Transcript Diapositive 1

ACTUALITES INDUSTRIELLES
5èmes RENCONTRES
DE L’IPIL
«PROPRIETE INTELLECTUELLE
DANS LES INDUSTRIES
DE SANTE»
13 Décembre 2007
POSTERS PRESENTES PAR LES ETUDIANTS
DU MASTER INGENIERIE POUR LA SANTE
ET LE MEDICAMENT
Spécialité Pharmacie, Cosmétologie
Industrielles et Management
de la Qualité
THE DECENTRALISED PROCEDURE: WHAT’S NEW IN 2007
Master ingénierie pour la Santé et le Médicament option Affaires Technico-Réglementaires
Barillot Anne-Lise, Chomette Amandine, Jerez Audrey
Mutual recognition procedure (MRP) VS decentralised procedure (DP)
The decentralised procedure has been introduced by directive 2004/27/CE.
Two procedures permit to obtain several marketing autorisations (MA) in E.U. countries chosen by the applicant.
MRP: the product must already have a MA in one of the member states, this state will be the reference member state (RMS).
DP: the product must not have a MA in one of the member states, the applicant will choose their RMS.
DP goals: the permit to accelerate MRP: all the member states receive the MA file at the same time, so the assessment is simultaneous. Since
D105, a MA can be obtained.
Decentralised procedure: setting up since 2005
The CMD(h) has replaced the MRFG and has become the agency in charge of all questions concerning the MA obtained under a DP or MRP.
Hindsight has permitted to underline the disadvantages of DP: as the clock-off period is undetermined, this could prolong the procedure more than
predicted.
Contrary to MRP, the RMS has not yet given the MA and as a consequence has not a defensive role but rather an « administrative » one:
disadvantage or advantage?
A « Standard Operating Procedure » written by the CMD(h) splits the procedure in 5 steps: validation, first assessment, second assessment,
discussion with the CMD(h) if necessary and the national MA.
FLOW CHART
WHAT’S NEW
Pre-procedural Step
Pre-procedural Step
Before Day -14 Applicant discussions with RMS. RMS allocates procedure number. Creation in CTS.
Day-14
Day 0
Day 70
Until Day 100
Until Day 105
Clock-off
period
Day 106
Day 106-120
Day 120
Day 120
(Day 0)
Submission of the dossier to the RMS and the CMSs
Validation of the application
• Submission SPC, labelling,
package leaflet project to
harmonize informations
Assessment step I
RMS starts the procedure
RMS forwards the Preliminary Assessment Report (PrAR), SPC, PL and labelling to the CMSs
CMSs send their comments to the RMS
Consultation between RMS and CMSs and applicant. If consensus not reached RMS stops the clock to
allow applicant to supplement the dossier and respond to the questions
•CMS does not receive anymore
information concerning a file
retired by the applicant in the
country
Applicant may send draft responses to the RMS and agrees the date with the RMS for submission of the
final response. Applicant sends the final response document to the RMSs and CMSs within a
recommended period of 3 months, which could be extended if justified
Valid submission of the response of the applicant received. RMS restarts the procedure
RMS updates PrAR to prepare Draft Assessment Report (DAR) draft SPC, draft labelling and draft PIL to
CMSs
RMS may close procedure if consensus reached. Proceed to national 30 days step for granting MA
Assessment step II
If consensus not reached RMS sends the DAR, draft SPC, draft labelling and draft PIL to CMSs
Day 145
(Day 25)
CMSs sends final comments to RMS
Day 150
(Day 30)
RMS may close procedure if consensus reached. Proceed to national 30 days step for granting MA
Until 180
(Day 60)
If consensus is not reached by day 150, RMS to communicate outstanding issues with applicant, receive
any additionnal classification and prepare a short report for discussion at Coordination Group
Until Day 205 Breakout Group of involved Member States reaches consensus on the matter
(Day 85)
Day 210
(Day 90)
•Strengthening contact between
RMS and applicant
Closure of the procedure including CMSs approval of assessment report, labelling and PIL, or referal to
Co-ordination group. Proceed to national 30 days step for granting MA
Day 210
If consensus was not reached at day 210, points of disagreement will be referred to the Co-ordination group
(at the latest) for reselution
Assessment Step I
If questions about the closed part
of DMF exist, concerning an
eventual major risk for public
health, RMS must inform the
applicant
Clock-off period
•Integration of user opinion
concerning the package leaflet
•RMS/applicant consultation
concerning answer project to
CMS and decision of the date of
submission of the finale answer
Assessment step II
•No new data can be submitted
by the applicant
• The procedure can be finished
at any time before D210 if
consensus has been reached by
CMS. RMS send SPC, package
leaflet, labelling final project
Day 270
Final position adopted by Co-ordination group with referral to CHMP/CVMP for arbritation in case of
(at the latest) unsolved disagreement
National step
Day
Applicant sends high quality national translations of SPC, labelling and PIL to CMS and RMS
110/125/155/21
5/279
National step
Blue box: refer to the chapter 7,
volume 2A of NTA
Day
Granting of national marketing autorisation in RMS and CMSs if no referral to the Co-ordination group;
135/150/180/24 (National Agencies will adopt the decision and will issue the marketing autorisation subject to submission
0
of acceptable translations).
Day 300
Granting of national marketing autorisation in RMS and CMSs if positive conclusion by the Co-ordination
group and no referral to the CHMP/CVMP. (National Agencies will adopt the decision and will issue the
marketing autorisation subject to submission of acceptable translations).
Impression Université Claude Bernard Lyon1 - PRACTICE
La contrefaçon des médicaments en Europe
Daphné Arnaud, Linda Cardo, Romain Juniet, Amandine Malignon
Définition de l’OMS :
Un médicament qui est délibérément et frauduleusement muni d’une étiquette n’indiquant pas son identité et/ou son origine véritable.
La contrefaçon peut viser une spécialité de référence (produit de marque) ou un médicament générique. Elle peut se manifester sous différentes
formes :
• présentation et/ou composition identique ;
• composition différente (absence, sous-dosage ou surdosage de principe actif, présence d’ingrédients nocifs) ;
• conditionnement falsifié (emballage contrefait, permettant par exemple de « repousser » la date de péremption de médicaments périmés).
N’est pas un médicament contrefait :
Quelques chiffres :
• Les médicaments périmés
• Les importations parallèles
• Les génériques
• Certaines ventes sur internet : e-pharmacies légales dans
certains pays européens (exemple : Allemagne)
• En 2002, marché de la contrefaçon : 4.3 milliards d’euros soit 4.1% du
marché européen du médicament
• En 2006, en Europe, 5èmes produits les plus contrefaits
• En 2006, 600 000 médicaments contrefaits saisis par les douanes françaises
De rares cas de médicaments contrefaits vendus en Europe
Aucun cas avéré en France
Impacts de la contrefaçon :
Moyen de lutte de grandes entreprises :
• Sur la santé publique
- Danger pour la santé des patients : potentiellement mortel
• Pour les entreprises
- Diminution des ventes
- Diminution du retour sur investissement
- Entache la réputation des firmes pour la qualité et la sécurité de leurs produits
• Pour les économies nationales et européennes
- Pertes d’emplois
- Réduction de la croissance économique
• Sanofi-Aventis: création d’un « département de sécurité
économique et patrimoniale » en 2005 qui traque les
contrefaçons des médicaments du groupe.
• GSK: - Mise en place de procédures anti-contrefaçons
- Dispositif anti-contrefaçons dans chaque boîte de
médicaments.
- Contrôle de la chaîne de production
Moyens de lutte :
• Traçabilité : - Le code Datamatrix incorpore un grand nombre d’informations permettant l’identification du produit.
- Les étiquettes RFID (Radio Frequency Identification) ou étiquettes intelligentes sont plus perfectionnées mais sont plus coûteuses.
•Amélioration de la diffusion de l’information aux patients et aux pharmaciens (exemple : disponibilité de brochures Afssaps en France, sur des
sites Internet et en pharmacie)
• Création d’IMPACT: Groupe spécial international anti-contrefaçon de produits médicaux au sein de l’OMS
• Création d’un pôle spécifique contrefaçons à l’AFSSAPS
• Contrôle des sites internet de vente de produits pharmaceutiques
• Renforcement de Bonnes Pratiques de Distribution
Transposition en droit français de la Directive 2004/48/CE sur la contrefaçon (octobre 2007) :
• Procédure accélérée de jugement
• Mesures à l’encontre des intermédiaires pour obtenir des informations sur l’origine des réseaux (saisie des biens, blocage des comptes bancaires)
• Calcul des dommages et intérêts en fonction des bénéfices faits par la contrefaçon
• Mise en place de juridictions spécialisées
• Augmentation des peines : passage de 300 000 à 500 000 euros d’amende et de 3 à 5 ans d’emprisonnement
Conclusion
Les médicaments contrefaits sont différents suivant les types de pays :
 Pays développés : médicaments de confort ou de société (anorexigènes, traitement des dysfonctionnements érectiles, …)
 Pays en développement : médicaments vitaux (anti-paludéens, antirétroviraux, …)
Les grands groupes essaient de lutter individuellement contre les contrefaçons.
Impression Université Claude Bernard Lyon1 - PRACTICE
by Céline Cao, Xavier Dejacques, Guillaume Thirion
The Association of Southeast Asian Nations or ASEAN was established on 8th August 1967 in Bangkok by the five original
Member Countries, namely, Indonesia, Malaysia, Philippines, Singapore, and Thailand in order to accelerate economic
growth, social progress and cultural development in the area and to promote regional peace and stability.
Concerned Member States (CMS)
Brunei Darussalam
Cambodia
Indonesia
Lao PDR
Malaysia
Competent Authorities for harmonization
(1984)
(1999)
(1967)
(1997)
(1967)
Myanmar
Philippines
Singapore
Thailand
Vietnam
Objectives
Total Population
Harmonizing "Standard & requirement " posed by
regulation
Asean vs ICH1,2
Establishing "Mutual Recognition Agreement-MRA"
Complying with "High Level Task Force- HTLF
Recommendation"
Target5
SCOPE
Generics
Modified
NCEs
Biotechnology
5for human use
2
ACCSQ : Asean Consultative Committee for Standards
and Quality
PPWG : Pharmaceutical Product Working Group
National Authorities of Asean countries
Beginning of ASEAN harmonization
1992 ACCSQ creation by AEM3
1998 PPWG initiation by ACCSQ
Working to facilitate the "Asean Free Trade Area-AFTA"
Aim &
(1997)
(1967)
(1967)
(1967)
(1995)
~ 520 millions
vs
~ 1 billion
1
EU, Japan, US
1999 TOR4 finalization by PPWG
STARTED TO FUNCTION
3Asean
4Term
Economic Ministers
of Reference (6 articles)
Requirements for ASEAN CTD = ACTR
PROCEDURE
Centralised
Decentralised
Mutual recognition
National
Edited guidelines on Quality, Safety & Efficacy from Asean CMS
Based on ICH guidelines
Accepted Pharmacopoeiae : national pharmacopoeia, USP, BP
Stability on storage conditions in zone IV b
i.e. 30°C ± 2°C / 75% RH ± 5% - ICH Guideline Q1A(R2)
-
"Stability
Testing of New Drug Substances and Products"
International Conference of Harmonization
TIMEFRAME ACCORDING TO THE TYPES OF SUBMISSION
Regional Part
First Submission
Renewal
Part I
TOC
Admin. Data
/ Product
Info
Part II
Part III
Part IV
Quality
Non-clinical
Clinical
Overall
Summary &
report
Overview
Summary &
Study report
Overview,
Summary &
Study report
For Generic, modified, and New
Chemical Entities and Bio product
ACTD format excepted for
Quality data
ASEAN Harmonized product by 2002
Starting from january 2009
Trial Period
Full Implementation
by january 2009 !
Mandatory Update
by january 2012 !
How to submit a Marketing Authorisation Application (MAA) already approved in ICH area ?
To obtain an MAA in the AFTA, companies must submit by 1st January 2009 the 4 parts ACTD format including stability
requirements for zone IV b.
To avoid the design of a new file for ASEAN community, companies have to adapted the Quality part by reducing
shelf-life of the drug product or by changing the primary container in accordance to the climatical area.
Furthermore, in all ASEAN countries, a Certificate of Pharmaceutical Product from the reference country is required
builds the basis of the drug approval.
Impression Université Claude Bernard Lyon1 - PRACTICE
the
and