Proposal

for the OC proposed PreGA workshop on

Conflict of Interest in Access to Treatment

IFMSA March Meeting 2013, USA

Proposed by NMSA-Norway, IMCC-Denmark and AMSA-USA the en

Introduction

enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being... WHO constitution

Per year, it is estimated that 10 million people die because they cannot access life-saving, essential medical treatments. Additionally, the plague of antibiotic resistance is rapidly rising as evidenced by the example of 440,000 new cases emerging annually of multidrug resistant tuberculosis leading to 150,000 deaths per year [1]. In spite of this crisis, very few novel antibiotics have been developed in recent years leading the rise of superbugs. In fact, according to Light and Lexchin, since the mid-1990s, 85-90% of new drugs provide little to no therapeutic gains for patients [2]. In fact, according to the same study, it is estimated that for every $1 spent on basic research and development, $19 is spent on marketing. Clearly, there is a misalignment between the priority of industry to maximize profits and the public health need for new treatments and better access to affordable medicines. Additionally, there is a growing concern regarding the influence of the pharmaceutical and device industries on physicians worldwide. Scholarly research has shown that physician prescribing behavior can be directly and indirectly influenced by acceptance of gifts including meals [3]. These studies have demonstrated that industry-sponsored gifts to physicians are associated with the inclusion of expensive, brand-name prescription drugs into hospital formularies and an increase in the feelings of reciprocity toward industry. In recent years, governments such as India have been attempting to revisit ethic codes to control such prevalent marketing behaviors in fears that medical professionalism will be compromised and patients will have to bear the staggering costs of expensive brand name drugs rather than affordable generics. The influence of industry however goes farther than just that of the doctors office. Currently being negotiated is a historic, multilateral free trade agreement called the Trans-Pacific Partnership Agreement whose country partners include the United States, Canada, New Zealand, Australia, Brunei, Vietnam, Malaysia, Singapore, Mexico, Peru, and Chile. According to the United States Trade Representative, this agreement will "set the standard for 21st-century trade agreements going forward [4]. The negotiations are occurring completely in secret and civil society groups including IFMSA, Public Citizen, and Doctors Without Borders are unable to access the most recent text in order to effectively advocate for provisions that ensure access to affordable treatments. While such stakeholder organizations are barred from sitting at the negotiating table or accessing the text, the U.S. Trade Representative has granted approximately 600 corporate lobbyists including those from the pharmaceutical and device industries special cleared advisor status that enables them to review and comment upon specific negotiating drafts, allowing them to directly influence the U.S. Trade Representative to push for aggressive provisions that would limit access to life-saving generic medications through enhanced patent protections and data exclusivity favoring these companies. Other provisions

threaten providers from not being able to choose the best procedure for their patient in fear of infringing on a patent. These are some of the biggest health challenges currently that will only be exacerbated if solutions are not developed for the future. Solutions are necessary to bridge the disconnect between an industry driven by profit and the dire public health need for truly innovative and affordable treatments. It is time to intervene, as future physicians, and ensure that our patients are put before profits and that the integrity of our profession remains intact. The health of billions are at stake making it necessary to educate and organize IFMSA members around this crucial issue; thus, NMSA-Norway, IMCC-Denmark and AMSA-USA together propose this preGA workshop.

Executive summary

Access to essential medicines Every year, 10 million people die from diseases for which medical treatment exists but simply because they are tragically unable to access them. Nearly a third of the worlds population does not have regular access to essential medicines, and in the poorest parts of Africa and Asia this figure rises to over 50% [5]. During the fifteen seconds it takes to read this paragraph, five people have died from preventable causes. Many diseases affecting millions of the worlds poorest remain entirely overlooked. Countless people suffer in developing countries from sleeping sickness, lymphatic filariasis, blinding trachoma, and other neglected diseases, because these destitute sick do not constitute a sufficient market opportunity to attract commercial research and development. In fact, only 10% of research and development (R&D) dollars go towards research into 90% of the worlds health problems [6]. The health burden facing millions in the developing world is one of the most pressing moral issues of our time. In this environment, public sector research institutions, universities is most cases, have a critical role to play. The literature shows that public-sector research is not the foremost source of medical innovations, but they do account for a significant amount of the drug discoveries. When we look at priority review drugs and new molecular entities, the amount derived from universities increases. Richard Keller shows in a review published in Nature in 2010 (5) that the universities have increased their contribution to medical innovations the last decade. Furthermore, the discovered drugs from the public sector have a disproportionately large therapeutic effect and a more immediate effect on public health, as concluded by Stevens and co-workers in an article called The role of Public-Sector Research in the Discovery of Drugs and Vaccines published New England Journal of Medicine [7]. The efforts of public research in the discovery of new drugs are particularly visible when looking at the funding for research on tropical neglected diseases. As we see from this figure, public- sector research institutes and non-profits collectively invested over 90% of the total funding in

2007 [8]. The amount of funding for R & D on neglected diseases is still too low, but the public research institutions are playing an increasingly bigger part in the financing. What can public sector research institutions do to increase access to medicines? Public-sector research institutions, like many universities and public research institutes, are envisioned to provide knowledge for the public good. They should be disseminating knowledge for the purpose of education and research in order to ensure improvements in our societies. Therefore, they should be applying knowledge to current challenges in addition to the pursuit of unapplied scientific research. An interpretation of knowledge for the public good would therefore be that innovations derived from public-sector research institutions should be managed to meet the needs of the society. Expanding on this, we believe that these institutions may serve to meet global needs. One of the main challenges is how the universities handle their intellectual property rights. The global accessibility of research/products and technologies depends critically on this. As research institutions that exist to serve the public good, universities are natural leaders in the search for new treatments for neglected diseases. Universities have a social contract with society and, as educational and research institutions, they have a responsibility to promote and manage the deployment of innovations for the public benefit. In no field are the moral imperatives to do so as clear as they are in medicine. As medical students, we have a unique opportunity to push for normative change in our universities and research institutions. We can advocate for more research on neglected tropical diseases and make our universities conscious on how they handle intellectual property rights, and to make sure that patenting of research from public sector research institutions only occurs when necessary. In the cases where patenting is necessary, the universities should have equitable access licensing frameworks implemented in their policy to make sure that IPRs wont be at hinder for accessibility for the populations in need. We will motivate our dedicated IFMSA members to use their knowledge gained from this preGA workshop to fight for increased innovation as well as access to medicines and health-related technologies for all. This has been done before with great success, as seen in 2001, when public pressure from students, researchers, and MSF led Yale and the pharmaceutical company Bristol-Myers Squibb change their exclusive rights to the antiviral drug d4t (Stavudine) discovered by researchers at Yale University. This made it possible for the South Africas leading generic manufacturer, Aspen Pharmacare, to produce the drug for sale in South Africa. The price dropped 30-fold afterwards and many lives were saved [9]. Industry Conflict of Interest and AMSA-USAs PharmFree Campaign A major impediment to patient access to medicines is the staggering cost of medicines and treatments. This can be partially attributed to the marketing influence of pharmaceutical and device industries on academic medical centers and healthcare providers leading to the overprescribing of brand-name expensive medicines rather than robust generic alternatives to patients. In recent decades, in spite of the growing need, research and development budgets have not significantly increased whereas marketing budgets have dramatically skyrocketed with

the largest increase in targeted promotion to healthcare providers [10]. Evidence has shown even the solicitation of pharmaceutical sales representatives into clinical settings for mere minutes can influence a physicians prescribing behavior. Other studies have shown that conflicts of interest can lead to an increase in the number of expensive, brand name drugs into the hospital formulary and overprescribing of such drugs over generics by physicians [3]. Such marketing practices also begin early in medical training - one study noted that without safeguards such as an institutional conflict of interest policy, medical students at an American medical school reported up to 20 encounters with pharmaceutical sales representatives in just one year [11]. Additionally, within recent years, world media has shed light on even more aggressive marketing tactics from pharmaceutical companies towards physicians and trainees in other countries. For example, in India this year, there was a nationwide strike from pharmaceutical sales representatives in response to the governments creation of a statutory code for ethical sales and marketing practices to prevent widely prevalent practices of gift giving to physicians [12]. Additionally, the German Court of Justice this past summer ruled that National Health Service doctors are allowed to receive up to 10,000 Euros worth of gifts, holidays, and favors without any fear of being charged with corruption [13]. Not only this but the United States own Security and Exchange Commission also this summer charged Pfizer and Wyeth with Foreign Corruption Practices Act violations alleging that employees and agents of Pfizers subsidiaries in Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia made improper payments to foreign officials to obtain regulatory and formulary approvals, sales, and increased prescriptions for the companys pharmaceutical products[and] tried to conceal the bribery by improperly recording the transactions in accounting records as legitimate expenses for promotional activities, marketing, training, travel and entertainment, clinical trials, freight, conferences, and advertising [14]. The SEC also subpoenaed documents from Teva and Bristol- Myers Squibb for investigations of similar activity [15]. In response to concerns that both medical education and clinical practice was being too influenced by industry, AMSA-USA members began the PharmFree Campaign in 2002. The goal of the campaign is to promote evidence-based medical education rather than marketing-based medical education in order to ensure that trainees are receiving information that is scientifically based and without industry bias. From this campaign came the AMSA-USA PharmFree Scorecard which for five years has collected conflict of interest policies from all domestic medical schools and given them a letter grade based on scoring of 11 conflict of interest domains: gifts and meals, consulting relationships, industry-funded speaking relationships, disclosure, pharmaceutical samples, purchasing and formularies, industry sales representatives, on-campus education, etc [16]. The grades are then publicly posted on a website and released to schools as a way to leverage schools to improve their policies. Currently, the Scorecard is being revised and expanded to teaching hospitals as well. Besides the Scorecard, AMSA-USA has also developed a Model Curriculum on conflict of interest for medical students based on recommendations from the American Association of Medical Colleges and the Institute of Medicine. The purpose of the curriculum is to educate students on the consequences of financial relationships of industry and the ultimate impact these will have on patient care.

 Medicines undoubtedly play a crucial role in the maintenance of health, but it is vital that they are used rationally. We as future health care professionals will play a key role in ensuring that patients are not prescribed medicines that they do not need, are unsafe, or unnecessarily expensive. We are also expected to be able to recognize when information given to us about a treatment is inaccurate or misleading. However, health-care professionals receive little or no instruction on how to assess pharmaceutical promotion and how to understand its often subtle influence on their behavior[17]. We aim to address this problem by educating students about some forms of drug promotion they may encounter during their training and future careers and offer them training in ways to assess promotional material. We want to encourage students to consider the impact that drug promotion may have on future prescribing habit and educate them about the evidence on pharma- funded research and offer training on critical appraisal of drug trials. Last but not least we want to explore ways in which we can improve our medical training on this subject at our universities through examples such as the AMSA-USA PharmFree Scorecard and Model Curriculum.

Goals and Objectives of the workshop:

Give participants a good understanding of the area of access to essential medicines in low and middle income countries. Explore the drug development pipeline and which segments of this process IFMSA members can target. Encourage the preGA participants to set up a cooperation between their NMO and UAEM (University Allied for Essential Medicines) http://essentialmedicine.org Give participants guidance in how they can advocate for more research in neglected diseases. Introduce them to tools and give them advice on how to influence their universities to change their intellectual property rights and conflict of interest policies Give participants a good understanding of the different forms of drug promotion and marketing techniques used by the pharmaceutical industry. Explain and discuss the ways that drug promotion may influence our behavior as health professionals and how this can have an unfortunate impact for our patients. Explore the problem of counterfeit medicines in developing countries. Provide students with skills in advocacy and campaigning Introduction to the IFMSA policy statements on Access to Essential Medicines, the AMSA-USA PharmFree Campaign and Pharmaceutical Promotion Awareness and how these can be used as advocacy tools for campaigns participants can bring back to their NMO or institution Create student groups/ campaigns in the NMOs, which can work further on the specific topics Encourage and help the participants of the preGA to take the lead on forming the IFMSA SWG on Ethical Guidelines to be presented at the AM2013 in Chile.

Methodology:
We will use a variety of methods to make the workshop as interactive as possible and maximize the learning. We will have presentations both from the facilitators and externals. We have been in contact with several external speakers, who are very interested in speaking among those are Krista Cox (Knowledge Ecology International), Peter Maybarduk (Public Citizen), Dr. Jerry Avorn (Harvard Division of Pharmacoepidemiology and Pharmacoeconomics) and Rose de Groot (Health Action International). We will have group discussions and debates as well as small working group times to ensure that participants will be engaged and empowered to carry back resources to their own NMOs and institutions following the preGA. During SWG times, we will allow the participants to take on facilitation roles when appropriate to give them leadership training and the ability to develop their own initiatives. We will use case studies and scenarios to illustrate points and have time set aside at the end of the preGA where participants will work together to create something specific towards the general assembly ( e.g. a flash mob, hand out poster, actions in front of pharmaceutical companies, etc) and beyond. This will assure that the motivation and enthusiasm they gained from the preGA workshop will be shared with those IFMSA members unable to attend. We will also use games and energizers when needed and use different media tools including videos to vary the learning process. The facilitators of the preGA all have extensive training experience from IFMSA and their NMO, which will help guarantee a fruitful outcome for the participants. Proposed agenda: Day 1 Introductory lectures; building a knowledge base: Introductory presentations covering the following topics: For proposed speakers for the introductory lectures, see list under next point. 8.30- 9.00: Check- in: introduction and expectations 9.00- 10.00 What is Global Health? 10.00- 12.30 Access to Essential Medicines and neglected diseases The various factors that impede access to medicines in low- and middle income countries In what ways are Neglected Tropical Diseases neglected, what are the reasons for this and how could this be changed. The importance of public sector research institutions in research and development of

new drugs How can we as students make our university change their intellectual property rights? New models: research and development; financing and coordination medicines patent pool, de linkage of R & D, Health Impact Fund what role can public sector research institutions play in development of new models for R & D 13.30- 15.30 Conflict of Interest and the Rational Prescription of Drugs Basic introductions to the following topics Direct to consumer advertising and misleading patient information Drug promotion to health care professionals Privately-funded research and ghost-authorship Counterfeit medicines Overview of some of the solutions to these problems What can we as students do about it? Introduction to other NGOs working on it 15.30- 17.30 Trade and Health How international trade agreements and multilateral agreements influence health WTO, WHO, WIPO Free-Trade Agreements 17.30: Check- out Day 2 Trainings and lectures 08.30- 09.00: Good morning and check in 09.00- 10.30: Introduction to AMSA Pharm-Free Campaign 10.30- 12.30: Training: Advocacy and Campaigning 12.30- 13.30: Lunch 12.30- 14.00: Lecture by external Anthony So/Suerie Moon 14.00- 15.00: Crash course in rhetoric and debate skills 15.00- 16.00: Debate exercise: Industry vs public health activists 16.00- 16.30: How to start a student group and campaign? 16.30- 17.30: Divide into the specific groups; prepare for day 3 17.30: Check out Day 3: Working group day 08.30- 09.00: Good morning and check in 09.00- 11.00: Training: Advanced advocacy

11.00-12.30: Working time for the working groups 12.30-13.30: Lunch 13.30- 16.30: Working time for the working groups Topic suggestions: Make a campaign on industry conflict of interest in medical education Advocacy campaign towards government on university IPR Awareness campaign around the lack of R&D for neglected diseases Awareness activities to be followed up during the GA Start SWG on ethical guidelines for the IFMSA 16.30-17.30: Presentations of work 17.30-18.00: Evaluation Distribution of useful materials, contact information Check-out Proposed list of speakers/trainers Speakers for the introductory presentations: Krista Cox - Knowledge Ecology International, Washingthon - www.keionline.org Peter Maybarduk - Public Citizen, Washington - www.citizen.org/access Rose de Groot - Health Action International, Amsterdam - www.hai.org Dr. Jerry Avorn, Division of Pharmacoepidemiology and Pharmacoeconomics, Harvard Medical School - http://powerfulmedicines.org/pages/1/index.htm Dr. Peter Lurie, Food and Drug Administration, www.fda.gov Dr. Daniel Carlat, Pew Prescription Project, http://www.pewhealth.org/projects/pew- prescription-project-85899367092 Dr. Anthony So, Duke Program on Global Health and Technology Access, http://ghta.sanford.duke.edu/ Trainers to guide the group discussions: Johanne Iversen (President and international coordinator of Access to medicines, NMSA- Norway) - johanne.h.iversen@gmail.com Anna Roe Rasmussen (UAEM European Coordinator, IMCC-Denmark) - anna.roe.rasmussen@gmail.com Reshma Ramachandran (PharmFree Fellow, AMSA-USA) - pff@amsa.org If necessary we will find more eligible trainers once we know who have been selected by their NMOs to attend the GA in Baltimore. Budget: Materials for the workshop:

 Flip charts Marker pens Printing handouts Printing case studies, scenarios, materials Anticipated cost: $200 USD, will be covered by the organising committee. Travel costs for externals: We plan to get locally based externals, thus there will be no great travel costs. We are prepared to pay bus tickets for maximum $100 USD Total cost: $300 USD Fundraising plans: We will explore the possibility of having NMSA-Norway, AMSA-USA and IMCC Denmark cover expenses for transport of the external speakers. If not the speakers are willing to pay on their own. Expected number of participants: 25-50 Follow up plan: The preGA aims to highlight the issues concerning access to medicines and conflict of interest to catch the interest of students that hopefully would like to start a project or campaign on one of these issues in their local NMO. Once the workshop is over and the goals and objectives are met, our follow-up during and the next months after the GA in USA will include setting up a mailing group in order to share future accomplishments and campaigning materials. We will provide the participants with all the learning materials, presentations and videos in the last day of the preGA, so the participants have enough material to build on their new learned knowledge. We will also provide them with contact details for setting up collaboration with UAEM, The AMSA-USA PharmFree campaign and the other external speaker present at the preGA. We will encourage the participants of the preGA to take the lead on forming the IFMSA SWG on Ethical Guidelines after the MM2013 to ensure that IFMSA will have clear guidelines on who they work with in the future and we will help them getting started with their work. We aim to give the participants a good base of understanding about advocacy and campaigning in order to push for political change in their own countries. We will encourage them to work on a IFMSA policy statement if found relevant regarding these issues and to share what they learn from the preGA by making presentations at their NMOs national assemblies. We will set up SWG on different topics for those with special interest and follow up on these by mail and skype meetings. We will send an electronic evaluation after the GA in order to keep improving the quality of the preGA workshops and facilitation skills of the trainers. The participants have to fill in the electronic evaluation in order to get their electronic preGA certificate. We will also arrange a reunion at the next GA, where the participants present at AM2013, can share what they have

been working on in their NMO and SWG and hopefully many of them will also facilitate SWG on these issues in their respective standing committee sessions for the AM2013 Chile. Selection criteria: The applicants have to write a 1 page motivation letter where they state previous experience within any of these three topics. Why they are interested to learn more about it and why they believe the future of drug development is important. Coordinators contact details - Johanne Helene Iversen, NMSA-Norway: johanne.h.iversen@gmail.com - Anna Roe Rasmussen, IMCC-Denmark: anna.roe.rasmussen@gmail.com - Reshma Ramachandran (PharmFree Fellow, AMSA-USA) - pff@amsa.org Please contact us if you have any questions concerning the proposal. References 1. http://www.who.int/mediacentre/factsheets/fs194/en/ 2. http://www.bmj.com/content/345/bmj.e4348 3. Wazana A. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?. JAMA. 2000;283(3):373-380. doi:10.1001/jama.283.3.373. 4. http://aids2012.msf.org/wp-content/uploads/2012/07/TPP-Issue-Brief-IAC-July2012.pdf 5. Toreele E, Usdin M, Chirac P (2004) A needs-based pharmaceutical R&D agenda for neglected diseases. World Health Organization. http://www.who.int/intellectualproperty/topics/research/Needs%20based%20R&D%20f o r%20neglected%20diseases%20Els%20Pierre%20Martine.pdf 6. Kneller R, The importance of new companies for drug discovery: origins of a decade of new drugs, Nature, 2010 7. Ashley J. Stevens et al, The role of public-sector research in the discovery of drugs and vaccines, New England Journal of Medicine, febuary 9, 2011 8. Moran et al, Neglected Disease Research and Development: How Much Are We Really Spending?, PlosMed, 2009 9. University Allied for Essential Medicines, 2011. Stavudine and Yale. Available at: http://essentialmedicine.org/our-work/successes/stavudine-and-yale/ 10. http://www.cbo.gov/ftpdocs/105xx/doc10522/12-02-DrugPromo_Brief.pdf 11. Acad Med. 2004 Nov;79(11):1041-5 12. http://www.reuters.com/article/2012/09/17/us-india-pharma-kickbacks- idUSBRE88G0I820120917 13. http://www.reuters.com/article/2012/06/22/germany-corruption-court- idUSL5E8HM6JT20120622

14. http://www.sec.gov/news/press/2012/2012-152.htm 15. http://finance.yahoo.com/news/teva-pharma-discloses-sec-bribery-164913800.html 16. http://www.amsascorecard.org/ 17. Health Action Internationals Drug Promotion Manual