Dr. Warwick Neville Regulatory Institutions Network Australian National University 17 June 2005

1. Patient Rights or Patent Rites?Justice and a Jurisprudence of HealthPatent Law, Health Care & Access to Essential Medicines Dr. Warwick Neville Regulatory Institutions Network Australian National University 17 June 2005

2. Patient Rights or Patent Rites? Justice and a Jurisprudence of Health It is in justice that the ordering of society is centred Aristotle Those who share Law must also share Justice; and those who share these are to be regarded as members of the same commonwealth. …our whole discourse is intended to promote the firm foundation of States, the strengthening of cities, and the curing of the ills of peoples. Cicero Justice is the constant and perpetual desire to give each man his due right. …These are the precepts of the law: to live justly, not to injure another and to render to each his own. Justinian And so if justice is left out, what are kingdoms except great robber bands Augustine

3. Jurisprudence & Ethics – • Themes and Principles: • To protect • To educate • To regulate

4. WHO definition of Health Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. “Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19-22 June, 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948.” The Definition has not been amended since 1948.

5. The Hippocratic Oath (extract: 5th century BC) I swear by Apollo the healer, by Aesculapius, by Health and all the powers of healing, and call to witness all the gods and goddesses that I may keep this Oath and Promise to the best of my ability and judgment. … I will regard [the sons of my master in the Science] as my brothers and teach them the Science, if they desire to learn it, without fee or contract. I will hand on precepts, lectures and all other learning to my sons, to those of my master and to those pupils duly apprenticed and sworn, and to none other. I will use my power to help the sick … … Whenever I go into a house, I will go to help the sick and never with the intention of doing harm or injury.

6. Universal Declaration of Human Rights (1948) Preamble Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world, … Whereas the peoples of the United Nations have in the Charter reaffirmed their faith in fundamental human rights, in the dignity and worth of the human person and in the equal rights of men and women, and have determined to promote social progress and better standards of life in larger freedom, Whereas Member States have pledged themselves to achieve, in cooperation with the United Nations, the promotion of universal respect for and observance of human rights and fundamental freedoms, Whereas a common understanding of these rights and freedoms is of the greatest importance for the full realization of this pledge, • Article 25 • Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and • the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. • 2. Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.

7. World Medical Association Declaration of Ottawa on the Rights of the Child to Health Care Adopted by the 50th World Medical Assembly Ottawa, Canada, October 1998 • PREAMBLE • The health care of a child, whether at home or in hospital, includes medical, emotional, social and financial aspects which interact in the healing process and which require special attention to the rights of the child as a patient. • Article 24 of the 1989 United Nations Convention on the Rights of the Child recognises 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, and states that nations shall strive to ensure that no child is deprived of his or her right of access to such health care services. • In the context of this Declaration a child signifies a human being between the time of birth and the end of her/his seventeenth year, unless under the law applicable in the country concerned children are legally recognized as adults at some other age.

8. Declaration of Helsinki World Medical Association (2000) It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

9. World Medical Association International Code of Medical Ethics Adopted by the 3rd General Assembly of the World Medical Association, London, England, October 1949 and amended by the 22nd World Medical Assembly Sydney, Australia, August 1968 and the 35th World Medical Assembly Venice, Italy, October 1983 A PHYSICIAN SHALL respect the rights of patients, of colleagues, and of other health professionals and shall safeguard patient confidences. A PHYSICIAN SHALL act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. A PHYSICIAN SHALL use great caution in divulging discoveries or new techniques or treatment through non-professional channels. A PHYSICIAN SHALL certify only that which he has personally verified. DUTIES OF PHYSICIANS TO THE SICK A PHYSICIAN SHALL always bear in mind the obligation of preserving human life. A PHYSICIAN SHALL owe his patients complete loyalty and all the resources of his science. Whenever an examination or treatment is beyond the physician's capacity he should summon another physician who has the necessary ability. A PHYSICIAN SHALL preserve absolute confidentiality on all he knows about his patient even after the patient has died. A PHYSICIAN SHALL give emergency care as a humanitarian duty unless he is assured that others are willing and able to give such care. DUTIES OF PHYSICIANS TO EACH OTHERA PHYSICIAN SHALL behave towards his colleagues as he would have them behave towards him. A PHYSICIAN SHALL NOT entice patients from his colleagues. A PHYSICIAN SHALL observe the principles of the "Declaration of Geneva" approved by the World Medical Association.

10. Declaration of Geneva World Medical Association (Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 46th WMA General Assembly, Stockholm, Sweden, September 1994) AT THE TIME OF BEING ADMITTED AS A MEMBER OF THE MEDICAL PROFESSION: I SOLEMNLY PLEDGE myself to consecrate my life to the service of humanity; I WILL GIVE to my teachers the respect and gratitude which is their due; I WILL PRACTICE my profession with conscience and dignity; THE HEALTH OF MY PATIENT will be my first consideration;I WILL RESPECT the secrets which are confided in me, even after the patient has died; I WILL MAINTAIN by all the means in my power, the honor and the noble traditions of the medical profession; MY COLLEAGUES will be my sisters and brothers; I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, or social standing to intervenebetween my duty and my patient; I WILL MAINTAIN the utmost respect for human life from its beginning even under threat and I will not use my medical knowledge contrary to the laws of humanity; I MAKE THESE PROMISES solemnly, freely and upon my honor.

11. We have among us men of great genius, apt to invent and discover ingenious devices… …if provision were made for the works and devices discovered by such persons, so that others who may see them could not build them and take the inventor’s honour away, more men would then apply their genius, would discover, and would build devices of great utility and benefit to our Commonwealth. [emphasis added] Venetian Patent Statute 1474

12. Darcy v Allen (1602) • The Case of Monopolies • Monopolies are odious things for four reasons: • All trades are profitable for the commonwealth. To grant another a monopoly is against the common law and the “equity of the law of God.”. • 2. Granting a monopoly damages others who labour in the same trade but also it provides a private gain solely for the benefit of the patentee who, in turn, will have regard only to his private wealth and not to the common good. • Granting a monopoly deprives others of their trade and therefore leads to impoverishment. • Granting a monopoly is a dangerous precedent and should not be granted in the realm. Monopolies restrained trade and did not allow the passing on of knowledge to the next generation. They were regarded as being not only in restraint of trade but, by definition, a restraint against the bono publico.Knowledge was intended to be passed on to the next generation to encourage the transfer and growth of valuable trades and technologies. It was not, and should not be, the privilege of a few individuals.

13. Statute of Monopolies (1624) Declared all monopolies for the sole buying, selling, making or using of anything in the realm to be void – subject to the exception in s IV, which enabled the granting of a monopoly in relation to an appropriate subject matter, that is, a “manner of a new manufacture” by an inventor.

14. The Right to Health & Access to Medicines in Australia – • The Pharmaceutical Benefits Scheme: Lessons from History • 1943 – 1949: Five (5) Pharmaceutical Benefits Acts • 1943, 1944 & 1945 Joint Committee on Social Security • 1946 & 1949: Two (2) High Court Challenges • 1946 Successful Constitutional Amendment • 1953 National Health Act

15. We are accounted poor citizens, the patricians good; What authority surfeits on, would relieve us … The leanness that afflicts us, the object of our misery, Is as an inventory to particularise their abundance; Our sufferance is a gain to them. Let us revenge this with our pikes, ere we become rakes: For the gods know. We speak this in hunger for bread, And not in thirst for revenge. Coriolanus: Act 1, Scene 1 Used by President Nelson Mandela in his speech to the Joint Houses of Parliament of the United Kingdom, Westminster Hall, London 11th July 1996

16. IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION) Case no: 4183/98 In the matter between: PHARMACEUTICAL MANUFACTURERS’ ASSOCIATION OF SOUTH AFRICA AND OTHERS Applicants and THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA AND OTHERS Respondents and TREATMENT ACTION CAMPAIGN (TAC) Amicus Curiae

17. Amendments to the South African Medicines and Related Substances Control Act No. 101 of 1965 Section 15C The minister may prescribe conditions for the supply of more affordable medicines in certain circumstances so as to protect the health of the public, and in particular may- • notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act No. 57 of 1978), determine that the rights with regard to any medicine under a patent granted in the Republic shall not extend to acts in respect of such medicine which has been put onto the market by the owner of the medicine, or with his or her consent; • prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the Republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the council in the prescribed manner, may be imported: • prescribe the registration procedure for, as well as the use of, the medicine referred to in paragraph (b).

18. NOTICE OF MOTION IN THE HIGH COURT OF SOUTH AFICA (TRANSVAAL PROVINCIAL DIVISION) Case number: 4183/98 In the matter between: THE PHARMACEUTICAL MANUFACTURERS' ASSOCIATION OF SOUTH AFRICAFirst Applicant ALCON LABORATORIES (S.A.) (PROPRIETARY) LIMITEDSecond Applicant BAYER (PROPRIETARY) LIMITEDThird Applicant BRISTOL-MYERS SQUIBB (PROPRIETARY) LIMITEDFourth Applicant BYK MADAUS (PROPRIETARY) LIMITEDFifth Applicant ELI LILLY (SOUTH AFRICA) (PROPRIETARY) LIMITEDSixth Applicant GLAXO WELLCOME (SOUTH AFRICA) (PROPRIETARY) LIMITEDSeventh Applicant HOECSHT MARION ROUSSEL LIMITEDEighth Applicant INGELHEIM PHARMACEUTICALS (PROPRIETARY) LIMITEDNinth Applicant JANSSEN-CILAG PHARMACEUTICA (PROPRIETARY) LIMITEDTenth Applicant KNOLL PHARMACEUTICALS SOUTH AFRICA (PROPRIETARY) LIMITEDEleventh Applicant LUNDBECK SOUTH AFRICA (PROPRIETARY) LIMITEDTwelfth Applicant MERCK (PROPRIETARY) LIMITEDThirteenth Applicant MSD (PROPRIETARY) LIMITEDFourteenth Applicant NOVARTIS SOUTH AFRICA (PROPRIETARY) LIMITEDFifteenth Applicant NOVO NORDISK (PROPRIETARY) LIMITEDSixteenth Applicant PHARMACIA & UPJOHN (PROPIETARY) LIMITEDSeventeenth Applicant RHONE-POULENC RORER SOUTH AFRICA (PROPRIETARY) LIMITEDEighteenth Applicant ROCHE PRODUCTS (PROPRIETARY) LIMITEDNineteenth Applicant SCHERING (PROPRIETARY) LIMITEDTwentieth Applicant SCHERING-PLOUGH (PROPRIETARY) LIMITEDTwenty-First Applicant S.A. SCIENTIFIC PHARMACEUTICALS (PROPRIETARY) LIMITEDTwenty-Second Applicant

19. SMITHKLINE BEECHAM PHARMACEUTICALS (PROPRIETARY) LIMITEDTwenty-Third Applicant UNIVERSAL PHARMACEUTICALS (PROPRIETARY) LIMITEDTwenty-Fourth Applicant WARNER-LAMBERT S.A. (PROPRIETARY) LIMITEDTwenty-Fifth Applicant WYETH (PROPRIETARY) LIMITEDTwenty-Sixth Applicant XIXIA PHARMACEUTICALS (PROPRIETARY) LIMITEDTwenty-Seventh Applicant ZENECA SOUTH AFRICA (PROPRIETARY) LIMITEDTwenty-Eight Applicant BAYER AGTwenty-Ninth Applicant BOEHRINGER-INGELHEIM INTERNATIONAL GmbHThirtieth Applicant BOEHRINGER-INGELHEIM KGThirty-First Applicant BRISTOL-MYERS SQUIBB COMPANYThirty-Second Applicant BYK GULDEN LOMBERG CHEMISCHE FABRIK GmbHThirty-Third Applicant DR. KARL THOMAE GmbHThirty-Fourth Applicant ELI LILLY AND COMPANYThirty-Fifth Applicant F. HOFFMAN-LA ROCHE AGThirty-Sixth Applicant MERCK KGaAThirty-Seventh Applicant MERCK & CO., INC.Thirty-Eighth Applicant RHONE-POULENC RORER S.A.Thirty-Ninth Applicant SMITHKLINE BEECHAMFortieth Applicant WARNER-LAMBERT COMPANYForty-First Applicant OLIVER CORNISHForty-Second Applicant

20. And THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA, THE HONOURABLE MR N.R. MANDELA N.O.First Respondent THE SPEAKER OF THE NATIONAL ASSEMBLY, THE HONOURABLE DR. F.N. GINWALA N.O.Second Respondent THE CHAIRPERSON OF THE NATIONAL COUNCIL OF PROVINCES, THE HONOURABLE MR. M.G.P. LEKOTA N.O.Third Respondent THE MINISTER OF HEALTH, THE HONOURABLE DR. N.C. DLAMINI ZUMA N.O.Fourth Respondent THE CHAIRPERSON OF THE PORTFOLIO COMMITTEE ON HEALTH [NATIONAL ASSEMBLY], THE HONOURABLE DR. A.S. NKOMO N.O.Fifth Respondent THE CHAIRPERSON OF THE SELECT COMMITTEE ON SOCIAL SERVICES [COUNCIL OF PROVINCES], THE HONOURABLE DR. S.C. CWELE N.O.Sixth Respondent THE CHAIRPERSON OF THE MEDICINES CONTROL COUNCIL, PROFESSOR P.I. FOLB N.O.Seventh Respondent THE PREMIER OF THE GAUTENG PROVINCE, THE HONOURABLE MR. M. MOTSHEKGA N.O.Eighth Respondent THE MEMBER OF THE EXECUTIVE COMMITTEE FOR HEALTH OF THE GAUTENG PROVINCE, THE HONOURABLE MR. A. MASONDO N.O.Ninth Respondent THE REGISTRAR OF PATENTS MR. C. BURTON-DURHAM N.O.Tenth Respondent

21. I believe the question is not to be opposed to patents. The solution is not to abolish the patent system. But protecting human life must take precedence over protecting intellectual property. There are safeguards, compliant with the international WTO agreements and incorporated already in many developed countries’ legislation, to address this imbalance; including paralleling imports, compulsory licenses, and strategies to accelerate the introduction of generics. Affidavit of Carmen Perez-Casas (par.12) The Pharmaceutical Manufacturers’ Association of South Africa and Others V. The President of the Republic of South Africa and Others and Treatment Action Campaign

22. The passage of a measure through the legislature confers a unique stamp of democratic legitimacy, valuable in a country possessing democratic traditions. Moreover, the legislative process is exposed to, and provides a safety valve for, those community pressures which, if not released in this way, build up to levels dangerous to the system itself. An elected legislature as the identified and visible maker of laws can be seen to be responsive to legitimate pressures and to the strongly held views of the community. Sir Ninian Stephen (1981) quoted by Professor Louis Waller, “Regulating Birth Technology," (1998) 7 Res Publica 18-24 at p.20

23. You know as well as we do that right, as the world goes, is only in question between equals in power, while the strong do what they can and the weak suffer what they must. Thucydides, The Peloponnesian War