Accountability of the pharmaceutical industryTo whom does the pharmaceutical industry owe a duty?Priorities in researchDrug pricesDrug information and promotionThe need for a balanceProblems with surveillanceGovernments and intergovernmental organisationsApproaches for today, and tomorrowReferencesFor personal use. Only reproduce with permission from The Lancet Publishing Group.1682 THE LANCET • Vol 360 • November 23, 2002 • www.thelancet.comMEDICINES, SOCIETY, AND INDUSTRY IVPrevious articles in this series have considered the broadrole that the pharmaceutical industry has in society. Thisindustry is not merely a provider of drugs, but is now asubstantial purveyor of information and persuasion. Thecost of the drugs it supplies (and indirectly the cost of itsancillary activities) weighs greatly on public and privatepurses. In some countries, pharmaceutical companies aremajor employers, innovators, science financiers,taxpayers, and earners of foreign exchange. In theserespects, the commercial interests of a pharmaceuticalcompany could run parallel to those of the community atlarge. Yet, these interests on occasion diverge, and whenthey do a solution has to be found. To whom does the pharmaceutical industryowe a duty?Accountability of one party to another is not mainly amatter of statute law, though law and regulation canreflect and formalise the relationship. More usually,accountability arises because a particular party hasvoluntarily taken upon itself—or agreed to do—certainduties, or has simply undertaken these duties over a longperiod, so that others have come to rely on them. Two definitions of industry accountability pre-dominate: commercial duty to shareholders; and duty tothe community. In the commercial sense, a pharmaceutical company isobliged to deliver a sound return on investment forshareholders. That return must be adequate to rewardinvestors but also be sufficient to attract new capital whenneeded. From this point of view, the pharmaceuticalindustry has done very well. Throughout periods ofeconomic stagnation and even recession over the past 30 years, it has remained highly and increasinglyprofitable. Mergers have hardly ever taken place because offailing companies; the strong have simply linked up withthe even stronger (see article by Henry and Lexchin,published in The Lancet on Nov 16, p 1590). From the broad social point of view, the pharmaceuticalindustry has a duty to supply communities with good drugsat an affordable price, and to provide reliable informationLancet 2002; 360: 1682–84Institute of Pharmacotherapy, University of Oslo, Trosterudveien 19,0778 Oslo, Norway (M N G Dukes MD)(e-mail: [email protected])on them. Accountability of a corporation is argued to befounded in human rights principles.1,2In a narrowerinterpretation, the industry has legal duties to agencies,such as drug regulatory bodies established by government,to ensure that the public interest is served (see article byCollier and Iheanacho, published in The Lancet on Nov 2,p 1405). In this respect, the pharmaceutical industry is,despite all its achievements, presently under fire. Qualityhas been maintained and the innovative process has mostcertainly continued, but critical questions have beenraised, notably about priorities set in research, the level ofdrug prices, and the manner in which information isprovided.Priorities in research Publicly funded programmes are underway to developdrugs for disorders that affect the world’s poorest people.These programmes show the extent to which industrialscience has neglected this unprofitable area, insteadcompanies have developed drugs for affluent societies thatcan pay for them.3–7It is hard to see that the worldwidepharmaceutical industry—if is to be judged accountable tosociety—can be said to be discharging its duties adequatelyas long as it continues to neglect the desperate needs of theworld’s poorest populations. Drug pricesDrug pricing has become a contested issue in poor andaffluent countries. In developed countries, a new drug isgenerally sold at the ex-factory price, which is 30 times ormore of basic manufacturing cost. However, cost of drugshas become one of the substantial elements in costing ofpublic health care,8to the point at which it is increasinglydifficult to sustain adequate services.9However, the issue is of much greater importance in thedeveloping world, where lifesaving products are, as a rule,financially out of reach of most people who need them.The solution to this problem is less likely to lie indonations, most of which have little overall effect and dono lasting good10(see article by Henry and Lexchin,published in The Lancet on Nov 16, p 1590), than in ageneral readjustment of the manner in which drugs arepriced and sold across the world. Major corporations thatnegotiate with international agencies for bulk contracts inthe developing world have found it possible to reduce theirprices to 5% or less of those maintained elsewhere, whichhas been shown with vaccines11and oral contraceptives,12Accountability of the pharmaceutical industryM N Graham Dukes The pharmaceutical industry is accountable on the one hand to its shareholders and on the other to the community atlarge. These two obligations can, in principle, be met. However, the industry has developed practices that do notconsider society, including excessive or inappropriate pricing of drugs, an indifference to the needs and limitations ofthe developing world, an imbalance between true innovation and promotional activity, interference with clinicalinvestigations, and efforts to mould medical thinking and priorities as a means to enlarge the market. In suchrespects, the pharmaceutical industry must now be called to order. The industry has shown itself to be sufficientlyresilient to adapt to change if society insists on it. However, to influence multinational corporations effectively, theefforts of governments will have to be complemented by others, notably the many voluntary organisations that haveshown they can effectively represent society’s public-health interests. Medicines, society, and industry