By UAEM-Edinburgh and Emma Preston (National UAEM-coordinator ‘09/’10), updated by Fiona Rae (Outreach Coordinator ‘11/’12)
General Introduction (Essay) ……………………………………………………………………. page 2
Useful facts for flyers ……………………………………...………………………………......... page 5
What has UAEM achieved so far? ……………………………………………………………….. page 6
Tips for new UAEM branches and Step-by Step Guide to setting up a chapter……….………… page 8
Reflections from UAEM-Edinburgh …………………..………………………………................ page 9
Useful websites and suggestions for further reading ………………………………….………... page 10
Important UAEM contacts and contacts of existing branches ………………………………….. page 11
UAEM – FAQ …………………………………………………………………………………... page 13
by Neha Jain (UAEM-Bristol) and Pascal Geldsetzer (UAEM-Edinburgh) - http://www.thelancetstudent.com/2008/10/25/bridging-the-research-and-access-gap-%E2%80%93-the-role-of-universities/
Human rights affecting the health of people are violated everyday. Outcries at the most obvious deplorable acts – such as rape, torture, murders, and human experimentation – resonate through almost all forms of media into our lives. However, parallel to these are the more subtle, equally detrimental stories, which are often unheard. One such case is that of access to essential medicines, or rather, a lack of.
Being able to access a basic but essential level of health care is considered a fundamental component of the ‘right to health’. Yet one third of the world’s population, from rural and remote villages in Sub-Saharan Africa to the urban centres of America, are still unable to access proper healthcare. (1) Every year, 10 million lives could be saved through the expansion of existing and effective medical interventions. (2) This global health and medicines crisis is attributable to many factors; increased microbial resistance to older medicines, discontinued production of unprofitable existing medicines, prohibitive prices of many drugs, lack of research into new drugs to tackle ‘neglected diseases’ and logistical problems in the supply and storage chain to name but a few. (3)
The story of business & health – the gaps
The profit seeking behaviour of the pharmaceutical industry has given rise to the frequently aired term, the “90/10 gap”. The term alludes to the fact that, of the more than US$100 billion spent worldwide on health research every year, only an estimated 10% is allocated for health problems existing predominantly in developing countries; yet, these illnesses account for over 90% of the world’s disease burden.(4) Often referred to as ‘neglected diseases’, the majority of these consist of infectious diseases. The WHO has stated that the following neglected diseases in particular require more Research&Development: Malaria, Tuberculosis, African trypanosomiasis, Chagas disease, Leishmaniasis, Lymphatic filariasis, Onchocerciasis and Schistosomiasis. (5) This imbalance in research spending has lead to the frightening statistic that only 21 of the 1,556 drugs brought onto the market from 1975 to 2004 were destined to fight neglected diseases. (6)
This distinct lack of research constitutes one part of the problem; the other being a discrepancy between what is available and what is accessible. Doctors Without Borders (MSF) point out that the patent protection of drugs by pharmaceutical companies and universities creates a monopoly for the originator institution for up to 20 years. The resulting high prices of medicines are unaffordable to most people in low-and middle-income countries. Furthermore, registration of new medications and changes in treatment policies often require extended periods of time, which causes considerable delays until new treatments become available to patients. (7) This creates a vicious cycle; sparse pharmaceutical innovations are insufficient to combat microbial resistance; the medicines that are available often reach those who need it very late and when they do get there they are often too expensive. So, they won’t be bought and therefore the industry will not invest in additional drug development. Thus, without altering the current market-driven equilibrium from an industry focussing heavily on profit to that of responsible drug research, the poor will remain outside the domain of mainstream developments and their health will suffer for it. There is much debate on whose responsibility it is to address this imbalance and many are surprised that universities could bring about a positive change to this dilemma.
Breaking the cycle – what can universities do?
Research universities can contribute to narrowing this gap hugely. Large sums are pumped into the drug development pipeline by universities every year. In 2002, $19.6 billion was spent in the US alone, highlighting their potential forces for considerable influence. (8)
Representing the student movement “Universities Allied for Essential Medicines” (UAEM), we believe that whenever universities license new drug candidates to pharmaceutical companies, they should make companies obliged to make the drug available in low-and middle-income countries at the lowest possible cost. This would have a negligible financial impact on companies and universities, because low-priced drugs would only be introduced into markets that otherwise cannot afford them. (9) Moreover, the percentage of pharmaceutical revenue derived from low-and middle-income countries is insignificant (for instance 1% from the entire African continent (10)) and both pharmaceutical companies and universities would receive royalties from generic sales. (9)
Furthermore, we think that changing how university offices evaluate technology transfer practices based purely on economic indicators instead of on their global public health impact will help universities conduct research in more socially responsible ways.
Examples of important achievements in tackling the problem:
-In September 2006, the Senator of Vermont, Patrick Leahy, introduced the “Public Research in the Public Interest Act of 2006″ which would force every federally-funded US research institutions (including universities) to ensure that their drugs are offered at the lowest possible price in developing countries. (9)
- The Association of American Medical Colleges and eleven major US universities met for the first time in March 2008 to discuss access to medicines issues. In their final statement, they recognise that their discoveries must be made available “globally, at sustainable and affordable prices, for the benefit of the world’s poor.” (11)
- Ed4T is a potential antiretroviral drug to treat AIDS (12), which Yale University licensed to Oncolys BioPharma in July 2006. According to Yale’s International Cooperation Treaty, the university planned to patent the drug in 76 countries. (13) However, students and media pressurised Yale, which gave in and promised not to patent the drug in low-income and most middle-income countries. (14)
Universities are expected to be responsive to reasoned debate with students and faculty; we believe it is time that students start a tough dialogue about access to and research into essential medicines. You can join thousands of students at over a hundred university campuses in signing our statement of principles, the Philadelphia Consensus Statement (http://consensus.essentialmedicine.org/), and urge classmates and faculty to do so, too (a ready-made petition is available on our website – http://www.essentialmedicine.org/add-your-voice/). To take action at your university; join or start a UAEM chapter!
(1) Ahmad, K. (2002) Access denied to essential medicines in developing world. TheLancet, 2(12):711
(2) Department for International Development (2004). Increasing access to essential medicines in the developing world: UK Government policy and plans. London: DFID. Available from: http://www.dfid.gov.uk/Pubs/files/accessmedicines.pdf
(3) T’Hoen EFM (2003). The responsibility of research universities to promote access to essential medicines. Yale Journal of Health policy, Law, and Ethics, 3 (2):293-300
(4) Secretariat of the Global Forum for Health Research (2004). 10/90 Report on Health Research 2003-2004. Global forum for health research. Geneva. Available from: http://www.globalforumhealth.org/Site/002__What%20we%20do/005__Publications/001__10%2090%20reports.php
(5) WHO/Industry Drug Development Working Group. Working paper on priority infectious diseases requiring additional R&D. WHO. Available from: http://www.who.int/intellectualproperty/documents/en/IFPMA.pdf
(6) MSF Campaign for Access to Essential Medicines (2006). Addressing the Crisis in Research and Development for Neglected Diseases [document on the internet]. Médecins Sans Frontières [cited 14 Aug 2008]. Available from: http://www.msf.ca/fileadmin/documents/themes/expo2006/BRIEF_access.pdf
(7) MSF Campaign for Access to Essential Medicines. What is the Campaign [document on the internet]. Médecins Sans Frontières [cited on 14 Aug 2008]. Available from: http://www.accessmed-msf.org/about-us/
(8) Dave A, Rajkumar R. (2007). Leveraging University Research to Advance Global Health Journal of the American Medical Association, 298:1934-1936.
(9) Leahy P (2006). S. 4040 A bill to ensure that innovations developed at federally-funded institutions are available in certain developing countries at the lowest possible cost. In the Senate of the United States. Available from: http://www.essentialmedicine.org/wordpress/wp-content/uploads/2007/04/S4040.pdf
(10) Gellman B (2000). An Unequal Calculus of Life and Death. The Washington Post, [Online]. Available from: http://www.washingtonpost.com/ [cited on Aug 14 2008].
(11) Pradhan AS (2007). Statement of Arundeep S. Pradhan before the U.S Congress House of Representatives. The Association of University Technology Masters. Available from: http://www.autm.org/aboutTT/Pradhan_Pt1and2.pdf [cited on 14 Aug 2008].
(12) Tanaka H, Haraguchi K, Kumamoto H, Baba M, Cheng YC (2005). 4′-Ethynylstavudine (4′-Ed4T) has potent anti-HIV-1 activity with reduced toxicity and shows a unique activity profile against drug-resistant mutants. Antiviral chemistry & chemotherapy. 16(4):217-21.
(13) Check E (2006). Universities urged to do more for poor nations. Nature 444, 412-413. Available from: www.nature.com/nature/journal/v444/n7118/full/444412b.html
(14) Aitken K (2006). University not to patent chemical [document on the internet]. Yale Daily News. Available from: http://www.yaledailynews.com/articles/view/19195 [cited on 14 Aug 2008
Useful facts (for flyers etc.)
The WHO estimates that 10 million people die each year due to lack of access to medicines and vaccines that already exist. (http://www.dfid.gov.uk/Pubs/files/accessmedicines.pdf)
Many diseases affecting millions of the world’s poorest are neglected because they do not attract a profitable market for commercial research and development.
Only 10% of the global research and development funding goes towards research into 90% of the world’s disease burden (termed the “90/10 gap” - http://www.globalforumhealth.org/Site/002__What%20we%20do/005__Publications/001__10%2090%20reports.php).
15 of the 21 drugs with the greatest global therapeutic impact were results of research funded by the US government. The vast majority of US government-funded research is carried out at US universities (http://www.meduohio.edu/research/nih_research_benefits.pdf).
Only 21 of the 1,556 drugs brought onto the market from 1975 to 2004 were destined to fight neglected diseases (http://www.msf.ca/fileadmin/documents/themes/expo2006/BRIEF_access.pdf).
Universities’ mission statements aim to promote public welfare – in fact, most UK universities have charity status.
Universities are taking out more patents than ever before (e.g. 3,000 in the US in 2001) including patents on life-saving drugs which then become unaffordable in the developing world (http://www.sciencemag.org/cgi/content/summary/301/5640/1629).
In 2006, the WHO’s Commission on Intellectual Property Rights, Innovation and Public Health recommended the following: “Public research institutions and universities in developed countries should seriously consider initiatives designed to ensure that access to R&D outputs relevant to the health concerns of developing countries and to products derived therefrom, are facilitated through appropriate licensing policies and practices.” (WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH).http://essentialmedicine.org/action/?p=12)
For information on UAEM’s aims and why UAEM targets universities, please refer to http://www.essentialmedicine.org/our-proposals/ and http://www.essentialmedicine.org/why-universities/.
What has UAEM achieved so far?
D4T and the Yale Campaign: This success in 2001 was the start of the UAEM campaign. Yale had a “use patent” on D4T (Stavudine), an important HIV/AIDS drug but they had licensed it to a large pharmaceutical company (Bristol-Myers Squibb) thereby giving BMS exclusive rights to produce it – a monopoly which allowed them to decide the price for this life-saving drug. At the time this drug was extremely expensive and inaccessible for many in immediate need of it. Students along with MSF (Doctors Without Borders) campaigned for Yale to allow generic manufacture. It was with this student pressure that BMS finally agreed to allow for generic manufacture in poor countries bringing down the price of D4T by 95% (http://www.yale.edu/yjhple/thoen.pdf).
UAEM has grown to become a large international coalition of students and faculty at dozens of major research universities in the U.S., Canada, Europe, Africa, Australia and Asia
The Philadelphia Consensus Statement is UAEM’s statement of principles and has been signed by luminaries such as Paul Farmer, Jeffrey Sachs, four Noble Prize Laureates and many other top intellectual property professors. The list goes on with students, faculty and supporters from over a hundred campuses from around the world.
The introduction of The Public Research for the Public Interest Act (S. 4040) by Senator Leahy in September 2006 which mandates humanitarian licensing terms that UAEM has been promoting(http://www.essentialmedicine.org/wordpress/wpcontent/uploads/2007/04/S4040.pdf
UAEM’s activities have appeared in Nature, Science, PLoS, the British Medical Journal, the Chronicle of Higher Education as well as in a wealth of other online, university and local publications (http://www.essentialmedicine.org/why-now/).
In March 2008, eleven prominent universities and the Association of American Medical Colleges came together for the first time to publicly recognize their fundamental responsibility to ensure the fruits of university research benefit the world’s poor and to commit to the simple principle at the heart of our policy proposals (http://www.essentialmedicine.org/why-now/).
Recently in November 2009, Boston University, Brown, Harvard, the Oregon Health and Science University, the University of Pennsylvania, Yale and AUTM released a public document entitled “Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies” (available here: http://www.autm.net/endorse; UAEM’s comments on this can be found here: http://www.essentialmedicine.org/big-victory-6-universities-autm-and-nih-agree-to-access-principles/).
Three ‘access’ policies regarding licensing have been passed in the UK. One was passed in Oxford in 2007, Edinburgh in 2009 and most recently in Dundee in April 2011. Several other UK universities are also in the process of negotiating global access policies such as in Manchester University, the University of Bristol and Imperial College London.
UAEM UK is now striving to reach ‘access policy’ standards equal to and beyond those achieved in the US. We have been collaborating with the UK union on Technology Transfer Managers (PraxisUnico) and this year earned a spot at their AGM. We are also participating in and international conference to be held in Warwick this year on November 19 and 20th . 2011 entitled Socially Responsible Licensing Achieving Social Equity through Voluntary Licensing”. Some of the organizations that will be presenting include Aspen Pharma, Bioventures for Global Health, DNDi, Gilead, Glaxo, MPEG LA, Merck, the Medicines Patent Pool, PIPRA, Sterne Kessler, the Universities of Boston, Costa Rica, Oxford and Warwick, and WIPO.
MedAccess (UAEM-Edinburgh) – Our experiences so far: We had our biggest success last year when we passed a motion, relating to the “access to essential medicines” aim of UAEM, through the university court. The motion can be viewed here: http://www.planning.ed.ac.uk/Governance/CMG/Pub/20090318/PaperJ-EssentialMedicinesPositionStatement.pdf. This success has also been covered in The Guardian as well as various student newspapers: http://www.guardian.co.uk/science/2009/apr/26/cheaper-medicines-edinburgh-university; http://www.journal-online.co.uk/article/5743-university-medicine-ruling-could-save-thousands. It is, however, a fairly non-specific statement and we are now in the process of trying to figure out how we can improve it.
Professor David Webb, who is a pharmacology professor at the university, initiated the motion. We heard about it and so we worked together with Professor Webb. We also talked to the president of the Edinburgh University Students' Association, who was really keen to help us in any way he could. Our biggest achievement probably was to get over 300 students to come to the annual general meeting of the Edinburgh University Students' Association (EUSA) to have them vote on our motion - the motion was accepted unanimously and so we could prove to the university that we had large student support. In addition, the passing of the motion officially obliged EUSA to campaign for our cause. We also got in touch with "Edinburgh Research & Innovation" (ERI) which is the licensing and commercialisation department of the university (http://www.research-innovation.ed.ac.uk/). ERI was quite willing to support us as well and they accepted the motion as one of the internal ERI policies. Finally, we got the head of ERI (Derek Waddell) to sign our motion as well as the head of the medical school and vice principal of the university (Sir John Savill) which then made the motion a university-wide policy.
We are now working with Professor Webb to publicise the motion to researchers. We have also started to think about how we, as students, can best help to increase research into neglected diseases at Edinburgh University. In addition, we are trying to find out if there is any point in trying to pass a motion through the Scottish Parliament – we are meeting one of our MSPs soon to discuss this.
During the last couple of years, we hosted several talks, stalls, film showings and stunts to raise awareness; had several fundraising events for the MSF Access to essential medicines campaign and tried to get more global health into the medical undergraduate curriculum. We did the latter by supervising, together with a member of staff, a student selected component (these are small projects medical students have to undertake) on neglected tropical diseases; and we created computer assisted learning packages for medical undergrads on HIV/AIDS and malaria. We definitely want to continue working in these areas in the future as well.
One of our main aims this year is to help new UAEM branches start up and to encourage Medsin branches to start UAEM groups. We also want to cooperate more with existing branches so that we might be able to host national UK events as well as European-wide events.
Tips for new UAEM branches:
“Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has” – Margaret Mead
As you have read, UAEM has had tremendous success over the past eight years in North America and now in the UK. Starting a UAEM chapter is an incredibly rewarding undertaking but it is important to remember that when starting a new UAEM branch there can be a steep learning curve. UAEM is such an interdisciplinary group, composed of law students, medical students, undergraduates and graduate students from a number of different disciplines. Getting a grasp on the “intellectual property” jargon, figuring out metrics, properly pronouncing Neglected Tropical Diseases like ‘Onchoceriasis,’ and understanding the ins and outs of the drug development pipeline is no easy task. But fear not! With a small but dedicated group of students, as a part of the UAEM global student network, you’ll be able to make an impact at your university. We have a network of students across the UK, Europe and the world who are able to answer your questions. In the UK, Edinburgh University is the designated ‘outreach’ chapter and we are your first port of call for any queries you might have (email – firstname.lastname@example.org). We also have several resources for you to help you get started! In the UK we have a ‘dropbox’ with key powerpoints, leaflets and information packs which can help you get started. Once you have registered potential interest in starting a chapter, you will be directed towards these resources. You can also be allocated an international ‘partner’ chapter who can share with you their practical experiences of running a chapter at their university.
Step-by-step Guide to Starting up a UAEM Chapter
Contact the UAEM UK co-ordinators (email@example.com and firstname.lastname@example.org) and/or the Outreach Co-ordinator (email@example.com) to register your potential interest and get some support.
Familiarize your self with the UAEM campaign using any of the sources suggested, the website is particularly easy-to-read (www.uaem.org)
Start Talking to people about the UAEM campaign to see if anyone is interested in joining you. Your friends, your classmates, your local campaign groups (Medsin, StopAIDS, Friends of MSF, People and Planet etc)
Form an electronic group: Set up a google email and google group so that you have a forum to discuss things from and organize any emails you get.
Set up a first meeting: Perhaps you want to present at the end of another campaign event or meeting (Medsin StopAIDS). Perhaps you want to set up your own first meeting to talk to people about UASEM. Your Outreach Co-ordinator can direct you towards ready made powerpoints, leaflets and videos to help you do this!
Make a plan: Who at your university can help you (staff, students, campaign groups) what do you want to achieve this year and in the long term? How are you going to do this?
Identify and Contact: Key players are your university. With your colleagues, brainstorm professors, faculty members, and administrators who you think might be supportive. Remember to think about a diverse range of faculties and departments (Law, Medicine, Pharmacy, Biology etc.…even Journalism). Staff advisors can be immensely helpful.
Investigate: How things work at your university: (but don’t get too bogged down with details)
Find out how your University deals with Research and Intellectual Property
Does your Uni have a Technology Transfer Office/ Patenting and Licensing Department?
Are there any spinoff companies that professors at your school might be involved in?
Find out what research is being done at your Uni (often easier said than done…)
Check your Uni’s website, newspapers, and magazines and talk to your profs
How are research priorities decided?
What are the major sources of funding of research at your school?
Is there any Neglected Tropical Disease research being done?
Pass an Access to Medicines Policy: We hope that every university in the UK will draft a policy declaring how they hope to ensure university-researched drugs reach the developing world. This works differently at different universities but several steps can be helpful:
Petition: What do you want students and staff to sign up for? You can make a facebook group, electronic petition, hard copy, use the Philadelphia Consensus Statement
Student Motion: Can you get the Student Union to declare their official support for your campaign? Investigate how motions get passed at your university
Technology Transfer Office: (TTO) Set up a meeting with your TTO to talk to them about these issues. Start off by just going on a fact-finding mission, before you come back to them later with more knowledge and your proposal
Organise a Fundraising Event: To get people interested in your campaign and get new members! You could do a pub quiz, show a film (we have many suggested titles), do a bake sale. This will help you bond as a UAEM group and help you get some funds to do things like printing leaflets etc.
Reflections from UAEM Edinburgh: One mistake we made in Edinburgh is that, for quite a while, we were trying to get information on how research funding and patenting, etc. works at Edinburgh University by surfing the internet. While we think it is important to know your stuff, it’s almost impossible to learn everything about the details of research funding and patenting at individual UK universities. We think the best way forward is to learn your basics about UAEM (see the essentialmedicine.org website and the further reading list) and to then start talking to university staff members and find out how they think UAEM’s aims could be realised at their university. We have made friends with a professor in neglected disease research at Edinburgh for example and she has been very helpful for us. It would probably also be a good idea to get in touch with the patenting and licensing department at your university to find out what their thoughts are on the UAEM aims and how they think it could be achieved at your university. Finally, we found it extremely helpful to get in touch with our student union - we got massive support from the student union president. I think student union presidents are very likely to be supportive because they can get a lot of good publicity out of UAEM and passing an access motion can be accomplished relatively quickly so that the student union president could list it as one of his/her achievements.
These ideas are mainly for the access aim of UAEM - promoting research into neglected diseases is obviously a much longer term goal but again finding out from staff how they think research could be increased may be a good way forward (and support from your student union president will help obviously). We don’t have much experience yet with promoting research into neglected diseases.
In terms of recruiting new members to your group, we found that giving brief 5 minute presentations before lectures is very effective. We then asked students to pass a sheet around during the lecture where people could sign up to the Philadelphia Consensus Statement and could also tick whether they wanted to be put onto our mailing list. I have uploaded the powerpoint we used for that at http://www.slideshare.net/guest192d09/uaem-presentation-for-recruitment and the sign-up sheet at http://www.docstoc.com/docs/16159903/Sign-up-sheet-Philadelphia-Consensus-statement. We have also attached the PCS petition document from the essentialmedicine.org website.
Aren't universities the wrong place to start trying to solve the access problem? Isn't the real issue industry, or trade law, or infrastructure? Yes and no. Changing university policy alone is of course not enough, but it can help, both by removing potential barriers to access, and by setting an example. Universities are essential to the world's drug development system, and engage in much of the world's basic research. They're successful at it because their norms are different than those of industry - more cooperative, more open, and dedicated to the public good, rather than profit. Many of the most important medical innovations have some connection to universities. In some cases, universities have rights to drugs and processes right now that, if they took the right steps, could be made more accessible. In other cases, adopting a policy will be preventative medicine, to ensure that problems do not arise, and that the university is remaining true to its mission.
If a university takes a stand on this issue, won't industry partners refuse to deal with them?
The simple answer is, no. If universities act collectively, they can maintain their integrity even in the face of opposition from industry—they have done it before, successfully establishing the norm that industry should not be able to require lengthy publication delays periods for research they sponsor at universities. While industry may not need any particular university, they do need universities as a whole. Furthermore, negotiations on particular licenses are very particular to the circumstance and invention—sometimes universities will have lots of bargaining power, other times they won't. But even where their power is weakest, industry should not be dissuaded by an access-friendly policy. There are almost no profits to be made in non-OECD countries and many benefits to the university and company that handle the access issue wisely.
How does the EAL measure an access gap? The EAL does not require for an access gap to be established. This was a consideration in the drafting of the license but the data required to objectively establish an access gap is not fully accessible or completely reliable. Instead, the EAL operates on a very simple principle. In all low and middle income countries, if someone wishes to compete with the licensee to supply the end product (final drug), they must only notify the university and licensee and then they will be granted an open license for manufacturing, selling, exporting, and importing.
Won't the EAL kill innovation for diseases affecting developing countries?
No. Unfortunately, there is already a real dearth of research on diseases that affect the world's poor. The problem is market failure—and since patents in developing countries aren't making anyone any significant amount of money, even eliminating those profits altogether wouldn't hurt innovation (because there is none). In very rare instances, universities may need to override access-friendly default rules in order to ensure that a product makes it to market, and we would support that—but these cases will be few and far between, if they exist at all.
If many drugs are not patented in the world's poorest countries how is the EAL relevant in these situations?
Even if there are no patents in a specific country other barriers may exist. Under the EAL regulatory barriers are lifted through open licensing of any property data held by the university or licensee. Importantly, since a country may not have the infrastructure to manufacture a drug within its own boards the EAL lifts manufacturing barriers. The EAL provides for open licensing of the right to manufacture in any country for export to low and middle income countries.
If Universities ultimately hold the patent for a given drug, why is it necessary to even negotiate with drug companies to allow for generic manufacture and distribution? Couldn't universities simply directly license their patents to third parties for generic distribution?
It is very rare that only one patent goes into making a new drug and that therefore the power is solely in the hands of a university. More often is the case that the university has a patent for a very early stage component of the drug. In developing the drug the pharmaceutical company will take out several more patents for further developments along the away. In addition to those additional patents taken out in the initial manufacturing of the drug, any subsequent improvements on the drug such as a better formulation that might reduce it to once a day dosage or the development of a pediatric form will also be separately patented. In a traditional licensing agreement the university has very little power over the pharmaceutical company's patents related to the drug.
How would pharmaceutical companies react to the EAL? Don't they have a valid concern about parallel importing?
Pharmaceutical companies will have probably voice a concern over parallel importing (low-priced generics produced under the EAL finding their way into the black market in developed countries), but is this concern valid? Not really. New regulatory barriers and customs regulations have minimized the threat of this, so the idea is being used more as a political excuse than as a practical concern. This concern finds little empirical support, and can be addressed in the same manner that the WTO has elected to treat the issue: requiring use of different packaging, pill color, and shape in different countries to facilitate identification of illegal importations.
What is a patent?
According to the US Patent and Trademark Office (PTO): "A patent for an invention is the grant of a property right to the inventor, issued by the PTO." The term of a new patent is SO years from the date on which the application for the patent was filed in the United States or, in special cases, from the date an earlier related application was filed, subject to the payment of maintenance fees. US patent grants are effective only within the US, US territories, and US possessions. The right conferred by the patent grant is, in the language of the statute and of the grant itself, "the right to exclude others from making, using, offering for sale, or selling" the invention in the United States or "importing" the invention into the United States. What is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. The theory is that the higher prices that patents allow companies to charge provide incentives to develop and commercialize new products.
What is parallel importing?
Parallel importing is importing cheaper medicines in order to take advantage of the fact that patented drugs are sold at different prices in different countries.
Parallel importing is allowed under the TRIPS agreement. (Parallel importing is what busloads of senior US citizens do when they go to Canada to fill their prescriptions - buying the same brand-name drugs in a country where they are less expensive.)
What part of the market are we talking about, exactly? Low and Middle Income(LMI) countries, which make up 88.3% of the world’s population, account for only 5-7% of the overall pharmaceutical market. This is overall bulk sales, however. Pharmaceutical companies make only a tiny part of their profits in these countries, either because of lower prices or because there is simply not enough demand in particular countries. These statistics represent the market failure that is causing many of the world’s neediest populations to lack necessary medicines. The flip side of this point is that pharmaceutical companies still have a profit-incentive to develop drugs for only high-income countries, while allowing generic competition in the rest of the world.
If drug companies are already implementing some differential pricing schemes, what role do universities have to play in this?
It is true that recent pressure has convinced pharmaceutical companies to lower their prices for selected drugs in the developing world and in some cases allow generic production of particular drugs there. There is still a very important gap, however. While the cost of a year’s worth of anti-retroviral drugs (against HIV) in South Africa has been lowered to US$ 199 in recent years, second-line therapy remains at an unattainable US$2,500 per year. This is a pattern seen in most of the newest drugs, which can arrive in the developing world decades after they are saving lives in high-income countries. Today, fewer than 10% of Africans in need of treatment for HIV infection are receiving it, and new innovations such as a non-refrigerated version of the ARV Kaletra is not available in Africa. Universities, which are at the forefront of creating new medical innovations, can change this picture from the first step in the drug pipeline.
Will parallel importing become a problem when allowing generic production of patented medicines in low and middle income countries?
Diversion from poor countries is rarely observed. Generic drugs have been produced in India for decades without apparently infiltrating or undermining Western markets. (Review of court cases by Andrew Farlow, Oxford University: ‘Costs of Monopoly Pricing Under Patent Protection’, Presentation at Columbia University, slide 19.) The only significant media reports of diversion have been shown to be overblown. GlaxoSmithKline charged that 36000 packages of HIV/AIDS medicines worth approximately $18 million were found to have been diverted from West Africa to the EU. (Naik, Asian Wall Street Journal; Boseley and Carroll, The Guardian; ‘HIV Drugs for Africa Diverted to Europe,’ Washington Post.). GlaxoSmithKline sued a legal parallel trader named Dowelhurst for this violation. In the court case, it turned out that 99% of the packages handled by Dowelhurst were not part of Glaxo’s charitable access initiative but rather ordinary commercial sales at prices approximating EU prices. Also, Glaxo did not label the packages as ineligible for sale or re-importation in the EU. (Outterson, Yale Journal of Health Policy, Law, and Ethics 2005). Insofar as diversion is a concern, it can be addressed in the same manner that the WTO has—by requiring use of different packaging, pill color, and pill shape in different countries to facilitate the identification of illegal imports. (‘Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’, World Trade Organization 2003.)
Are there any examples of university action making a difference?
Yale and Bristol Meyers Squib reduced the price of stavudine (d4T) in South Africa by more than 95% by agreeing not to enforce the patent there. Though it took pressure from students, the researcher who discovered the drug, and Doctors Without Borders, both Yale and BMS benefited from the positive publicity generated by their arrangement. These trailblazing efforts led the way for the reduction in price of many other drugs, which together enabled non-governmental organizations as well as governments to begin treating people infected with HIV in developing countries. Yale continues to have strong and healthy ties to the pharmaceutical companies, and Pfizer has recently built a new $35 million dollar Clinical Research Unit in cooperation with Yale.
Will universities or pharmaceutical companies be liable for drugs produced generically under the EAL?
As there will be no direct relationships between pharmaceutical developers and generic manufacturers as part of the EAL, and the creation of the generic market is automatic and open, neither Penn nor the pharmaceutical developer should be in any way legally liable for the actions of generic manufacturers. The EAL should not set up any unique liability situations not currently seen in the pharmaceutical market.
Where do vaccines fit into UAEM policies?
Vaccines are a special case in that they are important for both the developing and developed world, but their lack of profit potential has made pharmaceutical success difficult. The economic reality of this market, coupled with liability concerns and high manufacturing costs (manufacturing fixed costs represents roughly 60% of the expenditure per dose), many pharmaceuticals companies have exited the market. In cases where new vaccines have actually reached the market, prices can be prohibitive. Vaccines would likely be best addressed with policies under our Research Gap proposals.