouwer
 Muir Gray
 Bengt Jönsson
 Fernando Lamata
Orsy Nagy is attending the meetings on behalf of
DG Sante of the European Commission.
d. Scientific advisor post could still
disappear
According to a press article published in EurActiv
on 23 April, the position of Chief Scientific Advisor
of the European Commission may finally be
dropped. Actually, the post "ceased to exist" as the
Barroso II Commission mandate came to an end in
November last year, but was later reinstated by the
new Commission following pressure from MEPs
and research organisations.
The Commissioner for Research Carlos Moedas,
has been asked by Juncker to present a report
before the summer outlining how a new chief
scientific advisor could work with the EU executive.

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However, an EU official told EurActiv that the
position could be scrapped if no candidate fits the
job description (to be defined by Moedas in his
report).
e. Call for proposals on
Diagnostics and intervention in
chronic non-communicable
diseases
The INNO INDIGO project launched its EU-India
Joint Call on 'Diagnostics and interventions in
Chronic non-communicable diseases' on 13 April.
Deadline for submission of proposals is 22 June
2015.
The sub-thematic areas are:
 Development of tools and technologies for the
diagnostics of chronic non-communicable
diseases
 Research and innovation within interventions for
chronic non-communicable diseases
 Mechanisms in chronic non-communicable
diseases
Research and development projects will be funded
for a period of three years. Each consortium
applying for this call should consist of at least 3
partners, 1 from India and 2 from two different
European countries participating in the Call
(Norway, France, Belgium, Estonia, Germany,
Portugal).
Applications may be submitted by academics,
higher education institutions and/or research
organisations. SMEs are also eligible depending
on national regulations.
For more information on the call, pleas click here.
f. WHO calls for increased
transparency in medical research
On 14 April, WHO issued a public statement calling
for the disclosure of results from clinical trials for
medical products, regardless of the results. The
move aims to ensure that decisions related to the
safety and efficacy of vaccines, drugs and medical
devices for use by populations are supported by
the best available evidence.
WHO’s call for disclosure includes older
unreported clinical trials, the results of which may
still have an important bearing on scientific
research today. WHO also reaffirms the need for
all clinical trials to be registered on a WHO primary
clinical trial registry so that they can be accessible
through the International Clinical Trials Registry
platform.
g. Consultation on the Role of
Research in Global Food and
Nutrition Security
The European Commission has launched an
online consultation on the role of research in global
food and nutrition security. The aim of the
consultation is to gather the views of stakeholders,
especially from the scientific community.
The questions of the survey are based on a
discussion paper which mentions, amongst the
examples of research areas: risk assessment and
management strategies for complex whole foods of
microbial, plant or animal origin (including
identifying allergenicity risks).
The consultation will remain open for contributions
until the 1st September 2015.
EU Public Health Policies
a. Update on TTIP-medical devices
9th
Round of TTIP
The 9th round of the Transatlantic Trade and
Investment Partnership (TTIP) negotiations
between the US and the EU took place in New
York on 20-24 April. Please see below the main
highlights of the round:
 Progress has been made on the regulatory
pillar. Negotiators are confident to be able to
reach an agreement by the end of the year.

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 Discussion of a new US proposal on removal
of technical barriers to trade, towards for
example mutual recognition of testing and
certification of products (to eliminate
duplication of testing requirements, but also to
set a model for third countries)
 Medical devices: exchange of views on the
potential mutual recognition of quality
management system audits
 No intention of excluding the chemical sector
from negotiations despite NGOs and MEPs
criticism.
 The 10th round will be in Brussels before the
summer break and a joint review on regulatory
cooperation is expected after the summer
EU position on medical devices for TTIP
The European Commission has made public its
long awaited position paper on medical devices for
the Transatlantic Trade and Investment
Partnership (TTIP) negotiations. The document
explains and expands on the topics treated in the
fact sheet on TTIP and medical devices, published
some months ago. In general terms, the paper
provides a clearer and more consistent view of the
Commission position as what medical devices in
TTIP regards.
The position paper identifies three key areas that
an annex in medical devices should cover
according to the Commission:
 Recognition of the manufacturers’ quality
management systems (QMS) audits
 Convergence of systems for identifying
and tracing medical devices: Unique
Device Identification (UDI)
 Convergence of models for marketing
submission: Regulated Product
Submission (RPS)
The paper recognizes that these three work items
presume the exchange of confidential information
between regulators, an aspect that was not
mentioned in the fact sheet. Another aspect
emphasised in the paper is the need to reinforce
the international mechanisms of cooperation
already in place
Other news on TTIP
On 20th April, Trade Commissioner Cecilia
Malmström presented the results of a survey
conducted by the Commission on current
administrative burdens in the trade between the
EU and the US. One of the main burdens identified
by industry was the labelling for chemicals. The
Commission states that this may be linked to the
fact that the US has not fully implemented the
relevant UN Globally Harmonized System (GHS)
standard for classification and labelling of
substances.
Trade Commissioner Cecilia Malmström is
expected to brief MEPs on her plans for a reform of
the ISDS (Investor-State-Dispute-Settlement)
mechanism on 6-7 May at the INTA Committee
meeting. Draft agenda here.
b. MEPs want certain health areas
to be excluded from TTIP
The ENVI Committee of the European Parliament,
responsible for health policies, voted on 14 April its
opinion on TTIP. MEPs have asked for five health-
related areas to be excluded from the trade deal
between the US and the EU:
a. Public health services
b. Genetically-modified organisms
c. Use of hormones in the bovine sector
d. Chemical legislation
e. Cloning
The ENVI report calls also for the safeguarding of
the 'precautionary principle' in regulatory
cooperation, further transparency in the
negotiations and opposes the investor-state
dispute settlement (ISDS).
c. Update on HTA network
The Commission published in April the meeting
documents of the 4
th
meeting of the HTA network,
which took place on 23 March. Amongst the
presentations, of special interest might be HTA for
Medical Devices -expectations and limits of the EU

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cooperation on HTA, the view of med tech Industry
by Eucomed and Cocir representatives, as well as
Mapping HTA structures and processes in the
Member States by the HTA Network Secretariat;
Safe and Timely Access to Medicines for Patients
(STAMP) EC Expert Group by DG SANTE of the
European Commission; and Innovative Medicines
Initiative (IMI) projects relevant for HTA by IMI.
d. WHO-Europe: Call for papers on
inter-sectorial action for Public
Health Panorama
Public Health Panorama is the new public health
journal of WHO Europe. The journal will have a
themed issue on inter-sectorial action in public
health and is seeking authors for contributions.
Authors may submit papers on scientific research
or practice-oriented case studies; manuscripts can
be submitted in either Russian or English and
deadline for submissions is 14 June.
Priority will be given to papers that can
demonstrate outcome-oriented approaches,
successful practices, innovative solutions and
lessons learned from experience. For more
information on the call and to apply, please click
here.
e. Parliamentary question on Health
cards and information on blood
type and allergies
In April, a parliamentary question on health cards
containing information on blood type and allergies
was answered by the Commission:
Question tabled by MEP Enrico Gasbarra
Health insurance cards are a great help to EU
citizens, providing access to healthcare services in
their own Member States and doubling up as a
European Health Insurance Card (EHIC) ‐ the
replacement for the old E-111 card - which
guarantees the bearer access to healthcare
elsewhere in the EU, under the rules of each
Member State.
Although the establishment of a European health
insurance network covering all EU citizens is a
considerable achievement in itself, would the
Commission agree that the system could be even
more effective if the card's cross-border chip also
contained basic health information, such as the
cardholder's blood type and any allergies he or she
may have.
Answer given by Commissioner Thyssen on
behalf of the Commission
With the introduction of the European Health
Insurance Card (EHIC) the idea was put forward to
enable the use of an electronic medium at a later
stage, which may contain the EHIC dataset.
The best way to introduce an electronic EHIC,
including the options to include additional
information, such as blood type or allergies, was
subject to a thorough assessment in cooperation
with experts from Member States within the
framework of the Administrative Commission for
the Coordination of Social Security Systems.
The investigation came to a preliminary conclusion
that a physical card-based approach may be too
narrow, and the discussion should be broadened
to cover other means of electronic exchange of
EHIC datasets. This examination is currently
ongoing.
Environmental Health
a. European Parliament update on
air pollution
MEPs debate on 2025 air pollution goals
On April, the ENVI Committee of the European
Parliament (responsible for environment and health
policies) debated on the Commission’s proposal to
update the National Emission Ceilings (NEC)
Directive. The proposal includes binding targets for
2020 and 2030, but a majority in ENVI wants also

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binding intermediate targets for 2025, according to
the debate.
ENVI’s MEP responsible for the dossier, Julie
Girling, stated that binding intermediate limits
would ensure that member states meet their 2030
targets to reduce air pollution.
MEP Peter Liese of the centre-right EPP group
dismissed binding intermediate targets, but his
colleague Karl-Heinz Florenz argued in favour of
such targets, backing Ms. Girling reasoning.
Amendments were tabled until 21 April and a vote
is scheduled for 15 July. The Commission has said
that it will look into the possibility of amending its
original proposal after that to align it more closely
with the EU’s 2030 climate and energy legislation.
The Parliament on reduction of pollutant
emissions from road vehicles
On 6 May, the ENVI Committee considered the
draft report on the Commission’s proposal for a
regulation on reduction of pollutant emissions from
road vehicles. The Commission proposal focuses
on emission calculations and internal procedures
to implement the regulation. The draft report was
conducted by MEP Albert Deß.
Mid-April, the European Parliamentary Research
Service (EPRS) published an initial appraisal of the
European Commission's Impact Assessment
accompanying the proposal. The Parliament
research service has found 6 specific problem
areas within the Commission’s work.
b. Commission public consultation
on the effort of Member States to
reduce their greenhouse gas
emissions
The European Commission has launched a public
consultation on the preparation of a legislative
proposal on the effort of Member States to reduce
their greenhouse gas emissions to meet the
European Union's greenhouse gas emission
reduction commitment in a 2030 perspective. The
consultation will be open until 18 June.
c. Update Atopica project: allergy
to ambrosia, a significant public
health problem in Europe
EU-funded project Atopica is showing that allergy
to Ambrosia artemisiifolia L. - common ragweed -
is likely to become a significant public health
problem throughout Europe.
According to the coordinator of the project, the
expected changes in climate and land use will help
this invasive alien species to spread, creating
many more — or more severe — cases of allergy,
and add to the burden on health care systems.
In April, the Commission answered a
Parliamentary question by MEP Béla Kovács, who
warned against the inclusion of ragweed under the
EU list of Invasive Alien Species. Commissioner
Vella answered that ragweed was unintentionally
introduced from North America to Europe in the
mid-19th century. According to the Commissioner,
it is causing allergic asthma and allergic rhinitis
involving medical costs worth EUR 118 to 763
million per year and workforce productivity loss
worth EUR 0.05 to 1.36 billion per year.
Annexes
a. Parliamentary questions
Questions answered in April:
Question E-003893/2015:
CYTOSPACE experiment and closer monitoring of
activities at national level
Question E-003233/2015:
The health costs of endocrine disrupting chemicals
Question E-003896/2015:
Orthostatic Tolerance experiment and commitment
to ensure the implementation of Horizon 2020 in
the most efficient and effective way possible
Question E-003490/2015:
Reduction of funding for Horizon 2020 programme

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Question E-003668/2015:
Adverse events linked to use of medicines
Question E-002572/2015:
IT-based identification of patient data throughout
the EU
Question E-000193/2015:
Transfer of responsibility for medical technologies
to DG ENTR
Question E- 002273/2015:
Social attitudes towards vaccination, and vaccine
uptake
Question E- 002582/2015:
Bisphenol A, studies and precautions
Question E-002376/2015:
Suppressed report on the dangers of endocrine
disruptors
Question E- 002220/2015:
Restrictions on access to medicines that can save
lives
Question E- 002018/2015:
Damage to the environment and to human health:
the 'ex Legnochimica' site in Rende, Italy
Question E-001940/2015:
Cuts to the Horizon 2020 programme
Question E-000988/2015:
Funding cuts for the European Institute of
Innovation and Technology and the European
Research Council
Question E-002631/2015:
Checks on generic drugs
Question E-004254/2015:
Sugar levels in milk-based drinks for young
children
Question P-004285/2015:
EFSI - Detailed breakdown of cuts to Horizon 2020
Question E-004185/2015:
EFSI/Horizon 2020
Question P-003632/2015:
Financing the European Fund for Strategic
Investments (EFSI) at the expense of Horizon
2020
Question E-003295/2015:
Horizon 2020 and the European Fund for Strategic
Investments
Question E-003668/2015:
Adverse events linked to use of medicines
Question E-002950/2015:
Ambrosia artemisiifolia
Questions tabled in April:
Question E-004192/2015:
Safeguarding the objectives of Horizon 2020 and
Connecting Europe Facility (CEF) under the
European Fund for Strategic Investments (EFSI)
programme
Question E-003965/2015:
Operation of the common system of identification
of medicinal products in the EU
Question E-004181/2015:
European Patients Ombudsman
Question E-003832/2015:
Barriers to the access of generic medicines on the
internal market
Question E-004193/2015:
EFSI investment in fundamental research
Question E-004835/2015:
Exempting medical e-consultations from VAT
Question E-004688/2015:
Vaccination of children - the impact on the child's
health
Question E-004699/2015:
Compulsory vaccination of children - impact on
citizens' health
Question E-004856/2015:
Access to medication and medical care
Question E-005018/2015:
Problems with hospital treatment in the Prefecture
of Heraklion due to the healthcare policies
imposed under the memorandum in Greece
Question E-005071/2015:
Five pesticides declared potentially carcinogenic
Question E-005585/2015:
Monitoring the presence of pesticides in the
European Union
Question E-005800/2015:
Acrylamide
Question E-006098/2015:
Link between insecticides and contraction of
illnesses
Question E-006190/2015:
Pre-packaged meals for food intolerance sufferers
Question E-005823/2015:
Problems with disposable nappies
Question E-006468/2015:
Medicines banned in other countries are marketed
in Romania
b. EU events tracker
 15 May, A food and health research
infrastructure for Europe, Milan, Italy
 14 May, New York Academy of Sciences two-
day event “Human health in the face of climate

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change: Science, medicine and adaptation” in
Barcelona, Spain.
 18 May. The Belgian Royal Academy Of
Medicine hosts an event on Environmental
idiopathic intolerance: What role for EMFs and
multiple chemicals?
 18 May, The Health 2.0 Europe Conference is
held in Barcelona during three days.
 22 May, Horizon 2020 event on “Science with
and for Society 2015”, Brussels
 27 May, re-launch of The MEP Friends of the
Liver group , Brussels
 27 May, The European Federation for Medical
Informatics (EFMI three-day event on “Digital
healthcare empowering Europeans” in Madrid
 28 May, workshop of the European Network of
Paediatric Research at the European
Medicines Agency
 3 June, DG SANTE Conference 'Innovative
Financing Opportunities for Active & Healthy
Ageing', Brussels
 23 June, PALANTE Final Conference:
Empowering Patients through eHealth - the
European Evidence, Brussels