Public health, innovation and intellectual property 1 |1 | Dr Germán Velásquez Director WHO...

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


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


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…


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.


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


WTOWTO

Entered into force in 1995

123 countries participating in the Uruguay Round negotiations

Today, 153 Members and 30 observer governments


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


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


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


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


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


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


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


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


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)


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)


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


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


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


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


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


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).

Public health, innovation and intellectual property 1 |1 | Dr Germán Velásquez Director WHO...

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