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PRIORITY%20MEDICINES%20FOR%20EUROPE%20AND%20THE%20WORLD

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Current capacity to produce either vaccines or antiviral medicines is not sufficient ... Gaps in basic biology, stem cell research, transplantation research ... – PowerPoint PPT presentation

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Title: PRIORITY%20MEDICINES%20FOR%20EUROPE%20AND%20THE%20WORLD


1
PRIORITY MEDICINES FOR EUROPE AND THE WORLD
  • A report prepared by WHO for the Netherlands
    Government
  • by
  • Warren Kaplan
  • Richard Laing
  • and

Saloni Tanna Marjolein Willemen Eduardo
Sabaté Monique Renevier Joyce Wilson Lisa
Greenough Ann Wilberforce Kathy Hurst
2
Priority Medicines Project
  • Background/Introduction
  • Priority Setting
  • Methods
  • Results/Conclusions

3
Context/Background
  • Pammoli, G-10 and EU Commission Reports
  • Europe was lagging behind in its ability to
    generate, organize, and sustain innovation
    processes that are increasingly expensive and
    organizationally complex.
  • The Lisbon and Barcelona European Councils the
    3 solution
  • Framework Programmes FP6 FP7
  • European and Developing Countries Clinical Trials
    Partnership (EDCTP)

4
Objectives of Priority Medicines Project
  • Provide a methodology for identifying
    pharmaceutical gaps from a public health
    perspective, for Europe and the World .
  • Provide a public-health based pharmaceutical RD
    agenda for use by the EU in the 7th Framework
    Programme,
  • Good public policy should spend public funds on
    areas of greatest public needs

5
"Priority Medicines"
  • Medicines which are needed to meet the priority
    health care needs of the population but which
    have not yet been developed.
  • pharmaceutical gap when treatment for a
    disease/condition
  • does not yet exist OR
  • will become ineffective soon OR
  • is available but the delivery mechanism or
    formulation is not appropriate for the target
    patient group.

6
What this Report does not address
  • Health system issues such as access or quality of
    care, or logistical or sociological barriers.
  • Underlying risk factors which can be considered a
    major cause of morbidity or mortality.
  • Availability of diagnostics or medical devices
  • Relationship between trade, pricing, intellectual
    property, as this is the subject of the WHO
    Commission on Intellectual Property Rights,
    Innovation and Public Health.
  • (See http//www.who.int/intellectualproperty/en/)

7
Priority Medicines Project
  • Background/Introduction
  • Priority Setting
  • Methods
  • Results/Conclusions

8
Prioritization must be multifactorial
9
Priority Medicines Project
  • Background/Introduction
  • Priority Setting
  • Methods
  • Results/Conclusions

10
Generating a Preliminary List of Diseases and Gaps
11
Pharmaceutical "Gap"
12
Example of an absent pharmaceutical gap
13
Priority Medicines Project
  • Background/Introduction
  • Priority Setting
  • Methods
  • Results/Conclusions

14
"Commonality of interest"
15
Global Public Health Threats
  • Antibacterial Resistance
  • Infectious diseases low burden in Europe removes
    incentive for RD
  • Most antibiotics are inexpensive- removing
    incentives to create new antibiotics
  • Antibacterials are widely misused creating
    resistance
  • Little RD on antibacterials has consequences for
    future generations with the global increase in
    the spread of drug-resistant bacteria.

16
The Rise of Antibacterial Resistance and the
Decline in Innovation
The proportion of MRSA among positive blood
cultures of Staphylococcus Aureus in England
Wales1989-2002
Antibacterial new molecular entities approved for
use in the United States 1983-2002
17
Global Public Health Threats (2)
Rates of vaccine distribution per 1000 total
population by country
  • Pandemic Influenza
  • Overdue for a new pandemic
  • Uptake of existing vaccines is poor
  • Current capacity to produce either vaccines or
    antiviral medicines is not sufficient

18
Secondary Prevention of Cardiovascular Disease
Stroke
  • Patients with a heart attack or stroke could
    reduce their risk of a repeat attack by 66 by
    taking 4 medicines (good evidence)
  • Yet uptake is low lt20
  • The "polypill" using fixed dose combination
    (aspirin, statin, ACE inhibitor and beta-blocker
    or thiazide diuretic) deserves further urgent
    study.

19
High burden, preventable diseases with
pharmaceutical gaps
  • Smoking-related conditions
  • Public health anti-smoking policies are key
    interventions
  • Effective pharmaceutical interventions are
    needed.
  • Treatment of acute stroke
  • A major basic and clinical research effort is
    required as the current treatment of acute stroke
    is unsatisfactory.
  • Most agents are not effective associated with
    increased risk of adverse events.

20
High burden, preventable diseases with
pharmaceutical gaps
  • HIV/AIDS
  • HIV formulations for children urgently needed
  • HIV Vaccine
  • Alcoholic liver disease
  • Reduce prevalence and incidence of alcohol abuse
  • Translational research to convert basic science
    advances into products for clinical trials.

21
High burden diseases without bio markers
  • Osteoarthritis
  • New diagnostics, biomarkers and imaging
    technology will help determine who is likely to
    get osteoarthritis, and the response to treatment
  • Alzheimer disease
  • More sensitive, reliable and valid tools for
    detecting changes in normal ageing and the onset
    of early Alzheimer disease needed.
  • Lack of surrogate markers remains a major barrier
    in the clinical development of AD drugs

22
High burden diseases where existing therapies
could be improved
  • Cancer
  • More capacity (infrastructure and human
    resources) and coordination to conduct
    comparative clinical trials
  • Continue to invest in basic research into cancer
    biology
  • Diabetes
  • Heat stable insulin would be a major advance in
    public health
  • Gaps in basic biology, stem cell research,
    transplantation research
  • Depression in adolescents elderly
  • Gaps in understanding biology of depression and
    its treatments in these groups

23
"Neglected" diseasesLack of EU support for
translational research for market failure
diseases
  • Malaria
  • Lack of experimental models for medicines
    discovery and development.
  • Tuberculosis
  • More FDCs for second-line treatment of
    multidrug-resistant TB Diagnostics
  • Leishmaniasis, trypanosomiasis, Buruli ulcer
  • Most of the medicines being used are "old" and
    often dangerous
  • Post-partum haemorrhage
  • Major cause of maternal mortality in developing
    countries, heat stable oxytocin would be a major
    advance in public health for women

24
Special Needs for Women, Children, and the
Elderly
  • All groups neglected in drug development
  • Complicated by different physiology metabolism
  • Recent improvements in situation of women and
    children
  • Considerable gaps remain for the elderly who use
    the most medicines

25
Promoting Innovation and Removing Barriers
  • Public Private Partnerships may be a vehicle to
    address market failure
  • Pricing issues are critical to the future of the
    European pharmaceutical industry. Propose
    investigating differential pricing based on GNI
    per capita and efficacy measures. Reseach
    prospective price setting.
  • EMEA, FDA, Rawlins and Industry have all proposed
    similar measures to remove barriers
  • Comparative trials provide critical information
    on head to head comparisons. Use of European
    databases may facilitate such studies

26
Differential Pricing Indicative prices in
US/annum of highly active antiretrovirals
(HAART) and a new hypothetical regimen in
countries of variable wealth
27
Role of Patients remains unclear
  • Patients have speeded innovation e.g. AIDS and
    Orphan diseases
  • Valuable role in treatment guideline development
    emerging e.g. NICE
  • Patients play important role in ethical
    hospital committees e.g. IRB DTCs
  • Will now be part of CSM in UK
  • Future role likely to be important and growing

28
ConclusionsPriority Medicines for Europe and the
World
  • Commonality of interest exists for chronic
    diseases between Europe and the World
  • Priorities can be set based on evidence, trends
    and projections and social solidarity
  • Pharmaceutical gaps exist as a result of
    biological challenges and market failure
  • Highest priorities are antibacterial resistance,
    influenza, smoking cessation and neglected
    diseases
  • Pricing issues and barriers to innovation
    strongly affect the European industry
  • The EU needs to find a way to support
    translational research for market failure
    pharmaceutical gaps

29
Priority Medicines Project
  • For further questions, please contact
  • laingr_at_who.int
  • wak22_at_comcast.net
  • 41-22-791-4533
  • http//mednet3.who.int/prioritymeds/report/index.h
    tm

30
Identifying gaps (unmet therapeutic needs)a
public health perspective
31
International organizations and less formal
groups have developed methods for prioritizing
health research
  • The Commission on Health Research for Development
    (1990)
  • The World Development Report (1993 )
  • The Ad Hoc Committee on Health Research (1996)
  • The Global Forum for Health Research (2000)
  • WHO-IFPMA Round Table (2000-2001)
  • The UNDP/World Bank/WHO Special Programme for
    Research and Training in Tropical Diseases (TDR)
  • The US National Institutes of Health (NIH) (1998)
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