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Articles 1 - 11 of 11
Full-Text Articles in Law
History, Trips, And Common Sense: Curbing The Counterfeit Drug Market In Sub-Saharan Africa, Hannah Elizabeth Jarrells
History, Trips, And Common Sense: Curbing The Counterfeit Drug Market In Sub-Saharan Africa, Hannah Elizabeth Jarrells
Georgia Journal of International & Comparative Law
No abstract provided.
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston Nagan
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston Nagan
Winston P Nagan
This Article examines the question of access to patented medicines in international law. It analyzes the extent to which international agreements may lawfully limit affordable versions of these medicines that may be available through parallel imports or compulsory licensing procedures. It considers the concept of intellectual property rights from a national and international perspective to determine how these rights must be sensitive to matters of national sovereignty when extraordinary, life-threatening diseases afflict societies in catastrophic ways. This Article suggests that viewing property (including intellectual property) as a human right requires that its scope be delimited and understood in the context …
Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese
Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese
Brooklyn Journal of International Law
Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The …
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Michigan Journal of Race and Law
With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …
Intellectual Property As An ‘Investment’ In International Law: A Question Of Access To Medicines Vs Access To Justice, Christopher Wadlow
Intellectual Property As An ‘Investment’ In International Law: A Question Of Access To Medicines Vs Access To Justice, Christopher Wadlow
Christopher Wadlow
No abstract provided.
The Great Pharmaceutical Patent Robbery, And The Curious Case Of The Chemical Foundation, Christopher Wadlow
The Great Pharmaceutical Patent Robbery, And The Curious Case Of The Chemical Foundation, Christopher Wadlow
Christopher Wadlow
In 1918, the United States confiscated virtually all German-owned intellectual property assets within its jurisdiction. Out of 6,000 patents in the chemical field, 4,500 were assigned for a very modest consideration to an newly-established entity, the Chemical Foundation, which was incorporated with the objective of licensing and managing them for the benefit of the United States chemical industry. This article describes the origins and activities of the Chemical Foundation, and considers whether it provides a useful model, or at least useful lessons, for the collective management of patents today.
The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang
The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang
Michigan Telecommunications & Technology Law Review
China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …
Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason
Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason
San Diego International Law Journal
At a fundamental level, pharmaceuticals serve two roles: both as a cure for disease and as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. In least developed nations the barriers to drug access are not solely economic. National regulatory systems for market approval are being used to prevent external pharmaceutical manufacturers from participating in a national market. This article will address how the regulatory framework of pharmaceutical registration may serve as a barrier to trade in drugs, …
Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller
Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller
Faculty Scholarship
Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate,' the costs of lharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). …
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston P. Nagan
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston P. Nagan
UF Law Faculty Publications
This Article examines the question of access to patented medicines in international law. It analyzes the extent to which international agreements may lawfully limit affordable versions of these medicines that may be available through parallel imports or compulsory licensing procedures. It considers the concept of intellectual property rights from a national and international perspective to determine how these rights must be sensitive to matters of national sovereignty when extraordinary, life-threatening diseases afflict societies in catastrophic ways. This Article suggests that viewing property (including intellectual property) as a human right requires that its scope be delimited and understood in the context …