Combining health and social protection measures to reach the ultra ...

Research resourcesthis process in a way that is usually well beyond the smallerpartner’s resources.Likewise, these smaller groups – as well as manymultinational companies who have limited experience inneglected disease or developing country public healthmarkets – can benefit greatly from PPP input of neglecteddisease and public health knowledge, ranging from provisionof partners or contractors with parasite testing facilities(unlikely to be found in most private firms), to location ofsuitable developing country clinical trial sites or assistancewith senior contacts in developing country public healthprogrammes.PPP’s flexible modular approach to drug development isopening up alternative R&D avenuesAs noted above, under the classical model, PPPs providefunds (and sometimes skills) while the compounds beingdeveloped come from drug companies, and often largemultinational companies. Under this model, PPPs (or,indeed, any public group or government) have no control overthe original intellectual property (the background IP) andtherefore very little control over what is or is not developed,how quickly it is developed and at what price it is madeavailable to developing country patients. In practice, this isless a problem than perceived, since most companies agreeto contractual obligations on delivery, price etc. In otherwords, the PPP can exercise control through contracts ratherthan through intellectual property (IP) ownership per se.However, this model represents just under half of all PPPdeals. The remaining half are more interesting, since theydemonstrate quite different ways of developing drugs forpublic health use. In many of these cases, it is the PPP whohas control over IP issues relating to the compound, forexample, because the compound being developed is alreadyin the public domain (so no one has background IP rights),because it has been licensed to the PPP by an academic or acompany (so the PPP has the rights it needs for its mission),or because the PPP owns the relevant background IP (so thePPP owns all the rights). However, it is not the IP ownershipitself that is central, but the fact that this ownership conferson the PPP the full responsibility for developing the product,thus giving them far greater choice in how the product isdeveloped, by whom and how quickly, and how it will bepriced, produced, registered and distributed to developingcountry patients.One major outcome of this flexibility is that it allows PPPsto develop new drugs from leads that fall outside the normalcommercial model i.e. the PPP does not have to rely solely oncompanies for access to and development of in-housecompounds. For example, the PPP can develop:✜ Public domain IP, i.e. drugs or compounds whose patentrights have expired. For example, paromomycin is beingdeveloped for use against Indian and African visceralleishmaniasis strains by iOWH and DNDi respectively.The interesting point is that, unlike commercial groups,PPPs do not need orphan drug monopoly provisions inWestern markets (and the profits these promise) as apre-requisite to developing these public-domain drugssince the PPP is seeking a health return, not a financialreturn, on their R&D investment.✜ Shelved company compounds. For instance, the anti-TBdrug, PA-824, was shelved by Chiron (who inherited thepatent family from a smaller firm, PathoGenesis).However, Chiron were willing to license the compound tothe TB Alliance for further development in return for avery modest fee and an option to buy-back the Westernrights on any final product that the PPP developed. Bytaking the risk and cost out of developing shelvedcompany compounds, PPPs can make it more attractivefor companies to hand over unwanted compounds thanto sit on them.✜ Academic leads without commercial potential e.g.compounds such as synthetic peroxide for malaria,which could have a dramatic impact on malariatreatment but has limited potential for Western sales andtherefore little likelihood of attracting industrydevelopment partners. PPPs offer a new route foracademics to see their promising drug leads developed,i.e. PPPs offer a pathway for non-commercial leads to bedeveloped, in addition to the traditional industry pathwayfor commercial leads. This option has not previouslyexisted.It is worth a closer examination of how PPPs are able todevelop these leads from different sectors. In practice, PPPsuse a variety of approaches, some of which deviate markedlyfrom the Public-Private Partnership approach described underthe classical model:✜ On some projects, they choose to work with no partner,by simply subcontracting out R&D to multiple industryand academic/public groups but retaining overall controlthemselves. (That is, there are no “partnerships”.)✜ On others, they develop the compound themselves in theearlier stages using academic or industry subcontractors,but bring in an industry partner (in some cases adeveloping country firm) at a later stage, for example toassist with large-scale manufacture and distribution.(This is a mixed model, with industry partnering only atcertain stages and if needed.)✜ Others forgo industry input altogether, with R&D beingconducted solely by public partners and publicsubcontractors. This happens particularly with early-stageprojects (although industry input would be expectedfurther down the development line), but sometimes alsowith late-stage registration projects, e.g. DNDi’sregistration of paromomycin for African leishmaniasis.(This approach has no “private” input to the R&D.)In each of these cases, PPPs develop the product usingindustry’s modular approach, where the relevant IP is derivedfrom external sources, and development work is shared bythe PPP on a paid or unpaid basis with a range of “partners”with different skills, some or all of whom may have no role injoint decision-making and no stake in the final product.The modular PPP approach has two importantimplications. The first is that it allows PPPs to developGlobal Forum Update on Research for Health Volume 4 ✜ 143