There are numerous medicines on the market today, but they do not
all have the same risk-benefit balance. Comparing them in clinical
trials makes it possible to assess their respective "added
"New drug" does not necessarily mean
Older medicines have not been superseded by more recent ones. This
is true, for example, of paracetamol, which remains the most effective
analgesic for light to moderate pain, the one which has the best
risk-benefit balance, even thought it is more than 100 years old.
The same also applies to thiazide diuretics, which are now proved
to be the best first-line antihypertensive drugs. There are numerous
diseases or symptoms for which the most effective medicines are
10, 20, or even 50 years old.
Conversely, many supposedly "innovative" new drugs do
not offer patients any real improvements.
Free trade and public health do not necessarily
go hand in hand
How is it possible for new medicinal products that do not offer
patients any tangible improvements to be put on the market? Simply
because the principle of free trade applies to the pharmaceuticals
sector: currently, the health authorities cannot legally refuse
to authorise the sale of a medicinal product which is more or less
"as good as" a product already on the market.
Naturally, the pharmaceutical companies support this principle according
to which new medicines are not required to be an "improvement"
on existing ones. They use it as an argument against new medicines
being systematically compared to older medicines prescribed for
the same diseases.
Patients, health professionals and social protection
bodies want to be able to make the best choices
Health professionals, patients and the public at large who use and
pay for medicines need to know whether a new drug is or is not an
improvement on existing treatments, in terms of benefits, risks
or even convenience.
Furthermore, the resources of mutual insurance systems are being
stretched by the proliferation of increasingly expensive medicines,
often to the detriment of other necessary medical or social expenses.
All these factors make a strong case for providing data on the added
therapeutic value of new medicines when they are authorised and
marketed. And to assess this added therapeutic value, appropriate
comparative clinical trials must be carried out.
Once a drug has been authorised for sale, the five-year re-evaluation
should be seen as a valuable second opportunity to analyse the available
data thoroughly, taking into account its use in real situations.
Useful up - dated information on the drug's risk-benefit balance
and on its relative added therapeutic value could then be made public.
Amendments for the best use of medicines
The Medicines in Europe Forum supports several amendments seeking
to make data on the added therapeutic value of new medicinal products
public at the time of their initial authorisation for sale and after
the five-year re-evaluation.
It is a question of enabling health professionals and patients to
be fully informed about the drugs they are using, in particular
new ones. Useful information on a drug comes from trials comparing
it with other treatments already available.
©Medicines in Europe Forum 15 November