| On 2
June 2003, EU health ministers agreed to European Commission
proposals to modernise European medicines regulations, albeit
only by a qualified majority. After a second reading in the
European Parliament, the regulatory package should be ready
for final adoption by the end of 2003. The
package consists of:
- a
regulation on the European Agency for the Evaluation of
Medicinal Products (EMEA) and its marketing authorisation
procedure
- a
directive on human medicines
- a
directive on veterinary medicines
.According
to Erkki Liikanen, European Commissioner for Enterprise,
Europe should gain “a more robust, modern, effective
and competitive framework for pharmaceuticals” as
a result of the new laws.
The
new legislation will seek to extend the scope of mandatory
centralised marketing authorisation (beyond just biotech
products as at present) to all medicines for the treatment
of cancer, AIDS, neuro-degenerative diseases (for example,
Parkinson's and Alzheimer's) and diabetes. For other products,
companies will continue to be able to choose between the
centralised and mutual
recognition procedures.
This
does not go as far as earlier proposals, which suggested
that the centralised system should be compulsory for all
new product approvals in the EU, but Liikanen believes that
reinforcement of the centralised procedure will speed up
marketing authorisations and result in faster market access.
Data
protection rules set to change
In addition
to changing the parameters for centralised approvals, the
legislation will clear up anomalies in one of the most sensitive
areas of European drug regulation: data
protection. Under the current regulations, some member
states have seven years protection and others 10 (the so-called
'10-year rule').
All
member states will have 10 years data protection under the
mandatory system, extendable by one year if the producer
can show that the drug can be used for a new treatment.
For all other new approvals (mutual recognition or optional
centralised applications), generic producers will be able
to submit applications for marketing authorisation two years
before the 10-year period expires.
Slowing
pipelines worry Commission
The
EC moves come at a time of increased concern on both sides
of the Atlantic about perceived
dips in output from pharmaceutical industry pipelines.
Indeed, in Europe the EMEA is facing a financial crisis
due to a dramatic drop in new drug applications. The number
of applications fell from 54 in 2000 and 58 in 2001 to just
31 in 2002.
IMS
Global Consulting believes that the slackening
in R&D could be due to a number of factors in Europe,
including:
-
Formal or informal adoption of the ‘fourth hurdle’
in many markets, requiring new drugs increasingly to fulfil
unmet needs and to demonstrate cost-benefit over existing
therapies
- Growing
price sensitivity among governments and physicians
-
Pressure from investors to launch successful blockbusters
-
Mergers
and acquisitions leading companies to rationalise
their pipelines more rigorously
-
Greater demands in setting up clinical trials, as more
products in R&D are designed to treat chronic diseases,
including duration of trials, patient recruitment issues
and increasing red tape
-
Process and technology improvements that have allowed
only truly promising drug candidates to enter clinical
trials, with weaker candidates weeded out earlier
-
The high cost of new drug development, now estimated by
the Tufts Centre for the Study of Drug Development to
total $897 million per drug.
R&D
becoming more concentrated
These
factors also have led to a concentration of R&D into
a small number of therapy classes, led by cancer treatments,
vaccines and HIV treatments.
R&D
and New Product Focus, 2001
Source:
IMS
MIDAS, IMS
LifeCycle
It remains
to be seen how welcome the proposed changes will be to the
pharmaceutical industry, since some companies prefer to
submit their new drugs initially to local regulatory bodies
to undergo the mutual recognition procedure. This is partly
because it allows them to have co-marketing agreements using
different brand names (a single brand name has to be used
under the centralised procedure), and provides more flexibility
in product roll-out.
The
European Commission fears that many larger companies are
shifting their R&D to the US, where the FDA and the
market are seen to be more business friendly and less bureaucratic.
Any changes that simplify the procedure within the EU, therefore,
should be welcomed. |
