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July
2006 - Issue 14
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EuropaBio celebrated this year on
the 30th May 2006 in
Brussels its 10-year anniversary
In view of this
event and in order to give you an idea of EuropaBio’s annual
activities and achievements, we are delighted to inform you that
the the EuropaBio Annual Report and the Critical I study and
short film are on display, for online consultation or hard
copies can be ordered free of charge from the following address:
http://www.europabio.org/form-2006.h
Brussels Day October 11th
EuropaBio, the
European Association for Bioindustries, is organising the
Brussels Day event
from 10 to 11 October 2006.
Brussels Day is a national outreach event where key CEOs from
different European countries such as France, U.K., Portugal,
Spain, Finland, Sweden, Ireland, Belgium and the Netherlands
will meet their national representatives from Permanent
Representations, European Parliament and media. Each national
delegation will include the head of the national biotech
industry association and two or three CEOs of biotech SMEs.
Contact Alina Cornea
for more information
a.cornea@europabio.org
Finland
takes over EU Presidency
Emphasis
will be on innovation.
Finnish Presidency website:
www.eu2006.fi
Comitology – MEPs get
right to block decisions
NEW rules giving MEPs the same
powers as the Council of Ministers over implementing legislation
could come into force by the autumn under a deal struck by the
Austrian presidency. The agreement means that MEPs will call a
halt to its practice of imposing four-year review, know as
sunset clauses, on a range of legislation including new
financial services laws. UK Socialist Richard Corbett who led the
Parliament’s negotiating team, called the agreement “a huge
breakthrough” for MEPs as it gave them the right to block
decisions taken by the Council or the European Commission on
secondary or delegated legislation. He predicted that the new
deal could apply from July or September depending on when the
Parliament and Council had completed their approval process.
The deal concerns legislation approved under the so-called
comitology procedure where decisions on implementing rules for
primary legislation are delegated to hundreds of committees
chaired by the Commission and made up of member states’
representatives. These committees deal with thousands of
decisions on mainly technical rules each year. (Editor’s
notes-this applies to for example all GMO and pharmaceutical
approvals). The Parliament’s frustrations over its rights in the
procedure date back 20 years but the issue has come to a head
over the past 20 months as MEPs have sought to strengthen their
powers. Under the deal, the Parliament will have three months to
object to Commission proposals and refer them back for changes.
Until now, only Council could block the proposals. “The system
lacked transparency and democratic control,” said Corbett. In
return, MEPs have agreed that they will not normally impose a
”sunset clause” on legislation, which has been through the
comitology procedure. Having reached a deal, the Parliament will
now unblock funding for committee meetings.
Source by Simon Taylor – European Voice
simontaylor@economist.com
See also
under Healthcare Council for more on comitology
Change
in Verheugen’s Cabinet
Nils Behrndt
former head of unit of the DG Enterprise’s Pharmaceutical Unit
is now working for the cabinet of
Verheugen and is responsible
for pharmaceutical and biotechnology policies.
http://ec.europa.eu/staffdir/plsql/gsys_fonct.properties?pLang=FR&pSernum=732915
EuropaBio sets the standards for an efficient Biotechnology
strategy
EuropaBio welcomed the initiative of
the Austrian and Finnish Presidencies to bring together
industry, the EU institutions, and Member States to discuss the
EU’s Life Sciences and Biotechnology Strategy and policy issues
at a Round Table in Helsinki on 20th June 2006. The
Round Table, that was the fourth in a series, brought together
some 150 competent biotech competitiveness authorities to
examine the progress made to date and new policies that are
required to advance Europe’s biotech base. EuropaBio sees
this effort as a way to reinvigorate the process and to
accelerate the pace of implementation of the Life Sciences and
Biotechnology Strategy by all 25 Member States. The
implementation will help the creation of predictable rules for
all biotech sectors, enacting of EU legislation at national
level, an increase of public awareness of biotech benefits and
support for research and innovation.
EuropaBio press release:
http://www.europabio.org/articles/PR%20200606%20EUpj2006Biotech_Roundtable_en.doc
Austrian and Finnish Presidency joint
press release:
http://www.ktm.fi/index.phtml?i=1697&l=en&s=674
EuropaBio Extranet “Members Only” pages on the EU Biotech
strategy:
http://www.members.europabio.org/Groups/welcome-EUBiotechStrategy.htm
Consultation
on the Mid-Term Review of the Life Sciences and Biotechnology
Strategy 2002-2010
The EU Commission has launched an
online
consultation inviting
the public to present its assessment of the implementation and
the way forward of the 30 actions included in the 2002 Life
Sciences and Biotechnology Strategy Action Plan in order for the
Commission to evaluate the merits and possible shortcomings of
the Strategy and draw conclusions on the best ways to maximise
the contribution of modern biotechnology to the major European
policy goals formulated in the renewed Lisbon Agenda, or
“Partnership for Growth and Jobs”, and the Sustainable
Development Strategy. Comments should reach the Commission’s
services no later than 30
September 2006.
http://ec.europa.eu/biotechnology/index_en.htm
European Commission
and US renew Biotech Task Force
The United States and European
Commission (EC) renewed a consultative task force on
biotechnology research in an agreement signed on June 8th
by John Marburger, director of the White House Office of Science
and Technology Policy, and Janez Potocňik, Commissioner for
Science and Research for the European Commission. Established in
1990, the task force fosters open communication between the EC
and U.S. agencies that conduct biotechnology research. The task
force will meet on July 19-20 in Brussels, Belgium. "The renewal
of this task force agreement ensures that we continue this
successful partnership between Europe and the United States in
biotechnology research," said Marburger.
http://useu.usmission.gov/Article.asp?ID=4885564A-6146-4C06-B303-47E4B399C72A
Europeans gain faith on Biotechnological applications except for
GMOs
Optimism and faith towards
Biotechnology and the changes that it can bring in the
improvement of the quality of human life. The latest
Eurobarometer Survey on Biotechnology showed that Europeans are
more and more in favour of Red (healthcare) and White
(industrial) Biotechnological applications, but remain skeptical
about green (agro-food) biotech. Overall 52% of Europeans are
in favour of Biotechnology applications to the 12% who are
against. For further information or to access the results:
http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/06/799&format=
HTML&aged=0&language=EN&guiLanguage=ensince%201991
The Biotechnology for Europe study – The
JRC study
Following a request of the European Parliament, the Joint
Research Centre – JRC - on behalf of the European Commission
carries out The Biotechnology for Europe study. This multitask
study is an assessment of modern biotechnology and an evaluation
of its consequences, opportunities and challenges for Europe in
terms of economic, social and environmental aspects. It will
constitute the primary input upon the reflection on the role of
the Life Sciences and Biotechnology in the renewed Lisbon
Agenda. The final report on task 1 on “data needs and developing
indicators to map modern biotechnology applications and
industrial sectors” has just been published. The task 2 concerns
the "Adoption of modern biotechnologies and its consequences,
opportunities and challenges”, where 29 topics have been
published for which a case study will be developed covering the
following fields: human health, primary production and
agro-food, industrial processes, energy and environment. So far,
the JRC and the European Commission has acknowledged the
submissions provided by EuropaBio. EuropaBio would like to thank
all those who contributed information on Biotech products from
their companies. The final report of task 1, the list of the
case studies and any other relevant information on the project
can be found on the EuropaBio extranet or the JRC website.
EuropaBio Extranet:
http://www.members.europabio.org/Groups/welcome-JRC.htm
JRC web site:
http://bio4eu.jrc.es/
European Commission
wants to triple early-stage capital investments
On the 30th of June, the
Commission (DG ENTR) confirmed measures and policies to increase
access to the financing of SMEs. EuropaBio’s and our Emerging
Enterprises Council achievements: Competitiveness and Innovation
Program (CIP): shift from SME guarantees to venture capital. As
stated before, the Commission has decided internally to even go
further up to 75% budget allocation to venture capital. The
second is that for the first time in public the Commission used
of the Young Innovative Company terminology executing our
strategy according to plan; And while the general principles and
rationale of the YIC status have recently been “accepted” at
European level (i.e. step 1), the Commission has now started to
apply a top-down approach inviting the Member States to evaluate
the implementation of the YIC at national level (i.e. step 2).
Later this summer, we will start to implement “step 3”, which
will involve providing support to the national and other biotech
associations (upon request) to back up their campaign at
national level. The Commission will organise a Round Table
between banks and SMEs and invite Member States to study the
advantages of introducing a Young Innovative Company Scheme and
evaluate the advantages of tax relief systems for Young
Innovative Companies.
Fiscal incentives – Benchmarking
study
A number of EuropaBio’s National
Associations have published a benchmarking report on the fiscal
incentives in place across the member states and their impact.
Study can be downloaded from the project website:
www.sik.se/yicstatus
European Commission
supports small business in Europe
Marked as one of the top priorities in the
European Community’s agenda, the Austrian Presidency and the EC
organised a two-day event to encourage the exchange of good
practices between Member States so as to improve the environment
for the establishment of SME’s. The Commission now supports
simplified and quicker procedures in order to achieve effective
improvements concerning the financial and regulatory environment
supportive to SMEs.
European
Commission press release:
http://europa.eu/rapid/pressReleasesAction.do?reference=
IP/06/770&format=HTML&aged=0&language=EN&guiLanguage=en
All Member
States have implemented the Biotech Patents Directive, says the
Commission
The Commission
welcomes the fact that all Member States have now implemented in
their national laws Directive 98/44/EC on the legal protection
of biotechnological inventions. This Directive aims to clarify
certain principles of patent law applied to biotechnological
inventions whilst ensuring that strict ethical rules are
respected.
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/900&format=
HTML&aged=0&language=EN&guiLanguage=en
Bioprospecting - EuropaBio publishes
principles
The "EuropaBio principles for accessing
genetic resources” were approved at the EuropaBio Board
meeting on 20th of June in Helsinki.
This document sets out general
principles and practices that
EuropaBio and its members believe are appropriate to follow when
engaging in bioprospecting activities.
EuropaBio Principles -
http://www.europabio.org/documents/BioprospectingPrinciples.pdf
Disclosure of Origin in
IPR Applications: Options and Perspectives of Users and
Providers of Genetic Resources
The
aims of this Chatham House project were to assess
the effectiveness, feasibility, and acceptance of newly proposed
and established national legislation on Disclosure Requirements
(DRs), - The final report that is now published, states the
difficulty in determining the negative or positive influence
that Disclosure Requirements might reflect.
There is no consensus on this. Among the developing countries,
difficulties in complying with the legislation were encountered.
Another aspect of feasibility is the cost of implementing such
legislation and of establishing systems to monitor and enforce
compliance.
http://www.ip4development.org/Resources.html
WHO – New report
WHO
new report on IP, Innovation and Health.
http://www.who.int/intellectualproperty/documents/thereport/en/index.html
MEP’s allocate 54.5€ for
European research in the R&D Framework Program
MEP’s
chose the scientific path when it came to voting on stem cell
research and the Committee on Industry and Research authorized
the funding for research using human embryos under very strict
conditions. The funding, which will depend on the legislation of
each Member State, will set strict licensing regimes to research
institutes and bodies. All activities concerning human cloning
and creation of human embryos for research purposes or to
provide stem cells and intended to modify the genetic heritage
of human beings were absolutely excluded. Emphasis on Health and
on energy was also given to the 7th Framework program
that was adopted by the European Parliament at the Plenary
sessions along with the role of SMES in the FP7 which set a
quantitative target for the participation of SMEs through
strategic projects and European Technology Platforms. On June
28th the Commission adopted its revised proposals for
FP7 to take account of the Parliament vote.
Contact Laurens Theunis for more information (l.theunis@europabio.org)
Update on
FP7 -
http://cordis.europa.eu/fp7/home.html
100 Technology offers stemming from EU Biotechnology RTD
results
The
European Commission has presented a catalogue of biotechnology
developments arising from EU-funded research projects over the
last 10 years. The catalogue aims to help researchers and
companies come together, transform research into innovation and
lead to products and processes based on this research. The
catalogue contains examples from Biotech areas and proves that
the European Commission supports research and innovation as well
as the development of a technological implementation plans
relating to intellectual property and entrepreneurship.
Full Online
EU Biotechnology Report:
ftp://ftp.cordis.lu/pub/lifescihealth/docs/booklet_100_off.pdf
EU invites
EuropaBio members
participate in
Bio-Preparedness
workshop
EuropaBio - the
European Bio-Industries Association in collaboration with EBSA -
the European BioSafety Association have received the Draft
Agenda from the Commission’s seminar on
European Bio-Preparedness, which takes place on the 24-25 July.
On the 24th July only representatives from public
authorities of the Member States, European institutions,
agencies and bodies may attend. The private sector and other
relevant actors will participate in the debate
on the 25th July.
Two parallel workshops are organised for each
day. The first workshop will discuss Bio-safety,
bio-security and personnel security in Europe. The second
workshop will discuss the European capacity to respond to
bio-threat. EuropaBio
is looking for companies willing to make a presentation for the
second workshop on European capacity to respond to
bio-threats. Deadline to register for participants is 20th of July.
To register
(free of charge) please send email to: Lukas Holub, EU
Commission, DG Justice Freedom and Security
lukas.holub@cec.eu.int.
European week of the Regions opens in Brussels in October
Preparations for the European week of
regions and cities (2006 Open Days), which will run from 9 to 12
October in Brussels, have entered their final phase.
Registration requests for workshops and seminars staged during
the event can now be submitted. The theme this year is
"Investing in Europe's Regions and Cities: Public and Private
Partners for Growth and Jobs".
Details on seminars, speakers and registration are available
at:
http://ec.europa.eu/regional_policy/conferences/od2006/programme.cfm?nmenu=10
Pharmaceutical Forum Working Groups working to boost patient’s
access to innovative medicine and the sector’s competitiveness
Under the Pharmaceutical Forum
Framework, the Pricing Working Group and the Information to
Patients Working Group met in June to prepare the EU Health
ministers’ meeting in September. EuropaBio, with representatives
from the Member States, patients, insurances, healthcare
professionals and industry, developed a set of recommendations
for the Pharmaceutical Forum, which are not yet finalised. For more
information on this issue, please contact:
a.vandeputte@europabio.org
EuropaBio contributed to the consultation on the Guideline
on Compassionate Use
EuropaBio’s Legislative Working Group contributed to the CHMP
consultation for the draft guideline on Compassionate Use. The
guideline is for compassionate use of programs for a group of
patients, suffering of a chronically, seriously debilitating or
life threatening disease and for products either pending on a
centralised marketing authorisation or undergoing clinical
trials. For more information, please contact:
a.vandeputte@europabio.org
WHO – New report
WHO
Commission on Intellectual property Rights, Innovation and
Public Health has released a report on IP, Innovation and Health
in all UN Officials languages.
Report:
http://www.who.int/intellectualproperty/documents/thereport/en/index.html
OECD:
9% rise in Health spending between 1990 and 2004
According to OECD Health Data 2006
health spending between 1998 and 2004 grew faster than GDP in
every OECD country except Finland. If the trend continues,
governments will have to raise taxes, cut spending in other
areas or make people pay more out of their own pockets, warns
OECD. The study is available at:
http://www.oecd.org/document/37/0,2340,en_2649_201185_36986213_1_1_1_1,00.html
EU Recommends Approval for First Animal-Made Pharmaceutical
On June 1, the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP)
recommended the approval of ATryn, an anti-clotting agent
produced in the milk of biotech goats. The Committee's approval
was a reversal of a February decision, after re-examination of
the scientific evidence supporting the drug. The drug was
developed by BIO member GTC Biotherapeutics, and could be used
to treat patients with a rare inherited disease who are
undergoing surgery, in order to prevent deep-vein thrombosis.
European regulators are expected issue a final decision on the
application within three months.
EMEA press release:
http://www.emea.eu.int/pdfs/general/direct/pr/20316306en.pdf
EMEA
Management Board policy for greater transparency
Transparency was the main topic of
discussion at the European Medicines Agency's Management Board
meeting on the 8th June 2006. The Board agreed to
publish its meeting agendas and minutes, along with all
non-confidential documents it adopts. Details will be set out in
a policy document that will be presented at the next Board
meeting on the 28th of September 2006. Information
on the work of the European Medicines Agency can be found on the
EMEA website:
http://www.emea.eu.int.
Be part of the future of
BioTechnology
Each year, the
BioTech Hot Spot descends upon a different European city,
bringing along its entourage of participating companies and
visiting professionals.
Developed five
years ago as a unique biotech event the BioTech Hot Spot
pavilion gives biotech companies an opportunity to attract an
audience specifically interested in this sector of the
pharmaceutical manufacturing business. Organised as an integral
part of ICSE and CPhI Worldwide exhibitors on the BioTech Hot
Spot can expect to meet thousands of pharmaceutical prospects
from over 110 countries.Biotech
companies that participate in the BioTech Hot Spot will get the
opportunity to:
- Introduce their services to the pharmaceutical industry;
- Raise new venture capital;
- Exchange technology with established pharmaceutical companies
More
info:
http://www.europabio.org/events/October3_2006.htm
Commission confirms success of the Orphan
Medicinal Products Regulation
European Commission claims success
over the Orphan medicinal product Regulation (141/2000) and its
implementation .The implementation of the regulation sets the
Framework for the commercialisation of orphan drugs targeting
rare disease patients or life-threatening conditions. The EU
Regulation brings together a centralised authorisation process
through the EMEA and the provision of incentives for a ten-year
market exclusivity, which opens the way to investment. At the
same time, the Regulation reduces approval fees and promotes
EMEA’s collaboration in research and in clinical trials. The
Regulation also establishes some ground rules as to the
definition of Orphan Medicinal Drugs. EuropaBio and EBE insisted
though that the access of patients to Orphan drugs throughout
Europe should be guaranteed.
Commission
report
http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/index.htm
European Commission’s Press Release
http://europa.eu/rapid/pressReleasesAction.do?reference=
IP/06/844&format=HTML&aged=0&language=EN&guiLanguage=en
Joint EuropaBio/EBE Press Release
http://www.europabio.org/articles/PROrphanMedicinesReview_060627.doc
EuropaBio
together with EBE submitted policy suggestions for the COMP WGIP
Further to the last Committee for Orphan Medicinal Products
Working Group for Interested Parties meeting, the EuropaBio -
EBE Task Force on Orphan Medicinal Products contributed to
consultation by the COMP WGIP on policy suggestions for its
future work program. Suggestions were submitted to the two
chairs, Agnes Saint Raymond and Yann Le Cam. For more
information:
a.vandeputte@europabio.org
Speakers
Plaza - Register your profile online!
Would you
like to be considered to present at one of our upcoming
conferences? Do you want to take the opportunity to share ideas
with other colleagues involved in your sector? Do you have
expertise in specific fields and would like to share your
experience and knowledge? Then fill in our electronic form to
submit your application.
http://www.europabio.org/speakers.asp
EuropaBio Job PLAZA – Post your vacancies Free-of-Charge
The
EuropaBio Life Science Jobs in Europe database offers the possibility of
posting job vacancies in the European biotech industry. The database is
open to all European biotech companies; there is no registration or
login required.
Surf to and post at:
http://www.europabio.org/jobs.htm
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