Prof. Ralf Boscheck |
International
intellectual property regulations are doing serious damage to the
pharmaceutical industry and, by extension, to the health of people around the
world.
The core of
the problem: growing global concern about how to ensure affordable access to
medicine without damaging the initiatives that sustain pharmaceutical research.
Attempts to address the issues have resulted in significant disagreement
between developed and emerging economies about just how much protection should
be available to companies that develop new drugs.
Members of
the World Intellectual Property Organisation, which celebrated its 40th
anniversary this year, are trying to resolve their differences on how – and
even whether – emerging market countries should move to a framework that offers
greater intellectual property (IP) protection, but the results to date are not
promising.
'Access to medicine' advocates propose measures based on national income levels; branded
drug producers want a time-based transition schedule; others argue that patent
protection should be linked with the UN’s Human Development Index, which is a
relative scale with frequently-changing outcomes and policy incomes.
The case
for strong patent protection
Developed
countries, particularly the United States, usually try to commit emerging
economies to more stringent intellectual property right rules in exchange for
bilateral concessions in other areas of trade. These arrangements typically
involve an extension of patent terms and data exclusivity as well as limits to
parallel trade and accelerated marketing approval for generic producers.
Strengthening
intellectual property rights, they argue, incentivises research on diseases
that are specific to developing countries and promotes technology transfer
through the localisation of R&D and production investments. This then
contributes to improving typically inadequate health service infrastructures.
...
The
'evergreening' debate
'Evergreening'
is a series of techniques used by pharmaceutical firms to continue protecting
their drugs after the initial patent expires in order to maximise their return
on R&D investments. That is, they prevent or limit the manufacture of
generic drugs for longer.
The
specific approaches used are numerous, but include
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The 'evergreening' debate
- continued differentiation of branding, dosing, formulation or mode of action;
- patenting active compounds or co-specialised delivery systems; and
- seeking to expand a compound’s market through approvals for new indications.
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The 'evergreening' debate
Critics of
evergreening strategies argue that this means that patients miss out on the
benefits of cheaper generic drugs. However, they also usually neglect the
existence of regulatory and market responses that limit the risk of abusive
patenting.
For
instance, patentability typically requires an invention to be novel,
non-obvious and useful in the sense of capable of industrial application. The
coloring and scoring of a drug may appear on the surface to be purely
aesthetic, but if it can be shown to improve patient compliance, and therefore
efficacy, that is novel and not obvious, and must therefore be patentable. In
short, properly designed and implemented patent systems already deal with some
of the often claimed evergreening concerns.
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Evergreening of patents in pharma field / Novartis en India...
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Conclusion
Escalating
healthcare expenditures and the need to ensure access to affordable medicine in
both emerging and emerged economies are fuelling calls for containing
evergreening practices around the world. But such practices are the necessary
outcome of a system that responds to market incentives and is already
sufficiently controlled by established patentability standards and policies to
determine patent term extension. Even reverse payment arrangements may
ultimately deliver consumer net benefits. They present a challenge for
efficient rule writing and a reminder of the need for better and coordinated
policy analysis.(Más)
Ver:
Access to medicines.
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Access to medicines.
(*) Ralf
Boscheck is the Lundin Family professor of economics and business policy at IMD
and director of IMD’s MBA program. With more than 20 years of teaching,
Boscheck believes in using intensive and direct interaction to develop
technical competencies, self-awareness and moral judgment.