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Non-Communicable Diseases, and Essential Medicines: Saving 10 million lives a year, the University Challenge Universities Allied for Essential Medicines (UAEM)
UAEM is an international student led 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.
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.
The Problem: Access to Medicines, NCDs and Drug Patents
It is estimated that 10 million lives could be saved each year by providing better access to existing essential medicines.
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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.
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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
D.
Pharmaceutical Company for Brand Name Drug Patent
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.
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A.
B.
Patent
C.
Pharmaceutical Company for Brand Name Drug
E.
Pharmaceutical Company for Generic Drug
F.
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 only
$55 per year
.
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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.
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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).
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Drugs for NCDs with Academic Patents (selection) filed for FDA approval 1988-2005 Active Agent Adenosine a Busulfan Latanoprost Lovastatin Bicarbonate) a
Anti-arrhythmic Anti-Neoplastic Chemotherapeutic Prostaglandin Analogue Statin
Properties
– Lipid Lowering
Indication
Heart Disease Leukaemia Glaucoma Heart Disease
Omeprazole (with Sodium
Immediate Release Oral Peptic Ulcer Proton-Pump Inhibitor Disease
Patent Holder
University of Virginia University of Texas Columbia University Children’s Hospital Boston University of Missouri
Pemetrexed a Pregabalin a
Anti-Neoplastic Chemotherapeutic Anti-convulsant + analgesic Lung Cancer Epilepsy/ Neuropathic Pain
a = New Molecular Entity that received ‘priority’ FDA approval
Princeton University North-western University
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.
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Treatments for NCDs make up the majority of these new innovations.
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(Both charts were constructed by Rae, F on behalf of UAEM from data gathered by Stevens et al, 2011 12)
UAEM’s Proposal #2: Students should be empowered to advocate for access to NCD treatments
UAEM believes students are well placed 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).
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.
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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.
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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
July
Data regarding cost effectiveness and safety/efficacy of statins assembled for application
September
UAEM partners with CeVEAS, Rockefeller Foundation, Public Health Foundation of India and Weill Cornell Medical College
November
UAEM submits application to WHO
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, 2009 13 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-access licensing-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,
99:9 17 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-transition document-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