[Pharm-policy] Greg Perry on EU and Health Registration Data
James Love
love@cptech.org
Fri, 28 Jan 2000 15:46:44 -0500
These are two emails and a short response with Greg Perry regarding
the EU provisions on data exclusivity. Jamie
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From: "Greg Perry" <EGA2@csi.com>
To: "James Love" <love@cptech.org>
Subject: Re: Health registration data
Date: Thu, 27 Jan 2000 09:42:02 -0000
1. EU authorisation system
Jamie,
I explain various issues you raised below
Authorisation of medical products can either go through:
- The Centralised European system (obligatory for bio-tech product) or
through
- National registrations/Mutual Recognition
Law on the exclusivity of clinical information is covered by the EU.
However, in case of national authorisations Members States are given various
options under the law as to how long a period of protection is given for
national registrations.
2.Periods of exclusivity
Products which received their authorisation through the European Centralised
system receive a 10 year data exclusivity.
Products which received their authorisation nationally will have data
exclusivity periods according to the time frame option operated in the
Member State. The protection period for each EU Member States is as follows:
- 10 years in Belgium,Germany,France,Italy,the Netherlands,Sweden,UK
- 6 years in Austria,Denmark, Finland,Ireland Luxembourg ,
- maximum 6 years but can not go beyond period of patent protection in
Spain,Greece, Portugal, .
- Iceland and Norway (EFTA countries) have also adopted 6 years.
- New member scheduled for 2003 I.e. Poland, Hungary, Slovenia and Czech
Republic are expected to opt for 6 years, Poland and Hungary are also
expected to opt for 6 years but not beyond patent period.Hungary has also
asked for transitional period of years after EU accession to implement law.
3. What is covered by Data Exclusivity
It is important to note that under EU law, data exclusivity only relates to
the NCE for which the first registration was made. Consequently, any new
indications, dosage strength, or dosage form will not be covered by
additional or new periods of data exclusivity.
This was made clear in the so called "Generics case" of the European Court
of Justice C 368/96 of December 3, 1998. Until this ruling certain Member
States were "illegally" granting data exclusivity for new indications.
There has been intense lobbying from EFPIA to change this law .They are
demanding 10 years for all new indications, strengths and formulations. They
claim that new indications are brought about by extensive trials and costs
and should be protected. We argue that if they are "innovative" new uses
they would be covered by a patent. Protection of innovation should be made
by patent protection and not by data exclusivity.Clearly ,as in USA, the
originator pharmaceutical industry is trying to have both patents and data
exclusivity for protection.
The EU Commission is now considering this issue and at TABD they indicated
that they wanted to review the financial, competition, and health
implications of such a change in the law to cover indications. The European
Commission is also considering paediatric indications very seriously and may
propose a 6 month-1 year exclusivity period to encourage companies to cover
"children's needs".
4. Harmonisation
There is also serious discussion to harmonise all data exclusivity
provisions at national level. This is required for the proper function of
the single market and the Mutual Recognition Procedure. EFPIA are calling
for 10 years. We have called for 5 years and only covering NCEs. The
Commission has floated the idea of 7-8 years and dropping the link to
patent. However the 10 year period for Centralised Products will remain as
part of this plan. There has also been low key talk of linking the
introduction of data exclusivity for indications with a Bolar
provision.Originator companies might accept this deal especially now that
the WTO Panel has favoured Bolar provisions I.e. they see the writing on the
whole and want to get something out it for themselves. All this talk of
change falls within the so called "2001 Review" of Pharmaceutical
legislation which has already begun. The idea is that by end of 2001 the
European Union will be ready to update its pharmaceutical law so at be
operative say by 2003/2004.
5 Paclitaxol
The attempted registration of paclitaxol was made through the bibliographic
procedure I.e. scientific literature based application. At the time the law
was unclear as to the term "well established use" which was the term given
it the type of product that could use such a system. As you know the Dutch
authorities approved YEWTREE's product under this procedure but was
challenged by BMS and the European Commission. The later argued that " well
established" required at least 10 years on the market and made reference to
the statements of a a judgement in ECJ case. I think you know the rest of
the story... but in short the Law has just been amended to clearly indicate
that "Well establish" means 10 years. As a result in Europe there is no
clear avenue for getting "generic" versions of unpatented products made
publicly available through scientific knowledge on the market . As you know
the WHO has defined "Well established " as 5 years on the market . The EU is
yet again out of line with rest of the world and using scientific language
to provide excessive protection.
6. Withdrawal for the market
You should also be aware of a new strategy being developed in the EU to
prevent generic competition and parallel importing. Brand companies have
started withdrawing their products/ revoking their licences just before
patent expiry and replacing with a formation changed version of the product.
in so doing they are claiming that a generic of the first version can not
be placed on the market since there is no longer any brand reference product
that the generic can make reference to! Worst still the national
registration authorities and the EU Commission are agreeing to this!They are
doing so because the way the EU law is written states that an abridged
application must be made based on a product that has been authorised in the
EU and "is marketed" in the Member State that the application is made". The
EU Commission is seeking to have a guideline that will say that if the
originator product was authorised at time of generic application that
generic application can go ahead.However if generic applications are made
after the revoking of the licence then the generic can not proceed. We are
still pursuing this issue.
I hope this is all of help. I wish you all the best in TACD and we are very
lucky that some one like you on the consumer side takes such an interest
inthese issues.
Greg
<------------------------------------------------------------------------>
Date: Fri, 28 Jan 2000 05:47:00 -0500 (EST)
To: e-drug@usa.healthnet.org
From: Greg Perry <gperry@egagenerics.com>
Subject: [e-drug] TACD on Pharma Registration Data Exclusivity (cont'd)
E-drug: TACD on Pharma Registration Data Exclusivity (cont'd)
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Jamie,
Just one point:
The 10 year data exclusivity period was indeed introduced to make
up for a lack of patent protection though mainly for biotech products
and not so much for lack of patent laws in Spain and Portugal.
However, you are quite right to emphasise tht since EU national laws
and TRIPs have provided for 20 year patents the arguments for such
long data exclusivity should end. Indeed the EU has now adopted a
Bio-tech patent and this should make the 10 year data exclusivity
period unnecessary. This may be a very good point for you to push.
Greg
Greg Perry
Director General
European Generic Medicines Association (EGA)
PO Box 193
Brussels 1040, Belgium
Tel 32.2.7368411
Fax: 32 2 7367438
e mail: gperry@egagenerics.com
web: www.egagenerics.com
<---------------------------------------------------------------------->
Date: Fri, 28 Jan 2000 09:50:20 -0500 (EST)
To: e-drug@usa.healthnet.org
From: James Love <love@cptech.org>
Subject: e-drug] TACD on Pharma Registration Data Exclusivity (cont'd)
E-drug: TACD on Pharma Registration Data Exclusivity (cont'd)
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Greg, thanks for this information. When I visited with DGIII in 1998, I
talked with them directly about data exclusivity issue, and they
brought up the issue of patents in Spain and Portugal, and offered that
as the main reason. However, I was not aware that there was a
separate issue regarding biologics, and will add a discussion of this
too.
Jamie
James Love, Consumer Project on Technology
P.O. Box 19367 | http://www.cptech.org
Washington, DC 20036 | love@cptech.org
Voice 202/387-8030 | Fax 202/234-5176
--
James Love, Consumer Project on Technology
P.O. Box 19367 | http://www.cptech.org
Washington, DC 20036 | mailto:love@cptech.org
Voice 1.202.387.8030 | fax 1.202.387.8030