1. The Right to Health Care A.P. den Exter A.denexter@erasmusmc.nl

2. Structure -The Right to Health: Legal Framework -Justiciability -Example: Big Pharma and access to medicines -Discussion

3. Right to Health in International Law: IHR and Trade law IHR Law: -Article 25 Universal Declaration and article 12(1) International Covenant on Economic, Social and Cultural Rights (ICESCR): 'highest attainable standard of physical and mental health' -Constitution World Health Organization (WHO): 'a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity' -Regional documents such as: the American Convention on Human Rights; the African Charter on Human Rights; the Biomedicine Convention Trade Law: -International Labour Organization (ILO): Social security Conventions -World Trade Organization (TRIPS)

4. Meaning of a right to health care Article 12(2) ICESCR General Comment No. 14 on Health ‘Minimum core obligations'- Non-compliance to ‘core obligations’ violates treaty Implementation by national legislation Consequences Non-state parties

5. Justiciability of a right to health National (Constitutional) Courts Eur. Convention on Human Rights: –ECrtHR: concept of ‘positive obligations’ linked to health care Art. 2 (life): safety measures nuclear tests Art. 3 (torture): forced examination/feeding prisoners, deportation aliens, forced therapeutic intervention Art. 8 (private life): health insurance entitlement –Reference to Biomedicine Convention

6. Example Pharmaceuticals

7. Access to Pharmaceuticals and ITL: Patents and Public Health -TRIPS Agreement: Patent Rights -Dilemma: Innovation and access essential medicines -Doha Declaration and Public Health: compulsory patent licensing system

8. Pharmaceuticals and Human Rights -Access to pharmaceutical care -International treaty law State obligations -Responsibilities Big Pharma (HR Guidelines SR) and corporate liability under IHRL -Unethical clinical trials -Big Pharma ’ s indifference to third world killers -Solutions

9. Discussion statements -The enforcement of patents over essential drugs should be classified as a breach of human rights - Pharmaceutical patents are justified within international HRL, as they promote R&D which is essential for future enhancement of rights to life and health.

10. Case I: Novartis Challenges India's Patent Law New Delhi/Geneva — A challenge against India's patent law filed by the Swiss pharmaceutical company Novartis will be heard in the Chennai High Court in India today. The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) warns that the case may have serious implications for future access to essential drugs worldwide. Novartis is challenging a crucial part of Indian law that protects patients from the patenting of trivial improvements of known molecules. Novartis is also seeking to have a January 2006 decision to reject its patent application for the cancer drug Gleevec reversed, and is seeking review by the Chennai High Court. "If Novartis' challenge against the Indian patent law is successful, a key safeguard that can protect the production of affordable medicines will be lost," said Ellen 't Hoen, policy director at MSF's Campaign for Access to Essential Medicines. "People the world over who rely on India as a source for their medicines may be affected if Novartis gets its way." India has been a crucial source of affordable generic medicines; 84 percent of the AIDS drugs MSF uses to treat over 60,000 patients in more than 30 countries are generic medicines produced in India. India began reviewing pharmaceutical product patent applications in 2005, when it was required to become fully compliant with World Trade Organization rules on intellectual property. The Indian patent law has strict criteria regarding which inventions qualify for patenting, and allows for any party to oppose a patent before it is granted. In 2005, cancer groups filed the first ever 'pre-grant opposition', against Novartis' patent application for Gleevec. MSF has supported similar oppositions filed by patient groups in India against patent applications on key AIDS drugs. "The public health safeguards of the Indian Patent law have given hope to many who depend on the manufacture of generics. The Novartis litigation is a direct challenge to those safeguards," said Leena Menghaney, MSF campaigner in India. Novartis claims that Section 3(d) of the Indian Patents Act is not compliant with the WTO rules outlined in the agreement on Trade-related Aspects of Intellectual Property (TRIPS). Section 3(d) formed a substantial part of the basis on which the Gleevec patent was originally denied. Many public interest and health groups will be watching the case closely, as the Gleevec patent order set an important precedent for the examination of other drug patent applications. September 26, 2006

11. Case II: Karara case Facts: A citizen of Uganda, is detained facing deportation from Finland. Request for a further residence permit were refused, given his criminal behaviour. Applicant has been treated against his HIV infection. A. is divorced. Question: expulsion Uganda violation of the ECHR?

12. Case IIIStrategy for Health Care Development in Montenegro... The former health care system of the Republic of Montenegro was part of the health care system of the former SFRY, which was characterized by irrational and inefficient organization while promoting access to all health care rights. In that way a picture was formed that citizens have rights to any kind of health care service, regardless of necessity, but without previously developing the conscience of citizens that every health care service has its price and that health care is not free.... source: MoH, Montenegro, 2005 During the latest health care system reforms, the MoH in Podgorica (Montenegro) requests for legal advice on the introduction of a more market based health insurance system. Task: Identify the relevant topics for regulation and discuss the general outlines of the legal framework, while taking into account both international health law and Art. 57 of the Constitution, reading: “Everyone shall be entitled to health care. Children, expectant mothers and elderly persons shall be entitled to publicly financed health care, if they are not covered by another insurance program.” Question: What would be the outcomes of such a discussion, advising the MoH?