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PharmaceuticalKnowledge

Governance:A Human RightsPerspectiveTrudo Lemmens

IntroductionIn recent years, the development process o pharma-ceuticals, medical devices, and related products andthe overall market o these products have becomeincreasingly global.1 This paper discusses the needor better governance o one aspect o this market:the production, distribution, and use o pharmaceuti-cal knowledge.2 Various controversies, some o whichwill be described in this paper, highlight how indus-try control over pharmaceutical data production hasresulted in very serious threats to public health. Di-erent practices and regulatory elds that aect whatI will reer to in this paper as pharmaceutical knowl-edge production are all too oten articially separatedand dealt with in isolation, which seriously aects thequality o the available inormation on the saety andeectiveness o products.3 I will examine here how ahuman rights-based approach should inspire us to

look more careully not only at the signicant humanrights-related interests that are at stake, but also at therelations between the dierent interwoven regulatory,cultural, and social actors and how these play out atthe various stages o knowledge production. Follow-ing a brie discussion o these stages and o the publichealth challenges raised, I will briey explore someo the human rights-associated interests that are atstake. I will then give a brie overview o the contex-tual and multiaceted nature o the problem o whatI term the pharmaceutical knowledge decit thatis to say the serious deciencies in the way pharma-

ceutical knowledge is produced, distributed (includ-ing through journals, advertisements, and educationalinitiatives), and used. In this discussion, I will high-light the need or a comprehensive global response,which will be addressed in the nal section.

1. Pharmaceutical Knowledge Production: AGlobal Public Health Challenge1. 1. The Challenge o Knowledge Production in aGlobal EnvironmentWhile historically, pharmaceutical research and devel-opment was concentrated in Europe, North America,and Japan, the last decades have seen a clear shit

towards more globalized knowledge production.4 This

Trudo Lemmens, LL.M., D.C.L., is the Scholl Chair inHealth Law and Policy at the Faculty o Law o the Univer-sity o Toronto, where he also holds cross-appointments in theFaculty o Medicine and the Joint Centre or Bioethics. Dur-ing the academic year 2012-2013, he is teaching at the Centreor Transnational Legal Studies in London, and is an aca-demic visitor at the Faculty o Law and the HeLEX Centre orHealth, Law and Emerging Technologies o the University oOxord. His research is primarily ocused on the intersectiono law, ethics, biomedical innovation, and medical researchand practice.


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trend can be noted across all stages o knowledge pro-duction: rom pre-clinical research all the way throughto marketing.

At the pre-clinical stage, it increasingly involvescomputer-driven analyses o stored biological sam-ples, paired with clinical and amilial health inorma-

tion gleaned rom biobank conglomerates that havemushroomed all around the globe. Global exchangeo samples and patient data is standard practice inthese global research inrastructures,5 which areoten organized in complex collaborative groups6

and unded through public-private partnerships thatinvolve large multinational companies, niche biotech-nology start-ups, and unding agencies in dierentjurisdictions.7 Global commercial biobanks are alsoexpected to grow signicantly in the coming years.8

Clinical drug testing involving human research

subjects, estimated to have become a U.S.$50 billionindustry,9 is also a global venture, gradually movingrom industrialized countries to middle- and low-income countries.10

Knowledge production continues ater drugapproval, with the collection and storage o data onbillions o patients. Physicians,11 patients12 and phar-maceutical companies are expected to submit adverseevent reports to regulatory agencies. There is alsoa growing trend to promote data sharing amongpatients outside the traditional (and not always well-unctioning) adverse reporting systems.13

Publication processes o clinical studies also cross

borders. In industry-sponsored studies, medical com-munication companies coordinate the process, withinvolvement o academic specialists sometimes asmere guest-authors14 and organize strategic place-ment o articles in journals, oten aligned with themarket launch o products.15 The scientic literaturewhich eeds into global clinical practice guidelines israrely strictly local.

In addition to traditional means o direct-to-con-sumer advertising, new and increasingly global com-

munication tools via the Internet and social mediasites such as Facebook create virtual patient andconsumer communities to which inormation can bechanneled.

The globalization o these practices has repercus-sions or the development o good knowledge gover-

nance. Enorcing standards becomes even more di-cult, particularly due to the absence o accountabletransnational governance structures. National andregional regulations (e.g., at the European level) mayexist with respect to particular parts o the process,

but many aspects o the knowledge produc-tion process are dealt with through nationaland international sot guidance documents,proessional scientiic standards, andindustry sel-regulation.16 Moreover, regu-latory agencies in one state cannot controlas easily how data are produced and dis-

tributed in another state, even when thesedata have a global impact.17

Yet, the globalization o knowledge pro-duction, combined with new computerand data storage technologies, also cre-ates opportunities. For example, experts

have pointed out that better global communication oresults o early phase clinical trials enables scientiststo connect dierent small-scale data sets, which cansometimes raise saety concerns well beore large-scale studies are inalized.18 Global governance oinormation can thus help ensure that patients, con-

sumers, health care agencies, physicians, and indus-try benet rom the wealth o data generated by morestreamlined global data gathering and analysis.

While problems in knowledge production are admit-tedly not necessarily causally connected to its globalcharacter, the global nature o the production processcertainly urther limits the level o control regulatoryagencies, proessional organizations and other bodiesare able to exercise.

1.2. Integrity and Accountability o PharmaceuticalKnowledge Production: A Public Health ChallengeIn the last decade, numerous reports have highlighted

the problems associated with the promotion, pre-scription and overconsumption o pharmaceuticalsand medical devices.19 Particularly in the U.S., manyo these practices have lead to skyrocketing criminalnes and penalties imposed on nearly all o the largepharmaceutical companies.20 A 2010 report by thePublic Citizens Health Research Group notes thatthe pharmaceutical industry now tops not only thedeense industry, but all other industries in the totalamount o raud payments or actions against the

While problems in knowledge production areadmittedly not necessarily causally connectedto its global character, the global natureo the production process certainly urther

limits the level o control regulatory agencies,proessional organizations and other bodiesare able to exercise.

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ederal government under the False Claims Act.21The trend has continued, as higlighted by the 2012record-setting $3 billion settlement with accompany-ing criminal guilty plea by GlaxoSmithKline or o-label promotion o anti-depressants and ailure toreport saety data about Avandia, a top-selling diabe-

tes drug.22 Interestingly, a recent $60.2 million settle-ment between Pzer and U.S. ederal prosecutors alsohighlights the global nature o pharmaceutical corpo-rate maleasance: prosecutors accused Pzer o brib-ing physicians, hospital administrators and regulatorsin several European and Asian countries, includingChina.23

Not all o these penalties are or manipulation oresearch ndings or intentional concealment o rel-evant saety and eicacy data, but most deal withsome aspect o pharmaceutical promotion and mosthave signicant public health implications. How seri-

ous are the consequences o the practices targeted bythese penalties? It is hard to come up with a preciseestimate o how many people have died or been seri-ously injured. The multiaceted nature o knowledgeproduction and the oten insurmountable difculty inestablishing a clear causal relation between specicpractices and serious adverse events constitutes, inact, one o the most signicant hurdles or tort-basedclaims.

Figures on adverse events, nevertheless, give usan indirect idea o the magnitude o the problem. Arecent analysis based on data rom the U.S. Centers or

Disease Control and Prevention suggests that atali-ties associated with adverse eects o medication nowsurpass those caused by trafc accidents in the U.S.24While prescription and patient errors are also likelyinvolved, awed knowledge production practices mayin part be responsible or those problems. Even moreinormative are the estimates o the stunning numbero people seriously injured as a result o pharmaceuti-cal products which were promoted through practiceswhich allegedly also involved hiding or misrepresent-ing data. For example, it is estimated that the aggres-sive promotion o Vioxx may have resulted in hun-dreds o thousands o inarctions and strokes.25 The

signicant impact o the aggressive promotion o Hor-mone Replacement Therapy (HRT), which involvedthe controversial use o ghost-written publications, onbreast cancer rates in industrialized countries can alsobe mentioned here.26 Almost all major pharmaceuti-cal companies have been associated with problematicpromotional practices o blockbuster drugs that mayhave caused signicant injuries and death. The listincludes drugs such as Oxycontin, Neurontin, Paxil,Zyprexa, Celebrex, Fen-Phen, Prempro, Prepulsid,Depakote, Avandia, and Risperdal.27

Failures in good knowledge governance can alsolead to enormous waste o health care unds. The con-troversy surrounding the promotion o Tamiu in thewake o the H1N1 outbreak should be a wake-up call.There is now serious doubt about the reliability o thecompany-produced synthesis o the data that under-

pinned public health agencies stockpiling o the drugaround the world.28 The decisions to stockpile stand insharp contrast to the U.S. FDAs assessment o the dataand its decision to challenge Roche under FDA regu-lations or claiming that Tamiu reduced inuenza-related complications.29 Peter Doshi and colleagues,who identied problems with the reliability o thecompany-controlled analysis based on partially hid-den data and who tried in vain to get access to the ulldata, cynically comment that i the FDA is right, thedrugs eectiveness may be no better than aspirin.30

Yet billions o dollars have been spent in stockpiling

Tamiu around the world $1.5 billion in the U.S.alone.31Currently, these problems particularly aect the

industrialized world, where more people can aordpharmaceutical products and more health care und-ing is available. Yet, over-prescription and overcon-sumption can clearly impinge on middle-income anddeveloping countries. In act, their impact risks beingproportionally worse. The challenges in dealing withthese practices will be greater in countries with lessresources. Moreover, money wasted on ineectiveor unsae products cannot be used to address other

priorities.2. Human Rights Dimensions of KnowledgeProduction ChallengesThere are practical reasons to tackle the issue oknowledge production rom a human rights perspec-tive. One o the practical reasons is that it lays bare thesocietal importance o the issue and can help mobilizecivil society and advocacy groups. It calls or prioriti-zation o the issue on the public policy agenda. Mostimportantly, advocates can invoke the human rightsdimensions to tackle restrictions on inormationaccess based on claims related to international trade

obligations and trade secrets.32 I will not discuss thispractical issue here in much detail, but want to ocuson how specic human rights claims can be made topush or access to inormation and or recognizing agovernments role in establishing good knowledgegovernance; and on how a human rights lens alsoserves as a powerul analytical tool to explore the mul-tiaceted nature o the problem.

As the late Jonathan Mann pointed out, traditionalpublic health measures have, in the past, all too otenaccepted existing societal structures. They ocused


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on individual behavioral changes, on health careservices and targeted state action, and on contribu-tions by health care and public health proessionals.33Mann called or a more complex human rights-basedapproach, which gives attention to the impact o socialdeterminants o health, the interrelation between

regulatory structures and health care systems, andthe potential role and inuence o other proessionals.One advantage, he suggests, is that a human rightsanalysis can disaggregate a seemingly overwhelmingproblem into many component parts capable o beingacted upon.34 This disentangling o the problem andtargeting o various distinct components should, how-ever, be accompanied by a thorough understanding otheir interrelations. Interventions designed to addressone issue should be implemented with proper atten-tion to how these impact elsewhere.

This approach is not solely linked to a broad inter-

pretation o the right to health. Rather, it embracesa variety o human rights as tools to deal with pub-lic health issues. But the emphasis that Manns modelplaces on the complex interaction between health andvarious human rights as they exist within a larger soci-etal, cultural and political context also ts well witha more comprehensive interpretation o the right tohealth itsel.35 A meaningul implementation o theright to health necessarily implies an assessment o theunique social, cultural, political and economic contextin which the right is invoked. The language used ininternational conventions36 and in many o the consti-

tutions that contain a reerence to the right to health37

clearly reects its undamentally contextual natureand its linkage with other undamental rights.38 It isinteresting to identiy here briey what dierent typeo rights can be invoked to argue or better knowledgegovernance and access to inormation.

2.1. Access to Inormation, the Right to Healthand the Right to LieIn recent publications, both Aaron Dhir, as wellas Candice Teler and I have situated the need oraccountable pharmaceutical knowledge governancein the context o this multiaceted concept o the right

to health.39 Candice Teler and I constructed our argu-ment around the well-recognized notion that the rightto health not only empowers people to make health-related claims, but also creates a gamut o obligationsor states related to the implementation o determi-nants o the right to health. One o these crucial deter-minants is the right to inormation. We argued thatbecause o the connection between the right to healthand the right to inormation, states have an obliga-tion to actively promote and support the creation oreliable knowledge production systems in the context

o pharmaceutical product development, includingmandatory trial registrations and results reporting oall trials.40

We linked in our argument the right to health, theright to inormation, and reedom o expression. Thisconnection has to some degree been recognized in

earlier cases o the European Court o Human Rights(ECHR).41 In one o these cases,42 which dealt with thecritical reporting o the Sunday Times on proposedsettlements in the atermath o the withdrawal o thedrug thalidomide rom the market, the ECHR ruledthat reedom o speech also entails the right o thepublic to be properly inormed.43 We emphasized thelinkage between the right to inormation and reedomo expression that was made in this and other ECHRcases44 because it highlights the role not only o themedia, but also o civil society, in promoting publicinterest oriented science and the role o the state in

creating the conditions that enable this.45 By discuss-ing this connection between access to inormation andreedom o expression and thus also participationo civil society in discussions o public interest inthe context o access to clinical trials data, we wantedto emphasize that the issue o access to reliable clinicaltrials data goes beyond immediate individual healthclaims and concerns but also entails the protectionand promotion o public health.

Our argument that the link between access toinormation and reedom o expression could also beinvoked to impose a specic duty on states to imple-

ment public health-ocused knowledge productionsystems, however, has not received unconditionalapproval. In the 1998 case o Guerra and others v.Italy,46 or example, the ECHR ruled that the gov-ernments ailure to provide essential inormationabout the level o risks associated with living close to achemical plant constituted a violation o citizens rightto private and amily lie47 rather than o reedom oexpression. The ECHR limited in this case the ree-dom o expression clause to situations where the gov-ernment is restricting the ability o the media to ulllits public interest role in the distribution o inorma-tion already compiled by the government. as part o

their obligation to protect reedom o expression.47The Inter-American Court o Human Rights, how-

ever, has emphasized more recently in much rmerterms the link between access to inormation, demo-cratic decision making, and the role o civil societygroups, and this with wording that clearly stresses themuch broader, social role o governmental inorma-tion sharing and the need to maximally restrict excep-tions to data sharing. In the 2006 case oClaude Reyeset al. v. Chile,48 the court dealt with a reusal o provid-ing three representatives o public interest organiza-


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tions access to some o the inormation gathered bya governmental oreign investment committee in thecontext o an application or a controversial deor-estation project. The environmentalists requestedaccess to assess the potential environmental impacto the project. Although the case also involved access

to inormation already held by the government, thecourts strong emphasis on both the individual andsocial dimensions as well as the positive obligationso the state49 embedded in the reedom o expres-sion clause o the American Convention on Human

Rights stands out.50 [P]rinciples o disclosure andtransparency in public administration the courtruled enabledemocratic control o [governmental]actions, and[allows citizens to] question, investigate

and consider whether public unctions are being per-ormed adequately.51 The court characterized socialcontrol, enabled through access to inormation, asan essential component o accountable government.52The decision clearly recognizes the importance o civilsocietys counterbalancing o public decision making.Considering how oten the soundness o drug approvaldecisions have been questioned,53 the reasoning o thecourt is highly relevant the context o pharmaceuticalknowledge production.

Another human rights concept that is also re-quently connected to health-related claims, particu-larly in the context o access to potentially lie-saving

health care services and technology, is the right tolie. The right to lie has in some countries, such asCanada, been used as a substitute in the absence oa more specic right to health clause in the consti-tution.54 In the international human rights context,there are also some interesting precedents linking theright to lie with access to crucial saety inormationto enable the protection o peoples physical integrity.For example, in neryildiz v. Turkey the ECHR ruledthat Turkey had violated the right to lie55 o peopleliving in illegal huts surrounding a garbage tip, where

a methane explosion killed nine relatives o the plain-ti.56 The Court ocused particularly on the act thatthe government had not put in place appropriate pro-cedures to prevent such explosions although it knewor ought to have known o the danger. But it urthernoted that the publics right to inormationmay

also, in principle, be relied on or the protection o theright to lie.57 The circumstances o this case have tobe taken into consideration, though, in that reliableinormation about a serious and imminent risk o anexplosion was available. In the context o pharma-

ceuticals, the risk is oten but not always moreremote, and risk assessment oten requires the link-ing o data sets, careul observation o adverse events,and interpretation o statistical data that suggests that

some people may benet, whereas others could beseriously harmed. The risk in the neryildiz case wasclearly more straightorward.

2.2. Privacy, Dignity, and the UniqueNature o Health InormationAs mentioned earlier, the ECHR accepted in theGuerra case that governments have, as part o theirobligation to ensure respect or private and amily lie,an obligation to provide access to inormation theyalready possess and which should enable individualpeople to make decisions about their health and well-being.58 The existence o positive obligations o the

state under this provision has been conrmed in latercases,59 sometimes in the context o access to inor-mation cases where a link can be made to argumentsinvoked in the access to pharmaceutical data debate.In Roche v. the United Kingdom,60 or example, theECHR recognized that the right to private lie o aormer soldier had been violated because o his dif-culties in obtaining access to risk inormation aboutmustard gas tests the army had conducted on him.The Court stressed that this was not a case o the gov-ernment ailing to disclose clear and known risks, but

Another human rights concept that is also requently connected to health-related claims, particularly in the context o access to potentially lie-saving

health care services and technology, is the right to lie. The right to liehas in some countries, such as Canada, been used as a substitute in the

absence o a more specic right to health clause in the constitution.In the international human rights context, there are also some interesting

precedents linking the right to lie with access to crucial saetyinormation to enable the protection o peoples physical integrity.


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one where the hurdles in accessing all relevant datacaused considerable anxiety as a result o the uncer-tainty it created. It analyzed in detail the various waysin which the government had provided access to somedata and concluded that the State has not ullled thepositive obligations to provide an efective and accessi-

ble procedure enabling the applicant to have access toall relevant and appropriate inormation that wouldallow him to assess any risk to which he had beenexposed.61

In the recent case o RR v. Poland62 the ECHR alsorecognized that states may have a positive obligationto acilitate access to relevant inormation, in this casein the context o a situation where timely access wasnecessary to enable a decision about a state-supportedmedical procedure. The case involved the States ail-ure to provide inormation about genetic testing,which the applicant needed to decide whether to

undergo an abortion. The act that the procedure itselwas available and explicitly supported by the state wasa key component o the decision and limits to somedegree its ambit.

These cases open the door or arguing that statesclearly have to actively contribute to citizens inorma-tional sel-empowerment when government actionscontribute to a potential dangerous situation, and thatgovenments have to set up eective and accessibleaccess to inormation procedures.63 With the RR v.Poland case, an interesting analogy can also be madebetween the role o governments in providing access to

inormation about services it provides, and the statesrole in pharmaceutical knowledge production. Statescurrently exercise some level o scrutiny over the saetyand efcacy o pharmaceutical products. In act, indi-vidual access to pharmaceutical products is restrictedthrough the regime o regulatory approval combinedwith a prescription-only system or some drugs. I, as Iwill argue urther, this regulatory system also contrib-utes to the creation o consumer condence in theseproducts, it appears absolutely crucial that the statealso ensures that the inormation provided in the con-text o this system is reliable and accurate. One couldargue, rom that perspective, that the states ailure to

ensure that its drug regulatory system provides accessto reliable product inormation violates the right toprivate and amily lie.

The right to private and amily lie could clearly beinvoked, in line with these cases, to argue that underthe European Convention, governments should estab-lish adverse event reporting systems, which can havedirect relevance to patients who may be aected bymedication. But it remains more speculative to invokethis right to request the establishment o more com-plex knowledge production systems, where access to

inormation on clinical trials could potentially in theuture provide important inormation on the saety oreectivenes o a product.

Another aspect o pharmaceutical knowledge pro-duction that evokes privacy interests is that mucho this knowledge is constructed on the basis o inti-

mately personal health inormation. Patients and vol-unteers contribute to the establishment o biobankswith the donation o their own uniquely personalbiological material (blood samples or other tissues).Some o these patients may even undergo additionalinvasive biopsies, or example in the context o cancerresearch.64 When clinical trials are conducted to testthe saety and efcacy o new products, they inevitablyinvolve exposing people to the potential risks o exper-imental products. People agree to have their bodiesused as a testing site and to have data gleaned romvarious research-related tests on their bodies, arguably

at least in part with the understanding that this con-tributes to better science and product development.The discussion o the nature o the rights people

have over their bodies is complex and multiaceted.65Some courts have rejected the idea that people havedignitary interests in biological material such ascells.66 Yet, the special status o the human body andthe importance o bodily integrity are widely recog-nized in law, including in international conventionsand human rights documents. Human research eth-ics systems have been developed on the premise thatthere is something unique about the act that medi-

cal research involves an instrumental use o humanbodies and an invasion o bodily integrity. Medicalresearch oten involves a transgression o individualsphysical boundaries or what is largely the pursuit oother peoples interests. This arguably creates specicmoral duties o respect or those using the inorma-tion gained rom these bodily invasions invasionsthat clearly are associated with human dignity-relatedinterests.

Even when it comes to research purely based onstored health data or biological samples, there is a con-nection to questions o bodily integrity and person-hood. Some courts have emphasized the special nature

o health inormation as intimately personal and evok-ing autonomy interests. For example, the CanadianSupreme Court conrmed in McInerney v. MacDon-ald, which dealt with a patients right to access hermedical records, that such inormation remains in aundamental sense ones own.67 The Court also char-acterized health inormation contained in medicalrecords as highly private and personal and approv-ingly quoted the patients counsel who had stressedthat this was about getting access to inormation onher body, the body o Mrs. MacDonald.68


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In a very dierent context, but also relevant to men-tion here in light o the growing importance o bio-banks as essential components o knowledge creation,the Icelandic Supreme Court recognized in a widelycited decision that a woman had a privacy interest inthe health inormation o her deceased ather con-

tained in the publicly unded biobank, as this inor-mation also related to her.69 Genetic research hasrevealed how genetic inormation is undamentallyshared and never completely ones own, and otenhas direct relevance or amily members with whomgenetic inormation is necessarily shared in the case obiological relatives.

Obviously, a right over or interest in ones ownhealth inormation can hardly be used as a directly

enorceable tool to obtain access to research data

that pertain to hundreds, i not thousands, o otherpatients. In addition, in the context o scientic dataanalysis, it will not be the individuals themselves whoconnect data sets, conduct the statistical analysis,and interpret them. Further, the scientic analysishas to be translated into useul inormation that canbe transmitted to patients through learned interme-diaries. But the privacy and dignitary interestspatients and research subjects have in their own datashould inspire advocacy groups to come up with mod-els based on meaningul citizen involvement in publichealth-oriented science. They should make the case

or empowerment o individual patients and researchsubjects and their communal interests. They should atleast be able to collectively claim access to data theyphysically contributed to data that, in connectionwith other data sets, are relevant or their health andthe health o their amily members, riends, and thecommunity at large. Patient advocacy groups couldpush, or example, or an explicit stipulation in con-sent orms o the need or transparency o clinical tri-als data and results reporting.

It seems ironic that governments and pharmaceu-tical companies tend to invoke the privacy interestso individuals in way that is diametrically opposedto what is arguably the ultimate goal o privacy pro-tection. Indeed, privacy o health inormation is re-quently cited as one o the main reasons or restricting

access to important adverse event reporting data andclinical trials data.70 A more complex human rightsapproach invites us to look beyond purely individualinterest-related aspects o human rights claims and toconsider their social and public components. It seemsto run counter to such an approach to invoke individ-ual rights such as privacy in a manner that indirectlyundermines the health interests o the very samepeople (and the relatives and community members o

those) whose health inormation is claimed to be in

need o protection.

2.3. The Communal Interest in Health Inormationand Human RightsThis brings me to another human rights-associatedinterest in the production o scientic knowledge:the communal interest in health inormation result-ing rom research and patient care. This communalinterest has in recent years been highlighted particu-larly in the context o biobanks and genetic research,even though the right to enjoy the benets o scienticprogress was already explicitly recognized in earlier

human rights documents such as the Universal Dec-laration on Human Rights as well as in the Interna-tional Covenant on Economic, Social, and CulturalRights.71 Commentators72 and statements by interna-tional organizations such as HUGO73 have evoked theconcept o the Common Inheritance o Humankindor Heritage o Humanity to reect the shared com-munal interests associated with genetic inormationcontained in stored samples.74

The growing literature and public statements onthe public goods dimensions o scientiic research

Although it would be hard to see any immediately enorceable human rights

claim associated with the emphasis on the public investment in research,there is a connection to the growing recognition o the governments role incontributing to the progressive realization o the right to health. From this

perspective, one can argue that with nite resources, citizens can expect thatgovernments behave rationally when they invest in the development o healthcare goods and technology that can assist with, or aect the realization o, the

right to health.


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and knowledge production are also worth mention-ing here.75 Access to inormation in the context opharmaceutical research as a human right, the rightto benet rom scientic progress, and access to inor-mation based on a public good approach have closeconceptual kinship, to use a term coined by Philip

Alston and Nehal Bhuta in a recent paper on the rightto education.76

This conceptual kinship is relected in varioushuman rights documents and statements, such as therecent UNESCO Universal Declaration on the HumanGenome and Human Rights. In Article 12, the Decla-ration reers to the importance o reedom o researchand the act that research has to benet health careand humankind as a whole (Art. 12(b)). The Declara-tion also emphasizes the act that the benets o sci-entic research have to be made available with dueregard or the dignity and human rights o each indi-

vidual.77 The right to benet rom the results o sci-entic research has received renewed attention rominuential human rights bodies. In July 2012, theUnited Nations Human Rights Council responded toa report by the Special Rapporteur or cultural diver-sity, by inviting academia and civil society to partici-pate in the urther examination o the content o theright to enjoy the benets o scientic progress and itsapplications.78

This public interest component o research andtechnological development can also be linked to pub-lic investment in pharmaceutical research. Although

it would be hard to see any immediately enorceablehuman rights claim associated with the emphasis onthe public investment in research, there is a connec-tion to the growing recognition o the governmentsrole in contributing to the progressive realization othe right to health. From this perspective, one canargue that with nite resources, citizens can expectthat governments behave rationally when they investin the development o health care goods and technol-ogy that can assist with, or aect the realization o, theright to health.

As pointed out earlier, governments have investedsignicantly in the development o biobanks, which

are increasingly used as widely-accessible researchinrastructures or both academic and commerciallyocused research endeavors. In addition, there is agrowing emphasis in all orms o research on public-private partnerships, in which academic researchersand public unding agencies participate with industryin research and health product development. Publicinvestment in research and health product develop-ment also occurs in various other orms, such as taxbreaks, training programs or researchers, and sci-ence education in general. Finally, publicly unded

health care systems are also among the largest buy-ers o pharmaceutical products. This again providesan important and steady stream o income to theindustry, which arguably can be seen as signicantpublic support. The signiicant public investmentand public contributions calls or some level o reci-

procity and benet sharing.79 At a minimum, citizensshould expect air and reliable knowledge productionprocesses and accountable access to inormationpractices.

Finally, global equity concerns associated withclinical trials and drug development can also be men-tioned here.80 As pointed out earlier, clinical trials areincreasingly taking place in lower and middle-incomecountries, even when they involve drugs and healthcare products that will not necessarily be available inthese countries. In industrialized countries, poor andotherwise vulnerable people are also disproportion-

ally represented in clinical trials.81 In general, Phase Itrials are conducted on people who participate almostexclusively because they have nancial needs.82 Thisraises larger ethical concerns about the exploitationo vulnerable people and communities. In addition tothe risk o exploitation, the act that it involves peo-ple who are in need may even legally compromise theinormed consent o research participants, as a resulto the duress under which they accept to participate. Itis worth noting here that conducting medical experi-mentation without inormed consent is explicitly tar-geted as a human rights violation by Article 7 o the

International Covenant on Civil and Political Rights.83

2.4. Enorceability o Human Rights ClaimsRelated to Access to InormationThe translation o socio-economic rights into speciclegal claims which can be judicially enorced is in gen-eral already not straightorward.84 Some o the rightsor concepts evoked earlier, such as the communalinterests in health inormation, are even less likely toprovide a tangible legal remedy at this point than someo the more commonly invoked socio-economic rights.A human rights discourse based on these notions hasprimarily rhetorical orce. It draws attention to the

signicance o the issues and may help mobilize thecommunity to support urther policy in this area.

More individual interest-style human rights, suchas the right to health, the right to private and amilylie, and the right to lie, are more likely to provide abasis or legal claims, as in the cases discussed above.Yet, as other articles in this special issue85 and else-where86 highlight, the judicial enorcement o theright to health at the national level varies widely. Di-erent actors will play a role here: the integrationo the right to health in national constitutions;87 the


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interpretation o related constitutional rights such asthe right to lie by national courts; whether nationalcourts have recognized the legal status o the rules ointernational conventions ratied by the state withindomestic law;88 and also a host o social, historical,and cultural actors that inuence the judicial culture

o a country, including the presence o organized andproactive civil society groups.89

The right to health is, as a socio-economic right,clearly not as easily enorceable as civil and politicalrights. The International Convention on Economic,Social and Cultural Rights, one o the major interna-tional sources o such human rights, stipulates, orexample, in its Article 2 that states have an obligationto progressively achieve the realization o these rights.Under the concept o progressive realization, theextent o a states obligation depends on the availableresources, and states have much leeway in determin-

ing the pace o the realization o these rights and whatthey want to ocus on.90 At the same time, even underthe ICESCR, states have some minimal core obliga-tions, such as the obligation to ensure a minimumlevel o access to the essential material componentso the right to health.91 The Committee on Economic,Social and Cultural Rights mentions the provision oessential primary health care92 as one o these corestate obligations. When specic inormation relates tohealth care products that can be connected to essen-tial primary health care, it can thus clearly be arguedthat states have an obligation to ensure the accuracy

o the available inormation or even public access toall relevant data. One could also argue that even orhealth care services which do not themselves consti-tute essential primary health care, important saetyand efcacy inormation about such services remainsa component o essential primary health care sincethe lack o inormation can create saety concerns.

This cursory overview o some relevant humanrights cases suggests that the more pharmaceuticalinormation is immediately relevant to the health oindividuals, the more likely providing access to thisinormation can be ormulated as a specic human-rights-based obligation. The claim that states also

have an obligation to implement reliable knowledgeproduction systems, based on ull access to data setseven when the separate data sets are in and o them-selves not immediately relevant or individual peopleshealth, appears more speculative, and is based on amore exible interpretation o the right to health andother related human rights discussed earlier.

A urther limitation traditionally associated withhuman rights claims based on international conven-tions is that these only bind states and cannot bedirectly invoked against private actors such as phar-

maceutical companies, which clearly play a dominantrole in the context o pharmaceutical knowledge gov-ernance. Some interesting developments are, however,worth noting here. First, it is increasingly recognized particularly in the context o growing privatizationand mixed public-private partnerships in areas such

as health that a strict division between governmen-tal and private actor decision-making no longer makessense. Human rights norms, including socio-economicones, are increasingly inuencing judicial interpreta-tion o private law obligations.93 The argument that astrict division does not correspond with current real-ity rings particularly true in the context o pharma-ceutical knowledge production, where as I will dis-cuss urther there is wide support or historicallydeveloped governmental regulation, but where a cru-cial component, i.e., knowledge production on whichregulatory review is based, is controlled by industry.

This seems also in line with some o the human rightscase law discussed above, which reects a willingnessto hold states accountable or their ailure to ensurethat people are sufciently inormed about the harm-ul practices industry is engaged in with explicit gov-ernmental permission.

A second development worth mentioning is thegrowing pressure on corporations to accept humanrights obligations and on states to ensure that appo-priate legal accountability mechanisms or corpora-tions exist.94 A detailed discussion o the various civilsociety95 and more public initiatives exceed the scope

o this paper, but some key initiatives in this contextare worth mentioning. A signicant development isthe adoption in 2008 by the United Nations HumanRights Council o the U.N. Protect, Respect and Rem-edy Framework on Human Rights, prepared by JohnRuggie, the UN Secretary-Generals Special Represen-tative on Business and Human Rights.96 The Frame-work emphasizes the primacy o states obligations toensure corporate respect or human rights throughappropriate legal and regulatory rameworks. But italso calls or corporate responsibility and embracesrespect or human rights as a standard o expectedconduct. This Framework was implemented in 2011

through the Guiding Principles on Business andHuman Rights, which aim at establishing a com-mon global platorm or action, on which cumulativeprogress can be built97 and which esh out the impli-cations o existing standards and practices or Statesand businesses.98 The Guiding Principles emphasizecorporate responsibility in respecting human rights,expect corporations to actively contribute to the miti-gation o the human rights impact o their activities,99and also call on them to establish processes to identiy,prevent and remedy adverse human rights impacts.100


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Interestingly, the guidelines identiy the need orappropriate transparency and communication abouthuman rights violations.101 Arguably, i the right toinormation about drug saety is a human right, theguidelines would impose on pharmacuetical compa-nies obligations to publicly identiy instances where

important saety and eectiveness inormation hasresulted in harm to the well-being o patients.

The development o these guidelines and the debateollowing their adoption have led to increased discus-sion and awareness about the need to promote cor-porate respect or human rights and the need to holdcompanies accountable through appropriate stateaction. The Organization o Economic Cooperationand Development has already updated in 2011 itsGuidelines or Multinational Enterprises with a newchapter on human rights, which implements manyo the Guiding Principles.102 States adhering to the

OECD guidelines, which include about all industrial-ized countries, oer a complaints mechanism throughthe use o a Specic Instance Procedure, whereby alle-gations o violations o human rights by multination-als can be submited to OECD National Contact Points.The latter are national governmental agencies man-dated to help implement the guidelines. Yet, as withall o these sot-law initiatives, the lack o enorceabil-ity limits the impact o these guidelines.103 There arealso questions about the willingness o the nationalagencies to deal with violations, as the rejection o aseries o complaints based on pharmaceutical promo-

tion practices has highlighted.104

In the context o pharmaceuticals, the work othe UN Rapporteur on the Right to Health alsodeserves attention. The Human Rights Guidelinesor Pharmaceutical Companies in Relation to Accessto Medicines105 prepared under the leadership othen Rapporteur Paul Hunt strongly argues or cor-porate responsibility in implementing human rightsstandards. Although it ocuses primarily on access tomedicines, there is also an explicit reerence, undera section on Ethical Promotion and Marketing, tothe need to take eective measures to ensure that allinormation bearing upon the saety, efcacy, and pos-

sible side eects o a medicine are easily accessible toindividuals.106

The growing emphasis on the corporate responsi-bility in the implementation o human rights normscould clearly also be invoked to call or greater indus-try responsibility in promoting reliable knowledgeproduction processes. Yet, the most direct obliga-tion to ensure the implementation o human rightsnorms still resides with national states. It would alsobe nave to belie that sot law norms such as OECDguidelines and the Framework on Human Rights

will be sufcient to ensure ull corporate compli-ance. In the past, the regulatory system has alreadysignicantly relied upon air practices by industryor the production o reliable data, and it has clearlynot lived up to that expectation. As Paul Hunt andRajat Khosla argue in the context o the access to

medicines debate, The apparent non-compliance opharmaceutical companies with their human rightsobligations underscores the vital importance oaccountability mechanisms.107

3. Historical, Regulatory, Social, Culturaland Economic Factors of KnowledgeProduction as Components of a ContextualHuman Rights AnalysisI we recognize that states have an obligation to ensuregovernance o inormation that conorms with thehuman rights interests discussed earlier, how do they

have to go about this? Human rights law imposes aduty on states not only to respect and protect, but alsoto ulll the respective rights, including the right tohealth and the right to inormation as one o its keydeterminants.108 This ulllment has to be inormedby a recognition o the various challenges to their real-ization. These challenges have to be situated within acomplex network o interacting social, cultural, regu-latory, and economic components. Untangling theinterwoven components o knowledge-productionrequires careul observation o the multiple ways inwhich numerous actors intermingle. Pulling hard at

one end o the knowledge production knot may appearto provide relie but it may end up aggravating anothercomponent. A comprehensive, context-driven humanrights approach orces us to start with an evaluation othe interacting historical, social, cultural, economic,and technological actors.

3.1. Drug Regulatory Developmentsin Historical ContextThe drug regulatory system originated in the early1900s in reaction to abysmal ood industry practicesand the untrammeled marketing o oten highly toxicproducts.109 It was tightened in subsequent decades

in the wake o various controversies, particularly ol-lowing the thalidomide saga o the 1960s, which ledto the introduction o the rst efcacy requirements.Notwithstanding gradual expansion o the require-ments,110 the ocus has largely remained on pre-mar-ket approval based on the provision o data showinga minimal level o saety and efcacy in a vaguelydened population through a number o pivotal clini-cal trials. The regulatory emphasis on clinical trialsdata resulted in the birth o the clinical trials industry,which now largely controls the rst stage o pharma-


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ceutical knowledge production. Academic institutionsand even organizations such as the American MedicalAssociation were originally quite actively involved inthe conduct o clinical trials and primary evaluationo drug saety and efcacy.110 But the gradual increasein requirements with respect to the length, magnitude

and thus also costs o clinical trials indirectly contrib-uted to the growing power o this booming industry.Academic investigators, to the extent that they are stillinvolved, are now largely integrated within industry-controlled knowledge production processes.

Governments, on the other hand, have watchedsomewhat rom the sidelines. They have introduceda host o evidentiary standards, but have largelyrespected the mantra o sel-regulation. The sophis-ticated review and re-evaluation systems largely workwith data produced by the industry. The drug evalua-tion system provide regulatory imprimatur112 to prod-ucts with still largely uncertain saety and eective-

ness proles that have been tested internally by thosewith phenomenal nancial interests in their wide-spread use. It attaches a label o saety and efcacyto products, surrounding them with an aura o trust-worthiness, even i the data supporting the approvaldecision oten only suggest a very limited efcacy othe product.113

While the system has historically led to the removalo many quackeries rom the market, it has, oddlyenough, gradually given the ultimate power o knowl-edge production to large pharmaceutical companiesand their contractual parties.114 At present, ewer com-

pletely awed products may slip through the regula-tory cracks, but there is now a concern that remainingsaety and efcacy problems will be concealed under acomortable and reassuring regulatory blanket.

Admittedly, some signiicant regulatory changeshave taken place in the last couple o years. Particularlyin the U.S., but also in other industrialized countries,these changes have resulted in better post-marketingsurveillance and the expanded use o conditionalapproval. In addition, the FDA has gained more regu-latory powers with respect to post-marketing surveil-

lance as a result o the recent amendments to the Foodand Drug Act.115 Nonetheless, drug regulatory controlremains characteristically ocused on the approvalstage and the market entry o new drugs, with propor-tionally little attention to ongoing review. At the sametime, there is a concern that the move towards better

ongoing review may lead to less rigorous assessmentat the approval stage.116

A historical understanding o the development odrug regulation is in this context particularly interestingor several reasons: it helps to understand why regula-

tions have taken a certain shape and where mistakeswere made. In the context o the transparency debate,it is helps to see the oddity that regulatory requirementsaimed at the production o more reliable saety and ef-cacy data have given industry more control over dataand more sophisticated means to misrepresent. Whenarguments are made about proprietary rights over thosedata and data secrecy obligations, we should remind

those making such claims that the clinical trials industryitsel is the product o growing regulatory requirementsaimed at providing more reliable data used in the con-text o a regulatory process which should be ocused onthe public good.

3.2. The Evidence-Based Medicine ParadigmMedical practice, health policy, and regulation are,one might say, addicted to evidence-based medicine(EBM). Developed in reaction to oten arbitrary medi-cal practices that were previously all-too-seldom ques-tioned, EBM has embraced statistical evidence as a

tool to reute or conrm claims about the eectivenesso therapies and interventions.117 It is hard to ignorethe attractiveness and importance o this approach,particularly as it rationalizes regulatory processes andthe practice o medicine. It has oten led to better useo scarce resources and the elimination o harmulpractices, even i supporters appear to overestimate itsimpact.118 EBM is popular or pragmatic reasons andts well with our societal trust in science.

Two serious threats result, however, rom the all-too-oten blind ocus o EBM on statistical evidence.

When arguments are made about proprietary rights over those data and datasecrecy obligations, we should remind those making such claims that the

clinical trials industry itsel is the product o growing regulatory requirements

aimed at providing more reliable data used in the context o a regulatoryprocess which should be ocused on the public good.


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First, it has contributed to a worrisome transorma-tion o medical practice. Statistical evidence otenappears to have replaced sound clinical judgment andperhaps more cautious prescription and drug moni-toring practices.119 Physicians have lost touch withthe individual patients in ront o them, embracing

statistical results as irreutable truths.120 They nowoten orget that statistical data have no eyes to see theindividual patient, no ears to understand her suer-ing, and no brain to connect serious problems with astatistically indicated, but perhaps individually inap-propriate, therapeutic agent.

The second problem is that evidence is created, con-structed, interpreted, and used in a particular social,cultural, historical, and economic context.121 It can beshaped and manipulated by those with a vested inter-est in its use.122 In part as a result o well-intendedregulatory interventions, those with huge nancial

interests in pharmaceutical knowledge productionhave become its quasi-exclusive producers. Industrycan use EBM as a shield to protect promotional andsales practices, convincing many who tend to conusean absence o available evidence o harm with evi-dence o absence o harm.

3.3. Power-Relations and Interests o Industry,Proessional Organizations, and RegulatorsThe existence o various vested interests and power-relations associated with pharmaceutical knowledgecreation also merits urther analysis. Industry inter-

ests have received the most attention. The billion dol-lar prots associated with the sale o blockbuster drugsclearly inuence the knowledge production process.There is overwhelming evidence o repeated indus-try manipulation, misrepresentation and misleadinguse o data.123 The magnitude o the interests impactsthe eectiveness o regulatory strategies. Critics havepointed out that even billion dollar penalties imposedin the US pale in comparison to the potential gainsassociated with some o the unlawul practices.124

Notwithstanding the exposure o many o thesepractices and the sanctions imposed, some continue toturn a blind eye to the problem. At the same time that

companies are being prosecuted or the manipulationand misrepresentation o data and o-label promo-tion, unding agencies, proessional organizations,university executives and government ofcials courtcompany executives to promote co-unding initiatives,sponsorship o events, and the establishment o aca-demic chairs. These relationships obuscate boundar-ies, which oten complicates regulatory and proes-sional intervention.

In the international context, the nancial power othe regulatory and proessional agencies involved in

drug regulation can also be contrasted with that oindustry. The health care budgets o most countriespale in comparison to the sheer nancial power othe pharmaceutical and related industries. Regula-tory initiatives and controls that can be condentlyimplemented in industrialized countries are out o

reach or low- and middle-income countries. This mayexplain, or example, why the more stringent clinicaltrials and results reporting requirements introducedthrough the 2007 FDA Amendment Act have inspiredew countries to do the same.125 Clearly, governmen-tal agencies can be put under industry pressure. Cor-porate capture is a major concern in many countries.This also highlights the need or global coordinationand enorcement o standards.

Industry interests are the most signiicant andprobably hardest to address. Yet, they clearly do notexist in isolation. Various other stakeholders have

vested interests in the governance o pharmaceuticalknowledge. The promotion o better standards will,or example, inevitably have to deal with the nancialinterests o connected industries such as the clinicaltrials and commercial research ethics review indus-tries, and the medical communications agencies.Several commentators have, or example, proposedto undamentally reorm drug regulation by remov-ing the power o the pharmaceutical industry overthe design, conduct, analysis and reporting o clinicaltrials.126 This could result in a signicant shrinkage, inot disappearance, o the Contract Research Organi-

zations and commercial IRB industries, at least as weknow them now.127 Even tinkering at the margins othe current knowledge production industry may evokeresistance and will have to address the various inter-ests and power-relations involved.

The regulator itsel also has vested interests. Thereis a rather odd and conicting client-provider relation-ship between those who are expected to provide publicaccess to essential, publicly-relevant saety and eec-tiveness data with clear regulatory nality, and thosewho order the data and have huge nancial stakes inwhat the data reveals, how it is later presented, andhow it is used. The data produced in the context o

drug development is inherently complex, oten con-tradictory, and above all, undamentally uncertain.128This should ideally evoke caution and prudence. Yet,the entity controlling the data, industry, has an inter-est in selling a message associated with the data thatis diametrically opposed to caution and reluctance. Asan administrative agency under political supervision,the drug regulator tends to reassure the public thatit is exercising its role judiciously and independentlyrom industry. This can make it difcult or the regu-lator to admit that it inappropriately approved market


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entry based on industry data. Moreover, it is oten inan all too intimate relationship with industry itsel. Asa result o the integration o innovation initiatives indrug regulation, it is also increasingly required to lookat the promotion o industry interests.129

Others also have vested interests in the current

knowledge production system. Science publicationsare highly lucrative inancial ventures, generatingmillions o dollars or investors and or proessionalorganizations such as the American and British Medi-cal Associations. Scientic journals have an interestin being valued or their integrity and reliability, yetthey also have nancial interests in publishing andreprinting articles o industry-sponsored clinical tri-als.130 Medical associations oten have signicant tieswith industry, as highlighted in the context o a 2008controversy surrounding a joint educational programset up by the Canadian Medical Association and phar-

maceutical giant Pzer.131 Some academic authors arealso willing contributors to the current knowledgeproduction system controlled by industry because othe payments they receive or lending their name asguest authors to ghost-written publications, but evenmore so because o the signicant interests they havein obtaining additional peer-reviewed publications.In act, within an increasingly competitive publish-or-perish culture, the interests o academic authorsin publications may negatively aect the distributiono scientic knowledge. There are growing concernsover the misrepresentations and alse claims made in

research reports, industry-sponsored or not, becauseo the interests o scientists in coming up with inter-esting, hence publishable, results.132

3.4. Psychological and Social FactorsBad knowledge production practices are only prob-lematic i they work, that is, i people (health careproviders, patients, unding agencies) take the knowl-edge generated seriously and act upon it. I alreadymentioned that the EBM paradigm may be so par-ticularly successul because o our societal trust in sci-ence. Other psychological, cultural and social actorsinluence knowledge governance. A growing body

o literature on disease mongering emphasizes,or example, how industry interests create conceptso disease and partly shape our societal perceptiono what requires pharmaceutical treatment.133 Thisoccurs through sophisticated marketing practicesthat span the whole knowledge production process.It involves the subtle inuencing and manipulation oscientic and proessional organizations, regulatoryagencies, and most importantly, consumers. A typicalaspect o these marketing practices is, or example,

the use o awareness campaigns by industry-undedpatients groups.134

I this concern is to be taken seriously, it means thatinordinate reliance on individual consumer choicewill hardly provide protection. More sophisticatedknowledge governance will thus necessarily require a

detailed assessment o how industry interests shapeperceptions o disease, and how regulatory agencies,proessional bodies, and advocacy groups can coun-terbalance the subliminal messages contained in mul-tiaceted marketing campaigns, which oten involvethe manipulation o traditional sources o scienticknowledge.135

A related concern worth mentioning here is whatI would term the quasi-religious belie in the healingpower o pharmaceutical products.136 Ours is a culturewhich appears obsessed with health and wellness, andone dominated by a belie in the endless ability o tech-

nological and external xes to achieve them. In 1980 over 30 years ago the sociologist Renee C. Foxwrote that [m]edical advanceseems to have createda rise in expectations about health and well-being,longevity, and elimination o disease.137 She suggeststhat this has diminished public tolerance o medicaluncertainty, but perhaps partly as a result o sophis-ticated marketing practices it may also have resultedin an over-condence in the ability o new technolo-gies and pharmaceutical products to solve remainingchallenges.

In research ethics, the term therapeutic miscon-

ception is oten used to describe the tendency oresearch subjects to believe that when they participatein clinical trials o unproven therapeutic agents, theywill necessarily benet.138 I suggest that the term couldbe more widely applied to recognize how many o ustend to uncritically absorb pharmaceutical promotion,potentially ignore proessional trepidation and warn-ings about potential side-eects by still oten consci-entious treating physicians, orget about clear publicexposure o pharmaceutical industry misbehavior,and continue to believe that there is an eective andsae pharmaceutical cure or each and every minorand major ailment. One o the most psychologically,

politically, and socially challenging aspects o dealingwith misleading knowledge occurs when physicians orhealth care unders reuse individual patients access topharmaceutical products when the latter are wronglymade to believe that they will benet rom them.

3.5. Technological FactorsKnowledge governance clearly needs to be attuned tomodern technology. The clearest example in this con-text is direct-to-consumer advertising (DTCA). Whilemost countries have some, albeit only somewhat eec-


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tive, regulatory control over DTCA in the traditionalmedia such as television, magazines and newspapers,new orms o inormation sharing may totally escaperegulatory control.139 Pharmaceutical promotionemploys the most sophisticated and innovative toolsto shape demands and interests. New communica-

tions platorms such as Facebook, Twitter, and vari-ous other tools will undoubtedly require appropriatetechnology-savvy responses.

At the same time, new technologies provide extraor-dinary tools or cohesive global knowledge gover-nance. First o all, global surveillance o adverse

events in both clinical trials and post-marketing isclearly acilitated by new computer technologies andthe Internet. Clinical trials registration and resultsreporting systems have only become a reality becauseo the available technology. Technology also allows

patient participation in adverse event reporting, ashas been highlighted by various recent regulatory140and advocacy141 initiatives in that context. New com-munications tools also provide enormous potential orglobal communication o knowledge at a pittance othe traditional cost o printing and scientic journalpublications. The EvipNet initiative spearheaded bythe Pan American Health Organization, which ocuseson the acilitation o evidence-inormed policy mak-ing through partnerships between policy-makers,researchers and civil society, can be mentioned inthis context as a perect example o good knowledgesharing practices.142 International organizations and

advocacy groups can clearly use new computer-basedknowledge technologies to counterbalance existingknowledge oligarchies.

4. Global Governance ofPharmaceutical KnowledgeThis brings me back to the global nature o knowledgegovernance. Knowledge knows no boundaries andneither should its governance. Particularly in light othe overwhelming political, economic, cultural, andsocial power o the multinational pharmaceutical

industry, there is a need or a global counterbalancingorce. Notwithstanding the WHOs signicant successin promoting global health, it clearly cannot ensureappropriate knowledge governance at a global levelwithout a stronger mandate. The saga o the interna-tional clinical trials registration and results report-

ing initiatives are a case in point. Although the WHOhas sponsored important international statements,and has set up, or coordination purposes, a crucialInternational Clinical Trial Registry, many nationshave ignored its call or clinical trials registration. Itspromotion o results reporting, a logical and essen-

tial continuum to clinical trials registration, seems tohave stalled.143 Appropriate knowledge governancerequires strict international standards and enorce-ment mechanisms.

Lawrence O. Gostins proposal or a Framework

Convention on Global Health (FCGH) can be approv-ingly mentioned here as a model, but with a caveatabout the recommended gradual nature o imple-mentation.143 Gostin suggests that such a conven-tion be established through a process o incrementalregime development.145 The ramework conventionapproach would allow parties to the Convention tosave more complex or contentious issues to be built inlater protocols.146 I international trade negotiationsoer any insight,147 transparency o clinical trials dataand other relevant public health data will be one othese issues. The history o international governance-style clinical trials registration and results reporting

initiatives suggest that measures that impinge onnancial interests o industry are all too easily put onthe back burner and ramed as too complex, so thatimportant actions tend to be delayed. Yet, i access toresearch data is, as I have argued, a key determinanto the right to health, then governments and manu-acturers o health care products will be hard-pressedto justiy any ailure to disclose important saety andeectiveness data. Some o the key modalities o theFCGH would include empirical monitoring (includ-

Knowledge knows no boundaries and neither should its governance. Particularlyin light o the overwhelming political, economic, cultural, and social power o themultinational pharmaceutical industry, there is a need or a global counterbalancing

orce. Notwithstanding the WHOs signicant success in promoting global health,it clearly cannot ensure appropriate knowledge governance at a global levelwithout a stronger mandate. The saga o the international clinical trials

registration and results reporting initiatives are a case in point.


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ing data gathering) and stringent enorcement mech-anisms, which are clearly needed in this context.148

Gostin and colleagues note that key challenges oglobal health include a lack o transparency, account-ability, and enorcement.149 Several o their recom-mendations resonate with suggestions made in this

paper: the need or active citizen participation toensure transparency, collaboration, accountabil-ity and better resource mobilization;150 the need orimproved stakeholder accountability; and the needor education initiatives to ensure that civil societyis well-inormed about right to health obligations inorder to strengthen political accountability. Many othese recommendations could be translated into thecontext o good knowledge governance. But, as Bur-ris and Anderson prudently point out, the successo such an initiative will inevitably depend upon theactions o those who really wield power internation-

ally and within individual nations,151 the pharmaceuti-cal industry certainly being one o them.

ConclusionThis suggestion allows me to conclude on a cautiouslyoptimistic note, invoking again the example o trans-parency o clinical trial data. Many countries, includ-ing Canada, have ailed to implement adequate trans-parency measures through enorceable and stringentregulation.152 Yet, at least some national and regionalregulatory agencies have moved ahead and imple-mented partial registration and results reporting

requirements,

in the U.S. even surrounded by strin-gent sanctions.153 In the past, the U.S. and Europehave in international trade agreement negotiationsoten set up roadblocks against rules promoting pub-lic health. With new measures in place in their juris-dictions, the U.S., Europe, and Brazil could gain moralcredibility and inuence in international negotiationsby putting transparent knowledge production orwardas an essential oundation or a rational implementa-tion o a ramework convention or global health. Par-ticularly interesting discussions and initiatives aretaking place in Europe, where drug regulators haveexplicitly endorsed the need or transparency o data

and are willing to look into more coherent implemen-tation o data transparency.154 In November 2012, theEuropean Medicines Agency started a consultationprocess ocused on transparency, which was at anintroductory meeting explicitly introduced as a con-sultation about how not whether data such asadverse event reports and clinical trials data couldbe made publicly accessible.155 In another interestingmove, the European Union also included in its recentdrat regulation on clinical trials new albeit all tooprudent transparency stipulations.156 With inu-

ential trading partners at least partially on board, itseems more likely that the wider international com-munity will ollow.

Finally, commentators have called or a strongerleadership role or the WHO in directing and coordi-nating international health activities.157 Awaiting the

urther development o an international rameworkconvention, it seems crucial that the WHO take up thetorch and reinvigorate one o the key conditions orthe realization o the right to health: the promotiono global knowledge governance through adequatetransparency measures.158

AcknowledgementsI presented versions o this paper at the ollowing venues andthank the participants in these events or their comments andeedback: the 2012 Global Health and the Law conerence; a 2012University o Toronto Faculty o Law Seminar; a McGill Universityworkshop in July 2012 on Innovations technologiques, incertitudeet droit de la responsabilit; and presentations at the Centre orTransnational Legal Studies, the HeLEX Centre or Health, Lawand Emerging Technologies o the University o Oxord, and theSchools o Law o the Universities o Reading and Edinburgh.Shannon Gibson and Andrew Martin provided excellent researchsupport and made insightul comments and editorial suggestions.Matthew Herder critically reviewed the paper and provided equallysolid eedback. I received unding or my research rom a CanadianSocial Sciences and Humanities Research Council Grant on Pro-moting the Integrity o Biomedical Research: The Janus Face oRegulation and rom a Genome Canada grant on the Social, Legaland Ethical issues o Cancer Initiating Stem Cell Research.

Reerences1. The discussion in this article will primarily ocus on phar-

maceutical products, but it should be recognized that related

arguments can be made in the context o medical devices andin the context o novel therapeutic products (e.g., companionproducts, nanotechnology devices, and biologics). Since I willprimarily invoke examples rom the pharmaceutical context,I will generally only reer to pharmaceuticals or pharma-ceutical products in the text. There are dierences betweenthe pharmaceutical, medical device markets, and other healthproduct markets, but those dierences are beyond the scopeo this paper. The core o what is being argued applies to theother sectors.

2. For brevity, I will use the term knowledge production, orwhere appropriate, pharmaceutical knowledge production,particularly when discussing in more detail the pharmaceuti-cal context.

3. I previously explored this idea in T. Lemmens, Leopards inthe Temple: Restoring Scientic Integrity to the Commercial-ized Research Scene, Journal o Law, Medicine & Ethics 32,no. 4 (2004): 641-657 [hereinater cited as Lemmens, Leop-ards in the Temple].

4. The undamental international nature o research is empha-sized in Science as an Open Enterprise, The Royal Society Sci-ence Policy Centre report 02/12 (London, UK: Royal Society,2012): at 9 and 17-19. See in general also the interesting dis-cussion in the report o the current-day practice o science andthe emphasis on transparency o data. Thanks to Graeme Lau-rie or pointing this out.

5. See J. Kaye, From Single Biobanks to International Net-works: 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: Understandingthe Interplay between Law and Practice (Portland, OR: Hart


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Publishing, 2012). For some examples o biobanks, see UKBiobank, available at ; Generation Scotland, Health Science Scotland,available at ; the Ontario Health Study, avail-able at ; the Canadian Lon-gitudinal Study on Aging, available at ; the Estonian Genome Centre, available at (all last visited February 15, 2013). Thereare also numerous initiatives designed around specic diseases,exposures or populations. See, e.g., Ontario Tumour Bank,available at , Autism GeneticResource Exchange, available at ;and Manchester Cancer Research Centre Biobank, availableat (all last vis-ited February 15, 2013).

6. See, or example, the International Cancer Genome Consor-tium, available at (last visited February15, 2013).

7. See, or example, the unding initiative between GenomeCanada and the Caliornia Stem Cell Initiative which partlyunded research or this paper: Genome Canada, CorporatePlan 200708, available at (lastvisited February 15, 2013).

8. According to a June 2011 report on biobanking, Private sec-tor biobanks will experience the greatest increase with growtho 64%, at a 5-year CAGR [compound annual growth rate] o10.4% and [the private sector biobank market]is expected toreach $69.6 billion by 2015. See Biobanking: Technology andGlobal Markets, BCC Research website, available at (last visited February 15, 2013).

9. Visionagain, Global Clinical Trial Business Report & Analysis2008-2018 (October 7, 2008).

10. See A. Petryna, When Experiments Travel: Clinical Trials andthe Global Search or Human Subjects (Princeton: PrincetonUniversity Press, 2009). An interesting collection o paperscan be ound in A. Petryna, A. Lako, 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. Cali et al., Ethical and Scientic Implications othe Globalization o Clinical Research, New England Journalo Medicine 360, no. 8 (2009): 816-823.

11. In Canada, see or example the Canada Vigilance Programme,Health Canada website, available at (last visited February 15,2013).

12. See the program or adverse event reporting by individu-als: Medefect Canada, Health Canada Website, available at(last visited February 15, 2013).

13. See, or example, the recent initiative by Dr. David Healy:Rxisk Making Medicine Saer For All o Us, RxISK.org,available at (last visitedFebruary 15, 2013).

14. See, in general, A. Matheson, Corporate Science and theHusbandry o Scientic and Medical Knowledge by the Phar-maceutical Industry, BioSocieties 3, no. 4 (2008): 355-382;B. Moatt and C. Elliott, Ghost Marketing: PharmaceuticalCompanies and Ghostwritten Journal Articles, Perspectivesin Biology and Medicine 50, no. 1 (2007): 18-31; or a criti-cal discussion o the regulatory and legal options to deal withthe practice, see S. Stern and T. Lemmens, Legal Remediesor Medical Ghostwriting: Imposing Fraud Liability on GuestAuthors o Ghostwritten Articles, Public Library o ScienceMedicine 8, no. 8 (2011): e1001070 (1-5); and X. Bosch, B.Esandiari, and L. McHenry, Challenging Medical Ghostwrit-

ing in US Courts, Public Library o Science Medicine 9, no. 1(2012): e1001163 (1-4).

15. See S. Sismundo, Ghosts in the Machine: Publication Plan-ning in the Medical Sciences, Social Studies o Science 39, no.2 (2009): 171-198; and S. Sismundo, Ghost-Management:How Much o the Medical Literature Is Shaped behind theScenes by the Pharmaceutical Industry? Public Library oScience Medicine 4, no. 9 (2007): e286 (1429-1433).

16. Examples o such sot governance include: (1) good clinicalpractices, such as the ICH GCP and the World Health Orga-nization, Guidelines or Good Clinical Practice or Trials onPharmaceutical Products, WHO Technical Report Series, No.850, Annex 3 (1995); (2) research ethics guidelines such asWorld Medical Association, Declaration o Helsinki EthicalPrinciples or Medical Research Involving Human Subjects (1964); (3) standards o peer review and authorship establishedby international organizations o biomedical journals such asInternational Committee o Medical Journal Editors, UniormRequirements or Manuscripts Submitted to Biomedical Jour-nals, ICMJE website, available at (last visited February 15, 2013); and (4) governance models ointernational biobank conglomerates, e.g., Public PopulationProject in Genomics, P3G website, available at and E. S. Dove, Y. Joly, and B. M. Knoppers, Power tothe People: A Wiki-Governance Model or Biobanks, GenomeBiology 13, no. 5 (2012): 158. With respect to the most directlyrelevant pharmaceutical governance systems at a global level,see the interesting discussion in A. Spina, The Regulation oPharmaceuticals beyond the State: EU and Global Adminis-trative Systems, in E. Chiti and B.G. Mattarella, eds., GlobalAdministrative Law (Berlin: Springer Verlag, 2011): at 249-268. Spina discusses in detail the ICH/GCP system and thermer regulatory intervention at a transnational level in thecontext o the European pharmaceutical regulations. See inparticular the discussion at 256-258.

17. A good example o this is the use o scientic publicationsbased on data collected in one state, published in another,or indirect publicity purposes in multiple other jurisdictions.Note, however, that there are initiatives by national regula-tory agencies to exercise tighter control o oreign clinical drugsites, to promote the integrity o these data. See, e.g., the U.S.

FDAs establishment o an ofce in India in 2008: (last visited February 14, 2013).

18. This argument has been made with respect to hormonereplacement therapy and antiarrhythmic drugs. See the dis-cussion in T. Lemmens and C. Teler, Access to Inormationand the Right to Health: The Human Rights Case or ClinicalTrials Transparency, American Journal o Law and Medicine38, no. 1 (2011): 63-112 [hereinater cited as Lemmens andTeler].

19. See, in general, D. Evans, Big Pharmas Crime Spree, Bloom-berg Markets, December 2009, available at (last visited February 15, 2013); D. Light, ed., TheRisks o Prescription Drugs (New York: Columbia UniversityPress, 2010); D. Healy, Pharmageddon (Berkeley: Universityo Caliornia Press, 2012); and R. Moynihan and A. Cassels,Selling Sickness: How the Worlds Biggest Phrmaceutical Com-panies Are Turning Us All into Patients (Vancouver: GreystoneBooks, 2005). For accounts zooming also in on specic con-troversies, see T. Young, Death by Prescription (Toronto:Key Porter Books, 2009); A. Bass, Side Efects: A Prosecutor,a Whistleblower, and a Bestselling Antidepressant on Trial(Chappil Hill: Algonquin Books, 2008); T. Nesi, Poison Pills:The Untold Story o the Vioxx Drug Scandal (New York: St.Martins Press, 2008).

20. S. Almashat, C. Preston, T. Waterman, and S. Wole, RapidlyIncreasing Criminal and Civil Monetary Penalties against thePharmaceutical Industry: 1991 to 2010 (December 16, 2010),


17/22


Trudo Lemmens

Public Citizen Website, available at (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 (last visited February 15, 2013).

23. See J. D. Rocko and C. M. Matthews, Pzer Settles FederalBribery Investigation, Wall Street Journal, August 8, 2012,available at (last visited Febru-ary 15, 2013); under the settlement, Pzer did not admit ordeny the allegations, and it pointed out that the allegationsdid not indicate that US management knew about the allegedpractices. The article also reports on other recent settlements.

24. L. Girion, S. Glover, and D. Smith, Drug Deaths Now Out-number Trafc Fatalities in U.S., LA Times, September 17,2011, available at (last visited February15, 2013).

25. Topol estimates myocardial inarction or stroke in 160,000 oevery ten million people taking Vioxx. E. J. Topol, Failing thePublic Health Roecoxib, Merck, and the FDA, New EnglandJournal o Medicine 351, no. 17 (2004): 1707-1709, at 1708;see also D. J. Graham et al., Risk o Acute Myocardial Inarc-tion and Sudden Cardiac Death in Patients Treated with Cyclo-Oxygenase 2 Selective and Non-Selective Non-Steroidal Anti-Inammatory Drugs: Nested Case-Control Study, The Lancet36, no. 9458 (2005): 475-481, at 480.

26. Combined HRT is associated with an increased risk o coro-nary heart disease, breast cancer, and stroke. Millions owomen have been treated with combined HRT around theworld. See A. L. Hersh, M. L. Steanick, and R. S. Staord,National Use o Postmenopausal Hormone Therapy: AnnualTrends and Response to Recent Evidence, JAMA 291, no. 1(2004): 47-53.

27. For detailed discussions o these controversies, see reerencessupra note 19.

28. See P. Doshi, T. Jeerson, and C. Del Mar, The Imperativeto Share Clinical Study Reports: Recommendations rom the

Tamiu Experience, Public Library o Science Medicine 9, no.4 (2012): e1001201, at 1.29. Id.30. Id.31. Id.32. See Lemmens and Teler, 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 o the right to health has in some

jurisdictions distorted more complex questions o equity inhealth care and resource allocations. See G. Backman, P. Hunt,and R. Khosla et al., Health Systems and the Right to Health:An Assessment o 194 Countries, The Lancet 372, no. 9655(2008): 2047-2085.

36. See, or example, Article 12 o the International Covenanton Economic, Social and Cultural Rights (ICESCR), GA Res.2200A (XXI), U.N. GAOR, 21st Sess., Supp. No. 16 at 49, 993U.N.T.S. 3, U.N. Doc. A/6316 (1966) [ICESCR], which denesthe right to health as the right to the highest attainable stan-dard o physical and mental health.

37. See, or example, the overview in E. D. Kinney and B. A. Clark,Provisions or Health and Health Care in the Constitutions othe Countries o the World, Cornell International Law Jour-nal 37, no. 2 (2004): 285-355.

38. See, or example, U.N. Committee on Economic, Social andCultural Rights, Substantive Issues Arising in the Implemen-tation o the International Covenant on Economic, Socialand Cultural Rights: General Comment No. 14 , U.N. Doc.E/C.12/2000/4, August 11, 2000, at para. 33 [hereinater

cited as General Comment 14]: The Committee recognizesthe connection between the right to health and other humanrights such as: the right to ood, housing, work, education,human dignity, lie, privacy, and interestingly or the pur-pose o this discussion access to inormation (at para. 3). Seealso: U.N. Special Rapporteur on the Highest Attainable Standardo Health, Promotion and Protection o Human Rights: HumanRights Questions, Including Alternative Approaches or Improv-

ing the Eective Enjoyment o Human Rights and FundamentalFreedoms, U.N. Doc. A/61/338, September 13, 2006, para. 18.The essential links between the right to health and the right toinormation is clearly also reected in the approach taken by theFramework Convention on Tobacco Control. See the detailed dis-cussion in O.A. Cabrera and L. O. Gostin, Human rights and theFramework Convention on Tobacco Control: Mutually Reinorc-ing Systems International Journal o Law in Context 7, no. 3(2011): 285-303.

39. See A. A. Dhir, Corporate Selective Reporting o Clinical DrugTrial Results as a Violation o the Right to Health, in L. A.Basser, M. Jones, and M. Rioux, eds., Critical Perspectives onHuman Rights and Disability Law (Leiden: Martinus NijhoPublishers, 2011): 341-366, in particular at 356-64; and Lem-mens and Teler, supra note 18.

40. For a general overview o legislative and regulatory initiativesregarding clinical trials registration and results reporting, seeD. Ghersi and T. Pang, From Mexico to Mali: Four Years inthe History o Clinical Trial Registration, Journal o Evidence-Based Medicine 2, no. 1 (2009): 1-7. See also, or an overviewand discussion o international initiatives with a ocus on theAmericas, K. Krlea-Jeri and T. Lemmens et al., ProspectiveRegistration and Results Disclosure o Clinical Trials in theAmericas: A Roadmap toward Transparency, Pan AmericanJournal o Public Health 30, no. 1 (2011): 87-96.

41. The rst case involved the states intererence with two IrishNGOs, Open Door Counselling and Dublin Well Woman Cen-tre, which provided inormation to women about reproduc-tive choices, including the identity and contact inormation oabortion clinics operating in the United Kingdom. The IrishSupreme Court had prohibited the organizations rom pro-viding inormation about the latter. Without ruling about theright to abortion itsel, the ECHR considered the restrictions

on the reedom o ex

pharma knowledge governance

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