Pharmaceutical IP: Issues in Ethics and Equity

Manimuthu Gandhi, VIT University Law

Panel

Panel 4: Drug Cost and Access II

Moderator

Gordian Hasselblatt, Partner, CMS Hasche Sigle

Description

Bio-pharmaceuticals provide hope for the treatment of debilitating diseases including autoimmune diseases, metabolic disorders, degenerative diseases, blood disorders and cancer. However, patenting of Biotech products very often raised bioethical, moral and public policy issues. Bio ethic issues arise in the context of the dignity of the human being, consent to medical treatment, freedom of research, the consent of the donor of human genetic material, access to health care and distribution of health resources, and equitable access to the outcomes of biological research, as well as animal protection and environmental ethics. When biotechnological innovations are made involving human beings, genetic materials etc. by violating bioethics the products become ineligible to be patented. The case in point is gene patenting which is not permitted in most of the jurisdictions. Another problem is the high cost involved in R&D of biopharmaceuticals which giving rise to fixation of high price for the biologics that obviously results in the exclusion of poor patients from accessing to life saving medicines. This inequity has been addressed by a number of measures such as differential pricing in different geographical area, parallel imports, compulsory licensing on public interest, consensual licensing, Government negotiation with pharma companies to reduce the price at least for the poor section of the people. Concessions in price as a corporate social responsibility, providing biopharmaceuticals to the developing countries under Public Private partnership are certain additional measures suggested to address the equitable distribution of biopharmaceutical drugs to meet the stated aspirations of the world in Universal Declaration on Bioethics and Human Rights and SDG3 affordable medicines for all. Yet the problem of high price of biopharmaceutical drugs continued to be the concern of vast majority of population both in the developing and the developed world. This needs to be addressed at all levels.

Speaker Bio

Professor Dr. M. Gandhi, Dean, VIT School of Law,VIT University, Chennai Campus, Chennai (2015 – till date)

Previous position held:

  • Professor & Executive Director, Centre for International Legal Studies, Jindal Global Law School, O.P. Jindal Global University, Sonepat (Haryana) NCR of Delhi (2012-2015)
  • Joint Secretary & Legal Adviser in the Ministry of External Affairs, Government of India.

Education:

  • Ph. D in International and Constitutional Laws, Department of Legal Studies, University of Madras, Madras, (March 1992).
  • Holds a Masters Degree (M.L) in International and Constitutional Laws from the Univesity of Madras and also a Masters Degree (MA) in Political Science & Public Administration from Madurai Kamaraj University.

Fellowships/Prizes/Honors

  • Recipient of L.C. Miller Gold Medal for best performance in M.L. Degree Examinations of University of Madras. (First Class, First.) May1981.
  • Recipient of A.L. Mudaliar Prize for best performance in M.L, Degree Examinations, May 1981.
  • Madras University Research Fellow, Department of Legal Studies, 1983.
  • Underwent a course in Legal Advice and International contracts under Colombo Plan in the Institute of Advanced Legal Studies, University of London, UK, in 1997.
  • UNITAR Visiting Fellow, Columbia Law School, New York, spring 2005.
  • Taught International Law, Constitutional Law and Jurisprudence for around 17 years in the Indian Universities, co-authored Books and published a number research articles in International law.
  • Joined the Legal and Treaties Division of the Ministry of External Affairs in 1995.

Experience: U.G and PG Law Teaching around 20 years. Administrative Experience in the Government of India for more than 17 years.

Other Important assignments:

  • Served as Member Secretary to the High Level Committee of Government of India to formulate legislation on civil liability for nuclear damage (2001-2002) and submitted a Report to the Department of Atomic Energy; Government of India on that basis the Govt.of India formulated legislation on this aspect.
  • Served as Government of India’s Special Adviser to the Government of Mauritius to assess the prospects of its legal claim to Chagos archipelago (2001)
  • Served as one of the counsel’s for India in the case concerning Aerial Incident of August 10, 1999 (Pakistan v India) in the International Court of Justice, The Hague, The Netherlands, (April 2000).
  • Served as Legal Adviser to the Permanent Mission of India to UN, New York, from 1May 2002- February 2006.
  • Represented India in the VI (Legal) Committee of the United Nations from May 2002 to January 2006.
  • Served as elected member of the Finance Committee of the International Sea Bed Authority, Jamaica, from 2003-2006.
  • Member of the Indian delegation to 30th International Conference of the Red Cross and Red Crescent(2007) Geneva.
  • Commonwealth Red Cross and Red Crescent international humanitarian Law Conference, Newzealand (2007)
  • Member of the negotiating team CCW(cluster Munitions),Member of the Indian delegation to Underwater Cultural Heritage Convention (UNESCO).
  • Member of the delegation to discuss organized crime (UNODC)
  • Lectured on “International criminal tribunals and ICC “ during the South Asian Teaching Session on Humanitarian Law organized by ICRC in Bangalore (2007) and Vishakapatnam (2008)
  • Delivered a Lecture in Hague Academy of International law External Course: 2013 titled :Peaceful uses of the Indian Ocean and the Challenges for the 21 Century and the Functioning of the International Sea Bed Authority, at Gujarat National Law University, Gandhi Nagar, 8 November 2013.
  • Represented India in UNCITRAL Working Groups including Arbitration Working Groups.
  • Representing India in the Asian African Legal Consultation Organization from 2006 - 2012.
  • Published a number of articles in scholarly journals in India and abroad.

Location

Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA

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Apr 5th, 11:45 AM Apr 5th, 1:30 PM

Pharmaceutical IP: Issues in Ethics and Equity

Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA

Bio-pharmaceuticals provide hope for the treatment of debilitating diseases including autoimmune diseases, metabolic disorders, degenerative diseases, blood disorders and cancer. However, patenting of Biotech products very often raised bioethical, moral and public policy issues. Bio ethic issues arise in the context of the dignity of the human being, consent to medical treatment, freedom of research, the consent of the donor of human genetic material, access to health care and distribution of health resources, and equitable access to the outcomes of biological research, as well as animal protection and environmental ethics. When biotechnological innovations are made involving human beings, genetic materials etc. by violating bioethics the products become ineligible to be patented. The case in point is gene patenting which is not permitted in most of the jurisdictions. Another problem is the high cost involved in R&D of biopharmaceuticals which giving rise to fixation of high price for the biologics that obviously results in the exclusion of poor patients from accessing to life saving medicines. This inequity has been addressed by a number of measures such as differential pricing in different geographical area, parallel imports, compulsory licensing on public interest, consensual licensing, Government negotiation with pharma companies to reduce the price at least for the poor section of the people. Concessions in price as a corporate social responsibility, providing biopharmaceuticals to the developing countries under Public Private partnership are certain additional measures suggested to address the equitable distribution of biopharmaceutical drugs to meet the stated aspirations of the world in Universal Declaration on Bioethics and Human Rights and SDG3 affordable medicines for all. Yet the problem of high price of biopharmaceutical drugs continued to be the concern of vast majority of population both in the developing and the developed world. This needs to be addressed at all levels.