Anda di halaman 1dari 22

Pharmaceutical Knowledge Governance: A Human Rights Perspective

Trudo Lemmens

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global.1 This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge.2 Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect what I will refer to in this paper as pharmaceutical knowledge production are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products.3 I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. Following a brief discussion of these stages and of the public health challenges raised, I will briefly explore some of the human rights-associated interests that are at stake. I will then give a brief overview of the contextual and multifaceted nature of the problem of what I term the pharmaceutical knowledge deficit that is to say the serious deficiencies in the way pharmaceutical knowledge is produced, distributed (including through journals, advertisements, and educational initiatives), and used. In this discussion, I will highlight the need for a comprehensive global response, which will be addressed in the final section.

1. Pharmaceutical Knowledge Production: A Global Public Health Challenge

1. 1. The Challenge of Knowledge Production in a Global Environment While historically, pharmaceutical research and development was concentrated in Europe, North America, and Japan, the last decades have seen a clear shift towards more globalized knowledge production.4 This
Trudo Lemmens, LL.M., D.C.L., is the Scholl Chair in Health Law and Policy at the Faculty of Law of the University of Toronto, where he also holds cross-appointments in the Faculty of Medicine and the Joint Centre for Bioethics. During the academic year 2012-2013, he is teaching at the Centre for Transnational Legal Studies in London, and is an academic visitor at the Faculty of Law and the HeLEX Centre for Health, Law and Emerging Technologies of the University of Oxford. His research is primarily focused on the intersection of law, ethics, biomedical innovation, and medical research and practice. global health and the law spring 2013



munication tools via the Internet and social media sites such as Facebook create virtual patient and consumer communities to which information can be channeled. The globalization of these practices has repercussions for the development of good knowledge governance. Enforcing standards becomes even more difficult, particularly due to the absence of accountable transnational governance structures. National and regional regulations (e.g., at the European level) may exist with respect to particular parts of the process, but many aspects of the knowledge production process are dealt with through national While problems in knowledge production are and international soft guidance documents, admittedly not necessarily causally connected professional scientific16 standards, and industry self-regulation. Moreover, reguto its global character, the global nature latory agencies in one state cannot control as easily how data are produced and disof the production process certainly further even when these limits the level of control regulatory agencies, tributed in another state,17 data have a global impact. professional organizations and other bodies Yet, the globalization of knowledge production, combined with new computer are able to exercise. and data storage technologies, also creates opportunities. For example, experts and funded through public-private partnerships that have pointed out that better global communication of involve large multinational companies, niche biotechresults of early phase clinical trials enables scientists nology start-ups, and funding agencies in different to connect different small-scale data sets, which can jurisdictions.7 Global commercial biobanks are also sometimes raise safety concerns well before largeexpected to grow significantly in the coming years.8 scale studies are finalized.18 Global governance of Clinical drug testing involving human research information can thus help ensure that patients, consubjects, estimated to have become a U.S.$50 billion sumers, health care agencies, physicians, and indusindustry,9 is also a global venture, gradually moving try benefit from the wealth of data generated by more from industrialized countries to middle- and lowstreamlined global data gathering and analysis. income countries.10 While problems in knowledge production are admitKnowledge production continues after drug tedly not necessarily causally connected to its global approval, with the collection and storage of data on character, the global nature of the production process billions of patients. Physicians,11 patients12 and pharcertainly further limits the level of control regulatory maceutical companies are expected to submit adverse agencies, professional organizations and other bodies event reports to regulatory agencies. There is also are able to exercise. a growing trend to promote data sharing among patients outside the traditional (and not always well1.2. Integrity and Accountability of Pharmaceutical functioning) adverse reporting systems.13 Knowledge Production: A Public Health Challenge Publication processes of clinical studies also cross In the last decade, numerous reports have highlighted borders. In industry-sponsored studies, medical comthe problems associated with the promotion, premunication companies coordinate the process, with scription and overconsumption of pharmaceuticals involvement of academic specialists sometimes as and medical devices.19 Particularly in the U.S., many mere guest-authors14 and organize strategic placeof these practices have lead to skyrocketing criminal ment of articles in journals, often aligned with the fines and penalties imposed on nearly all of the large market launch of products.15 The scientific literature pharmaceutical companies.20 A 2010 report by the which feeds into global clinical practice guidelines is Public Citizens Health Research Group notes that rarely strictly local. the pharmaceutical industry now tops not only the In addition to traditional means of direct-to-condefense industry, but all other industries in the total sumer advertising, new and increasingly global comamount of fraud payments for actions against the

trend can be noted across all stages of knowledge production: from pre-clinical research all the way through to marketing. At the pre-clinical stage, it increasingly involves computer-driven analyses of stored biological samples, paired with clinical and familial health information gleaned from biobank conglomerates that have mushroomed all around the globe. Global exchange of samples and patient data is standard practice in these global research infrastructures,5 which are often organized in complex collaborative groups 6


journal of law, medicine & ethics

Trudo Lemmens

federal government under the False Claims Act.21 The trend has continued, as higlighted by the 2012 record-setting $3 billion settlement with accompanying criminal guilty plea by GlaxoSmithKline for offlabel promotion of anti-depressants and failure to report safety data about Avandia, a top-selling diabetes drug.22 Interestingly, a recent $60.2 million settlement between Pfizer and U.S. federal prosecutors also highlights the global nature of pharmaceutical corporate malfeasance: prosecutors accused Pfizer of bribing physicians, hospital administrators and regulators in several European and Asian countries, including China.23 Not all of these penalties are for manipulation of research findings or intentional concealment of relevant safety and efficacy data, but most deal with some aspect of pharmaceutical promotion and most have significant public health implications. How serious are the consequences of the practices targeted by these penalties? It is hard to come up with a precise estimate of how many people have died or been seriously injured. The multifaceted nature of knowledge production and the often insurmountable difficulty in establishing a clear causal relation between specific practices and serious adverse events constitutes, in fact, one of the most significant hurdles for tort-based claims. Figures on adverse events, nevertheless, give us an indirect idea of the magnitude of the problem. A recent analysis based on data from the U.S. Centers for Disease Control and Prevention suggests that fatalities associated with adverse effects of medication now surpass those caused by traffic accidents in the U.S.24 While prescription and patient errors are also likely involved, flawed knowledge production practices may in part be responsible for those problems. Even more informative are the estimates of the stunning number of people seriously injured as a result of pharmaceutical products which were promoted through practices which allegedly also involved hiding or misrepresenting data. For example, it is estimated that the aggressive promotion of Vioxx may have resulted in hundreds of thousands of infarctions and strokes.25 The significant impact of the aggressive promotion of Hormone Replacement Therapy (HRT), which involved the controversial use of ghost-written publications, on breast cancer rates in industrialized countries can also be mentioned here.26 Almost all major pharmaceutical companies have been associated with problematic promotional practices of blockbuster drugs that may have caused significant injuries and death. The list includes drugs such as Oxycontin, Neurontin, Paxil, Zyprexa, Celebrex, Fen-Phen, Prempro, Prepulsid, Depakote, Avandia, and Risperdal.27
global health and the law spring 2013

Failures in good knowledge governance can also lead to enormous waste of health care funds. The controversy surrounding the promotion of Tamiflu in the wake of the H1N1 outbreak should be a wake-up call. There is now serious doubt about the reliability of the company-produced synthesis of the data that underpinned public health agencies stockpiling of the drug around the world.28 The decisions to stockpile stand in sharp contrast to the U.S. FDAs assessment of the data and its decision to challenge Roche under FDA regulations for claiming that Tamiflu reduced influenzarelated complications.29 Peter Doshi and colleagues, who identified problems with the reliability of the company-controlled analysis based on partially hidden data and who tried in vain to get access to the full data, cynically comment that if the FDA is right, the drugs effectiveness may be no better than aspirin.30 Yet billions of dollars have been spent in stockpiling Tamiflu around the world $1.5 billion in the U.S. alone.31 Currently, these problems particularly affect the industrialized world, where more people can afford pharmaceutical products and more health care funding is available. Yet, over-prescription and overconsumption can clearly impinge on middle-income and developing countries. In fact, their impact risks being proportionally worse. The challenges in dealing with these practices will be greater in countries with less resources. Moreover, money wasted on ineffective or unsafe products cannot be used to address other priorities.

2. Human Rights Dimensions of Knowledge Production Challenges

There are practical reasons to tackle the issue of knowledge production from a human rights perspective. One of the practical reasons is that it lays bare the societal importance of the issue and can help mobilize civil society and advocacy groups. It calls for prioritization of the issue on the public policy agenda. Most importantly, advocates can invoke the human rights dimensions to tackle restrictions on information access based on claims related to international trade obligations and trade secrets.32 I will not discuss this practical issue here in much detail, but want to focus on how specific human rights claims can be made to push for access to information and for recognizing a governments role in establishing good knowledge governance; and on how a human rights lens also serves as a powerful analytical tool to explore the multifaceted nature of the problem. As the late Jonathan Mann pointed out, traditional public health measures have, in the past, all too often accepted existing societal structures. They focused 165


on individual behavioral changes, on health care services and targeted state action, and on contributions by health care and public health professionals.33 Mann called for a more complex human rights-based approach, which gives attention to the impact of social determinants of health, the interrelation between regulatory structures and health care systems, and the potential role and influence of other professionals. One advantage, he suggests, is that a human rights analysis can disaggregate a seemingly overwhelming problem into many component parts capable of being acted upon.34 This disentangling of the problem and targeting of various distinct components should, however, be accompanied by a thorough understanding of their interrelations. Interventions designed to address one issue should be implemented with proper attention to how these impact elsewhere. This approach is not solely linked to a broad interpretation of the right to health. Rather, it embraces a variety of human rights as tools to deal with public health issues. But the emphasis that Manns model places on the complex interaction between health and various human rights as they exist within a larger societal, cultural and political context also fits well with a more comprehensive interpretation of the right to health itself.35 A meaningful implementation of the right to health necessarily implies an assessment of the unique social, cultural, political and economic context in which the right is invoked. The language used in international conventions36 and in many of the constitutions that contain a reference to the right to health37 clearly reflects its fundamentally contextual nature and its linkage with other fundamental rights.38 It is interesting to identify here briefly what different type of rights can be invoked to argue for better knowledge governance and access to information. 2.1. Access to Information, the Right to Health and the Right to Life In recent publications, both Aaron Dhir, as well as Candice Telfer and I have situated the need for accountable pharmaceutical knowledge governance in the context of this multifaceted concept of the right to health.39 Candice Telfer and I constructed our argument around the well-recognized notion that the right to health not only empowers people to make healthrelated claims, but also creates a gamut of obligations for states related to the implementation of determinants of the right to health. One of these crucial determinants is the right to information. We argued that because of the connection between the right to health and the right to information, states have an obligation to actively promote and support the creation of reliable knowledge production systems in the context 166

of pharmaceutical product development, including mandatory trial registrations and results reporting of all trials.40 We linked in our argument the right to health, the right to information, and freedom of expression. This connection has to some degree been recognized in earlier cases of the European Court of Human Rights (ECHR).41 In one of these cases,42 which dealt with the critical reporting of the Sunday Times on proposed settlements in the aftermath of the withdrawal of the drug thalidomide from the market, the ECHR ruled that freedom of speech also entails the right of the public to be properly informed.43 We emphasized the linkage between the right to information and freedom of expression that was made in this and other ECHR cases44 because it highlights the role not only of the media, but also of civil society, in promoting public interest oriented science and the role of the state in creating the conditions that enable this.45 By discussing this connection between access to information and freedom of expression and thus also participation of civil society in discussions of public interest in the context of access to clinical trials data, we wanted to emphasize that the issue of access to reliable clinical trials data goes beyond immediate individual health claims and concerns but also entails the protection and promotion of public health. Our argument that the link between access to information and freedom of expression could also be invoked to impose a specific duty on states to implement public health-focused knowledge production systems, however, has not received unconditional approval. In the 1998 case of Guerra and others v. Italy,46 for example, the ECHR ruled that the governments failure to provide essential information about the level of risks associated with living close to a chemical plant constituted a violation of citizens right to private and family life47 rather than of freedom of expression. The ECHR limited in this case the freedom of expression clause to situations where the government is restricting the ability of the media to fulfill its public interest role in the distribution of information already compiled by the government. as part of their obligation to protect freedom of expression.47 The Inter-American Court of Human Rights, however, has emphasized more recently in much firmer terms the link between access to information, democratic decision making, and the role of civil society groups, and this with wording that clearly stresses the much broader, social role of governmental information sharing and the need to maximally restrict exceptions to data sharing. In the 2006 case of Claude Reyes et al. v. Chile,48 the court dealt with a refusal of providing three representatives of public interest organizajournal of law, medicine & ethics

Trudo Lemmens

tions access to some of the information gathered by a governmental foreign investment committee in the context of an application for a controversial deforestation project. The environmentalists requested access to assess the potential environmental impact of the project. Although the case also involved access to information already held by the government, the courts strong emphasis on both the individual and social dimensions as well as the positive obligations of the state49 embedded in the freedom of expression clause of the American Convention on Human

a methane explosion killed nine relatives of the plaintiff.56 The Court focused particularly on the fact that the government had not put in place appropriate procedures to prevent such explosions although it knew or ought to have known of the danger. But it further noted that the publics right to informationmay also, in principle, be relied on for the protection of the right to life.57 The circumstances of this case have to be taken into consideration, though, in that reliable information about a serious and imminent risk of an explosion was available. In the context of pharma-

Another human rights concept that is also frequently connected to healthrelated claims, particularly in the context of access to potentially life-saving health care services and technology, is the right to life. The right to life has in some countries, such as Canada, been used as a substitute in the absence of a more specific right to health clause in the constitution. In the international human rights context, there are also some interesting precedents linking the right to life with access to crucial safety information to enable the protection of peoples physical integrity.
Rights stands out.50 [P]rinciples of disclosure and transparency in public administration the court ruled enabledemocratic control of [governmental] actions, and[allows citizens to] question, investigate and consider whether public functions are being performed adequately.51 The court characterized social control, enabled through access to information, as an essential component of accountable government.52 The decision clearly recognizes the importance of civil societys counterbalancing of public decision making. Considering how often the soundness of drug approval decisions have been questioned,53 the reasoning of the court is highly relevant the context of pharmaceutical knowledge production. Another human rights concept that is also frequently connected to health-related claims, particularly in the context of access to potentially life-saving health care services and technology, is the right to life. The right to life has in some countries, such as Canada, been used as a substitute in the absence of a more specific right to health clause in the constitution.54 In the international human rights context, there are also some interesting precedents linking the right to life with access to crucial safety information to enable the protection of peoples physical integrity. For example, in neryildiz v. Turkey the ECHR ruled that Turkey had violated the right to life55 of people living in illegal huts surrounding a garbage tip, where
global health and the law spring 2013

ceuticals, the risk is often but not always more remote, and risk assessment often requires the linking of data sets, careful observation of adverse events, and interpretation of statistical data that suggests that some people may benefit, whereas others could be seriously harmed. The risk in the neryildiz case was clearly more straightforward. 2.2. Privacy, Dignity, and the Unique Nature of Health Information As mentioned earlier, the ECHR accepted in the Guerra case that governments have, as part of their obligation to ensure respect for private and family life, an obligation to provide access to information they already possess and which should enable individual people to make decisions about their health and wellbeing.58 The existence of positive obligations of the state under this provision has been confirmed in later cases,59 sometimes in the context of access to information cases where a link can be made to arguments invoked in the access to pharmaceutical data debate. In Roche v. the United Kingdom,60 for example, the ECHR recognized that the right to private life of a former soldier had been violated because of his difficulties in obtaining access to risk information about mustard gas tests the army had conducted on him. The Court stressed that this was not a case of the government failing to disclose clear and known risks, but 167


one where the hurdles in accessing all relevant data caused considerable anxiety as a result of the uncertainty it created. It analyzed in detail the various ways in which the government had provided access to some data and concluded that the State has not fulfilled the positive obligations to provide an effective and accessible procedure enabling the applicant to have access to all relevant and appropriate information that would allow him to assess any risk to which he had been exposed.61 In the recent case of RR v. Poland62 the ECHR also recognized that states may have a positive obligation to facilitate access to relevant information, in this case in the context of a situation where timely access was necessary to enable a decision about a state-supported medical procedure. The case involved the States failure to provide information about genetic testing, which the applicant needed to decide whether to undergo an abortion. The fact that the procedure itself was available and explicitly supported by the state was a key component of the decision and limits to some degree its ambit. These cases open the door for arguing that states clearly have to actively contribute to citizens informational self-empowerment when government actions contribute to a potential dangerous situation, and that govenments have to set up effective and accessible access to information procedures.63 With the RR v. Poland case, an interesting analogy can also be made between the role of governments in providing access to information about services it provides, and the states role in pharmaceutical knowledge production. States currently exercise some level of scrutiny over the safety and efficacy of pharmaceutical products. In fact, individual access to pharmaceutical products is restricted through the regime of regulatory approval combined with a prescription-only system for some drugs. If, as I will argue further, this regulatory system also contributes to the creation of consumer confidence in these products, it appears absolutely crucial that the state also ensures that the information provided in the context of this system is reliable and accurate. One could argue, from that perspective, that the states failure to ensure that its drug regulatory system provides access to reliable product information violates the right to private and family life. The right to private and family life could clearly be invoked, in line with these cases, to argue that under the European Convention, governments should establish adverse event reporting systems, which can have direct relevance to patients who may be affected by medication. But it remains more speculative to invoke this right to request the establishment of more complex knowledge production systems, where access to 168

information on clinical trials could potentially in the future provide important information on the safety or effectivenes of a product. Another aspect of pharmaceutical knowledge production that evokes privacy interests is that much of this knowledge is constructed on the basis of intimately personal health information. Patients and volunteers contribute to the establishment of biobanks with the donation of their own uniquely personal biological material (blood samples or other tissues). Some of these patients may even undergo additional invasive biopsies, for example in the context of cancer research.64 When clinical trials are conducted to test the safety and efficacy of new products, they inevitably involve exposing people to the potential risks of experimental products. People agree to have their bodies used as a testing site and to have data gleaned from various research-related tests on their bodies, arguably at least in part with the understanding that this contributes to better science and product development. The discussion of the nature of the rights people have over their bodies is complex and multifaceted.65 Some courts have rejected the idea that people have dignitary interests in biological material such as cells.66 Yet, the special status of the human body and the importance of bodily integrity are widely recognized in law, including in international conventions and human rights documents. Human research ethics systems have been developed on the premise that there is something unique about the fact that medical research involves an instrumental use of human bodies and an invasion of bodily integrity. Medical research often involves a transgression of individuals physical boundaries for what is largely the pursuit of other peoples interests. This arguably creates specific moral duties of respect for those using the information gained from these bodily invasions invasions that clearly are associated with human dignity-related interests. Even when it comes to research purely based on stored health data or biological samples, there is a connection to questions of bodily integrity and personhood. Some courts have emphasized the special nature of health information as intimately personal and evoking autonomy interests. For example, the Canadian Supreme Court confirmed in McInerney v. MacDonald, which dealt with a patients right to access her medical records, that such information remains in a fundamental sense ones own.67 The Court also characterized health information contained in medical records as highly private and personal and approvingly quoted the patients counsel who had stressed that this was about getting access to information on her body, the body of Mrs. MacDonald.68
journal of law, medicine & ethics

Trudo Lemmens

In a very different context, but also relevant to mention here in light of the growing importance of biobanks as essential components of knowledge creation, the Icelandic Supreme Court recognized in a widely cited decision that a woman had a privacy interest in the health information of her deceased father contained in the publicly funded biobank, as this information also related to her. 69 Genetic research has revealed how genetic information is fundamentally shared and never completely ones own, and often has direct relevance for family members with whom genetic information is necessarily shared in the case of biological relatives. Obviously, a right over or interest in ones own health information can hardly be used as a directly

It seems ironic that governments and pharmaceutical companies tend to invoke the privacy interests of individuals in way that is diametrically opposed to what is arguably the ultimate goal of privacy protection. Indeed, privacy of health information is frequently cited as one of the main reasons for restricting access to important adverse event reporting data and clinical trials data.70 A more complex human rights approach invites us to look beyond purely individual interest-related aspects of human rights claims and to consider their social and public components. It seems to run counter to such an approach to invoke individual rights such as privacy in a manner that indirectly undermines the health interests of the very same people (and the relatives and community members of

Although it would be hard to see any immediately enforceable human rights claim associated with the emphasis on the public investment in research, there is a connection to the growing recognition of the governments role in contributing to the progressive realization of the right to health. From this perspective, one can argue that with finite resources, citizens can expect that governments behave rationally when they invest in the development of health care goods and technology that can assist with, or affect the realization of, the right to health.
enforceable tool to obtain access to research data that pertain to hundreds, if not thousands, of other patients. In addition, in the context of scientific data analysis, it will not be the individuals themselves who connect data sets, conduct the statistical analysis, and interpret them. Further, the scientific analysis has to be translated into useful information that can be transmitted to patients through learned intermediaries. But the privacy and dignitary interests patients and research subjects have in their own data should inspire advocacy groups to come up with models based on meaningful citizen involvement in public health-oriented science. They should make the case for empowerment of individual patients and research subjects and their communal interests. They should at least be able to collectively claim access to data they physically contributed to data that, in connection with other data sets, are relevant for their health and the health of their family members, friends, and the community at large. Patient advocacy groups could push, for example, for an explicit stipulation in consent forms of the need for transparency of clinical trials data and results reporting. those) whose health information is claimed to be in need of protection. 2.3. The Communal Interest in Health Information and Human Rights This brings me to another human rights-associated interest in the production of scientific knowledge: the communal interest in health information resulting from research and patient care. This communal interest has in recent years been highlighted particularly in the context of biobanks and genetic research, even though the right to enjoy the benefits of scientific progress was already explicitly recognized in earlier human rights documents such as the Universal Declaration on Human Rights as well as in the International Covenant on Economic, Social, and Cultural Rights.71 Commentators72 and statements by international organizations such as HUGO73 have evoked the concept of the Common Inheritance of Humankind or Heritage of Humanity to reflect the shared communal interests associated with genetic information contained in stored samples.74 The growing literature and public statements on the public goods dimensions of scientific research 169

global health and the law spring 2013


and knowledge production are also worth mentioning here.75 Access to information in the context of pharmaceutical research as a human right, the right to benefit from scientific progress, and access to information based on a public good approach have close conceptual kinship, to use a term coined by Philip Alston and Nehal Bhuta in a recent paper on the right to education.76 This conceptual kinship is reflected in various human rights documents and statements, such as the recent UNESCO Universal Declaration on the Human Genome and Human Rights. In Article 12, the Declaration refers to the importance of freedom of research and the fact that research has to benefit health care and humankind as a whole (Art. 12(b)). The Declaration also emphasizes the fact that the benefits of scientific research have to be made available with due regard for the dignity and human rights of each individual.77 The right to benefit from the results of scientific research has received renewed attention from influential human rights bodies. In July 2012, the United Nations Human Rights Council responded to a report by the Special Rapporteur for cultural diversity, by inviting academia and civil society to participate in the further examination of the content of the right to enjoy the benefits of scientific progress and its applications.78 This public interest component of research and technological development can also be linked to public investment in pharmaceutical research. Although it would be hard to see any immediately enforceable human rights claim associated with the emphasis on the public investment in research, there is a connection to the growing recognition of the governments role in contributing to the progressive realization of the right to health. From this perspective, one can argue that with finite resources, citizens can expect that governments behave rationally when they invest in the development of health care goods and technology that can assist with, or affect the realization of, the right to health. As pointed out earlier, governments have invested significantly in the development of biobanks, which are increasingly used as widely-accessible research infrastructures for both academic and commercially focused research endeavors. In addition, there is a growing emphasis in all forms of research on publicprivate partnerships, in which academic researchers and public funding agencies participate with industry in research and health product development. Public investment in research and health product development also occurs in various other forms, such as tax breaks, training programs for researchers, and science education in general. Finally, publicly funded 170

health care systems are also among the largest buyers of pharmaceutical products. This again provides an important and steady stream of income to the industry, which arguably can be seen as significant public support. The significant public investment and public contributions calls for some level of reciprocity and benefit sharing.79 At a minimum, citizens should expect fair and reliable knowledge production processes and accountable access to information practices. Finally, global equity concerns associated with clinical trials and drug development can also be mentioned here.80 As pointed out earlier, clinical trials are increasingly taking place in lower and middle-income countries, even when they involve drugs and health care products that will not necessarily be available in these countries. In industrialized countries, poor and otherwise vulnerable people are also disproportionally represented in clinical trials.81 In general, Phase I trials are conducted on people who participate almost exclusively because they have financial needs.82 This raises larger ethical concerns about the exploitation of vulnerable people and communities. In addition to the risk of exploitation, the fact that it involves people who are in need may even legally compromise the informed consent of research participants, as a result of the duress under which they accept to participate. It is worth noting here that conducting medical experimentation without informed consent is explicitly targeted as a human rights violation by Article 7 of the International Covenant on Civil and Political Rights.83 2.4. Enforceability of Human Rights Claims Related to Access to Information The translation of socio-economic rights into specific legal claims which can be judicially enforced is in general already not straightforward.84 Some of the rights or concepts evoked earlier, such as the communal interests in health information, are even less likely to provide a tangible legal remedy at this point than some of the more commonly invoked socio-economic rights. A human rights discourse based on these notions has primarily rhetorical force. It draws attention to the significance of the issues and may help mobilize the community to support further policy in this area. More individual interest-style human rights, such as the right to health, the right to private and family life, and the right to life, are more likely to provide a basis for legal claims, as in the cases discussed above. Yet, as other articles in this special issue85 and elsewhere86 highlight, the judicial enforcement of the right to health at the national level varies widely. Different factors will play a role here: the integration of the right to health in national constitutions;87 the
journal of law, medicine & ethics

Trudo Lemmens

interpretation of related constitutional rights such as the right to life by national courts; whether national courts have recognized the legal status of the rules of international conventions ratified by the state within domestic law;88 and also a host of social, historical, and cultural factors that influence the judicial culture of a country, including the presence of organized and proactive civil society groups.89 The right to health is, as a socio-economic right, clearly not as easily enforceable as civil and political rights. The International Convention on Economic, Social and Cultural Rights, one of the major international sources of such human rights, stipulates, for example, in its Article 2 that states have an obligation to progressively achieve the realization of these rights. Under the concept of progressive realization, the extent of a states obligation depends on the available resources, and states have much leeway in determining the pace of the realization of these rights and what they want to focus on.90 At the same time, even under the ICESCR, states have some minimal core obligations, such as the obligation to ensure a minimum level of access to the essential material components of the right to health.91 The Committee on Economic, Social and Cultural Rights mentions the provision of essential primary health care92 as one of these core state obligations. When specific information relates to health care products that can be connected to essential primary health care, it can thus clearly be argued that states have an obligation to ensure the accuracy of the available information or even public access to all relevant data. One could also argue that even for health care services which do not themselves constitute essential primary health care, important safety and efficacy information about such services remains a component of essential primary health care since the lack of information can create safety concerns. This cursory overview of some relevant human rights cases suggests that the more pharmaceutical information is immediately relevant to the health of individuals, the more likely providing access to this information can be formulated as a specific humanrights-based obligation. The claim that states also have an obligation to implement reliable knowledge production systems, based on full access to data sets even when the separate data sets are in and of themselves not immediately relevant for individual peoples health, appears more speculative, and is based on a more flexible interpretation of the right to health and other related human rights discussed earlier. A further limitation traditionally associated with human rights claims based on international conventions is that these only bind states and cannot be directly invoked against private actors such as pharglobal health and the law spring 2013

maceutical companies, which clearly play a dominant role in the context of pharmaceutical knowledge governance. Some interesting developments are, however, worth noting here. First, it is increasingly recognized particularly in the context of growing privatization and mixed public-private partnerships in areas such as health that a strict division between governmental and private actor decision-making no longer makes sense. Human rights norms, including socio-economic ones, are increasingly influencing judicial interpretation of private law obligations.93 The argument that a strict division does not correspond with current reality rings particularly true in the context of pharmaceutical knowledge production, where as I will discuss further there is wide support for historically developed governmental regulation, but where a crucial component, i.e., knowledge production on which regulatory review is based, is controlled by industry. This seems also in line with some of the human rights case law discussed above, which reflects a willingness to hold states accountable for their failure to ensure that people are sufficiently informed about the harmful practices industry is engaged in with explicit governmental permission. A second development worth mentioning is the growing pressure on corporations to accept human rights obligations and on states to ensure that appopriate legal accountability mechanisms for corporations exist.94 A detailed discussion of the various civil society95 and more public initiatives exceed the scope of this paper, but some key initiatives in this context are worth mentioning. A significant development is the adoption in 2008 by the United Nations Human Rights Council of the U.N. Protect, Respect and Remedy Framework on Human Rights, prepared by John Ruggie, the UN Secretary-Generals Special Representative on Business and Human Rights.96 The Framework emphasizes the primacy of states obligations to ensure corporate respect for human rights through appropriate legal and regulatory frameworks. But it also calls for corporate responsibility and embraces respect for human rights as a standard of expected conduct. This Framework was implemented in 2011 through the Guiding Principles on Business and Human Rights, which aim at establishing a common global platform for action, on which cumulative progress can be built97 and which flesh out the implications of existing standards and practices for States and businesses.98 The Guiding Principles emphasize corporate responsibility in respecting human rights, expect corporations to actively contribute to the mitigation of the human rights impact of their activities,99 and also call on them to establish processes to identify, prevent and remedy adverse human rights impacts.100 171


Interestingly, the guidelines identify the need for appropriate transparency and communication about human rights violations.101 Arguably, if the right to information about drug safety is a human right, the guidelines would impose on pharmacuetical companies obligations to publicly identify instances where important safety and effectiveness information has resulted in harm to the well-being of patients. The development of these guidelines and the debate following their adoption have led to increased discussion and awareness about the need to promote corporate respect for human rights and the need to hold companies accountable through appropriate state action. The Organization of Economic Cooperation and Development has already updated in 2011 its Guidelines for Multinational Enterprises with a new chapter on human rights, which implements many of the Guiding Principles.102 States adhering to the OECD guidelines, which include about all industrialized countries, offer a complaints mechanism through the use of a Specific Instance Procedure, whereby allegations of violations of human rights by multinationals can be submited to OECD National Contact Points. The latter are national governmental agencies mandated to help implement the guidelines. Yet, as with all of these soft-law initiatives, the lack of enforceability limits the impact of these guidelines.103 There are also questions about the willingness of the national agencies to deal with violations, as the rejection of a series of complaints based on pharmaceutical promotion practices has highlighted.104 In the context of pharmaceuticals, the work of the UN Rapporteur on the Right to Health also deserves attention. The Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines105 prepared under the leadership of then Rapporteur Paul Hunt strongly argues for corporate responsibility in implementing human rights standards. Although it focuses primarily on access to medicines, there is also an explicit reference, under a section on Ethical Promotion and Marketing, to the need to take effective measures to ensure that all information bearing upon the safety, efficacy, and possible side effects of a medicine are easily accessible to individuals.106 The growing emphasis on the corporate responsibility in the implementation of human rights norms could clearly also be invoked to call for greater industry responsibility in promoting reliable knowledge production processes. Yet, the most direct obligation to ensure the implementation of human rights norms still resides with national states. It would also be nave to belief that soft law norms such as OECD guidelines and the Framework on Human Rights 172

will be sufficient to ensure full corporate compliance. In the past, the regulatory system has already significantly relied upon fair practices by industry for the production of reliable data, and it has clearly not lived up to that expectation. As Paul Hunt and Rajat Khosla argue in the context of the access to medicines debate, The apparent non-compliance of pharmaceutical companies with their human rights obligations underscores the vital importance of accountability mechanisms.107

3. Historical, Regulatory, Social, Cultural and Economic Factors of Knowledge Production as Components of a Contextual Human Rights Analysis
If we recognize that states have an obligation to ensure governance of information that conforms with the human rights interests discussed earlier, how do they have to go about this? Human rights law imposes a duty on states not only to respect and protect, but also to fulfill the respective rights, including the right to health and the right to information as one of its key determinants.108 This fulfillment has to be informed by a recognition of the various challenges to their realization. These challenges have to be situated within a complex network of interacting social, cultural, regulatory, and economic components. Untangling the interwoven components of knowledge-production requires careful observation of the multiple ways in which numerous factors intermingle. Pulling hard at one end of the knowledge production knot may appear to provide relief but it may end up aggravating another component. A comprehensive, context-driven human rights approach forces us to start with an evaluation of the interacting historical, social, cultural, economic, and technological factors. 3.1. Drug Regulatory Developments in Historical Context The drug regulatory system originated in the early 1900s in reaction to abysmal food industry practices and the untrammeled marketing of often highly toxic products.109 It was tightened in subsequent decades in the wake of various controversies, particularly following the thalidomide saga of the 1960s, which led to the introduction of the first efficacy requirements. Notwithstanding gradual expansion of the requirements,110 the focus has largely remained on pre-market approval based on the provision of data showing a minimal level of safety and efficacy in a vaguely defined population through a number of pivotal clinical trials. The regulatory emphasis on clinical trials data resulted in the birth of the clinical trials industry, which now largely controls the first stage of pharmajournal of law, medicine & ethics

Trudo Lemmens

ceutical knowledge production. Academic institutions and even organizations such as the American Medical Association were originally quite actively involved in the conduct of clinical trials and primary evaluation of drug safety and efficacy.110 But the gradual increase in requirements with respect to the length, magnitude and thus also costs of clinical trials indirectly contributed to the growing power of this booming industry. Academic investigators, to the extent that they are still involved, are now largely integrated within industrycontrolled knowledge production processes.

lance as a result of the recent amendments to the Food and Drug Act.115 Nonetheless, drug regulatory control remains characteristically focused on the approval stage and the market entry of new drugs, with proportionally little attention to ongoing review. At the same time, there is a concern that the move towards better ongoing review may lead to less rigorous assessment at the approval stage.116 A historical understanding of the development of drug regulation is in this context particularly interesting for several reasons: it helps to understand why regula-

When arguments are made about proprietary rights over those data and data secrecy obligations, we should remind those making such claims that the clinical trials industry itself is the product of growing regulatory requirements aimed at providing more reliable data used in the context of a regulatory process which should be focused on the public good.
Governments, on the other hand, have watched somewhat from the sidelines. They have introduced a host of evidentiary standards, but have largely respected the mantra of self-regulation. The sophisticated review and re-evaluation systems largely work with data produced by the industry. The drug evaluation system provide regulatory imprimatur112 to products with still largely uncertain safety and effectiveness profiles that have been tested internally by those with phenomenal financial interests in their widespread use. It attaches a label of safety and efficacy to products, surrounding them with an aura of trustworthiness, even if the data supporting the approval decision often only suggest a very limited efficacy of the product.113 While the system has historically led to the removal of many quackeries from the market, it has, oddly enough, gradually given the ultimate power of knowledge production to large pharmaceutical companies and their contractual parties.114 At present, fewer completely flawed products may slip through the regulatory cracks, but there is now a concern that remaining safety and efficacy problems will be concealed under a comfortable and reassuring regulatory blanket. Admittedly, some significant regulatory changes have taken place in the last couple of years. Particularly in the U.S., but also in other industrialized countries, these changes have resulted in better post-marketing surveillance and the expanded use of conditional approval. In addition, the FDA has gained more regulatory powers with respect to post-marketing surveiltions have taken a certain shape and where mistakes were made. In the context of the transparency debate, it is helps to see the oddity that regulatory requirements aimed at the production of more reliable safety and efficacy data have given industry more control over data and more sophisticated means to misrepresent. When arguments are made about proprietary rights over those data and data secrecy obligations, we should remind those making such claims that the clinical trials industry itself is the product of growing regulatory requirements aimed at providing more reliable data used in the context of a regulatory process which should be focused on the public good. 3.2. The Evidence-Based Medicine Paradigm Medical practice, health policy, and regulation are, one might say, addicted to evidence-based medicine (EBM). Developed in reaction to often arbitrary medical practices that were previously all-too-seldom questioned, EBM has embraced statistical evidence as a tool to refute or confirm claims about the effectiveness of therapies and interventions.117 It is hard to ignore the attractiveness and importance of this approach, particularly as it rationalizes regulatory processes and the practice of medicine. It has often led to better use of scarce resources and the elimination of harmful practices, even if supporters appear to overestimate its impact.118 EBM is popular for pragmatic reasons and fits well with our societal trust in science. Two serious threats result, however, from the alltoo-often blind focus of EBM on statistical evidence. 173

global health and the law spring 2013


First, it has contributed to a worrisome transformation of medical practice. Statistical evidence often appears to have replaced sound clinical judgment and perhaps more cautious prescription and drug monitoring practices.119 Physicians have lost touch with the individual patients in front of them, embracing statistical results as irrefutable truths.120 They now often forget that statistical data have no eyes to see the individual patient, no ears to understand her suffering, and no brain to connect serious problems with a statistically indicated, but perhaps individually inappropriate, therapeutic agent. The second problem is that evidence is created, constructed, interpreted, and used in a particular social, cultural, historical, and economic context.121 It can be shaped and manipulated by those with a vested interest in its use.122 In part as a result of well-intended regulatory interventions, those with huge financial interests in pharmaceutical knowledge production have become its quasi-exclusive producers. Industry can use EBM as a shield to protect promotional and sales practices, convincing many who tend to confuse an absence of available evidence of harm with evidence of absence of harm. 3.3. Power-Relations and Interests of Industry, Professional Organizations, and Regulators The existence of various vested interests and powerrelations associated with pharmaceutical knowledge creation also merits further analysis. Industry interests have received the most attention. The billion dollar profits associated with the sale of blockbuster drugs clearly influence the knowledge production process. There is overwhelming evidence of repeated industry manipulation, misrepresentation and misleading use of data.123 The magnitude of the interests impacts the effectiveness of regulatory strategies. Critics have pointed out that even billion dollar penalties imposed in the US pale in comparison to the potential gains associated with some of the unlawful practices.124 Notwithstanding the exposure of many of these practices and the sanctions imposed, some continue to turn a blind eye to the problem. At the same time that companies are being prosecuted for the manipulation and misrepresentation of data and off-label promotion, funding agencies, professional organizations, university executives and government officials court company executives to promote co-funding initiatives, sponsorship of events, and the establishment of academic chairs. These relationships obfuscate boundaries, which often complicates regulatory and professional intervention. In the international context, the financial power of the regulatory and professional agencies involved in 174

drug regulation can also be contrasted with that of industry. The health care budgets of most countries pale in comparison to the sheer financial power of the pharmaceutical and related industries. Regulatory initiatives and controls that can be confidently implemented in industrialized countries are out of reach for low- and middle-income countries. This may explain, for example, why the more stringent clinical trials and results reporting requirements introduced through the 2007 FDA Amendment Act have inspired few countries to do the same.125 Clearly, governmental agencies can be put under industry pressure. Corporate capture is a major concern in many countries. This also highlights the need for global coordination and enforcement of standards. Industry interests are the most significant and probably hardest to address. Yet, they clearly do not exist in isolation. Various other stakeholders have vested interests in the governance of pharmaceutical knowledge. The promotion of better standards will, for example, inevitably have to deal with the financial interests of connected industries such as the clinical trials and commercial research ethics review industries, and the medical communications agencies. Several commentators have, for example, proposed to fundamentally reform drug regulation by removing the power of the pharmaceutical industry over the design, conduct, analysis and reporting of clinical trials.126 This could result in a significant shrinkage, if not disappearance, of the Contract Research Organizations and commercial IRB industries, at least as we know them now.127 Even tinkering at the margins of the current knowledge production industry may evoke resistance and will have to address the various interests and power-relations involved. The regulator itself also has vested interests. There is a rather odd and conflicting client-provider relationship between those who are expected to provide public access to essential, publicly-relevant safety and effectiveness data with clear regulatory finality, and those who order the data and have huge financial stakes in what the data reveals, how it is later presented, and how it is used. The data produced in the context of drug development is inherently complex, often contradictory, and above all, fundamentally uncertain.128 This should ideally evoke caution and prudence. Yet, the entity controlling the data, industry, has an interest in selling a message associated with the data that is diametrically opposed to caution and reluctance. As an administrative agency under political supervision, the drug regulator tends to reassure the public that it is exercising its role judiciously and independently from industry. This can make it difficult for the regulator to admit that it inappropriately approved market
journal of law, medicine & ethics

Trudo Lemmens

entry based on industry data. Moreover, it is often in an all too intimate relationship with industry itself. As a result of the integration of innovation initiatives in drug regulation, it is also increasingly required to look at the promotion of industry interests.129 Others also have vested interests in the current knowledge production system. Science publications are highly lucrative financial ventures, generating millions of dollars for investors and for professional organizations such as the American and British Medical Associations. Scientific journals have an interest in being valued for their integrity and reliability, yet they also have financial interests in publishing and reprinting articles of industry-sponsored clinical trials.130 Medical associations often have significant ties with industry, as highlighted in the context of a 2008 controversy surrounding a joint educational program set up by the Canadian Medical Association and pharmaceutical giant Pfizer.131 Some academic authors are also willing contributors to the current knowledge production system controlled by industry because of the payments they receive for lending their name as guest authors to ghost-written publications, but even more so because of the significant interests they have in obtaining additional peer-reviewed publications. In fact, within an increasingly competitive publishor-perish culture, the interests of academic authors in publications may negatively affect the distribution of scientific knowledge. There are growing concerns over the misrepresentations and false claims made in research reports, industry-sponsored or not, because of the interests of scientists in coming up with interesting, hence publishable, results.132 3.4. Psychological and Social Factors Bad knowledge production practices are only problematic if they work, that is, if people (health care providers, patients, funding agencies) take the knowledge generated seriously and act upon it. I already mentioned that the EBM paradigm may be so particularly successful because of our societal trust in science. Other psychological, cultural and social factors influence knowledge governance. A growing body of literature on disease mongering emphasizes, for example, how industry interests create concepts of disease and partly shape our societal perception of what requires pharmaceutical treatment.133 This occurs through sophisticated marketing practices that span the whole knowledge production process. It involves the subtle influencing and manipulation of scientific and professional organizations, regulatory agencies, and most importantly, consumers. A typical aspect of these marketing practices is, for example,

the use of awareness campaigns by industry-funded patients groups.134 If this concern is to be taken seriously, it means that inordinate reliance on individual consumer choice will hardly provide protection. More sophisticated knowledge governance will thus necessarily require a detailed assessment of how industry interests shape perceptions of disease, and how regulatory agencies, professional bodies, and advocacy groups can counterbalance the subliminal messages contained in multifaceted marketing campaigns, which often involve the manipulation of traditional sources of scientific knowledge.135 A related concern worth mentioning here is what I would term the quasi-religious belief in the healing power of pharmaceutical products.136 Ours is a culture which appears obsessed with health and wellness, and one dominated by a belief in the endless ability of technological and external fixes to achieve them. In 1980 over 30 years ago the sociologist Renee C. Fox wrote that [m]edical advanceseems to have created a rise in expectations about health and well-being, longevity, and elimination of disease.137 She suggests that this has diminished public tolerance of medical uncertainty, but perhaps partly as a result of sophisticated marketing practices it may also have resulted in an over-confidence in the ability of new technologies and pharmaceutical products to solve remaining challenges. In research ethics, the term therapeutic misconception is often used to describe the tendency of research subjects to believe that when they participate in clinical trials of unproven therapeutic agents, they will necessarily benefit.138 I suggest that the term could be more widely applied to recognize how many of us tend to uncritically absorb pharmaceutical promotion, potentially ignore professional trepidation and warnings about potential side-effects by still often conscientious treating physicians, forget about clear public exposure of pharmaceutical industry misbehavior, and continue to believe that there is an effective and safe pharmaceutical cure for each and every minor and major ailment. One of the most psychologically, politically, and socially challenging aspects of dealing with misleading knowledge occurs when physicians or health care funders refuse individual patients access to pharmaceutical products when the latter are wrongly made to believe that they will benefit from them. 3.5. Technological Factors Knowledge governance clearly needs to be attuned to modern technology. The clearest example in this context is direct-to-consumer advertising (DTCA). While most countries have some, albeit only somewhat effec175

global health and the law spring 2013


tive, regulatory control over DTCA in the traditional media such as television, magazines and newspapers, new forms of information sharing may totally escape regulatory control. 139 Pharmaceutical promotion employs the most sophisticated and innovative tools to shape demands and interests. New communications platforms such as Facebook, Twitter, and various other tools will undoubtedly require appropriate technology-savvy responses. At the same time, new technologies provide extraordinary tools for cohesive global knowledge governance. First of all, global surveillance of adverse

industry, there is a need for a global counterbalancing force. Notwithstanding the WHOs significant success in promoting global health, it clearly cannot ensure appropriate knowledge governance at a global level without a stronger mandate. The saga of the international clinical trials registration and results reporting initiatives are a case in point. Although the WHO has sponsored important international statements, and has set up, for coordination purposes, a crucial International Clinical Trial Registry, many nations have ignored its call for clinical trials registration. Its promotion of results reporting, a logical and essen-

Knowledge knows no boundaries and neither should its governance. Particularly in light of the overwhelming political, economic, cultural, and social power of the multinational pharmaceutical industry, there is a need for a global counterbalancing force. Notwithstanding the WHOs significant success in promoting global health, it clearly cannot ensure appropriate knowledge governance at a global level without a stronger mandate. The saga of the international clinical trials registration and results reporting initiatives are a case in point.
events in both clinical trials and post-marketing is clearly facilitated by new computer technologies and the Internet. Clinical trials registration and results reporting systems have only become a reality because of the available technology. Technology also allows patient participation in adverse event reporting, as has been highlighted by various recent regulatory140 and advocacy141 initiatives in that context. New communications tools also provide enormous potential for global communication of knowledge at a pittance of the traditional cost of printing and scientific journal publications. The EvipNet initiative spearheaded by the Pan American Health Organization, which focuses on the facilitation of evidence-informed policy making through partnerships between policy-makers, researchers and civil society, can be mentioned in this context as a perfect example of good knowledge sharing practices.142 International organizations and advocacy groups can clearly use new computer-based knowledge technologies to counterbalance existing knowledge oligarchies. tial continuum to clinical trials registration, seems to have stalled.143 Appropriate knowledge governance requires strict international standards and enforcement mechanisms. Lawrence O. Gostins proposal for a Framework Convention on Global Health (FCGH) can be approvingly mentioned here as a model, but with a caveat about the recommended gradual nature of implementation.143 Gostin suggests that such a convention be established through a process of incremental regime development.145 The framework convention approach would allow parties to the Convention to save more complex or contentious issues to be built in later protocols.146 If international trade negotiations offer any insight,147 transparency of clinical trials data and other relevant public health data will be one of these issues. The history of international governancestyle clinical trials registration and results reporting initiatives suggest that measures that impinge on financial interests of industry are all too easily put on the back burner and framed as too complex, so that important actions tend to be delayed. Yet, if access to research data is, as I have argued, a key determinant of the right to health, then governments and manufacturers of health care products will be hard-pressed to justify any failure to disclose important safety and effectiveness data. Some of the key modalities of the FCGH would include empirical monitoring (includ-

4. Global Governance of Pharmaceutical Knowledge

This brings me back to the global nature of knowledge governance. Knowledge knows no boundaries and neither should its governance. Particularly in light of the overwhelming political, economic, cultural, and social power of the multinational pharmaceutical 176

journal of law, medicine & ethics

Trudo Lemmens

ing data gathering) and stringent enforcement mechanisms, which are clearly needed in this context.148 Gostin and colleagues note that key challenges of global health include a lack of transparency, accountability, and enforcement.149 Several of their recommendations resonate with suggestions made in this paper: the need for active citizen participation to ensure transparency, collaboration, accountability and better resource mobilization;150 the need for improved stakeholder accountability; and the need for education initiatives to ensure that civil society is well-informed about right to health obligations in order to strengthen political accountability. Many of these recommendations could be translated into the context of good knowledge governance. But, as Burris and Anderson prudently point out, the success of such an initiative will inevitably depend upon the actions of those who really wield power internationally and within individual nations,151 the pharmaceutical industry certainly being one of them.

ential trading partners at least partially on board, it seems more likely that the wider international community will follow. Finally, commentators have called for a stronger leadership role for the WHO in directing and coordinating international health activities.157 Awaiting the further development of an international framework convention, it seems crucial that the WHO take up the torch and reinvigorate one of the key conditions for the realization of the right to health: the promotion of global knowledge governance through adequate transparency measures.158
I presented versions of this paper at the following venues and thank the participants in these events for their comments and feedback: the 2012 Global Health and the Law conference; a 2012 University of Toronto Faculty of Law Seminar; a McGill University workshop in July 2012 on Innovations technologiques, incertitude et droit de la responsabilit; and presentations at the Centre for Transnational Legal Studies, the HeLEX Centre for Health, Law and Emerging Technologies of the University of Oxford, and the Schools of Law of the Universities of Reading and Edinburgh. Shannon Gibson and Andrew Martin provided excellent research support and made insightful comments and editorial suggestions. Matthew Herder critically reviewed the paper and provided equally solid feedback. I received funding for my research from a Canadian Social Sciences and Humanities Research Council Grant on Promoting the Integrity of Biomedical Research: The Janus Face of Regulation and from a Genome Canada grant on the Social, Legal and Ethical issues of Cancer Initiating Stem Cell Research.


This suggestion allows me to conclude on a cautiously optimistic note, invoking again the example of transparency of clinical trial data. Many countries, including Canada, have failed to implement adequate transparency measures through enforceable and stringent regulation.152 Yet, at least some national and regional regulatory agencies have moved ahead and implemented partial registration and results reporting requirements, in the U.S. even surrounded by stringent sanctions.153 In the past, the U.S. and Europe have in international trade agreement negotiations often set up roadblocks against rules promoting public health. With new measures in place in their jurisdictions, the U.S., Europe, and Brazil could gain moral credibility and influence in international negotiations by putting transparent knowledge production forward as an essential foundation for a rational implementation of a framework convention for global health. Particularly interesting discussions and initiatives are taking place in Europe, where drug regulators have explicitly endorsed the need for transparency of data and are willing to look into more coherent implementation of data transparency.154 In November 2012, the European Medicines Agency started a consultation process focused on transparency, which was at an introductory meeting explicitly introduced as a consultation about how not whether data such as adverse event reports and clinical trials data could be made publicly accessible.155 In another interesting move, the European Union also included in its recent draft regulation on clinical trials new albeit all too prudent transparency stipulations.156 With influglobal health and the law spring 2013


1.  The discussion in this article will primarily focus on pharmaceutical products, but it should be recognized that related arguments can be made in the context of medical devices and in the context of novel therapeutic products (e.g., companion products, nanotechnology devices, and biologics). Since I will primarily invoke examples from the pharmaceutical context, I will generally only refer to pharmaceuticals or pharmaceutical products in the text. There are differences between the pharmaceutical, medical device markets, and other health product markets, but those differences are beyond the scope of this paper. The core of what is being argued applies to the other sectors. 2.  For brevity, I will use the term knowledge production, or where appropriate, pharmaceutical knowledge production, particularly when discussing in more detail the pharmaceutical context. 3.  I previously explored this idea in T. Lemmens, Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene, Journal of Law, Medicine & Ethics 32, no. 4 (2004): 641-657 [hereinafter cited as Lemmens, Leopards in the Temple]. 4.  The fundamental international nature of research is emphasized in Science as an Open Enterprise, The Royal Society Science Policy Centre report 02/12 (London, UK: Royal Society, 2012): at 9 and 17-19. See in general also the interesting discussion in the report of the current-day practice of science and the emphasis on transparency of data. Thanks to Graeme Laurie for pointing this out. 5.  See J. Kaye, From Single Biobanks to International Networks: Developing E-Governance, Human Genetics 130, no. 33 (2011): 377-382; J. Kaye, S. M. C. Gibbons, C. Heeney, M. Parker, and A. Smart, Governing Biobanks: Understanding the Interplay between Law and Practice (Portland, OR: Hart


S Y MPO SIUM Publishing, 2012). For some examples of biobanks, see UK Biobank, available at <>; Generation Scotland, Health Science Scotland, available at < GenerationScotland.html>; the Ontario Health Study, available at <>; the Canadian Longitudinal Study on Aging, available at <http://www.clsa-elcv. ca/>; the Estonian Genome Centre, available at <http://www.> (all last visited February 15, 2013). There are also numerous initiatives designed around specific diseases, exposures or populations. See, e.g., Ontario Tumour Bank, available at < technology-platforms/ontario-tumour-bank>, Autism Genetic Resource Exchange, available at <http://agre.autismspeaks. org/site/c.lwLZKnN1LtH/b.5002149/k.E3CE/Overview.htm>; and Manchester Cancer Research Centre Biobank, available at <> (all last visited February 15, 2013). 6.  See, for example, the International Cancer Genome Consortium, available at <> (last visited February 15, 2013). 7.  See, for example, the funding initiative between Genome Canada and the California Stem Cell Initiative which partly funded research for this paper: Genome Canada, Corporate Plan 200708, available at < medias/PDF/EN/CorporatePlan2007-08-english.pdf> (last visited February 15, 2013). 8.  According to a June 2011 report on biobanking, Private sector biobanks will experience the greatest increase with growth of 64%, at a 5-year CAGR [compound annual growth rate] of 10.4% and [the private sector biobank market]is expected to reach $69.6 billion by 2015. See Biobanking: Technology and Global Markets, BCC Research website, available at <http://> (last visited February 15, 2013). 9. Visionagain, Global Clinical Trial Business Report & Analysis 2008-2018 (October 7, 2008). 10.  See A. Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press, 2009). An interesting collection of papers can be found in A. Petryna, A. Lakoff, and A. Kleinman, eds., Global Pharmaceuticals: Ethics, Markets, Practices (Durham: Duke University Press, 2006). See also S. W. Glickman, J. G. McHutchison, E. D. Peterson, C. B. Cairns, R. A. Harrington, and R. M. Califf et al., Ethical and Scientific Implications of the Globalization of Clinical Research, New England Journal of Medicine 360, no. 8 (2009): 816-823. 11.  In Canada, see for example the Canada Vigilance Programme, Health Canada website, available at < dhp-mps/medeff/vigilance-eng.php> (last visited February 15, 2013). 12.  See the program for adverse event reporting by individuals: Medeffect Canada, Health Canada Website, available at <> (last visited February 15, 2013). 13.  See, for example, the recent initiative by Dr. David Healy: Rxisk Making Medicine Safer For All of Us,, available at <> (last visited February 15, 2013). 14.  See, in general, A. Matheson, Corporate Science and the Husbandry of Scientific and Medical Knowledge by the Pharmaceutical Industry, BioSocieties 3, no. 4 (2008): 355-382; B. Moffatt and C. Elliott, Ghost Marketing: Pharmaceutical Companies and Ghostwritten Journal Articles, Perspectives in Biology and Medicine 50, no. 1 (2007): 18-31; for a critical discussion of the regulatory and legal options to deal with the practice, see S. Stern and T. Lemmens, Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles, Public Library of Science Medicine 8, no. 8 (2011): e1001070 (1-5); and X. Bosch, B. Esfandiari, and L. McHenry, Challenging Medical Ghostwriting in US Courts, Public Library of Science Medicine 9, no. 1 (2012): e1001163 (1-4). 15.  See S. Sismundo, Ghosts in the Machine: Publication Planning in the Medical Sciences, Social Studies of Science 39, no. 2 (2009): 171-198; and S. Sismundo, Ghost-Management: How Much of the Medical Literature Is Shaped behind the Scenes by the Pharmaceutical Industry? Public Library of Science Medicine 4, no. 9 (2007): e286 (1429-1433). 16.  Examples of such soft governance include: (1) good clinical practices, such as the ICH GCP and the World Health Organization, Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, WHO Technical Report Series, No. 850, Annex 3 (1995); (2) research ethics guidelines such as World Medical Association, Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects (1964); (3) standards of peer review and authorship established by international organizations of biomedical journals such as International Committee of Medical Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, ICMJE website, available at <> (last visited February 15, 2013); and (4) governance models of international biobank conglomerates, e.g., Public Population Project in Genomics, P3G website, available at <http://www.> and E. S. Dove, Y. Joly, and B. M. Knoppers, Power to the People: A Wiki-Governance Model for Biobanks, Genome Biology 13, no. 5 (2012): 158. With respect to the most directly relevant pharmaceutical governance systems at a global level, see the interesting discussion in A. Spina, The Regulation of Pharmaceuticals beyond the State: EU and Global Administrative Systems, in E. Chiti and B.G. Mattarella, eds., Global Administrative Law (Berlin: Springer Verlag, 2011): at 249268. Spina discusses in detail the ICH/GCP system and the firmer regulatory intervention at a transnational level in the context of the European pharmaceutical regulations. See in particular the discussion at 256-258. 17.  A good example of this is the use of scientific publications based on data collected in one state, published in another, for indirect publicity purposes in multiple other jurisdictions. Note, however, that there are initiatives by national regulatory agencies to exercise tighter control of foreign clinical drug sites, to promote the integrity of these data. See, e.g., the U.S. FDAs establishment of an office in India in 2008: <http:// ucm243680.htm> (last visited February 14, 2013). 18.  T his argument has been made with respect to hormone replacement therapy and antiarrhythmic drugs. See the discussion in T. Lemmens and C. Telfer, Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency, American Journal of Law and Medicine 38, no. 1 (2011): 63-112 [hereinafter cited as Lemmens and Telfer]. 19.  See, in general, D. Evans, Big Pharmas Crime Spree, Bloomberg Markets, December 2009, available at <http://www. story2.html> (last visited February 15, 2013); D. Light, ed., The Risks of Prescription Drugs (New York: Columbia University Press, 2010); D. Healy, Pharmageddon (Berkeley: University of California Press, 2012); and R. Moynihan and A. Cassels, Selling Sickness: How the Worlds Biggest Phrmaceutical Companies Are Turning Us All into Patients (Vancouver: Greystone Books, 2005). For accounts zooming also in on specific controversies, see T. Young, Death by Prescription (Toronto: Key Porter Books, 2009); A. Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial (Chappil Hill: Algonquin Books, 2008); T. Nesi, Poison Pills: The Untold Story of the Vioxx Drug Scandal (New York: St. Martins Press, 2008). 20.  S. Almashat, C. Preston, T. Waterman, and S. Wolfe, Rapidly Increasing Criminal and Civil Monetary Penalties against the Pharmaceutical Industry: 1991 to 2010 (December 16, 2010),


journal of law, medicine & ethics

Trudo Lemmens Public Citizen Website, available at < hrg1924> (last visited February 15, 2013). 21. See id. 22.  See K. Thomas and M. S. Schmidt, Glaxo Agrees to Pay $3 Billion in Fraud Settlement, New York Times, July 2, 2012, available at < glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement. html?pagewanted=all> (last visited February 15, 2013). 23.  See J. D. Rockoff and C. M. Matthews, Pfizer Settles Federal Bribery Investigation, Wall Street Journal, August 8, 2012, available at < 90444246904577575110723150588.html> (last visited February 15, 2013); under the settlement, Pfizer did not admit or deny the allegations, and it pointed out that the allegations did not indicate that US management knew about the alleged practices. The article also reports on other recent settlements. 24.  L. Girion, S. Glover, and D. Smith, Drug Deaths Now Outnumber Traffic Fatalities in U.S., LA Times, September 17, 2011, available at < local/la-me-drugs-epidemic-20110918> (last visited February 15, 2013). 25.  Topol estimates myocardial infarction or stroke in 160,000 of every ten million people taking Vioxx. E. J. Topol, Failing the Public Health Rofecoxib, Merck, and the FDA, New England Journal of Medicine 351, no. 17 (2004): 1707-1709, at 1708; see also D. J. Graham et al., Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with CycloOxygenase 2 Selective and Non-Selective Non-Steroidal AntiInammatory Drugs: Nested Case-Control Study, The Lancet 36, no. 9458 (2005): 475-481, at 480. 26.  Combined HRT is associated with an increased risk of coronary heart disease, breast cancer, and stroke. Millions of women have been treated with combined HRT around the world. See A. L. Hersh, M. L. Stefanick, and R. S. Stafford, National Use of Postmenopausal Hormone Therapy: Annual Trends and Response to Recent Evidence, JAMA 291, no. 1 (2004): 47-53. 27.  For detailed discussions of these controversies, see references supra note 19. 28.  See P. Doshi, T. Jefferson, and C. Del Mar, The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience, Public Library of Science Medicine 9, no. 4 (2012): e1001201, at 1. 29.  Id. 30.  Id. 31.  Id. 32.  See Lemmens and Telfer, supra note 18. 33.  J. Mann, Editorial: Human Rights and the New Public Health, Health and Human Rights 1, no. 3 (1995): 229-233, at 229. 34.  Id., at 231. 35.  Note how the judicialization of the right to health has in some jurisdictions distorted more complex questions of equity in health care and resource allocations. See G. Backman, P. Hunt, and R. Khosla et al., Health Systems and the Right to Health: An Assessment of 194 Countries, The Lancet 372, no. 9655 (2008): 2047-2085. 36.  See, for example, Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), GA Res. 2200A (XXI), U.N. GAOR, 21st Sess., Supp. No. 16 at 49, 993 U.N.T.S. 3, U.N. Doc. A/6316 (1966) [ICESCR], which defines the right to health as the right to the highest attainable standard of physical and mental health. 37.  See, for example, the overview in E. D. Kinney and B. A. Clark, Provisions for Health and Health Care in the Constitutions of the Countries of the World, Cornell International Law Journal 37, no. 2 (2004): 285-355. 38.  See, for example, U.N. Committee on Economic, Social and Cultural Rights, Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights: General Comment No. 14, U.N. Doc. E/C.12/2000/4, August 11, 2000, at para. 33 [hereinafter cited as General Comment 14]: The Committee recognizes the connection between the right to health and other human rights such as: the right to food, housing, work, education, human dignity, life, privacy, and interestingly for the purpose of this discussion access to information (at para. 3). See also: U.N. Special Rapporteur on the Highest Attainable Standard
of Health, Promotion and Protection of Human Rights: Human Rights Questions, Including Alternative Approaches for Improving the Effective Enjoyment of Human Rights and Fundamental Freedoms, U.N. Doc. A/61/338, September 13, 2006, para. 18. The essential links between the right to health and the right to information is clearly also reflected in the approach taken by the Framework Convention on Tobacco Control. See the detailed discussion in O.A. Cabrera and L. O. Gostin, Human rights and the Framework Convention on Tobacco Control: Mutually Reinforcing Systems International Journal of Law in Context 7, no. 3 (2011): 285-303.

39.  See A. A. Dhir, Corporate Selective Reporting of Clinical Drug Trial Results as a Violation of the Right to Health, in L. A. Basser, M. Jones, and M. Rioux, eds., Critical Perspectives on Human Rights and Disability Law (Leiden: Martinus Nijhoff Publishers, 2011): 341-366, in particular at 356-64; and Lemmens and Telfer, supra note 18. 40.  For a general overview of legislative and regulatory initiatives regarding clinical trials registration and results reporting, see D. Ghersi and T. Pang, From Mexico to Mali: Four Years in the History of Clinical Trial Registration, Journal of EvidenceBased Medicine 2, no. 1 (2009): 1-7. See also, for an overview and discussion of international initiatives with a focus on the Americas, K. Krlea-Jeri and T. Lemmens et al., Prospective Registration and Results Disclosure of Clinical Trials in the Americas: A Roadmap toward Transparency, Pan American Journal of Public Health 30, no. 1 (2011): 87-96. 41.  The first case involved the states interference with two Irish NGOs, Open Door Counselling and Dublin Well Woman Centre, which provided information to women about reproductive choices, including the identity and contact information of abortion clinics operating in the United Kingdom. The Irish Supreme Court had prohibited the organizations from providing information about the latter. Without ruling about the right to abortion itself, the ECHR considered the restrictions on the freedom of expression disproportionate. Open Door and Dublin Well Woman v. Ireland, No. 14234/88, Eur. Ct. H.R. 68 (1992), available at < docid/3ae6b7020.html> (last visited February 15, 2013). See in general also the interesting discussion of the connection between access to information and abortion in J. Erdman, Access to Information on Safe Abortion: A Harm Reduction and Human Rights Approach 34 Harvard Journal of Law and Gender 34, no. 2 (2011): 413-462. 42.  The Sunday Times v United Kingdom (Series A No 30), European Court of Human Rights (1979-80) 2 EHRR 245, April 26, 1979. 43.  Id., at para. 66. Freedom of speech is protected by article 10 of the European Convention on Human Rights. 44.  See, e.g., also Trsasg a Szabadsgjogokrt v. Hungary, No 37374.05, Eur. Ct. H.R. 618 (2009), in which the ECHR ruled that a human rights organization involved in the promotion of democracy had to be able to exercise their function as public watchdog and that States should be prevented from exercising censorial power of an information monopoly. 45.  This seems in line with Alicia Ely Yamins emphasis on intersectoral collaboration in promoting human rights. A. E. Yamin, Will We Take Suffering Seriously? Reflections on What Applying a Human Rights Framework to Health Means and Why We Should Care, Health and Human Rights 10, no. 1 (2008): 45-63, at 49-50. There are, in fact, some interesting and fruitful examples of collaboration between the legal community, the media, and professional organizations in promoting access to information about pharmaceuticals. A case in point is how the New York Times and the medical journal PLoS Medicine recently joined forces as public interest interveners in litiga-

global health and the law spring 2013


S Y MPO SIUM tion against Merck for its alleged failures to adequately warn the public about the potential side effects of hormone replacement drugs. The goal of the intervention was to obtain access to the substantial clinical trials data and company documents associated with the product. The court granted their request and PLoS made all documents available on its website. Motion granted on July 24, 2009, by U.S. District Judge William Wilson, Jr. See Wyeth Ghostwriting Archive, Public Library of Science Medicine Website, available at <> (last visited February 15, 2013). 46.  Guerra and Others v. Italy, 26 Eur. Ct. H.R. 357 (1998) at para. 60. I am indebted to Alessandro Spina for alerting me to the relevance of this case and some relevant literature. See also Roche v. United Kingdom, 43 Eur. Ct. H.R. 30 (2006) where the court also decided that the governments failure to provide adequate information about the potential impact of the testing of chemical weapons in which the claimant had been involved was a violation of article 8, not article 10. In the 2006 case of Sdruen Jihoesk matky v. Czech Republic, [2006] Eur. Ct. H.R. 1205, however, the court recognized that a refusal to grant access to information regarding a nuclear power plant was a restriction of article 10, although it considered the refusal justified. Wouter Hins and Dirk Voorhoof prudently suggest that the case opens new perspectives, even though, as they recognize, it clearly does not imply a recognition of a duty to create information. See W. Hins and D. Voorhoof, Access to State-Held Information as a Fundamental Right under the European Convention on Human Rights, European Constitutional Law Review 3, no. 1 (2007) : 114-126, at 123-125. 47.  Article 8 subsection 1: Everyone has the right to respect for his private and family life, his home and his correspondence. Council of Europe, Convention for the Protection of Human Rights and Fundamental Freedoms CETS No. 005, 4 November 1950,available at < docid/3ae6b3b04.html> (last visited February 15, 2013) [hereinafter cited as European Convention on Human Rights]. 48.  Claude Reyes et al. v. Chile, Inter-American Court of Human Rights, Series C No. 151 (September 19, 2006). Hins and Voorhoof suggest the ECHR could draw inspiration from this case, supra note 46 at 121-122 [hereinafter cited as Reyes]. 49.  See, for example, id., at paras. 75-77. 50.  See article 13 Freedom of Thought and Expression: Organization of American States, American Convention on Human Rights, Pact of San Jose, Costa Rica, November 22, 1969,available at < html> (last visited February 15, 2013). 51. See Reyes, supra note 48, at para. 86. 52.  Id., at para. 87. 53.  See, for example, the recent challenge by Public Citizens of the FDAs decision to approve a higher dosage version of Eisai/ Pfizers Alzheimers drug Aricept, notwithstanding the primary reviewer and statisiticians recommendation to reject the application based on the serious side-effects of the higher dosage. Public Citizens petition to the FDA to ban the higher dosage version was rejected. Public Citizens director of Health Research Sidney M. Wolfe asked in his editorial in the organizations newsletter whether [w]ith close to $700 million in drug industry money directly funding FDA drug review each year, the FDA, in this instance, is protecting the public health orcolluding with the drug industry (Did Drug Companies and the FDA Collude to Harm Patients with Alzheimers Disease? (editorial) Worst Pills, Best Pills 18, no. 12 (2012): 2 at 2. See also the discussion of some of the pressures on and flaws of the drug regulatory review structure in Lemmens, Leopards in the Temple, supra note 3 at 650-652, and references there. 54.  See, for example, Chaoulli v. Quebec (Attorney General), [2005] 1 S.C.R. 791, 2005 SCC 35. Dhir discusses the right to health claims specifically in the context of Canadian law. See Dhir, supra note 39 at 356-364. 55. See European Convention on Human Rights, supra note 47, Art. 2. 56.  neryildiz v. Turkey, 2004-XII Eur. Ct. H.R., November 30, 2004. 57.  Id., at para. 90. 58.  See also the interesting discussion in the Explanatory Report ETS No. 164 (Council of Europe, December 17, 1996, available at < htm> [last visited February 15, 2013), at paras. 63-70 of the individually focused right to information protected by Article 10 of the Convention on Human Rights and Biomedicine (available at < Html/164.htm> [last visited February 15, 2013]). Article 10 provides: 1. Everyone has the right to respect for private life in relation to information about his or her health. 2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed. 3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient. 59.  For an interesting discussion of the ECHR developments in access-to-information case law, see Hins and Voorhoof, supra note 46. See also C. Hilson, Risk and the European Convention on Human Rights: Towards a New Approach, in C. Barnard and O. Odudu, eds., The Cambridge Yearbook of European Studies Volume 11, 2008-2009 (Oxford: Hart Publishing, 2009): at 353-375, in particular at pages 355-365. 60. See Roche v. United Kingdom, supra note 46. 61.  Id., at para. 167. Interestingly, the applicant also claimed that the State had a duty, under art. 10, to conduct a long-term follow-up study as part of its positive obligation. The Court considered it was not necessary to examine this claim (at para. 168). The court referred among other cases to Guerra, and to McGinley v. the United Kingdom, where it ruled that [w]here a Government engages in hazardous activities,respect for private and family liferequires that an effective and accessible procedure be established which enablespersons to seek all relevant and appropriate information. See McGinley and Egan v. the United Kingdom, [1998] Eur. Ct. H.R. 51. 62.  RR v. Poland, [2011] Eur. Ct. H.R. 828. 63.  Jean-Francois Akandji-Khombe invokes these cases to suggest that the ECHR recognizes the right to a healthy environment in P.-F. Akandji-Khombe, Positive Obligations Under the European Convention on Human Rights: A Guide to the Implementation of the European Convention on Human Rights. Human Rights Handbook no. 7 (Strasbourg: Council of Europe Director General on Human Rights, 2007): at 47-48. 64.  For a discussion of research ethics questions related to informed consent and invasive biopsies, see J. Kimmelman, T. Lemmens, and S. Y. H. Kim, Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures, IRB: Ethics and Human Research 34, no. 5 (2012): 1-7. 65.  For an interesting discussion from the perspective of bioethics, but with relevant discussion of legal issues, see A. Campbell, The Body in Bioethics (London: Routledge, 2009). See also D. Dickenson, Property in the Body: Feminist Perspectives (Cambridge: Cambridge University Press, 2007). 66.  See, for example, Moore v. Regents of the University of California, 51 Cal. 3d 120, 793 P.2d 479, 271 Cal. Rptr. 146 (Cal. 1990). 67.  McInerney v. MacDonald, [1992] 2 S.C.R. 138 at 13. Justice La Forest refers with this quote to his earlier statement in R. v. Dyment, [1988] 2 S.C.R. 417. 68.  Id. 69.  Ragnhildur Gumundsdttir v. The State of Iceland, 2003, No. 151/2003 at 9, Icelandic Supreme Court, available at <http://> (last visited February 15, 2013). The court recognized that the Appellant may herself have an interest in preventing the transfer of information from her fathers medical records into the Health Sector Database because of the risk that inferences could be made from such information which could concern her private affairs.


journal of law, medicine & ethics

Trudo Lemmens 70.  See the recent controversy surrounding the restriction of data access imposed by the British Columbia minister of health on the basis of allegations of violation of privacy, and the impact on the drug safety research conducted by the Therapeutics Initiative: A. MacLeod, Research Stopped by Ministry Might Have Cut Big Pharma Profits, The Tyee, September 12, 2012, available at < BC-Pharma-Research/> (last visited February 15, 2013). The controversy occurred agains the background of earlier tension between the ministry of health, the pharmaceutical industry, and the independent Therapeutics Initiative: A. MacLeod, Life Saving Drug Watchdog May Be Scrapped, The Tyee, May 23, 2008, available at < DrugWatch/> (last visited February 15, 2013). For a discussion of how to deal with the tension between privacy and comparative effectiveness research, see D. Peddicord, A. B. Waldo, and M. Boutin et al., A Proposal to Protect Privacy of Health Information While Accelerating Comparative Effectiveness Research, Health Affairs 29, no. 11 (2010): 2082-2090. 71.  See the discussion in R. A. Chapman, Towards an Understanding of the Right to Enjoy the Benefits from Scientific Progress and Its Applications, Journal of Human Rights 8, no. 1 (2009): 1-36; and Y. Donders, The Right to Enjoy the Benefits of Scientific Progress: In Search of State Obligations in Relation to Health, Medicine Health Care & Philosophy 14, no. 4 (2011): 371-381. 72.  See, e.g., B. M. Knoppers, Population Genetics and Benefit Sharing, Community Genetics 3, no. 4 (2000): 212-214. See, in general, J. Sulston and G. Ferry, The Common Thread: A Story of Science, Politics, Ethics, and the Human Genome (London: Bantam Press, 2002). 73.  E stablished in 1988, the Human Genome Organization (HUGO) is an international organization of scientists that has the mission to promote international collaborative effort to study the human genome and the myriad issues raised by knowledge of the genome. See HUGO website, About Us, available at < php> (last visited February 15, 2013). 74.  See also UNESCO, Universal Declaration on the Human Genome and Human Rights (Paris: UNESCO, signed November 11, 1997), Art. 1: The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity. Available at < themes/bioethics/human-genome-and-human-rights/> (last visited February 15, 2013). 75.  See, for example, J. H. Reichman, Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach, Marquette Intellectual Property Law Review 13, no. 1 (2009): 1-68; L. Gibault, Owning the Right to Open Up Access to Scientific Publications, Amsterdam Law School Legal Studies Research Paper No. 2012-25 (2012); and the discussion in Science as an Open Enterprise, supra note 4. 76.  P. Alston and N. Bhuta, Human Rights and Public Goods: Education as a Fundamental Right in India, in P. Alston and M. Robinson, eds., Human Rights and Development: Towards Mutual Reinforcement (Oxford: Oxford University Press, 2005): 242-265, at 247. 77.  See UNESCO Declaration, supra note 74, at Art. 12. See also Art. 27 of the Universal Declaration on Human Rights which states that [e]veryone has the rightto share in scientific advances and its benefits and related formulations in the International Covenant on Economic, Social and Cultural Rights (art.15); the American Declaration on the Rights and Duties of Man (art. 13); and the Charter of the Organization of American States (art. 38). 78.  United Nations Human Rights Council, Twentieth Session, Promotion and Protection of All Human Rights, Civil, Political, Economic, Social and Cultural Rights, including the Right to Development: 20. Promotion of the Enjoyment of the Cultural Rights of Everyone and Respect for Cultural Diversity (July 2, 2012), A/HRC/20/L.18. The Resolution is in part a response to an interesting Report of the Special Rapporteur in the field of cultural rights, Farida Shaheed, United Nations Human Rights Council, 20th session (May 14, 2012) A/HRC/20/26. 79.  See the discussion in R. A. Bouchard and T. Lemmens, Privatizing Biomedical Research: A Third Way? Nature Biotechnology 26, no. 1 (2008): 31-36; R. A. Bouchard, Balancing Public and Private Interests in the Commercialization of Publicly Funded Medical Research: Is There a Role for Compulsory Government Royalty Fees? Boston University Journal of Science and Technology Law 13, no. 2 (2007): 120-192. See also the discussion in Chapman, supra note 71, at 8-9. 80.  Alicia Ely Yamin argues, also in general in relation to the right to health, that a rights framework demands that equity and non-discrimination be placed at the center of a public health agenda. See Yamin, supra note 45, at 49. 81.  Jill Fisher discusses how even in industrialized countries like the U.S., people participate in clinical trials to access therapies that they cannot otherwise afford. J. I. Fisher, Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (New Jersey: Rutgers University Press, 2009). 82.  C. Elliott, Exploiting a Research Underclass in Phase 1 Clinical Trials, New England Journal of Medicine 358, no. 22 (2008): 2316-2317; T. Lemmens and C. Elliott, Guinea Pigs on the Payroll: The Ethics of Paying Healthy Subjects, Accountability in Research 7, no. 1 (1999): 3-21. 83.  Article 7 states that No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation. See International Covenant on Civil and Political Rights, G.A. Res. 2200A (XXI), U.N. GAOR, 21st Sess., Supp. No. 16, 999 U.N.T.S. 171, U.N. Doc. A/6316 (1966) [ICCPR]. For an interesting discussion, see E. Rosenthal, The International Covenant on Civil and Political Rights and the Rights of Research Subjects, Accountability in Research 4, nos. 3-4 (2008): 253-260. 84.  See E. Wiles, Aspirational Principles or Enforceable Rights? The Future for Socio-Economic Rights in National Law, American University International Law Review 22, no. 1 (2006): 35-64. 85.  See M. M. Prado, The Debatable Role of Courts in Brazils Health Care System: Does Litigation Harm or Help? (on the right to health under the Brazilian constitution and the potential positive impact of health-rights litigation); C. MacIntosh, The Role of Law in Ameliorating Global Inequalities in Indigenous Peoples Health (on the application of the Indigenous and Tribal Peoples Convention, ILO 169, and its requirement for sufficient health services for the indigenous population by courts in Colombia and Argentina); O. Cabrera and J. Carballo, Tobacco Control Litigation: Broader Impacts on Health Rights Adjudication (on the application of the right to health in the context of tobacco control litigation by courts in India, Mexico, Peru, Colombia, Guatemala, and Belgium); and A. Gross, Is There a Human Right to Private Health Care? (on litigation regarding private health care insurance in Israeli and Canadian courts). All these articles can be found in the Journal of Law, Medicine & Ethics 41, no. 1 (2013). 86.  See, for example, C. M. Flood and Y. Y. Chen, Charter Rights & Health Care Funding: A Typology of Canadian Health Rights Litigation, Annals of Health Law 19, no. 3 (2010): 479-526; I. Byrne, Enforcing the Right to Health: Innovative Lessons From Domestic Courts, in A. Clapham and M. Robinson, eds., Swiss Human Rights Book, vol. 3 (Zurich: Ruffer & Rub, 2009): at 525-538, available at < pdf> (last visited February 21, 2013). 87.  Some constitutions contain detailed provisions related to the right to health and at least some of them indicate specifically that the states obligations to protect and fulfill the right to health include the obligation to ensure the safety and effectiveness of pharmaceutical products. It would be worth exploring

global health and the law spring 2013


S Y MPO SIUM if this could provide a basis in these countries for a direct legal claim against the state based on a failure of knowledge governance. See e.g. art. 64 (3) of the Portuguese Constitution (Constituio da Repblica Portuguesa), which indicates that the right to health protection includes an obligation for the state to control and monitor the production, distribution, commercialization and use of chemical, biological and pharmaceutical products and other treatment and diagnostic methods. (Para assegurar o direito proteco da sade, incumbe prioritariamente ao Estado: . . . e) Disciplinar e controlar a produo, a distribuio, a comercializao e o uso dos produtos qumicos, biolgicos e farmacuticos e outros meios de tratamento e diagnstico.) I am indebted to Joana Mendes for pointing this out and for providing the basis of the translation. 88.  See, for example, A. Aust, Handbook of International Law, 2d ed. (Cambridge: Cambridge University Press, 2010): at 74-80. Dhir discusses in some detail and specifically in the context of the debate about access to clinical trials data the difficulty of determining whether the right to health recognized by art. 12 ICESCR has been implemented in Canadian law. See Dhir, supra note 39, in particular 358-361, with references to J. Brunne and S. Toope, A Hesitant Embrace: the Application of International Law by Canadian Courts, Canadian Yearbook of International Law 40 (2002): 3-60, at 6, and at 20-23. 89.  See D. M. Brinks and V. Gauri, A New Policy Landscape: Legalizing Social and Economic Rights in the Developing World, in V. Gauri and D. M. Brinks, eds., Courting Social Justice: Judicial Enforcement of Social and Economic Rights in the Developing World (New York: Cambridge University Press, 2008): 303-352, at 315-317. 90.  International Covenant on Economic, Social and Cultural Rights, adopted by General Assembly resolution 2200A (XXI) of December 16, 1966, available at < english/law/pdf/cescr.pdf> (last visited February 18, 2013). See also General Comment 14, supra note 38, at paras. 31-32. 91.  Office of the United Nations High Commissioner for Human Rights and World Health Organization, The Right to Health, Fact Sheet No. 31, at 5, available at < Documents/Publications/Factsheet31.pdf> (last visited February 18, 2013). 92.  See General Comment 14, supra note 38, at para. 43. 93.  H. Hershkoff, Transforming Legal Theory in Light of Practice: The Judicial Application of Economic and Social Rights to Private Ordenings, in V. Gauri and D. Brinks, eds., Courting Social Justice: Judicial Enforcement of Social and Economic Rights in the Developing World (New York: Cambridge University Press, 2008): at 268-302, in particular at 281-286. See also in general for a discussion of corporate responsibility for human rights violations, S. R. Ratner, Corporations and Human Rights: A Theory of Legal Responsibility, Yale Law Journal 111, no. 3 (2001): 443-545 . The point is also made in the context I discuss here by Dhir, supra note 39, at 356-357, with references to Ratner. 94.  I am indebted for some of the discussion here to Kelly Tai and her research as part of a 2012 summer internship organized by the University of Toronto International Human Rights Clinic with the Open Society Foundations, which resulted in a draft background document, The Right to Drug Safety and Efficacy Information: A Human Rights Approach. (Copy on file with author). 95.  See, e.g., the work of the influential Business and Human Rights Resource Centre, available at <> (last visited February 18, 2013). 96.  Report of the Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises, John Ruggie, Protect, Respect and Remedy: A Framework for Business and Human Rights, U.N. Doc. A/HRC/8/5, April 7, 2008, available at <http:// htm> (last visited February 18, 2013). For additional information on work of the Special Representative, see <http://www.> (last visited February 18, 2013). 97.  Report of the Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises, John Ruggie, Guiding Principles on Business and Human Rights: Implementing the United Nations Protect, Respect and Remedy Framework, U.N. Doc. A/HRC/17/31, March 21, 2011, at para. 13, available at < docs/17session/A.HRC.17.31_en.pdf> (last visited February 18, 2013). 98.  Id., at para. 14. 99.  Id., at guiding principle 13. 100.  Id., at guiding principle 15. 101.  Id., at guiding principle 21. 102.  Organization of Economic Cooperation and Development, OECD Guidelines for Multinational Enterprises (2011), available at < guidelinesformultinationalenterprises/oecdguidelinesformultinationalenterprises.htm> (last visited February 18, 2013). For additional information concerning the Guidelines, see <> (last visited February 18, 2013). See the more detailed discussion in Tai, supra note 94 at 39-41. 103.  J. Oldenziel, J. Wilde-Ramsing, and P. Feeney, OECD Watch - 10 Years On: Assessing the contribution of the OECD Guidelines for Multinational Enterprises to Responsible Business Conduct (2010), OECD Watch, at 24-27, available at <http://> (last visited February 18, 2013). 104.  See Tai, supra note 94 at 40, with reference to the discussion in S. van Buiren, National Contact Points and the Handling of Complaints - Is the Functional Equivalency Gap Widening? (2007), OECD Watch, at 1-2, available at <http://oecdwatch. org/cases/Case_102/376/at_download/file> (last visited February 18, 2013). 105.  Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, P. Hunt, Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines, U.N. Doc A/63/263, August 11, 2008, available at < A63_263.pdf> (last visited February 18, 2013). 106.  Id., at guideline 39. 107.  P. Hunt and R. Khosla, Are Drug Companies Living Up to Their Human Rights Responsibilities? The Perspective of the Former United Nations Special Rapporteur (2002-2008), Public Library of Science Medicine 7, no. 9 (2010): e1000330 (1-3), at 3. 108.  See, for example, General Comment 14, supra note 38, at para. 33: The right to health, like all human rights, imposes three types or levels of obligations on States parties: the obligations to respect, protect and fulfil. In turn, the obligation to fulfil contains obligations to facilitate, provide and promote. The obligation to respect requires States to refrain from interfering directly or indirectly with the enjoyment of the right to health. The obligation to protect requires States to take measures that prevent third parties from interfering with article 12 guarantees. Finally, the obligation to fulfil requires States to adopt appropriate legislative, administrative, budgetary, judicial, promotional and other measures towards the full realization of the right to health. (Citation omitted.) 109.  See P. J. Hilts, Protecting Americas Health: The FDA, Business, and One Hundred Years of Regulation (North Carolina: University of North Carolina Press, 2003). 110.  See, in general, id. See also B. Evans, Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era, Notre Dame Law Review 85, no. 2 (2009): 419-524. 111. See Hilts, supra note 109.


journal of law, medicine & ethics

Trudo Lemmens 112.  For an interesting analysis of the drug regulatory system as quality assurance, see A. Katz, Pharmaceutical Lemons: Innovations and Regulation in the Drug Industry, Michigan Telecommunications and Technology Law Review 14, no. 1 (2007): 1-41. 113.  For a more detailed discussion, see Lemmens, supra note 3, at 651-652 and its references. See also T. A. Ban, Postscript to the Series,in M. Katz, volume ed., Volume 10: History of the ACNP, in T. A. Ban, An Oral History of Neuropsychopharmacology The First Fifty Years: Peer Interviews (Nashville: American College of Neuropsychopharmacology, 2011): at 229-237, at 235: [T]reatment in psychiatry became evidence-based, albeit the evidence for demonstrated efficacy that was stipulated by regulatory authorities [that] has made drugs available for clinical use even if only 1 in 4 patients was expected to respond favourably. 114.  See Lemmens, Leopards in the Temple, supra note 3. 115.  Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (2007). 116.  See J. Graham, Smart Regulation: Will the Governments Strategy Work? Canadian Medical Association Journal 173, no. 12 (2005): 1469-1470. 117.  See, for example, S. Timmermans and M. Berg, The Gold Standard: The Challenge of Evidence-Based Medicine and Standardization in Health Care (Philidelphia: Temple University Press, 2003); see also Healy, supra note 19. 118.  For a critical discussion of the difficulties in implementating the EBM paradigm of clinical practice guidelines, and a critical examination of two successful implementations, see S. Timmermans and A. Mauck, The Promises and Pitfalls of Evidence-Based Medicine, Health Affairs 24, no. 1 (2005): 18-28. 119.  See the interesting discussion in Healy, supra note 19. 120.  See Timmermans and Berg, supra note 117. 121.  Id. 122.  For a discussion of three different examples of how biases can shape EBM, see R. Devries, T. Lemmens, and C. Bosk, The Subjectivity of Objectivity: The Social, Cultural and Political Shaping of EBM, in B. Bennett, T. Karney, and I. Karpin, eds., The Brave New World of Health (Sydney: Federation Press, 2008): 144-165. 123.  See, for example, Healy, supra note 19; Young, supra note 19; M. Angell, The Clinical Trials Business: Who Gains? in D. G. Stein, ed., Buying In or Selling Out? The Commercialization of the American Research University (Piscatawnay, NJ: Rutgers University Press, 2004): at 127-132; J. P. Kassirer, On The Take: How Medicines Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2004). 124.  See D. Evans, Big Pharmas Crime Spree, Bloomberg Markets, December 2009, available at < wp-content/uploads/2011/03/big-pharmas-crime-spree.pdf> (last visited February 18, 2013). 125.  See Food and Drug Administration Amendment Act, supra note 115. I am indebted to David Schneiderman for this suggestion. 126.  See, for example, Angell, supra note 123; W. A. Ray and C. M. Stein, Reform of Drug Regulation Beyond an Independent Drug-Safety Board, New England Journal of Medicine 354, no. 2 (2006): 194-201; Lemmens, supra note 3. This also rejoins the Public Goods Approach defended by commentators such as J. H. Reichman, Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach, Marquette Intellectual Property Law Review 13, no. 1 (2009): 168. 127.  For a debate with information about the for-profit IRB phenomenon, see E. J. Emmanuel, T. Lemmens, and C. Elliot, Should Society Allow Research Ethics Boards to Be Run as For-Profit Enterprises? Public Library of Science Medicine 3, no. 7 (2006): e309 (0941-0944) . See also T. Lemmens and B. Freedman, Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards, Millbank Quarterly 78, no. 4 (2000): 547-584. 128.  In light of this complexity, it would appear all too easy to rely completely on publication of data as a means to protect consumers. Data have to be interpreted, contrasted, debated, and translated through expert intermediaries; see the discussion in S. Jasanoff, Transparency in Public Science: Purposes, Reasons, Limits, Law and Commentary Problems 69, no. 3 (2006): 21-45. It is also worth mentioning that several recent publications highlight problems with the reliability of the evidence cited in much of the published scientific literature, which receives little attention outside of the scientific community. See in particular J. P. A. Ioannidis, Why Most Published Research Findings Are False, Public Library of Science Medicine 2, no. 8 (2005): e124 (0696-0701), and references therein; see also J. P. A. Ioannidis, Contradicted and Initially Stronger Effects in Highly Cited Clinical Research, JAMA 294, no. 2 (2005): 218-228. 129.  See the discussion on the role of drug regulators in the context of data exclusivity in Lemmens, supra note 3, with references therein; Bouchard and Lemmens, supra note 79. 130.  See R. Smith, Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies, Public Library of Science Medicine 2, no. 5 (2005): e138 (0364-0366), and The PLoS Medicine Editors, An Unbiased Scientific Record Should Be Everyones Agenda, Public Library of Science Medicine 6, no. 2 (2009): e1000038 (0119-0121). 131.  C. Weeks, Medical Association Takes Heat for Pfizer Funding, Globe and Mail, December 3, 2009, available at <http://> (last visited February 18, 2013). For the media announcement of the initiative, see < news_releases/article?year=2009&article=303> (last visited February 18, 2013). Interestingly this controversial initiative was announced shortly after an editorial in the Canadian Medical Association Journal strongly criticized corporate control over continuing medical education and argued for a major overhaul of the CME system. See P. C. Hbert, Editorial, The Need for an Institute of Continuing Health Education, Canadian Medical Association Journal 178, no. 7 (2008): 805-806, available at <> (last visited February 18, 2013). 132.  See the point made by H. Eichler et al., Open Clinical Trial Data for All? A View from Regulators, Public Library of Science Medicine 9, no. 4 (2012): e1001202 (1-2), at 2. For example, the number of retractions from PubMed, a biomedical literature database, have increased sharply over the last decade. This trend is also evident in the retractions specifically citing fraud as a reason for withdrawal. See R. G. Steen, Retractions in the Scientific Literature: Is the Incidence of Research Fraud Increasing? Journal of Medical Ethics 37, no. 4 (2011): 249-253. 133. See, e.g., PLoS Medicine Disease Mongering Collection, Public Library of Science Collections (Special Issue, Public Library of Science Medicine 3, no. 4 [2006]), available at <http:// nfo%3Adoi%2F10.1371%2Fissue.pcol.v07.i02> (last visited February 18, 2013). 134.  The fact that these campaigns can be extraordinarily successful is evidenced by the paradigm example of disease-creation in the context of Paxil, a leading antidepressant. The manufacturer GlaxoSmithKline greatly expanded its markets by promoting the drug for a range of new psychiatric conditions such as Social Anxiety Disorder (shyness) and Generalized Anxiety Disorder (constant worry). The proliferation of diagnoses has contributed to a dramatic rise in anti-depressant sales, which increased eightfold between 1990 and 2000. See B. I. Koerner, First, You Market the Disease... Then You Push the Pills to Treat It, The Guardian, July 30, 2002, available at <> (last visited February 18, 2013). For GlaxoSmith-

global health and the law spring 2013


S Y MPO SIUM Klines 2003 campaign to promote awareness about restless legs syndrome, see S. Woloshin and L. M. Schwartz, Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick, Public Library of Science Medicine 3, no. 4 (2006): e170 (0452-0455). For strategies used by Pfizer to promote Viagra as a legitimate therapy for erectile dysfunction for all men, see J. Lexchin, Bigger and Better: How Pfizer Redefined Erectile Dysfunction, Public Library of Science Medicine 3, no. 4 (2006): e132 (0429-0432). 135.  For a discussion of the relevance of this issue for DTCA, see C. Flood, The Evidentiary Burden for Overturning Governments Choice of Regulatory Instrument: The Case of Directto-Consumer Advertising of Prescription Drugs, University of Toronto Law Journal 60, no. 2 (2010): 397-424. 136.  For an interesting discussion of some of the socio-cultural aspects, see, e.g., C. Elliott, Better Than Well: American Medicine Meets the American Dream (New York: W.W. Norton, 2003). 137.  R. C. Fox, The Evolution of Medical Uncertainty, Milbank Quarterly 58, no. 1 (1980): 1-49, at 19. 138.  See P. S. Appelbaum et al., False Hopes and Best Data: Consent to Research and the Therapeutic Misconception, Hastings Center Report 17, no. 2 (1987): 20-24. 139.  See, with respect to problems in the enforcement of DTCA in Canada, D. M. Gardner, B. Mintzes, and A. Ostry, Directto-Consumer Prescription Drug Advertising in Canada: Permission by Default? Canadian Medical Association Journal 169, no. 5 (2003): 425-427. See in this issue Lopert and Gleeson who discuss how the Korea-US Free Trade Agreement (KORUS) and a proposed annex to the Trans Pacific Partnership Agreement (TPPA) chapter on Transparency require countries to allow internet-based DTCA. 140.  See Health Canada website, MedEffect Canada, available at <> (last visited February 18, 2013). 141.  See David Healys initiative, supra note 13. 142.  See EVIPNet (Evidence-Informed Policy Network) website, available at <> (last visited February 18, 2013). EVIPNet promotes partnerships at the country level between policy-makers, researchers and civil society in order to facilitate both policy development and policy implementation through the use of the best scientific evidence available.: <> (last visited February 18, 2013). 143.  See the discussion in Lemmens and Telfer, supra note 18, at 75. 144.  L. O. Gostin, Meeting Basic Survival Needs of the Worlds Least Healthy People: Toward a Framework Convention on Global Health, Georgetown Law Journal 96, no. 2 (2008): 331-392; see also L. O. Gostin, E. A. Friedman, G. Ooms, T. Gebauer, and N. Gupta et al., The Joint Action and Learning Initiative: Towards a Global Agreement on National and Global Responsibilities for Health, Public Library of Science Medicine 8, no. 5 (2011): e1001031 (1-5). 145.  Id. 146.  Id., at 386. 147.  See D. Gervais, TRIPS Agreement: Drafting History and Analysis, 3rd ed. (London: Sweet & Maxwell, 2008). 148. See Gostin, supra note 144, at 34. 149.  See Gostin et al., supra note 144. 150.  See in this context also the point made and examples given in R. Magnusson and D. Patterson, Role of Law in Global Response to Non-Communicable Diseases, The Lancet 378, no. 9794 (2011): 859-860, at 860, where the authors state: An empowered sector of non-governmental organisations is crucial for holding governments to account and advocating for law reform. 151.  S. Burris and E. D. Anderson, A Framework Convention on Global Health: Social Justice Lite, or Light on Social Justice? Journal of Law, Medicine and Ethics 38, no. 3 (2010): 580593, at 589. 152.  See M. Herder, Unlocking Health Canadas Cache of Trade Secrets: Mandatory Disclosure of Clinical Trials Results, Canadian Medical Association Journal 184, no. 2 (2012): 194-199; J. Lexchin and B. Mintzes, Transparency in Drug Regulation: Mirage or Oasis? Canadian Medical Association 171, no. 11 (2004): 1363-1365; and Lemmens and Telfer, supra note 18. 153.  For an overview of countries that have implemented trial registration and results reporting, and for an overview of the clinical trial registries that follow WHO standards and feed into its International Clinical Trial Registry Platform search portal, see Krleza-Jeric, Lemmens et al., supra note 40. 154.  See Eichler et al., supra note 132. 155.  The driving forces behind the meeting include, among others, the public and professsional debate following the Doshi et al. paper on Tamiflu (see supra note 28) and subsequent editorials in leading medical journals and media reports (see, for example, F. Godlee, Editorial, Clinical Trial Data for All Drugs in Current Use British Medical Journal 345[2012]: e7304; and two 2012 inquiries by the European Ombudsman into the access to information procedures of the European Medicines Agency (EMA). The first involved a citizens complaint about the EMAs refusal to provide access to adverse event reports in its EudraVigilance data base on Roaccutane, a product to treat severe acne. In his recommendations, the Ombudsman explicitly recognized a duty to provide access to such reports and emphasized the importance of access to data in the context of democratic accountability. See Decision of the European Ombudsman closing his inquiry into complaint 2493/2008/(BB)(TS)FOR against the European Medicines Agency (available at < cases/decision.faces/en/11360/html.bookmark> [last visited February 18, 2013]). The second case involved a complaint from two pharmaceutical companies about the fact that the EMA failed to justify why they could not also benefit from the waiver to conduct certain paediatric trials for the approval of their products, as two competitors did. While the Ombudsman concluded that the decision was defensible in substance, he criticized the EMA for failing to ensure transparency of the process and of its decision-making, and for failing to provide adequate reasons. See Draft recommendation of the European Ombudsman in his inquiry into complaint 2575/2009/ (TS)(TN)RA* against the European Medicines Agency (available at <> [last visited February 18, 2013]). 156.  European Commission, Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, COM(2101) 369 final, 2012/0192, more specifically art. 78.3 (imposing public accessibility of the EU clinical trials database, with exceptions) and art. 25.6 (obligation to register clinical trials in a primary registry of the WHO platform). The proposal has been criticized for various reasons, including the vagueness of various requirements, the absence of stringent requirements related to ethics review, and the open-ended exception to the transparency requirements. Amendments, including many focusing on strengthening the transparency requirements, have been proposed by European Parliamentary Rapporteur on Clinical Trials Regulations Glenis Willmott and are currently being discussed at the level of the European Parliament. See particularly on the transparency issue and the proposed regulation, P. C. Gotzsche, Deficiencies in Proposed New EU Regulation of Clinical Trials BMJ 345 e8522 (2012): 1-3 available at <http://dx.doi. org/10.1136/bmj.e8522> (last visited March 12, 2013). 157.  See Gostin et al., supra note 133; see also I. Kickbusch, W. Hein, and G. Silberschmidt, Addressing Global Health Governance Challenges through a New Mechanism: The Proposal for a Committee C of the World Health Assembly, Journal of Law, Medicine and Ethics 38, no. 3 (2010): 550-563. 158.  See my earlier criticism of the reorganization at WHO and its apparent impact on the results reporting initiatives in Lemmens and Telfer, supra note 18, at 75-76.


journal of law, medicine & ethics