Dear Sir/Madam
The Medicines in Europe Forum welcomes the proposal aiming
to make appropriate drugs available to children and to those treating them. However,
the Forum believes that this proposal needs to be significantly amended for the
regulation on medicinal products for paediatric use genuinely to meet the needs
of children. Why
such haste? An in-depth discussion on the proposal for a regulation
on medicinal products for paediatric use is vital, even if the Environment and
Health Commission is currently busy considering other very important bills. Yet
the Medicines in Europe Forum has noted that you will only have a few days to
table amendments after the Commission has discussed the proposal. We feel this
schedule does not allow sufficient time to introduce the necessary improvements
to the proposed regulation. Better
than nothing? Some MEPs may be tempted to feel that this proposed regulation
does not require much involvement on their part, because the regulation will be
"better than nothing ". But in fact, it is untrue that there is currently
"nothing" for children. Quite the opposite: there is a wealth of accumulated
experience which we should start capitalising on in order to identify the true
needs and priorities. The regulation should aim therefore not to be "better
than nothing", but to be "better than what there already is".
Do
better, at the best cost The proposed regulation aims to offer additional
incentives (paid for out of public funds) to pharmaceuticals firms to encourage
them to fund more studies involving children. The cost of these incentives to
society (the human cost associated with using children in clinical trials, additional
operational costs for the European Medicines Agency, and funding the incentives)
requires striking a scrupulous balance between the interests of the pharmaceuticals
industry and children's best interests. Incentives for developing paediatric drugs
are unacceptable unless they offer children genuine therapeutic benefits and particularly
stringent pharmacovigilance measures are in place. This balance can only be
achieved through: 1- a meticulous definition and evaluation of children's
real needs; 2- the setting up of appropriate resources; 3- total transparency
regarding the process; 4- active gathering of pharmacovigilance data; 5-
rewards proportionate to the pharmaceuticals firms' efforts.
An
escalation of "incentives" to drugs companies If we take a
detached look at the proposal for a regulation on medicinal products for paediatric
use, we note that one of the European Commission's stated objectives is to give
European pharmaceuticals firms the same advantages as American firms (where there
is already a six-month monopoly extension to encourage firms to develop medicines
for paediatric use). However, in times when drugs research and development is
less fruitful, the firms increase their requests to extend their monopolies, claimed
as incentives for concentrating on a particular therapeutic field. In the
United States, under the Bioshield Plan (against bioterrorism), pharmaceuticals
firms are about to win the right to extend their monopoly on a drug of their choice
for six months if they develop a new antibiotic, for example. Children today,
antibiotics tomorrow, women or the elderly the next day
, to what extent
can societies agree to give special funding to research that was previously part
of the pharmaceuticals firms normal activity? How long will societies agree to
extend monopolies on drugs that are becoming increasingly expensive? The fact
that the proposal for a regulation on medicinal products for paediatric use systematically
grants an additional six-month monopoly for drugs (for both paediatric and adult
use) irrespective of research and development costs and unrelated to the therapeutic
benefits of the drugs, amounts to a blind allocation of public resources.
Take the
time to improve the proposed regulation The proposal for a regulation
on medicinal products for paediatric use is an opportunity to respond better to
the real needs of children. But for this regulation wholly to fulfil this objective,
it requires significant improvement, over and above the proposals of the rapporteur.
This requires you to take the time to analyse the issues, and to have sufficient
time to table any amendments.
We are sure you will agree with us, and are
counting on you. Yours sincerely ©The Medicines
in Europe Forum 1 May 2005 europedumedicament@free.fr
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