This presentation contains an overview of recent Greek jurisprudence on parallel trade in the pharmaceutical industry.
Contents include circulars, laws and recent case studies.
This document provides an introduction and overview of parallel imports in the pharmaceutical industry. It discusses the legal treatments of parallel imports according to international trade agreements and the impact of parallel imports on pricing and innovation. The document contains an acknowledgements section, table of contents, and bibliography. It examines the debate around parallel imports and international exhaustion of intellectual property rights as they relate to pharmaceutical patent and pricing policies in developing countries.
This document discusses parallel imports of pharmaceuticals. It begins by defining parallel imports as the importation of non-counterfeit products without the authorization of the patent holder, often occurring when prices vary between markets. It then examines reasons for price differentiations internationally and provides examples of large price differences for common drugs between the US and India. The document outlines arguments for and against parallel imports, different countries' legal approaches, and India's stance, concluding that parallel imports have limited practical utility for India.
Exhaustion of IPRs: introductory conceptsenfresdezh
This document discusses the concept of exhaustion of intellectual property rights as it relates to parallel imports of patented pharmaceutical products. It describes three typical types of exhaustion: international, regional, and national. International exhaustion allows parallel imports from any country, providing the least protection and most access. National exhaustion does not allow parallel imports, providing the most protection and least access. The document also examines factors around balancing more access versus more protection. It outlines Singapore's hybrid approach, which applies national exhaustion before first sale in Singapore but international exhaustion after, seeking to balance access and protection for patented pharmaceuticals.
This document discusses parallel imports of Samsung products into India. It begins by defining parallel imports as non-counterfeit products imported without the intellectual property owner's permission. It then classifies parallel imports and discusses the different regulatory principles around exhaustion of intellectual property rights. The document analyzes the Samsung v. Kapil Wadhwa case, where Samsung sued to restrain parallel imports of its printers. The court ultimately ruled that Section 30(3) of India's Trademarks Act recognizes the principle of international exhaustion of rights, allowing parallel imports. The implications for multinational companies are that it prevents restrictions on genuine imports. The document concludes by discussing another similar case involving Dell computers and issues around trademark infringement for meta-tagging.
Parallel importation refers to the import of legitimate products into a country without the permission of the intellectual property owner. It occurs when there are differences in pricing strategies across international markets. The ability of the original owner to prevent parallel imports depends on the importing country's treatment of the exhaustion principle under intellectual property law. For patents and trademarks, India follows a rule of international exhaustion, but for copyrights, parallel imports are prohibited. The impact of parallel imports is debated, with arguments on both sides around benefits to consumers versus effects on innovation incentives.
This document analyzes the legal and moral aspects of product and process patenting in the pharmaceutical industry. It discusses how patents allow pharmaceutical companies to monopolize drugs, preventing competition from generic drugs. While patents incentivize innovation, they can also limit access to life-saving drugs in developing countries where people cannot afford high drug prices. The TRIPS agreement established universal patent standards but had both positive and negative impacts on innovation and access to healthcare globally.
Remedial TRIPS Flexbilities and Good Practices for Public Health relating to ...MakeMedicinesAffordable
The slideshow is about remedial TRIPS flexibilities and good practices for public health relating to access to and price of HIV drugs. It is prepared by Tahir Amin who works for the Initiative for Medicine Access and Knowledge.
It includes:
- Post-grant opposition, revocation, invalidation
- Compulsory licensing
- Government use authorisation
- Exceptions to patent rights
Inter Partes Review (IPR) - A Brief UnderstandingsManoj Prajapati
An Inter Partes Review (IPR) is, Mini trial on Patent Validity before a panel of Patent Experts, Patent trial and Appeal Board, for challenging the validity of a United States patent on a ground that could be raised under 35 U.S.C. §§ 102 or 103, and on the basis of prior art consisting of patents or printed publications before the United States Patent and Trademark Office (USPTO). Became effective on 16 September 2012 and emerging as a revolutionary tool in the field of Innovation.
This document provides an introduction and overview of parallel imports in the pharmaceutical industry. It discusses the legal treatments of parallel imports according to international trade agreements and the impact of parallel imports on pricing and innovation. The document contains an acknowledgements section, table of contents, and bibliography. It examines the debate around parallel imports and international exhaustion of intellectual property rights as they relate to pharmaceutical patent and pricing policies in developing countries.
This document discusses parallel imports of pharmaceuticals. It begins by defining parallel imports as the importation of non-counterfeit products without the authorization of the patent holder, often occurring when prices vary between markets. It then examines reasons for price differentiations internationally and provides examples of large price differences for common drugs between the US and India. The document outlines arguments for and against parallel imports, different countries' legal approaches, and India's stance, concluding that parallel imports have limited practical utility for India.
Exhaustion of IPRs: introductory conceptsenfresdezh
This document discusses the concept of exhaustion of intellectual property rights as it relates to parallel imports of patented pharmaceutical products. It describes three typical types of exhaustion: international, regional, and national. International exhaustion allows parallel imports from any country, providing the least protection and most access. National exhaustion does not allow parallel imports, providing the most protection and least access. The document also examines factors around balancing more access versus more protection. It outlines Singapore's hybrid approach, which applies national exhaustion before first sale in Singapore but international exhaustion after, seeking to balance access and protection for patented pharmaceuticals.
This document discusses parallel imports of Samsung products into India. It begins by defining parallel imports as non-counterfeit products imported without the intellectual property owner's permission. It then classifies parallel imports and discusses the different regulatory principles around exhaustion of intellectual property rights. The document analyzes the Samsung v. Kapil Wadhwa case, where Samsung sued to restrain parallel imports of its printers. The court ultimately ruled that Section 30(3) of India's Trademarks Act recognizes the principle of international exhaustion of rights, allowing parallel imports. The implications for multinational companies are that it prevents restrictions on genuine imports. The document concludes by discussing another similar case involving Dell computers and issues around trademark infringement for meta-tagging.
Parallel importation refers to the import of legitimate products into a country without the permission of the intellectual property owner. It occurs when there are differences in pricing strategies across international markets. The ability of the original owner to prevent parallel imports depends on the importing country's treatment of the exhaustion principle under intellectual property law. For patents and trademarks, India follows a rule of international exhaustion, but for copyrights, parallel imports are prohibited. The impact of parallel imports is debated, with arguments on both sides around benefits to consumers versus effects on innovation incentives.
This document analyzes the legal and moral aspects of product and process patenting in the pharmaceutical industry. It discusses how patents allow pharmaceutical companies to monopolize drugs, preventing competition from generic drugs. While patents incentivize innovation, they can also limit access to life-saving drugs in developing countries where people cannot afford high drug prices. The TRIPS agreement established universal patent standards but had both positive and negative impacts on innovation and access to healthcare globally.
Remedial TRIPS Flexbilities and Good Practices for Public Health relating to ...MakeMedicinesAffordable
The slideshow is about remedial TRIPS flexibilities and good practices for public health relating to access to and price of HIV drugs. It is prepared by Tahir Amin who works for the Initiative for Medicine Access and Knowledge.
It includes:
- Post-grant opposition, revocation, invalidation
- Compulsory licensing
- Government use authorisation
- Exceptions to patent rights
Inter Partes Review (IPR) - A Brief UnderstandingsManoj Prajapati
An Inter Partes Review (IPR) is, Mini trial on Patent Validity before a panel of Patent Experts, Patent trial and Appeal Board, for challenging the validity of a United States patent on a ground that could be raised under 35 U.S.C. §§ 102 or 103, and on the basis of prior art consisting of patents or printed publications before the United States Patent and Trademark Office (USPTO). Became effective on 16 September 2012 and emerging as a revolutionary tool in the field of Innovation.
This document discusses key provisions of the Hatch-Waxman Act, which established the modern system of regulating generic drugs in the US. It aims to balance the interests of branded drug companies, generic companies, and consumers. Some key points covered include:
- It allows generic companies to submit abbreviated new drug applications without repeating clinical trials by proving bioequivalence.
- It provides patent term extensions for branded drugs and 180-day exclusivity periods for first generic applicants challenging a patent.
- It established a pathway for early experimental use of patented drugs and a 30-month stay on generic approvals if patents are challenged.
Pay-for-delay settlements, also known as reverse payment settlements, involve pharmaceutical patent holders paying generic drug manufacturers to delay introducing generic drugs. While the FTC views these settlements as illegal restraints of trade, costing consumers $3.5 billion per year, most federal courts have found them legal if the terms do not extend beyond the patent's exclusionary scope. The document outlines the legal framework and ongoing debate around pay-for-delay settlements.
This document outlines a patent infringement case between AstraZeneca and Ranbaxy regarding AstraZeneca's heartburn medication Nexium. It provides background on both parties and how Ranbaxy sought approval for a generic version. It describes how AstraZeneca sued Ranbaxy for patent infringement, triggering a 30 month stay of FDA approval for Ranbaxy. It then summarizes how AstraZeneca later settled litigation with Ranbaxy and other generic manufacturers, agreeing to drop lawsuits in exchange for the generics admitting patent validity and delaying market entry until May 2014.
GSIPA2M, Parallel session 2, Making compulsory licenses routine - James LoveMakeMedicinesAffordable
This document discusses non-voluntary use of patents, including compulsory licenses, and the relevant international legal frameworks. It summarizes key provisions of the TRIPS agreement and Doha Declaration that provide flexibilities for countries to issue compulsory licenses on patents. It also discusses cases where courts have ordered reasonable royalties as an alternative to injunctions for patent infringement. Specific examples of compulsory licenses granted for pharmaceutical products are mentioned, including cases involving treatments for HIV, hepatitis C, and Fabry disease. Considerations for determining appropriate compensation or remuneration in the form of royalties are also covered.
Patents, Competition, Antitrust and Generic Drugs: Resolving Hatch-Waxman IssuesKirby Drake
This document summarizes the Hatch-Waxman Act and related issues involving patents, competition, and generic drugs. It discusses the Bayer-Barr litigation over the drug Cipro and the resulting antitrust litigation. While private plaintiffs argued the settlement violated antitrust laws by delaying generic competition, courts found the settlement was within Bayer's patent rights as it did not prevent other challenges and fell within the exclusionary zone of the patent. However, conflicts remain around balancing patent and drug competition policies.
The Hatch-Waxman Act, passed in 1984, aims to balance incentives for drug innovators and generic companies. It established the modern framework for generic drug approval through the ANDA process. This streamlined process requires generics to show bioequivalence rather than repeating clinical trials, expediting market entry. The Act also provides incentives for generics by allowing challenges to drug patents and provisions for patent term extensions to innovators. It created a more efficient pathway for generics while continuing to reward pharmaceutical innovation.
This document outlines provisions for drug registration in China, including:
- The State Food and Drug Administration is responsible for drug registration nationwide and oversees clinical trials, production, and importation of drugs.
- The registration process involves application and review of drugs for safety, efficacy, and quality. It includes clinical trials and inspections of manufacturing facilities.
- Applications are reviewed following principles of openness, fairness and protecting confidential information submitted by applicants.
This document outlines the Import Policy Order for 2009-2012 issued by the Ministry of Commerce of Bangladesh. It contains 9 chapters that cover topics such as general provisions for imports, import fees, miscellaneous provisions for industrial and commercial imports, and provisions for public sector importers. Some key points include:
- The Import Policy Order regulates all imports into Bangladesh and is effective from 2009-2012, though it can be extended if a new order is not issued.
- It defines important terms related to imports and trade.
- Imports are either freely allowed or restricted/banned based on an annexed control list, with conditions specified for restricted items.
- General conditions for imports include using HS codes, obtaining no
MERGERS AND ACQUISITIONS IN PHARMACEUTICAL SECTORHarshitGandhi16
The document discusses mergers and acquisitions in the Indian pharmaceutical sector. It provides context on the size and growth of the Indian pharmaceutical industry. It then discusses some major M&A deals involving Indian pharmaceutical companies both outbound and inbound. Reasons for M&As include increasing market share, addressing generic competition and lack of R&D facilities. The largest M&A deal was Daiichi Sankyo's acquisition of Ranbaxy for $4.2 billion, providing both companies access to new markets and products. However, increased consolidation could reduce availability of drugs and increase prices if it limits competition in the sector.
Pre-Grant & Post- Grant Opposition to IPRs in IndiaBindu Kshtriya
Patents
Trade Marks
Copyrights
Generic Labelling
Role of NGO to fight for patient’s right against Patent’s Right.
Leading Cases of IPRs that shows ramifications in Indian IPR system.
Indian Patent Regime after 1995 amendments, NIB patent warsManasi Vakil
Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...
The document discusses regulations around Abbreviated New Drug Applications (ANDAs) for generic drugs in the US. It notes that ANDAs must include a patent certification stating that the generic drug will not infringe on patents listed for the branded drug. There are four types of certifications, with Paragraph IV certification asserting a listed patent is invalid or will not be infringed. Filing a Paragraph IV certification allows the first generic to receive 180 days of market exclusivity upon approval. The branded company then has 45 days to sue the generic for patent infringement and trigger a 30-month stay of FDA approval while the case is litigated.
THE FARMERS’ PRODUCE TRADE AND COMMERCE (PROMOTION AND FACILITATION) BILL, 2020Harminder Singh
1) The document introduces the Farmers' Produce Trade and Commerce (Promotion and Facilitation) Bill, 2020, which aims to create an ecosystem where farmers can freely trade produce outside of government-regulated markets.
2) It defines key terms related to farmers, trading, and electronic platforms. It also establishes the freedom for farmers and traders to conduct inter-state and intra-state trade in a trade area, which can be farm gates, warehouses, etc. but not government-regulated markets.
3) It allows for electronic registration of traders and electronic trading platforms. It prohibits any market fees from being charged on trade outside of government markets. It also provides for a dispute resolution process between farmers and
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
The document discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Kefauver-Harris Amendments of 1962. The FFDCA was passed in 1938 in response to tragedies from unsafe drugs and gave more authority to the FDA. The Kefauver-Harris Amendments of 1962 required drug manufacturers to prove a drug's efficacy and safety before approval in response to the thalidomide crisis. The amendments strengthened pre-market drug approval processes and mandated new drug efficacy studies.
(This is an extract from the lecture delivered by Shyamsunder Panchavati on 2nd September 2010 at Hyderabad)
Human being lives in whirlpool of Industries. All the industries revolve around the living beings specially the human beings. One industry or profession that keeps the human being fit enough to wither the whirlpool and keeps the industry going is the Medical Profession. Hence the Medical Profession occupies the high pedestal in this world.
View the abstract at
http://capacitybuildingdevelopment.blogspot.com/2010/09/pharmaceutical-industry-overview_06.html
The Indian pharmaceutical industry has grown tremendously over the past few decades from being almost non-existent to meeting nearly 95% of the country's pharmaceutical needs. It is now self-reliant in terms of production capabilities across a wide range of medicines. The industry is highly fragmented with over 20,000 registered units and is characterized by intense price competition and government price controls. Exports have also increased significantly and are expected to surpass domestic sales in the coming years, driven primarily by growth in formulation exports. India also has the most FDA-approved manufacturing facilities outside of the US, positioning it as an important supplier for the global pharmaceutical market.
Evolution of pharma industry and related opportunitiesBioValley Basel
The document discusses the evolution of the pharmaceutical industry and related career opportunities. It notes that while research was traditionally conducted in-house, there is now more outsourcing of drug discovery and development. New opportunities exist in startups, clinical research organizations, and complementary sectors like diagnostics and medical devices. Skills in areas like project management, communication, and working in multicultural environments are important for career success in the evolving industry.
This document provides an overview of the pharmaceutical industry in India. It discusses the history and growth of the Indian pharmaceutical market. It also describes the various types of companies, customers, marketing approaches, distribution channels, roles of sales, marketing, and other teams, pricing regulations, and opportunities and changes in the industry. The document is an extensive guide covering many aspects of the pharmaceutical business in India.
The document provides an overview of the pharmaceutical industry in India and details regarding Sun Pharma and Lupin, two major Indian pharmaceutical companies. It discusses the regulatory environment, business models, financial performance, acquisitions, and growth strategies of Sun Pharma and Lupin. The summary highlights both companies' focus on expanding their global footprint and specialty product portfolios through acquisitions and internal research and development.
The report contains the following four chapters:
Chapter 1: Global Pharmaceutical Market
Chapter 2: Solutions to Challenges
Chapter 3: Global Players
Chapter 4: Overview of Industry Trends
You may follow my blog: biostrategyanalytics.wordpress.com for further posts related to financial and strategic issues in the Pharmaceutical / Biotechnology sector.
For any questions or recommendations do not hesitate to contact me.
This document discusses key provisions of the Hatch-Waxman Act, which established the modern system of regulating generic drugs in the US. It aims to balance the interests of branded drug companies, generic companies, and consumers. Some key points covered include:
- It allows generic companies to submit abbreviated new drug applications without repeating clinical trials by proving bioequivalence.
- It provides patent term extensions for branded drugs and 180-day exclusivity periods for first generic applicants challenging a patent.
- It established a pathway for early experimental use of patented drugs and a 30-month stay on generic approvals if patents are challenged.
Pay-for-delay settlements, also known as reverse payment settlements, involve pharmaceutical patent holders paying generic drug manufacturers to delay introducing generic drugs. While the FTC views these settlements as illegal restraints of trade, costing consumers $3.5 billion per year, most federal courts have found them legal if the terms do not extend beyond the patent's exclusionary scope. The document outlines the legal framework and ongoing debate around pay-for-delay settlements.
This document outlines a patent infringement case between AstraZeneca and Ranbaxy regarding AstraZeneca's heartburn medication Nexium. It provides background on both parties and how Ranbaxy sought approval for a generic version. It describes how AstraZeneca sued Ranbaxy for patent infringement, triggering a 30 month stay of FDA approval for Ranbaxy. It then summarizes how AstraZeneca later settled litigation with Ranbaxy and other generic manufacturers, agreeing to drop lawsuits in exchange for the generics admitting patent validity and delaying market entry until May 2014.
GSIPA2M, Parallel session 2, Making compulsory licenses routine - James LoveMakeMedicinesAffordable
This document discusses non-voluntary use of patents, including compulsory licenses, and the relevant international legal frameworks. It summarizes key provisions of the TRIPS agreement and Doha Declaration that provide flexibilities for countries to issue compulsory licenses on patents. It also discusses cases where courts have ordered reasonable royalties as an alternative to injunctions for patent infringement. Specific examples of compulsory licenses granted for pharmaceutical products are mentioned, including cases involving treatments for HIV, hepatitis C, and Fabry disease. Considerations for determining appropriate compensation or remuneration in the form of royalties are also covered.
Patents, Competition, Antitrust and Generic Drugs: Resolving Hatch-Waxman IssuesKirby Drake
This document summarizes the Hatch-Waxman Act and related issues involving patents, competition, and generic drugs. It discusses the Bayer-Barr litigation over the drug Cipro and the resulting antitrust litigation. While private plaintiffs argued the settlement violated antitrust laws by delaying generic competition, courts found the settlement was within Bayer's patent rights as it did not prevent other challenges and fell within the exclusionary zone of the patent. However, conflicts remain around balancing patent and drug competition policies.
The Hatch-Waxman Act, passed in 1984, aims to balance incentives for drug innovators and generic companies. It established the modern framework for generic drug approval through the ANDA process. This streamlined process requires generics to show bioequivalence rather than repeating clinical trials, expediting market entry. The Act also provides incentives for generics by allowing challenges to drug patents and provisions for patent term extensions to innovators. It created a more efficient pathway for generics while continuing to reward pharmaceutical innovation.
This document outlines provisions for drug registration in China, including:
- The State Food and Drug Administration is responsible for drug registration nationwide and oversees clinical trials, production, and importation of drugs.
- The registration process involves application and review of drugs for safety, efficacy, and quality. It includes clinical trials and inspections of manufacturing facilities.
- Applications are reviewed following principles of openness, fairness and protecting confidential information submitted by applicants.
This document outlines the Import Policy Order for 2009-2012 issued by the Ministry of Commerce of Bangladesh. It contains 9 chapters that cover topics such as general provisions for imports, import fees, miscellaneous provisions for industrial and commercial imports, and provisions for public sector importers. Some key points include:
- The Import Policy Order regulates all imports into Bangladesh and is effective from 2009-2012, though it can be extended if a new order is not issued.
- It defines important terms related to imports and trade.
- Imports are either freely allowed or restricted/banned based on an annexed control list, with conditions specified for restricted items.
- General conditions for imports include using HS codes, obtaining no
MERGERS AND ACQUISITIONS IN PHARMACEUTICAL SECTORHarshitGandhi16
The document discusses mergers and acquisitions in the Indian pharmaceutical sector. It provides context on the size and growth of the Indian pharmaceutical industry. It then discusses some major M&A deals involving Indian pharmaceutical companies both outbound and inbound. Reasons for M&As include increasing market share, addressing generic competition and lack of R&D facilities. The largest M&A deal was Daiichi Sankyo's acquisition of Ranbaxy for $4.2 billion, providing both companies access to new markets and products. However, increased consolidation could reduce availability of drugs and increase prices if it limits competition in the sector.
Pre-Grant & Post- Grant Opposition to IPRs in IndiaBindu Kshtriya
Patents
Trade Marks
Copyrights
Generic Labelling
Role of NGO to fight for patient’s right against Patent’s Right.
Leading Cases of IPRs that shows ramifications in Indian IPR system.
Indian Patent Regime after 1995 amendments, NIB patent warsManasi Vakil
Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...
The document discusses regulations around Abbreviated New Drug Applications (ANDAs) for generic drugs in the US. It notes that ANDAs must include a patent certification stating that the generic drug will not infringe on patents listed for the branded drug. There are four types of certifications, with Paragraph IV certification asserting a listed patent is invalid or will not be infringed. Filing a Paragraph IV certification allows the first generic to receive 180 days of market exclusivity upon approval. The branded company then has 45 days to sue the generic for patent infringement and trigger a 30-month stay of FDA approval while the case is litigated.
THE FARMERS’ PRODUCE TRADE AND COMMERCE (PROMOTION AND FACILITATION) BILL, 2020Harminder Singh
1) The document introduces the Farmers' Produce Trade and Commerce (Promotion and Facilitation) Bill, 2020, which aims to create an ecosystem where farmers can freely trade produce outside of government-regulated markets.
2) It defines key terms related to farmers, trading, and electronic platforms. It also establishes the freedom for farmers and traders to conduct inter-state and intra-state trade in a trade area, which can be farm gates, warehouses, etc. but not government-regulated markets.
3) It allows for electronic registration of traders and electronic trading platforms. It prohibits any market fees from being charged on trade outside of government markets. It also provides for a dispute resolution process between farmers and
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
The document discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Kefauver-Harris Amendments of 1962. The FFDCA was passed in 1938 in response to tragedies from unsafe drugs and gave more authority to the FDA. The Kefauver-Harris Amendments of 1962 required drug manufacturers to prove a drug's efficacy and safety before approval in response to the thalidomide crisis. The amendments strengthened pre-market drug approval processes and mandated new drug efficacy studies.
(This is an extract from the lecture delivered by Shyamsunder Panchavati on 2nd September 2010 at Hyderabad)
Human being lives in whirlpool of Industries. All the industries revolve around the living beings specially the human beings. One industry or profession that keeps the human being fit enough to wither the whirlpool and keeps the industry going is the Medical Profession. Hence the Medical Profession occupies the high pedestal in this world.
View the abstract at
http://capacitybuildingdevelopment.blogspot.com/2010/09/pharmaceutical-industry-overview_06.html
The Indian pharmaceutical industry has grown tremendously over the past few decades from being almost non-existent to meeting nearly 95% of the country's pharmaceutical needs. It is now self-reliant in terms of production capabilities across a wide range of medicines. The industry is highly fragmented with over 20,000 registered units and is characterized by intense price competition and government price controls. Exports have also increased significantly and are expected to surpass domestic sales in the coming years, driven primarily by growth in formulation exports. India also has the most FDA-approved manufacturing facilities outside of the US, positioning it as an important supplier for the global pharmaceutical market.
Evolution of pharma industry and related opportunitiesBioValley Basel
The document discusses the evolution of the pharmaceutical industry and related career opportunities. It notes that while research was traditionally conducted in-house, there is now more outsourcing of drug discovery and development. New opportunities exist in startups, clinical research organizations, and complementary sectors like diagnostics and medical devices. Skills in areas like project management, communication, and working in multicultural environments are important for career success in the evolving industry.
This document provides an overview of the pharmaceutical industry in India. It discusses the history and growth of the Indian pharmaceutical market. It also describes the various types of companies, customers, marketing approaches, distribution channels, roles of sales, marketing, and other teams, pricing regulations, and opportunities and changes in the industry. The document is an extensive guide covering many aspects of the pharmaceutical business in India.
The document provides an overview of the pharmaceutical industry in India and details regarding Sun Pharma and Lupin, two major Indian pharmaceutical companies. It discusses the regulatory environment, business models, financial performance, acquisitions, and growth strategies of Sun Pharma and Lupin. The summary highlights both companies' focus on expanding their global footprint and specialty product portfolios through acquisitions and internal research and development.
The report contains the following four chapters:
Chapter 1: Global Pharmaceutical Market
Chapter 2: Solutions to Challenges
Chapter 3: Global Players
Chapter 4: Overview of Industry Trends
You may follow my blog: biostrategyanalytics.wordpress.com for further posts related to financial and strategic issues in the Pharmaceutical / Biotechnology sector.
For any questions or recommendations do not hesitate to contact me.
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.
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
Pakistan has a growing pharmaceutical market valued at $2.6 billion in 2015. Systemic anti-infectives and alimentary tract and metabolism drugs make up nearly half of total market share. The top 20 pharmaceutical companies, including GlaxoSmithKline and Abbott Laboratories, account for over 50% of total market value. Major trading partners for pharmaceutical imports and exports include Afghanistan, Denmark, Switzerland, and Germany.
Here are some key points to consider when managing a pharmaceutical product portfolio across the product life cycle:
- Balance pipeline, in-line, and mature products to ensure continuous revenue and profit streams as products move through stages of the PLC
- Allocate R&D, marketing resources appropriately based on products' stage in PLC
- Consider portfolio synergies - how products complement each other's markets, sales forces, etc.
- Manage patent expirations and generic competition for in-line products
- Continuously evaluate portfolio for gaps, underperformers, and divestment/acquisition opportunities
- Ensure pipeline has mix of early/late stage products and therapeutic areas for future growth
The goal is a balanced,
The document provides an overview of regulations for medicinal products in Germany. Medicinal products are regulated by laws addressing manufacturing, marketing, distribution, and pharmacovigilance. Medicinal products for human use require a marketing authorization from either the Federal Institute for Drugs and Medical Devices or the Federal Agency for Sera and Vaccines. The document then discusses specific regulations regarding pricing and state funding, manufacturing, clinical trials, marketing, advertising, packaging and labeling, traditional herbal medicines, patents, trademarks, and regulatory authorities.
I.s. forrester, a. dawes, parallel trade in medicinesMichal
The document provides an introduction and overview of issues related to parallel trade in prescription medicines in the European Union. It makes three main points:
1) Parallel trade in prescription medicines is different than parallel trade in other goods because patients do not shop based on price and national governments set medicine prices, not the market. Parallel trade does not significantly lower costs for patients or governments.
2) Parallel trade reduces profits for pharmaceutical companies that fund research and development of new medicines. It may also delay access to new medicines in some countries.
3) Parallel trade risks increasing the entry of counterfeit medicines into legitimate supply chains, as counterfeits are commonly made outside the EU and enter through parallel trade routes.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
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
Pfizer and Ranbaxy were sued for allegedly engaging in an anticompetitive scheme to delay the entry of generic Lipitor into the market. The plaintiffs claim that Pfizer and Ranbaxy agreed to delay generic Lipitor for 20 months, costing purchasers more than they would have paid for the generic version. As a result of the delayed entry, which was not until November 2011, the plaintiffs and others were forced to pay billions more for Lipitor. Both drug companies were previously sued for similar allegations of holding back the generic version in the US and then fixing its price.
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 document discusses Italy's system of capping public pharmaceutical spending and the role of the Italian Medicines Agency (AIFA) in regulating and monitoring spending. It notes that spending caps were previously separated but have now been combined, and AIFA assigns annual budgets to drug makers. If spending exceeds caps, a payback system applies where drug makers repay excess amounts. However, drug makers have challenged the system as non-transparent. Proposed reforms stalled and a comprehensive reform remains unlikely in the near future due to political uncertainty.
- Pharma Group represents innovative pharmaceutical companies in Vietnam and aims to ensure Vietnamese people have access to high-quality medicines.
- Vietnam faces challenges like low healthcare access in some areas, overburdened infrastructure, and an underdeveloped local pharmaceutical industry. However, opportunities exist from healthcare reforms, trade agreements, and an emerging ASEAN market.
- Pharma Group recommends clarifying regulations to allow foreign-invested pharmaceutical enterprises to import, distribute, and market medicines in Vietnam, in line with WTO commitments. This would boost investment and access to innovative treatments for Vietnamese patients.
The document provides an overview of pharmaceutical pricing and reimbursement regulations across European countries. It discusses how different countries approach price controls, reimbursement decisions, and supply-side measures to influence the pharmaceutical market. Price controls are implemented through various methods including price negotiation, international price comparisons, and price-volume agreements. Countries also use positive and negative drug formularies, reference pricing, and pharmacoeconomic evaluations to make reimbursement determinations and control pharmaceutical spending. Overall the approaches vary significantly between countries and aim to balance health priorities with industrial and budgetary considerations.
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Parallel Trade in the Pharma Industry Overview - Recent Greek Jurisprudence
1. Parallel Trade in the Pharma Industry Overview
Recent Greek Jurisprudence
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2. Parallel Trade : EU Fundamental Freedoms & National Legislation
• Freedom TO OPERATE / TO CONTRACT
• FREE MOVEMENT OF GOODS (ART. 28-29 &34-35 TFEU)
• ART. 36 EXCEPTION FOR PUBLIC POLICY GROUNDS (eg. Protection of Health)
• FREE COMPETITION (ART. 101 TFEU)
• ABUSE OF DOMINANT POSITION (ART. 102 TFEU)
• EOF Circular 66249/8.11.2005
Producers, importers, representatives and medical warehouses must supply
pharmacies and treatment centers of all categories with substance quantities which
ensure a 25% security surplus.
• Law 4238/17.2.2014
…foresees up-to-€1m penalties for pharmaceutical companies and wholesalers which
do not comply with parallel trade legislation or who induce local market deficiencies.
3. ECJ Jurisprudence
ECJ C53/03: SYFAIT vs. GLAXO GREECE
The ECJ recalled that “the refusal by an undertaking occupying a dominant position on
the market of a given product to meet the orders of an existing customer constitutes
abuse of that dominant position under Article 102 TFEU where, without any objective
justification, that conduct is liable to eliminate a trading party as a competitor”
BUT under which conditions the REFUSAL TO SUPPLY by an undertaking in a
DOMINANT POSITION may amount to an abuse?
“It is permissible for a company to counter in a reasonable and proportionate way the threat to its commercial
interests potentially posed by the activities of a wholesaler which wished to be supplied with significant quantities
of products that are essentially destined for parallel exports” (points 69 and 71)
The Court further held that a pharmaceutical company must therefore be able to protect itself against orders
that are out of the ordinary in terms of quantity (point 70 and 76)
This must be assessed in the light of both
(i) the previous business relations between the pharmaceuticals company and the wholesalers concerned and
(ii) the size of the orders in relation to domestic demand (point 73)
→ a company, even in dominant position, can protect its legitimate commercial
interests by refusing orders which are “out of the ordinary” in respect of (i) the history
of orders and (ii) the size in relation to domestic demand.
4. ECJ Jurisprudence
ECJ 2008/12: LELOS & Sia EE and Others vs. GLAXO SMITH KLINE
The ECJ ruled that the refusal to supply by a dominant undertaking falls indeed
ambit of Article 102 TFEU but it should be examined if the undertaking has
objective reasons for this refusal and not as reasonable & proportionate
measure in defense of its commercial interests (and not as its primary intent).
The ECJ also examined whether GSK conduct was harmful for final customers by
abusing its dominant position.
An undertaking abuses its dominant position where, in order to restrict
parallel exports, it refuses to meet orders which are “out of the ordinary in
terms of quantity” and “are out of all proportion to those previously sold by
the same wholesaler to meet the needs of the national market”.
A manufacturer may refuse an individual order when it either exceeds what
the particular wholesaler used to order in the past, or when the total
aggregate amount of the orders in the national market already have exceeded
the aggregate domestic consumption.
5. Greek Jurisprudence
Athens High Court 1355/2011
Farmaservis (Pharma Wholesaler) vs. Astra Zeneca
Farnaservis Arguments:
AZ didn’t meet its contractual obligations to purchase Farmaservis adequate
quantities during 2009
AZ purchased pharmacists DIRECTLY aiming to substitute Farmaservis in the
market
AZ abused its dominant market position
Astra Zeneca Arguments:
The company delivered all adequate quantities (based on IMS data) in order for the
patients’ needs to be met.
AZ delivers specific quantities sufficient to demand and in order to meet both the
local needs based on its QMS system calculated on local market needs (IMS data)
according last years’ market needs, seasoning, wholesaler’s expansion (calculated
on 15% average) always covering expected demand by 25%
It does not hold any dominant position in the local market
6. Greek Jurisprudence
Judgment:
The quantities of the drugs sold have been calculated by the objective distribution system
(IMS)
The non fulfillment of unusual demands does not constitute denial but is justifiable given
that AZ’s scope has been to objectively distribute drugs to ALL the wholesalers in Greece
The quantities ordered by Farmaservis has been proven that were destinated to be
exported
A producer is in position to defend his commercial interests given unusual demands, as
these are defined by previous claims
7. Athens High Court 6373/2012
SyfakSynPe (Pharma Wholesalers’ Partnership in Crete) vs. Pfizer
SyfakSynPe Arguments:
Pfizer didn’t meet its contractual obligations to purchase adequate quantities
during 2010 in comparison with previous years), given a 20% demand increase
By this practice, the needs of the pharmacists have NOT been met
Pfizer abused its dominant market position
Pfizer Arguments:
The company delivered all adequate quantities (based on IMS data) in order for the
patients’ needs to be met.
Pfizer delivers specific quantities sufficient to meet both the local needs and also
cover a 25% monthly security surplus
It does not hold any dominant position in the local market
SyfakSynPe has ordered (without justification) uncommonly high quantities for
pharmacies (1,5-2,5 times over the usual orders) and well-above the national
demand (up 13% from 2010 figures).
Greek Jurisprudence
8. Judgment:
The quantities of the drugs sold have been calculated by the objective
distribution system (IMS)
The non fulfillment of unusual demands does not constitute denial but is
justifiable given that PZ’s scope has been to objectively distribute drugs to
ALL the wholesalers in Greece
The quantities ordered by Farmaservis were destinated to be exported
A producer is in position to defend his commercial interests given unusual
demands, as these are defined by previous claims
Greek Jurisprudence
9. Some OBJECTIVE FACTS to be taken into account are:
THE BUSINESS RATIONALE as long as the supply & distribution system is
fair & non-discriminatory and serves the local demand
THE REASONABLE CHARACTER OF THE ENVISIONED SOLUTION along with
an objective method for distributing the available quantities to
wholesalers
THE TEMPORARY CHARACTER OF EXCEPTIONAL MEASURES LINKED TO
SHORTAGES
BUT: Jurisprudence on the above cases is based on particular & proven facts,
relationships, circumstances etc.
Conclusion