|
Early in 2001, the European
Commission formally adopted the review of proposals for
regulatory reform of the pharmaceutical industry (deliberations
have not yet begun). One of these proposals is to extend
the list of products for which the centralised procedure
is compulsory to include all new chemical entities (NCEs).
Preempting the review, several
speakers at the European Federation of Pharmaceutical
Industries and Associations (EFPIA) information day,
held in London in October 2001, recommended that innovative
pharmaceutical companies should still be allowed to choose
between the mutual recognition procedure (MRP) and the centralised
procedure when they apply for marketing authorization for
an NCE.
The proposal has arisen despite
the fact that, since the introduction of MRP, the
Mutual Recognition Facilitation Group (MRFG), concerned
member states and applicants have made considerable efforts
to improve the MRP, although it is acknowledged that further
improvements are still needed.
Current state of play
The European pharmaceutical regulatory
system is based on three complementary procedures for the
registration of medicinal products:
- The Centralised Procedure
- is mandatory for certain biotechnological medicinal
products and optional for other innovative products. A
pharmaceutical company established in the European Union
can submit a marketing authorisation application to the
European Agency for the Evaluation of Medicinal Products
(EMEA). The recommendation of the EMEA’s Committee for
Proprietary Medicinal Products (CPMP), the scientific
advisory committee for the EU registration system, serves
as the basis for approval by the EC (typically issued
within three to four months of a positive CPMP opinion).
Approval results in a single marketing authorisation valid
in all 15 member states of the EU.
- The Mutual Recognition
Procedure - a route for non-biotech products. A pharmaceutical
company established in the EU, which has already obtained
a marketing authorisation in one EU member state, can
apply to one or more other member states to recognise
it, in accordance with the mutual recognition principle.
- The National Procedure
- used to authorise medicinal products for local use
in individual member states.
Performance of the MRP
According to the MRFG, during
the three years of the transition period (1995-1997), 249
new applications were finalised through the MRP. The number
of procedures finalised
each year has continued to grow, reaching 287 in 2000.
MRP statistics
| |
1995-1997
|
1998
|
1999
|
2000
|
Total
|
|
Number of procedures finalised
|
249
|
180
|
253
|
287
|
969
|
|
% of procedures with at
least one CMS withdrawn
|
46%
|
47%
|
28%
|
36%
|
39%*
|
|
% of national withdrawn
applications relating to all CMSs
|
12%
|
16.5%
|
8.2%
|
5.5%
|
10.5%*
|
Source: MRFG
*Note: as of 30 September 2000
Of the procedures finalised in
2000, around 36% were withdrawn from at least one CMS (concerned
member state), with the majority of withdrawals coming from
two countries: France and Spain. Companies frequently
withdraw applications for products in countries that raise
objections in order to avoid arbitration and to speed up
registration in the remaining EU countries.
Although mutual recognition use
continued to increase in 2000, the overall number of withdrawals
(primarily relating to generics and line extensions) is
still regarded as too high, with the MRP being perceived
a failure compared to the centralised process.
Barriers to mutual recognition
Generic
substitution has grown in France
and Spain since recent
legislative changes. In order to obtain registration, however,
generic applicants in these countries have to be identical
to original products - having the same number of indications,
the same strength, the same side effect profile and even
the same product information. Generic companies often complain
that they are unable to successfully register their products
via the MRP because of the discrepancies in the originator
product’s labeling in various member states.
Also, as reported in IMS HEALTH’s
Pharma
Prognosis International,
there is a reluctance of member states to accept the reference
member state’s assessment without change, particularly
the summary of product characteristics.
Progress made
In order to assess the recent
trends regarding the operation of the MRP, the EFPIA conducted
a short survey in early October 2001.
The main improvements found were:
- increasing interactions and
dialogue between all stakeholders (reference member state,
concerned member state and companies)
- better compliance of component
authorities with different time periods
- improvement with respect to
additional documents requested
- most of the companies that
have experienced the change in the MRP timetable (questions
due on Day 50 instead of Day 55) consider it useful (more
time devoted to clarification and dialogue phase).
Remaining concerns
According to the EFPIA, areas
where the MRP still has problems are:
- Defining what represents a
‘serious public health issue’ in the EU
There remain too many objections
referred to as ‘serious public health issues’.
A clear differentiation is needed to separate real serious
health issues (no longer to be called major issues) and
points for clarification (no longer to be called minor).
The latter should not delay the national approval.
- Delays in the granting of
national marketing authorisations
To anticipate problems before
granting the first marketing authorisation, there should
be more collaborative work between the reference member
state and the applicant as early as possible. It is proposed
that the RMS, together with the applicant and/or concerned
member states, should prepare a list of potential problems,
taking into account medical practices in the CMSs. Any fundamental
issue identified by the RMS could then be discussed on a
case-by-case basis in the MRFG.
- Insufficient use of electronic
tools to facilitate communication and transmission of
documents
Problems relating to logistics, copies, translations and
additional documents persist.
|
