PHARMACEUTICAL COMPANIES,INTELLECTUAL PROPERTY,AND THE GLOBAL AIDS EPIDEMICRakesh Bhaskar
This document discusses the issues around intellectual property rights (IPR) for pharmaceutical companies and access to HIV/AIDS drugs in developing countries. It provides details on:
- The US pharmaceutical industry initially opposing relaxation of IPR under WTO rules to allow generic drugs in developing countries like South Africa facing health crises.
- HIV/AIDS remaining a top global cause of death in 2008 despite decades of efforts, with most deaths in sub-Saharan Africa.
- The high costs of antiretroviral drug cocktails that made treatment unaffordable for most in developing countries.
- Pharmaceutical companies holding patents that limit competition from generic drugs and efforts by countries and organizations to expand access to affordable treatment
This document discusses generic drugs and access to medicines globally. It notes that non-communicable diseases account for over 60% of global deaths and many major drug companies rely on profits from drugs for these diseases. The document outlines that generic drugs make up 79% of the global drug market, with many HIV/AIDS drugs being produced generically in India. It also discusses mechanisms like tiered drug pricing, patent pooling, compulsory licensing, and international agreements like TRIPS and Doha Declaration that aim to balance drug innovation and accessibility. Key debates around patenting and profiting from lifesaving drugs are also presented.
Crystina Riffel: Pharmaceutical Drug Policiesmerlyna
The document discusses how intellectual property rights and patents create health inequalities between developed and developing countries. It analyzes how the TRIPS agreement established global intellectual property standards but did not consider the needs of poor countries. This allows pharmaceutical companies to charge high prices for drugs in developing countries without generic competition. The document also discusses how South Africa implemented compulsory licensing to access affordable medicines, facing a lawsuit from drug companies, but eventually was able to enforce its law. It proposes alternatives like orphan drug policies and bulk purchasing initiatives to incentivize research for diseases prevalent in developing countries.
The Medicines Patent Pool Presentation during the session "Market Interventions for Innovation and Access", UN High Level Meeting on HIV/AIDS
New York, 9 June 2011
Evangeline Chee - China and India making inroads in Biotech Drugscynrx
1) Chinese and Indian drug makers are on the verge of selling cheaper copies of complex biotech drugs to treat diseases like cancer, diabetes, and arthritis that are currently only affordable in rich nations.
2) This could transform healthcare in much of the world but spark backlash from major pharmaceutical companies and rich countries seeking to protect drug patents.
3) Advocates argue these copycat drugs could increase access to life-saving treatments, while others argue ensuring drug company profits is needed to drive innovation.
This document counters arguments made by opponents of the Trans-Pacific Partnership (TPP) agreement. It addresses opponents' concerns about the Investor-State Dispute Settlement (ISDS) provision, which allows corporations to challenge laws and regulations of sovereign countries. The document argues that ISDS provides procedural mechanisms to protect foreign investment from illegal expropriation or discrimination. It also notes that corporations have a low success rate in ISDS cases and are usually awarded small monetary settlements, not changes to laws. The document maintains that ISDS helps provide transparency in dispute settlements and does not prevent countries from regulating in the public interest.
The document provides an overview of the pharmaceutical industry globally and in Pakistan. It discusses that global pharmaceutical sales will grow 5-6% annually to over $735 billion by 2008. There will be a shift in growth from developed to emerging markets and from primary to specialty care drugs. In Pakistan, the pharmaceutical market was worth Rs. 62 billion in 2007-08 and is dominated by therapeutic areas like gastrointestinal, vitamins and cardiovascular drugs. It also outlines marketing strategies used in the pharmaceutical industry like direct promotion to physicians.
Plant layout refers to the configuration and placement of departments, work centers, equipment, and the flow of materials through the production process. Layout decisions are important because they require substantial investments, involve long-term commitments, and significantly impact costs and efficiency. The main types of layouts are product layouts which focus on smooth material flow, process layouts which group similar machinery together, and combination layouts which blend aspects of both. The objective is to facilitate smooth and efficient material and information flow while minimizing costs and non-value added activities.
PHARMACEUTICAL COMPANIES,INTELLECTUAL PROPERTY,AND THE GLOBAL AIDS EPIDEMICRakesh Bhaskar
This document discusses the issues around intellectual property rights (IPR) for pharmaceutical companies and access to HIV/AIDS drugs in developing countries. It provides details on:
- The US pharmaceutical industry initially opposing relaxation of IPR under WTO rules to allow generic drugs in developing countries like South Africa facing health crises.
- HIV/AIDS remaining a top global cause of death in 2008 despite decades of efforts, with most deaths in sub-Saharan Africa.
- The high costs of antiretroviral drug cocktails that made treatment unaffordable for most in developing countries.
- Pharmaceutical companies holding patents that limit competition from generic drugs and efforts by countries and organizations to expand access to affordable treatment
This document discusses generic drugs and access to medicines globally. It notes that non-communicable diseases account for over 60% of global deaths and many major drug companies rely on profits from drugs for these diseases. The document outlines that generic drugs make up 79% of the global drug market, with many HIV/AIDS drugs being produced generically in India. It also discusses mechanisms like tiered drug pricing, patent pooling, compulsory licensing, and international agreements like TRIPS and Doha Declaration that aim to balance drug innovation and accessibility. Key debates around patenting and profiting from lifesaving drugs are also presented.
Crystina Riffel: Pharmaceutical Drug Policiesmerlyna
The document discusses how intellectual property rights and patents create health inequalities between developed and developing countries. It analyzes how the TRIPS agreement established global intellectual property standards but did not consider the needs of poor countries. This allows pharmaceutical companies to charge high prices for drugs in developing countries without generic competition. The document also discusses how South Africa implemented compulsory licensing to access affordable medicines, facing a lawsuit from drug companies, but eventually was able to enforce its law. It proposes alternatives like orphan drug policies and bulk purchasing initiatives to incentivize research for diseases prevalent in developing countries.
The Medicines Patent Pool Presentation during the session "Market Interventions for Innovation and Access", UN High Level Meeting on HIV/AIDS
New York, 9 June 2011
Evangeline Chee - China and India making inroads in Biotech Drugscynrx
1) Chinese and Indian drug makers are on the verge of selling cheaper copies of complex biotech drugs to treat diseases like cancer, diabetes, and arthritis that are currently only affordable in rich nations.
2) This could transform healthcare in much of the world but spark backlash from major pharmaceutical companies and rich countries seeking to protect drug patents.
3) Advocates argue these copycat drugs could increase access to life-saving treatments, while others argue ensuring drug company profits is needed to drive innovation.
This document counters arguments made by opponents of the Trans-Pacific Partnership (TPP) agreement. It addresses opponents' concerns about the Investor-State Dispute Settlement (ISDS) provision, which allows corporations to challenge laws and regulations of sovereign countries. The document argues that ISDS provides procedural mechanisms to protect foreign investment from illegal expropriation or discrimination. It also notes that corporations have a low success rate in ISDS cases and are usually awarded small monetary settlements, not changes to laws. The document maintains that ISDS helps provide transparency in dispute settlements and does not prevent countries from regulating in the public interest.
The document provides an overview of the pharmaceutical industry globally and in Pakistan. It discusses that global pharmaceutical sales will grow 5-6% annually to over $735 billion by 2008. There will be a shift in growth from developed to emerging markets and from primary to specialty care drugs. In Pakistan, the pharmaceutical market was worth Rs. 62 billion in 2007-08 and is dominated by therapeutic areas like gastrointestinal, vitamins and cardiovascular drugs. It also outlines marketing strategies used in the pharmaceutical industry like direct promotion to physicians.
Plant layout refers to the configuration and placement of departments, work centers, equipment, and the flow of materials through the production process. Layout decisions are important because they require substantial investments, involve long-term commitments, and significantly impact costs and efficiency. The main types of layouts are product layouts which focus on smooth material flow, process layouts which group similar machinery together, and combination layouts which blend aspects of both. The objective is to facilitate smooth and efficient material and information flow while minimizing costs and non-value added activities.
Pharmaceutical industry and unit processibtihal osman
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
The document discusses plant layout, which refers to the arrangement of machinery, equipment, and other physical facilities within a factory. The overall goal of plant layout is to optimize material flow and minimize costs. There are different types of layouts, including product layouts that arrange machines by the sequence of operations, and process layouts that group similar machines together. When designing a layout, factors like the factory building, production process, type of equipment, and human needs must all be considered.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
This document discusses the pharmaceutical industry in Pakistan. It provides an introduction to pharmaceuticals and outlines the key members of a group discussing the topic. The history of the pharmaceutical industry in Pakistan is described, noting it was non-existent before the 1970s and now there are over 600 companies. The top challenges facing the industry are listed as a lack of trained manpower, difficulty exporting, and a lack of new technology.
This document provides an analysis of the pharmaceutical industry in Pakistan. It begins with an acknowledgement and executive summary. It then discusses the history, characteristics, contribution to GDP, major companies, benefits, growth, problems, impact, and challenges of the pharmaceutical industry in Pakistan. The industry has grown significantly since the early 1970s and now meets around 90% of Pakistan's pharmaceutical needs. However, it faces challenges such as power shortages, lack of trained personnel, import reliance, and changing economic policies. The government has taken steps to support the industry's development.
As the worldwide business climate has grown increasingly complex – due to globalization, consolidation, governmental regulation, labour issues, financial pressures, supply chain management and security concerns – the purview of “operations management” has expanded.
Operations management is the business function that plans, organizes coordinates and controls the resources needed to produce a company’s goods and services.
It is mainly concerned with managing the process that converts inputs into outputs.
It closely interacts with the accounting, finance and human resource management function in an organization.
Pharmacy is a highly competitive industry, and companies are experiencing financial pressures more than ever before.
Hence OPERATIONS MANAGEMENT IS THE CENTRAL CORE FUNCTION OF EVERY COMPANY
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
The document discusses the globalization of drug discovery and development. It examines factors that influence where research and production occurs such as workforce costs, market size, intellectual property laws, and government policies. Countries like the US and Europe have traditionally led in innovation due to strong markets and patent protection, but Asia is increasing its role with lower costs and a growing skilled workforce. Where drugs are invented is shifting over time, with the US share declining and Asia rising in recent decades.
Using patent information to track globalizationthinkBiotech
This document discusses using patent information to track the globalization of innovation in the biopharmaceutical industry. It examines how location affects R&D and production decisions and outlines three models countries use: weak intellectual property laws to focus on generic production (India, Brazil, Thailand), moderate intellectual property to leverage generic skills and develop innovative drugs (Israel, Cuba), and strong intellectual property to attract manufacturing investments (Singapore, Puerto Rico). Analysis of patent data shows while the US remains the top location for pharmaceutical innovation, Asia is rising and the EU is stable as the US is slipping as the sole global leader.
WHAT IF: A health impact fund rewarded innovation and managed spending on new...CFHI-FCASS
The document proposes the Health Impact Fund (HIF) as a solution to weak market incentives for developing drugs for diseases that primarily affect the poor. The HIF would reward drug developers based on the assessed health impact of their drugs. Developers could optionally register drugs with the HIF, making them available globally at cost while receiving rewards from the HIF over 10 years for new drugs or 5 years for new uses. The rewards would be billions annually and scaled based on each drug's share of total health impact achieved by all registered drugs. This would incentivize development of drugs for important diseases of the poor by rewarding drugs with high health impact.
The document discusses the pharmaceutical industry and challenges it faces. It notes that global spending on prescription drugs was $954 billion in 2011 and the top 12 companies by revenue. It also discusses the high costs of research and development, limited intellectual property protection, pressure from generic brands, neglected therapeutic areas, and efforts by PhRMA and governments to improve access to medicines globally.
The document discusses issues around balancing intellectual property rights and access to patented medicines in developing countries. It proposes a model that would allow for compulsory licensing of medicines while still preserving incentives for pharmaceutical innovation. Key aspects include allowing developing countries to declare "medical emergencies" to access affordable generic medicines without delay, establishing impartial bodies like WHO to assess such determinations, and ensuring compulsory licenses are limited in scope and term to prevent abuse. The goal is to reform intellectual property rules in a balanced way that addresses public health needs in the global south.
UNITAID's Brenda Waning Presentation at the UNITAID/UNAIDS/Medicines Patent Pool Side Event,
United Nations High Level Meeting on AIDS
New York
9 June, 2011
Development of drugs in public-private partnership (PPP) environmentspmaugeri
The document discusses public-private partnerships (PPPs) for drug development, specifically for orphan and neglected diseases. It outlines the traditional private drug development process, challenges of developing drugs for diseases that do not have large patient populations able to pay, and how PPPs aim to address this by bringing together public and private sector expertise and resources. One example of a PPP, Bayer's Grants4Targets program, provides early-stage research funding for academic scientists while allowing them to retain intellectual property rights. The document raises debates around ensuring PPPs are effective and that resulting drugs are accessible to those in need.
What can we do to ensure that patients have the medicines they need? FernandoLamata
Thousands of people suffer and die because they don't have access to medicines. The main cause of this problem is that prices of medicines are too high, are abusive.
Different actions that governments can adopt to improve access to medicines
The document discusses improving access to essential medicines and identifies several problems. It notes that two billion people lack access to essential medicines, and there is a large price variation for treatments between countries. Stockouts of essential medicines also occur when health facilities experience shortages. The document proposes several solutions, including greater use of generics, changing how innovation is rewarded, improving governance and transparency, and partnerships between different stakeholders.
The document discusses how intellectual property rights and trade policies can impact access to medicines in developing countries. It summarizes key issues including how patents extend drug company monopolies and raise drug prices, the flexibilities in international trade agreements like TRIPS that aim to promote access to generics, and ways powerful countries like the US have attempted to undermine these public health safeguards through additional trade agreements and political pressure on other nations.
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
GSK’S Andrew Witty: Addressing Neglected Tropical Diseases and global health ...Nejmeddine Jemaa
Every day, Non Governmental Organization NGOs is confronted with the lack of access to adequate or affordable medical tools in the field. They face two major challenges the high cost of existing medicines on the one hand, and the absence of appropriate or effective treatments for many of the diseases affecting our patients on the other, we are talking about Neglected Tropical Disease NTD in the Least developed Countries LDCs.
Andrew Witty, Chief Executive Officer of Glaxo Smith Klein (GSK) delivered a speech at the Harvard Business School in Boston on February 2009 entitled “Big pharma a catalyst for Change” focused on two issues: a) promoting innovation to prevent or treat NTDs in the world’s Least Developed Countries by creating a “pharmaceutical patent pool”; b) improving the access to medicine in the poorer countries by lowering the prices of GSK’s medicines.
In deed, we are assisting a radical change in pharma Business model, we are moving from conflict to collaboration through the Medicines Patent Pool in the hope that it speed up access to newer medicines, and boost initiatives that make use of alternative financing mechanisms in order to develop new, more appropriate treatments that respond to medical needs.
On the other hand the pricing strategy dilemma facing the generic manufacturers and the non inclusion of HIV which is a major neglected disease in LDCs in the patent pool may compromise the success of such business model.
In order to deal with that two issues, GSK should include HIV drugs in their patent pool as other manufacturers and NGO are doing, and concerning the pricing strategy they should emphasize on the high quality of the original drug mandatory to eradicate this NTDs and communicate more on the fact that GSK will invest 20% of these drugs profit to improve the infrastructure of these LDCs.
Intellectual Property Rights and Access to
Essential Medicines
Thomas Pogge
Professor of Political Science, Columbia University
Centre for Applied Philosophy and Public Ethics, Australian National University
Centre for the Study of Mind in Nature, University of Oslo
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
Pharmaceutical industry and unit processibtihal osman
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
The document discusses plant layout, which refers to the arrangement of machinery, equipment, and other physical facilities within a factory. The overall goal of plant layout is to optimize material flow and minimize costs. There are different types of layouts, including product layouts that arrange machines by the sequence of operations, and process layouts that group similar machines together. When designing a layout, factors like the factory building, production process, type of equipment, and human needs must all be considered.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
This document discusses the pharmaceutical industry in Pakistan. It provides an introduction to pharmaceuticals and outlines the key members of a group discussing the topic. The history of the pharmaceutical industry in Pakistan is described, noting it was non-existent before the 1970s and now there are over 600 companies. The top challenges facing the industry are listed as a lack of trained manpower, difficulty exporting, and a lack of new technology.
This document provides an analysis of the pharmaceutical industry in Pakistan. It begins with an acknowledgement and executive summary. It then discusses the history, characteristics, contribution to GDP, major companies, benefits, growth, problems, impact, and challenges of the pharmaceutical industry in Pakistan. The industry has grown significantly since the early 1970s and now meets around 90% of Pakistan's pharmaceutical needs. However, it faces challenges such as power shortages, lack of trained personnel, import reliance, and changing economic policies. The government has taken steps to support the industry's development.
As the worldwide business climate has grown increasingly complex – due to globalization, consolidation, governmental regulation, labour issues, financial pressures, supply chain management and security concerns – the purview of “operations management” has expanded.
Operations management is the business function that plans, organizes coordinates and controls the resources needed to produce a company’s goods and services.
It is mainly concerned with managing the process that converts inputs into outputs.
It closely interacts with the accounting, finance and human resource management function in an organization.
Pharmacy is a highly competitive industry, and companies are experiencing financial pressures more than ever before.
Hence OPERATIONS MANAGEMENT IS THE CENTRAL CORE FUNCTION OF EVERY COMPANY
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
The document discusses the globalization of drug discovery and development. It examines factors that influence where research and production occurs such as workforce costs, market size, intellectual property laws, and government policies. Countries like the US and Europe have traditionally led in innovation due to strong markets and patent protection, but Asia is increasing its role with lower costs and a growing skilled workforce. Where drugs are invented is shifting over time, with the US share declining and Asia rising in recent decades.
Using patent information to track globalizationthinkBiotech
This document discusses using patent information to track the globalization of innovation in the biopharmaceutical industry. It examines how location affects R&D and production decisions and outlines three models countries use: weak intellectual property laws to focus on generic production (India, Brazil, Thailand), moderate intellectual property to leverage generic skills and develop innovative drugs (Israel, Cuba), and strong intellectual property to attract manufacturing investments (Singapore, Puerto Rico). Analysis of patent data shows while the US remains the top location for pharmaceutical innovation, Asia is rising and the EU is stable as the US is slipping as the sole global leader.
WHAT IF: A health impact fund rewarded innovation and managed spending on new...CFHI-FCASS
The document proposes the Health Impact Fund (HIF) as a solution to weak market incentives for developing drugs for diseases that primarily affect the poor. The HIF would reward drug developers based on the assessed health impact of their drugs. Developers could optionally register drugs with the HIF, making them available globally at cost while receiving rewards from the HIF over 10 years for new drugs or 5 years for new uses. The rewards would be billions annually and scaled based on each drug's share of total health impact achieved by all registered drugs. This would incentivize development of drugs for important diseases of the poor by rewarding drugs with high health impact.
The document discusses the pharmaceutical industry and challenges it faces. It notes that global spending on prescription drugs was $954 billion in 2011 and the top 12 companies by revenue. It also discusses the high costs of research and development, limited intellectual property protection, pressure from generic brands, neglected therapeutic areas, and efforts by PhRMA and governments to improve access to medicines globally.
The document discusses issues around balancing intellectual property rights and access to patented medicines in developing countries. It proposes a model that would allow for compulsory licensing of medicines while still preserving incentives for pharmaceutical innovation. Key aspects include allowing developing countries to declare "medical emergencies" to access affordable generic medicines without delay, establishing impartial bodies like WHO to assess such determinations, and ensuring compulsory licenses are limited in scope and term to prevent abuse. The goal is to reform intellectual property rules in a balanced way that addresses public health needs in the global south.
UNITAID's Brenda Waning Presentation at the UNITAID/UNAIDS/Medicines Patent Pool Side Event,
United Nations High Level Meeting on AIDS
New York
9 June, 2011
Development of drugs in public-private partnership (PPP) environmentspmaugeri
The document discusses public-private partnerships (PPPs) for drug development, specifically for orphan and neglected diseases. It outlines the traditional private drug development process, challenges of developing drugs for diseases that do not have large patient populations able to pay, and how PPPs aim to address this by bringing together public and private sector expertise and resources. One example of a PPP, Bayer's Grants4Targets program, provides early-stage research funding for academic scientists while allowing them to retain intellectual property rights. The document raises debates around ensuring PPPs are effective and that resulting drugs are accessible to those in need.
What can we do to ensure that patients have the medicines they need? FernandoLamata
Thousands of people suffer and die because they don't have access to medicines. The main cause of this problem is that prices of medicines are too high, are abusive.
Different actions that governments can adopt to improve access to medicines
The document discusses improving access to essential medicines and identifies several problems. It notes that two billion people lack access to essential medicines, and there is a large price variation for treatments between countries. Stockouts of essential medicines also occur when health facilities experience shortages. The document proposes several solutions, including greater use of generics, changing how innovation is rewarded, improving governance and transparency, and partnerships between different stakeholders.
The document discusses how intellectual property rights and trade policies can impact access to medicines in developing countries. It summarizes key issues including how patents extend drug company monopolies and raise drug prices, the flexibilities in international trade agreements like TRIPS that aim to promote access to generics, and ways powerful countries like the US have attempted to undermine these public health safeguards through additional trade agreements and political pressure on other nations.
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
GSK’S Andrew Witty: Addressing Neglected Tropical Diseases and global health ...Nejmeddine Jemaa
Every day, Non Governmental Organization NGOs is confronted with the lack of access to adequate or affordable medical tools in the field. They face two major challenges the high cost of existing medicines on the one hand, and the absence of appropriate or effective treatments for many of the diseases affecting our patients on the other, we are talking about Neglected Tropical Disease NTD in the Least developed Countries LDCs.
Andrew Witty, Chief Executive Officer of Glaxo Smith Klein (GSK) delivered a speech at the Harvard Business School in Boston on February 2009 entitled “Big pharma a catalyst for Change” focused on two issues: a) promoting innovation to prevent or treat NTDs in the world’s Least Developed Countries by creating a “pharmaceutical patent pool”; b) improving the access to medicine in the poorer countries by lowering the prices of GSK’s medicines.
In deed, we are assisting a radical change in pharma Business model, we are moving from conflict to collaboration through the Medicines Patent Pool in the hope that it speed up access to newer medicines, and boost initiatives that make use of alternative financing mechanisms in order to develop new, more appropriate treatments that respond to medical needs.
On the other hand the pricing strategy dilemma facing the generic manufacturers and the non inclusion of HIV which is a major neglected disease in LDCs in the patent pool may compromise the success of such business model.
In order to deal with that two issues, GSK should include HIV drugs in their patent pool as other manufacturers and NGO are doing, and concerning the pricing strategy they should emphasize on the high quality of the original drug mandatory to eradicate this NTDs and communicate more on the fact that GSK will invest 20% of these drugs profit to improve the infrastructure of these LDCs.
Intellectual Property Rights and Access to
Essential Medicines
Thomas Pogge
Professor of Political Science, Columbia University
Centre for Applied Philosophy and Public Ethics, Australian National University
Centre for the Study of Mind in Nature, University of Oslo
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
The pharmaceutical industry is facing many challenges today including declining drug approvals, rising generics competition, increased regulatory scrutiny, and a broken R&D process. Proposed changes like high-throughput screening and biomarkers have failed to significantly improve R&D productivity. Outsourcing drug development and focusing on commercialization may be a solution. Healthcare is also transitioning to personalized and preventative care focused on diagnosis over acute treatment, making patients more proactive consumers. Pharmaceutical companies will need new business models that integrate with changing healthcare systems.
The document summarizes the key points made by Bienvenido Oplas Jr. in his presentation on the impacts of the Cheaper Medicines Law (RA 9502) in the Philippines. It finds that while the law aimed to lower drug prices through price controls, this has unintentionally hurt supply and local pharmaceutical producers. Price controls have led to price cuts that exceed production costs, reduced sales volumes, business losses for drugstores and hospitals, and declining incentives for private research which benefits public health. Alternative policies that respect property rights and encourage competition are suggested to better achieve affordable access to medicines.
Please read below case and individually take the role of “NGOsAdvoc.pdfpallavi953613
Please read below case and individually take the role of “NGOs/Advocacy Groups” as one of the
important stakeholder.
Discuss the case, from your chosen stakeholder as “NGOs/Advocacy Groups” and perspective
analyzing the reasons for the current situation and the changes you would propose for the future,
supported with additionally researched relevant information.
Please mention your list of references and at least 400 words.
In-Depth Integrative Case 1.2
Pharmaceutical Companies, Intellectual Property,
and the Global AIDS Epidemic
In August 2003, after heavy lobbying from nongovernmental
organizations (NGOs) such as Doctors Without
Borders, the U.S. pharmaceutical industry finally dropped
its opposition to relaxation of the intellectual property
rights (IPR) provisions under World Trade Organization
(WTO) regulations to make generic, low-cost antiviral
drugs available to developing countries like South Africa
facing epidemics or other health emergencies. 1 Although
this announcement appeared to end a three-year dispute
between multinational pharmaceutical companies, governments,
and NGOs over the most appropriate and effective
response to viral pandemics in the developing world, the
specific procedures for determining what constitutes a
health emergency had yet to be worked out. Nonetheless,
the day after the agreement was announced, the government
of Brazil said it would publish a decree authorizing
imports of generic versions of patented AIDS drugs that
the country said it could no longer afford to buy from
multinational pharmaceutical companies. Although the
tentative WTO agreement would appear to allow such
production under limited circumstances, former U.S. trade
official Jon Huenemann remarked, “They’re playing with
fire. . . . The sensitivities of this are obvious and we’re
right on the edge here.”
Despite the role of developed and developing country
governments, NGOs, large pharmaceutical companies,
and their generic competitors in crafting this agreement,
it was unclear how it would be implemented and whether
action would be swift enough to stem the HIV/AIDS epidemic
ravaging South Africa and many other countries.
The AIDS Epidemic and Potential
Treatment
In 2008, after over two decades of fighting the AIDS epidemic
and raising the public awareness, HIV/AIDS still
remained one of the leading causes of death in the world,
occupying the 6th position in WHO Top 10 Causes of
Death list. 3 According to the World Health Organization
(WHO), in 2008 there were approximately 33.4 million
people living with AIDS, with 2.7 million newly infected,
and 2 millions deaths (see Table 1). Since 1980, AIDS has
killed more than 25 million people. HIV is especially
deadly because it often remains dormant in an infected person
for years without showing symptoms and is transmitted
to others often without the knowledge of either person. HIV
leads to AIDS when the virus attacks the immune system
and cripples it, making the person vulnerable to diseases. 4
Th.
Case Study: Treating AIDs: The Global Ethical Dilemma (MGT4810)Afifah Nabilah
This document discusses the global ethical dilemma surrounding the treatment of AIDS. It outlines the perspectives of multiple stakeholders involved, including drug companies, governments, and health organizations. Drug companies aim to protect intellectual property rights and profits, while governments want to provide affordable treatment to citizens. The high cost of drugs conflicts with making them accessible. Solutions proposed include joint ventures between international and local drug firms to produce low-cost generic medicines. Utilitarian ethics is suggested to maximize benefit for all parties.
As part of an initiative to increase campus sustainability at UW, I did a study on fluorescent bulbs and the costs and benefits of upgrading to more energy-efficient lighting.
Fair Trade and Sustainable Business Practicestchykita
I gave this presentation at the 2nd Annual Good Mule conference which was organized by a group of students (including myself). It is a modified version of the presentation I gave to defend my Senior Honors Thesis entitled "Free Trade Problems, Fair Trade Solutions."
2. What about generic drugs? TRIPs – Trade Related Aspects of Intellectual Property Uruguay Round of trade negotiations (1994) A single standard for intellectual property law on the world raise the price of drugs to levels that were unaffordable in much of the world Big drug companies want TRIPs to make it more difficult for generics to be produced Profits = keeping as many generic drugs as possible off the market as long as possible
3. Why keep generics off the market? Higher prices = more research? …Not really More $ spent on advertising than on research More research on lifestyle drugs than for disease Little research done on disease affecting LDCs Basic research funded by government Companies make huge profit!
4. Why keep generics off the market? Allowing trade in generic drugs means low drug prices elsewhere will spoil domestic market Already huge disparities (Europe); problem limited Pharmaceuticals industry very regulated Most of the cost paid by insurance companies and governments Difficult to get drugs outside domestic economy
5. Counterargument Providing LDCs with lifesaving drugs will: Have a negligible effect on drug companies’ investments in the diseases that affect LDCs Have a negligible effect on drug companies’ revenue (little revenue to begin with—under 2%) Save lives Increase productivity and economic efficiency in LDCs
6. Knowledge and Innovation Knowledge is a public good Restricting knowledge = inefficiency and a lower pace of innovation Restricting knowledge in the case of AIDS medications = death “The marvels of modern medicine are truly astonishing; but the gap between the successes of the sciences in finding cures and the failures of the social sciences in finding ways of ensuring that the benefits of that knowledge are made available to all is equally astonishing.” –Joseph Stiglitz
7. Solution #1 Advanced industrial countries provide drugs or at least subsidize them Criticism: free-riding on industrial countries Response: yes, and they should No additional cost for developed countries (knowledge is a public good) Benefits to developing countries enormous
8. Solution #2 Compulsory licensing (when there is an urgent need to broaden access to technology or medicines) Right recognized globally 2001 Anthrax scare and Cipro Firms can produce a drug and sell it at just above cost Efficiency = lots of money saved
9. Solution #3 A market-based incentive: a guarantee fund Developed world governments make a purchase guarantee Criticism: still monopoly problem and creates a winner-takes-all system
10. Solution #4 Innovation fund (prize system) Really important discoveries get really big rewards Allows for generic production Benefits developing countries (low-cost drugs) Benefits developed countries (improved knowledge) Bonus: developed-country governments able to aid the developing world without worrying whether the money will be well spent.
Editor's Notes
lifestyle drugs (e.g., drugs for hair growth or male impotence)
African sales represent under 2 percent of the total—because the people are simply too poor to buy expensive drugs; and they spend little on the diseases that most affect developing countries.
2001 anthrax scare, the U.S. government threatened to force the drug company Bayer to allow others to produce Cipro, the antibiotic most effective against anthrax at that time.For instance, Brazil’s state-run drug company, Farmanguinhos, estimates that in can produce the AIDS medicine Kaletra for a fraction of what Abbott charges in the United States. With more than 600,000 HIV-positive patients in the country, at one time, it was estimated that a generic Kaletra would save Brazil some $55 million off even the highly discounted price at which Abbott was then selling the drug to Brazil.
The prize fund concept has been championed by James Love and the Consumer Project on Technology. Congressman Bernard Sanders introduced HR 417, the Medical Innovation Prize Act of 2005, to implement the idea.)