Pharmaceuticals
are not only protected by various types of patents. In Europe, the
results of clinical trials sponsored by marketing authorisation
holders are protected from exploitation by competitors. This places
added constraints on generics manufacturers.
Generics
are currently approved through a "light" (abridged) marketing
authorisation procedure. The clinical evaluation dossier is not
required to contain results from clinical trials conducted with
the generic product: the data obtained with the originator product
are considered sufficient, and can be included in the marketing
application for the generic.
"Data
protection" consists of forbidding competitors from using data
on the originator substance for a fixed number of years. This period
is currently six years in about half the European Union member states,
and 10 years in the remainder. It is 10 years for all "biotech"
drugs, which must be approved through the centralised procedure.
In
2001 the draft Directive and Regulation drawn up by the European
Commission advocated that data protection be extended to 10 years
for all drugs, and that an extra year be added for a new therapeutic
indication.
In
2003, after amendment by the European Parliament and Council of
Ministers, the draft Directive has been modified to permit "light"
marketing applications to be made 8 years after initial authorisation
of the originator drug, with market release two years later. In
other words, data protection (and therefore marketing exclusivity)
would amount to 10 years (8+2) for all drugs authorised by individual
member states or through the mutual recognition procedure. The draft
Regulation also recommended 10 years of data protection for drugs
authorised through the centralised procedure, plus an extra year
(once only) when one or several new therapeutic indications are
granted.
As
things stand, data protection is going to be significantly extended
in the European Union, even though it is already among the longest
in the world. The consequences would be delayed generic development
and added financial constraints for national welfare systems (especially
problematic for the poorer member states and acceding countries).
We
found no historical reasons and no rational for extending the monopoly
position of originator drugs, and the European Commission offers
no figure to support their current position.
The
proposed extension is clearly not intended to compensate manufacturers
for time lost in administrative procedures (marketing application,
health economic assessment, refunding negotiations, etc.): under
pressure from the pharmaceutical industry, the time available for
medicines agencies to evaluate new applications is already shrinking
to dangerous levels.
In
addition, the industry has obtained granting of "supplementary
protection certificates" that prolong patent protection up
to five years.
This
is quite enough: no further lengthening of the data protection period
is justified.
©Medicines in Europe Forum 15 October
2003
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