| Joint statement
from European Patient groups on
The European Commission's proposal
to amend
the Directive on Community Code relating to Products
for Human use
(Directive 92/28/EEC) - Articles 86 to 100 |
|
Patients demand access to information for
ALL disease areas in Europe
Introduction
European patient groups believe that ALL patients, no matter
their condition, background or nationality, have a fundamental
and legitimate human right of access to all kinds of information
about their health, medical conditions and the availability
of treatments including knowledge of the best available management
for their disease. It is a question of solidarity, equity
and patients' rights.
We would draw attention to, and agree with the assertion
in the Commission's legal text that patients have a "legitimate
need" for information.
From our perspective EU patients/citizens need factually accurate,
reliable, easily understandable information to be able to
make informed decisions. They need to understand their condition
and do want to receive information on treatments available.
As patients, we welcome information from different sources
including the pharmaceutical industry, provided they meet
the above-mentioned criteria, the ownership of the source
is clearly identified and agreed safeguards are in place.
Such information would enable patients/citizens all over
Europe to:
As patients, we recognise that governments fear increased
pressure on health care budgets
since informed patient might demand better and more effective
drugs for his/her diseases.
However, we consider this a positive consequence of better
and more information to the public.
We argue that informed patients are more efficient and prudent
users of health care resources. Often underprescribing, non-compliance
or irrational prescribing are a heavier overall financial
burden for health care and social security budgets. Better
disease management increases the quality of life and well-being
of patients.
Information should be seen as an enabling tool to improve
health care for all EU citizens
- not as a cost/control instrument for EU Member States.
Those suspicious of patient information base their arguments
on the US experience of advertising. However, advertising
is not equivalent to the provision of information.
While we do not want US style advertising, European patient
groups are happy to contribute to a more thoughtful and constructive
debate, to find a solution for Europe appropriate to the Information
Age.
10 April 2002
Co-signed by:
GAMIAN Europe
EUFAMI - European Federation of Associations of Families of
Mentally Ill People
European Cystic Fibrosis Policy Network
Euro ATAXIA
European Coalition of Positive People
European Patients' Voice
EIWH - European Institute of Women's Health
EATG - European AIDS Treatment Group
DEBRA Europe
Retina Europe
The International Osteoporosis Foundation
AMD Alliance International - European Affairs Office
European patient groups cannot agree with the discriminatory
approach taken by the present Commission proposal and we have
the following detailed comments to offer:
ARTICLE 88 - INFORMATION RESTRICTED TO 3 DISEASE AREAS
IN THE PILOT
Restricting the information pilot study to only three disease
areas, Diabetes, HIV and Asthma, is inequitable because patients
suffering from other diseases have exactly the same need for
information as patients suffering from the 3 disease areas
in the proposal.
"Moving with the times" is how the Commission referred
to its proposals when they were released in July 2001. We
feel that the proposed pilot is unacceptable in an open and
democratic society, and any such new policy direction must
apply to all diseases, unless there are justifiable public
health reasons that would endanger anyone's health.
In fact, the pilot is a traditional way of approaching a
challenge, and does not respond to patients' needs and demand
for information in our Internet age.
If adopted it will be to the detriment of patients who will
be without access to information in their own language and
will create a divided society of informed and non-informed
patients.
The proposed pilot study would not only create discrimination
between patient groups in different disease areas; patients
excluded from the pilot will have to wait at least 10 years
before they too may be entitled to information (5 years for
adoption and implementation of the proposal, and 5 more years
for an evaluation report of the pilot).
In the interest of patients' rights, equity and solidarity
we must ensure that the health divide is not further aggravated
by such an information divide.
ARTICLE 86 - DEFINITION OF ADVERTISING
The definition of Advertising of a medicinal product is amended
to include "any activity … designed to promote…
awareness of the availability of medicinal products."
This new definition is flawed and undermines efforts to distinguish
between advertisements and other forms of information.
We believe in our right to information and this includes
the right to know about available medicines. Inclusion of
awareness of the availability of medicines under the definition
of advertising might decrease the present information already
available to patients.
The amendment will undermine information and education programmes
produced by patient organisations and other external independent
sources.
In the interest of a high level of health protection, which
is a European Treaty goal, we feel that Patient education
activities and disease awareness campaigns should be encouraged
and not restricted, as long as such material respects the
quality criteria set out above and has appropriate safeguards
in place.
ARTICLE 88.2. - PRINCIPLES OF GOOD CONDUCT
The proposal heavily relies on the promulgation of guidelines
which will apparently contain most of the detailed rules for
communicating with patients.
European patient groups wish to be consulted in a formal role
to ensure that the communication, rules and criteria set are
meaningful from the patient's perspective.
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