Faculty of Arts and Education

Centre for Citizenship and Globalisation

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Pharmaceuticals in Developing and Emerging Economies:
Production, Innovation, and Access to Medicines in the wake of TRIPS

 

Conference Panels


Access to ARVs in Sub-Saharan Africa: implications of the patents amendment bill in India

Panel convenor: Dr Christiane Fischer ( BUKO Pharma-Kampagne, Germany)

Indian firms play a crucial role in manufacturing and exporting affordable generics. India's patent amendment bill (2005) required the introduction of product patents on pharmaceuticals. This reduces the scope for the production and exports of generic versions of antiretroviral (ARV) medicines to suppress the HIV virus and stop the progression of HIV disease. Civil society organisations play an important role through public pressure and dialogue with the pharmaceutical industry and governments in advocating for access to generic ARV drugs.

Speakers

  1. Dr Christiane Fischer (BUKO Pharma-Kampagne)
    Introduction into the issue TRIPS and the Indian patent amendment bill
  2. Ramya Shashedri, Advocacy Officer (Lawyers Collective HIV/AIDS Unit, Bangalore, India)
    The problem of patenting incremental innovantions and the advantes of section 3d.
  3. Professor Andy Gray (University of Durban, South Africa)
    Impact of the Indian patent law on access in SSA
  4. Mr. Bhavesh Shah (Vice President International Operations, Hetero Drugs, Hyderabad, India)
    The impact for the generic industry
  5. Dr Chinu Srinivas (Locost, India)
    Which role should the industry play, chances and challenges for the future
  6. Dr. Gopal Dabade MD (All India Drug Action Network (AIDAN))
    Moderator/chair

The panel will

  • present the results from a systematic literature review on the issue
  • examine the extent to which access to ART is threatened in Sub-Saharan Africa
  • explore the implications of the Indian patent amendment bill (2005)

Pharmaceuticals Production: Environmental, Social and Political Dimensions

Panel convenor: Dr G. Vijay (The University of Hyderabad, India)

The pharmaceutical bulk drugs industry has been characterized as a Sun Rise industry. Although the benefits of production reflected in the value of the product, patents acquired, export earnings, employment etc., are emphasized, the costs of engaging with this industrial segment is often underplayed. Pharmaceutical and bulk drug manufacturing could in-fact be characterized as dirty goods segment since its production involves emission of polluting, toxic and hazardous effluents. In the absence of international process standards, self-regulating corporate social responsibility or good manufacturing practices, and effective regulatory legal mechanisms, Pharmaceutical and Bulk Drug manufacturing could involve undesirable ecological dumping and cost shifting. Often characterized as environmental injustice, dumping of toxic and hazardous pollutants involves adverse ecological, livelihood and health outcomes for poor, marginalized and vulnerable. Based on the case study of Pharmaceutical and Bulk Drug Manufacturing cluster in several Industrial Development Areas of Medak district of Andhra Pradesh, this panel brings to relief both these dimensions of dynamics of regulation of pollution involving controversies around corporate self-regulation and failure of legal, institutional mechanisms and social concerns involving food safety, ecological and health issues.

Speakers

  1. Prof. V. Sudarshan Rao (Food and Drug Toxicology Research Center, National Institute of Nutrition, Hyderabad)
    Pharmaceutical Industrial Pollution and Food Safety
  2. Mr Bidhan Chandra Singh (Former Toxics Campaigner and Currently Projects Manager with Greenpeace India)
    Social Impact of Hazardous Waste Dumping by Pharmaceutical Industries in Medak District
  3. Dr K. L. Rao (Whole-time Director, Jeedimetla Effluent Treatment Limited)
    Pharmaceutical Production, Pollution and the Experience of JETL
  4. Dr. G. Vijay (Lecturer, Dept. of Economics, University of Hyderabad)
    From Anomaly to Systemic Distortion; Understanding Phamaceutical Industrial Pollution and Regulatory Failure

The panel will:

  • examine dynamics of regulation of pollution involving controversies around corporate self-regulation and
  • examine the failure of legal, institutional mechanisms and social concerns involving food safety, ecological and health issues

Biosimilars/biogenrics in Developing Countries: Challenges and Opportunities

Panel convenor: Prof. Mohamed A Eldawy (Emeritus Professor and Founding Dean, Faculty of Pharmacy, Tanta University, Tanta, Egypt)

Speakers:

  1. Prof. Mohamed A Eldawy Tanta University, Egypt
  2. Dr Sriram Akundi V., Head of Quality and Regulatory Affairs, Biocon, Bangalore
  3. Dr. Krishna Ella, Chairman and CEO, Bharat Biotech, Hyderabad
  4. Dr Wael Mohamed Ebied, SEDICO Pharmaceutical Co., Egypt

This panel will:

  • present the perspectives of all stakeholders on the issue
  • examine the status of North-South and South-South collaboration in this therapeutic arena
  • discuss lessons to be learned from Indian home grown biotechnology
  • explore the road forward

Alternative R&D Funding Models: Should the IPR system be Abandoned?

Panel Convenor: Professor Manohar Rao (The University of Hyderabad, India)

Speakers:

  1. Professor Pranav Desai, Chairperson, Centre for Studies in Science Policy, Jawaharlal Nehru University
  2. Dr Dinesh Abrol (NISTADS)
  3. Dr Zaki Thomas (CSIR)
  4. Prof. Javed Iqbal, The University of Hyderabad, India)
  5. Prof. Haribababu, The University of Hyderabad, India)
  6. Mr James Love, Director of Knowledge Ecology International (KEI), USA
  7. Mr Philip Soos, Deakin University, Australia

Free Trade Agreements and Access to Medicines: A real or imagined threat?

Panel Convenor: Ms Kajal Bhardwaj (Legal Consultant, Delhi, India)

In 1994, developing and least developed countries reluctantly agreed to accede to the TRIPS Agreement. In the course of negotiating TRIPS, these countries negotiated some hard fought safeguards. In 2005, they won an acknowledgment from all WTO members that TRIPS had an impact on health and the Doha Declaration signed as a result re-iterated the right of all WTO members to fulfil their obligations of the right to health and in particular access to medicines for all. Yet, these hard fought for safeguards have been negotiated away by several countries over the years in the context of free trade agreement negotiations. The first wave of FTAs by the US contained several TRIPS-plus measures and evidence of their impact on access to medicines is now available. Yet the pressure to adopt these TRIPS-plus measures continues from developed countries most notably the European Union (EU).

Now India is negotiating Free Trade Agreements with the EU and Japan. Both negotiations feature TRIPS-plus demands. Will India accept the TRIPS-plus measures being proposed through these FTAs and what implications will this have not just for India and the Indian generic industry but for access to treatment across the developing world. This Panel explores not only the specific demands and provisions of these FTAs and their impact but also the larger connections between global trade and global health.

Speakers:

  1. Dr. Mohammed El-Said (Lancashire Law School, University of Central Lancashire (UCLAN), UK)
    Free Trade Agreements and TRIPS-plus measures: A review of evidence on the impact on access to medicines and treatment
  2. (Lawyers Collective HIV/AIDS Unit) (TBC)
    Undermining India’s Public Health Safeguards: A review of the EU and Japan FTA negotiating texts
  3. Leena Menghaney (Campaign for Access to Essential Medicines, Doctors Without Borders)
    Shutting Down the Pharmacy of the Developing World
  4. K.M. Gopakumar (Third World Network)
    The New Intellectual Property Enforcement Agenda: FTAs, ACTA, WHO, WCO and all the acronyms you need to know
  5. Dr. Owain Williams (Centre for Health and International Relations, Aberstwyth University, UK)
    Bilateral trade deals and the Global Governance of Access: Broad Trends and Implications
  6. Mr. Anand Grover (UN Special Rapportuer on the Right to Health) (TBC)
    Discussant
  7. Dr. Hans Lofgren (School of International and Political Studies, Deakin University)
    Moderator/Chair

The Panel will:

  • review Evidence of the impact of FTAs on access to medicines
  • provide an update on the state of negotiations between India and the EU and Japan
  • discuss the changing global trade and IP scenario and its possible impact on access to healthcare and medicines

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13th September 2010