Medical Products and the Internet

Document Sample
Medical Products and the Internet Powered By Docstoc
					                     DIA ANNUAL MEETING
                           CHICAGO


               INN Programme
             International Nonproprietary Names

                               Dr Raffaella Balocco-Mattavelli
                           Quality Assurance and Safety: Medicines
                            Essential Drugs and Medicines Policy
                                 World Health Organization



Dr. Raffaella Balocco-Mattavelli                  WHO - EDM
Chicago, 19 June 2002
              WHO - some basic
                   facts
• 191 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
Dr. Raffaella Balocco-Mattavelli      WHO - EDM
Chicago, 19 June 2002
                      WHO’S
                   CONSTITUTION
                                   Inter alia:
       to act as the directing and co-ordinating
        authority on international health work
        to develop, establish and promote
   international standards for food, biological,
       pharmaceutical and similar products

Dr. Raffaella Balocco-Mattavelli          WHO - EDM
Chicago, 19 June 2002
         How does WHO work
           and for whom?
 WHO’s main functions:
 • To act as the directing and coordinating
 authority on international health work
 • To encourage technical cooperation for
 health with Member States


Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
     The International Nonproprietary
         Name (INN) Programme
Programme activity: to ensure WHO’s responsibilities in the
field of drug Nomenclature by providing one single name
worldwide (INN ) for active pharmaceutical substances
     • Administered by WHO
     • Initiated in 1950 by a World Health
       Assembly resolution (WHA3.11)
     • Operational since 1953
     • Enforced by the World Health Assembly
       resolution (WHA46.19) in 1993
    Dr. Raffaella Balocco-Mattavelli   WHO - EDM
    Chicago, 19 June 2002
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.
  Dr. Raffaella Balocco-Mattavelli   WHO - EDM
  Chicago, 19 June 2002
International Nonproprietary Name
• 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 whatsoever to
  identify pharmaceutical substances


Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
INN – Stem philosophy/system
Another important feature of the INN
system is that the names of
pharmacologically-related substances
demonstrate their relationship by using a
common "stem".



Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
       INN – Stem philosophy/system
Latin                English

-acum                -ac          antinflammatory agents, ibufenac derivatives
                                                                         (diclofenac)
-cain-               -cain- antifibrillant substances with local anaesthetic activity
                                                                         (procainamide)
gli-                 gli-         sulfonamide hypoglycemics

                                                                         (glibenclamide)




   Dr. Raffaella Balocco-Mattavelli                  WHO - EDM
   Chicago, 19 June 2002
                                       Use of INNs
• pharmacopoeias
• labelling, product information, advertising and
  other promotional material
• drug regulation /registration
• scientific literature
• as a basis for product names, e.g. for generics
N.B. As a result of ongoing collaboration, national names such as British Approved Names (BAN),
    Dénominations Communes Françaises (DCF), Japanese Adopted Names (JAN) and United
    States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INN.



    Dr. Raffaella Balocco-Mattavelli                 WHO - EDM
    Chicago, 19 June 2002
                    INN – Business process
•   INN application
•   Basic requirements
•   Information required
•   Assessment Process
•   Publications
•   Final stage


    Dr. Raffaella Balocco-Mattavelli   WHO - EDM
    Chicago, 19 June 2002
                       Basic requirements
• Proposed names should be clear of conflict
  with existing INN and international trade
  marks
• Names should reflect analogies with existing
  INN, usually pharmacological or therapeutic,
  through use of common “stems”
• Substance should have entered clinical phase


 Dr. Raffaella Balocco-Mattavelli   WHO - EDM
 Chicago, 19 June 2002
            Information required
• scientific definition of substance (not mixture)
• structural formula (wherever possible)
• molecular formula
• CAS Registry Number
• any published company code numbers
• statement of pharmacological action and/or
  therapeutic use
• summary of pharmacology where novel action
  being claimed and all relevant published literature


Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
           Assessment Process &
                publication
•   by correspondence
•   the meeting (INNs Consultations /twice a year)
•   the follow up
•   publication (name,definition, molecular formula,
    CAS registry number, chemical structure, the
    mechanism of action and the therapeutic use (if
    known))


Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
                                Publication
• All newly selected INNs are published, after informing the originator of
  the request, in the journal WHO Drug Information.
  Two proposed and two recommended lists are published per year. The
  lists are trilingual, in English, French and Spanish, and include Latin
  INNs.
• All INNs are published in a cumulative list of INNs, which is updated
  periodically and includes INNs in Arabic, Chinese and Russian, as well
  as reference to other common names. At present, some 8000 INNs have
  been published.
• On-line information about INNs can be accessed free-of-charge via the
  Internet. To access the INN database, please send a request to
  mednet@who.int



 Dr. Raffaella Balocco-Mattavelli       WHO - EDM
 Chicago, 19 June 2002
                                      Guidelines on the Use of
                                   International Nonproprietary
                                         Names (INNs) for
                                    Pharmaceutical Substances

                                   “…INNs have to be
                                   distinctive in sound and
                                   spelling, and should not be
                                   liable to confusion with other
                                   names in common use….they
                                   are formally placed by WHO
                                   in the public domain….”
                                   http://www.who.int/medicines/




Dr. Raffaella Balocco-Mattavelli           WHO - EDM
Chicago, 19 June 2002
       INN- Progress and challenge
•Improved system for International Non-proprietary
Nomenclature names (INN)
•Well defined and documented
business process
•Improved tools for WHO’s
scientific screening process
•Web-based request status
 •Web-based on-line queries




 Dr. Raffaella Balocco-Mattavelli   WHO - EDM
 Chicago, 19 June 2002
 CD Rom -Cumulative List No. 10




Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
      Challenges for the future

Automated publication process
Internet enabled INN submission tool
Promotion of training initiatives on the
 use protection and awareness of INNs to
 improve skills of national officials and
 applicants



Dr. Raffaella Balocco-Mattavelli   WHO - EDM
Chicago, 19 June 2002
       Thank you for your attention

                                   http://www.who.int/medicines/


                                     innprogramme@who.int


                                      http://mednet.who.int/




Dr. Raffaella Balocco-Mattavelli    WHO - EDM
Chicago, 19 June 2002

				
DOCUMENT INFO