Transcript Slide 1

Non-Communicable Diseases, and Essential Medicines:
Saving 10 million lives a year, the University Challenge
Universities Allied for Essential
Medicines (UAEM)
The Problem: Access to Medicines,
NCDs and Drug Patents
UAEM is an international studentled not-for profit organization with
chapters at more than 60 major
research universities across North
America, Europe and around the
world. Our vision is that universities
and publicly funded research
institutions will be part of the
solution to the access to medicines
crisis by promoting medical
innovation in the public interest and
ensuring that all people regardless
of income have access to essential
medicines and other health-related
technologies.
It is estimated that 10 million lives
could be saved each year by
providing better access to existing
1
essential medicines. However
according to the World Health
Organization, as well as numerous civil
society and patient organizations, the
affordability and availability of NCD
medications is limited globally, in both
the public and private sectors.2,3,4 In
light of this increasing access gap, an
important concern for UAEM is the high
cost expected for new treatments for
chronic diseases, as a result of drug
patenting.5,6,7
Patent
Pharmaceutical
Company for
Brand Name Drug
UAEM’s Role in Relation to NCDs
UAEM aims to improve access to
NCD medicines by:Implementing equitable licensing
agreements at universities to
ensure that future NCD medicines
developed at our institutions will be
affordable and available in the
developing world
Raising awareness of the
importance of rational procurement
of NCD medications, by
empowering students to take action
on this issue.
UAEM’s Proposal: #1 Global Access
Licensing at Universities
When a university licenses a promising
new drug candidate to a
pharmaceutical company, we believe it
should be a requirement that the
company allows the drug to be made
available in poor countries at the lowest
possible cost. Universities can ensure
this through licensing principles that
enable generic manufacture of the drug
in the developing world. This would
have virtually no financial impact on the
company or university, but could
ultimately save millions of lives.8
Success Story #1: Global Access
Licensing
Stavudine, an antiretroviral (ARV),
was originally developed at Yale
University and later exclusively
licensed to Bristol-Myers Squibb,
which sold it at a prohibitively high
price ($1600 per year).
UAEM petitioned Yale University to
change the licensing agreement and
enable generic manufacture of
Stavudine in South Africa. As a result
of this campaign’s success, the price
of the treatment dropped by 96% to
9
only $55 per year.
How Global Access Licenses Might
Impact on NCDs: Implications from
the Past
Universities are significant
contributors to the drug development
pipeline. A study conducted in 2000
found that 15 of the 21 drugs which
were considered to have had the
greatest therapeutic impact over the
past 30 years were developed at
government-funded institutes, mainly
universities.10
Moreover publicly funded research
has been particularly important to the
development of therapies for NCDs.
Indeed universities hold patents on
many key drugs used to treat chronic
diseases such as for cardiovascular
disease and cancer (see table).11
Drugs for NCDs with Academic Patents (selection) filed for FDA
approval 1988-2005
Active Agent
Adenosinea
Properties
Anti-arrhythmic
Busulfan
Latanoprosta
Anti-Neoplastic
Chemotherapeutic
Prostaglandin Analogue
Lovastatin
Statin – Lipid Lowering
Pemetrexeda
Anti-Neoplastic
Chemotherapeutic
Anti-convulsant +
analgesic
A.
B.
C.
E.
D.
Pharmaceutical
Company for
Brand Name Drug
Pharmaceutical
Company for
Generic Drug
F.
Pregabalina
a
U n i v e r s i t i e s
Indication
Heart
Disease
Leukaemia
Glaucoma
Heart
Disease
Omeprazole Immediate Release Oral Peptic Ulcer
(with Sodium Proton-Pump Inhibitor
Disease
Bicarbonate)
Patent
How Global Access Licenses Might
Impact on NCDs: Future Prospects
A study, evaluating recent drug
innovation, demonstrates that
universities continue to play an
important role in drug discovery,
particularly in the development of the
most clinically effective new chemical
entities.12
A l l i e d
Patent Holder
University of
Virginia
University of
Texas
Columbia
University
Children’s
Hospital Boston
University of
Missouri
Lung Cancer
Epilepsy/
Neuropathic
Pain
= New Molecular Entity that received ‘priority’ FDA approval
f o r
Princeton
University
North-western
University
Treatments for NCDs make up the
majority of these new innovations.12
Success Story #2: Expanding the
WHO Model List of Essential
Medicines to include NCDs
As a result of UAEM applications to
the WHO, statins and proton-pump
inhibitors were added to the Essential
Medicines List (EML) in 2007 and
2009 respectively.13 This is an
important step for these medicines as
incorporation on the EML affords
drugs increased international
attention, and strong evidence
suggests it improves their availability
and affordability at a national
level.14,15 In 2011, UAEMers
petitioned for the addition of
bisoprolol (a modern beta blocker),
glucagon (a key diabetic
treatment),and propofol (a powerful
anaesthetic) to the EML.
Adding Statins to the 15h WHO Model List of
Essential Medicines : Steps taken by UAEM
2006
June
Merck’s patent on
Zocor (simvasatin)
expires
September
UAEM partners with
CeVEAS, Rockefeller
Foundation, Public
Health Foundation of
India and Weill
Cornell Medical
College
1
(Both charts were constructed by Rae, F on behalf of UAEM from data gathered by Stevens et al, 201112)
UAEM’s Proposal #2: Students
should be empowered to advocate
for access to NCD treatments
UAEM believes students are wellplaced to advocate for increased
international attention to achieving
access to NCD treatments. At a
grass-roots level we aim to do this as
an extension of our educational and
awareness-raising activities on
campus. At an international level we
intend add the politically strong
student voice to the concerns of other
NGO networks, such as is our
mission in the upcoming Moscow
Ministerial Conference on NCDs
(April, 2011).
E s s e n t i a l
November
UAEM submits
application to
WHO
July
Data regarding costeffectiveness and
safety/efficacy of
statins assembled for
application
October
UAEM identifies
reliable multisource,
high-quality and
inexpensive statins
with help of Clinton
Foundation and Dr
Reddy’s
Pharmaceuticals
2007
April
WHO approves that statins should be incorporated
into EML. Statin drugs officially eligible for drug
donation in 156 countries
(Figure adapted from Kishore et al, 200913 with permission)
References
1. WHO, World Health Organisation (2004) ‘WHO Medicines Strategy: Countries at the core: 2004-2007’. World Health Organisation,
Geneva. Available at: http://apps.who.int/medicinedocs/en/d/Js5416e/5.1.html [Accessed 29/3/11]
2. Cameron, A. Roubos, I. Ewen, M. Mantel-Teeuwisse, Leufkens, H. Laing, R. (2011) ‘Differences in the availability of medicines for
chronic and acute conditions in the public and private sectors of developing countries’, Bulletin of the World Health Organisation.
Available at: http://www.who.int/bulletin/online_first/10-084327.pdf [Accessed 30/3/11]
3. Mourik, M. Cameron, A. Ewen, M. Laing, R. (2010) ‘Availability, price and affordability of cardiovascular medicines: A comparison
across countries using WHO/HAI data’, BMC Cardiovascular Disorders, 10: 25. Available at:
http://preview.biomedcentral.com/content/pdf/1471-2261-10-25.pdf [Accessed 30/3/11]
4. Cameron, A. Ewen, M. Ross-Degnan, D. Ball, D. Laing, R. (2009) Medicine prices, availability, and affordability in 36 developing
and middle-income countries: a secondary analysis;, The Lancet, 373: 250-249
5. MSF (2011) The Impact of Patents on Access to Medicines’. MSF Access to Medicines Campaign. Available at:
http://www.msfaccess.org/main/access-patents/introduction-to-access-and-patents/the-impact-of-patents-on-access-to-medicines/.
[Accessed 29/3/11]
6. WHO (2005). ‘Preventing Chronic Disease: A Vital Investment’, Available at:
http://www.who.int/chp/chronic_disease_report/en/. Accessed [28/3/11]
7. Dobert, R. Van den Daele, W. Seiler A. (2003) ‘Access to Essential Medicines – Rationality and
Consensus in the Conflict Over Intellectual Property Rights’ WZB Social Science Research
Centre Berlin, Discussion Paper SP IV 2003-108. Available at: http://bibliothek.wzberlin.
de/pdf/2003/iv03-108.pdf [Accessed 28/3/11]
8. UAEM (2011) ‘Global Access Licensing Framework (v.2.0). Available at: http://essentialmedicine.org/archive/global-accesslicensing-framework-galf-v20 [Accessed 28/3/11]
9. UAEM (2009) ‘Stavudine and Yale’. Available at: http://essentialmedicine.org/our-work/successes/stavudine-and-yale/ [Accessed
28/3/11]
10. United States Senate (2000) ‘The benefits of medical research and the role of the NIH’. Office of the Chairman, Connie Mack.
Available at: http://www.lifestarinstitute.org/files/library/BenefitsofResearch.pdf [Accessed: 29.3.11]
11.Sampat, B.(2009) ‘Academic Patents and Access to Medicines in Developing Countries’, American Journal of Public Health, 99:917
12. Stevens, A, Jenson, J. Wyller, K. Kilgore, P. Chatterjee, S. Rohrbaugh, M. (2011) ‘The Role of Public-Sector Research in the
Discovery of Drugs and Vaccines’, The New England Journal of Medicine, 364: 535-541
13. UAEM (2011) ‘UAEM History Transition Document 2011’. Available at: http://essentialmedicine.org/archive/uaem-history-transitiondocument-2011 [Accessed 31/3/11]
14. Kishore, S. Herbstman, B. (2009) ‘Adding a Medicine to the WHO Model List of Essential Medicines’’, Clinical Pharmacology and
Therapeutics, 3: 237- 239
15. Twaqirumkiza, M. Annemans, L. Kips, J. Bienevus, E. Van, Bortel, L. (2010) ‘Prices of antihypertensive medicines in Sub-Saharan
Africa and alignment to WHO’s model list of essential medicines.’ Tropical Medicine and International Health, 15: 350-362
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