Impact of Accession on Impact of Accession on Generics in Candidate Generics in Candidate

CountriesCountries

Beata StepniewskaBeata StepniewskaEU Accession Manager EU Accession Manager

EGA EGA

25 February 200325 February 2003PraguePrague

EGA Representing EGA Representing Europe’sEurope’sGeneric Medicines Generic Medicines IndustryIndustry

Truly Pan European. Truly Pan European. Representing over 500 companies Representing over 500 companies

(excluding subsidiaries) and national (excluding subsidiaries) and national associations.associations.

Providing employment for over 85,000 Providing employment for over 85,000 people.people.

Promoting affordability and access to Promoting affordability and access to quality pharmaceutical care.quality pharmaceutical care.

Increasing the science base and export Increasing the science base and export potential of European industry.potential of European industry.

Enlargement in the EGA Enlargement in the EGA has already been done…has already been done…

Czech Rep.Czech Rep. PolandPoland Hungary Hungary SloveniaSlovenia Slovak RepSlovak Rep CyprusCyprus

Croatia Croatia TurkeyTurkey BulgariaBulgaria

New members:New members: RumaniaRumania Ex- New YugoslaviaEx- New Yugoslavia

Wide representation of generic Wide representation of generic companies form Candidate Countriescompanies form Candidate Countries

11stst of May 2004 of May 2004

2007

??????

Day X is coming…Day X is coming…

Impact of Accession on Impact of Accession on genericsgenerics

Accession TreatyAccession Treaty Free movement of goods (chapter 1)Free movement of goods (chapter 1) Company law (chapter 5)Company law (chapter 5)

New pharmaceutical legislation New pharmaceutical legislation (Review 2001)(Review 2001)

Impact of Accession Impact of Accession Negotiation on genericsNegotiation on generics

Accession TreatyAccession Treaty SPCSPC Parallel import Parallel import Update of documentation for existing Update of documentation for existing

products (transitional period for some products (transitional period for some countries) countries)

SPC in Accession TreatySPC in Accession Treaty

Common conditions: Common conditions: valid basic patentvalid basic patent link to the moment of first Marketing link to the moment of first Marketing

Authorisation (MA) Authorisation (MA)

Last change made by COREPER in February Last change made by COREPER in February first Marketing Authorisation (MA) first Marketing Authorisation (MA) in any of in any of

the Member Statesthe Member States,, not in Candidate not in Candidate Country concernedCountry concerned

““Potential Candidates for Potential Candidates for SPC”SPC” Products with the Products with the first MAfirst MA granted granted

Czech Rep - after 10Czech Rep - after 10thth of November 1999; of November 1999; Cyprus - prior to date of AccessionCyprus - prior to date of Accession Estonia – prior to date of AccessionEstonia – prior to date of Accession Hungary – after 1Hungary – after 1stst of January 2000 of January 2000 Latvia - prior to date of AccessionLatvia - prior to date of Accession Lithuania - prior to date of AccessionLithuania - prior to date of Accession Malta- prior to date of AccessionMalta- prior to date of Accession Poland - after 1Poland - after 1stst of January 2000 of January 2000 Slovakia - after 1Slovakia - after 1stst of January 2000 of January 2000 Slovenia - prior to date of AccessionSlovenia - prior to date of Accession

Parallel import in Accession Parallel import in Accession TreatyTreaty With regard to the Czech, Estonia, Latvia, Lithuania, With regard to the Czech, Estonia, Latvia, Lithuania,

Hungary, Poland, Slovenia or Slovakia the holder of Hungary, Poland, Slovenia or Slovakia the holder of patent or SPC of a pharm. product (…) may relay on the patent or SPC of a pharm. product (…) may relay on the rights granted by that patent or SPC in order to prevent rights granted by that patent or SPC in order to prevent the import and marketing of that product (…)the import and marketing of that product (…)

Any person intending to import or market a Any person intending to import or market a pharmaceutical product covered by the above pharmaceutical product covered by the above paragraph in a Member state where the product enjoys paragraph in a Member state where the product enjoys patent or supplementary protection shall demonstrate patent or supplementary protection shall demonstrate to the competent authorities in the application to the competent authorities in the application regarding that import that one month’s prior regarding that import that one month’s prior notification has been given to the holder or beneficiary notification has been given to the holder or beneficiary of such protection of such protection

Update of documentation Update of documentation for existing productsfor existing products

Czech Republic – date of accessionCzech Republic – date of accession Transitional period for some Transitional period for some

countriescountries(Poland, Slovenia, Cyprus, Malta, Lithuania)(Poland, Slovenia, Cyprus, Malta, Lithuania) Renewal in compliance with the Renewal in compliance with the acquisacquis and in and in

accordance with the timeframe set out in the accordance with the timeframe set out in the attached list or until attached list or until 31 December 2007 (in 31 December 2007 (in Slovenia)Slovenia) or or 31 December 2008 (in Poland),31 December 2008 (in Poland), whichever is earlier.whichever is earlier.

Impact of new legislation on Impact of new legislation on generics after Accessiongenerics after Accession

New pharmaceutical legislation (Review New pharmaceutical legislation (Review 2001)2001) Regulation 2309/93Regulation 2309/93 laying down Community laying down Community

procedures for the authorisation and procedures for the authorisation and supervision of medicinal products for human supervision of medicinal products for human and veterinary use and establishing a European and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products Agency for the Evaluation of Medicinal Products

Directive 2001/83Directive 2001/83 Community code relating Community code relating to medicinal products for human use to medicinal products for human use

Directive 2001/82Directive 2001/82 Community code relating Community code relating to medicinal products for veterinary useto medicinal products for veterinary use

Legislative procedureLegislative procedure

R e v ise d P os it ion

C o m m o n P o s it ion

C o u n c il o f M in is te rs(E s ta b lish e s w o rk in g g ro u p)

S e co n d R e ad ing

F irs t R e a d ing

E u rop e an P arlia m e nt(S e le c ts a C o m m itte e)

F o rm a l C om m iss io n P ro p o sa l(M a d e b y 2 0 C o lleg e o f C o m m iss ion e rs an d P u b lishe d in O J C )

C o m m iss io n D ra ft (m a de b y the P h a rm a ce u tica l U n it)

Modifiedproposal

Oct 2002

ConciliationFinal Text

I Q 2003

Next StepsNext Steps European Commission will propose modified European Commission will propose modified

proposals (Regulation already published/ March proposals (Regulation already published/ March 2003 Directive)2003 Directive)

Council of Ministers Working Group to agree Council of Ministers Working Group to agree Common Position (March 2003 Regulation / Common Position (March 2003 Regulation / III/IV Q 2003 (?) Directive)III/IV Q 2003 (?) Directive)

Second Reading in European Parliament Second Reading in European Parliament IV Q 2003 (?)IV Q 2003 (?)

Revised Common Position of the Council I Q 04?Revised Common Position of the Council I Q 04? Conciliation Committee Spring 2004Conciliation Committee Spring 2004 ? ?

3 Foundation Stones3 Foundation Stones

PrescribingDispensingPractices

EfficientRegulatory

System

Balanced PatentSystem

Access to Affordable Medicines

3 Basic Principles3 Basic Principles

Encourage doctors to prescribe and Encourage doctors to prescribe and pharmacists to dispense generics;pharmacists to dispense generics;

Ensure that regulatory system Ensure that regulatory system enables generic medicines to come enables generic medicines to come on the market immediately after on the market immediately after patent expiry;patent expiry;

Create a “balanced” Intellectual Create a “balanced” Intellectual Property system which encourages Property system which encourages real real innovation and not prolongation innovation and not prolongation of monopoly of old innovationof monopoly of old innovation

How far are these How far are these principles affected by principles affected by modified proposal of modified proposal of Regulation and Directive?Regulation and Directive?

Review 2001

Review 2001 -Main Issues Review 2001 -Main Issues Affecting Access to GenericsAffecting Access to Generics

Bolar provisionBolar provision ExportExport Data exclusivityData exclusivity Definition of generic, reference product Definition of generic, reference product

and EU reference productand EU reference product Definiton of biosimilar medicinal productDefiniton of biosimilar medicinal product Harmonisation of Product information Harmonisation of Product information

(SmPC summary of product (SmPC summary of product characteristics)characteristics)

Autorisation procedureAutorisation procedure

‘‘Bolar’-type Provision Bolar’-type Provision Introduced by ECIntroduced by EC

‘‘Conducting the necessary tests and trials Conducting the necessary tests and trials with a view to application to a generic with a view to application to a generic medicinal product shall not be regarded medicinal product shall not be regarded as contrary to patent related rights or to as contrary to patent related rights or to supplementary protection certificates for supplementary protection certificates for those medicinal products.’those medicinal products.’

The purpose of this provision is to bring The purpose of this provision is to bring the development work back into the EU; the development work back into the EU; it does not affect the date on which the it does not affect the date on which the generic product arrives on the marketgeneric product arrives on the market

Improved ‘Bolar’ adopted by Improved ‘Bolar’ adopted by EP EP

Submission of an application, Submission of an application, submission of samples, granting of a submission of samples, granting of a marketing authorisation and all same marketing authorisation and all same activities for export added to the activities for export added to the Commission’s Bolar provisionCommission’s Bolar provision

Rejection by Commission expectedRejection by Commission expected PartPartialial adoption by Council expected adoption by Council expected

Export Amendment for Export Amendment for Developing CountriesDeveloping Countries

Equivalent to Doha amendment as it Equivalent to Doha amendment as it allows export of generic versions of allows export of generic versions of patented products to countries which patented products to countries which have issued a compulsory licensehave issued a compulsory license

EGA welcomes EGA welcomes Rejection by Commission expectedRejection by Commission expected Adoption by Council – debate expectedAdoption by Council – debate expected

Data Exclusivity TodayData Exclusivity Today During data exclusivity period health During data exclusivity period health

authorities do not accept abridged authorities do not accept abridged «generic» applications relying on safety «generic» applications relying on safety and efficacy data of an originator product and efficacy data of an originator product used as reference productused as reference product

d.e. period starts from the date of d.e. period starts from the date of marketing authorisation of original marketing authorisation of original product in the Community product in the Community

6 years in AT, DK, FI, SP, IRL, PT, EL (NO, 6 years in AT, DK, FI, SP, IRL, PT, EL (NO, IS)IS)

10 years in BE, LU, FR, IT, DE ,NL ,SE ,UK10 years in BE, LU, FR, IT, DE ,NL ,SE ,UK Candidate Countries – 6 years!!!Candidate Countries – 6 years!!!

Data Exclusivity TomorrowData Exclusivity Tomorrow

EC proposal to harmonise at 10 years EC proposal to harmonise at 10 years and extend to 11 years where new and extend to 11 years where new indication of indication of significant clinical benefitsignificant clinical benefit

EGA has argued for:EGA has argued for: Harmonisation at 6 years on basis of Harmonisation at 6 years on basis of

significant improvement in IP over significant improvement in IP over past 15 years past 15 years

1 year extension only for indications 1 year extension only for indications not covered by patentnot covered by patent

Data ExclusivityData Exclusivity No No economic assessment was made by the economic assessment was made by the

Commission to arrive at a harmonised Commission to arrive at a harmonised period of 10/11 yearsperiod of 10/11 years

NoNo impact assessment on costs to impact assessment on costs to healthcare systemshealthcare systems

NoNo right to challenge - as in case of patents right to challenge - as in case of patents Data exclusivity was initially intended for Data exclusivity was initially intended for

products which cannot be patented (e.g. products which cannot be patented (e.g. natural substance)natural substance)

Data exclusivity period may be close or even Data exclusivity period may be close or even go beyond patent period in certain casesgo beyond patent period in certain cases

EP Compromise Amendment EP Compromise Amendment on on Data ExclusivityData Exclusivity

8 years harmonised data exclusivity (i.e. 8 years harmonised data exclusivity (i.e. submission and assessment of generic submission and assessment of generic application possible after 8 years) but application possible after 8 years) but granting of the marketing authorisation, granting of the marketing authorisation, manufacturing and marketing of the generic manufacturing and marketing of the generic only possible after 10/11 years from the only possible after 10/11 years from the first first authorisation of the original reference productauthorisation of the original reference product

Compromise adopted by very large majority Compromise adopted by very large majority (493 in favour, 53 against and 3 abstentions)(493 in favour, 53 against and 3 abstentions)

Rejection by Commission expectedRejection by Commission expected Council – possible reintroducing of 8 yearsCouncil – possible reintroducing of 8 years

Additional Data Exclusivity Additional Data Exclusivity Amendments of EPAmendments of EP

3-years data exclusivity for new indication 3-years data exclusivity for new indication of well-established substance (i.e. after 10 of well-established substance (i.e. after 10 years of use) years of use)

major threat as it may lead to 14 years major threat as it may lead to 14 years marketmarket exclusivity, further ‘vertical’ disharmony within exclusivity, further ‘vertical’ disharmony within Member States and undermining of national Member States and undermining of national substitution and reimbursement poiliciessubstitution and reimbursement poilicies Introducing by Commision under disscussion- Introducing by Commision under disscussion-

key issue!!key issue!! 3 years data exclusivity for OTC switch 3 years data exclusivity for OTC switch

Introducing by Commision expected –Council not Introducing by Commision expected –Council not fully supportivefully supportive

Definition of GenericDefinition of Generic

EC definition based on current EC definition based on current practice of the MSs and practice of the MSs and international scientific consensusinternational scientific consensus

Definition amended by EP requiring Definition amended by EP requiring for the active substance of the for the active substance of the generic strict chemical identicality generic strict chemical identicality with the active substance of the with the active substance of the reference productreference product

EP Definition of GenericEP Definition of Generic ‘‘Generic medicinal product shall mean Generic medicinal product shall mean

a medicinal product which has the same a medicinal product which has the same qualitative and quantitative composition qualitative and quantitative composition in active substance (s) (in active substance (s) (chemically chemically identical in terms of isomer, complex, identical in terms of isomer, complex, crystal polymorphic form, simple ester crystal polymorphic form, simple ester or salt form of the activeor salt form of the active moiety)moiety) and and the same pharmaceutical form and is the same pharmaceutical form and is bio-equivalent to the reference product, bio-equivalent to the reference product, unless it differs significantly from the unless it differs significantly from the original product as regards safety and original product as regards safety and efficacy’efficacy’

EP Definition of GenericEP Definition of Generic

Anticompetitive as it provides excellent Anticompetitive as it provides excellent tool for originator companies to block tool for originator companies to block genericsgenerics

Dramatic consequences on national Dramatic consequences on national healthcare budgetshealthcare budgets

Unscientific as different forms of the Unscientific as different forms of the active moiety can be bioequivalent and active moiety can be bioequivalent and have the same safety and efficacy have the same safety and efficacy profileprofile

Definition of Reference Definition of Reference Product (single MA)Product (single MA)

Commission’s definition refers to new Commission’s definition refers to new concept of single marketing concept of single marketing authorisation authorisation

Consequently additional data exclusivity Consequently additional data exclusivity for e.g. new pharmaceutical forms, for e.g. new pharmaceutical forms, strengths is excludedstrengths is excluded

Single MA concept now rejected by EPSingle MA concept now rejected by EP Definition of reference product becomes Definition of reference product becomes

crucial for access to genericscrucial for access to generics

EU Reference ProductEU Reference Product EP proposed possibility to be able to refer to a EP proposed possibility to be able to refer to a

reference product from another MS when absent in reference product from another MS when absent in first MSfirst MS

Commission accepted “in principle”Commission accepted “in principle” important for accession states in keeping existing important for accession states in keeping existing

products on market/updating dossiersproducts on market/updating dossiers Important for small CCs Important for small CCs Single market as the EU principleSingle market as the EU principle Solution to prevent strategic withdrawals of originator Solution to prevent strategic withdrawals of originator

productsproducts Council expected to be very careful of practical Council expected to be very careful of practical

detailsdetails

Definition of Biosimilar Definition of Biosimilar ProductProduct

Unethical, anticompetitive and unscientific Unethical, anticompetitive and unscientific defintion suggested by EP (full dossier in any defintion suggested by EP (full dossier in any case)case)

Rejection by the Commission expectedRejection by the Commission expected Definition being developed by CPMP Biotech WP Definition being developed by CPMP Biotech WP

expected to be accepted by Commission and Councilexpected to be accepted by Commission and Council New legal/regulatory framework introduced New legal/regulatory framework introduced

into Annex I of Directive 2001/83/EC (case-by-into Annex I of Directive 2001/83/EC (case-by-case approach)case approach)

Other Regulatory IssuesOther Regulatory Issues Scope of Centralised Procedure – all Scope of Centralised Procedure – all

NCEs obliged to use CPNCEs obliged to use CP Validity of MA Validity of MA

MA renewal once, after 5 years MA renewal once, after 5 years MA – expiry after 3 years if product not MA – expiry after 3 years if product not

marketedmarketed Area still not sufficiently covered by new Area still not sufficiently covered by new

proposalproposal Harmonisation of SmPCsHarmonisation of SmPCs Usage patentUsage patent

Harmonisation of SmPCsHarmonisation of SmPCs (Summary of product (Summary of product characteristics)characteristics)

Harmonisation of product information Harmonisation of product information is major issue as 50% of generic MRP is major issue as 50% of generic MRP applications are withdrawn or have applications are withdrawn or have reduced indicationsreduced indications

Legal provision for harmonisation Legal provision for harmonisation introduced by Commissionintroduced by Commission

It is crucial that harmonisation of It is crucial that harmonisation of reference products takes place before reference products takes place before expiration of data exclusivity periodexpiration of data exclusivity period

’’Vertical’ HarmonisationVertical’ Harmonisation

Even if harmonisation process becomes Even if harmonisation process becomes successful, successful, vertical disharmony will not vertical disharmony will not disappeardisappear because of second medical because of second medical use use patents and possible new data exclusivity patents and possible new data exclusivity on new minor indicationson new minor indications

Use PatentsUse Patents “C “Catch 22atch 22”” situation situation:: If patented use included in SmPC then If patented use included in SmPC then

breach of patentbreach of patent If not included, breach of public health or If not included, breach of public health or

no no reimbursement and substitution reimbursement and substitution statusstatus!!

Why should we fight for Why should we fight for generics in CCs? generics in CCs?

Generic Medicines Critical for Generic Medicines Critical for New EU Members’ Health Care New EU Members’ Health Care SystemSystem

Average GDP per Average GDP per capita in capita in Candidate Candidate Countries (CCs) is Countries (CCs) is 5 times lower 5 times lower than EU average.than EU average.

Real spending per Real spending per capita on health capita on health in CCs is in CCs is <400Euros <400Euros compared to compared to >1,600 Euros in >1,600 Euros in EUEU

Access to Generics in Access to Generics in EEuropeurope

Generic Market Share (2002)Generic Market Share (2002) Germany 23% Value 36% VolumeGermany 23% Value 36% Volume UK 13% Value 42.% UK 13% Value 42.%

VolumeVolume Denmark 15% Value 57% VolumeDenmark 15% Value 57% Volume Netherlands 14% Value 37% VolumeNetherlands 14% Value 37% Volume Ireland 8% Value 12% Volume Ireland 8% Value 12% Volume Spain, Italy, Spain, Italy, 2-3%2-3% Value 2-5% Value 2-5%

VolumeVolume

PortugalPortugal CEE (average) 30% Value 70% CEE (average) 30% Value 70%

VolumeVolume

Generics Generics 70% of Volume for 30% of Costs70% of Volume for 30% of Costs

0

10

20

30

40

50

60

70

Originals Generics

V CC V

4 Key Reasons to promote 4 Key Reasons to promote Generic MedicinesGeneric Medicines

Increases access to health (generics are Increases access to health (generics are usually 20-80% of original price)usually 20-80% of original price)

Competition stimulates innovationCompetition stimulates innovation Provides “headroom” for innovation - Provides “headroom” for innovation -

savings from using generics can help savings from using generics can help health budgets pay for new expensive health budgets pay for new expensive products. products.

Stimulates local production and Stimulates local production and pharmaceutical developmentpharmaceutical development

Major SavingsMajor Savings

In the European In the European Union Over 12 Union Over 12 Billion Euros Billion Euros saved per year by saved per year by use of generic use of generic medicinesmedicines

By 2004 35% of By 2004 35% of top molecules’ top molecules’ patents expire = patents expire = increases savings increases savings potentialpotential

GG

Generic Availability Needs Generic Availability Needs Government ActionGovernment Action

Access to generic Access to generic medicines requires medicines requires supportive supportive government government measures because:measures because: Demand is Demand is

stimulated by stimulated by prescribing and prescribing and dispensing habits dispensing habits not by purchasers not by purchasers

Supply is Supply is dependent on dependent on Regulatory and IP Regulatory and IP practicespractices

G

EU is EU is atat aa crossroad crossroadss•20 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

uncompetitiveindustry, low affordability,unstable H-C budget

competitive industry, affordability,stable budget

New EU Medicines Law being developed New EU Medicines Law being developed Candidate Countries must seek to influence Candidate Countries must seek to influence now!now!

Still a chance!!!Still a chance!!! First common position of the First common position of the

Council III/IVQ 03– observers Council III/IVQ 03– observers from CCs after signature of from CCs after signature of the Treaty (16the Treaty (16thth of April of April 2003)2003)

IVQ 03/IQ 04 (?) Second IVQ 03/IQ 04 (?) Second Reading of European Reading of European Parliament (EP) – influence Parliament (EP) – influence from National Parliaments from National Parliaments (interparliamentary (interparliamentary cooperation)cooperation)

Conciliation Spring 04 ?Conciliation Spring 04 ? Accession 1 May 2004 Accession 1 May 2004 New law starts Spring 2005?New law starts Spring 2005?

Too late!!

Ministers of Health from CCs

In 2003 EGA together with In 2003 EGA together with New EU Members are New EU Members are working for…working for… 6 years/8 years compromise Data 6 years/8 years compromise Data

Exclusivity. Exclusivity. No data exclusvity for minor new No data exclusvity for minor new

indications.indications. Appropriate defintions for generic. Appropriate defintions for generic. Framework for Bio-comparable products. Framework for Bio-comparable products. Harmonised SmPCs. Harmonised SmPCs. Resolving « is/has been authorised » Resolving « is/has been authorised »

problem. problem. An EU Bolar provision. An EU Bolar provision. An EU reference product. An EU reference product.

Thank You ! Thank You !

ACZ E G