Transcript Local Production of Pharmeceuticals in

Local Production of Pharmaceuticals in
Developing Countries
Taking advantage of TRIPS flexibilities
Study Tour University of West Indies
Geneva, 13 May 2009
Christoph Spennemann, Legal Expert, IP Team
Division on Investment and Enterprise
UNCTAD
UNCTAD/CD-TFT
1
Overview of Presentation
• Intellectual Property Rights (IPRs) and
Access to Medicines (ATM)
• The Example of Uganda
• The Local Production Initiative
UNCTAD/CD-TFT
2
IPRs and ATM (1)
Historical facts
• Concerns about access & price  OECD
governments refused patents on
pharmaceutical products
•
•
•
•
•
•
France until 1960
Germany until 1968
Japan until 1976
Switzerland until 1977
Italy & Sweden until 1978
Spain until 1992
UNCTAD/CD-TFT
3
IPRs and ATM (2)
General issue
• Drug development by industry is costly &
risky  incentives needed to encourage R&D
investment  TRIPS obligation to make
patents available for drugs
• Exclusive rights contribute to higher drug
prices
• OECD countries: safeguards (insurance
schemes; competition law & policy to address
IP abuses)
• DCs: no or only few safeguards  access
problem (IP as one among many factors)
UNCTAD/CD-TFT
4
Factors inhibiting ATM in DCs
(Example: Uganda)
• Poor health care infrastructure
• Corruption in the management of public
funds
• Weak drug regulatory/quality control systems
• High prices of procured pharmaceutical
products and diagnostic kits
• Lack of vaccines/cures for HIV/AIDS &
tropical diseases
UNCTAD/CD-TFT
5
Striking a balance: IPRs and ATM
• Important incentives for pharmaceutical R&D
• Impact on prices
• WTO Doha Declaration on TRIPS & Public Health
• India as source of affordable generics
• Industry engagement on tiered pricing (e.g. Gilead, 2008)
and non-enforcement of IP (Roche)
• Impact on pharmaceutical innovation
• Tropical diseases: alternative incentives? (WHO Global
Strategy & Plan of Action)
• Innovation through competition: generic fixed dose
combination HIV/AIDS drugs (e.g. Cipla’s Triomune)
UNCTAD/CD-TFT
6
Striking a balance: Patents as a Policy Measure
Protection (P) vs. Innovation (I)
Maximal
innovation
level
I
Source: Swiss Federal Institute of Intellectual Property,
October 2006
Minimal protection level
UNCTAD/CD-TFT
Optimal protection level
P
7
TRIPS Agreement: tools for balance
• In order to become operational on national
level, most TRIPS provisions need further
elaboration by domestic law makers
• This leeway in implementation is referred to
as « TRIPS flexibilities »
• UNCTAD assists DCs and LDCs in the
implementation of flexibilities
• Examples: East African Community (EAC)
Secretariat, Kenya, Rwanda, Uganda, Tanzania
UNCTAD/CD-TFT
8
The Local Production Initiative
• Rationale: production of affordable drugs
•
•
•
•
BMZ/Germany: Overall coordination
UNCTAD: Legal advice facility
InWEnt: training courses on TRIPS flexibilities
UNIDO: Economic feasibility studies, promotion of
business partnerships, plant-level advice (quality
issues)
• GTZ: Production-related assistance & equipment
• action medeor: training of pharmacists
• Bank for Reconstruction (KfW): funding of SMEs
UNCTAD/CD-TFT
9
A beneficiary: Pharmakina/DRC
• Located in Bukavu/DR Congo
• Independent business since 1999
• Technical & financial support from GTZ & action
medeor
• World’s leading producer of quinine (for antimalarials)
• Since 2005: production of ARV «Afri-Vir»
• Combination therapy: 3 ingredients in one pill (stavudine,
lamivudine, nevirapine)
• Costs per patient: 15 Euros per month
• At present: therapy for 200 locals
• Envisaged: WHO prequalification (for international procurement)
• Capacity to produce 180,000 tablets per day
UNCTAD/CD-TFT
10
Local production in Uganda
• Joint venture: Quality Chemicals – Cipla
• Production of ARVs since February 2009
• Envisaged $9 per month per patient
• Envisaged two million tablets per day
• Incentives to attract Indian producer
• Government provides land & funds infrastructure
• Government pledges to procure ARVs worth of $45 million
per year for seven years
• Government implements TRIPS transition period on pharma
patents until 2016 (as opposed to India)
• « This plant exists largely thanks to TRIPS », Quality Chem.
Finance Director
• Cipla provides training & technology transfer
UNCTAD/CD-TFT
11
Contact
Christoph Spennemann
Legal Expert
Intellectual Property Team
Division on Investment and Enterprise (DIAE)
UNCTAD
E-mail: [email protected]
Tel: ++41 (0) 22 917 59 99
Fax: ++41 (0) 22 917 01 94
http://www.unctad.org/tot-ip
UNCTAD/CD-TFT
12