Transcript Geistigen Eigentums und Entwicklung: Möglichkeiten mit

Patents and Public Health
Dr. Eric Noehrenberg
Director
International Trade and Market Policy, IFPMA
WIPO Open Forum on the draft SPLT,
Geneva, 3 March 2006
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R&D Addressing Global Burden of
Disease
Disease
Health Burden (% of global
deaths/DALYs)
HIV/AIDS 4.9/5.7
Respiratory 6.9/6.3
Infections
Cardiovasc 29.3/9.9
ular disease
Cancer
12.5 / 5.1
Depression 0 / 4.5
Existing treatments
discovered by R&D
pharma industry
All 21 drugs in 4
different classes
All recent and
effective antibiotics
All drugs in 8
different classes
All most effective
drugs in 8 classes
All recent drugs in 4
different classes 2
Number of Compounds in
Development by Selected Major
Disease Categories
22
Sense o rgan diso rders
33
Digestive diseases
Respirato ry diseases
44
Diabetes
50
M usculo skeletal diseases
55
86
HIV/A IDS**
123
Cardio vascular diseases
Infectio us diseases + Respirato ry infectio ns*
185
Neuro psychiatric diseases
271
Cancers
395
0
100
200
300
400
500
* Excluding HIV/A IDS; including 61vaccines
** Including 15 vaccines
Source: PhRMA, Medicines in Development Surveys 2003/2004
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Are We Getting Innovation?
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R&D Industry addressing
Developing Country Health Needs

90% of innovative drugs on the WHO
Model Essential Medicines List were
developed by the R&D-based
pharmaceutical industry
 Best current treatments for truly “neglected
diseases” come from R&D-based industry:
– Sleeping sickness – Sanofi Aventis
– River blindness – Merck
– Leishmaniasis – Merck + GSK
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Patents NOT blocking access to
essential medicines in poor countries

Over 95% of drugs on WHO Essential
Medicines List off-patent worldwide; 99%
in poorest countries
 Patented drugs on EML are being offered by
patent-holders to poor countries at cost,
below cost or even for free
– Antiretrovirals via AAI, reaching over 455’000
people in developing countries worldwide
– Coartem® from Novartis in partnership with
WHO
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Export CL TRIPS Amendment

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If country sees patents as a barrier and cannot
produce domestically via CL, then they can go to
foreign suppliers to get alternative supplies via
export CL
Waiver of TRIPS Art. 31(f) and (h)
Solution ensures transparency and non-diversion
Humanitarian purposes, non-commercial, nonindustrial policy use
Non-bureaucratic procedure, simple notifications
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Who are the authors of the
solution?

South Africa
 Kenya
 India
 Brazil
 USA
 Chaired by Singapore
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“Flexibilities” are not public
health solutions
 International
exhaustion =>
« parallel trade »
 Compulsory
licensing
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Parallel Trade

Parallel trade is bad for poor countries – their
supplies disappear!
– Parallel trade moves products from low-price markets
to higher-priced markets
– Parallel trade will interrupt stable supply chain in
importing and exporting countries
– Parallel trade will harm ability of companies to
distribute differentially priced drugs


Price differences may be short lived; parallel trade
not reliable over long term
Parallel trade can contribute to trade in substandard
and counterfeit drugs – African regulators at WHO
Conference in Rome two weeks ago
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Realities in Zimbabwe after
Compulsory Licensing

Compulsory licenses in 2002
 Prices are high = US$1638 per year, about
equal to annual salary
 Access is poor, with fewer than 20'000 Zim
residents out of an estimated 1.8 million
living with HIV getting ARVs
 What is the quality of the drugs available?
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Realities in Zambia and
Mozambique after CL

Zambia : No patents on the drugs
 Mozambique : No patents from MNCs;
CIPLA’s TRIOMUNE patent affected
Access to quality medicines was NOT
improved due to CL
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“Flexibilities” are INDUSTRIAL
policy, not “health policy”

Beneficiaries are copy companies, not
consumers
 Foreign manufacturers benefit more than
local manufacturers
 Policy choice is: do you prefer to promote
an innovative, value-added market model,
or an old-fashioned copying model?
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Effective use of IPR incentives
improves public health through
innovation

90% of innovative drugs on WHO EML
originated from MNCs using incentives of
patent system, including for “tropical
diseases”
 PPPs such as Medicines for Malaria Venture
address areas where partnerships can best
address health research needs
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IPRs create therapeutic
competition
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In 1987, one antiretroviral
Thanks to patents, innovators had to find new
ways of attacking HIV
Now, over 20 ARVs on the market and over 80
compounds in development
Through AAI – over 455’000 patients getting topquality, triple-ARV therapy
“Drug portfolio” important in all areas of health –
not everyone responds the same way to the same
drug!
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Second Use and Adaptive
Innovation bring health benefits

Study shows that circa 25% of drugs on
EML are indicated for uses other than the
original indication
 The large majority of drugs on EML are not
the first drugs in their class on the market
 Most drugs on EML are modified
formulations of original products
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Adaptive innovation is patentable

Indian generic drug manufacturers have 84 patents
pending in Brazil on new salts, esters, polymorphs
and similar "incremental innovation” on existing
pharmaceutical products – ironically, they cannot get
the same protection in India itself;
 Indeed, patentability of adaptive innovation is limited
in India, removing incentives for needed innovations
(heat-stable insulin, for example)
 Thousands of patents applied for in China based on
traditional Chinese medicine
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Cases of adaptive innovation
bringing public health benefits
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Zithromax SR – improving an existing antibiotic into a
single-dose form, now used to treat trachoma
effectively
Neurontin – new production process brought effective
epilepsy drug to broader populations
Procardia XL – new administration technology for
existing drug more than tripled population which could
benefit from therapy to treat agina
Agenerase – new formulation brought new protease
inhibitor in fight against AIDS
Effexor – slow-release formulation improved use of
antidepressant
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Conclusions
Debate over “flexibilities” in international agreements
is an industrial policy debate, not a health policy debate
 IPRs spur innovation which promotes public health
 Protection of adaptive innovation and “second use”
brings public health benefits, including for developing
countries
 IPR definitions should be harmonized via WIPO to
recognize all innovation, including adaptive innovation

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