Anand Grover UN Special Rappourteur on the Right to the Highest Attainable Standard of Physical and

Mental health

Erasmus University, Rotterdam,6th July, 2009

Right to health: international law: recognition

Universal Declaration of Human Rights (Art. 24)International Convention on the Elimination of All

Forms of Racial Discrimination (Art. 5(e)(iv) 1965Convention on the Elimination of All Forms of

Discrimination against Women (CEDAW). (Art. 11(1)(f), 12, 14(2)(b)) 1979

Convention on the Rights of the Child: Art (24) 1989International Convention on the Protection of the

Rights of All Migrant Workers and Members of their Families: arts. (28, 43 (e), 45(c).) 1990

Convention on the Rights of Persons with Disabilities: art. 25 (2006)

ICESCR Art. 12The Charter of Fundamental Rights of the European

Union (2000)European Convention of the Protection of Human

Rights and Fundamental Freedoms (1950)

WHO Constitution (1946)“The States parties to this Constitution declare,

in conformity with the Charter of the United Nations, that the following principles are basic to the happiness, harmonious relations and security of all peoples.”

“Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”

“The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition”

Universal Declaration of Human Rights (1948)

“Everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services” (Article 25)

1979: Convention on Elimination of all forms of discrimination Against Women(Article 12):“States must take all appropriate measures to

eliminate discrimination against women in the field of health care in order to ensure, on a basis of equality of men and women, access to health care services, including those related to family planning.”

“States shall ensure to women appropriate services in connection with pregnancy, confinement and the post-natal period, granting free services where necessary, as well as adequate nutrition during pregnancy and lactation.”

1989: Convention on the Rights of the Child (Article 24):

"States Parties recognize the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health...."

International Covenant on Economic, Social and Cultural Rights (ICESCR)

ICESCR Art. 12 Article 12.1 provides the definition of the right to health1) “The States Parties to the present Covenant recognize

the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”

2)The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: the provision for the reduction of the stillbirth rate

and of infant mortality and for the healthy development of the child;

the improvement of all aspects of environmental and industrial hygiene;

the prevention, treatment and control of epidemic, endemic, occupational and other diseases; the creation of conditions which would assure to all medical service and medical attention in the event of sickness.”

More specifically…(a) Reducing maternal and infant mortality

implies a priority for services for and protection of women and children

(b) environmental and industrial hygiene implies assuring physical conditions for health – clean water, air

(c) control of epidemic and occupational implies public health policies—vaccinations, surveillance

(d) medical service an medical attention in the event of sickness implies health care services

Adequate Progress & Non-retrogression Progressive realization implies adequate

progress and non-retrogressionThere cannot be any steps backwardsBoth impose the obligation to have

benchmarks and indicators which allow for monitoring

In HIV these indicators are available on a yearly basis in the form of the UNAIDS reports pursuant to UNGASS

However certain issues, e.g. Non-discrimination, non-consensual treatment are. Not amenable to progressive realization

These are immediately applicableSankalpRehabiltation versus Union of India

The right to Life (Health): International and Domestic Law

Division between Monist and Dualist system; Monism: Ratification implies enforceabilityDualism: Requires Domestication of laws; But

interpretation is in accord with International Covenants; In the absence of domestication Principles are followed;

Lot of countries have provided for the Right to Life (which has been interpreted to include the Right to Health) or the Right to Health in their Constitutions

These rights are immediately enforceable at lawMoreover the Right to Life is considered the

highest right

The right to health framework: Elements Goods, services and facilities must be:Available: Health care facilities, health

care providers available in adequate numbers; Lack of adequate numbers: death

Accessible: Physically and ge0graphically; economically (affordable); non-discriminatory;

Acceptable: Respectful of culture (indigenous, religious communities) and medical ethics

Good quality: Quality care has to be provided

The right to health: framework• Respect: states must refrain from interfering

directly or indirectly with the right to healthProtect: States must take measures to prevent

third parties from interfering with the right to mental health of its peoples.

Fulfill: states required to adopt appropriate legislative, judicial, promotional etc. measures towards the realization of the right to mental health.

Fulfill Includes the following:Facilitate: states need to take positive measures

that enable and assist individuals to enjoy the right to mental health.

Provide: states need to provide a specific right to individuals, if they are unable for reasons beyond their control, to realize the rights themselves.

Promote: states need to undertake actions that create, maintain and restore the health of their people. E.g. Through research and provision of information.

The right to health: frameworkGeneral Comment 14 (2000), establishes a

framework for the realization of the right to health.

Underlying conditions & Determinants of healthSafe drinking water and adequate sanitationHealthy nutrition ,nutritional supplements etcHealth related education and informationHealthy working and environmental conditionsHousing, Unemployment, Income supportAddressing povertyGender equalityNon-discrimination and social inclusion

The right to health: frameworkPrinciple of non-discrimination and equalityCEDAW Definition: Any distinction, exclusion, restriction

made on basis of diverse grounds which has the effect of nullifying the recognition, enjoyment or exercise of the human right and fundamental freedom.

Human rights treaties were developed with a key to consider rights on a basis of non-discrimination.

Non exhaustive grounds include: race, color, sex, caste, language, religion, political or other opinion, national, ethnic or social origin, property, disability, birth or other status

In the HIV context it would imply the right to health for marginalized groups: MSM, sex workers, People using drugs

States have an obligation to make health services available on a basis of non-discrimination and equality.

This right is immediately applicable under International Law

Freedoms With the Right to HealthRight to be free from non-consensual medical

treatment- ex. Medical experiments and research or forced sterilization. This therefore includes- right to control one’s health and body, including sexual and reproductive freedom.

Freedom from torture and other cruel, inhuman or degrading treatment or punishment

In the HIV context consent to testing is a major issue

Also consent to breach confidentiality of a persons medical or other status

The case of S [Blood transfusion]

Obligations of StatesCore Minimum obligations- States must ensure:The right of access to health facilities, goods and

services on a non-discriminatory basis, especially for vulnerable/marginalized groups

Access to the minimum essential food which is nutritionally adequate and safe

Access to shelter, housing and sanitation, and adequate supply of safe drinking water.

The provision of essential drugsEquitable distribution of all health facilities,

goods and servicesSankalpv/s Union of India

Right to Health frameworkParticipationIL recognizes the principle of participation of all stake

holders in the processes: MIPA principle in HIV/AIDSMonitoring and Accountability Duty bearers: States are held to account Independent body with sufficient powers to monitor

and account This body must include affected personsUNGASS monitoring is done in HIV by PLHIV

communitiesCommunity involvement In all aspects of the processes: decision making,

delivery of services, monitoring, evaluation; KEY LESSON IN HIV

International CooperationGlobal Fund on HIV/TB and Malaria

HIV: Public health Value of RightsWHY ARE RIGHTS IMPORTANT? In the at the start of the epidemic the vast majority

HIV+ persons were WHITE, MALE, HOMOSEXUALS

NOW the vast majority are BLACK, HISPANIC, HETEROSEXUAL, WOMEN

Higher sero-prevalence in certain groups [Sex-workers, Men having sex with Men, People using drugs]

CERTAIN GROUPS ARE MORE VULNERABLE: Issue of empowerment and disempowerment

RIGHTS ARE GREEN LEAVES ON THE TREES OF THE FOREST: IMAGINE A FIRE IN A FOREST

Committee on Economic, Social and Cultural Rights:

General Comment No. 14(2000)

Right to prevention, treatment and control of diseases includes creation of a system of urgent medical care in case of accidents, epidemics; and disaster relief and humanitarian assistance

Right to health facilities, goods and services includes appropriate treatment of prevalent diseases, preferably at community level; and the provision of essential drugs as defined by the WHO Action Programme on Essential Drugs

General Comment No. 14State parties are under immediate

obligation to guarantee that the right to health care is exercised without discrimination, and that concrete steps are taken towards full realization,  with emphasis on vulnerable and marginal groups

Sonagachi: A Best practice model of the Rights based approach

Intervention STD/HIV/AIDS project

introduced in 1992 Components: STD

treatment, IEC & Condom promotion

Strategies: Participatory, Peer oriented&Rights based

Impact Condom use: Up from

3% in 1992 to 90% in 1998

STD rates: Fell from from 25.4% in 1992 to 11.5% in 1998

HIV prevalence: Only marginally increased

Epidemiological Evidence for The Rights based approach

Fall in HIV prevalence rates in the south States of Karnataka, Maharashtra, Andhra Pradesh and Tamil Nadu. Reasons were attributed to increased condom use or increased abstinence.

In 2004,about 70–80% of female sex workers in Maharashtra and Tamil Nadu reported condom use with their last client

Indirect evidence from surveys of female sex workers in Tamil Nadu in 1996–2004 has shown increases in condom use, but no change in the number of clients per day.

Prevalence in women aged 15-24 yrs, tested nationally at ante-natal clinics shows a decrease of 54% between 2000-2007.

(Lancet Report, 26 July 2008)

LEGAL RESPONSES TO HIV/AIDSIsolationist

mandatory testingconfidentiality

breacheddiscrimination of

PLHIVsCriminalization of

practices of marginalized groups…..leading to isolationdriving the HIV epidemic underground

IntegrationistIntegrationistvoluntary testing confidentiality maintained non-discrimination of PLHAs Non-criminalization of practices of marginalized goups

…….leading to .leading to integration allowing access to facilities by PLHIVs

INFORMED CONSENT for HIVtestingCONFIDENTIALITY of HIV status

NON DISCRIMINATION based on HIV status (in healthcare, employment, insurance,

education & other services)ACCESS TO TREATMENT

NON-CRIMINALIZATION OF PRACTICES OF MARGINALIZED GROUPS

RIGHT TO CONSENT

Consent is required as : “Every human being of adult years and sound mind has a right to determine what should be done with his body.”

Every touching of the body is potentially battery or assault, unless consented to

Touching without consent amounts to Battery [intentional application of harmful physical contact to a person.]

e.g. : Medical examination of a patient against his/her wishes is battery.

CONSENTDOCTOR - PATIENT RELATIONSHIP:

relationship between un-equals as doctors have better knowledgelarger experiencetrust

Therefore the duty of the physician to provide honest information [Informed consent]

Varying approaches in the US, Canada and England, India as to how much information should be given

INFORMED CONSENTWhy is informed Consent for HIV

testing and treatment required:HIV infection is not curableOther diagnostic tests do not have life-

threatening implicationsHIV test has life threatening

implicationsKnowledge of HIV-positive status itself

may lead a person to untold trauma like taking one’s life

Counseling for Adherence/side effects of ARVs

PITC: Universalization of testing

CONFIDENTIALITY in Medical Settings A confidential relationship, the nature of which may be

dependent on factors of trust, knowledge and skill Confidential information

Objective: Community health

Not Maintaining confidentiality

Maintaining confidentiality

Community benefits Community suffers

Allow patients to disclose true information and seek proper

medical treatment

Prevents patients from disclosing all information; hinders proper treatment

IS DISCLOSURE PERMISSIBLE?WEIGHING COMPETING PUBLIC

INTERESTSInterest of the PLWHA to keep HIV-positive

status confidential is in Public Interest versus

Interest of the community, society, to have knowledge of the individual’s HIV-positive status which may also be in Public Interest

In certain circumstances, disclosure of confidential information may be allowed if:public interest to disclose outweighs public interest to maintain

confidentialityPartner Notification

Mr. X versus Hospital Z

SUPPRESSION OF IDENITY

Suppression of identity, whereby a person can litigate under a pseudonym, is a beneficent litigation strategy, long established in the area of family law

In the context of HIV/AIDS, using suppression of identity PLWHA can now seek justice without the fear of their HIV status becoming public knowledge

MX versus ZY, AIR 1997 Bombay 406

DISCRIMINATION no discrimination in the areas of

medical care employment travel & immigration services Insurance on the basis of a person’s HIV status or

perceived status or association with HIV

MX v/s ZY, AIR 1997 Bomb 406Non-discrimination (Constitutional)

provisions apply to State bodies, not to the Private sector: Need a law

NEW DRUG APPROVALS [1989-2000]

1,035 new drugs approved by US FDA (1989-2000)

Only 15% of new drugs approved in 1989–2000 were highly innovative priority NMEs.

In India it is estimated 12,000 pharmaceutical applications have been filed mostly relating to incremental improvement over existing old drugs. “Changing Patterns of Pharmaceutical Innovation”, National Institute for

Health Care, Management Research and Educational Foundation, May 2002

No therapeuticbenefit overexisting

Therapeutic benefit

76% %

24%

Ever-greeningPharmaceutical companies obtain patents on

different aspects of the same drug to extend their monopoly. Eg: formulations, salts, esters dosages, combinations, etc.

Due to this, a single drug has multiple patents.This prevents introduction of generic versions of the

drug even after the expiry of the original patent. e.g. : Combivir is a combination of Zidovudine and

Lamivudine.

Product patents confer absolute monopoly whereas process patents confer a relative monopoly

Indian Companies were able to reduce prices because of no product patent production in India from 1972 on wards

Indian companies could reverse engineer and make better and cheaper drugs

EFFECT OF COMPETITION ON PRICES

TRIPS REGIMEMinimum standards of intellectual property protection with

effect from 1 January 1995.What is patentable?: Invention which

is new, involves an inventive stepand is capable of industrial application. [Article 27]

Protection to both products and processes [Article 27]Period of protection: Minimum 20 years [Article 33]Varying deadlines for developing and least developed

countries on condition of provisions for Exclusive Marketing Rights and mailbox facility [Article 70]

Prospective operation: Inventions on or post 1 January 1995

Dispute settlement mechanism [Article 64]Non-compliance can lead to imposition of sanctions.

India became TRIPS compliant from 1st January 2005 Introduced product patent protection for 20 years

Section 3 (d) Indian Patent ActWhat are not inventions [Section 3 (d)]:

The MERE DISCOVERY OF A NEW FORM OF A KNOWN SUBSTANCE which does not result in the enhancement of the known efficacy of that substance OR the MERE DISCOVERY OF ANY NEW PROPERTY OR NEW USE of a known substance OR of the MERE USE of a known process, machine or apparatus unless such know process results in a product or employs at least one new reactant [Section 3(d)]

Explanation: “salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. [Explanation to Section 3(d)]

Novartis v/s Union of India upheld the constitutional validity of Section 3 (d)

Oppositions to Patent Applications Procedure for Pre-grant and Post grant oppositions Lawyers Collective has done a large number:- Gleevec Combivir Atazanavir Amprevaviragenerase Valganciclovir Tenofovir Kaletra soft gel Lopinavir Rtonavir Abacavir Sulfate Efavirence NevirapineHemihydrate Pegasys

FREE TRADE AGREEMENTS (FTAs)

FTAsare bilateral and regional trade agreements generally between two countries.

Due to the reluctance of the multilateral system in the WTO to introduce new changes providing higher levels of IP protection, the US, EU, Japan has chosen to rely on the bilateral approach.

A number of countries have signed or are negotiating Free Trade Agreements with the US, EU, Japan

These FTAs and BITs contain provision for low level of grant of patents (second uses), patent term extensions, data exclusivity, restrictions on the use of compulsory licenses TRIPS- plus provisions- not required by TRIPs agreement.

Patents are granted more easily; Monopolies and monopoly prices are established; Access to medicines difficult

Criminalization of practices of Vulnerable Groups

Criminalization of HIV transmissionVulnerable Groups in HIV include:-Men Having Sex with MenSex workersPeople using DrugsThey are disproportionately affected by

HIVAsia Commission Report: The future of HIV

in Asia depends how we empower these groups

The practices of such groups are criminalized in a large number of countries

Need to De-criminalization practices of VGWe NEED to Encourage condom use amongst MSM and sex workers

(prevention) Initiate and step up Harm Reduction (Needle Syringe

Programmes: prevention) and scientific Drug Dependence Treatment [Opioid Substitution Therapy (OST)] for people using drugs

This is best achieved by decriminalizing practices of VGsMSM Naz Foundation v/sUnion of India, 2nd July 2009: Delhi High Court Challenged the oldest British law criminalizing “unnatural sex”:

penile non-vaginal sex; Held that consensual sex between adults in private which is

criminalized under British colonial anti-sodomy laws violates the Right to Life, Liberty and Health (Article 21); Discrimination

(Article 14) and Discrimination on the ground of sexual orientation (Article 15)

Thus consensual penile non-vaginal sex between adults in private is no longer criminal

Need to De-criminalization practices of VGSex Workers Though sex work itself has historically not been

criminalized But practices around it (it is now being criminalized,,

brothel running or keeping; Earnings from prostitution; recruitment for prostitution; detaining for prostitution; prostitution in public places; soliciting for prostitution) are penalized;

As a result sex work becomes penalized in practice; Now there is trend to penalize clients of sex workers; These impactdelivery of and access to health services In India the attempt to constitutionally challenge

criminalizing of practices around sex work hasnot been very successful

There areattempts to amend the law to punish clients of sex workers has been thwarted

Swedish model is being promoted all over the world

TowardsDe-criminalizing practices of VGPeople using drugs Possession of small quantities (for consumption) and

Consumption of narcotic or psychotropic substances is penalized

This also has a cultural aspect: alcohol consumption is not penalized

People using drugs are treated as criminals and not persons in need drug dependence treatment

Even if they are given drug dependence treatment; it is notevidence based

People using drugs are not given OST Punjab Petition on people using drugs: Punjab and Haryana

High Court directed that drug dependence treatment protocols be formulated

Self Organization of Vulnerable Groups

All vulnerable groups (directly affected) need to be organized into associations to articulate and exercise their own rights

This is different from NGOs who are not self-organizations of those persons directly affected

They also need to be part of the decision making, implementing and monitoring process

That is how good laws, policies and practices would develop and be formulated, implemented and be monitored

The Mandate of the Special Rapporteur on the Right to HealthThe Special Rapporteur is requested to:

(a) gather, request, receive and exchange right to health information from all relevant sources; (b) dialogue and discuss possible areas of cooperation with all relevant actors, including Governments, relevant United Nations bodies, specialized agencies and programmes, in particular the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS, as well as non-governmental organizations (NGOs) and international financial institutions; (c) report on the status, throughout the world, of the right to health, including laws, policies, good practices and obstacles; (d) make recommendations on appropriate measures that promote and protect the right to health.

Current Issues for the SR:Maternal MortalityAccess to Medicines and TRIPSInformed ConsentHIV/AIDS testing and counseling

The Special Rapporteur is further asked to apply a gender perspective and to pay special attention to the needs of children in the realization of the right

to health, to take into account the relevant provisions, inter alia, of the

Durban Declaration and Programme of Action … and General Recommendation No. 24 (Women and health)

of CEDAW

Maternal Mortality and Women’s Sexual and Reproductive RightsRecent teports on Maternal Mortality in India (Paul

Hunt, 2008; Center for Reproductive Rights, 2009) Almost all cases of maternal mortality are

preventable. Most parts of the world are off-track to meet the MDG target of reducing maternal mortality, and maternal mortality statistics are often a good indicator of a country’s overall respect for the right to health

General Comment No. 14 requires: “measures to improve child and maternal health, sexual and reproductive health services, including access to family planning, pre- and post-natal care, emergency obstetric services and access to information, as well as to resources necessary to act on that information”

Access to Medicines and TRIPS

Special Rapporteur’s Report (2009)A crucial element of the right to health includes

access to essential medicines as defined by WHOThe objectives and principles of TRIPS

emphasize the balance of rights and obligations, providing the basis for countries to utilize flexibilities and adopt IP protection at the national level to meet their public health needs. Article 8 specifically provides that member States may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health.

The practice of ever-greening seriously threatens progress towards access to medicines for all

A rights-based approach to access to medicines is particularly important with regards to accessing expensive treatments such as second-line drugs for HIV and TB

Informed ConsentForthcoming Special Rapporteur’s

ReportThe right to free and informed consent

allows a patient to exercise autonomy in becoming informed about and making health care decisions

Informed consent is difficult to achieve due to inherent imbalances in the doctor-patient relationship, but it forms the basis for providing adequate counseling and treatment to patients, particularly in the realm of HIV/AIDS and tuberculosis

Certain vulnerable groups are at high risk of having their right to informed consent violated, especially in medical research

Role of the Special RapporteurThe Special Rapporteur on Health can examine,

monitor, advise, and publicly report on human rights violations world wide.

Communications: NGOs, individuals can send communications and individual complaints to the SR. SR will send the Communications through the Geneva office of the country concerned

Thematic Reports: SR is mandated to conduct two thematic reports a year and submitted to the HRC and GA

Country missions: SR is mandated to conduct two country missions a year and submit the report of the mission to the HRC

Contact: specialrapporteurhealth@lawyerscollective.org