Medicines and Health Technologies News  

• Countries have access to affordable medicines for hypertension and other chronic diseases through the PAHO Strategic Fund

Washington, D.C., April 8 2013 (PAHO/WHO) — Countries in the Americas can save money and improve their access to medicines for hypertension, diabetes, cardiovascular diseases, and cancer through the Revolving Fund for Strategic Public Health Supplies of the Pan American Health Organization/World Health Organization (PAHO/WHO), known as the PAHO Strategic Fund.

“The objective is to help countries increase their access to medicines and assure these are of high quality and available at competitive prices, to help them deal with the chronic disease epidemic in the Americas,” said James Fitzgerald, PAHO/WHO senior advisor on medicines and health technologies.

Noncommunicable diseases (NCDs) are the leading cause of death in the Western Hemisphere. More than 200 million people in the Americas suffer from a noncommunicable disease, and many suffer from more than one, making NCD prevention, treatment, and care a major challenge for the region’s countries.

As of April 2013, the list of products available through the Strategic Fund includes 16 essential medicines for hypertension, diabetes, cardiovascular diseases, and cancer.

The expanded list of medicines is part of the implementation of the 2012-2025 Strategy to Prevent and Control Noncommunicable Diseases, approved in 2012 by PAHO/WHO Member States. The strategy seeks to reduce premature mortality from four main NCDs by at least 25% by 2025, as well as to reduce morbidity, risk factors, and their associated costs.

          For more information click here.

• VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH)

The Pan American Health Organization (PAHO) together with Health Canada are pleased to announced the VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH), which will be held in Ottawa, Canada from September 5th-7th, 2013 with the theme “Sixteen years promoting Good Regulatory Practices in the Region of the Americas”. This Conference is coordinated by PAHO, with the collaboration and financial support of the Regulatory Authority of Canada (Health Canada).

Among the key issues to be discussed at this conference is the PANDRH Strategic Development Plan 2014-2020, which aim to:

• Promote efficient governance of the network, active participation and cooperation of National Regulatory Authorities (NRAs);
• Establish priorities for regulatory harmonization and support their dissemination, adoption and implementation;
• Promote strengthening of Good Regulatory Practices; and
• Promote exchanges of experiences and lessons learned between NRAs of the Americas and NRAs of other regions.

Importantly, the reception is open from posters to be presented at the conference; more information can be found by clicking here.

The VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH) is held every two or three years. Its mission “to promote drug regulatory harmonization for all aspects of quality, safety, and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas”. 

The first CPANDRH was held in 1997 in Washington, D.C., and is considered to have been the first step in the creation of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Since then, a total of six conferences have taken place;  three in the United States of America (1997, 1999 and 2002) in the Dominican Republic (2005), in Argentina (2008), and most recently in Brazil (2011).

Valuable technical documents and guidelines related to drug regulation in the region of the Americas and information from previous CPANDRH are available  at: www.paho.org/pandrh.

Subsequently after the VII CPANDRH, from September 9th -13th, Health Canada will be hosting the V Annual Health Products and Food Branch (HPFB) International Regulatory Forum, as part of their international regulatory cooperation and capacity building programs. This Forum provides an overview of Canadian regulatory processes for multiple human health products, including biological products, pharmaceuticals and medical devices, throughout the pre- and post-market life cycle.

The HPFB has been held annually since 2009 and is open to all regulatory agencies only, from around the world, to exchange regulatory experience and expertise in different discussion areas, through panels, plenary sessions and cases studies.  Please note that the Forum is exclusive to regulators only.

There is no registration fee for NRA representatives who wish to participate in either of these two events. However, all expenses related to hotel, travel and transportation as well as visa formalities are the responsibility of the concerned parties, who are required to notify their interest in participating by completing the registration forms and sending them to the main contacts listed below.

 
Meeting logistics

Place

Delta Ottawa City Centre - http://www.deltaottawacitycentre.com
101 Lyon Street Ottawa, ON, K1R579, Canadá. Tel.: +1-866-599-6674

Main contacts

Tania Pereyra, VII CPANDRH Meeting Logistic Coordinator. Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Anita Ng, Policy Analyst for the Canadian HIV Vaccine Initiative - Regulatory Capacity Building Program. E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Registration forms for participants

The VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH)

Request for Registration for the Health Products and Food Branch (HPFB) International Regulatory Forum 2013  

 

• Pharmaceutical Situation in Jamaica: WHO Level II Assessment-Health Facilities and Household Survey

On February 26, 2013, Ms. Margareta Skold, PAHO/WHO Representative in Jamaica made an official presentation of the publication “Pharmaceutical Situation in Jamaica: WHO Level II Assessment – Health Facilities and Household Survey” to the Minister of Health, the Honorable Dr. Fenton Ferguson. 

Following the official presentation, Mrs. Princess Thomas Osbourne, Director of the Standards and Regulations Division in the Jamaica Ministry of Health and Ms. Marilyn Entwistle, PAHO Health Systems and Services Advisor in the PAHO/WHO Jamaica office, made a detailed Power point presentation on the findings and recommendations of the assessment.

The assessment of the pharmaceutical situation was undertaken in Jamaica from July 2009 to May 2010, with technical and financial support from PAHO/WHO through the EU/WHO ACP Project “Partnership on Pharmaceutical Policies” and the Centre for Pharmaceutical Policies of the Oswaldo Cruz Foundation in Brazil, PAHO/WHO Collaborating Centre on Pharmaceutical Policies.  Mrs. Cynthia Lewis Graham from the Ministry of Health was the principal investigator for this assessment.

Overall access indicators showed that key essential medicines were largely available in public health facilities (93.3%), warehouses that supply the public health system (100%) and private pharmacies (93.3%) and 76.7% of the prescribed medicines were dispensed or administered to patients at public health facility dispensaries. One recommendation was the development and official adoption of a national pharmaceutical policy to address the main challenges and constraints identified in the surveys. The report can be accessed at:

http://new.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=19301&Itemid=

Using a standardized methodology developed by the WHO, the study had two components: health facilities and households survey.

• In the first approach, data related to the pharmaceutical policy outcome was collected from public healthcare facilities, public and private pharmacies and public warehouse that supply public facilities.
• In the second, data came from a survey conducted at household level.

The Honourable Dr. Ferguson indicated that he was pleased to receive the publication “in consonance with Ministry of Health’s mandate of ensuring the provision of quality health services and promoting healthy lifestyles and environmental practices as well as the efforts of the Ministry to promote universal health coverage providing Jamaican citizens medicines of ensured quality, safety and promoting their rational use. The gaps identified are an important resource for the development of the National Pharmaceutical Policy and to continue improving the quality of care across the country.”

Additionally, Ms. Margareta Skold stated that “PAHO/WHO’s essential mission is to strengthen national and local health systems and improve the health of the peoples of the Americas, in collaboration with Ministries of Health, other government and international agencies, nongovernmental organizations, universities, social security agencies, community groups, and many others.  PAHO/WHO seeks to strengthen the health sector capacity in countries to advance their priority programs through intersectoral action, promoting an integral approach to health problems.

PAHO/WHO is pleased to support the Ministry of Health in the collection, analysis and use of the data.  A comprehensive assessment of the pharmaceutical sector helps to determine what the gaps are in order to design effective interventions and allows evaluation of the impact of interventions over time and are crucial for informing pharmaceutical policies and advocacy work. We look forward to continue technical cooperation with the Ministry as it proceeds to consider implementation of recommendations from the report.”

• Experts Develop New Regional Blood Safety Strategy for PAHO

A group of blood services experts met last week in Washington, D.C. at the Pan American Health Organization (PAHO) headquarters for a four-day planning session to develop a new blood strategy and blood safety plan for the next five years. America’s Blood Centers, represented by Miriam Bolaños, ABC’s manager of Executive Services, and Nora Hirschler, MD, president and CEO of Blood Centers of the Pacific, was among the organizations invited to participate in the discussion.

PAHO is an international public health agency that provides technical cooperation and mobilizes partnerships to improve health and quality of life in the countries of the Americas. It also serves as the Regional Office for the Americas of the World Health Organization (WHO). As ABC continues working to develop ALAS (Alianza Latinoamericana de Sangre), a selfgoverned Latin American alliance for nonprofit blood organizations, it is important for ABC and ALAS to be aligned with PAHO’s blood safety plan.

During the first day of the meeting, experts from other technical areas of PAHO provided
a comprehensive vision of health and other services, within the national health system. The other technical areas of PAHO that were represented included Area Health Systems based on Primary Health Care, Family and Community Health, Non-Communicable Diseases, Sustainable Development and Environment.

Presentations and discussions on the first day focused on revising the current context of blood services in Latin America and the Caribbean. The discussion covered topics such as, the supply of blood for transfusions, hemovigilance, and the organization of national blood systems in the countries of Latin America and the Caribbean.

The meeting attendees reviewed and revised the findings and recommendations from the evaluation of the previous Regional Blood Safety Plan 2006-2010. An assessment of the previous Blood Safety Plan was carried out in 2011 and was presented to the PAHO governing bodies in September 2011, when PAHO recommended the development of a new plan for the next five years.

The meeting participants also considered the assessments of blood services and the regulatory framework of the Andean countries, Central America, and the Dominican Republic. They also discussed the trends of Latin-American and Caribbean countries over the past five years in the PAHO/WHO External Evaluation of Performance in Serology and Immunohematology program. The group discussed experiences in these regions with regard to restructuring the national blood systems and availability and timely access to
safe blood and blood components to prevent mortality. The participants agreed that reducing maternal mortality must be a priority because many women in these regions die during childbirth due to lack of blood. In Latin American and Caribbean countries, 23 percent of this mortality is associated with hemorrhage.

These discussions and others throughout the planning session contributed to the development of the first draft of the new Regional Strategy and Plan titled “Universal Access to Safe Blood, Regional Strategy, and Plan 2013-2018,” which will be focused on the following four main areas:

1. Strengthening political, social, and economic integration to ensure effective and sustainable blood services in national health systems;

2. Achieving adequate blood safety by promoting voluntary, repetitive, and unpaid blood donation;

3. Strengthening the national blood and blood services, including the practice of transfusion medicine, focusing on strengthening the quality; and

4. Strengthening health surveillance, monitoring, and evaluation of hemovigilance.

“The objective is to have universal access to blood and components for transfusion in Latin America and Caribbean countries, to contribute to the reduction of mortality and to the improvement of patient care by making safe blood available in a timely manner for all those patients who need it,” said María Dolores Pérez-Rosales, MD, PAHO’s regional advisor of Blood Services and Organ Transplants. “As we know, blood transfusion is an essential component of healthcare, which saves thousands of lives each year in the Region. The need for universal, equitable, and timely access to safe blood is urgent. However, safe blood is not available to many patients requiring transfusion as part of their clinical management. Every country needs to meet its requirements for blood and blood products and ensure that blood suppliers are free from infections that can be transmitted through unsafe transfusion.”

Over the next few months, the first draft of the Regional Strategy and Plan will be reviewed by experts within PAHO’s various programs and other industry representatives. It will also be considered by those responsible for blood safety in the countries of the Americas, who are expected to provide their input for completion and subsequent validation.

• Drug Regulatory Authorities meet with PAHO Director

Representatives of national regulatory authorities (NRAs) for medicines and biologicals met on Feb. 7 with PAHO Director Carissa F. Etienne to discuss issues including strategic cooperation and regulatory harmonization; regional mechanisms for controlling substandard, counterfeit, and misleadingly labeled medical products; and integration among regulatory authorities

"If we want to achieve universal health coverage, we must continue to strengthen our regulatory systems to guarantee a reliable supply of safe and effective medicines and technologies," said Dr. Etienne. 

During a Feb. 6-7 technical meeting at PAHO headquarters, representatives of NRAs highlighted their commitment to promoting best practices in regulation through such mechanisms as the Regional Platform on Access and Innovation for Health Technologies (PRAIS), a virtual platform that allows users to share experiences and cooperate in areas including essential medicines, biologicals, and diagnostics. 

Participants in the technical meeting made progress on the development of a cooperation strategy and on the promotion and dissemination in other regions of regulatory models from the Americas. This week’s meeting is part of efforts called for in the 2010 PAHO Directing Council resolution "Strengthening National Regulatory Authorities for Medicines and Biologicals.”

Regulatory authorities represented at this week’s meeting included the National Administration for Drugs, Food and Medical Technology (ANMAT), the National Agency for Health Surveillance (ANVISA), the Center for State Control of Drugs and Medical Devices (CECMED), the National Institute for Drug and Food Surveillance (INVIMA) and the Federal Commission for Protection against Health Risks (COFEPRIS), as well as Health Canada and the U.S. Food and Drug Administration (FDA).

Link: 

Resolution CD50.R9 "National Regulatory Authorities for Medicines and Biologicals" 

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