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Overcoming Registration Barriers and Registering Bio-Generics Prof. Brook K. Baker ([email protected]) Northeastern U. School of Law Program on Human Rights and the Global Economy; Health GAP (www.healthgap.org) OSI Kiev – IPRs & A2M, Sept. 17, 2009 Part I: Multiple Registrations and Related Problems • The global/national architecture for registering medicines is extraordinarily complex and fraught with inefficiencies, duplications, delays, and in some instances corruption. • Registration-related problems arise because of mismatches in economic incentives for both innovator and generic producers, and because of regulatory inefficieny and unaccountability at the national and international level. Problem: No Int’l Registration Process • No int’l registration, only national • Calls for regulatory harmonization/ cooperation: plus & minuses • WHO Pre-Qualification Programme – – – – Stringent regulatory standards Site inspections Transparency But for selected products only: AIDS, TB, malaria, reproductive medicines • New WHO/Global Fund Expert Review Panel reviews risks/benefits of medicines not yet WHO –prequalified or authorized by a stringent regulatory authority Problem: Lack of Transparency • Lack of a global, up-to-date, accessible registry on registration status of HIV/AIDS and other important medicines. • Lack of information on status of pending registration applications Problem: Innovators Pick and Choose • Lack of incentive mechanisms or regulatory systems that compel innovator companies to promptly register their medicines for use in smaller and poorer countries with resulting excessive delay in access to newer medicines • Numerous important AIDS medicines are still not registered in many developing countries, including atazanavir, tenofovir, emtricitabine, lopinavir, ritonavir, and Atripla. Problem: Generic Disincentives • Lack of sufficient incentive mechanisms, technical assistance, or other measures to encourage generic companies to promptly register their therapeutic equivalents for use in smaller and poorer countries Problem: Regulatory Incapacity • Only one-sixth of WHO Member States, have well-developed drug regulatory systems that can assess a new pharmaceutical product. • Another fifty-percent have varying degrees of regulatory capacity. • One-third (many in Africa) have no or only very limited capacity. Additional Regulatory Problems • Inefficiency, high costs, regulatory variations, and occasional corruption in national drug regulatory authorities that create delays and disincentives to both innovators and producers of generic equivalents Problem: No Temporary, Emergency Registration • Absence of efficient, special authorization procedures that allow emergency access to important medicines while the formal registration process is being completed Problem: Poor Pharmacovigilence • Lack of post-approval quality assurance mechanisms throughout the supply chain • Lack of efficient supervision of the marketing of medicine to prevent the use of fake and substandard medicines Fast-Track & Emergency Registration • Some countries have adopted “fast-track” procedures for the registration of priority medicines after pressure both from producers and consumers who want expedited or special availability of medicines, i.e. for incurable conditions. • Priority can be established by moving applications to the front of the line, by devoting more human resources, or by applying simplified standards. • There are also “emergency” procedures allowing distribution pending final registration based on a preliminary showing of safety/efficacy/quality. Possible Solutions • Incentive/regulatory measures to promote registration by innovators and generics • Increased donor investments, technical assistance, capacity-building Possible Solutions • Regional harmonization/cooperation/ registration • Adoption of reliance/reference registration based on WHO prequalification or registration by a stringent regulatory authority (US, EU, SA, and others) Possible Solutions • Special temporary registration pending final approval for emergency/priority medicines (i.e., reliance on WHO ERP) • Increased investment/prioritization re pharmacovigilence (checking quality throughout distribution system; laboratories/personnel) Part II: Registering Bio-Generics • Medicines made with biotechnological processes are not as duplicable as smallchemical pharmaceuticals. • Biotech drugs are typically larger compounds, take many more steps to produce, and as a result are more costly. • Historically, there have been no processes for registering bio-generics or bio-similars because they were not “identical.” Europe Moves First • In order to introduce competition for bio-tech medicines, Europe adopted regulatory procedures for assessing biosimilar products (bio-generics). • There are requirements of partial clinical trials to prove therapeutic equivalence. • Normal data exclusivity rules apply. U.S. is proposing excessive data exclusivity • U.S. is also considering a procedure for registering bio-generics, but it has proposed 12 or more years of data exclusivity. • This 12 years of data exclusivity would be granted not just for new biotech medicines but for minor changes to the biotech product, permitting evergreening. • Normal data exclusivity extensions is much less for minor innovations (3 years in the U.S. and only 1 year in the E.U.) Evergreening • Modified products eligible for such repeat monopolies include: • Combination products (putting together two or more products previously available separately); • Changes in dosage (such as creating a once-a-day pill where the original product was a thrice-a-day product); • Changes in delivery mechanism or dosage form (such as a pill or inhalant to replace a shot); and • Changes to enable the body to absorb a product better. Conclusion • An unpatented generic medicine is not accessible if it is not registered • A cheap medicine of assured quality is not available if it is not registered • Generic biologics will not be available unless there is a regulatory pathway and unless excessive data exclusivity is avoided • Registration-related issues need urgent attention