Download Overcoming Registration Barriers

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
–
–
–
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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