EU Regulation Urgently Needed! European
Patients are Waiting for the Next Generation of Medical Treatments
Patients’ Organisations, Scientists and Life Sciences
Industry urge European Parliamentarians and Member States to adopt a
well-worded EU “Advanced Therapies” Regulation soon
BRUSSELS, 28th February 2007 – Representatives from European patients’
organisations, academia, science and industry urged Europe’s
decision-makers to approve the common framework for “Advanced Therapies”
– treatments made from cells, genes or tissue engineering – last evening
at a dinner debate organised by EPPOSI, hosted by Mrs. Avril Doyle,
Member of the European Parliament.
More than 9 MEPs and/or their Political Assistants gathered to listen to
points of view from across the stakeholder spectrum – including
patients’ representatives, scientists developing treatments for rare
genetic diseases and representatives of the Life Sciences sector – to
understand why the Regulation was important to them. And the
overwhelming message was: this Regulation is needed and it is needed
now.
The draft Regulation is currently under discussion at the European
Parliament, which is expected to vote on 13th March 2007. But
parliamentarians also need to reach agreement with Member States – whose
government representatives are set to meet tomorrow, 28th February 2007,
with the Parliament to discuss the chances of agreement.
“Advanced Therapies have the potential to revolutionise the way that
patients are treated and, in many cases, offer treatments where none
existed previously,” explained Mrs. Doyle. “This Regulation is the key
to getting those products out of the laboratories and making sure that
they are safely available to the patients,” she confirmed.
Currently, each individual Member State of the EU regulates these
products differently. In some countries, they are not regulated at all,
meaning that patients cannot be sure of the safety of products that they
might be receiving. Therefore, patients urged that all products should
be subject to the evaluation. “It is unacceptable that some products are
left in the unregulated grey zone,” explained Alastair Kent, president
of EGAN, the European Genetic Alliances Network. “Delaying the approval
of the Regulation, or excluding some products from this Regulation will
prevent some patients having access to them. But worse, those that do
get them will have no guarantee of their safety.”
And for the Life Sciences sector, the bewildering patchwork of rules and
regulations means that each product must be registered country by
country. Evidence must be gathered and formatted according to each
individual system, meaning that patients in one country will receive the
treatment long before others as the registration must be done step by
step.
The new EU Regulation would solve all of this by putting in place a
single EU evaluation – similar to that currently required for normal
medicines – which would allow patients all over the EU assurances of
safe, efficacious and high-quality products all at the same time.
The draft, endorsed by the European Parliament’s own Environment
Committee which has primary responsibility for the draft legislation,
calls for all products to be evaluated to the same standards,
nevertheless leaves it up to individual Member States to accept the
product in its market or not. “This is the same approach as that taken
with contraceptive products, where views differ from one country to
another,” continued Alastair Kent.
“This Regulation is particularly important for those who suffer from
incurable, often genetic diseases,” explained Flaminia Macchia, speaking
on behalf of EURORDIS, the European Organisation for Rare Diseases.
“Millions of patients are waiting for the fruits of new research and
this Regulation will open up that possibility,” she confirmed.
EPPOSI aims to positively work on policies in human healthcare in Europe
by facilitating discussion and identifying consensus between its
stakeholders. Any joint views developed by its stakeholders as consensus
recommendations are shared with European decision-makers at all levels.
– ENDS –
For further Information or interview opportunities, please contact:
Giovanni ASTA, Director EPPOSI
Tel: +32 2 503 1307 – Mobile: + 32 474 709 842
E-mail: info@epposi.org
NOTES TO EDITORS:
· The European Platform for Patients’ Organisations, Science & Industry
(EPPOSI) was founded in 1994 and is a Europe-wide patient-led
partnership of patients’ organisations, industry and academic science.
EPPOSI aims to advance healthcare policies for the prevention and
treatment of serious diseases. (
www.epposi.org ).
