inn programme, dr r. balocco mattavelli sct, wipo – geneva 18-21 september 2012 international...
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
International Nonproprietary NamesInternational Nonproprietary Names
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
Introduction to INN ProgrammeIntroduction to INN Programme
"Some activities undertaken by WHO are
largely invisible, quietly protecting the health of every person on this planet, every day. By assigning a single international name to drugs, WHO helps ensure that a prescription filled abroad is what doctor ordered back home."
Dr Margaret Chan, Director General – Working for Health: An introduction to the WHO
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
WHO some basic factsWHO some basic facts
193 Member States
Two governing bodies: - World Health Assembly - Executive Board
WHO Secretariat: - HQ - six Regional Offices
- WHO Expert Panels (e.g... on the
International Pharmacopoeia and Pharmaceutical Preparations etc.)
Constitution 1946, in force since 7 April 1948 (World Health Day)
Article 2 (u) International standards
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
WHO's constitutionWHO's constitution
Inter alia:
to act as the directing and coordinating authority on international health work
to develop, establish and promote international standards for food, biological, pharmaceutical and similar products
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
The WHO International Nonproprietary Name (INN) Programme
The WHO International Nonproprietary Name (INN) Programme
To provide one single name worldwide for active pharmaceutical substances
Initiated in 1950 by resolution WHA3.11 and based on constitution
Operational since 1953
To devise a single name for a substance for use globally
INNs are recognized in almost all Member States
INNs can be used freely and cannot be registered as trade names
Not concerned with formulation
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
The WHO International Nonproprietary Name (INN) Programme
The WHO International Nonproprietary Name (INN) Programme
WHO has responsibility to develop, establish and promote international standards for pharmaceutical and biological products
Need for universally available and accepted name for drug substance
INN is a unique generic name that is recognized globally and is public property
Intended for use in drug regulation, prescription, pharmacopoeias, labeling advertising, scientific literature
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
Interested parties outside WHOInterested parties outside WHO
USAN Program
Pharmacopoeias(BP, FP, JP….)
European Commission, WCO, WIPO, …
Research based industry
National trade-mark authorities
DRAs(EMEA, US-FDA….)
INN Programme
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
International Nonproprietary Name (INN) Programme
What's in a name?International Nonproprietary Name (INN) Programme
What's in a name?
Safety
Quality
Information
RegulationRational use
Procurement
Efficacy
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INNs…INNs…
unique name,
distinctive in sound and spelling
not liable to confusion with other names in common use
formally placed by WHO in the public domain, (hence their designation as nonproprietary)
can be used without any restriction to identify pharmaceutical substances
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
The INN SystemThe INN System
WHO Secretariat
INN Expert Group
-Can call on further experts if necessary
-INN Advisory Group on Biologicals
Publications
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN selection processINN selection process
Secretariat receives INN applications
Consultation / INN Expert Group
Secretariat informs applicants
Validation of Information
Published in a List of proposed INN
4-month period for objections and comments
Published in a List of recommended INN
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
The Business Process ModelThe Business Process Model
Broad consultation(experts, applicants, Nomenclature bodies, Pharmacopoeias, DRAsetc.)
Lot of correspondence
2 INN meetings/year
"Ad hoc" meetings
……
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
Use of stemsUse of stems
To indicate chemical and /or pharmacological group relationship
Published for 'established series of related compounds'
WHO publication 'The use of stems in the selection of INN' rev.2011 + addendum
INNs and stems have protection within trade mark arena
Stem book
Names of "pharmacologically-related" substances
have a common stem
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
PublicationsPublications
Selection process of an INN
Lists of proposed and recommended INN
Cumulative List of INN
Stem book "The use of stems in the selection of INN for pharmaceutical substances"
Radical book "Names for radicals, groups & others, comprehensive list"
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN ListsINN Lists
New INNs are published in WHO Drug Information: 2 proposed and 2 recommended lists every year in English, French, Spanish and Latin.
All INNs are published in a cumulative list with additionally INNs in Arabic, Chinese and Russian.
About 8500 INNs have been published
http://www.who.int/medicines/services/inn/publication/en/index.html.
On-line INN information: Mednet - INN Extranet
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN Cumulative List 14INN Cumulative List 14
Portable format– Information over 8500 published INN (names, structures,…)
Published every two years
Searchable database– All or part of name (e.g. -profen)– In the six UN official languages– CAS RN– Alternate names– ATC (Anatomic Therapeutic Chemical) codes– Etc…
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
ProtectionProtection
WHA46.19 requests Member States:
1) to enact rules and regulations, as necessary to ensure that INNs … used in the labellig and advertising of pharmaceutical products are displayed prominently;
2) to encourage manufacturers to rely on their coorporate name and the INNs, rather than on trade marks, to promote and market multisource products introduced after patent expiration;
3) to develop policy guidelines on the use and protection of INNs, and discourage the use of names derived from INNs, and particularly names including established INN stem as trade-marks.
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN Integrated Data Management Information System
INN Integrated Data Management Information System
Access from internet
Worldwide multiusers
Multiplatform application
All the user tasks have been "integrated" within the process
Standard and open source technologies
Secure and protected environment: confidentiality of data and process steps
Electronic documentation at each step
Track of each process step
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN On Line ApplicationINN On Line Application
• Hand made Data Entry
• Missing data validation
• Increasing Annex files dimension
• Missing electronic format for structures
• Automatic Data Entry
• Data Validation
• Confidential Communication
• Electronic format for structures
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
Searching INN on Public domainSearching INN on Public domain
http://mednet.who.int/
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN Challenge: collaborative network… …for a global data hub
INN Challenge: collaborative network… …for a global data hub
INN
Software Company Pharmaceutical Industry
IMGT
BPhSIB-University of
Geneva
DRAs
AFSAPS
WIPO FDA
VIDAL
USP
Trademark Dep
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN global data hub…interfaceINN global data hub…interface
INN
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
IT technical specificationsIT technical specifications
Common Structure (XML Schema)
Web service interface (INN protocol)
Java script on the client/server side
Access control
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
INN LinksINN Links
http://www.who.int/medicines/services/inn/en/index.html
http://mednet.who.int/
https://extranet.who.int/tools/inn_global_data_hub/
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INN Programme , Dr R. Balocco Mattavelli SCT, WIPO – Geneva 18-21 September 2012
THANK YOUTHANK YOU
Gracias Merci
谢谢
Grazie
Salamat