remedies were the rule in past centuries: you would take Doctor
What's-his-name's tablets for your stomachache but you were totally
unaware of exactly what were the substance and the dose.
regulations were reinforced during the 20th century in European
countries, not only for medicines, but also for most consumer goods,
including pre-packed food.
remedies were forbidden, i.e. medicines whose packaging did not
mention the type and dose of the active substances. Manufacturers
were also obliged to provide a leaflet listing the same information,
along with other essential one.
information was further enhanced with the introduction of international
non proprietary names (INN) by the World Health Organisation (WHO)
in the 1950s. INNs are universally adopted, WHO-approved names for
specific drug substances. They form a common scientific language,
enabling patients to know exactly what their doctor or pharmacist
has recommended, and whether two drugs with different trade names
contain the same or different substances.
Europe, it has been obligatory to use INNs on drug packaging and
the patient information leaflet for more than half a century. European
harmonisation of the regulations governing medicinal products, which
started in the 1970s, confirmed these rules, thereby guaranteeing
patients a high level of protection.
use of international non proprietary names is more than ever necessary
in 2003, especially with the boom in generic drugs. At the first
reading of the draft Directive and Regulation on medicinal products,
members of the European Parliament voted amendments aimed at ensuring
that the INN of each active substance figures systematically on
the drug packaging.
we were dumbfounded to learn that these amendments had not been
upheld in the draft texts proposed for the second reading. If the
Council's recommendations are adopted, pharmaceutical firms would
not to have to mention the INNs on the packaging (box and leaflet)
of preparations containing more than one active substance.
an antihypertensive combination of two active substances could be
designated by its trade name only. The same would apply to a contraceptive
pill combining an estrogen and a progestin (even though not all
compounds in these categories carry the same risks), and also to
multi-vitamin preparations, that may contain iron, fluoride, etc.
In other words, patients would know less about their drugs than
about their breakfast cereals.
hope this is a simple administrative error - one that will be corrected
packaging and patient information leaflet must mention all active
substances and their doses. It is high time to hammer the last nail
into the coffin of secret remedies dear to Middle-Age peddlers.
Drug companies may want to promote their trade names, but what patients
need most is detailed information on precisely what substances and
what doses they are taking.
as unacceptable is the proposal contained in the current draft Directive
authorising firms to mention only the trade name of their product
on recall advertisements.
advertisements are designed to ram home the trade name until the
prescriber (or the patient) adopts it instinctively. But we are
not talking about washing powder or socks here. Recall ads are already
legally exempted from mentioning a large body of information, including
side effects. At the very least they should be required to carry
the international non proprietary names of all the active substances
contained in the product concerned.
touting what amounts to secret remedies are totally unacceptable
in the 21st century. Companies want to impose their trade names,
but what health professionals and patients need most is thorough,
©Medicines in Europe Forum 1 November