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ICC and AIPLAParis, September 13, 2002

Felix AddorChief Legal Officer and Deputy Director GeneralSwiss Federal Institute of Intellectual PropertyMinistry of Justice

The Future of TRIPS:Impact of the Doha Public Health Declaration

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Switzerland’s «small» economy perspective ...

CH 46.9%

US 27.9%

CND 6.8%

AUS 3.8%

J 3.2%

Others 11.4%

Source: EFPIA in Figures 2001

The EU’s top 5 pharmaceutical trading partners (2000)

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Switzerland’s pharmaceutical industry (2001)

Exports: CHF 28 billion, 20% of all Swiss exports

Export surplus: CHF 14 billion

Worldwide first exporter of pharmaceutical products !

Employees: approx. 28’000 / 156’000

R&D expenditure: 40% of all Swiss private sector R&D expenditure (CHF 3,5 billion)

Results: 70 new, innovative drugs to market between 1981 and 2001

Patents protect Switzerland’s only «raw material»: Knowledge !

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Each countries’ patent law is proof of its technological strength

Patents serve as a key indicator in all rankings on the economic growth potential

The importance of patent lawThe importance of patent law

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R&D ↔ patent protection?Example HIV anti-retroviral compounds

260260170170

HIV ARV compounds in development

Criticism of patent protection ??

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WTO Declaration on TRIPS and Public Health Commitment to the TRIPS Agreement

Clarification of the relationship between

the TRIPS Agreement and public health policies

of WTO Members

Recognition of gravity of public health

problems afflicting DCs and LDCs

Members have the right to use, to the full,

the flexibility of the TRIPS Agreement!

«Definition» of some main points of TRIPS flexibility

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WTO Declaration on TRIPS and Public Health

THE TRIPS AGREEMENT RECONCILES

INTELLECTUAL PROPERTY WITH

PUBLIC HEALTH POLICIES

PATENTS ARE NOT AN OBSTACLE TO ACCESS TO

AFFORDABLE MEDICINES, BUT ARE PART OF THE

SOLUTION

CONSENSUS IS POSSIBLE

WHICH CONSENSUS FOR THE PARA 6 QUESTION ?

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One outstanding issue = para. 6 Doha Declaration

What are the

possibilities open to

Members with

insufficient or no

manufacturing

capacities in the

pharmaceutical sector ?

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Scope and coverage of any solution

Scope =

All diseases causing public health problemsespecially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics

Product coverage =

All patented pharmaceutical products and pharmaceutical products manufactured through a patented process, required when dealing with a public health problem

Open questions = Diagnostic kits ?

Medical equipment ?

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Scope and coverage of any solution

Beneficiary recipient countries =

All LDCs without any further examination

No OECD country

Other DCs on a case by case examination

on the basis of clear objective criteria

re “sufficient production capacities”

Eligible supplying countries = ?

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Conditions for any solution

Whatever the legal mechanism: clarity, adequacy and

transparency are needed

Transparency Allows for monitoring and reviewing of the

efficiency of the system Helps identify and inform potential suppliers increases competition among potential suppliers

Involvement of the right holder Delivery by the right holder = most expeditious Requires same rights and obligations

as any potential supplier

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Safeguards against product diversion

1. Production of the quantity needed by

beneficiary Member(s)

2. Entirety of production to be exported

to the beneficiary Member(s)

4. labelling, packaging, coloring and shaping

3. No (re-)exportation

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Possible legal mechanisms

Interpretation of TRIPS under Art IX WTO ?

Waiver under Art IX WTO ?

Amendment of TRIPS under Art X WTO ?

Art 31f TRIPS deletion / modification ?

Art 30 TRIPS authoritative interpretation ?

Dispute Settlement Moratorium ?

Solutions outside TRIPS (e.g. public tender) ?

„We need to combine incentives for research

with access to medication for the poor.“

(Kofi Annan, UN Secretary General, Statement in Amsterdam, 5 April 2001)

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Any solution should

be transparent, legally secure, practical

and economically viable

serve the interests of those really in need

include the patent holder

keep / enhance the incentive for research into diseases

of the developing world (“Don’t kill IP”!)

keep / create incentives for technology transfer

and foreign investment

Work Ahead: Goals and Objectives

Yes, Drugs for the Poor and Patents as well !

(Mike Moor, former Director-General to WTO, International Herald Tribune, 22.02.2001)