|Knowing which are the active ingredients of a drug,
being informed on the added therapeutic value of a new drug, benefiting
from a compassionate use programme when it is vital, reporting an
adverse effect, contributing to transparency of agencies by joining
their board, these are a few of patients needs.
Ultimately medicines are used and paid for by patients/citizens/national
The revision of the European Directive and Regulation on medicines
should, quite rightly, provide the opportunity to place the emphasis
on the needs of patients and of European citizens in general.
Information is key to making the best possible
use of medicines
The days when doctors and pharmacists spoke Latin and prescribed
"secret remedies" whose properties were known only to
them are long over. Today, patients have the right to know what
decisions are taken about their health and to be told about the
expected effects of their treatments.
This fundamental right includes being informed of the precise active
ingredients of medicines. In addition to the drug's brand name,
its International Nonproprietary Name (INN), i.e. its scientific
name, must be stated on the packaging and in advertisements.
Patients are also entitled to know whether the medicines they are
using really are the most suitable for their particular condition.
It is always astonishing to discover that many new medicines are
sold without having been compared to the most appropriate drugs
for the same disease already available on the market.
Health authorities must be able to supply information on the "added
therapeutic value" of new medicines, i.e. comparative data
on medicines, or on the lack of such data if that is the case. This
information can only be obtained if the appropriate clinical trials
are carried out. And it is this reliable information that patients
require, not information put out by the pharmaceutical companies
and designed for promotional purposes.
Representation of civil society on the boards
of medicines agencies
Each day European and national medicines agencies take decisions
that concern patients' health: the evaluation of new medicines and
their marketing authorisation; monitoring adverse effects and withdrawing
drugs from the market for safety reasons; the production of information
for health professionals and patients, etc.
Given that the pharmaceutical industry represents huge financial
stakes, it is essential for the decisions taken by the agencies
to be transparent, and for this duty of transparency to be enshrined
in law. Transparency must also be the watchword in the day-to-day
running of the agencies. It is necessary to have representatives
of civil society on the agencies' management boards to remind these
institutions at all times of their duty to protect the public interest.
Patients, healthcare professionals and social protection systems
must be represented on these boards.
Compassionate use for patients in a therapeutic
Patients with terminal diseases in a therapeutic impasse, i.e. those
for whom there are no effective existing treatments, must have access
to promising medicines which have not yet been authorised for sale.
This principle is readily acknowledged, but it will only become
practice if the national authorities are forced to set up compassionate
use programmes whenever necessary. It is therefore a question of
putting in place the application procedures for starting such a
programme at the request of health professionals or patient groups,
and of earmarking the necessary funding.
Direct reporting of adverse effects
Doctors and pharmacists can inform the national pharmacovigilance
system of adverse or unusual effects they have observed, in particular
where new medicines are concerned. This system is not ideal, however,
because not all health professionals are strongly motivated to report
adverse effects, and because they do not necessarily place the same
degree of importance on some adverse effects as the patients themselves.
And so it is essential to allow patients to report to the public
pharmacovigilance system directly any adverse effects. They could
do so by filling up a form available from community surgeries and
It is now recognized that patients have a role to play in the smooth
running of health care systems. But the European legislation on
medicines currently under revision still does not pay them enough
attention. Patients have specific demands and now is time to listen
©Medicines in Europe Forum 1 December