Transcript PORTUGAL

Polish pharmaceutical market in accession year
Negotiations on accession to the European Union
related to pharmaceutical sector 1999 – 2003
(case of Poland with some informations
on other countries positions)
Chapter 1 – Free Movement of Goods
Chapter 5 – Company Law
Cezary Sledziewski
Polish Union of Employers in Pharmaceutical Industry
Ankara, 2nd June 2005
Poland 2004 Market,
Reimbursement and Pricing System
Law of 27 August 2004 on public health system
 Law of 5 July 2001 on prices

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Poland, 2004 y – Pharmaceutical market
By quantity (pack)
Total
Hospital
8%
Pharmacy Rx
47%
Quantity
(pack)
Value (EUR)
Total Market
1 215 409 490
3 317 835 893,0
Pharmacy
1 121 535 560
2 933 025 188,8
574 736 670
2 235 319 707,0
Pharmacy Rx
Pharmacy OTC
Hospital
546 798 890
93 873 930
697 705 481,8
384 810 704,3
Copyright © 2005. IMS HEALTH. All rights reserved.
Pharmacy OTC
45%
By value
Hospital
12%
Pharmacy OTC
21%
Pharmacy Rx
67%
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Originals vs Generics (Rx)
by quantity
80%
by value
79%
60,0%
60%
40,0%
40%
20%
58%
50,0%
30,0%
42%
20,0%
21%
10,0%
0%
Originals
Generics
Copyright © 2005. IMS HEALTH. All rights reserved.
0,0%
Originals
Generics
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Import vs Domestic
by value
by quantity (pack)
80,00%
80%
67%
60%
64%
40,00%
40%
20%
60,00%
36%
33%
20,00%
0,00%
0%
Import
Domestic
Import
Domestic
Copyright © 2005. IMS HEALTH. All rights reserved.
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Top 10 Companies - 2004
Company
Value (mln Market share
EUR)
1.
GSK PHARMA
245 394
7,40%
2.
SANOFI-AVENTIS
178 516
5,38%
3.
POLPHARMA S.A.
172 523
5,20%
4.
SERVIER
164 365
4,95%
5.
NOVARTIS CORP.
130 493
3,93%
6.
ROCHE
122 383
3,69%
7.
POLISH PHARM. HOLDING „POLFA”
117 983
3,56%
8.
PFIZER CORP.
106 749
3,22%
9.
LEK
79 852
2,41%
10.
JOHNSON & JOHNSON
79 180
2,39%
11.
PLIVA
75 450
2,27%6
What is necessary to apply for generics
reimbursement status?

Marketing authorisation (also possible during validity
of patent /SPC owing to „Bolar” exemption)

Brand name is allowed, however INN must be part of
the product name

The generic SmPC should be identical to the
originator to gain substitution or interchangeably
status
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Positive lists by decision of Minister of
Health (reimbursement lists should be
revised twice a year)



Essential drug lists
 flat-rate (ca 0,7 € per pack)
2. Supplementary lists (partially reimbursed)
 30% patient co-payment
 50% patient co-payment
3. Chronic diseases lists
 free of charge
 Flat-rate (ca 0,7 € per pack)
 30% patient co-payment
 50% patient co-payment
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Reference price system fixed on the lowest
medicine price (understood as price limit
paid by National Health Found)

The same active substance

Group of medicines having similar therapeutica
mechanism.
Criteria to qualify:
 the same terapeutic indication,
 similar efficacy
 the same mechanism
 the same adverse reaction
 the same way administration

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Condition set-up by Minister of Health
1. To stay on reimbursement list:
-
2003 list – max 50% difference of the price, possible in
relation to the reference price
2. To enter with new brand the reimbursement list –
max 20% difference, possible in relation to the
reference price (lowest generic price).
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Pricing system



Prices of manufacturer are set up by Minister of Health on the basis of
proposals submitted by companies taking into consideration the
following elements:
 Price level in other countries of similar GDP
 Competitiveness of price
 Cost of treatment
 Effectiveness
 Cost of production
 Importance of drug on epidemiological diseases
Wholesaler margin fixed – 8,91%
Pharmacy margin degressive

Price up to
ca 0,75€ – 40%
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ca 20€ – 12 zł.
Generic prescribing and substitution
Generic prescribing – by brand name:
•
No restriction or incentive for doctors
•
Doctors are permitted to prevent generic substitution by marking
prescription with „NZ” (do not substitute).
Pharmacy substitution:
1. Product (brand name) on reimbursement list:
Pharmacies should offer cheapest drug, provided prescription
without doctor reservation (NZ).
2. Brand name not included into reimbursement lists.
Pharmacy substitution is possible, but on the level of reference
price (or lower).
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Chapter 1 – Free Movement of Goods
 Up-date of MA of old dossiers
 Application of Centralized Procedure and MRP
 Data exclusivity application
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Chapter 5 – Company Law
(Industrial and Intellectural Property
Rights)

Bolar Clause (testing and registration during patent
validity)

Parallel trade

SPC – Supplementary Protection Certificate
(Regulation 1768/92/EC)
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Update of documentation for existing
products


5 Countries (Cz, Hu, LV, SK, EST) – date of accession
Transitional period for: harmonization of MA to acquis
communautaire:
 Cyprus
- 31 December 2005
 Lithuania and Malta – 31 December 2006
 Slovenia - 31 December 2007
 Poland - 31 December 2008

Centralized Procedure (CP) & Mutual Recognition
Procedure (MRP) to be adopted in Poland on the date of
accession.
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Data Exclusivity (1)
1.
Situation in EU during negotiations:


6/10 year for national procedure/ MRP
 6 years (AT, DK, FI, SP, IRL, PT, EL) plus NO, IS
 10 years (BE, LU, FR, IT, DE, NL, SE, UK)
10 years for CP
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Data Exclusivity (2)
Introduction of Data Exclusivity in ACs
1997
Czech Republic
2000
Slovakia
2001
Estonia, Latvia, Slovenia
1 Jan 2003 (only for applications
submited after 12.04.01)
Hungary
On accession 1 May 2004,
hawever starting 2002 soft Data
Exclusivity were introduced – 3
years calculating from first
registration in the world (with no
practical value) .
Poland
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Data Exclusivity (3)
Revision of legislation - 2004

New rules
 8+2 (+1) for all procedures and all countries
 8 years data exclusivity but 10 years market
exclusivity
(filing after 8 years but marketing after 10 years)
 Additional 1 year (+1) in case of new idication
registered during first 8 years (significant clinical
benefit in comparison with existing therapies)- no
clear criteria
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Data exclusivity (4)
Revision of legislation 2004

8 + 2 +(1) formula for all MA procedures
0-8 years Data Excl.
Marketing
Authorisation of
Reference
Product
Generic
Application
2 years Market Excl.
Assessment, MA
granted, MRP, price,
reimbursement;
preparation of launch,
production (if there is
not patent)
(1 year ME)
Launch
of
generics
if no
patent, no
+1 year
Additional 1
year Market
Excl. if new
indication
registered by
originator
during first 8
years
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Data Exclusivity (5)
Acceding Countries position during
legislation process

Extension of DE - change of the negotiation position
(acquis communautaire)

“Milan Declaration” of 10 Health Ministers
Petition of Observers to EP (94 Observers from 9
countries)

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Data Exclusivity (6)
Prospective Implementation of DE

New rules 8+2+(1) applicable only for reference
products filed after date of transposition of new
legislation (end of 2005)
 significant delay of real impact of new DE expected in 2013
 Advantage:
 For 6-year all Acceding Countries and DE
Countries (AT, DK, FI, SP, IRL, PT, EL)
 Disadvantage:
 For 10-year DE Countries (BE, LU, FR, IT, DE,
NL, SE, UK)
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Data Exclusivity (7)
Prospective implementation of DE
Article 1a (new) (amending Directive)
The periods of protection foreseen in Article 1, point 8, that modifies
Article 10 (1), do not apply to reference medicinal products for which
an application for authorisation has been submitted before the date of
transposition referred to in Article 2 (1).
 Article 88a (new) (amending Regulation)
The periods of protection foreseen in Articles 14 (11) and 39 (10) do
not apply to reference medicinal products for which an application for
authorisation has been submitted before the date referred to in Article
89 (2)

Request for transitional period: Poland, Hungary, Slovakia, Slovenia,
Malta.
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Chapter 5



Bolar clause introduced in Poland 2001 (earlier in
Hungary) - Poland agreed to adapt regulation according
to WTO rules and EU acquis after accesion.
Parallel trade – specific mechanizm introduced in AT to
prevent re-export of patented medicinal products.
Specific mechanism- scope of application – exhaustion of
patent rights - Should apply to only to those products
which could not benefit from product patent protection but
still benefiting from patent in some EU States.
Supplementary Protection Certificate (SPC)
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SPC in Accession Treaty

Common conditions of transition regulation:
 valid basic patent,
 link to the moment of first Marketing Authorisation (MA)
in particular country, except PL, HU,
 no territory mentioned PL, HU,
 retrospective application- in most cases connected with
different time for filing – latest 6 months after Accession.
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SPC (AT cont.)
„Any medicinal product protected by a valid basic patent
and for which the first authorisation to place it on the
market as a medicinal product was obtained* after 1
January 2000 may be granted a certificate in Poland,
provided that the application for a certificate is lodged
within six months starting no later than the date of
accession;”
*Remark: first wording „was obtained in Poland after
January 2000”
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Retrospective implementation of SPC

Products with the first MA granted:





prior to date of Accession: Cyprus, Estonia, Latvia,
Lithuania, Malta, Slovenia.
Czech Rep - after 10th of November 1999
Slovakia - after 1st of January 2000 in Slovakia
Hungary – after 1st of January 2000
Poland - after 1st of January 2000
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Final remarks:

Have benefited from EGA - knowledge & exchange
informations in the frame of EGA Accession Committee,

Be precise in wording your preliminary agreement.
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