Transcript EGA Priorities 2002-2003

Impact of Accession on
Generics in Candidate Countries
Beata Stepniewska
EU Accession Manager
EGA
25 February 2003
Prague
EGA Representing Europe’s
Generic Medicines Industry
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Truly Pan European.
Representing over 500 companies (excluding
subsidiaries) and national associations.
Providing employment for over 85,000
people.
Promoting affordability and access to quality
pharmaceutical care.
Increasing the science base and export
potential of European industry.
Enlargement in the EGA has
already been done…
Wide representation of generic companies
form Candidate Countries
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Czech Rep.
Poland
Hungary
Slovenia
Slovak Rep
Cyprus
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Croatia
Turkey
Bulgaria
New members:
 Rumania
 Ex- New Yugoslavia
Day X is coming…
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1st of May 2004
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??? 2007
???
Impact of Accession on generics
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Accession Treaty
Free movement of goods (chapter 1)
 Company law (chapter 5)
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New pharmaceutical legislation (Review
2001)
Impact of Accession Negotiation
on generics
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Accession Treaty
SPC
 Parallel import
 Update of documentation for existing
products (transitional period for some
countries)
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SPC in Accession Treaty
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Common conditions:
valid basic patent
 link to the moment of first Marketing
Authorisation (MA)
Last change made by COREPER in February
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first Marketing Authorisation (MA) in any of the
Member States, not in Candidate Country
concerned
“Potential Candidates for SPC”
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Products with the first MA granted
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Czech Rep - after 10th of November 1999;
Cyprus - prior to date of Accession
Estonia – prior to date of Accession
Hungary – after 1st of January 2000
Latvia - prior to date of Accession
Lithuania - prior to date of Accession
Malta- prior to date of Accession
Poland - after 1st of January 2000
Slovakia - after 1st of January 2000
Slovenia - prior to date of Accession
Parallel import in Accession
Treaty
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With regard to the Czech, Estonia, Latvia, Lithuania,
Hungary, Poland, Slovenia or Slovakia the holder of patent
or SPC of a pharm. product (…) may relay on the rights
granted by that patent or SPC in order to prevent the
import and marketing of that product (…)
Any person intending to import or market a pharmaceutical
product covered by the above paragraph in a Member state
where the product enjoys patent or supplementary
protection shall demonstrate to the competent authorities
in the application regarding that import that one month’s
prior notification has been given to the holder or beneficiary
of such protection
Update of documentation for
existing products
Czech Republic – date of accession
 Transitional period for some countries
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(Poland, Slovenia, Cyprus, Malta, Lithuania)
 Renewal in compliance with the acquis and in accordance
with the timeframe set out in the attached list or until 31
December 2007 (in Slovenia) or 31 December 2008
(in Poland), whichever is earlier.
Impact of new legislation on
generics after Accession
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New pharmaceutical legislation (Review 2001)
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Regulation 2309/93 laying down Community
procedures for the authorisation and supervision
of medicinal products for human and veterinary
use and establishing a European Agency for the
Evaluation of Medicinal Products
Directive 2001/83 Community code relating to
medicinal products for human use
Directive 2001/82 Community code relating to
medicinal products for veterinary use
Legislative procedure
Commission Draft (made by the Pharmaceutical Unit)
Formal Commission Proposal
(Made by 20 College of Commissioners and Published in OJ C)
Modified
proposal
Council of Ministers
(Establishes working group)
European Parliament
(Selects a Committee)
Common Position
First Reading
Revised Position
Second Reading
I Q 2003
Conciliation
Oct
2002
Final
Text
Next Steps
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European Commission will propose modified
proposals (Regulation already published/ March
2003 Directive)
Council of Ministers Working Group to agree
Common Position (March 2003 Regulation / III/IV
Q 2003 (?) Directive)
Second Reading in European Parliament
IV Q 2003 (?)
Revised Common Position of the Council I Q 04?
Conciliation Committee Spring 2004 ?
3 Foundation Stones
Access to Affordable Medicines
Prescribing
Dispensing
Practices
Efficient
Regulatory
System
Balanced
Patent
System
3 Basic Principles
Encourage doctors to prescribe and
pharmacists to dispense generics;
 Ensure that regulatory system enables
generic medicines to come on the market
immediately after patent expiry;
 Create a “balanced” Intellectual Property
system which encourages real innovation
and not prolongation of monopoly of old
innovation
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How far are these principles
affected by modified proposal
of Regulation and Directive?
Review
2001
Review 2001 -Main Issues
Affecting Access to Generics
Bolar provision
 Export
 Data exclusivity
 Definition of generic, reference product
and EU reference product
 Definiton of biosimilar medicinal product
 Harmonisation of Product information
(SmPC summary of product characteristics)
 Autorisation procedure
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‘Bolar’-type Provision
Introduced by EC
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‘Conducting the necessary tests and trials
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The purpose of this provision is to bring the
development work back into the EU; it does
not affect the date on which the generic
product arrives on the market
with a view to application to a generic
medicinal product shall not be regarded as
contrary to patent related rights or to
supplementary protection certificates for
those medicinal products.’
Improved ‘Bolar’ adopted by EP
Submission of an application, submission of
samples, granting of a marketing
authorisation and all same activities for
export added to the Commission’s Bolar
provision
 Rejection by Commission expected
 Partial adoption by Council expected
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Export Amendment for
Developing Countries
Equivalent to Doha amendment as it allows
export of generic versions of patented
products to countries which have issued a
compulsory license
 EGA welcomes
 Rejection by Commission expected
 Adoption by Council – debate expected
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Data Exclusivity Today
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During data exclusivity period health authorities
do not accept abridged «generic» applications
relying on safety and efficacy data of an
originator product used as reference product
d.e. period starts from the date of marketing
authorisation of original product in the
Community
6 years in AT, DK, FI, SP, IRL, PT, EL (NO, IS)
10 years in BE, LU, FR, IT, DE ,NL ,SE ,UK
Candidate Countries – 6 years!!!
Data Exclusivity Tomorrow
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EC proposal to harmonise at 10 years and
extend to 11 years where new indication of
significant clinical benefit
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EGA has argued for:
 Harmonisation at 6 years on basis of
significant improvement in IP over past 15
years
 1 year extension only for indications not
covered by patent
Data Exclusivity
No economic assessment was made by the
Commission to arrive at a harmonised period
of 10/11 years
 No impact assessment on costs to healthcare
systems
 No right to challenge - as in case of patents
 Data exclusivity was initially intended for
products which cannot be patented (e.g.
natural substance)
 Data exclusivity period may be close or even
go beyond patent period in certain cases
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EP Compromise Amendment on
Data Exclusivity
8 years harmonised data exclusivity (i.e.
submission and assessment of generic
application possible after 8 years) but
granting of the marketing authorisation,
manufacturing and marketing of the generic
only possible after 10/11 years from the first
authorisation of the original reference product
 Compromise adopted by very large majority
(493 in favour, 53 against and 3 abstentions)
 Rejection by Commission expected
 Council – possible reintroducing of 8 years
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Additional Data Exclusivity
Amendments of EP
3-years data exclusivity for new indication of
well-established substance (i.e. after 10 years
of use)
major threat as it may lead to 14 years market
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exclusivity, further ‘vertical’ disharmony within
Member States and undermining of national
substitution and reimbursement poilicies
 Introducing by Commision under disscussion- key
issue!!
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3 years data exclusivity for OTC switch
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Introducing by Commision expected –Council not
fully supportive
Definition of Generic
EC definition based on current practice
of the MSs and international scientific
consensus
 Definition amended by EP requiring for
the active substance of the generic
strict chemical identicality with the
active substance of the reference
product
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EP Definition of Generic
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‘Generic medicinal product shall mean a
medicinal product which has the same
qualitative and quantitative composition in
active substance (s) (chemically identical in
terms of isomer, complex, crystal polymorphic
form, simple ester or salt form of the active
moiety) and the same pharmaceutical form
and is bio-equivalent to the reference
product, unless it differs significantly from the
original product as regards safety and
efficacy’
EP Definition of Generic
Anticompetitive as it provides excellent tool
for originator companies to block generics
 Dramatic consequences on national
healthcare budgets
 Unscientific as different forms of the active
moiety can be bioequivalent and have the
same safety and efficacy profile
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Definition of Reference Product
(single MA)
Commission’s definition refers to new concept
of single marketing authorisation
 Consequently additional data exclusivity for
e.g. new pharmaceutical forms, strengths is
excluded
 Single MA concept now rejected by EP
 Definition of reference product becomes
crucial for access to generics
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EU Reference Product
EP proposed possibility to be able to refer to a
reference product from another MS when absent in
first MS
 Commission accepted “in principle”
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important for accession states in keeping existing
products on market/updating dossiers
Important for small CCs
Single market as the EU principle
Solution to prevent strategic withdrawals of originator
products
Council expected to be very careful of practical
details
Definition of Biosimilar Product
Unethical, anticompetitive and unscientific defintion
suggested by EP (full dossier in any case)
 Rejection by the Commission expected
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Definition being developed by CPMP Biotech WP expected
to be accepted by Commission and Council
New legal/regulatory framework introduced into
Annex I of Directive 2001/83/EC (case-by-case
approach)
Other Regulatory Issues
Scope of Centralised Procedure – all NCEs
obliged to use CP
 Validity of MA
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MA renewal once, after 5 years
MA – expiry after 3 years if product not marketed
Area still not sufficiently covered by new
proposal
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Harmonisation of SmPCs
Usage patent
Harmonisation of SmPCs
(Summary of product characteristics)
Harmonisation of product information is
major issue as 50% of generic MRP
applications are withdrawn or have
reduced indications
 Legal provision for harmonisation
introduced by Commission
 It is crucial that harmonisation of reference
products takes place before expiration of
data exclusivity period
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’Vertical’ Harmonisation
Even if harmonisation process becomes
successful, vertical disharmony will not
disappear because of second medical use
patents and possible new data exclusivity on
new minor indications
 Use Patents “Catch 22” situation:
 If patented use included in SmPC then
breach of patent
 If not included, breach of public health or
no reimbursement and substitution status!
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Why should we fight for
generics in CCs?
Generic Medicines Critical for New
EU Members’ Health Care System
Average GDP per
capita in Candidate
Countries (CCs) is 5
times lower than EU
average.
 Real spending per
capita on health in
CCs is <400Euros
compared to >1,600
Euros in EU
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Access to Generics in Europe
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Generic Market Share (2002)
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Germany
UK
Denmark
Netherlands
Ireland
Spain, Italy,
Portugal
23% Value
13% Value
15% Value
14% Value
8% Value
2-3% Value
36% Volume
42.% Volume
57% Volume
37% Volume
12% Volume
2-5% Volume
CEE (average) 30% Value 70%
Volume
Generics
70% of Volume for 30% of Costs
70
60
50
40
30
20
10
0
C
V
Originals
C
V
Generics
4 Key Reasons to promote
Generic Medicines
Increases access to health (generics are
usually 20-80% of original price)
 Competition stimulates innovation
 Provides “headroom” for innovation - savings
from using generics can help health budgets
pay for new expensive products.
 Stimulates local production and
pharmaceutical development
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Major Savings
In the European
Union Over 12
Billion Euros saved
per year by use of
generic medicines
 By 2004 35% of top
molecules’ patents
expire = increases
savings potential
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GG
Generic Availability Needs
Government Action
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Access to generic
medicines requires
supportive government
measures because:
 Demand is
stimulated by
prescribing and
dispensing habits not
by purchasers
 Supply is dependent
on Regulatory and IP
practices
G
EU is at a•20crossroads
years patent +
indications, formulation
design patents.
•Strategic Withdrawals
•Restrictive definitions for
generics and bio-generics
•Standard DE 11 years
•OTC Switch exclusivity
•Indication exclusivity
•Pediatric exclusivity
•Geriatric exclusivity
•+….
•20 years patent protection
•Real Bolar
•No more SPCs
•Balanced Exclusivity
•Harmonised SmPC
•Real innovation promoted
uncompetitive
industry, low
affordability,
unstable H-C
budget
competitive
industry,
affordability,
stable budget
New EU Medicines Law being developed
Candidate Countries must seek to influence now!
Still a chance!!!
 First common position of the
Council III/IVQ 03– observers
from CCs after signature of the
Treaty (16th of April 2003)
 IVQ 03/IQ 04 (?) Second
Reading of European Parliament
(EP) – influence from National
Parliaments (interparliamentary
cooperation)
 Conciliation Spring 04 ?
 Accession 1 May 2004
 New law starts Spring 2005?
Too late!!
Ministers of
Health from CCs
In 2003 EGA together with New
EU Members are working for…
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6 years/8 years compromise Data Exclusivity.
No data exclusvity for minor new indications.
Appropriate defintions for generic.
Framework for Bio-comparable products.
Harmonised SmPCs.
Resolving « is/has been authorised » problem.
An EU Bolar provision.
An EU reference product.
Thank You !
CZ
E
G
A