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EBOLA VIRUS DISEASE: MATTERS
ARISING
Source: www.md-health.com
EBOLA TIMELINE
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First discovered in 1976 in Northern Zaire and
Southern Sudan
Subsequent outbreaks - Cote d’Ivoire, Gabon and
Uganda
2014 – Most recent outbreak traced to Guinea,
West Africa
Spread to Sierra Leone, Liberia, Nigeria and
Senegal
Global transmission – Spain, United States of
America
MATTERS ARISING
Human
Rights
10/90
Gap
Ebola
Clinical
Trials
Research
Funding
10/90 GAP – RESEARCH FUNDING
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10/90 Gap: Only 10% of global health research is devoted to
conditions that account for 90% of the global disease
burden.
Neglected Tropical Diseases: Group of tropical infections
which are especially endemic in low-income populations in
developing regions of Africa, Asia, and the Americas
Infectious communicable diseases arising from a diverse
group of parasitic worms, bacteria, and vector-borne
protozoa.
Ascariasis, Buruli ulcer, Chagas disease, dracunculiasis,
hookworm infection, human African trypanosomiasis,
Leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis,
schistosomiasis, trachoma, and trichuriasis
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Big three diseases: HIV/AIDS, tuberculosis, and
malaria
Greater funding and research
Ebola?????
NEGLECTED TROPICAL DISEASES
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Affects poorest countries of
the developing world
Lesser mortality rate
Long incubation periods
Needs based approach
BIG THREE DISEASES
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High Mortality rate
Public awareness
Market based approach
INCENTIVES
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Public private partnerships - the Sabin Vaccine
Institute, Norvartis Vaccines Institute for Global
Health, MSD Wellcome Trust Hilleman
Laboratories, Infectious Diseases Research
Institute, Institut Pasteur and INSERM, and the
International Vaccine Institute
Priority vouchers to speed drug approval processes
- Novartis' Coartem, Asset
Open source scientific collaborations – Malaria
GEN, WIPO Re:Search. Copyright matters, SPC
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Global R&D capacity building - Capacity building is the process
through which individuals, organizations and societies obtain,
strengthen and maintain their capabilities to support development. In
practice it encompasses human resources development, institutional
development, and the creation of appropriate policy and legal
frameworks.
The Special Program for Research and Training in Tropical Diseases
(TDR) is a global program of scientific collaboration that helps
coordinate, support and influence global efforts to combat a portfolio
of major diseases of the poor and disadvantaged. Established in
1975, TDR is based at and executed by the World Health
Organization (WHO), and is sponsored by the United Nations
Children's Fund (UNICEF), the United Nations Development Program
(UNDP), the World Bank and WHO.
TDR established its Career Development Fellowship on Clinical
Research & Development in 2009. Successful candidates are
seconded to leading pharmaceutical companies in order to to
develop their clinical trial management skills. Each of the qualified
professionals accepted as a Fellow trains for 12 months on location
at a facility of their hosting company’s, in order to develop specialized
skills not readily taught in academic centres, including research and
development (R&D) project management, regulatory requirements
and clinical good practice. Upon completing their Fellowships, the
individuals are expected to return to their home institute and assume
a leading role in the global effort on R&D for infectious diseases,
thereby enhancing developing country product development capacity
on diagnostics, drugs and vaccines for the diseases that
disproportionately affect poor and marginalized populations building.
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Innovation prizes and grants
Bill and Melinda Gates Foundation
WESTERN RESEARCH RE EBOLA
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Zmapp - an experimental drug developed by a US
biotech firm Mapp Biopharmaceutical Inc. (over a
decade)
Tekmira Pharmaceuticals (Canada), Sarepta
Therapeutics (US) and Profectus BioSciences, of
Tarrytown, NY.
MSF and Red Cross – return of infected aid
workers
Donations – GSK, Johnson & Johnson, Novartis,
Bayer, Pfizer etc.
AFRICA – RESEARCH AND FUNDING
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Congo
% devoted to research – Health workers on strike
in Nigeria, Insufficient health workers in Sierra
Leone
Independence vs Dependence for Aid
Sense of entitlement – West (Big brother), Grants
Indigenous drugs vs Generics (Brazil and China)
Patent protection – India and Evergreening
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Compulsory Licensing – Article 31bis TRIPS, Doha
Declaration, Rwanda-Canada Apotex
authorization on the individual merits
payment of adequate remuneration
unsuccessful efforts to obtain an authorization from
the patent-holder on reasonable commercial terms
within a reasonable period of time
Public health emergency
Supply of domestic market
Voluntary Licensing – Gilead’s Sovaldi
HUMAN RIGHTS
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Right to Health - right to the highest attainable
standard of physical and mental health, which
includes access to all medical services,
sanitation, adequate food, decent housing,
healthy working conditions, and a clean
environment. (UDHR Article 25)
Right to highest attainable standard of physical
and mental health – Accessibility, Availability,
Acceptability and Quality (ICESCR Article 12)
Health – state of complete physical, mental and
social well-being and not merely the absence of
disease or infirmity. (WHO)
State-guaranteed rights.
Availability: A sufficient quantity of
functioning public health and health
care facilities, goods and services, as
well as programmes.
Accessibility: Health facilities, goods
and services accessible to everyone.
Accessibility has four overlapping
dimensions:
non-discrimination
physical accessibility
economical accessibility
(affordability)
information accessibility.
Acceptability: All health facilities,
goods and services must be
respectful of medical ethics and
culturally appropriate as well as
sensitive to gender and life-cycle
requirements.
Quality: Health facilities, goods and
services must be scientifically and
medically appropriate and of good
quality.
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Right to Development -Everyone has the right to
enjoy the benefits of scientific progress and its
applications. The World Conference on Human
Rights notes that certain advances, notably in the
biomedical and life sciences as well as in
information technology, may have potentially
adverse consequences for the integrity, dignity and
human rights of the individual, and calls for
international cooperation to ensure that human
rights and dignity are fully respected in this area of
universal concern. (Vienna Declaration para 11)
Right to Culture - The States Parties to the present
Covenant recognize the right of everyone:
(a) To take part in cultural life;
(b) To enjoy the benefits of scientific progress and its
applications;
(c) To benefit from the protection of the moral and
material interests resulting from any scientific,
literary or artistic production of which he is the
author. (ICESCR Article 15)
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IP VERSUS HR
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Patent monopoly
Economic rights – cost of research (high costs
justifiable?)
Ethics
CLINICAL TRIALS
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Dr Kent Brantly and Nancy Writebol
Abdullahi v Pfizer Inc case in Kano, Nigeria where
11 children died in a clinical trial for Pfizer’s Trojan
– an antibiotic aimed at treating meningitis
US National Institutes of Health (NIH) and
GlaxoSmithKline – UK, Gambia and Mali
Johnson & Johnson
GSK
(Healthy Volunteers)
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Fast-tracking trials of experimental drugs and vaccine
candidates – FDA Approval
Facilitates the development, and expedites the review, of
drugs which treat a serious or life-threatening condition and
fill an unmet medical need.
Accelerated approval is meant for drugs that demonstrate an
effect on a surrogate, or intermediate endpoint reasonably
likely to predict clinical benefit.
Priority review shortens the FDA review process for a new
drug from ten months to six months, and is appropriate for
drugs that demonstrate significant improvements in both
safety and effectiveness of an existing therapy.
FINAL THOUGHTS
IS THERE REALLY INSUFFICIENT RESEARCH RE
10/90 GAP?
THANK YOU
QUESTIONS