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European biotech industry debates new Advanced
Therapies Regulation together with all stakeholders
Brussels, 9 November
2005: Today, for the first time, the European biotech industry holds a
public hearing with the EU stakeholders and authorities to share views on how
tissue engineered products should be regulated in Europe. This comes in advance
of a proposal for a new Advanced Therapies Regulation, covering both cell and
gene therapies, which is expected to be published by the EU Commission later
this month. The Hearing on Advanced Therapies brings one hundred stakeholders,
officials and industry representatives together. The hearing organized by
EuropaBio – the European Association for Bioindustries - enables stakeholders –
industry, science and patients - to give their views directly to the EU
Institutions - Commission, Parliament, Council and the EMEA - in charge of
regulating this exciting and emerging sector.
“Tissue Engineering has great potential with new regulations for Advanced
Therapies now being developed by the EU Commission, this is the time for all to
play an active role in shaping the rules that will determine this new business,”
says Johan Vanhemelrijck, Secretary General of EuropaBio.
Tissue engineered products are a brand new area of regenerative medicine,
treating skin diseases and burns, heart disease and cancer. This branch of
biotechnology-based therapies allows us to heal patients, using ground-breaking
new tissue transplants and cells. Some of the best-known treatments today in the
field involve fixing tendon injuries, repairing knee cartilage, or treating
burns victims and open skin ulcers. Without European rules, patients would have
different access levels in different countries.
“Research and development in these new treatments is growing rapidly in areas
such as cancer, Parkinson’s and heart disease. Regulators must find a way to
encourage the emergence of these new treatments while safeguarding the public
interest. This hearing is an important measure in helping the regulators
understand the views of stakeholders, while, at the same time enabling policy
makers to explain their objectives,” says Heidi de Wit, Genzyme, Chair of
EuropaBio’s Working Group on Advanced Therapies.
For further information, contact:
Adeline Farrelly, EuropaBio, Tel: +32 2 735 0313 Direct: +32 2 739 1174 Mobile:
+32 475 931724
About EuropaBio
EuropaBio is the political voice of the biotechnology industry in Europe. The
association for bioindustries has a membership of some 55 corporate members
operating worldwide, 11 associate organisations, 3 regions and 25 national
biotechnology associations. www.europabio.org
The EuropaBio Industry Hearing takes place just after the major conference run
by Jacob Fleming Group on "Tissue Engineering and Regenerative Medicine -
Commercializing Future Life Saver". This conference brings together speakers
form leading companies worldwide to discuss the hottest issues regarding tissue
engineering and marketing strategies for these new products in Europe.
About Jacob Flemming Group
www.jacobfleming.com
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