Transcript The Emerging Paradigm of Global IP Enforcement in FTAs and

The Emerging Paradigm of Global IP
Enforcement in FTAs and TRIPS-plus
Agreements: Implications for Access to
Medicines
Mr. Anand Grover
Senior Advocate, Supreme Court of India,
Director- Lawyers Collective and the UN Special
Rapporteur to the Right to Health
MHRD IP Chair Roundtable Symposium on IP
and Pharmaceutical Policy, NLU- Jodhpur
17th and 18th March, 2012
RIGHT TO HEALTH
• Art 12 ICESCR: “the right of everyone to the enjoyment of
the highest attainable standard of physical and mental
health”.
• Meaning of ‘highest attainable standard of physical and
mental health’
• It does not mean merely absence of diseases or right to health
care.
• General Comment No.14 on Art 12 of ICESCR interprets it to
mean:
“right to health embraces a wide range of socio-economic
factors that promote conditions in which people can lead a
healthy life, and extends to the underlying determinants of
health, such as, food and nutrition, housing, access to safe
and potable water and adequate sanitation, safe and
healthy working conditions and a healthy environment,
access to health related education and information,
including on sexual and reproductive health”
RIGHT TO HEALTH
• Medical care and treatment which are dependent on
medicines are key features of the right to health.
• Access to medicines is an integral part of the right to
health.
• The States have an obligation under the right to health to
ensure that:
– medicines are available;
– financially affordable and
– physically accessible on a basis of non-discrimination to
everyone within their jurisdiction.
• The developed States also have a responsibility to take steps
towards the full realization of the right to health through
international assistance and cooperation. [E/CN.4/2004/49/Add.1,
para. 28]
• Participation of the community and Civil society is an important in
decision making, implementing and monitoring and implementing is
an important principle in right to health framework
RIGHT TO HEALTH: INDIA
• The right to health, enshrined in numerous international and
regional human rights treaties and in many national constitutions.
[Article 25, UDHR,1948; Article 12, ICESCR, 1966]
• Right to life [Article 21] has been interpreted by the Supreme Court
of India to include the right to health. [Vincent Panikurlangara v.
Union of India (1987) 2 SCC 165; and State of Punjab v. Ram
Lubhaya Bagga (1998) 4 SCC 117.]
• Article 21 read with Article 14 obliges the State to provide
health services, including, testing, diagnostic facilities as well
as medicines to protect life without any discrimination.
• International Law

International covenants and conventions and other
international agreements signed onto or ratified by India can be
read into fundamental rights to interpret it and expand its
scope.

ICESR are incorporated domestically in India in the Protection
of Human Rights Act
•
Accessibility of medicines has different dimensions one of which is
financial affordability. In this regard intellectual property (IP) laws as they
impact on the affordability of medicines can have a significant bearing on
access to medicines.
•
Cost of medicines is one of the key factors that affect the access to
medicines. In low and middle income countries, medicines account
for 60% of the healthcare cost. [The World Medicines Situation, WHO,
2004].
•
In India, 70% of household out of pocket expenditure on health is set
aside for buying drugs. [Report of National Health Accounts of India]
•
Millions will be pushed into poverty by purchasing high cost medicines,
especially branded medicines. [Niëns LM, et al, “Quantifying the
Impoverishing Effects of Purchasing Medicines: A Cross-Country
Comparison of the Affordability of Medicines in the Developing World”,
PLoS Med 7(8) e1000333 (2010)]
IMPACT OF GENERIC MEDICINES AND
THEIR COST
• Presently, India is the largest supplier of low-cost, high quality
medicines for the entire developing world.
• Countries across the developing world have been able to upscale
treatment access for persons living with HIV primarily because of
domestic production of generic anti-HIV medicines in India.
• In 2008, about 89% of adult ARV purchases for the donor funded
programmes in developing countries was from the Indian generic
market.
• While there has been a huge fall in prices of first-line ARVs, the cost
of second-line and third-line drugs are very high.
– For instance, the cost of tenofovir-based regimens range from
$246 to $309 per patient per year. This is about 3.3 to 4 times
higher than the price for the older regimens.
[Brenda Waning, et al, “A lifeline to treatment: the role of Indian generic
manufacturers in supplying antiretroviral medicines to developing
countries”, Journal of the International AIDS Society, 2010, 13:35]
IMPACT OF GENERIC MEDICINES AND
THEIR COST
• Apart from India, China, Brazil, Thailand and South
Africa also produce a significant amount of generic
drugs.
• Brazil, Russia, India and China have capacity to
produce active pharmaceutical ingredients (APIs). [As
reported by Thomson Reuters, 2008]
• However, the trade agreements seeking
higher
intellectual property protection undermines the
capacity of countries like India, Brazil, China, Thailand
etc. to manufacture low cost generic medicines.
WHY ARE WE CONCERNED?
1980s to 1994
• Multilateral trade
negotiations.
• Developed countries
pushed for and
obtained inclusion of
intellectual property
rights (IPRs) in
Agreement
establishing WTO.
• Developing countries
were able to obtain
flexibilities.
1995
Since 1995
• TRIPS came into force.
• Lays down minimal
standards of IP
protection and
enforcement
• Contains flexibilities.
• It, inter alia, refers to
protection and
enforcement of IPRs in a
manner conducive to
social and economic
welfare of people,
balance of rights and
obligations and transfer
of technology.
• Through trade
agreements, developed
countries have been
attempting to:
• Obtain additional IP
protection and
enforcement provisions
beyond TRIPS.
• Dilute TRIPS
flexibilities
• These agreements are
negotiated
• secretly
• without transparency
• without consulting
community
TRADE AGREEMENTS
• Trade Agreements:
• Bilateral or regional trade agreements
• or economic partnership agreements
– EU FTAs with India, Malaysia
– US FTAs with Bahrain, Chile, Peru, Columbia,
Jordan.
– EU FTAs with ASEAN , MERCOSUR
• Plurilateral agreements
•Trans-Pacific Partnership Agreement
•Anti-Counterfeiting Agreement
NEGOTIATING POSITIONS AND
INTERNATIONAL PRESSURE
•
•
•
EU, US and other developed countries are negotiating to increase
access to developing country markets for its multinational corporations
and to secure maximal profits for them.
– For this, they are seeking increased IP protection and enforcement
standards.
– Increased IP protection and enforcement  higher profits
USTR in its Special 301 report has placed India, Brazil, Thailand,
countries with capacity to manufacture generic medicines, in the Priority
Watch List threatening to take actions for inadequately protecting
intellectual property even though the countries are TRIPS compliant.
EU demands for TRIPS-plus intellectual property provisions is based on
the European Commissions’ strategy—Global Europe: Competing in the
World (2006)—which sets an aggressive trade and investment agenda
for expanding the competitiveness of the EU’s industries.
NEGOTIATING POSITIONS AND
INTERNATIONAL PRESSURE…..contd
• Reports that industry associations in EU and their Indian
counterparts are setting the agenda [“Trade Invaders. How big
business is driving the EU-India free trade negotiations”,
Corporate Europe Observatory, 2010].
• India is a socio-economic welfare State established by its
Constitution and has to secure the fundamental rights (right to
life, right to health, etc) of its peoples.
• Brazil [Art.196, Brazilian Constitution] and Thailand [Section 51,
Constitution of the Kingdom of Thailand,2007] have a
constitutional obligation to protect right to health of its citizens.
• Developing countries are being pushed to accept provisions that
will benefit a few and harm a vast majority of people.
FREE TRADE AGREEMENTS:COUNTRIES
INVOLVED
United
States:
European
Union:
• The United States has 12 FTAs in force with 17 countries
• AUSTRALIA,
BAHRAIN,
CHILE,
OMAN,
PERU,
SINGAPORE, ISRAEL, JORDAN, MOROCCO
• CAFTA COSTA RICA, DOMINICAN REPUBLIC, EL
SALVADOR, GUATEMALA, HONDURAS, & NICARAGUA
• NAFTA: CANADA & MEXICO
• In addition, the United States has negotiated FTAs with
Korea, Panama and Colombia, but these agreements have
not yet entered into force. [www.ustr.gov/tradeagreements]
• UNDER NEGOTIATION
• ASIA: INDIA, SINGAPORE , MALAYASIA, ASEAN,
MERCOSUR
• EASTERN EUROPE: UKRAINE
• EPA WITH AFRICAN, CARIBEAN AND PACIFIC
COUNTRIES
• CONCLUDED:
• CENTRAL AMERICA [COSTA RICA, DOMINICAN
REPUBLIC,
EL
SALVADOR,
GUATEMALA,
HONDURAS,
&
NICARAGUA]
AND
ANDEAN
COMMUNITY [COLUMBIA AND PERU]
• SUSPENDED:
• LIBYA and GCC [http://trade.ec.europa.eu]
SUBSTANTIVE ISSUES
Protection of
data
Patent term
extension
TRIPS: Balance of
rights and obligations,
social and economic
welfare, transfer of
technology
TRIPS: Data
protection
TRIPS: 20 years’
protection inclusive of
time taken for patent
and regulatory
approval
EU: Protection and
enforcement of IPR
and its
commercialization
EU: Data exclusivity
(will delay entry of
generic competition,
affect compulsory
license, etc)
EU: Patent term
extension
Stated objective
PATENT LINKAGE
Consent of patent
holder  marketing
approval granted
Drug patented
No consent 
marketing approval
withheld
Drug Regulatory
System
Drug not patented
Marketing approval
granted
•Requirement of patent linkage is a standard clause in many bilateral FTAs
negotiated by US.
• US FTAs with Singapore, Chile, Morocco, Bahrain
•Pressure from US Trade Representative and pharma companies on
developing countries for higher IP standards.
In the Bayer matter patent linkage was not accepted
ENFORCEMENT
• IPRs are private rights.
• In case of patents and trademarks, IP holders
have exclusive right to enforce them.
• EU FTAs seek stronger enforcement
mechanisms that:
– Harmonize laws of developing countries with
its own internal trade rules
– Shift burden of enforcement of private
rights to State
ENFORCEMENT
• EU FTAs seek
mechanisms that:
– Facilitate litigation
obtaining:
stronger
to
deter
enforcement
competitors
by
• Injunctions more easily to thwart competition
• Injunctions against intermediaries
• Far-reaching information-gathering provisions that
undermine freedom of trade and private and
confidential data
• Compulsory damages and under expanded heads of
damage
• Orders to seize and destroy goods
ENFORCEMENT
• TRIPS only requires border measures at point of import in
cases of copyright piracy and counterfeit trademarks [Article
51].
• EU FTAs seeking stronger enforcement mechanisms that:
– Expands scope to patents, the infringement of which
cannot be determined by visual inspection;
– Require mandatory border measures by State not only:
• at import, but also for export, re-export, goods in transit;
• for copyright piracy and counterfeit trademarks, but
also for patents.
ENFORCEMENT
• Border measures – How they affect
access?
– Generic drugs seized [Late-2008]:
• Drug: WHO per-qualified ARVs for Clinton
Foundation funded treatment project purchased by
UNITAID
• Source: India  Transit: Amsterdam 
Destination: Nigeria
• 17 other such seizures; in some cases, drugs
released after a few months, either forwarded to
destination or returned to India.
INDIA TAKES EU TO WTO
• India and Brazil sought consultation under the WTO
Dispute Settlement Mechanism.
• Thereafter countries such as Canada, China, Japan,
Turkey and Ecuador requested to join the consultations.
• July 2011: India and EU entered into an
understanding that EU would amend its rules and
replace Regulation 1383/2003.
• Meanwhile India has agreed not to proceed with case
further.
• However, the case has not been withdrawn.
INVESTMENT
• Definition of Investment : inclusion of “intellectual property
rights”
• This will enable investors (private corporations) to sue
the Government of India at international arbitral bodies if
their investment (intellectual property) is affected.
• This would deter India from:
– enacting laws or policies aimed at securing access to
medicines.
– Controlling prices of medicines
– Regulating foreign investment in local production
• Available records show how several developing countries
have been taken to arbitral bodies by multinational
corporations for having adopted policies to protect public
health, environment and public security system.
INVESTMENT: HOW IT WILL AFFECT
• Uruguay : 80% of the bottom portion of all cigarette
packages should contain prescribed health
messages.
• Switzerland-Uruguay BIT: Philip Morris, a US
based tobacco company, filed a claim at the
International Centre for Settlement of Investment
Disputes (ICSID), a World Bank branch.
• Phillip Morris claimed that Uruguay’s tobacco control
policies are damaging their trademark rights (IPR),
which is their investment. It sought damages
/compensation from Uruguay.
TRANS-PACIFIC PARTNERSHIP AGREEMENT
• TPPA: is a multilateral free trade agreement that aims to
further liberalise the economies of the Asia-Pacific region.
• Countries involved: United States,
Australia, Brunei
Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore
and Vietnam.
• The TPP contains a chapter on Intellectual Property
(copyright,
trademarks,
patents
and
perhaps
geographical indications) which extends beyond TRIPS
Agreement.
• TPP is intended to harmonize laws of TPP member countries
to that of US IP and trade laws.
TRANS-PACIFIC PARTNERSHIP AGREEMENT
• TPP seeks increased IP protection and eliminates TRIPS
flexibilities.
– Extends scope of patentability to [Art. 8.1 and 8.2]:
• new use, forms or methods of using a new products
• diagnostic ,therapeutic and surgical methods
– Extends the term of patent beyond 20 years to compensate for
the delays [Art. 8.6]:
• in granting patents or granting regulatory approvals to
medicines.
– Mandates the adoption of patent linkage system [Art.9.5]
– Provides for Data Exclusivity for [Art. 9.2]:
• New Pharmaceutical product
• Extends the scope of DE to drugs registered in another territory
• New use or form of an approved chemical entity
TRANS-PACIFIC PARTNERSHIP AGREEMENT
• Eliminates pre-grant opposition provision [Art. 8.7]
• Mandates countries to allow patent applicants to make multiple
amendments to their patent claims prior to approval on merits.
[Art.8.9]Thus making it harder to challenge the patent.
• Minimizes the duty of patent applicant to make required
disclosure [Art.8.10 and 8.11]
• Obligation relating to Enforcement:
– Mandates a presumption of validity of patents in any
proceeding involving patents. [Art. 10.2]
– Mandates the judiciary to measure damages based on retail
price or other measure suggested by the patent holder. [Art.
12.3] So the damage could be based on the high price fixed by
the Patent holder
HOW WILL BI-,MULTI-LATERAL AND REGIONAL TRADE
AGREEMENTS AFFECT ACCESS TO MEDICINES?
• Data Exclusivity, Patent Term Extension and Patent Linkage:
– would increase IP protection for medicines and will result in
extension of monopolies ;
• Enforcement provisions:
– would allow IP holders to take steps that would deter or delay
generic competition;
– curtailing the discretionary powers of municipal Courts in the
adjudication of disputes relating to private rights;
– prioritizes private rights over public health and public interest.
• Investment provisions would undermining the sovereign rights of
Governments to take steps to ensure that the right to health is
protected and promoted;
• Delay in entry of generic competition will keep prices of medicines at
higher level
RECOMMENDATIONS
• Advocate and encourage countries to use
TRIPS flexibilities.
• Resist TRIPS-Plus provisions into domestic
legislation through regional and bilateral trade
agreements.
• To collaborate and develop a South-South
Intellectual Property road map.