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WHO Essential Drugs Strategy (PowerPoint)

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WHO Essential Drugs Strategy (PowerPoint) Powered By Docstoc
					          Access to Generic
           Pharmaceuticals




            Dr Jonathan D. Quick, Director
       Essential Drugs and Medicines Policy - EDM
Health Technology and Pharmaceuticals Cluster - HTP
               World Health Organization
                      June, 2002
         The worldwide role of generic pharmaceuticals




                              Price-lowering
                              competition


                              Global generic market



                              National strategies




2   Generics Strategies.ppt
         The worldwide role of generic pharmaceuticals




                              Price-lowering
                              competition


                              Global generic market



                              National strategies




3   Generics Strategies.ppt
         Price-lowering competition
         In poor countries drugs are largest household and second
         largest public expenditure for health
         Pharmaceutical spending, as % of total health spending
           Greece
         Germany                                      Developed countries
              Italy
           France                                           (7 - 20%)
            Spain
         Denmark
                UK
     United States
      Netherlands
           Norway

        Bulgaria                                      Transitional countries
       Czech Rep.
        Hungary
                                                           (15 - 30%)
          Croatia
          Poland
         Estonia
         Slovenia
        Lithuania

              Mali
            Egypt
            China
        Indonesia
         Thailand
           Tunisia                                    Developing countries
           Jordan                                          (24 - 66 %)
        Argentina
      South Africa

                      0       10   20       30         40             50       60   70




4   Generics Strategies.ppt
         Price-lowering competition
        Competition is perhaps the single most powerful policy
        instrument for lowering medicine prices

        USA - when patent expires the average wholesale price
         falls to:

              60% of the branded drug‟s price with 1 generic competitor

              29% with 10 competitors




5   Generics Strategies.ppt
         Global generic market

        Price differentials between generic and brand products
        vary greatly among countries

                              Belgium               20%
                              Italy                 20% +
                              Spain                 25%
                              Germany               25% - 30%
                              France                25% - 35%
                              Canada                40% - 50%
                              UK                    80% +
                              US                    50% - 90%


               Source: IMS, Pharma Strategy Group

6   Generics Strategies.ppt
          Contraceptive price reductions through UNFPA
          procurement practices

     Item                             Unit        UNFPA           US Price     Percent
                                                  Price                        reduction
     Oral Contraceptives –            Cycle               0.175        30.00       99.4%
     generic (off-patent)
     Oral Contraceptive –             Cycle               0.364        34.00       98.9%
     single-source (on-patent)*
     Condom                           Piece               0.025         0.50       95.0%
     Intrauterine device              Piece               0.430       350.00       99.9%
     Injectable contraceptives        Dose                0.675        65.00       99.0%
     Spermicides                      Table               0.060         1.20       95.0%
     Hormonal contraceptive           Set              23.000         393.00       94.1%
     implants
    * Example of third generation oral contraceptive
    Source: Presentation by Mr C. Saunders



7     Generics Strategies.ppt
           Pharmaceuticals and trade

         Competition is highly effective in reducing prices - the
         example of antiretrovirals

        Cost per capsule or tablet (US $)
                    No competition                  Competition (2 to 6 producers per product)
    5
    4
                                                   2.90
    3
          2.00                                                                     1.85
    2                     1.72
                                 1.31
                                                                   1.55
                                            1.04
    1                                                       0.83
                                                                                             0.51
                                                                            0.08
    0
           Product A              Product B         Product C       Product D        Product E

                                        1996       1997     1998     1999     2000

           Source = UNAIDS, B. Samb, 2000



8   Generics Strategies.ppt
         Price-lowering competition
        Advocacy, corporate responsiveness, & competition
        have reduced antiretroviral prices 95% in 3 years

             Indicative annual cost per person for triple therapy in
                                 Africa (US $)
    $10,000

     $8,000
                      UN Drug Access Initiative

     $6,000

     $4,000                      Domestic production


     $2,000                         Accelerated access initiative
                                                                                        ??
                                                         Generic offers
            $0
                          1996       1997         1998          1999      2000   2001   2002



9   Generics Strategies.ppt
          The worldwide role of generic pharmaceuticals



                               Price-lowering
                               competition


                               Global generic market



                               National strategies



10   Generics Strategies.ppt
            Global generic market
              As of the mid-1990‟s, few countries had achieved large
              generic coverage
          DEVELOPED COUNTRIES
                         Denmark
                     United States
                   United Kingdom
                         Germany

                      Netherlands
                           Ireland
                          Portugal

                      New Zealand

                            Japan
                           France

                            Spain
          DEVELOPING COUNTRIES
                        Indonesia
                          Morocco
                       Philippines



                                     0   10        20         30           40     50    60   70
                                                              % prescriptions generic


     Source: DAP Global comparative pharmaceutical expenditures and IGPA
11     Generics Strategies.ppt
          Drug sales 1990 and 2000: originator/licensed products
          and unbranded/other brand generics

                  market value in
                   US $ billion
             200
                                          180.2
             180
             160
             140                                                                     1990
             120                                                                     2000
                                                        Generics: 30% of
             100
                                                        global market
               80                                                             69.7
                              63.5
               60                                                      44.8
               40
                                                        14
               20                                 6.1
                 0
                            Orig+licensed         Unbranded           Other brands




         Source: IMS Health, customised
         study. Data from 52
         countries/areas
12   Generics Strategies.ppt
         Against the trend - Pakistan 1990 and 2000: growth of
         “other than originator” brands

        100%

         90%                   16.1                              9.8
         80%

         70%                                                    37.6
         60%                   42.2
         50%

         40%

         30%
                                                                50.5
         20%
                               36.5
         10%

          0%                   5.2                                2
                               1990                              2000


                      Unbranded       Other brands   Origin/licensed    status n/a


13   Generics Strategies.ppt
         Rapidly changing drugs markets (1) Republic of
         Korea*, 1990 and 2000

             100%

                                         14.3                             10.5
              80%
                                         17.4                             30.8
              60%




              40%
                                         59.3
                                                                          50.2
              20%




               0%
                                          9                                8.5
                                         1990                              2000


                          Unbranded             Other brands   Origin/licensed    status n/a
                *2000 Population: 46.7
                million
14   Generics Strategies.ppt
         Rapidly changing drugs markets (2) Hungary*, 1990
         and 2000

             100%

                                        15.1                              7.4
              90%

              80%

              70%
                                        34.2                             56.7
              60%

              50%

              40%

              30%
                                        45.6
              20%                                                        31.4
              10%

               0%                       5.1                               4.5
                                        1990                              2000


                          Unbranded            Other brands   Origin/licensed    status n/a
                *2000 Population: 9.9
                million
15   Generics Strategies.ppt
         Rapidly changing drugs markets (3) Czech Republic*,
         1990 and 2000

             100%
                                                                           8.5
              90%                        19.7
              80%

              70%                        15.5                             44.6
              60%

              50%

              40%                        48.6
              30%
                                                                          39.8
              20%

              10%
                                         16.2
               0%
                                                                           7.1
                                         1990                              2000


                          Unbranded             Other brands   Origin/licensed    status n/a
                *2000 Population: 10.3
                million
16   Generics Strategies.ppt
         Generic shares (unbranded plus other brands) in high,
         middle and low income markets, 1990 and 2000
                           Low                 Middle                        High
     100%


      90%


      80%


      70%                                                                                     status n/a


      60%                                                                                     Origin/licensed

                                                                                              Other brands
      50%
                                                                                              Unbranded
      40%


      30%


      20%


      10%


       0%
                Low 1990       Low 2000   Middle 1990   Middle 2000   High 1990   High 2000




17   Generics Strategies.ppt
          Global generic market


         Global generics picture 1990 to 2000

     1. Definition: generics = off-patent non-innovator drugs
               About 30% of world sales by value
               Unbranded generics - about 10% of world sales
               Commercial literature understates the share of generics by
                only looking at 2.
     2. Declining share of generics in the high income countries
        over the last decade
     3. Generics now dominant in markets of low income countries
     4. Very rapid move away from generics to innovator drugs in
        some markets (C & E Europe, Former Soviet Union, Korea)



18   Generics Strategies.ppt
          Local pharmaceutical production capacity varies
          greatly among countries




                                                 Unavailable                                    (23)
                                                 Sophisticated industry, significant research   (10)
                                                 Innovative capability                          (17)
                                                 Active ingredients & finished products         (13)
                                                 Finished products from imported ingredients    (84)
                                                 No pharmaceutical industry                     (42)




                             Source: UNIDO: The world's pharmaceutical industries. an international
19   Generics Strategies.ppt perspective on innovation , competition and policy. 1992
          The worldwide role of generic pharmaceuticals



                               Price-lowering competition



                               Global generic market



                               National strategies



20   Generics Strategies.ppt
          National strategies
            Building a large generic market takes time
            - and requires a combination of strategies
                           National strategies for generics:
                           1.   Supportive legislation & regulation
                50         2.   Reliable quality assurance
                45         3.   Professional, public acceptance
                40         4.   Economic incentives
                35
                30
                25
                20
                                                Percent of new prescriptions, U.S.
                15
                10
                 5
                 0




                                                                                *
               85

                          86

                                    87

                                           88

                                                  89

                                                         90

                                                                91

                                                                       92

                                                                               93

                                                                              94
             19

                        19

                                  19

                                         19

                                                19

                                                       19

                                                              19

                                                                     19

                                                                             19

                                                                            19
21   Generics Strategies.ppt
          National strategies


         1. Supportive legislation and regulation


             product development authorized during patent life
             abbreviated marketing authorization
             differential registration fees
             generic labeling
             generic prescribing and substitution




22   Generics Strategies.ppt
           National strategies

         Product development during patent period
         varies among countries

         Examples of “early workings” for generics
               access to innovator product safety and efficacy data
               production tests on a patent-protected product
               laboratory tests for marketing approval
                – e.g. bioequivalence
               production and stockpiling prior to patent expiry
         Countries with some early workings provisions
               Argentina         Hungary
               Australia         Israel
               Canada            USA




23   Generics Strategies.ppt
         Source of „market power‟ for branded product

         Market exclusivity
               patents
               data protection - ethics
               „sui generis‟ - orphan drugs, paediatric indications
               new types of patents - “use” “structure”
         Trademarks
         Perceived quality
         Promotion
         Service



24   Generics Strategies.ppt
           National strategies


         2. Reliable quality assurance

               substitution / non-substitution lists
               national quality assurance capacity
               enforcement of good manufacturing practices (GMP)
               distribution system inspection and enforcement

                                                            List of
                                                  International Comparator
                                                 Pharmaceutical Products for
                                                 Equivalence Assessment of
                                                       Interchangeable
                                                         Multi-source
                                                      (generic) Products
                                                          WHO, 1999



25   Generics Strategies.ppt
           National strategies


         3. Professional and public acceptance

                   involvement of professional groups
                   phased implementation
                   all training by generic name
                   use of generic names in clinical manuals
                   treatment guidelines
                   brand-generic / generic-brand indexes
                   public promotional information and activities




26   Generics Strategies.ppt
           National strategies

         Stages in Generic Substitution - legislative support for generic
         substitution may evolve over time



           1. No substitution
           2. Substitution permitted
                      brand dispensing assumed
                      generic may be requested
           3. Substitution encouraged
                      generic dispensing assumed
                      brand may be requested
            4. Substitution required

                                                      Increasing generic support


27   Generics Strategies.ppt
           National strategies


          Generic substitution laws can give each party a voice

          Regulatory authority
                 may declare products as „substitutable‟ or „non-substitutable‟
          Prescriber
                 may write „no substitution‟ by hand on the prescription
          Pharmacist - must substitute a generic unless:
                 prescriber or patient forbid substitution
                 retail price of generic is higher than the brand
                 product has been declared not substitutable
            Patient
                 may forbid generic substitution by the pharmacist




28   Generics Strategies.ppt
           National strategies

         Public education campaigns help professional and public
         acceptance to reinforce each other


         Posters and brochures
         Radio and TV messages
         Folk media




30   Generics Strategies.ppt
           National strategies


         4. Economic incentives

                  price information for professionals and the public
                  retail margins favorable to generics
                  use of generics for insurers / reimbursement
                  development of generic industry




31   Generics Strategies.ppt
            Indicative price information promotes
            transparency and competition

          MSH-WHO essential drugs price indicator

          Drugs and diagnostics for HIV/AIDS

          Pharmaceutical starting materials

          Antiretroviral drugs in the Americas

          AFRO Essential drugs




         http://www.who.int/medicines/organization/par/ipc/drugpriceinfo.shtml
32   Generics Strategies.ppt
           National strategies

         Price information - enlightens health professionals and
         empowers consumers


              relative / absolute price
               information in clinical manuals
              drug pricing guide
                     Colombia: WHO  MoH 
                      manufacturers‟ association
              publication of pricing surveys
                     Philippines, Georgia




33   Generics Strategies.ppt
           National strategies

         Different types of dispensing margins create different
         incentives for rational dispensing

                  Cost + fixed percentage
                        EG: cost to pharmacist + 20 %
                  Cost + declining percentage
                        EG: cost + 20% for cheaper drugs, declining to 5% for
                         expensive drugs
                  Cost + fixed dispensing fee
                        EG: cost + $3 professional dispensing fee
                  Cost + differential dispensing fee
                        cost + $4 for generic drugs, $2 for brand name drugs




34   Generics Strategies.ppt
           National strategies

            Insurance coverage is everywhere rising - generic essential
            drugs are needed for cost control
      Established Market6
          Economies
        Middle Eastern     5
          Crescent

     Transitional Economies
                        4


         Latin Americas    3
          & Caribbean

          Asia & Islands   2



       Sub-Saharan Africa
                        1



                           0
                               0   10   20   30   40   50   60   70   80   90   100
                                     Percentage coverage
         Each diamond represents % ofof population covered in one country
                                      population
         Source: WHO/DAP Global pharmaceutical expenditures
35   Generics Strategies.ppt
           National strategies

         National strategies for promoting use of generic
         essential drugs

              1. Supportive legislation and regulation


              2. Reliable quality assurance


              3. Professional and public acceptance


              4. Economic incentives




36   Generics Strategies.ppt
            Conclusion

         What can be done to increase acces to generic
         pharmaceuticals?


                      Price-lowering competition - better document
                      magnitude and sources of cost/price savings

                      Global generic market - analysis of trends and
                      reasons for high and low generic markets

                      National strategies - attack all 4 critical elements
                      - legislation, quality, acceptance, incentives




38   Generics Strategies.ppt

				
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