1
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
2
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)
3
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 !
4
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
1111 1
1
11
5
R&D ↔ patent protection?Example HIV anti-retroviral compounds
260260170170
HIV ARV compounds in development
Criticism of patent protection ??
6
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
7
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 ?
8
One outstanding issue = para. 6 Doha Declaration
What are the
possibilities open to
Members with
insufficient or no
manufacturing
capacities in the
pharmaceutical sector ?
9
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 ?
10
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 = ?
11
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
12
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
13
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)
14
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)