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Access to healthWhile there are some exceptions to this publicationrequirement, the patent system itself aims at promotingpublicity. Thus, information about development strategies andpotential new use strategies for existing drugs can be gleanedfrom the information contained in patent applications bycompetitors long before trial registration.Competitive advantage considerationsOther threats to market exclusivity and loss of competitiveadvantage have been invoked to justify delayed disclosure ofcertain clinical trial information in public registries. During theWHO consultation process, industry organizations providedexamples of situations in which, it alleged, clear commercialinterests are attached to delayed disclosure 37 . In thosesituations, registry fields would be considered “highlyproprietary”. This would be the case, for example, when acompany is testing a new method of delivery for a patentedproduct, and where competitors may learn about these efforts,speeding up the development of a new delivery of their owncompetitive product. Delayed disclosure would protect acompany’s interest in establishing a strong market positionthrough being the first entrant on the market. Another scenariowould be that a company is developing a product, new use, orline extension of an existing product, which it does not expectto be patentable. It may be inclined to test this productsecretly, again to keep a potential head-start over competitors.Another scenario pertains to orphan drugs. Under certainsystems of orphan market exclusivity, an inventor who hasdeveloped a product for a rare disorder can obtain marketexclusivity, keeping competitors off the market for a givenperiod. A competitor can break orphan market exclusivity,however, if it comes up with a product that is shown to besuperior to the product that obtained exclusivity. Under thisscenario, an innovator has a financial interest in staying aheadof competitors who could be inclined to attempt thedevelopment of a superior product in the same class.A number of arguments can be invoked to challenge theclaim that these scenarios justify delayed disclosure. First, it isworth pointing out that competitive intelligence currentlyalready provides information about a competitor’s strategicdevelopments. Pharmaceutical sponsors aggressively gathercompetitive intelligence on their own, and use due diligencedone by patient advocacy groups and individual patientsseeking trials involving potentially life-saving therapies.Intelligence may have become easier to accumulate becauseof the close links between several patient advocacy groups andindustry 38 . Second, when research subjects are recruited inclinical trials, there is an ethical and legal obligation to obtaininformed consent, which requires that patients receivemeaningful and thus reasonably detailed information aboutthe study. Gathering clinical trial information through researchsubjects rather than through a registry may be more timeconsuming, but is not impossible for a resource-rich industry.Third, even if access to registry data may affect in oneparticular trial a competitive advantage of one company overanother, the former may benefit in other circumstances of thefull disclosure regime. Over time, a level playing field shouldbe established as competition will simply start at an earlierstage. Fourth, the general claim that it will undermine acompany’s interest in refining and innovating its productsremains very speculative. Speculation about potential harm toeconomic interests is a poor basis for public policies that aimat protecting an important public interest. In the orphan drugcontext, even more so than in the other scenarios, publicinterest seems to be hampered by anything less than fulldisclosure. In fact, healthy and beneficial market competitionwill be stimulated by the registration of all trial components. Somuch the better if a competing innovator wants to invest in thedevelopment of a superior product. This competitor will stillcarry the risk that its attempts to develop a superior productwill fail. Moreover, as argued under the previous scenario,disclosure of basic aspects of clinical trials is most likely tohave occurred already anyway.The risk of loss of competitive advantage and thespeculative nature of the impact on innovative drugdevelopment strategies must be weighed against theimportance of public access to important clinical trial data.While the development of new therapeutic agents is bothdesirable and valuable, it seems hard to defend the claim thatit is more important to avoid the undefined and seeminglylimited risks that full registration may create for thedevelopment of these agents than to promote transparencyand sharing of information. More importantly, providingadequate information about clinical trials to research subjectsis an unavoidable ethical and legal obligation. Registeringbasic clinical trial information constitutes only one additionalstep and ought to be seen as a general moral obligationtowards the public and towards the goal of transparent andresponsible research, whose integrity and reputation isincreasingly challenged. It is worth pointing out here also thatthe TRIPS (Trade-Related Aspects of Intellectual PropertyRights) Agreement explicitly allows states to disclosecommercially sensitive information of pharmaceuticalcompanies because of public health interests 39 . Thisconstitutes an international recognition of the fact that publichealth interests trump trade-related interests.These arguments support the position of WHO clinical trialsplatform, that full disclosure of all minimal data at the time ofregistration is essential. But while full disclosure of theminimum data-set is an important first step in the promotionof the integrity and transparency of clinical research, it isnot a panacea.Limits of trial registrationOne of the most significant limits of WHO clinical trialsproposal is its lack of direct enforceability: the WHO has nojurisdiction to directly sanction or to directly enforceregistration through other means. This scenario is analogousto other international quasi-law vehicles such as the UnitedNations (UN), World Trade Organization (WTO) or WorldIntellectual Property Organization (WIPO), which depend onso-called “soft law” compliance measures to ensurecompliance by member states. The experience with the USClinicalTrials.gov database indicates what can happen if thereis no concrete penalty attached to registration. While the 1997US FDA Modernization Act 40 requires trials for all life-042 ✜ Global Forum Update on Research for Health Volume 4
Access to healththreatening and serious conditions to be registered on theClinicalTrials.gov databank, detailed analyses indicate that asignificant number of industry-sponsors do not comply withthe requirement 41 .To support WHO’s initiative, funding agencies, academiccentres, philanthropic organizations, and supportive industrialsponsors ought to develop strict compliance mechanisms.Registration should be imposed as a requirement for researchethics approval. Patient advocacy groups could attachregistration as a condition to support and advertise clinicaltrials. The best approach would be for domestic governmentswith control over existing primary registries to endow relevantgoverning bodies with the necessary legal jurisdiction to enforcecompliance through sanctions. Given industry’s concern aboutcompetitive advantage, it seems particularly important toassure pharmaceutical companies that there is a level playingfield, by ensuring compliance with registration requirements.Domestic regulations and state control can do that.Even though the WHO minimal data set extends wellbeyond information required to be registered in several otherregistries, some have criticized the WHO initiative for providinginsufficient information. The Ottawa Statement, for example,proposes that registration data further include information onthe full protocol and consent forms, details of ethics committeeapproval and other trial design information 42 .Registration of the WHO data set will indeed not resolve allproblems associated with manipulation of trial results 43 . It isunclear how the accuracy of registration data that are not peerreviewedas well as the scientific validity of statistical analysesand interpretations could be validated using information fromexisting registries or resources. The registration system doesnot alleviate concerns associated with the fact that sponsorswith vested commercial interests still control how research isdesigned, how subjects are recruited, how data are collected,and how results are presented 44 . The data set does not provideregistry staff or researchers with access to protocols or rawdata, which significantly hampers independent scientificreview of database entries. Without the ability toindependently review and validate entries, selective reportingof trial results may still occur. Finally, the basic principles ofevidence-based medicine require review of study design andquality in addition to other relevant scientific data prior todrawing conclusions from a single study 45 .Finally, WHO’s clinical trials registration system does notimpose results reporting. It allows the public, researchers, andgovernmental agencies to know that research is or has beenundertaken, which allows for further scrutiny and questionswhen publications come out. But it does not provide themwith direct access to final outcomes. Several influentialorganizations have called for public disclosure of results in amanner analogous to clinical trial registration, including theUS Institute of Medicine, ICMJE, and researchers 46 . As notedby the ICMJE in their most recent discussion statement onmandatory registration 47 , the climate for results registration willlikely change dramatically and unpredictably over comingyears but is sure to go ahead in some form.WHO has recognized that this is a next important step in thepromotion of research integrity. It has set up a Study Group onthe Reporting of Findings of Clinical Trials, which is looking atthe development of criteria and standards of disclosure ofresults 48 . This new initiative will constitute another importantstep towards more reliable and trustworthy clinical research.Result reporting will only have success, however, if a coherent,comprehensive, and mandatory registration system is in place.It seems therefore crucial that national governments,professional organizations, industry, and researchers committo such a registration system and fully support WHO in itsefforts. ❏Trudo Lemmens is an associate professor at the Faculties of Lawand Medicine of the University of Toronto. His research currentlyfocuses on how law and regulation contribute to the promotion ofethical standards in the context of medical research andbiotechnological innovations. Recent publications include the coeditedvolume Law and Ethics in Biomedical Research: Regulation,Conflict of Interest, and Liability and the co-authored book Readingthe future? Legal and Ethical Challenges of Predictive GeneticTesting. In the last four years, Trudo Lemmens has been a memberof the Institute for Advanced Studies in Princeton, a visitingprofessor at the KU Leuven and the University of Otago, and aFellow of the Royal Flemish Academy of Belgium for Science andthe Arts. Since 2006, he has been a member of the PAHO AdvisoryCommittee on Health Research.Ron A Bouchard is a doctoral candidate in law and runs his ownconsulting firm. His career has focused on the science, law andpolicy of pharmaceuticals and biotechnology as well as strategicplanning for commercialization of innovative technologies. Hebegan his career as a scientist, obtaining a doctorate and workingin the field of membrane electrophysiology. He shifted focus to law,and has been involved in the prosecution, acquisition, financing,distribution, and litigation of intellectual property rights relating topharmaceuticals and biotechnology. He has appeared before theFederal Court of Canada on trial and appeal matters and theSupreme Court of Canada. He currently conducts research on drugregulation and innovation from the perspective of systems dynamicsand complex adaptive systems.AcknowledgementsResearch for this chapter was funded by Genome Canada throughthe Ontario Genomics Institute, by Génome Québec, the Ministère duDéveloppement Économique et Régional et de la Recherche duQuébec and the Ontario Cancer Research Network, as part of theARCTIC project. Ron Bouchard also received support from the CIHRHealth Law & Policy Program and the Lupina FoundationComparative Program in Health and Society at the Munk Centre forInternational Studies. The authors thank Michelle Jackson for work onthe references.Global Forum Update on Research for Health Volume 4 ✜ 043
Page 3 and 4: Editorial Advisory Board:Luis Gabri
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Page 7 and 8: IntroductionResearch contributions
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