Presentations

Local Production of Pharmaceutical Products in Africa: the WHO approach

Frederick M. Abbott

Presentation at the 2014 Annual Meeting of the

Society for the Advancement of Socio-Economics (SASE)

Chicago, Illinois, US

 

July 11, 2014

 

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Abstract:

 

The WHO Global Strategy and Plan of Action mandated the Director General to support transfer of technology and local production of medicines in developing countries. This paper briefly lays out the conditions for local production in Africa and describes the on-going work program of the WHO Department of Public Health, Innovation, Intellectual Property and Trade (PHI) directed at supporting local production efforts. Encouragement of local production is not without controversy as governments must weigh their interest in pursuing the potential holistic benefits of security of supply, support for research and training, manufacturing employment and balance of payments improvements, with assuring that supplies are purchased at prices competitive with global lowest-priced supplies of assured quality. Ultimately, for local production efforts to be successful medicines must be provided at prices competitive with, and of comparable quality to, imported products. The African Union and national governments within Africa are promoting local production, and are working with the support of a number of multilateral organizations including UNIDO, UNCTAD, UNAIDS and WHO, with increasing interest of the African Development Bank. There is considerable attention both from local investors and multinational industry, and there are opportunities for technology leapfrogging. From the WHO perspective, the key element is to focus attention on the promotion of public health objectives, including through the strengthening of regulatory capacity. The author is consultant adviser to WHO PHI.

 

 

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ASIL-ILA Panel

Investment Chapters in Trade Agreements: IP Rights as Protected Investments

Sponsored by the ASIL Intellectual Property Interest Group and the ILA Committee on International Trade Law

April 11, 2014

Consolidated write-up of F. Abbott, S. Sell & J. Reichman (download below)

PowerPoint of Jerome Reichman (download below)

ASIL Cables Report Link

Investment chapters of trade and investment agreements have attracted renewed attention due to current disputes involving intellectual property rights affecting public health interests. This panel will examine issues that may arise from treating IP rights as protected investments in trade and investment agreements. Should foreign corporations be entitled to demand host country taxpayer compensation by bringing governments before trade and investment arbitration tribunals to challenge domestic court decisions on patents? May government standards regarding intellectual property rights constitute regulatory takings entailing compensation to the intellectual property owner?

Moderator: Frederick M. Abbott, Florida State University College of Law

Speakers:

• James Love, Knowledge Ecology International

• Jerome H. Reichman, Duke University School of Law

• Susan K. Sell, Elliott School of International Affairs, George Washington University

Comment: Gary Horlick, Washington, DC

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Audio: 

Presentation at OHCHR Seminar on the Right to Enjoy the Benefits of Scientific Progress and Its Applications

4 October 2013

Room XXIV, Palais des Nations, Geneva

Organized by the Office of the U.N. High Commissioner for Human Rights (OHCHR)

Session 1: The right to enjoy the benefits of scientific progress and intellectual property rights: conflict or complementarity

Frederick M. Abbott

Prepared Text of Remarks

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Audio: 

Science, Scarcity and Public Health: The search for new Pharma models

Frederick M. Abbott

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Distinguished Life Sciences Lecture, University of Basel, May 23, 2013

These are neither the best of times nor the worst of times for the pharmaceutical industry, or for global public health. Media reports regarding recent legal developments would suggest that the originator pharmaceutical industry is facing a new and dangerous threat to its long-term welfare, compounding the impact of the so-called patent cliffs. Governments around the world are facing budgetary shortfalls, and this has put considerable pressure on funding for public health projects, including for procurement of treatments for conditions such as HIV-AIDS.

Yet, both for the pharmaceutical industry and for public health more generally, the underlying reality is perhaps more positive than the headline news often suggests.

Human society has not proven very good at collective problem-solving, including public goods problems. It is easy enough to identify critical needs -- though even, as example in the case of global warming this identification can be politicized -- and, to a certain extent, it is often relatively easy to think about and postulate how human civilization as a whole could best address particular pressing problems. But that is often about the extent of how far we can go. Collective problem-solving at a global level quickly breaks down because of a number of built-in impediments: national sovereignty and public security concerns, inequalities in resource availability, differential needs and demands, existing patterns of ownership of resources and wealth, political outlooks, personality differences, and so on.

Regarding the way forward, first I start from a relatively optimistic premise. I do not see either the Pharma industry or global public health in the midst of a dire crisis. I think a combination of advances in technology and the opening of large new markets is encouraging for the industry, and statistically speaking global public health is trending to improvement.

Second, there is built into the Pharma R&D and distribution model a profound moral dilemma. That is, new and important drugs are developed and priced outside the budget of large parts of the global population. Governments that have a mission to promote and protect the health of their populations cannot realistically be expected to ignore this moral dilemma, and the public will not allow that to happen. This sets up an inevitable and continuing conflict.

Third, the present basis for Pharma reaction to the moral dilemma is to strengthen the legal and diplomatic walls protecting their pricing model. Investor pressure on Pharma executives to pursue this line is understandable in the logic of capital markets. But, it seems questionable that these walls can hold against public pressure over the longer term. They can probably extend the viability of the model, and perhaps for current management of the companies this is all that is important. But, someone should be thinking about the longer-term.

Fourth, governments are reacting to the moral dilemma with compulsory licensing, modifications to patent law, price controls, competition actions, and so forth. This is the control mechanism used to ameliorate the impact of the Pharma model.

We basically have a checks and balances, almost constitutional, system. On one hand, we have private ownership and exploitation of the market. On the other hand, we have governmental intervention supported by NGO involvement to police the market and keep the exploitation in check.

The global system for developing and distributing medicines and vaccines is an enormously complex structure with many moving parts. There are many problems and issues. it is doubtful they can be resolved with a single solution or model that will tackle all of them.

The main point I would like to make today is that the Pharma industry, a good part of it based here in Basel, should be more focused on finding ways to address the fundamental moral dilemma posed by its business model. Whatever legal walls it can build are going to be breached because the alternative is intolerable to governments and the wider public. It is my belief that the Pharma industry could address the moral dilemma without significant adverse impact on its bottom line, if it seriously set out to do that.

 

 

Access to Medicines as a Human Right: Case study of India

 
  

Frederick M. Abbott

Harvard Human Rights Journal Symposium

April 11, 2013

Harvard Law School

Cambridge, USA

PowerPoint of Presentation

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Law, Finance, Politics and Health: The complex access challenge

Global Health Law: Innovation, Access and Justice

The Annual Lecture of the LL.M Programme in Global Health Law and International Institutions, Graduate Institute of International Studies, Geneva, Switzerland, October 10, 2012

Audio of remarks by Frederick M. Abbott

 

IP-Watch Report of Event

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The Generics Pathway in the USA: the American experience, a model for the world?

Frederick M. Abbott

Presentation to:

Foro Latinoamericano

ALIFAR-ANAFAM

Asociación Latinoamericana de Industrias Farmacéuticas - La Asociación Nacional de Fabricantes de Medicamentos

XXIII Asamblea Anual

Mexico City

 

May 15, 2012

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Trends in local production of medical products in developing countries: integrating public health and industrial development

Frederick M. Abbott

Local Production for Access to Medicines – Stakeholder Meeting
World Health Organization, Geneva
February 9, 2012

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Trends in Local Production of Medicines and Related Technology Transfer - PowerPoint

Frederick M. Abbott

Presentation at seminar on local production and access to medical products, World Health Organization and European Parliament Working Group on innovation, access to medicines and poverty related diseases, European Parliament, Brussels, Dec. 7, 2011   

WHO Study Text: download here

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Ten Years After the Doha Declaration: The Future Agenda at the Interface of Public Health, Innovation and Trade

Council Room, World Trade Organization, Geneva, November 23, 2011

Intellectual Property and Public Health: Meeting the Challenge of Sustainability

Frederick Abbott

  

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