Transcript Intellectual Property Rights, Investment and Transfer of Technology in the Pharmaceutical Sector Patrizia Carlevaro Head of the International Aid Unit Syria, Damascus April 25 and 26,

Intellectual Property Rights,
Investment and Transfer of
Technology in the Pharmaceutical
Sector
Patrizia Carlevaro
Head of the International Aid Unit
Syria, Damascus April 25 and 26, 2005
Innovation for Better Health
The discovery of new drugs is the only way to address the
challenges of current and emerging diseases
It becomes more and more costly to discover and develop
new drugs (average 1 Billion USD) and, for the inventor, to
recoup its costs
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Innovation for Better Health
IP rights encourage discovery, recognize innovation as
being essential for the industry development and bring
improvement to public health
More than 95% of the WHO Essential Drugs ED List is off
patent
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Innovation for Better Health
Before the creation of the IPRs System, the knowledge
was not widely disseminated and societies could not benefit
from this disclosed information
The IPRs allow science to progress and people to benefit
from new discoveries
10,000 products have to be tested to eventually come up
to the discovery of one
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Innovation for Better Health
Within the same therapeutical class a considerable
competition exists in terms of quality, efficacy and price
Thanks to IPRs, the generic industry can have full access
to data related to invention and discovery
Most of the drugs used worldwide are developed and
marketed by the private industry
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Affordable Prices
 Access to healthcare services is not exclusively a drug
price issue
 Although a large number of generic drugs are available at
very competitive prices, they are not present in certain
markets and when they are, they have not been able to
change or improve the population’s health profile
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A Good IP System
 Adequate standards of protection
 System for applying the standards
 Limited exceptions
 A brief and effective transition period
The TRIPS agreement is the result of delicate
and careful negotiations, humanity needs it in
order to continue to progress
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A Good Data Exclusivity System

Is a key starting point for creating a core competency in life sciences,
pharmaceuticals, biotechnology

Aims to encourage development of all data (Phase I, II, III) necessary to
establish that a drug is both safe and efficacious for human consumption, and
to fully compensate the originator for its efforts

Provides incentives outside of traditional forms of IPR for companies to invest
in research and clinical development of drugs, drug combinations and uses

Spurs the development and testing of new active ingredients – particularly
when patents are not available
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Time Costs
5.5
6.3
5.1
5.9
6.1
1980's
1990's
0
1.8
2.1
10
5
2.8
1970's
Reference: DiMasi, J.R., New Drug Development
In the USA (1963-1999), Clinical Pharmacology &
Therapeutics 2001. May, 69(s).
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2.4
2.5
3.2
1960's
Development Time (Years)
Time to Bring an Innovative Drug to Market has
Increased Significantly
Pre-Clinical Phase
4.4
Clinical Phase
Approval Phase
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Development Costs
Companies are challenged to reduce costs and
increase productivity and efficiencies
Without IPR, a company is unlikely to invest in
product launch
 Physician education programs
 Clinical research efforts
 Public awareness efforts
 Corporate Philanthropy
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Potential Partnerships with the
Pharmaceutical Industry
 As much with the Public sector and as the Private sector
 Important to better serve the local markets and create a
long-term goal
 Contribute with the Transfer of Technology and its
competencies
 Contribute to the economical and social development
 Bring additional resources to populations most in need
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Factors Pharmaceutical Companies
Consider Prior to Investing
Country politically and economically stable
Barriers to entry (e.g. currency restrictions, slow regulatory
approvals)
Size of local pharmaceutical market and growth’s potential
Intellectual property protection and enforcement measures
 Patents for pharmaceutical (compound protection)
 Trademark and copyright laws
 Data for registration protected from disclosure
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Factors Pharmaceutical Companies
Consider Prior to Investing
WTO Member or in process of joining
Current Good Manufacturing Practices (cGMPs) available
Multinational companies treated same as local companies
Potential to export from country (free trade agreements)
Transparent regulatory/pricing and tender processes
Tax - other incentives to invest
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Investment Types / Cooperation

Develop research projects with local institutions both public & private

Build manufacturing facilities alone or with local partner

Use local manufacturers as 3rd parties

Use local manufacturers to toll manufacturing products (package)
 Multi-national or local company market or both (co-marketing)

Sell bulk products to local manufacturers allow them to market
 With or without manufacturing know how

Sell or license trademarks, patents or other rights to local companies
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Some Changes Required in Syrian Law
for TRIPS Compliance
Provide protection for Pharmaceutical compounds (product
protection)
Patent term of 20 years from filing date
Data package exclusivity – period during which another
company cannot rely on innovator’s safety and efficacy data
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Success in Jordan Provides a Good Example
for Syria

1980 - 90’s, No IPR protection for pharmaceuticals

1999, Jordan joined the WTO
TRIPS compliant January 1, 2000

Innovative Life Sciences Sector
Created
Syria
Population
GDP Growth
GDP/PPP*
18 million
0.9 %
US$ 3,300

New drug approvals take 120 days (previously it
was minimum 2 – 3 years)

Established 5 years of Data Exclusivity protection

Pharmaceutical exports increased by
more than 30% from 1999 – 2002

Jordanian CROs & Medical Tourism created

Jordan Becomes Springboard for Investment
& Development in Middle East
– Increased FDI by 500% since 1999
– US exports increased by 300%
Jordan
Population
GDP Growth
GDP/PPP*
5.6 million
3.1%
US$ 4,300
* CIA World Fact Book, 2005. This entry shows GDP on a purchasing power parity basis divided by
population as of 1 July for the same year (2003)
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