public health, innovation and intellectual property 1 |1 | dr germán velásquez director who...
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Public health, innovation and intellectual property1 |
Dr Germán VelásquezDirectorWHO SecretariatPublic Health, Innovationand Intellectual Property
The evolution of the access to medicines debate internationally
Access to Essential Medicines, HIV and Intellectual Property RightsRegional Meeting Sponsored by UNDP/OSI
21-22 September 2009Kiev, Ukraine
The evolution of the access to medicines debate internationally
Access to Essential Medicines, HIV and Intellectual Property RightsRegional Meeting Sponsored by UNDP/OSI
21-22 September 2009Kiev, Ukraine
Public health, innovation and intellectual property2 |
Plan of the presentationPlan of the presentation
1. Access to medicines: global overview
2. IP policy situation before 1995 from GATT to WTO
3. Changes with the WTO/TRIPS Agreement in 1995
4. WHO perspectives and technical assistance
Public health, innovation and intellectual property3 |
Access to ARVsAccess to ARVs
According to WHO/UNAIDS/UNICEF 2008 report, the number of people who need ARV treatment is estimated at 9 million
The report also says that only 3 million out of the 9 million people are receiving ARV treatment …
97% of the 3 million on ARVs are treated with the "first line" treatment, available in generic form at a cost of between US$ 150 and US$ 300 per person per year…
During the following years, many of the patients have to pass to the "second line" treatment (in some countries in Latin America, 30% of the patients are
already on "second line") and the cost increases to US$ 4 000 or US$ 5 000 per patient per year…
Public health, innovation and intellectual property4 |
People are dying because of lack of access to essential drugs
People are dying because of lack of access to essential drugs
10.3 million children under 5 years of age die in developing countries each year.
About 8.6 million of these deaths are due to communicable, perinatal and nutritional conditions. A large proportion of these deaths could be prevented if those at risk had access to essential drugs.
Public health, innovation and intellectual property5 |
Plan of the presentationPlan of the presentation
1. Access to medicines: global overview
2. IP policy situation before 1995 from GATT to WTO
3. Changes with the WTO/TRIPS Agreement in 1995
4. WHO perspectives and technical assistance
Public health, innovation and intellectual property6 |
GATT
GATT: General Agreement on Tariffs and Trade, signed in 1947 by 23 countries
Purpose: to reduce barriers to international trade and to lower customs tariffs
Method: the “Rounds” periodic negotiating cycles
the Kennedy Round, 1964-67
the Tokyo Round, 1973-79
the Uruguay Round, 1986-94
In 1994 the World Trade Organization replaces GATT
Public health, innovation and intellectual property7 |
WTOWTO
Entered into force in 1995
123 countries participating in the Uruguay Round negotiations
Today, 153 Members and 30 observer governments
Public health, innovation and intellectual property8 |
From Uruguay Round (1986-1994) to WTOFrom Uruguay Round (1986-1994) to WTO
The new World Trade Organization (WTO) replaces the previous GATT
New trade agreements are annexed to the WTO Agreement,
including the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS)
WTO members are automatically bound by all WTO multilateral trade agreements
Public health, innovation and intellectual property9 |
Plan of the presentationPlan of the presentation
1. Access to medicines: global overview
2. IP policy situation before 1995 from GATT to WTO
3. Changes with the WTO/TRIPS Agreement in 1995
4. WHO perspectives and technical assistance
Public health, innovation and intellectual property10 |
Differences GATT / WTODifferences GATT / WTO
GATT
only a treaty (no institutional basis)
trade of goods
free adherence to agreements annexed
dispute settlement system inefficient
WTO
a real and permanent international organization
trade of goods, services, intellectual property rights
multilateral trade agreements binding all members
an integrated and efficient dispute settlement system
Public health, innovation and intellectual property11 |
The TRIPS Agreement: “Trade-Related Aspects of Intellectual Property Rights” (1994)
The TRIPS Agreement: “Trade-Related Aspects of Intellectual Property Rights” (1994)
Some characteristics:
Minimum standards for intellectual property
Obligatory for all members of the WTO
New: patents for pharmaceuticals: products and processes
Patents for a minimum period of 20 years
A certain amount of freedom for Member States
Public health, innovation and intellectual property12 |
Before TRIPS: diversityBefore TRIPS: diversity
Patents granted either for pharmaceutical products, or for pharmaceutical processes, or both, or no patents available for drugs
Patent term protection varied from 5 to 20 years
Exceptions to patent exclusive rights and compulsory licences unlimited
Public health, innovation and intellectual property13 |
After TRIPS: uniformityAfter TRIPS: uniformity
Patents must be available in all WTO Member States for pharmaceutical products and processes
Minimum duration of 20 years from the filing date
Exceptions are limited
Compulsory licences are conditional
Public health, innovation and intellectual property14 |
PatentsPatents
Title granted by the public authorities conferring a temporary monopoly in a specific country on an invention, in exchange for divulging this invention to the public
Regulated by national law only (conditions of granting, duration, exceptions, compulsory licences)
No international patent exists: current international conventions only facilitate patent protection in different countries
Public health, innovation and intellectual property15 |
Application of TRIPSApplication of TRIPS
1996 in developed countries
2000 in developing countries in general
2005 in developing countries using the transitional period like India
2006 in least developed countries (LDC)
2016 extension given by Doha for LDC
Public health, innovation and intellectual property16 |
Plan of the presentationPlan of the presentation
1. Access to medicines: global overview
2. IP policy situation before 1995 from GATT to WTO
3. Changes with the WTO/TRIPS Agreement in 1995
4. WHO perspectives and technical assistance
Public health, innovation and intellectual property17 |
Concerns expressed by several countries on the impact of TRIPS Concerns expressed by several countries on the impact of TRIPS
High prices for new drugs in countries with no previous patent protection system
Generic competition delayed in countries with previous patent term less than 20 years
Weakening of local pharmaceutical industry -concentration of drug production … increasing dependence of developing countries
Public health, innovation and intellectual property18 |
TRIPS and public health tensionsTRIPS and public health tensions
Introduction of IP regimes of developed countries in developing countries
HIV epidemic – price of ARVs
Bilateral trade agreements/IP restrictions
WTO – TRIPS – Doha debate
Litigation from the pharmaceutical industry against developing country governments (South Africa, India…)
According to a EU report, pharmaceutical originator companies are delaying or blocking market entry of competing medicines (July 2009)
Public health, innovation and intellectual property19 |
May 1999 - Revised Drug StrategyMay 1999 - Revised Drug Strategy
The Fifty-second World Health Assembly, …
Requests the Director-General:
"...to cooperate with Member States, at their request …in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States … are able to maximize the positive and mitigate the negative impact of those agreements …" (resolution WHA52.19)
Public health, innovation and intellectual property20 |
WHO mandate on public health, innovation and intellectual property
WHO mandate on public health, innovation and intellectual property
1996 (WHA 49.14): requesting WHO to study and inform on the impact of WTO on medicines
1999 (WHA52.19): Revised drug strategy
2000 (WHA53.14): HIV/AIDS: confronting the epidemic
2001 (WHA54.10): Scaling up the response to HIV/AIDS
2001 (WHA54.11): WHO medicines strategy
2002 (WHA55.14): Ensuring accessibility of essential medicines
2003 (WHA56.27): Intellectual property rights, innovation and public health
2003 (WHA56.30): Global health sector strategy for HIV/AIDS
2004 (WHA57.14): Scaling up treatment for HIV/AIDS
2006 (WHA59.24): Public health, innovation, essential health research and IPR: towards a global strategy and plan of action
2006 (WHA59.26): International trade and health
2007 (WHA60.18): Malaria
2007 (WHA60.30): Public health, innovation and intellectual property
2008 (WHA61.21): the WHA adopts the global strategy and agreed parts of the plan of action on public health, innovation and intellectual property
Public health, innovation and intellectual property21 |
Background 1996–2009Background 1996–2009
Since 1999, four WHA resolutions have given WHO the mandate to:
Assist Members States to develop medicines and health policies related to international trade agreements
Monitor, analyse, study and report on health implications of international trade agreements
Provide technical and policy support to countries that intend to make use of TRIPS flexibilities
Promote new thinking on innovation and access to medicines
Promote education and training in the application and management of Intellectual Property from the public health perspective
Public health, innovation and intellectual property22 |
WHO programme of work on pharmaceuticals and IPR
WHO programme of work on pharmaceuticals and IPR
Guidance on cost-containment mechanisms and policies for essential medicines
Training and briefings on TRIPS flexibilities
Advice on the revision of national laws related to health and pharmaceuticals
Organization of inter-ministerial meetings (health, trade and patent offices)
Monitoring and evaluation of the impact of TRIPS
Public health, innovation and intellectual property23 |
WHO policy perspectives on access to essential medicines in the context of globalization
WHO policy perspectives on access to essential medicines in the context of globalization
WHO supports any measure which will improve access to all essential medicines, including mechanisms to promote competition, such as:
– price information– generic policies – reduced duties, taxes, mark ups– parallel imports– application of WTO/TRIPS flexibilities
Public health, innovation and intellectual property24 |
Conclusions: points for policy makers
Conclusions: points for policy makers
• Introduction of a public health perspective into the intellectual
property protection regime
• Incorporation and use of the flexibilities permitted by the TRIPS
Agreement in the revision of national laws and regulations (e.g. Bolar
provision, compulsory licensing, exceptions to exclusive rights, introduction of public health
perspective in the criteria of patentability, extension of the transitional period…)
• Implementation of the Doha Declaration
• Caution with «TRIPS-plus» provisions
• Monitoring of the public health impact of new trade agreements
Public health, innovation and intellectual property25 |
Summary Table: Examples of compulsory licences by/for developing countries
Summary Table: Examples of compulsory licences by/for developing countries
Date Country Type Product
April 2003 Zimbabwe CL all HIV/AIDS-related medicines
Oct. 2003 Malaysia GU didanosine
zidovudine
FDC didanosine+zidovudine
Sept. 2004 Zambia CL FDC of lamivudine+ stavudine+nevirapine
Oct. 2004 Indonesia GU lamivudine nevirapine
Nov. 2006 Thailand GU efavirenz
Jan. 2007 Thailand GU lopinavir/ritonavir
Jan. 2007 Thailand GU clopidogrel
March 2007 Indonesia GU efavirenz
May 2007 Brazil GU efavirenz
Sept. 2007 Canada for export to Rwanda CL FDC of lamivudine+ zidovudine+nevirapine
Jan. 2008 Thailand GU several cancer drugs
CL = compulsory license; GU = government use (CL for public non-commercial use).