[EQ] Open discussion on Proposed Harmonized Requirements for the Licensing of Vaccines in The Americas

PAHO/WHO Initiative
Proposed Harmonized Requirements for the Licensing of Vaccines in The Americas

 

The two draft documents are:
Proposed Harmonized Requirements for Licensing of Vaccines in the Americas, and an accompanying attachment entitled Guidelines for Preparation of Applications.

They are available in the original Spanish, as well as in English and French translations

Website: http://www.paho.org/English/AD/THS/PANDRH_Initiative_Eng.htm

 

The information required is structured using the International Conference on Harmonization (ICH) Common Technical Document (CTD), specifically adapted to the market authorization of vaccines, and complemented by Recommendations for vaccines published by the World Health Organization’s Technical Report Series. Because of their special characteristics, vaccines should always be considered as new products for the purpose of market authorization.

The purpose of these documents is to achieve greater harmonization in the information submitted in the application for Market Authorization of vaccines for human use. They apply to all vaccines to be registered, regardless of whether they are manufactured in the country of origin or not. Since the same information should be submitted to all countries in the Americas, the licensing process and ultimately the availability of vaccines should be facilitated. It is expected that having a common document will also benefit the region by making more efficient use of technical and financial resources, as well as facilitating mutual recognition processes where appropriate.

These draft documents are posted on the PAHO as well as the Health Canada websites for the purpose of inviting comments and suggestions on the proposals contained therein. 

Comments proposing modifications to the texts MUST be received by May 30, 2008 and should be addressed to:
Maria de los Angeles Cortes, Regional Advisor on Vaccines and Biologicals,
Technology, Health Care, & Research (THR/EV), Pan American Health Organization PAHO/WHO
Washington DC.  Email: cortesan@paho.org

 

Documents

Proposed Harmonized Requirements for Licensing of Vaccines in the Americas

(110 KB) Español

(63 KB) English

(96 KB) Français

Guidelines for Preparation of Applications

(108 KB) Español

(91 KB) English

(96 KB) Français

 

 

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This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate
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[EQ] Chile's Neoliberal Health Reform: An Assessment and a Critique

Chile's Neoliberal Health Reform: An Assessment and a Critique

Jean-Pierre Unger and Pierre De Paepe are in the Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Giorgio Solimano Cantuarias and Oscar Arteaga Herrera are in the School of Public Health–Faculty of Medicine, University of Chile, Santiago, Chile

PLoS Med 5(4): e79 doi:10.1371/journal.pmed.0050079 – April 2008

 

Available online at: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050079

 

Summary Points:

·         The Chilean health system underwent a drastic neoliberal reform in the 1980s, with the creation of a dual system: public and private health insurance and public and private provision of health services.

·         This reform served as a model for later World Bank–inspired reforms in countries like Colombia.

·         The private part of the Chilean health system, including private insurers and private providers, is highly inefficient and has decreased solidarity between rich and poor, sick and healthy, and young and old.

·         In spite of serious underfinancing during the Pinochet years, the public health component remains the backbone of the system and is responsible for the good health status of the Chilean population.

·         The Chilean health reform has lessons for other countries in Latin America and elsewhere: privatisation of health insurance services may not have the expected results according to neoliberal doctrine. On the contrary, it may increase unfairness in financing and inequitable access to quality care.

 

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This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate
information Related to: Equity; Health inequality; Socioeconomic inequality in health; Socioeconomic
health differentials; Gender; Violence; Poverty; Health Economics; Health Legislation; Ethnicity; Ethics;
Information Technology - Virtual libraries; Research & Science issues.  [DD/ KMS Area]

“Materials provided in this electronic list are provided "as is". Unless expressly stated otherwise, the findings
and interpretations included in the Materials are those of the authors and not necessarily of The Pan American
Health Organization PAHO/WHO or its country members”.
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    IMPORTANT: This transmission is for use by the intended recipient and it may contain privileged, proprietary or confidential information. If you are not the intended recipient or a person responsible for delivering this transmission to the intended recipient, you may not disclose, copy or distribute this transmission or take any action in reliance on it. If you received this transmission in error, please notify us immediately by email to infosec@paho.org, and please dispose of and delete this transmission. Thank you.  

[EQ] Pharmaceutical policies in Finland

Pharmaceutical policies in Finland - Challenges and opportunities

 

Elias Mossialos and Divya Srivastava

Prepared at the request of the Health Department, Ministry of Social Affairs and Health, Finland

World Health Organization 2008, on behalf of the European Observatory on Health Systems and Policies

 

Available online as PDF file at: http://www.euro.who.int/Document/E91239.pdf

 

“….Finland, like many other countries with well-developed health systems, has struggled with its pharmaceutical policy on issues such as needs-based universal access, cost–effectiveness (CE) and affordability of its growing drug budget. Incremental policy changes have been followed by some fairly drastic measures to control growth in pharmaceutical expenditure. There has been considerable public debate on pharmaceutical issues and the need for a more predictable overall strategy in this policy field…..”

 

Content:

Executive summary

Chapter 1: Introduction

Chapter 2: Overview of the pharmaceutical system in Finland

Chapter 3: Trends in pharmaceutical expenditure and consumption

Chapter 4: Supply-side policies concerning pharmaceuticals

Chapter 5: How to influence providers

Chapter 6: Evaluation of options and recommendations

Annex 1: Background information on the review of pharmaceutical policy prepared by the Ministry of Social Affairs and Health

Annex 2: Stakeholders consulted

References

 

 

 

 *      *      *     *

This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate
information Related to: Equity; Health inequality; Socioeconomic inequality in health; Socioeconomic
health differentials; Gender; Violence; Poverty; Health Economics; Health Legislation; Ethnicity; Ethics;
Information Technology - Virtual libraries; Research & Science issues.  [DD/ KMS Area]

“Materials provided in this electronic list are provided "as is". Unless expressly stated otherwise, the findings
and interpretations included in the Materials are those of the authors and not necessarily of The Pan American
Health Organization PAHO/WHO or its country members”.
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    IMPORTANT: This transmission is for use by the intended recipient and it may contain privileged, proprietary or confidential information. If you are not the intended recipient or a person responsible for delivering this transmission to the intended recipient, you may not disclose, copy or distribute this transmission or take any action in reliance on it. If you received this transmission in error, please notify us immediately by email to infosec@paho.org, and please dispose of and delete this transmission. Thank you.