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

KEYNOTE PAPER TITLES

Professor D. Balasubramanian - The birth and growth of the pharma and biotech industry in Andhra Pradesh- a ringside view.
Professor Bhargava P. M. -
'Medical and Health Care Scenario in 2050: Where India can contribute'
Dr Mira Shiva -
Access to Medicines , IPR and Public Health
James Love -
Strategy for de-linking R&D costs and drug prices, for sustainable innovation with access for all
Dr Usha Ramanathan
- ‘Pharmaceutical Production: Risk, Responsibility and Reparation’
Anand Grover - The future of access to medicines

ACCEPTED ABSTRACTS

Conference stream 1 : The pharmaceutical industry in the global South: country studies

PPN 013 - Assessing the impacts of Herbal Medicinal Products Research outcomes in Nigeria (A Dilemma of Universities Social Responsibility and Public Bureaucracy)
PPN 071 - Influence of Pharmaceutical Trade and Regulations on Medicine’s Affordability in Developing Countries
PPN 080 - Pharmaceutical Manufacturing in South Challenges and Scope
PPN 086 - Implication of TRIPS Agreement on the Pharmaceutical Sector of South Asia.
PPN 090 - Dynamics of Lobbies and Interest Groups in Indian Pharmaceutical Sector
PPN 091 - Compulsory Licensing As Public Policy Intervention: Case Of Pharmaceutical Industry

Conference stream 2 : TRIPS and national flexibilities: cases and disputes

PPN 005 - Knowledge management: Aspects related with Drug Pricing in India
PPN 007 - Product Patents and Access to Medicines: A Critical Review of the Implementation of TRIPS Patent Regime
PPN 009 -Providing Essential & Cost Effective Medicines to the Poor –A Global Perspective
PPN 010 - IPR In Indian Pharmaceutical Sector
PPN 014 - TRIPS and the Global Pharmaceutical Market
PPN 043 - Patent Battles in India and National Flexibilities-What is in Stake for consumers?
PPN 063 - TRIPping towards legitimacy? - A Public Health Norm in the World Trade Organization
PPN 075 - Impact of Trade and TRIPS on Affordability of Medicine in Tanzania

Conference stream 3 : Access to appropriate and affordable medicines

PPN 006 - Need to Reframe Drug Prices Control Order
PPN 008 - Access to Medicines in Developing Economies under Competition Law
PPN 015 - Trade and Access to Health in EMRO Countries: Current Status and Future Outlook
PPN 019 - Pharmaceutical Patents, Public Health and Access to Essential Medicines: Indian Patent law in post – TRIPS context
PPN 020 - Public funded research. What can tech transfer managers contribute to enhance access to medicine?
PPN 030 - Human Rights, TRIPS and Access to Medicines in India
PPN 034 - Patents and Access to Medicines:The Politics of AIDS Treatment in Brazil
PPN 036 - ‘The political domain of Global Health Governance: Norms, Tensions and Challenges’
PPN 050 - Understanding the TRIPs plus trend and access to medicines: a long view
PPN 064 - Analysing the issues in evergreening in the pharmaceutical sector from the developing countries’ perspective
PPN 065 - Novartis And Legal Battle for Access to Medicines
PPN 069 - Free Trade Agreements, TRIPS-Plus and Access to Health: The Arab World's Experience
PPN 070 - In Transit (Patent) Infringement Trouble Under TRIPS and Beyond
PPN 076 - Impact of European Union on Affordability of Medicine in African LDCs
PPN 081 - Access to Medicines and Pharma Industry in the aftermath of TRIPS: A transnational perspective
PPN 085 - Impact of Post-Trips Scenario: Drug Patents v. Access to Life
PPN 093 - Drug Price Controls and Access to Medicines in India
PPN 098 - Globalizing health tourism in South Asia: An issue of accessibility and affordability of medicines
PPN 099 - The Problems of Pharmaceutical Patents and Potential Solutions

Conference stream 4 : Business strategies in the pharmaceutical industry: perspectives from the South

PPN 021 - Comparative analysis of Indian pharmaceutical and medical devices sector
PPN 044 - Business strategies for SME pharmaceutical companies in the Product patent era
PPN 045 - Successful Business Models of Affordable Innovation in Indian Bio-pharmaceutical and Healthcare Sectors
PPN 067 - Human Capital Management Strategies: A Survey of the Indian Life Sciences Industry
PPN 074 - Path Dependence to Path Creation: Evolving Dynamic Capabilities of Indian Pharmaceutical Companies
PPN 082 - Role of Science Parks and Technology Business Incubators in Improving Healthcare Access and Needs

Conference stream 5 : Pharmaceutical manufacturing in the South: political, economic, social and environmental dimensions

PPN 002 - Export Potential of Herbal and Medicinal Plants as a Sourse of Alternative Medicine
PPN 029 - Operational and R&D Efficiencies of Indian Pharmaceutical Firms in Product Patent Regime
PPN 049 - Economic Implications of Pharmaceutical Manufacturing Industry in India
PPN 066 - Has Life become cheap when Drugs are costly?: an enquiry in the issue of Public Health in the Post Doha Round



PPN 002- Export Potential of Herbal and Medicinal Plants as a Sourse of Alternative Medicine

Asst. Professor Shaili Vadera, Ms. Payal Srivastav & Associate Professor Vinod Singh*
Amity Business School, Amity University, Lucknow Campus, India & * Department of Economics, Lucknow University

Abstract:
This paper is an attempt towards studying the export potential and opportunities related to Medicinal and Aromatic Plants to meet the demand of prominent industries, pharmaceuticals, cosmetics, for commercial purposes for sustainable rural development. Almost 80% of the world’s population depends on herbal medicine for their primary health care requirements. India is currently having 8.13% of the global market share as compared to that of China which has 28% of the world’s market share. India has registered 20% growth since last financial year. The exports of herbs during the year of 2007-08 were Rs. 470.73 crore against Rs 377.02 crore during 2006-07. India is rapidly emerging as a key player for supplying medicinal plants to the world. India’s major export destinations include countries like US, Germany, Russia, the UK, Taiwan, the UAE, Hong Kong and Malaysia.

Bio - Asst. Professor Shaili Vadera, Ms. Payal Srivastav & Associate Professor Vinod Singh

Shaili Vadera is Assistant Professor at Amity Business School, Amity University Uttar Pradesh, Lucknow. Her qualifications include Post Graduate Diploma in Business Management, M.A.(Economics), B.Sc. (Life Sciences), UGC NET June 2009, and presently pursuing Ph.D. from Department of Economics, Lucknow University. She has 7 years of Academic and industry experience and has published several papers.

Payal Shrivastava graduated B.Com(computer application) from V.I.T. University . Currently, doing M.B.A( Agribusiness) from Amity University Lucknow Campus.

Acknowledgement:
Dr Vinod Singh, Associate Professor, Department of Economics, Lucknow University, and PhD Supervisor who has given valuable contributions in bringing out the final paper.


PPN 005 - Knowledge management: Aspects related with Drug Pricing in India

Associate Professor Avinash Ganbote & Assistant Professor Neelkanth Dhone
Institute of Management, Pune, India

Abstract:
Health and its value is issue of debate all over world in last decade. Demand and supply sides of healthcare and its microeconomic evaluation is important issue of various aspects of intellectual property and its commercialization in terms of Intellectual Property Rights (IPRs). Establishment of market equilibrium as a result of demand and supply of health inputs and its monitoring mechanism is the area of study which is fast emerging in terms of health economics. Some factors which play important role in health economics are government intervention, uncertainty about patient outcome and financial concerns. Drug research and its actual cost in this equilibrium is debatable issue in international front. India as signatory to WTO is affected to some extend by this relationship between commercialization of patents and deadweight loss incurred due to IPRs and its resulting economic inefficiency. Imbalance of information and its implications in provision of drug cost in terms of patented and proprietary medicine is the impending factor leading to economic studies of this particular subject. Complex demand structure is observed for pharmaceutical goods due to presence of therapeutic substitute of drug and practice of drug manufacturer to differentiate their products through the use of trade marks and advertising. If patents are protected; the patent holder has monopoly for the chemical entity, but still competes with producers of therapeutic substitute. This makes TRIPs Flexibilities as important factor to solve impending issues related with availability of medicine in developing countries. Attempt is made in this paper to comment on issues pertaining to developing countries, particularly India.|

Bio -Associate Professor Avinash Ganbote & Assistant Professor Neelkanth Dhone

Dr Avinash Ganbote completed his graduation in Pharmaceutical Sciences (B.Pharm), Post Graduation (M.B.A.) and Doctorate in Management Studies (Ph.D.) from University of Pune, India. His area of specialization is Marketing Management; Organizational Management and Economic Environment of Business .He has teaching experience of about 17 years in Pharmacy and Management schools. Presently working as Associate Professor in Management Institution affiliated to Pune University, teaching subjects like Managerial Economics, Business Policy and Strategic Management and Project Management. He is interested to work in the area of Health economics so as to contribute positively in setting drug pricing models equally catering needs of Innovative entrepreneurs and availability of essential medicines at right price. He is life member of Professional organizations like Indian Pharmaceutical Association (IPA), Association of Pharmaceutical Teachers of India (APTI).He is member and Board of Director of Rotary club undertaking various social projects for local community.

Neelkanth C. Dhone is an engineering graduate with mechanical as specialization. Then completed post graduation in Master of Business Administration with Marketing as core and Production as dual specialization. Currently he is working as faculty with Shivnagar Vidya Prasarak Manadal’s Institute of Management. Baramati,Dist Pune, India. He is having total five years of experience in teaching, with good command in Basics of marketing, Retail Management, Services Management, and Supply chain management. In addition to that he got registered for Ph.D programme in National Institute of Industrial Engineering. Mumbai, which is of international repute. He has presented papers in various national and international conferences. He has also participated in two A.I.C.T.E sponsored Q.I.P programme.


PPN 006 - Need to Reframe Drug Prices Control Order

Mr Amit D. Arkad
Bombay College of Pharmacy, Mumbai.

Abstract:
The expenditure on health care has increased significantly in the last two decades. India is a country where 37% of the population still lives below the poverty line. Nearly 50% of healthcare costs are contributed by expenditure on drugs. The drug prices in India are controlled using what is called the Drugs Prices Control Order (DPCO). The DPCO is an order issued by the government under Section 3 of the Essential Commodities Act, 1955 empowering it to fix and regulate the prices of essential bulk drugs and their formulations. The first objective of DPCO was to make available essential drugs and prophylactics of good quality at affordable prices. Study was done on various aspects of current DPCO including current drug list, drug classes and total market share for these drugs. The data about the disease condition in India was obtained from committee’s setup for DPCO assessment and NGO organizations. It was noted that there has been onset of new diseases, increasing drug resistance and large variations in prices of branded drugs in this decade. The sera, vaccines, and drugs for non communicable diseases, which often carry the burden of lifelong therapy and require multiple medications are not under price control. So criteria for drugs under price control are not in tune with public health realities. The paper discusses the various drawbacks of the current drug price control regulation with respect to the company and Government policies. It also suggests some principles in order to fulfill the objective of providing drugs at affordable prices and also encouraging research and development.

Bio - Mr Amit D. Arkad

Amit Arkad is a final year student of Pharmacy in Bombay College of Pharmacy. His research interest includes pharmacoeconomics studies and Intellectual property rights-specifically patents. He intends to pursue masters degree in Innovation management. He is a member of Indian Pharmaceutical Association and Drug Information Association.


PPN 007 - Product Patents and Access to Medicines: A Critical Review of the Implementation of TRIPS Patent Regime

Mr K M Gopakumar
Legal Advisor and Senior Researcher, Third World Network(TWN), New Delhi, India

Abstract:
In 2005, India amended its Patents Act, 1970 to introduce TRIPS compliant product patent regime. Generally speaking, law and policy makers in India during the time of amendment were confronted with two major concerns viz. the future of the Indian pharmaceutical industry and access to affordable medicines in India and other developing countries. To address these concerns India along with many other developing countries attempted to incorporate TRIPS flexibilities in their domestic law. However, the success of the TRIPS flexibilities in addressing the question of access to affordable medicines mainly depends on three factors: a) the incorporation of flexibilities in the domestic law; b) the manufacturing capability of a country; and c) the political will to use the public interest safeguards provided in the domestic law. There are only a few countries like India, which satisfy the above-mentioned conditions to a certain extent. This article examines whether these premises holds true after five years into the implementation of the TRIPS compliant patent system in India. In this context the paper identifies and analyses the legal, policy and institutional challenges that India is currently facing in the implementation of TRIPS flexibilities. It also identifies the main legal, policy and institutional disconnect in the implementation of TRIPS flexibilities in India. It argues that to effectively use TRIPS flexibilities to address access to affordable medicines require changes in three areas viz law, policy and institutions. It clearly shows that mere incorporation of TRIPS flexibilities in the domestic legislation alone is not enough and the domestic legislation needs to be complemented with policy and institutional framework.

Bio -Mr K M Gopakumar

Legal advisor and Senior Researcher with the Third World Network(TWN). Educational qualifications : LL.B, LL.M (International Law), LL.M (IPR and Human Rights) and M.Phil (International Law). Since 1997 working on issues related to the implementation of TRIPS patent regime and its implications on access to medicines. Some select publications.

  • K M Gopakumar and Nirmalya Syam, “Health Services Liberalization in India” in Rupa Chanda (Editor), Trade in Services and India, Prospects and Strategies”, Wiley India, 2006.
  • Biswajit Dhar and K M Gopakumar, “Post-2005 TRIPS Scenario in Patent Protection in the Pharmaceutical Sector: The Case of the Generic Pharmaceutical Industry in India” (ICTSD-UNCTAD), 2006.
  • Biswajit Dhar and K M Gopakumar, “Data Exclusivity in Pharmaceuticals: Little Basis, False Claims”, Economic and Political Weekly (EPW), December 9 2006.
  • K M Gopakumar and Dr. Sanjeev Saxena, “Seeds Bill: For Whom?” Journal of Indian Law Institute (JILI), December 2005.
  • K M Gopakumar and Tahir Amin, “Patents Amendment Bill 2005: A Critique”, Economic and Political Weekly (EPW), April 8, 2005
  • K M Gopakumar, “The WTO Deal on Cheap Drugs: A Critique”, Journal of World Intellectual Property, Vol.7, No.7, January 2004

PPN 008 - Access to Medicines in Developing Economies under Competition Law

Dr. Tu Thanh Nguyen
Lecturer of Law, Ho Chi Minh City School of Law, Vietnam

Abstract:
IPRs are an important incentive and reward for innovation and the commercialization of such innovation. The protection of IPRs has now been globalized under the minimum standards established by the TRIPS Agreement. However, the protection and enforcement of IPRs should benefit both innovators and innovation users “in a manner conducive to social and economic welfare” by creating balanced rights and obligation among these “stakeholders”. The TRIPS Agreement and other international intellectual property conventions contain flexibilities that may facilitate access to medicines by developing countries. One such flexibility is the use of domestic competition law. Developing countries have rarely applied domestic competition law to promote access to IPRs and patented medicines. This is due to many reasons, especially the under-development of competition law in developing countries and the complexity of the interface between IPRs and competition law. It appears that the developing world is trying to use public-health related flexibilities to increase access to medicines. However, such limited flexibilities alone cannot solve all of the issues relating to access to medicines and medical devices. In May 2008, the WHO adopted its global strategy and plan of action on public health, innovation and intellectual property, which encourages and promotes the use of competition law and policy in order to improve availability and affordability of medicines. Therefore, the purpose of this paper is to investigate, through a handful of relevant cases in developing countries, whether and to which extent these countries can adopt and enforce domestic competition law in order to promote access to medicines under the support of competition flexibilities in the TRIPS Agreement.

Bio - Dr. Tu Thanh Nguyen

Dr. Tu T. Nguyen specializes in business law, including IPRs, competition law, WTO law and banking law. He has had 46 publications. He is currently Lecturer of Laws at the Ho Chi Minh City School of Law (Vietnam). He was a researcher and lecturer at the Faculty of Law, Lund University (Sweden); a trainee at the WTO (Switzerland); a scholarship holder at the Max Planck Institute for Intellectual Property, Competition and Tax Law (Munich, Germany); a visiting scholar at the Suffolk University School of Law (Boston, MA, US); and a visiting researcher at the Faculty of Law, Copenhagen University (Denmark).


PPN 009 - Providing Essential & Cost Effective Medicines to the Poor –A Global Perspective

Mr Chakrapani Kambhampati
Deputy Manager, Matrix Laboratories Limited, India
Conference stream: TRIPS and national flexibilities: cases and dispute

Abstract:
Medicines are too expensive to be bought by the people who need them the most. The two major challenges for Affordable & essential medicines to the poor are the high cost of existing medicines and the absence of effective treatments for many diseases affecting our patients. According to the World Health Organization (WHO), up to 90% of the population in developing countries purchases medicines through out-of-pocket payments, making medicines the largest family expenditure item after food. In Uganda, the annual cost of purchasing effective medicines to treat just malaria was equivalent to 62 days of household basic food costs. Studies have also shown that availability of essential medicines is often poor in the public sector where prices are usually cheaper, forcing patients to resort to the more expensive private sector. Since 2002, the Clinton HIV / AIDS Initiative (CHAI), a project of the WJ Clinton foundation, has assisted countries in implementing large –scale, integrate care, treatment and prevention programs. According to the UN Special Reporter on the Right to Health, ‘Almost 2 billion people lack access to essential medicines. Improving access to existing medicines could save 10 million lives each year, 4 million of them in Africa and South-East Asia. Access to medicines is characterized by profound global inequity. 15% of world’s population consumes over 90% of the world’s pharmaceuticals.’22 Though public spending in poor countries has increased, it is still not enough.23 Budgets are under enormous strain and medicine purchases can make up a significant proportion of total public spending. Novartis (Philippines) has voluntarily reduced the current retail price of its anti-psychotic brand of Clozapine, Leponex by 35 % to work with the government in providing more Filipino patients access to affordable essential medicines.Eisai India, has set up a mfg site in the state of Andhra Pradesh in India is gearing up to begin mass production in April will "produce low-price drugs that patients in emerging countries can afford". Globally, all Pharmaceutical Companies should ensure that there is abundant availability of good quality essential medicines at reasonable prices and to strengthen domestic capability for cost effective quality production of medicines. Access to medicines is fundamental for people to achieve their right to health.

Bio -Mr Chakrapani Kambhampati

Currently working with Mylan-Matrix (Mylan is the world’s third largest producer of generic and specialty pharmaceuticals & Mylan is the Second-largest Generic Pharmaceutical Company in the United States with a global commercial footprint that spans more than 140 countries and territories). Currently I am working as a Deputy Manager with Mylan-Matrix and previously worked with Dr Reddy's Laboratories Limited in Global Quality. Earlier to that, worked for Reputed Companies in Formulations.

10 years of experience in Pharma Industry in different capacities in Mktg, Quality Mgmt & Operations with globally reputed Pharmaceutical Companies. Trained 400- 500 people voluntarily (Fresh out of college who are entering the Pharma Industry) on different topics to enhance their knowledge levels so as to empower them and to share the knowledge what I have & to share the Learnings from the Industry.


PPN 010 - IPR In Indian Pharmaceutical Sector

Mr.Hirak V.Joshi, Mr Thakor R.S & Mr Patel J.K
Nootan Pharmacy college, Visnagar, India

Abstract:
Intellectual Property Rights (IPR) has evolved over the years as a strategic tool to create and sustain competitive positions in the global marketplace. Patents protect inventions that are novel, non-obvious and demonstrate utility. Pharmaceutical companies generally try to protect their innovations and build up the brands. A patent gives the monopoly to the owner up to 20 years. TRIPs, the intellectual property component of the Uruguay round of the GATT Treaty, has given rise to an acrimonious debate between the developed countries and less developed countries (LDCs). They also asserted that IPRs would benefit the developing countries by encouraging foreign investment, by enabling transfer of technology and greater domestic research and development (R&D). On the other side, LDC governments were worried about the higher prices that stronger IPRs would entail and about the harm that their introduction might cause to infant high tech industries. India was very actively involved in opposing the TRIPs component of the GATT agreement, especially the proposal for product patents on pharmaceuticalinnovations. Indira Gandhi succinctly summed up the national sentiment at the World Health Assembly in 1982: "The idea of a better-ordered world is one in which medical discoveries will be free of patents and there will be no profiteering from life and death." Now that India has signed the treaty, though most unwillingly, it is committed to introducing pharmaceutical product patents 2004, a value analysis i.e. cost-benefit analysis of this move is essential for India. First some history.

Bio - Mr.Hirak V.Joshi, Mr Thakor R.S & Mr Patel J.K

Hirak Joshi is a lecturer working at Nootan Pharamcy College, visnagar affiliated to hemchandracharya North Gujarat Unviersity, Patan and Gujarat Technological University Ahmedabad. He is also doing Ph.D at Jodhpur national university, Jodhpur and interested in research in Pharmaceutical analysis and method development as well as in study of impurity profile. He is engaged in academic field from last four years.

Mr.Rashmin Thakor is a lecturer working at Nootan Pharamcy College, visnagar affiliated to Hemchandracharya North Gujarat Unviersity, Patan and Gujarat Technological University Ahmedabad. He is also doing Ph.D at HNGU Patan. Interested in research in Pharmaceutical Technology and nanotechnology. He is engaged in academic field from last four years.

Dr.J.K.Patel is a Professor and Principal, Nootan Pharmacy College, Visnagar-384315, Gujarat, India. He has more than 14 years of academic and research experience, has published more than 140 research and review papers in international and national journals, and has presented more than 128 research papers at various international and national conferences as author and coauthor. Dr. Patel has guided 38 M Pharm students for dissertation work and 28 students are currently pursuing their PhDs under his guidance. Recently his research project recommended for Fast Track Young Scientists-2008, by Department of Sciences and Technology, Government of India, New Delhi worth of Rs 19.40 Lacs.


PPN 013 - Assessing the impacts of Herbal Medicinal Products Research outcomes in Nigeria (A Dilemma of Universities Social Responsibility and Public Beuracracy)

Mr Hamidu Oluyedun

Abstract:
Herbal Medicinal Products (HMPs) help meet some Primary Health Care Needs of up to 80% of the population in Africa, and in Nigeria, Ghana, Mali and Zambia the first line of treatment for 60% of children with malaria is the use of HMPs at home. The Global Market for HMPs currently stands at over US $60 billions annualy and it is growing steadly. The reseachers in faculties of pharmacy, medicinal chemistry and drug development units in Nigeria Universities and allied Institutions had made it a priority the scientific exploration of HMPs to clear misconceptions rergarding safety and efficacy, and to develop new and effective products from herbs. The study aimed at assesssing impacts of HMPs research outcomes on Health Care Institutions, and to know factors hindering or enhancing fulfilling of Universities social responsibilty. This is a descriptive survey study in 3 Federal Universities in Nigeria from three geo-political zones and 9 Health Care Institutions (HCIs) three from each geopolitical zones. Stratified random sampling was used in picking the 3 univerities and convinient sampling techniques used for the 9 HCIs. The quantitative data collected using 600 structured questionnaires for HCIs were analysed using simple percentages and graphical representations. The 30 in-depth interviews result for the reseachers and 27 key-informants interviews from HCIs admnistration were analysed contextually and ethnographically. Comparatively, there was a better collaboration on information between the 3 Universities and 3 Teaching Hospitals but admnistrative bottlenecks did not allow for clinical evaluation of new HMPs. NAFDAC (regulatoty agency) was seen as a stumbling blocks against drug discovery, drug screening, pre-clinical safety, toxicity testing and evaluations. The results from other 6 HCIs showed that only 5% testified to availability of HMPs information and products in their institutions. The result reviewed that 80% of respondents from HCIs are not adequately informed on research outcomes. Qualititative analysis showed that beuaracracy, formalisation, inadequate funding and suspicions were the bane to effective collaboration. The Universities research outcomes were still far from meeting its social responsibilty to the societies. There is need for freedom of information and economics empowerement to be able to achieve evidenced-based and value-based research oriented academias. The problems of alienation, hegemony and complexes between Universities and HCIs need to addressed.

Keywords: herbal medicinal products; health care institutions; safety and efficacy; research outcomes, primary health care, and needs.

Bio - Mr Hamidu Oluyedun

Born on 13th February 1961 in Ibadan, Nigeria. Graduated as a Pharmacist in 1989, Second degrees in Human Nutrition(1998) and Sociology(2005). Part I fellowship in 2006. An Instructor/Facilitator, Guest lecturer in Schools of Hygiene/Nursing.


PPN 014 - TRIPS and the Global Pharmaceutical Market

Associate Professor Alluri V. N. Varma & Associate Professor Y.Rama Krishna
P.G.Courses& Research Centre, D.N.R.College, Andhra Pradesh, India

Abstract:
This paper reviews the international controversy over patents and access to drugs in developing countries and explores the implications of the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, the 2001 Doha Declaration, and the 2003 agreement preceding the Cancun meeting. These agreements do not resolve the important funding issues that developing countries confront as they seek access to drugs. Also, the international debate and its resolution will complicate the importing of foreign pharmaceuticals into the United States and strengthen pressures both for expanding public support of U.S. drug purchases and, in the long run, for political control of U.S. pharmaceutical pricing. For the past sever al years there has been a widespread, bitter debate over access to pharmaceutical products in developing countries. The debate has focused largely on access to antiretroviral agents for HIV patients in sub-Saharan Africa. A group of nongovernmental organizations (NGOs) has argued that patents on these drugs in the developing world raise the prices of the products necessary to help such patients survive, whereas the research-based pharmaceutical industry has argued that many of the relevant products are not on patent in the countries involved and that the problem is not patents but inadequacy of the medical infrastructure.

Bio - Associate Professor Alluri V. N. Varma & Associate Professor Y. Rama Krishna

Dr.Alluri V. N. Varma is an Associate Professor in Economics in the P.G.Courses & Research Centre at D.N.R.College, Andhra Pradesh, India.

Dr Y.Rama Krishna is an Associate Professor in Economics in the P.G.Courses & Research Centre at D.N.R.College, Andhra Pradesh, India.


PPN 015 - Trade and Access to Health in EMRO Countries: Current Status and Future Outlook.

Dr Mohamed A Eldawy, Ph.D.,
Emeritus Professor and Founding Dean, Faculty of Pharmacy, Tanta University, Tanta, Egypt

Abstract:
The presentation will provide an overview of the impact of globalization on access to healthcare products and services in the 22 countries of the WHO's Eastern Mediterranean Region(EMRO), encompassing:

A)-An analysis of the IP regimes in place in each country of the EMRO region and their implications regarding access to medicines and health technologies that cover:

  1. Membership and accession status of the member states of the region with reference to WTO, WIPO, US/EU bilateral agreements, other intergovernmental bodies.
  2. The status of developments and modifications in the national patent laws of the region with reference to WTO& WIPO membership as well as because of bilateral agreements, analyzing their public health sensitivity.
  3. Lessons learnt from utilization of the "Transitional Period" and "Mail Box" applications in low income countries in the region.

B)-Identification of priority countries in the region which need assistance in this area, outlining the nature of this assistance in the technical directly trade related as well as in the indirectly trade related scientific/technological domains. Also identification of relevant institutions and researchers in each of these countries which can help provide real life solutions to face the challenges imposed by globalization.

C)-Providing an implementable time phased plan of action commensurate to the specific needs of each country, thus moving from words to deeds. The proposed country specific action plans delineate the rational, aims and purpose, role and functions, strategic directions of the work to be done by Ministries of health and other stakeholders during 2011and 2012 in order to materialize outcomes of the 63rd World Health Assembly(May 2010, Geneva) focusing on resolutions addressing its agenda item titled " Public health, innovation and intellectual property:global strategy and plan of action".

Bio - Dr Mohamed A Eldawy, Ph.D.,

Mohamed A Eldawy, B Pharm.Sci.(Cairo Univ.-1960).-M Sc. (Alexandria Univ.)-Ph.D (Univ. of Illinois, Chicago, USA).Professor and founding Dean, Faculty of Pharmacy, Tanta Univ. , Tanta, Egypt. Consultant for (several local, regional (EMRO"WHO" & MENA) and international healthcare products/services firms/institutions/organizations providing training and capacity building programs addressing their regulatory, scientific, technological, R&D, QA and trade-related IP needs. Teaching and research healthcare product's QC/QA and evidence based computer aided drug design and discovery.


PPN 019 - Pharmaceutical Patents, Public Health and Access to Essential Medicines: Indian Patent law in post – TRIPS context

Mr Pawan Kumar Pandey
Lecturer in Law, Dr. Ram Manohar Lohiya National Law University, Lucknow, India

Abstract:
The TRIPS Agreement , from its inception, has given rise to a discordant debate between the developed countries and less developed countries. The developed countries assert huge losses from the imitation and use of their innovations in less developed countries. They also assert that establishing strong intellectual property rights would actually benefit the less developed countries by encouraging foreign investment, the transfer of technology and greater domestic research and development. On the other side, less developed countries determinedly oppose this view, worrying about the higher prices that stronger intellectual property rights would bring and about the harm that their introduction might cause to toddler high tech industries in these countries. At the risk of oversimplification it can be said that no country was more actively involved in opposing TRIPS Agreement than India and no part of TRIPS was, and continues to be, more sensitive than the mandate for granting product patents for pharmaceutical innovations.

No issue, Patents encourage industries to engage in capital-intensive R&D because of getting option of charging monopoly prices and reaping high profits. But, as a reasonable consequence, that very monopoly prevents generic manufacturing and affects the prices and availability of the finished drugs in market. TRIPS gives considerable importance to public health, social, and economic concerns. It provides, the protection of intellectual property rights shall promote technological innovation and the transfer of technology “in a manner conductive to social and economic welfare, and to a balance of rights and obligations.” Appropriate measures may be taken to prevent abuse of intellectual property rights as long as they fall within the provisions of TRIPS. Instead, the TRIPS Agreement has come under fierce criticism because of the effects that increased levels of patent protection will have on drug prices.

The most recent three amendments to the Indian Patents Act, which have introduced a TRIPS consistent patent regime in the country, were brought about in the backdrop of intense debates that were focused on the need to establish a balance between the rights of the patent holders and the interests of the public at large. By purposely excluding pharmaceutical products from patent protection for more than three decades, India became a world leader in high-class generic drug manufacturing. But India’s becoming a member of the GATT /WTO, compelled it to once again grant patents on pharmaceutical products. From the perspective of millions suffering worldwide from life-threatening diseases, many of whom were previously benefited from the low-cost products of India’s blooming generic drug manufacturing industry, the introduction of a pharmaceutical product patents regime in India can obviously be viewed as an international healthcare catastrophe.

The present article aims to critically analyse the provisions of the India’s Patents Act, 1970 (2005) as far as they relate to the Pharmaceutical innovations with a view to trace the shift in Indian Patent law in post – TRIPS context. Attempt has also been made to investigate as to how, Indian Patent system as a successful intellectual property regime, has stricken a balance between creating incentives for innovation and protecting citizens’ access to essential medicines. Due reflection has also been made on recent judicial decisions from the Indian Courts viz., Cases involving Novatis, Roche and Bayer etc..

Bio - Mr Pawan Kumar Pandey

Pawan Kumar Pandey has previously served as Lecturer in Law at University of Delhi and National Law University, Jodhpur. He has done his B.Sc. from Puranchal University and has taken his LL.B. and LL.M. degrees from Banaras Hindu University. He has written his LL.M. dissertation on the topic “Infringement of Copyright and Moral Rights.” He is pursuing his Ph.D. on the topic “TRIPS Compliance of the Product Patent Regime in India with special reference to Pharmaceutical Products” from Babasaheb Bhimrao Ambedkar University (A Central University), Lucknow. He was recipient of UGC Merit Scholarship during LL.B. studies and Government of India National Scholarship during LL.M. studies. He has been actively involved in research and writings in the field of Intellectual Property Law. He has been member of Chair in IPR at the National Law University Jodhpur established by Ministry of Human Resource Development, Government of India. He has also coordinated a National workshop on Copyright and has presented research papers at several national conferences and seminars. In May 2008 he was invited by Albert-Ludwigs University, Freiberg, Germany to present a research paper in “Indo-German Conference on IPR”. During his visit to Germany he also participated in round – table meet on “Innovation in India: Current Policy and Trends” organized by the BMW Foundation. Again, he visited the European Patent office (EPO), Munich, and participated in the deliberations on “EC-ASEAN Intellectual Property Rights Co-operation Programme”. His special areas of interest are Intellectual Property Law, Information Technology Law, World Trade and WTO.


PPN 020 - Public funded research. What can tech transfer managers contribute to enhance access to medicine?

Dr. Christiane Fischer, Prof. Dr. Christine Godt, Dr. Peter Tinnemann, & Dr. Christian Wagner-Ahlfs,
BUKO Pharma-Kampagne Germany, University of Oldenburg, Germany, Charité University Medical Center, Berlin, Germany & BUKO Pharma-Kampagne Germany*

Abstract:
The project “Medicines for Developing Countries - Equitable and Social Licensing for University Patents” (www.med4all.org) analyses which role technology transfer offices (TTO) of publicly funded research institutions in Germany could play to enhance access to medicine.
In medical reasearch, public funding globally contributes about 50 % of the R&D spending. Therefore TTOs from universities and other publicly funded institutions are responsible towards the public, for example, to ensuring access to their research results. One possible approach to assume responsibility is using equitable licenses. This includes negotiating licenses that for example allow differential pricing of final product or non-exclusive licensing for generic production. Another approach is participation in non-commercial product development partnerships (PDPs).
We surveyed 37 TTOs research results portfolios and their licensing policies. Despite representing numerous inventions that might be relevant for use in developing countries, neither TTO in Germany has ever applied the concept of equitable licensing, nor arranged participation in PDPs.
Our analysis identified several factors that could change this situation, amongst them growing awareness of technology transfer managers for the needs of developing countries. Also a change of political framework by the German Federal Ministry of Education and Research could change the freedom to operate for the TTOs who are currently focused rather on commercial success then on social benefit. As TTO work is committed to certain research institutions, this institutions could adopt policy frameworks which support social licensing policies.

Bio - Dr. Christian Wagner-Ahlfs, Dr. Christiane Fischer, Prof. Dr. iur. Christine Godt & Dr. Peter Tinnemann

Dr. Christian Wagner-Ahlfs, PhD: chemist, Executive Director at BUKO Pharma-Kampagne Germany. Working areas: access to medicine and patents. Coordinating the research project med4all.org. Chair of Health Action International HAI Europe executive board. Until 2008 coordinating HAI global member activities related to “WHO Intergovernmental Working Group on Innovation, Public Health and Intellectual Property rights”.

Dr. Christiane Fischer MD, PhD: Executive Director at BUKO Pharma-Kampagne Germany. Working Areas: access to medicine, patents, TRIPS agreement. Board member of the network Action against AIDS Germany.

Prof. Dr. iur. Christine Godt, lawyer, Professor of European and International Law at the University of Oldenburg, Director Hanse Law School. Her special research interest is IP-law. Her focus in the “Equitable Licenses-Project” is the design of policies for universities and congruent contract clauses which assure the goals of equitable licensing.

Dr. Peter Tinnemann, MD, MPH, PhD is physician and health researcher at the Charité Universitätsmedizin Berlin, with a particular interest in social medicine, access to health care and health in a globalizing world. He holds a Master in Public Health from Cambridge University and has more than 10 years work experiences with various international humanitarian aid organisations.

* Correspondance to Project Coordinator


PPN 021 - Comparative analysis of Indian pharmaceutical and medical devices sector

Mr Dinar Kale
Lecturer in International Development and Innovation, Development Policy and Practise, The Open University, United Kingdom

Abstract:
Over the last decade the Indian pharmaceutical industry has emerged as a leading supplier of generic drugs to both developing and developed countries. The movement of the Indian pharmaceutical industry along the R&D value chain represents a remarkable shift for from public sector driven to private sector oriented innovation. Indian industry moved from an importer of drugs to imitator of drugs and a major supplier of medicines to other developing and advance countries. The Indian government’s industrial policies and adoption of weak regulatory system played a crucial role in shaping development of innovation capability. However compare to success of Indian pharmaceutical industry other crucial sectors in healthcare industry such as medical device industry has not witnessed similar growth. This paper studies factors that supported growth of pharmaceutical industry and issues that hampered development in the medical device industry in India. Evidence presented in this paper is based on the case studies of innovative products and firms in both sectors and for data analysis theoretical framework based on innovation systems literature is used. Initial findings suggest that highly knowledge intensive sector such as medical device requires interactive ecosystem of institutions compared to development of innovations in pharmaceutical industry. Further innovative product development in medical device industry is associated to firms and institutions working closely with practitioners and users unlike pharmaceutical product development where collaboration involves firms working with R&D institute and universities. Research reveals that in post independent era Indian government set up CSIR and other research institutes that created basic ecosystem which supported first, imitation and then innovation in Indian pharmaceutical industry. However Indian government failed to set up eco system of institutions and web of interactions between users and developers required for development of medical device industry.

Bio - Mr Dinar Kale

Dinar Kale currently works as a Lecturer in International Development and Innovation at the ESRC Innogen Centre, The Open University. Dinar holds an MSc in Organic Chemistry (University of Pune), an MBA in Marketing Management (University of Pune) and a PhD (The Open University Business School). He has conducted significant research on evolution of capabilities in the Indian pharmaceutical industry, particularly impact of regulation on capability development, technology and innovation management in Indian pharmaceutical firms. His main research interests include the impact of regulation on delivering health in developing countries, KM in life sciences industries, and innovation management. His work has been published in the reputed journals such as Technology Analysis and Strategic Management, Industry and Innovation, Industrial and Corporate Change and British Journal of Management.


PPN 029 - Operational and R&D Efficiencies of Indian Pharmaceutical Firms in Product Patent Regime

Ms Ishita G. Tripathy*, Professor Surendra S. Yadav** & Dr Seema Sharma***
Research Scholar *, Head of Department **, & Assistant Professor ***
Department of Management Studies, Indian Institute of Technology, Delhi, India

Abstract:
Researchers opine that the change in the patent regime from process to products, in the year 2005, necessitates a change in the growth strategies of Indian pharmaceutical firms. Operational and Research and Development (R&D) competencies of these firms are likely to guide them in the efficient utilization of their scarce resources and thereby lead to their growth. The specific objective of this paper is to examine the relative operational and R&D efficiencies of Indian pharmaceutical firms in the product patent regime. To meet this objective, this paper employs a non-parametric tool, Data Envelopment Analysis, to study primary data for the year 2009, collected from 30 Indian pharmaceutical firms.

Empirical results of this paper indicate that there is a high positive correlation between operational efficiencies and R&D efficiencies. Operationally efficient firms as compared to inefficient ones are bigger, older, more R&D-intensive and are recipients of Foreign Direct Investment (FDI). R&D efficient firms in comparison to R&D inefficient firms are bigger, more export-oriented and are recipients of FDI for their R&D activities. The research findings of this study can help the pharmaceutical industry to formulate appropriate action plans to enhance the pharmaceutical firms’ operational and R&D efficiencies in the new patent era.

Key Words: Product patent regime, operational efficiency, R&D efficiency, pharmaceutical firms, India

JEL Classification: C14, O39

Bio - Ms Ishita G. Tripathy, Professor Surendra S. Yadav & Dr Seema Sharma

Ishita G. Tripathy, a post-graduate in Economics and Population Studies, is pursuing her Ph.D. at the Department of Management Studies, Indian Institute of Technology Delhi, India. Her areas of interest include international finance and development economics.

Surendra S. Yadav is currently Professor of Finance and Head of the Department of Management Studies at the Indian Institute of Technology Delhi, India. He teaches Corporate Finance, International Finance, International Business, and Security Analysis and Portfolio Management. Dr. Yadav has been a Visiting Professor at the University of Paris, Paris School of Management, INSEEC Paris, and the University of Tampa, USA. He has published nine books and contributed more than 115 papers to research journals and conferences. He has also contributed more than 30 papers to financial/economic newspapers.

Seema Sharma is Assistant Professor in the Department of Management Studies at the Indian Institute of Technology Delhi (IIT Delhi), India. Her areas of interest include marketing research, statistical analysis and economics. The major area of research, among others, centres on productivity analysis. Dr. Sharma has participated and presented her research in many national conferences. She has also presented papers in international conferences in United States (University of Miami) and Australia (University of Queensland). She teaches courses in the area of statistics and economics.


PPN 030 - Human Rights, TRIPS and Access to Medicines in India

Ms BA Shilpa
Lecturer, Dept. Of Political Science, Maharani’s Arts, Commerce & Management College for Women, Bangalore, India

Abstract:
The human right to the highest attainable standard of health is present in numerous national constitutions, as well as legally binding international human rights treaties. Access to medicines is a vital feature of the right of everyone to the highest attainable standard of health.
From a public health perspective, access to essential drugs depends on:

  1. rational selection and use of medicines;
  2. sustainable adequate financing;
  3. affordable prices; and
  4. reliable health and supply systems.

With the implementation of TRIPS there is clash between patent system and the access to essential drugs especially for the poor. A “national health disaster” was anticipated by the Indian Drug Manufacturers Association (IDMA) as a result of the implementation of the TRIPS Agreement in the country, where only 30 percent of the population can afford modern medicines in spite of the fact that drug prices in India are one of the lowest in the world. Comparison of prices of drugs between India and countries where patent protection exists indicated that in some cases they are up to 41 times costlier in countries with patent protection.
This paper will analyse the current situation in India with regard to access to essential medicines after the implementation of TRIPS. It will further analyse how right to health as a human right can be protected in the patent regime.

Bio - Ms BA Shilpa

Ms BA Shilpa is presently working as Lecturer, Dept. Of Political Science, Maharani’s Arts, Commerce & Management College for Women, Bangalore, India. She completed her Master of Arts (Political Science) from University of Hyderabad. Her areas of interest are International Relations, Sustainable Development, Human Rights & Public Policy.


PPN 034 - Patents and Access to Medicines:The Politics of AIDS Treatment in Brazil

Dr André de Mello e Souza
Institute for Applied Economic Research, Brazil

Abstract:
Brazil’s widely recognized success in controlling AIDS resulted primarily from its provision of free and universal access to antiretroviral therapies since 1996. Yet, AIDS treatment in Brazil has, from the outset, been challenged by the high costs of patented antiretrovirals. Local pharmaceutical production has thus far ensured the affordability of such treatment both by offering cheaper generic anti-AIDS drugs and by enabling the government to make credible threats of compulsory licensing, thereby successfully negotiating considerable price discounts for patented antiretrovirals with brand-name pharmaceutical multinationals. Domestic and transnational political support helped Brazil resist resulting pressures and retaliations from these multinationals and the US government. This paper provides qualitative and quantitative evidence, gathered through extensive field research, that this strategy has ceased to be effective since 2005, when India and other suppliers of antiretroviral active ingredients to Brazil adopted stricter patent laws in accordance with TRIPS. It argues that the legal and institutional reforms which enable pre-grant patent opposition by health authorities, more flexible and easier compulsory licensing and expedite post-patent generic entry, while important, remain unable to ensure the sustainability of AIDS treatment in Brazil. Rather, the paper concludes that such sustainability depends crucially on further technological capacitation of the Brazilian pharmaceutical industry, without which neither domestic political support nor lax domestic patent rules will suffice in the context of TRIPS. In particular, the command over all phases of antiretroviral production is key for Brazil to exercise bargaining and market power in face of global patent rules and strong external opposition.

Bio - Dr André de Mello e Souza

André de Mello e Souza is a researcher at the Institute for Applied Economic Research, a governmental think-tank which guides and evaluates public policies in Brazil. He previously worked as a university professor, and holds a doctorate in Political Science from Stanford University, USA. His publications concern patents and health.


PPN 036 - ‘The political domain of Global Health Governance: Norms, Tensions and Challenges’

Ms Belinda Townsend
PhD scholar, School of International and Political Studies, Deakin University, Australia

Abstract:
This paper provides a historical analysis of the domain of Global Health Governance with the aim to identify and explore underlying tensions. It is argued that health has been brought onto the global agenda by two competing discursive perspectives. The first seeks to give a ‘voice to the people’, constructing health as a ‘human right’ with priority above trade. This understanding of health is associated with public health advocates, non government organisations and developing states in challenging the implementation of TRIPS. At the same time, health is now viewed as a global security concern. Global infectious disease outbreaks, such as SARS, have brought to the fore the realisation that the global political economy and global trade system can be made unstable by global health epidemics. These perceived threats to health have legitimised the political domain of Global Health Governance. The 2001 WTO Doha Declaration displayed a global recognition of the importance of public health, while renegotiation of WHO International Health Regulations in 2005 and a rise in global surveillance networks have institutionalised health as a security concern for global trade and growth in the global political economy.

Although the landscape of Global Health Governance has come to be recognised as a legitimate policy domain, evident in scholarly journals such as Global Public Health, Globalization and Health, Global Health Governance and Global Health Action, this political domain is fraught with tension between the competing perspectives. ‘Good governance’ is an ideologically laden concept, perceived differently in the perspective of democratic principles and global justice than in debates on security and cost effectiveness. Legitimacy in this domain is also contested; framed in democratic principles and equality or couched in the ability to deliver and achieve goals. This analysis identifies key issues regarding equity, accountability and legitimacy in the global health domain.

Bio - Ms Belinda Townsend

Belinda Townsend is a PhD scholar, School of International and Political Studies, Deakin University, Australia. The author has completed a BAppSc(HealthSc) and BA(Hon) at Deakin University.


PPN 043 - Patent Battles in India and National Flexibilities-What is in Stake for consumers?

Associate Professor Lalitha Narayanan
Gujarat Institute of Development Research, Ahmedabad, Gujarat, India

Abstract:
TRIPS flexibilities particularly those relating to health, address the gap between the multilateral agreements and the concerns on human rights to health. It is estimated that 10 to 15 per cent of the drugs in the Indian market would get affected because of patenting (Grace, 2005). Newer biotech based drugs, innovative drugs for HIV/AIDS, cancer, diabetes, and other diseases where the existing drugs have become ineffective come under this category. CL is a powerful tool and has spread as a movement around 2005, among the African and other countries, where it has been used as an option to (a) gain access to medicines, (b) check anti-competitive situations, (c) negotiate appropriate prices However, as ‘constructive destruction of innovations’ and ‘standing on the shoulders of giants’ are the characteristic features of the pharmaceutical industry, there are a few pre-grant and post-grant patent legal battles going on concerning the life saving drugs in India. These cases revolve around novelty and innovative steps claimed. This paper discusses (a) a few such cases that are currently being fought in India (b) the likely impact of the positive or negative legal outcomes on different stakeholders the (c) potential use of CL and the (d) lessons that could be learnt from the experience of other countries that have used CL.

Bio - Associate Professor Lalitha Narayanan

N.Lalitha, is a Ph.D in Economics and works as an Associate Professor at Gujarat Institute of Development Research, a premier social science research institute in India. Her research focuses on issues relating to access to medicines in developing countries that arise from strengthening intellectual property rights particularly in the field of pharmaceuticals.


PPN 044 - Business strategies for SME pharmaceutical companies in the Product patent era

Professor G.Mohan & Associate Professor Nirmalya Bagchi
Centre for Technology and Innovation,Administrative Staff College of India

Abstract:
India has a large pharmaceutical industry that is globally ranked 3rd in volume terms and 14th in terms of value. The pharmaceutical industry in India is highly fragmented and there are over 20,000 registered units and an estimated 6000 active units. Even the largest company does not command more than 6 % market-share. There is a large number of Small and Medium enterprises (SMEs) in the industry spread across India. There are several pharmaceutical clusters such as Ahmedabad, Hyderabad, Baddi , Indore etc.

Hyderabad is well-known as a Bulk Drug (API) producing centre. This cluster has nearly 250 SMEs producing over 200 different APIs and intermediates. These SMEs not only supply APIs and intermediates to the bigger formulation companies in India, they also export a significant fraction of their production.

The growth and evolution of the API industry in Hyderabad happened during the process patent era of the ‘80s and ‘90s. The implementation of the product patents as a part of TRIPs from 2005 onwards has brought about a radical change in the business strategies of the various industry players, particularly the large generic companies in India.

The business strategies of the generic companies are changing so as to adapt to the product-patent regime. The generic companies are adapting in a variety of ways for example, enhancing the investments in R & D for new drug discovery, filing ANDAs for drugs going off-patents, Para IV filings under Hatch Waxman Act, strategic alliances for contract manufacturing of authorised generics, merging with larger MNCs etc. This has a direct bearing on the APIs and intermediate suppliers to them, namely the SMEs

This paper will take a sample of SMEs from the Hyderabad cluster. Through case studies will identify the challenges faced by them particularly in the wake of patents and tightening regulations. The paper will propose strategies the SMEs can adopt so as to become competitive and innovative under the new regime.

Bio - Professor G.Mohan & Associate Professor Nirmalya Bagchi

Mr. Gopalratnam Mohan, currently Professor, Information Technology Area, Centre for Innovation and Technology, ASCI, is a B.Tech from Banaras Hindu University, Varanasi and an MBA from Xavier Institute of Management, Bhubaneswar. He has over 20 years of industry experience in leading consulting organizations, Tata Consultancy Services and MECON Ltd. His area of interests include application of IT and Internet to Business, Strategic management and Innovation Management.

Dr. Nirmalya Bagchi, currently Associate Professor, Technology Policy, Management and Innovation Area, Centre for Innovation and Technology, ASCI, is an M.B.A. and Ph.D in Business Management in the area of Information Management, from University of Calcutta. Dr. Bagchi has about 8 years of teaching experience and research experience in various management institutions. He has also authored several academic papers and books. His area of interests include Innovation management, Technology and Science Policy. Decision Support Systems.


PPN 045 - Successful Business Models of Affordable Innovation in Indian Bio-pharmaceutical and Healthcare Sectors

Dr S.Balasubrahmanyam*, Dr Prasad Kaipa*, Dr. Prasad VCS*, Mr Sourabh Gargav** & Mr Suresh MV*
*Centre for Leadership, Innovation, and Change (CLIC) & **Biocon Cell for Innovation Management (BCIM)
Indian School of Business, Hyderabad, India

Abstract:
Despite rapid advances in medical knowledge and augmentation of global wealth, health inequity between the rich and the poor has been widening paradoxically. The escalation of dejecting reports on global access to healthcare, right from spiraling infant mortality, to lists of preventable diseases that remain unaddressed or under-addressed, all point to a poignant scenario that needs phenomenal organizational and institutional interventions, particularly in the developing economies. The paper presents a comparative case analysis of two bio-pharmaceutical firms and two healthcare systems based in India that have been widely recognized as successful. Analysis of the business models of these four organizations has revealed adoption of inclusive or affordable innovations via new business models or/and novel technologies. While these business models can take the shape of full-scale vertical integration straddling the entire value chain (e.g., in the healthcare sector), it can as well be a case of a blend of strategic alliances (e.g., in the bio-pharmaceutical sector). In this regard, technological boundary-spanning, if not organizational boundary-spanning seems to be critical in either case. There are limitations in the sampling and data analysis approach, however, this study provides a first step towards a more inclusive empirical research agenda in the future. The paper offers interesting insights for existing for-profit organizations in the dual and allied sectors of healthcare and bio-pharmaceuticals, to rethink their business models, particularly for developing country contexts. It also encourages organizations to explore alternative business models.

Bio -Dr S.Balasubrahmanyam, Dr Prasad Kaipa, Dr. Prasad VCS, Mr Sourabh Gargav & Mr Suresh MV

S. Balasubrahmanyam is currently a post-doctoral fellow at the Centre for Leadership, Innovation, and Change, Indian School of Business, Hyderabad. He holds a bachelor’s degree in mechanical engineering, a master’s degree in marketing management and a doctoral degree in strategic management from Indian Institute of Science, Bangalore.

Prasad Kaipa is the executive director of the Centre for Leadership, Innovation, and Change, Indian School of Business, Hyderabad. He holds both masters’ and doctoral degrees in physics. He has two decades of consulting experience with more than 100 CEOs and other senior level managers of world-class organizations. He was an international marketing manager for Apple Computers and was a research fellow at Apple University.

Prasad VCS is the advisor for Biocon Cell for Innovation Management at the Centre for Leadership, Innovation, and Change, Indian School of Business, Hyderabad. He holds Master’s and Doctoral Degrees in Metallurgical Engineering from Indian Institute of Science, Bangalore and Indian Institute of Technology, Kanpur respectively. He has nearly four decades of industrial experience, right from Bharat Electronics Limited to Tata Consultancy Services as a researcher, at various levels.

Sourabh Gargav is currently working as a Research Assistant in the Biocon Cell for Innovation Management (BCIM) at the Centre for Leadership, Innovation and Change (CLIC) of the Indian School of Business (ISB), Hyderabad. He possesses degrees in Public Policy, Patent Laws, and Microbiology. He has a couple of years of, both, research and industrial experience.

Suresh MV is a research assistant at the Centre for Leadership, Innovation, and Change, Indian School of Business, Hyderabad. He has a master’s degree in Statistics – Operations Researcj from Central University of Hyderabad. He previously worked with Indian Statistical Institute, Kolkata as a statistical trainee.


PPN 049 - Economic Implications of Pharmaceutical Manufacturing Industry in India

Associate Professor V. Y. John
Department of Business Management, Aristotle P. G. College, Hyderabad, India

Abstract:
Indian Economy has been growing at a compounded annual growth rate of more than 8.5% during the years 2003-04 to 2007-08. Later on, it tapered off to 6.5% during the year 2008-09. It is recovering from the year 2009-10 onwards. The role of pharmaceutical industry which is slated to be around Rs.80,000 crores ($ 17 b) is phenomenal. About 30-60% of the turnover of the leading pharmaceutical companies in India is from abroad apart from contributing significantly to the domestic pharmaceutical industry.

The Indian pharmaceutical industry is a significant case of a manufacturing industry contributing to the economic growth in India in a comprehensive sense. Companies like Ranbaxy Laboratories, Dr.Reddy’s Laboratories, Aurobindo Pharma, Lupin Laboratories, Cipla and Sun Pharmaceuticals are some of those which have pursued inorganic growth routes as can be noted from the remarkable acquisitions or mergers which have taken place recently. It is observed that there is an exponential growth in the size of the operations, number of countries to which exports are being made and different segments of products catering to diseases like AIDS, cardiovascular, gastro enteric, carcinogenic and lifestyle diseases. The state of the art technology that is adopted by the companies to incorporate effective quality in the process of manufacturing speaks volumes of how Indian companies have grown to meet the expectations of the global market.

Key words: Active Pharmaceutical ingredients, manufacturing, growth and formulations.

Bio - Associate Professor V. Y. John

V. Y. John is an Associate Professor in Business Management at Aristotle P. G. College, affiliated to Osmania University, Hyderabad, India. He has fifteen years of teaching experience in the area of finance apart from having worked in the industry for two years in the area of finance and accounts. He has recently published two papers on pharmaceutical industry in India.


PPN 050 - Understanding the TRIPs plus trend and access to medicines: a long view

Dr Valbona Muzaka
Division of Politics and International Relations, School of Social Science, University of Southampton, UK

Abstract:
The aim of this paper is to explore the TRIPs plus trend in pharmaceutical intellectual property rights since TRIPs came into force. The focus of the paper is on the free trade agreements signed between US or EU and other developed and developing countries, as this is the most recent and successful channel through which TRIPs plus provisions are being secured by IP-rich state and business actors. These provisions pose new challenges to enhanced access to medicines beyond those already presented by the TRIPs Agreement. The paper discussed these challenges from a critical historical perspective, showing how the TRIPs plus trend in pharmaceuticals has been unfolding as soon as TRIPs came into force in 1995 in developed countries. It explores this trend in the context of two competing paradigms: that of ‘competitiveness’ on the part of pharmaceutical business actors and certain developed countries’ actors, and that of ‘public goods’ on the part of actors from certain developing countries and civil society.
This paper fits well within the access to medicines stream of the conference.

Bio -Dr Valbona Muzaka

Dr. Valbona Muzaka is Lecturer in Global Politics at the University of Southampton. Dr Muzaka has just finished writing a book on the politics of intellectual property rights and access to medicines, forthcoming (Palgrave). For full record of publications and research interests.


PPN 063 - TRIPping towards legitimacy? - A Public Health Norm in the World Trade Organization

Mr Dean Coldicott
Lecturer in International Relations, Deakin University, Australia

Abstract:
This paper traces the development of a ‘Public Health Norm’ within the WTO in response to concerns over the impact of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) on the provision of public health, particularly in lesser-developed and developing member countries. It argues the advent of this strong trade-resistant social norm poses a serious challenge to the legitimacy of the organization, particularly in relation to claims of overreach and conversely in the initial opposition of its incorporation by some WTO members. On 6 December 2005 WTO members approved amendments to the TRIPS agreement making permanent a decision on patents and public health originally adopted in 2003 which began officially with the Doha Development Agenda in 2001. This amendment is yet to receive the required level of acceptance to formally become a part of TRIPS. This paper argues that the public health issue has provided an interesting case study of the WTO’s legitimacy challenges in terms of policy and institutional overlap involving complex multilateral processes and actors that provides insight into a number of similar challenges for both the WTO and the international system more broadly.

Bio - Mr Dean Coldicott

Dean Coldicott is a Lecturer in International Relations at the School of International and Political Studies, Deakin University. Dean’s research interests are in International Organisations, Global Governance, and International Political Economy with his PhD thesis titled ‘Trading in Global Governance: The World Trade Organization and Non-Trade Norms’ currently in the final stages of preparation for examination at the University of Melbourne.


PPN 064 - Analysing the issues in evergreening in the pharmaceutical sector from the developing countries’ perspective

Ms Vinita Krishna
Research Scientist (Science and Development issues), New Delhi, India

Abstract:
The landmark judgement on Novartis patent on anti cancer drug Gleevec, has brought to the fore the debate on evergreening. ,a practice which allows for obtaining patents on improved versions of the existing products.Athough allowed in any industry, evergreening is said to be most common in the pharmaceutical industry where due to stockpiling of patents by manufacturers of blockbuster drugs,the domestic generic firms are unable to compete for similar products in the market.Its cascading effect is seen on the common people whose access to affordable medicine is restricted due to high prices of these drugs. In the post “product patent regime (2005) whereby TRIPS has legalized the patents on products,evergreening has become a serious challenge for the developing countries.The North -South perception on evergreening differs as on the other contemporary IPR issues. While on one hand, the ambiguous definition of invention in TRIPS Agreement leaves ample scope for evergreening as a legal practice in some developed countries,on the other hand it is considered an abuse of IPR by the developing countries.
Against this backdrop,this paper attempts to explore the flexibilities within the TRIPS Agreement and address the reasons and ways of preventing evergreening.Other areas of discussion would be how should a developing country orient itself in the global context to realize the optimum balance of IPRs, and for this, what synergies need to be established between the international and national legislations on this issue
The methodology in this review paper is based on relevant policy text analysis,contemporary research papers on these issues , the relevant case studies and pressclips.

Keywords: TRIPS; Patents; Evergreening; Novartis; Access to Medicines; Inventiveness

Bio - Ms Vinita Krishna

Vinita Krishna is a DST trained IPR Scientist, who has worked with Indian Council of Medical Research and Gene Campaign an NGO, in New Delhi Her publications include research reviews/reports and articles on various issues of IPR.Currently, while pursuing a course in IPR,she is working as an independent researcher,presenting papers in seminars and conferences.Some of her recent work includes TRIPS-CBD relationship, medicinal plants and biopiracy, benefit sharing mechanism, farmers’right and plant genetic resources.


PPN 065 - Novartis And Legal Battle for Access to Medicines

Dr Gopal Dabade
President, Drug Action Forum – Karnataka, (DAF-K), Co-convener, All India Drug Action Network (AIDAN), India

Abstract:
Globally huge populations (often the most needy) do not have access to life saving medicines, thus resulting in a great deal of avoidable morbidity and mortality. Today, one-third of the world's population lacks access to essential medicines; in the poorest parts of Africa and Asia this figure rises to one-half. In India alone 50% to 80% of population is without access to medicines (World Medicine Report, 2004 of WHO). That is 649 million people - largest number of people in the world, next only to Africa. One major factor for lack of life saving and essential medicines is its unaffordable price. Patents which grant monopoly to pharama companies to manufacture medicines, increase medicine prices and thus make these medicines unaffordable to vast majority. Novartis in its desire for unjustified patents on a particular medicine in Indian context has challenged some of the legal provisions under Indian patent act. If Novartis wins the case then it will have a long term implications on public health, not only in India but globally as well.
Novartis is a Switzerland-based pharma giant operating in 140 countries with a net sale of US $ 41.5 billion for the year 2008. Novartis has challenged in the Supreme Court of India, New Delhi certain provisions of the Indian patent act, that were resolved and passed in the Indian parliament, which were to safe guard the access to medicines (www.patentoffice.nic.in).

Bio - Dr Gopal Dabade

Dr Gopal Dabade is the President of Drug Action Forum – Karnataka, (DAF-K) and also the Co-convener of All India Drug Action Network (AIDAN).


PPN 066 - Has Life become cheap when Drugs are costly?: an enquiry in the issue of Public Health in the Post Doha Round

Assistant Professor Nalin Bharti
Indian Institute of Technology Patna, India

Abstract:
This paper provides a detailed discussion on the issue of public health which is one of the most pressing issues for the developing and least developed countries in Doha and post Doha round .Due to collective approach by the developing and least developing economies the Doha and post Doha round talks has considered the issue of public health seriously. But the matter does not end here because whatever trade concessions are given to these countries are temporary in nature and just help the country for few years only. Paper strongly advocates that the future of public health is still grim in the long run. Paper attempts to provide the historical note on public health in pre TRIPS era and it further will link the issue of public health with the post TRIPS era in which due to product patent regime medicine are costly and a huge population of the world in the developing and least developed economies will face the crisis of drug famine. The entire range of discussion warns for a serious mass awareness and intervention in the public policy and revisiting the role of the governments in developing country.

Key words: TRIPS, Public health, Doha Round, Drug famine, trade concessions.

Bio - Assistant Professor Nalin Bharti

Nalin Bharti (Ph.D, JNU) is currently an Assistant Professor in the Department of Humanities and Social Science at IIT Patna. He was awarded doctorate from School of International Studies, Jawaharlal Nehru University in 2005. His pre and post doctoral employment includes, visiting faculty in colleges at University of Delhi during 2000 to 2005, Research Associate in 12th Finance Commission, Government of India in 2004 and Lecturer Law and Economics at NALSAR University of Law, Hyderabad (2006-2008) and Hidayatullah National Law University, Raipur (2005-06). His recent Book is Privatization Unbound: Experiences in Bangladesh and India, Bookwell, 2009, New Delhi.


PPN 067 - Human Capital Management Strategies: A Survey of the Indian LifeSciences Industry

Ms Ritu Kamal*, Dr Devesh Kapur** & Dr Pankaj Chandra***
*AIIMS, New Delhi, India.
**Center for the Advanced Study of India, University of Pennsylvania, U.S.A.
*** Indian Institute of Management, Bangalore, India

Abstract:
The Indian lifesciences industry has traditionally thrived in the generics and the bulk drug manufacturing space where the competencies required of R&D employees differ considerably from the skills profile needed to conduct innovative research. In the post-TRIPS environment, more Indian pharmaceutical and biotech companies are moving towards original product development. However, previous studies show that firms across this sector are facing significant constraints in terms of suitably qualified researchers. In this paper we scrutinize the human capital management strategies of 254 Indian lifesciences companies using a custom-designed survey instrument. The survey investigates the educational backgrounds and skill-sets of R&D hires in these firms, the training programs used to further develop employee capabilities and the retention measures used to reduce staff attrition, inter alia. Using a variety of indicators such as research budgets and output, we divide the respondents into Research-Intensive and Non-Research-Intensive firms. We use this dichotomy to examine the disparities in human capital management strategies between companies that are successful in medical product innovation in post-TRIPS India, and those that have confined themselves to lower levels of the supply chain. These differing talent management strategies have implications not only for the Indian pharma-biotech industry but also for higher education in the lifesciences in India.

Bio - Ms Ritu Kamal, Dr Devesh Kapur & Dr Pankaj Chandra

Ritu is a Stanford India Biodesign Fellow (2010) and a former Research Associate at the Center for the Advanced Study of India, University of Pennsylvania. Her work focuses on the lifesciences sector in India, specifically in the area of low cost medical devices. She has a BS from Princeton University and a MS from the University of Pennsylvania.

Devesh Kapur, PhD, is the Director of the Center for the Advanced Study of India. He is Associate Professor of Political Science at the University of Pennsylvania, and holds the Madan Lal Sobti Professorship for the Study of Contemporary India.

Pankaj Chandra, PhD, is the Director of the Indian Institute of Management, Bangalore, where he has also been a Professor of Operations and Technology Management since 2007.


PPN 069 - Free Trade Agreements, TRIPS-Plus and Access to Health: The Arab World's Experience

Dr Mohammed El Said
Lancashire Law School, Amman, Jordan

Abstract:
The birth of the TRIPS agreement in 1995 signalled the inauguration of a new era in the global regulation of intellectual property. To many involved in the negotiations of the agreement, the thought that TRIPS represented the end of the global regulation of intellectual property turned to be a myth. Within a short period of time after TRIPS conclusion, efforts to raise the ceilings of global intellectual property protection were already underway. These were manifested by several initiatives at both the multilateral and bilateral levels. It is the latter initiatives that proved to be the most ferocious.
These bilateral initiatives championed by the US and the EU took several shapes such as bilateral free trade agreements (FTAs), bilateral cooperation agreements, bilateral association agreements (AAs) and so forth. Such agreements incorporated higher levels of intellectual property protection than those prescribed under TRIPS hence resulting in the so called ''TRIPS-Plus'' effect. One region which was heavily involved with such initiatives is the Arab World.
The negative impact of such agreements could be felt in many areas. However, it is in the area of public health and access to medicines where such impact may be worse felt. Such agreements are curtailing the flexibilities available to developing countries by imposing stringent demands in many areas including data exclusivity, patentability criteria, extension of patent term, restrictions on compulsory licensing and parallel importation…etc The outcome is eroding the flexibilities and restricting developing countries' ability to cater for their public's needs in the area of public to health and access to medicines.
This presentation will critically discuss and share the Arab World's experience in this regard and the lessons learned from such a process.

Bio - Dr Mohammed El Said

El Said works as a lecturer at Lancashire Law School. El Said is a qualified solicitor under the Jordanian Bar. He worked as a consultant on IP issues with leading media organizations in the Middle East and for other international organizations including the UNDP, WIPO, and WHO. El Said is the author of the book The Development of Intellectual Property Protection in the Arab World.


PPN 070 - In Transit (Patent) Infringement Trouble Under TRIPS and Beyond

Dr Cynthia M. Ho
Clifford E. Vickrey Research Professor, Loyola University of Chicago School of Law, Chicago

Abstract:
This article examines a disturbing phenomenon – seizures of generic drugs in Europe en route to countries where the drugs are needed, thus threatening public health. While EU law authorizes the seizures, whether they are consistent with TRIPS is questionable. Although heated international debate followed the public revelation of The seizures, the discussions, even amongst scholars, have not been well--‐grounded in the proper interpretation of international treaties. This article fills this gap by providing an authoritative interpretation of relevant provisions of TRIPS. This article also uses the discourse concerning the seizures to help illustrate the existence of competing perspectives concerning patents. At one extreme, patents are seen as a mere privilege granted by a nation and thus inherently subject to limitations to accommodate other societal goals, such as access to medicine. At the other extreme, however, patents have an exalted status that entitles owners to stronger rights than other property owners. Whereas the skeletal wording of TRIPS may seem to paper over differences in viewpoints, divergent views are sometimes exposed; weakly supported interpretations of TRIPS by countries and commentators may be explained at least in part by these perspectives. The ultimate goal of this article is not simply a better understanding of whether the EU law complies with TRIPS, but also a better understanding of how competing perspectives shape international law and policy impacting access to medicine.

Bio - Dr Cynthia M. Ho

Dr Cynthia M. Ho have a dedicated interest and scholarly agenda concerning access to medicine in the global economy. She has published number of articles focusing on TRIPS and TRIPS plus agreements. In addition, I am working on a book under contract with Oxford University Press focused on this important issue.


PPN 071 - Influence of Pharmaceutical Trade and Regulations on Medicine’s Affordability in Developing Countries

Mr Vishwajeet Mohan* & Mr Vikas Garg**
*Business Development, Shasun Research Centre, Chennai, **DATAMONITOR, India

Abstract:
The Globalization of IP protection and limiting healthcare flexibility first through TRIPS and later by regional/bilateral trade agreement has transformed the government’s ability to safeguard public health. The present work provides an overview of how global pharmaceutical market is dominated by few OECD countries with their strong and sustained presence across the geographical and economical regions of the world. To ensure their continued dominance, these countries are actively promoting stringent IP protection and drug regulations in developing countries. Promotion of TRIPS plus provision, anti-counterfeit regulations and limiting flexibility granted under TRIPS, in various trade agreements is providing an environment supportive to innovator companies while creating a substantial barrier for entry of affordable generics. The study finds that, while France remains the lead exporter to low income countries; India during the present decade has emerged as another major pharmaceutical supplier to these countries in value terms. The period has also observed an improved access to affordable medicines which is supported by several international healthcare organizations to which India has been the lead supplier for Pharmaceutical products. Developing countries sourcing medicines mainly from OECD countries demonstrated higher health care expenditure (HCE) than those importing mainly from other developing countries. This finding is supported by the fact that; medicines accounts for higher share of HCE in developing countries than those of developed countries. Several developing countries, inspired by highly regulated developed markets, are increasingly considering stringent regulatory and custom requirements which are poised to deter the generic market leading to increase in HCE.

Bio - Mr Vishwajeet Mohan, Mr Vikas Garg

Mr Vishwajeet Mohan is Officer - Business Development, Shasun Research Centre, Chennai. He is involved in preparation of pharmaceutical market & regulatory reports and has published an international article on Indian pharma industry.

Mr Vikas Garg is a senior researcher at Medtrack Datamonitor, India. He has completed his M.S. (Pharm) in Pharmacology & Toxicology from NIPER and has carried out his research projects in AIIMS and IICT. His field of interest is pharmaceutical market and regulations of low income countries.


PPN 074 - Path Dependence to Path Creation: Evolving Dynamic Capabilities of Indian Pharmaceutical Companies

Mr Suresh Dasari & Mr Amalesh Sharma
Indian School of Business, Hyderabad

Abstract:
Of late, the multifaceted dynamics of Indian pharmaceutical sector has hard-pressed the researchers to make a deliberate effort to understand the ensuing needs. Due to institutional reforms and availability of qualified (and mostly) skilled workforce in the country, pharmaceutical research is becoming more challenging in India day by day. This paper analyzes the underlying assumption of path creation as defined by Raghu Garud, Arun Kumaraswamy and Peter Karnoen (2010) in their paper “Path Dependence or Path Creation” in the Indian Pharmaceutical market. Moving out from the traditional path dependence concept of Vergne and Rodophe Durand (2010), how Indian Pharmaceutical Companies have been welcoming path creation in terms of drugs production is tried to analyze. We have discussed the strategic imperative of path creation relative to path dependence in the mentioned sector and also comparisons are sequenced based on the constituents’ elements of both the domain. The view of “self-reinforcing mechanisms” and “Lock-in” concepts has been changing in the competitive Indian market .Path creation demands the evolution of dynamic capabilities in terms of continuous innovation and rethinking of business strategies. We have shown that path creation implicates the three moments of time. Empirical research on various pharmaceutical companies depicts the shift of the trend from path dependence to path creation. Our findings suggest that path creation has been an episode in the pharmaceutical sector and the theoretical learning from this sector can create a sustainable growth and increasing profits for other sectors too.

Bio - Mr Suresh Dasari & Mr Amalesh Sharma

Suresh Dasari is an academic associate at Indian School of Business, Hyderabad. He researches in business strategies of firms in emerging markets. He received his Master of Business Administration (M.B.A.) degree from Indian Institute of Technology Madras,Chennai.

Amalesh Sharma is an academic associate at Indian School of Business, Hyderabad. His research interest includes marketing and competitive strategy. He is graduated from Delhi University and MBA from Mumbai. He has presented more than 15 research papers in International Conferences.


PPN 075 - Impact of Trade and TRIPS on Affordability of Medicine in Tanzania

Mr Deepak Kumar Jena
Research Analyst (Intl. Mkts), Pharmexcil, India

Abstract:
Tanzania has set an admirable example through its efforts in controlling diseases like Malaria, TB, Cholera, etc. while fighting AIDS/HIV pandemic. This coupled with foreign donations for alleviating poverty, disease and healthcare infrastructure has positively impacted the Tanzanian healthcare industry, infrastructure and accessibility to medicine in the country. The research analyses the import dependency on pharmaceuticals, the impact on affordability due to efficient sourcing stragies adopted by the country in terms of savings in import bill and reduction in cost of unit medicine imported and the reasons there of. The imports of the country from various source countries using UN trade statistics database ‘Comtrade’, country-wise, molecule-wise, therapy-wise product approvals for understanding competition and the country’s regulation impacting competition and prices of medicine were analysed. The analysis reveals that Tanzania could save US$139.55mn import bill in 2008 by sourcing from India and is the largest supplier of pharmaceuticals. India offers large number of suppliers (3.74 vis-à-vis 1.38 other countries) and the country has highest average share of 42% in all major therapeutic categories. The most important factor for the savings achieved is exemption granted to Tanzania as an LDC from compliance to TRIPS agreement which permits the country to import patented drugs. However, as India became TRIPS compliant the cost savings are set to erode and especially so in case of ARVs. Further, the cost of registration and inspection has been severely impacting the competition thereby raising the cost of medicine in the country.

Bio - Mr Deepak Kumar Jena

Deepak Kumar Jena is an MS (Pharm) from the National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad. He is currently working as a research analyst (International Markets) at Pharmaceuticals Exports Promotion Council (Pharmexcil), and is engaged in research on the regulatory approvals/procedures of various countries. Born in 1983, Mr. Jena received his Bachelor’s in Pharmacy from Sri Jayadev College of Pharmaceutical Sciences, Bhubaneshwar, Orissa. He was also a topper in the national and state-level competitive examinations such as the Graduate Aptitude Test Examination (GATE) 2007, with an All India Rank of 67, and he stood 3rd in the Orissa Joint Entrance Examination.


PPN 076 - Impact of European Union on Affordability of Medicine in African LDCs

Mr Poduri Balaram
Assistant Director, Pharmexcil, India

Abstract:
European Union is poised as the driving engine of pharmaceuticals across the world due to importance of the sector to the region and the regions overwhelming share in global trade. The region has therefore attained commanding influence on accessibility and affordability of medicine to the millions of suffering patients impacting not only their welfare but also health burden of many countries. The article attempts to analyze the EU’s influence on affordability of medicine in LDCs of Africa. Trade statistics available from United Nations were analysed and econometric analysis of Theil Index & Balassa Index were used for establishing concentration and comparative advantage of the industry in the countries of the region. Review of the current direction of drug regulatory policies of EU was also undertaken to understand its impact on affordability of medicine in African LDCs. The global pharmaceutical trade is highly concentrated with European Union (Theil Index of 7.25 vs -0.02 of Africa) and the region’s countries have high comparative advantage in the sector (Balassa Index of 7.11 in case of Ireland and 2.08 in case of UK). The imports of Least Developed Countries from EU occupy a significant share in their total pharma imports. Due to increasing competition from developing countries of India and China in LDCs, EU and its countries have taken several conscious and calibrated measures including introducing TRIPS plus provisions in bilateral trade agreements to thwart exports from these countries which is threatening the affordability of medicine in LDCs of Africa.

Bio - Mr Poduri Balaram

Mr Poduri Balaram is currently Assistant Director of Pharmexcil (Pharmaceuticals Export Promotion Council of India, set up by Government of India). He holds a Masters Degree in Business Administration with 16 years work experience in various positions such as Deputy Manager of a business consulting company and Assistant Professor with a specialization in foreign trade and has worked in an exports organization. His research experience includes several consulting projects for various Indian business houses, Indian government & trade associations and a foreign export promotion agency such as the Ministry of Commerce, the Ministry of External Affairs, the Japanese External Trade Organization, the Confederation of Indian Industry, UshaCom RPG, etc. He has also undergone several training programs from Indian Institute of Foreign Trade and one International Training program on Intellectual Property Rights at Korea.


PPN 080 - Pharmaceutical Manufacturing in South Challenges and Scope

Mr. Ajinkya B. Badwe & Prof Amit A. Kane
MITCON Institute of Management, Pune, Maharashtra, India

Abstract:
The South Asian Pharmaceutical Industry, a highly organized sector is estimated to be worth $ 9.48 billion, growing at about 13.5 percent annually. Countries like India, China are the major contributors. The Indian turnover for API manufacturing is approx US $ 27 million. The major factors which contribute to the facilitation of manufacturers include the political, economic, social and environmental dimensions. The Indian market attracted a number of foreign players with the implementation of product patent in January 2005. The FDI in pharma industry is estimated at $172 million, recording a CAGR of 62.6 percent The FDI investments lead to an increase in the manufacturing industry, by the government decreasing the CRR (6%) and SLR(25%) ratio in order to increase the FDI. This promptly includes the Labor policy, India also boasts a cheap, well-educated and English-speaking. labor force that is the base for the manufacturers gives them a competitive advantage. Pollution, Environmental Hap-hazards, considering all these effects steps taken towards betterment. are-Green Revolution, waste Management, bio-degradation of waste products and recycling process. All of these changes are ultimately good for the Indian pharmaceutical industry. They force the industry to reach a level necessary for global competitiveness. Due to the disconnect between curriculum and industry, pharmas in south also lack the academic collaboration that is crucial to drug development in the West. The concern is about the initial investments which an pharmaceutical organization puts in and return on investments regained is less as compared to other sectors.

Bio - Mr. Ajinkya B. Badwe & Prof Amit A. Kane

Mr. Ajinkya. B Badwe from MITCON Institute of Management, Pune completed B. Pharm from Pune University and has done his MBA in Pharmaceutical Management.

Prof Amit. A Kane worked 22 years with Merck as Manager in Pharma sales and distribution, Presently a Prof in Pharmaceutical management in MITCON.


PPN 081 - Access to Medicines and Pharma Industry in the aftermath of TRIPS: A transnational perspective

Ms Akanksha Mishra & Ms Shehnaz Ahmed
Studnets, B.A.LL.B (Hons), Dr Ram Manohar Lohia National Law University, Lucknow, India

Abstract:
With the coming into force of the TRIPS Agreement for the protection of IPR rights, the signatory countries had to make changes in their national laws to make it TRIPS compliant. This paper seeks to discuss the impact of TRIPS on the pharmaceutical industry and the access to medicines in developed and developing countries. The paper will also look into the Doha Declaration and WTO Decision on Paragraph 6. Further, the paper will discuss how developed (USA, EU, Japan, etc) and developing (India, Brazil, South Africa, China, Thailand, etc) countries have implemented the TRIPS obligations and the flexibilities in their national laws. The approach of the Legislators and the Judiciary in the aforementioned countries with regards to implementation of TRIPS mandate with a special focus on patents, data protection, data exclusivity and TRIPS flexibilities with a special focus on compulsory licensing and parallel imports will also be dealt with. USA’s Trade Act with the Special 301 provision, Hatch Waxman Act, Japan’s Law on intellectual property law, Law No. 122 of 2002, Brazil’s Industrial Property Law, South Africa’s Medicines and Related Substances Control Amendment Act, 1997, China’s revised Patent Law of 2009, Thailand’s Trade Secret Act, India’s Patent Act, etc will be discussed in detail. Analyzing the position in the aforementioned developed and developing countries, the paper seeks to explore how these countries have struck a balance between the interest of the pharma industry and that of need for essential medicines.

Bio - Ms Akanksha Mishra & Ms Shehnaz Ahmed

Ms Akanksha Mishra is 4th year student of B.A.LL.B (Hons) at Dr Ram Manohar Lohia National Law University, Lucknow, India. Her areas if interested are in Intellectual Property Rights, Human Rights, and Environmental Laws.

Ms Shehnaz Ahmed is 4th year student of B.A.LL.B (Hons) at Dr Ram Manohar Lohia National Law University, Lucknow, India. She is the Convenor, of the Journal Committee, Executive Editor of RMLNLU Law Review and her areas if interested are in Constitutional Law, Intellectual Property Law, Law of Arbitration, Women Rights, & Criminal Law.


PPN 082 - Role of Science Parks and Technology Business Incubators in Improving Healthcare Access and Needs

Dr Jitendra Kumar* & Ms Nirupama Lal
*Vice President, Life Science Incubator, IKP Knowledge Park, Hyderabad, India

Abstract:
Technology development for healthcare and access requires unique fusion of concepts derived from multi-disciplinary cross-talk and hybridization. While India has developed massive infrastructure for facilitating basic and applied scientific research and technology development there is a glaring lack of agility, mobilization and institutional mechanisms to facilitate multidisciplinary research and to address problems related to product development for healthcare access and reach. This assumes special significance in the light of the fact that India has a large population- a population below poverty line, illiterate and in rural setting. This calls for local solutions utilizing local resources. In other words the innovation needs to be inclusive in nature. The competitive advantage for India would also be achieved if these solutions will have global impact. Inclusive innovation can play a critical role in lowering the costs of healthcare access and increasing the earnings for rural people. Knowledge creation/commercialization and knowledge diffusion of pre –existing knowledge for resource poor settings are thus two critical ways that can unleash India’s growth potential. While both aspects are essential India stands to gain more from applying pre existing knowledge to new settings than creating new knowledge. India needs to provide enabling environment for diffusion and absorption of technology developed locally and globally. Science Parks and associated Technology Business Incubators are positioned uniquely in Indian context to promote business driven research, commercialization of technologies generated at public R&D laboratories, create new ventures and transfer technologies. They provide institutional mechanism of venture creation which is glaringly lacking in Indian scenario.

Bio - Dr Jitendra Kumar

Dr Jitendra Kumar is a Vice-President of Life Science incubator at IKP Knowledge Park, Hyderbad. He holds PhD (Biotechnology) degree from Institute of Microbial Technology, Chandigarh and received Post Doctoral training in Ohio State University, Columbus OHIO (USA) He also holds a MBA degree from Fisher College of Business at Ohio State University, USA.


PPN 085 - Impact of Post-Trips Scenario: Drug Patents v. Access to Life

Mr. Ravi K. Tripathi & Mr. Sudeep Shrivastava
Centre for International Sustainable Development Law (CISDL), National Law University (Lucknow) India

Abstract:
During the recent outbreak of recent Swine Flu pandemic, the major concern of the Indian government was not just the feared spread of the virus but to ensure the access of the Tamiflu drug to patients. The current legal debate in developing nations raises serious issues in regard with protecting Intellectual Property or putting profits before people. Since the advent of TRIPs as part of the newly created WTO in 1995, member states have recognized that significant gaps exist in the agreement with respect to patent protection and access to life-saving medicines in developing and least-developed countries (LDCs); but finding and agreeing on improvements to the system has proven to be a much harder proposition. Although this dexterous manoeuvring around competing interests deserves praise, the net result of such a compromise has been a lack of clarity in the law. The paper examines how implementation of the TRIPS agreement initially restricted health access in developing countries and whether these concerns have been subsequently addressed. In context of Indian Pharma Industry, the author relates to the rise and current status of pharma industry in India while analysing the Patents (Amendment) Act, 2005 attempting to balance out competing interests of a variety of stakeholders, including domestic generic medicine producers, foreign multinational pharmaceutical companies and civil society groups. The paper considers several approaches attempting to fix some of these shortcomings, and concludes by suggesting points essential to a comprehensive strategy to promote innovation while ensuring the affordability and accessibility of life saving drugs.

Key Words: TRIPS, Pharmaceutical Industry, Product Patent, developing countries, drug prices

Bio - Mr. Ravi K. Tripathi & Mr. Sudeep Shrivastava

Ravi K. Tripathi is an associate fellow with Centre for International Sustainable development Law (CISDL) based in Montreal. He has presented his research findings in numerous national and International seminars besides being invited as speaker by various institutes. He has also worked with leading Indian law firms and is currently discharging functions as coordinator of Youth Initiative Network in Lucknow.

Sudeep Shrivastava is a fourth year student of B.A. LL.B. (Hons.) program at National Law University (Lucknow).


PPN 086 - Implication of TRIPS Agreement on the Pharmaceutical Sector of South Asia

Ms Arundhati Sharma
Research Scholar, Jawaharlal University, India

Abstract:
The developing countries including South Asia came under pressure to extend IPR protection to pharmaceuticals with the conclusion of the TRIPS Agreement. Prior to the TRIPS Agreement, the product patent practised in the region allowed reverse engineering on which the major segment of pharmaceuticals thrived, particularly India. With the implementation of TRIPS Agreement, the growth of Indian pharmaceuticals industry has been greatly impacted. However, the Indian pharmaceutical industry is still one of the largest generic pharmaceutical industries in the world.
In South Asia, India is the only country to have the innovative capacity and the ability to copy new chemical entities by reverse engineering. The other countries of the region- Pakistan, Sri Lanka, Bangladesh and Nepal have the ability to reproduce finished products (formulations) from imported ingredients (bulk drugs). However, only Bangladesh and Pakistan have the self-sufficiency in the formulation process. Bhutan and Maldives have no capacity in the pharmaceutical industry.
The analysis of individual countries’ pattern of pharmaceutical industry reveals the strong presence of MNCs in pharmaceutical sector. It also shows that except India who has the capability to produce both bulk drugs and formulations, the rest of the countries of the region are mostly dependent on importation. One of the major importing countries is India. This evoked debate primarily on two major aspects:

  • India’s innovative capabilities of the pharmaceutical sector to develop drugs and protect health
  • India’s pharmaceutical exports of copied versions of patented drugs to developing countries under the new regime.

Bio - Ms Arundhati Sharma

Arundhati Sharma is a Research Scholar in the South Asian Division of School of International Studies, Jawaharlal Nehru University, New Delhi. She completed Bachelors’ and Masters’ in Political Science from Delhi University and currently pursuing M. Phil.


PPN 090 - Dynamics of Lobbies and Interest Groups in Indian Pharmaceutical Sector

Mr Santhosh M. R.
Associate Fellow, Centre for Trade and Development (Centad), New Delhi

Abstract:
In the post-TRIPS period, most of the studies on Indian Pharmaceutical politics mainly focused on the issues of access to medicines. However, there have not been any substantial studies on the dynamics of lobbies and interests groups involved in the Indian pharmaceutical politics. In other words, both the international and domestic literature failed to capture the reality of this important side of policy making. It is a widely known fact that these interest groups and lobbies are agents of change in pharmaceutical sector. Since the stakes involved in the pharmaceutical sector are high decision on policy making or regulatory interventions are highly scrutinized by various stake holders, especially, industrial organizations. Moreover, these decisions are very crucial to the business, it is obvious that there will be many efforts to intervene in the decision making process. This paper is an attempt to explore the dynamics of the lobbies and interest groups that are active in Indian pharmaceutical politics in the post-TRIPS period. The paper mainly focuses on the pharmaceutical industrial organizations such as Organisation of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers’ Association (IDMA), Indian pharmaceutical Alliance(IPA), SME Pharma Industries Confederation (SPIC) and Confederation of Indian pharmaceutical industries (CIPI) and their involvement in major issues in pharmaceutical politics in India. In order to track their positions on important issues such as Patenting, Data Exclusivity, Counterfeit Drugs and Drug Price Control, their press statements, submissions to the government and various committees are analyzed.

Bio - Mr Santhosh M. R.

Presently working with Centre for Trade and Development (Centad) an independent, not-for-profit organisation that carries out policy research and advocacy on issues around trade and development, with a focus on South Asia. Mr Santhosh M. R. joined Centad in July 2008 as an associate fellow and since then he has been working in the area of public health research and advocacy. Before Joining Centad he worked with the Delhi Team of Tracing Pharmaceuticals in South Asia (TPSA) project, which was headed by Prof. Roger Jeffery, University of Edinburgh, Scotland. Apart from this, he is doing Ph.D from Centre of Social Medicine and Community Health, School of Social Sciences, Jawaharlal Nehru University (JNU), New Delhi. He has an M.Phil degree from the Centre of Social Medicine and Community Health, School of Social Sciences, Jawaharlal Nehru University (JNU), The title of his M.Phil Dissertation is “The Political Economy of the Indian Drugs and Pharmaceutical Sector: A Preliminary Enquiry.”


PPN 091 - Compulsory Licensing As Public Policy Intervention: Case Of Pharmaceutical Industry

Dr Shishir K. Jha* & Mr Babu Paul**
*Associate Professor at the Shailesh J. Mehta School Of Management, IIT Bombay, India
**Research Scholar at the Humanities and Social Science Department, IIT Bombay, India

Abstract:
This paper seeks to examine the role of Compulsory Licensing in India as a public policy tool for improving access to medicines. The Indian Patent Act of 2005 enacted Compulsory Licensing mechanisms in accordance with the TRIPS agreement. We would like to closely examine compulsory licensing as used in the pharmaceutical industry within the context of its historical growth, from its pre World War II phase. This historical examination will be chiefly located within western Europe and the subsequent expansion in the size of the industry within the United States. The use of compulsory licensing is not an insignificant part of this earlier history. This growth appears to have placed considerable emphasis on profitability and product patenting to the considerable exclusion of broader public policy interests. The developing countries on their part due to both “state” and “market” failure are unable to produce drugs for infectious diseases such as TB, Malaria, HIV/AIDS among others. To partly address this failure the TRIPS agreement provides for the use of Compulsory Licensing mechanism. This does ameliorate the situation to some extent in a few developing countries such as Brazil and Thailand. However the general picture of inadequate access to drugs for infectious diseases remains largely unchanged. Given the above brief introduction we would like to specifically examine the following: a) how does the use of compulsory licensing in select developing countries compare with its historical use in developed countries and b) what are the contemporary public policy concerns in the use of compulsory licensing within a country like India.

Bio - Dr Shishir K. Jha & Mr Babu Paul

Shishir K. Jha is an Associate Professor at the Shailesh J. Mehta School Of Management, IIT Bombay, where he has been working since 2001. He earned his Phd, MBA and MA [International Relations] from Syracuse University, New York. His research interests are broadly in the areas of international business, Intellectual Property and the public domain and open innovation.

Babu Paul is an ABD [all but dissertation] Research Scholar at the Humanities and Social Science Department, IIT Bombay. His work is on the use of compulsory licensing as a public policy mechanism.


PPN 093 - Drug Price Controls and Access to Medicines in India

Dr Prabodh Malhotra
Centre for Strategic Economic Studies, Victoria University, Australia

Abstract:
India currently finds itself at crossroads in deciding the course of future drug price controls. On the one hand, only 35 per cent of the population currently has access to medicines, primarily because of costs. On the other hand, the pharmaceutical industry wants price controls relaxed further and replaced with price monitoring. To add a third dimension, the Supreme Court of India made an order in 2003, directing the Union Government to ensure that essential and life-saving drugs did not fall out of price control. In the wake of Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Pharmaceutical Policy - 2006 (draft) suggests price negotiations for patented drugs prior to granting market approvals. This paper examines from access to medicines perspective the impact of price controls that have been weakened over the last two decades. This paper would contribute to the broader discussions on the issue and finalisation of the policy.

Bio - Dr Prabodh Malhotra

Prabodh was born and brought up in India, lived in Austria and Germany in the 1970s, and migrated to Australia in 1980. Before returning to study in the 1990s, Prabodh worked with what was then known as the Victorian Railways. Dr. Prabodh Malhotra did his MIB from Swinburne University and completed PhD from Victoria University. Subsequent to completing his Masters in International Business, he taught International Business, International Trade Strategies, Transnational Marketing, Microeconomics and Foundations of Management at Swinburne University. Since finishing his PhD in Economics, Prabodh has been working at the Centre for Strategic Economic Studies, Victoria University.


PPN 098 - Globalizing health tourism in South Asia: An issue of accessibility and affordability of medicines

Dr Rajesh K
Cochin University, Cochin, Kerala

Abstract:
South Asian countries share common health challenges with very poor health indicators in the world due to several reasons like political apathy, poverty, staggering health infrastructure, etc. Even though, the proponents of health tourism found South Asia, especially India as a potential market for development. Medical tourism in India is projected to grow at an annual rate of 30 % to become Rs. 9,500-crore industry by 2015. It is evaluated that the major advantages of India is the cost of health treatment, i.e., surgery in India is 1/10 of what it is in US and Western Europe and sometimes even lesser. However, these statistics overlap certain facts that the per capita health care access in South Asia is less than half to China and health spending share of GDP in South Asia is 4.4% as compared to developed countries where it ranges from 7.9%-9%. Details of the doctor/patient ratio in India should also be unearthed, which is almost 1600 for one patient. Development of health tourism further raises this ratio. It pushes the demand where the supply is almost inelastic, naturally lead to price hike. Allopathic treatment, which is most popular in India, will become unaffordable for an average Indian. Current trend in health tourism ironically become a tool to destroy the health sector of the villages of South Asian countries. This study proposes an empirical evaluation of health tourism in the local economies of India and expects to suggest measures to accommodate all people to reap benefit from the health tourism.

Bio - Dr Rajesh K

Rajesh K, post graduated in Economics from University of Hyderabad he has done Ph.D from Cochin University, thesis entitled as ‘Coastal Tourism in Kerala: Its Impact on Economy and Environment’. Worked as a Faculty at ICFAI National College, Thrissur, Kerala from 2004 to 2009. Current profile is Guest Faculty at Cochin University. UGC/NET in Economics, which was held in June 2005, was also qualified.


PPN 099 - The Problems of Pharmaceutical Patents and Potential Solutions

Mr Philip Soos
Deakin University, Australia

Abstract:
Economic theory has provided the justification for government intervention in order to stimulate medical research and development, utilizing patents as the intervention of choice. Over the last couple of decades, economic, medical and legal analysis has uncovered many of the flaws of pharmaceutical patents. Some are well known, whereas others have not received wide attention. To date, no comprehensive aggregation of monetary and non-monetary costs has been performed, despite the considerable evidence found within the literature. To remedy these flaws, several alternatives are outlined, all offering substantial improvements over the patent system, with the primary feature being the pricing of pharmaceuticals at the cost of production, avoiding monopolistic pricing schemes.

Bio - Mr Philip Soos

Philip Soos is a Masters student at Deakin University. He is currently researching the costs and alternatives to pharmaceutical patents to establish whether patents really are the best option to finance pharmaceutical research and development. Philip also has MBA and IT degrees from RMIT University and Swinburne University of Technology, respectively.

 


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27th October 2010