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MINISTRY OF HEALTHFIOCRUZ – OSWALDO CRUZ FOUNDATION
SERGIO AROUCA NATIONAL SCHOOL OF PUBLIC HEALTH – ENSP
MANUAL
METHODOLOGY FOR THE EVALUATION OF PRICE NEGOTIATIONS OFANTI-RETROVIRALS IN LATIN AMERICAN
AND CARIBBEAN COUNTRIES
Maruja Crisante Nuñez
Claudia Garcia Serpa Osorio-de-Castro
Maria Auxiliadora Oliveira
Rio de Janeiro, July 2008
Liberté Ègalité Fraternité
REPUBLIQUE FRANCAISE
MINISTÉRE DES AFFAIRESÉTRANGÉRES
Joint United Nations Programme on HIV/AIDS
UNAIDSUNICEF WPF UNDP UNFPA UNODC
ILO UNESCO WHO WORLD BANK
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© Center for Pharmaceutical Policies, National School of Public Health. Oswaldo
Cruz Foundation, Ministry of Health, Brazil, 2008.
All rights reserved. This document, which is not a formal publication of UNAIDS,
WHO and the Ministry of Foreign Affairs (France), may be cited or reproduced, in
part or whole with acknowledgment of authorship and citation.
The document can not be sold or used for commercial purposes without prior written
approval of the Center for Pharmaceutical Policy (contact [email protected]).
The authors are responsible for the content of this document.
AuthorsMaruja Crisante Nuñez
Claudia Garcia Serpa Osorio de Castro
Maria Auxiliadora Oliveira
Technical Team – NAF/ENSP/FIOCRUZ
Cláudia Du Bocage Santos Pinto
UNAIDS Technical Officer
Erik Lamontagne
Translators
Isabel Cabral de Melo de Zepeda
Matthew Brian Flynn
Graphic Designer
Lúcia Regina Pantojo de Brito
C932m Nuñez, Maruja CrisanteManual: methodology for the evaluation of price negotiations
of anti-retrovirals in latin american and central americancountries. / Maruja Crisante Nuñez, Claudia Garcia Serpa Osorio-de-Castro e Maria Auxiliadora Oliveira. ¯ Rio de Janeiro : MS/FIOCRUZ/ENSP, 2008.
44 p.
1. Medicine price. 2. Anti-Retrovirals. 3. Evaluation.4. Latin America. 5. Caribbean. 6. Interview. 7. Questionaries.8. Manuals. I. Osorio-de-Castro, Claudia Garcia Serpa. II.Oliveira, Maria Auxiliadora. III. Título.
CDD - 22.ed. –
615.1098
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ACRONYMS AND ABBREVIATIONS
ARV Anti-retroviral
AZT Zidovudine
CIF Cost, Insurance and Freight
DDI Didanosine
DDP Delivered duty Paid
DDU Delivered duty Unpaid
D4T Estavudine
ENSP National School of Public Health
FOB Free on Board
GAN Monitoring Group of Anti-retroviral Negotiations
EML Essential Medicines List
LPV/RTV Lopinavir/ritonavir
NAF Pharmaceutical Assistance Nucleus
VIH/SIDA Human immunodeficiency virus/Acquired
immunodeficiency syndrome
NVP Nevirapine
PAHO Pan-American Health Organization
TP Treatment Protocol
REMSSA Meeting of the Ministers of Health and Social Security
of South America
3TC Lamivudine
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SUMARY
ACRONYMS AND ABBREVIATIONS .............................................. 3
SUMMARY ...................................................................................... 5
FOREWORD ...................................................................................... 7
PRESENTATION OF THE MANUAL ................................................... 9
BACKGROUND .................................................................................. 12
OPERATIONAL ISSUES ...................................................................... 16
Instruments for collecting data .......................................................... 16
Data sources ..................................................................................... 16
The Interview .................................................................... ...................19
Important definitions .............................................................................20
PLANNING THE STUDY .................................................................. 22
Composition of the organizing group of the study ................................ 22
Time period under study ...................................................................... 22
Extent of the study ............................................................................. 23
Identification of the institutions and key informants ............................. 23
Revising the forms and questionnaires of the study ............................ 24
Duration of the study ........................................................................... 24
Financing the study ........................................................................... 24
Composition and training of the team responsible ................................ 25
for the field research ........................................................................... 25
APLICATION OF THE METHODOLOGY ............................................... 26
Request authorization to undertake the study ........................................ 26
Carrying out logistical arrangements ....................................................... 26
Collecting data for the study ..................................................................... 27
Conducting interviews with key informants ............................................. 27
Building the data base .............................................................................. 27
Quality control of the field research and data entry
in the data base .......................................................................................... 28
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ANALYSIS OF THE INFORMATION, WRITING THE FINAL REPORT
AND PRESENTION OF THE RESULTS ............................................... 28
Data Analysis .............................................................................................. 28
Writing the final report .............................................................................. 30
Presentation of the results ....................................................................... 30
ANNEXES ................................................................................................. 31
REFERENCES .......................................................................................... 47
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FOREWORD
More than 33.2 million people live with HIV in the world. UNAIDS
estimates that the number of new infections reached 2.5 million, just in
2007. More than three million people infected now have access to treatment,
which represents a 47% advance in 2007. This access considerably
increases life expectancy of infected people, allowing them and the people
living around them to live a normal life.
Access to treatment is partially related to cost. Until recently, this cost
was too high for the majority of people that live with HIV in low and middle
income countries.
We know that the cost of anti-retroviral treatment is a delicate issue.
The economic challenges are important and each advance is the result of a
large negotiation process between States and the pharmaceutical industry.
The countries of Latin America and the Caribbean decided to share their
concern for the financing of anti-retroviral treatment and reagents. Three
sets of negotiations took place in 2002, 2003 and 2005. One result of these
negotiations was the reduction of the reference price of first line treatment
by more than 72%, which might have led to an increase of more than 150,000
additional people receiving treatment since the first set of negotiations.
Monitoring the execution of the results of the price negotiations has
not been easy. Until now, the monitoring mechanisms have focused
essentially on the price of treatments, which frequently created polemics
that often time were in vain. In effect, prices are only one of the elements in
the implementation of these negotiations. The legislative frames, the control
mechanisms, and administrative norms of the signatory countries are some
of the key elements that permit—or prevent—realizing the benefits of the
collective negotiations.
The value-added by this methodology developed by ENSP at FIOCRUZ
is based on the selection of indicators. These are especially pertinent and
focus on key aspects put into play during the negotiations. These key aspects
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are related to the legal and regulatory frameworks, the demand for ARVs,
the supply of ARVs, and sources of financing and the negotiation
mechanisms.
We are content that this methodology is now available not only for the
countries that participated in the negotiations for ARVs and reagents in
Central and Latin America, but also for other regions of the world that decided
to take advantage of the lessons learned from these experiences.
Robert Greener & Erik Lamontagne
Economics and Development Analysis Unit, UNAIDS, Geneva
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PRESENTATION OF THE MANUAL
Information about prices is a key mechanism for optimizing the
acquisition process, reduce information asymmetry between buyers and
suppliers, and making the supply system more transparent. It has a direct
impact on the financing, availability and supply of essential medicines.
In this context, this manual’s objective is to circulate a self-applying
methodology for evaluating the process of price negotiations of anti-retroviral
medicines in countries in the sub-region of Latin American and the
Caribbean.
The present methodology was developed by NAF/Fiocruz, a
Collaborating Center of the WHO and PAHO for Pharmaceutical Policies,
in the framework of the Project of Anti-retrovirals Financing Strategies, whose
institutional counterparts include UNAIDS, and the French Ministry of Foreign
Affairs.
The application of the methodology, the pertinence and sensibility of
the instruments proposed, the consistency and validity of the logic model,
the feasibility of obtaining the information and constructing the indicators
were all facets of the study that were developed and evaluated based on
the recommendations of a group of specialists on the subject and in their
implementation in three countries: Peru, Honduras and Barbados.
The methodology includes specific themes related to anti-retrovirals
(ARVs) including the processes of sanitary, economic and commercial
regulation as well as scheduling, negotiations, and acquisitions. Each one
of the themes corresponds to a set of qualitative and quantitative indicators.
The methodology could be applied in its totality, taking into account
the entire panorama of the situation of ARVs in a country, or it could be
applied selectively for some indicators according to necessity.
This manual is directed to: a) decision makers, administrators of
financial institutions related to the access of ARVs in a country, b)
administrators of institutions that offer ARV treatment in a country, c)
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specialists in public health and researchers in general interested in the
themes of financing, prices and the pharmaceutical market.
This evaluation has several potential applications, including the
following:
Knowing the characteristics of the pharmaceutical market of ARVs in the
country.
� Knowing the behavior of the evolution of ARVs in the country
and the different factors that could affect it.
� Evaluating the application of diverse price negotiation strategies in
the country.
� Taking into account relevant information so that decision makers and
managers apply intervention measures for the improvement and
sustainability of ARV access in the country.
� Comparing the efficiency of ARV acquisitions between institutions
and between countries.
� Diagnosing the necessary strategic areas for the negotiation of prices
in the country.
This evaluation could be undertaken by a team from outside the health
system or by the institutions themselves through self-evaluation.
The content of the manual is structured in the following manner:
Background: present the background of the medicine negotiation
process, as well as the importance of the price of medicines for access and
sustainability of ARV treatments.
Operational issues of the study: present the general characteristics of
the methodology, the instruments used for collecting information, the
application of the questionnaire technique, the make-up of the team leaders
of the study and the group responsible for field research.
Planning of the study: detail the main activities to develop in the phase
prior to undertaking the study.
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Application of the methodology: present the flow of activities to
undertake during the study’s execution.
Analysis of the information, elaboration of the report and presentation
of the results: present the general aspects of the final stage of the study.
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BACKGROUNDS
Prices are a key factor for access to essential medicines, insomuch as
these have the most relevance for high cost treatments like those used by
patients living with HIV/AIDS.
Prices are influenced by diverse factors, such as: the size of the
pharmaceutical market, the level of development of the domestic
pharmaceutical industry, the volume of the acquisitions, the information
about prices and suppliers, experience in the acquisition process, demands
concerning the quality of products, intellectual property rights, tax and tariff
policies, medicines price policy among others (1).
Experiences like collective price negotiations undertaken by countries
of Latin America and the Caribbean are strategies that have developed
towards the end of reducing acquisition prices and increasing treatment
coverage of patients living with HIV/AIDS.
Consequently, in June of 2003, the I Collective Negotiation of Prices
for anti-retroviral medicines and reagents was undertaking in the city of
Lima with the participation of the countries of the Andean sub-region (Bolivia,
Colombia, Chile, Ecuador, Peru, Venezuela), Argentina, Mexico, Paraguay
and Uruguay.
This I Negotiation resulted in reductions of up to 72% in the case of
reference prices of medicines and up to 60% in the case of reagents, which
would translate into an increase in coverage that would allow for the inclusion
of more than 150,000 people in anti-retroviral treatment.
In September of 2004, the Ministers of Health of the Andean Area
agreed to the necessity of evaluating the impact of the I Negotiation in
each of the countries that participated in the process with the goal that the
results would serve as a benchmark to kick start the II Collective Negotiation
of Medicines and Reagents.
Under the auspices of PAHO, two evaluations were carried out: one in
the ambit of the Andean countries, and the other in the countries of Argentina,
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Paraguay and Uruguay. These evaluations were developed by Ohio State
University (OSU) and by NAF/ENSP/Fiocruz and PAHO-Brazil, respectively.
The evaluations identified the following main problems in the in
negotiation process: 1) the lack of up-to-date studies about the prevalence
of HIV/AIDS (in order to estimate demand), coverage and access to anti-
retroviral medicines; 2) the lack of an analysis of the anti-retroviral medicine
market and of the pharmaceutical sector; 3) the lack of a regulatory and
political framework at both the national and supranational levels compatible
with the framework of the negotiation; 4) resistance by the multinational
pharmaceutical industry to participate in a collective negotiation based solely
on prices; 5) the weak participation of the Latin American pharmaceutical
industry; 6) the scarce participation of distinct public subsystems of health
and purchasing entities; and 7) problems with the interpretation of the prices
to be negotiated iii.
With respect to the results of the negotiation, these evaluations reveal
that these were clearly positive, achieving an important reduction in prices.
However, the lack of adapting the regulatory framework, the administrative
structure, and health system made it difficult for these countries to be able
to buy the medicines and reagents at the negotiated prices. This resulted in
the fact that the countries analyzed did not buy the ARV medicines from the
laboratories that signed off on the negotiations, nor with the criteria of quality
and bioequivalence demanded in the negotiation, nor the prices obtained,
thereby generating an expense greater than what would have resulted had
the medicines been bought at the negotiated priceiii.
In the REMSSA, undertaken on March 31, 2005 in Santiago de Chile,
the Ministers of health expressed the need for the consolidation of the
Negotiation process. Therefore, in the IV Meeting of Ministers of Health
and Social Security of South America, the results obtained in the I Negotiation
were recognized and that collective negotiations were reaffirmed as an
effective instrument for obtaining just prices, as well as being agreed the
undertaking a II round of Negotiation.
In August 2005, the II Collective Negotiation was carried out in the city
of Buenos Aires, with the participation of 11 countries (Argentina, Bolivia,
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Brazil, Chile, Colombia, Ecuador, Mexico, Paraguay, Peru, Venezuela and
Uruguay) and a group of ARV medicine (innovators and generics) and
reagents (for diagnostics and monitoring) producing companies based on
defined technical and commercial criteria.
This negotiation resulted in the reduction between 15% and 55% for
the region’s most widely used therapeutic schemes. Thus, a basic
therapeutic scheme (AZT+3TC+NVP) whose cost in 2003 was 350 dollars
per patient would cost 241 dollars; for the therapy (D4T+DDI+LPV/RTV)
whose cost was 2,489 dollars, would cost 1,123 dollarsIV.
With the aim of assuring the success of the negotiation and overcome
the difficulties that surfaced in the implementation of the I Negotiation in
the countries, it was agreed the necessity of fortifying the monitoring and
accompaniment of the activities of the II Negotiation. PAHO was chosen as
the coordinator for facilitating the assessment of the methodology to be
employed.
In March of 2006, Anti-retroviral Negotiations Monitoring Group (GAN/
ARV) was createdv, based on the fact that not taking into consideration the
positive impact and political repercussion of the I Negotiation, one of the
main critiques was the lack of a systematic monitoring of the implementation
of the accords in the participating countries.
The general objective of the GAN/ARV is to support the countries that
consented to the agreed prices in the Buenos Aires negotiationvi, with the
following specific objectives: 1) propose a monitoring system for the
implementation of the negotiation agreements; 2) identify opportunities for
the extension to all the countries of Latin America and the Caribbean; 3)
identify obstacles and barriers in the implementation of the accords; 4)
propose necessary interventions for achieving the general objective; and
5) share and disseminate the information.
With respect to the monitoring system, it was established that the
variables to be analyzed should be few, only those necessary for identifying
IF they are acquiring at the negotiated prices. It was agreed to use the
document of the negotiation as the baseline. The agreed variables were: 1)
people undergoing treatment, how many needed medicines; 2) who provided
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the medicines and how: public system, social security, private sector, in a
centralized or decentralized form.
Therefore, during the seminar “Alternatives for the Financing of ARVs
in Latin America, Angola and Mozambique” in September of 2005, organized
by the Secretariat of the Global Network on Financing of Care for people
living with HIV/AIDS with the goal of promoting the exchange of experiences
in financing anti-retrovirals (ARVs) between the 9 participating countries
(Argentina, Bolivia, Brazil, Colombia, Honduras, Guyana, Nicaragua, Angola
and Mozambique), the necessity of drawing up a methodology for monitoring
the negotiation process was established.
Later on, in the framework of the Cooperation Agreement established
between the Ministry of Foreign Relations, UNAIDS, the Sergio Arouca
National School of Public Health (ENSP) of the Oswaldo Cruz Foundation,
it was agreed that ENSP would develop a methodology that would allow for
evaluating the implementation process of the anti-retroviral price negotiations
in the countries.
Thus, the Center for Pharmaceutical Policies (NAF), pertaining to ENSP,
developed a methodology, based on its previous experiences in the area.
This manual has as its goal the dissemination of the methodology for
evaluating the implementation of the anti-retroviral and reagent price
negotiation process conducted in Latin America and the Caribbean, which
could be used by the countries in a regular format.
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OPERACIONAL ISSUES
This manual is to be used for the systematic evaluation of the
implementation processes of the anti-retroviral medicines price negotiations
carried out by the countries of Latin America and Central America.
The evaluation, based on a unique conceptual framework (to be
published in a scientific journal and involving a logic model, indicators and
conceptual discussion), collects relevant information with respect to ARV
supply and demand, sanitary and economic legal framework related to ARVs,
the financing and the price negotiation mechanisms, the acquisition
processes of ARVs. It employs methods for data collection: review of
documents and interviews.
Instruments for collecting data
Two instruments are employed for carrying out the study: a) forms for
the collection of data and b) questionnaires for semi-structured interviews.
Forms
The forms are employed for data collection that will later be used for
the construction of quantitative indicators. The first is a form for the collection
of information on registered anti-retrovirals and their characteristics (Annex
1 and 2), which include data on the maker, holder of the product registration,
patent and/or protection of the test data, inclusion in the essential medicines
list, treatment protocols.
This first form provides necessary information for calculating six of the
proposed indicators for measuring the supply of anti-retrovirals in the country
(suppliers and authorized products), and needs to be applied at the level of
the medicines regulatory authority and the national intellectual property rights
authority.
The second is a form for collecting data concerning the acquisition of
anti-retrovirals (Annex 3 and 4), which includes prices, form of acquisition,
supplier, quantity, among others.
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This second form offers information for the calculation of six of the
proposed indicators for measuring the indicator of the process “Acquisition
Prices”, as well as the indicators proposed for measuring the impact of the
study. This form should be applied at the level of the institutions that acquire
ARVs during the previously defined period.
If the country uses information systems for the registration process
and purchase of medicines, these data can be obtained using electronic
means and then adapted to the proposed structure of the forms described
in the annexes.
It is important to highlight that these forms are references that are to
be revised and adapted to the particularities of each country before being
put into use.
Questionnaires
The questionnaires are to be employed for the collection of data
required principally in the construction of qualitative indicators, as well as
for information about context, and for the some quantitative indicators
(Annex 5).
The questionnaire is to be used for carrying out interviews with key
informants, including representatives of the medicines regulatory authority,
of the national HIV/AIDS program, of the main anti-retroviral purchasing
institutions, of the national intellectual property institute, of a civil society
organization involved in the topic of anti-retrovirals and financial agencies
of ARV treatment.
The identification of the institutions involved in the development and
carrying out of the negotiation process and key informants in these
institutions is a crucial step for assuring the quality of the results of the
study. The selection of the actors should be undertaken according to country
context.
The characteristics of the questionnaires is that they serve as a guide
for the interviews, being of extreme importance that the interviewee be
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allowed to express their opinions, which will enrich the interpretation of the
results.
Just like the forms, the questionnaires should be revised and adapted
to the specifics of each country.
Types of questions
Many of the questions on the questionnaire are objective and allow
the interviewee to simply respond yes/no to a number or a data relationship.
As mentioned before, this does not rule out the possibility that the
interviewee specify, detail or explain their responses. Any interpretation
concerning the interviewee’s discussion should be added to a notebook
entitled “field diary.”
It is recommended that the interviewee be allowed to speak as freely
as possible, without forcing the responses and writing down exactly the
terms used by her or him.
The questions on the questionnaire are basically designed to be used
with a determined key actor. However, there are questions that can be asked
to a number of actors and thereby allowing to take into account a variety of
perspectives before the same specific question and indentify inconsistencies
or existence of a uniform handling of information between diverse
interviewees.
Data sources
The sources for obtaining information are mainly the following:
� Legal norms and reports – through the documentary review of
legal norms, administrative documents, publications, among others,
set aside for collecting information mainly about legislative aspects,
processes of purchasing medicines, financial aspects about the
provision of ARV medicines, epidemiological information, etc.
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� Data base – depending on the level of information supply systems
of the country, this is used mainly for obtaining data on registered
medicines, prices of acquisition, amount of financing,
epidemiological aspects, etc. This information could be found
available on official web pages.
� Key informants – these are obtained by carrying out structured
interviews to key informants that allows to take into account relevant
information, as well as recognize the perceptions and opinions
related to critical aspects of the implementation of the negotiation
and ARV price processes. It provides an understanding of the
perspectives of the decision makers and system managers.
The Interview
The quality of the interview depends in large part on the ability of the
interviewer to obtain the necessary information. We present some important
topics in order to guarantee the best possible outcome for the interviews.
Scheduling of interviews
It is important to establish ahead of time contact with the people to be
interviewed in order to set a date, time and place to carry out the interviews,
considering that as managers and representatives of critical areas, they
have a tight schedule. The appropriate scheduling will reduce the risk that
the interview be delegated to another employee with less knowledge of the
theme or be cancelled.
It is recommended to send prior to the interview, an executive summary
of the project, as well as request the information that will be required during
the interview or data for completing the forms. It is a good practice that
explains exactly what will be expected of the interviewees.
For collecting data, it is recommended that those periods in which the
area or institution is occupied with activities such as final evaluation,
scheduled events, audits or close to holidays be avoided.
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Presentation of the interviewer
The interviewer should start by presenting her(him)self, provide a brief
explanation about the study and who are the institutions conducting it, and
the motive for the interview.
Next, the interviewer should request related data that needs to be
delivered by the interviewee in written or electronic form. If possible, this
data should be turned in during the interview. The interviewer should
establish the following date (not greater than 48 hours).
How to execute the interview
The interview ideally should be undertaken in a relaxed and informal
environmental, not give the appearance of an interrogation or audit, in which
the interviewer should show an attitude of sympathy and comprehension,
emphasizing the idea that does not exist wrong or right answers.
The interviewer should read the questions exactly as they are found
on the questionnaire, neither adding nor cutting out phrases. The questions
should be read slowly and pronounced clearly so that the interviewee hears
the question before responding.
The interviewer should encourage the interviewee to give the clearest
response possible without influencing, suggesting, or interpreting any
response.
The responses should be registered in a legible form. In case of an
error, it should be crossed out and the correct answer written above or next
to previous answer. The commentaries that are provided by the interviewee
should be noted in a diary1.
It is not always possible for the interviewee to complete the
questionnaires or forms during the interview. However, before finalizing the
interview, the interviewee should make sure that all the necessary
1 The field diary is a notebook in which are registered the commentaries of the intervieweeas well as the observations of the interviewer.
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information has been collected and establish a means by which the
interviewee can be contacted at a later time in order to correct or complete
any information. Next, the interviewee should be thanked for her/his
cooperation and time provided.
Once the interview has ended, the interviewee should revise the
questionnaire and determine the complementary information that would
required to adequately fill it out. Once the complementary information has
been received, the interviewer should add the information in a clear form.
Important definitions
For the adequate development of the study, a glossary of operations
definitions have been drawn up that allows for a comprehensible and
standardized handling of the terminology during the application of the
methodology (Annex 6). If necessary, it is important that the glossary be
revised and adapted to each country to improve understanding.
It is recommended that special attention be given to the different types
of prices available, since the experience of regional negotiation processes
of the Andean countries revealed difficulties in their interpretation.
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PLANNING THE STUDY
Composition of the organizing group of the study
The institution or organization that will carry out the study should
schedule a date and time for coordinating, planning, organizing and
executing the study in the country.
Preference should be given to professionals with knowledge about
the areas of legislation related to pharmaceuticals, the pharmaceutical
market, acquisition processes, supply of ARVs, medicines prices, among
others, as well as to those with experience in carrying out studies.
The team should draw up a plan of action, laying out the activities,
responsibilities, timeline and necessary resources for carrying out the study.
Time period under study
Establishing the period of time for obtaining the respective data will
depend on a number of factors. Among them, the following could be
considered: a) the desired depth of the study, determined by the institution
that will carry it out, b) the availability of registrations and sources of
information on the ARV acquisition prices, c) the date of the start of the
negotiation process of national and regional prices, d) the beginning date
of the ARV acquisition prices, e) the start of the supply of ARV treatments
to in the country.
Ideally, the period of the study should begin with the period in which
the ARV acquisition processes occur to the start of treatment; however,
this will depend on the existence of trustworthy sources of information.
If the country has not begun the price negotiation process or the
implementation of negotiations carried out, this study could provide a
diagnostic of relevant aspects of the situation of ARVS in the country that
serves as an input for future actions.
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Extent of the study
In this stage, determining the extent of the study will depend on the
characteristics of the health system, its degree of segmentation and
fragmentation. Questions include what are the institutions that supply ARV
treatment, if they are public or private, what is the coverage achieved, who
are the financing organizations, who acquire the ARVs, if the acquisition is
centralized or decentralized, who will carry out the provision of the ARVs,
among others.
Depending on these characteristics and the feasibility of having access
to the information, it should determined if the study will include the public
and private sector, or if it will focus on the sector that supplies the greatest
amount of treatments, if it involves institutions at the national or decentralized
levels, if it includes every type of ARV treatment or just specific groups like
pregnant women or children, and if it will include medicines or reagents.
With respect to ARVs, it should be determined if the prices of all the
ARVs acquired, only those negotiated, of those included in the Essential
Medicines List or those in treatment protocols will be evaluated.
Identification of the institutions and key informants
Once the depth of the study has been determined, the institutions that
can supply the relevant information for evaluating the implementation of
the price negotiation process should be identified.
The model takes into consideration the following institutions: a) the
regulatory agency for the country’s medicines, which will provide information
concerning the pharmaceutical situation and its legislation, b) the national
HIV/AIDS program at the national level, c) the main health suppliers with
HIV/AIDS treatment coverage, like the Ministry of Health and of Social
Security, and those that will report on their coverage, negotiation
mechanisms, acquisition and supply of ARVs, d) the financing bodies of
ARV treatment, which will allow researchers to take into account information
about the situation of financing treatment, e) organizations of civil society
involved in the topic that will provide information on the degree of
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participation of civil society in the access to ARV in the country and the
results of negotiation perceived by people living with HIV/AIDS, and f) the
national intellectual property agency in order to know the situation of patent
protection on ARV medicines.
The selection of key informants is another fundamental element for
the success of the study. Identification of the person or employee should
take into consideration their level of knowledge with respect to the theme
about which s/he will be interviewed, that is to say, that person who can
supply current and accurate information, like experience in administration,
decision-making or participation in the critical processes covered by the
study.
For this reason, the awareness and involvement of the institutions in the
process are extremely important so that they recognize themselves as active
participants in the evaluation and so that they can take advantage the results
of the decision-making process.
Revising the forms and questionnaires of the study
The forms and questionnaires should be revised so as to be adjusted,
according to necessity, to the particularities of each country.
Duration of the study
A period of five weeks is proposed: two weeks for preparations and
planning, a week for collecting data, a week for entering data and analysis,
a week for drawing up a report and presentation of the results.
Financing the study
The financing of the study should take into consideration remuneration
of the researchers and typists, printing of the data collection forms and
questionnaires, the communications, expenses in local transportation,
among others.
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Composition and training of the team responsible for the field research
The experience gained from the testing phase of the methodology
showed that data collection could be carried out by two researchers over a
period of five days. The recommended profile of the researchers is:
professional pharmacists with experiences in acquisition process,
pharmaceutical legislation, provision of medicines, and organization of the
health sector. The researchers should receive training in the methodology,
filling out the forms and conducting the interview. A model of the structure
of the training is presented in Annex 7.
Data collection
During the preparation phase, the team responsible for the field
research should start by collecting general information like epidemiological
data about the disease, the type of foreign exchange rate for each year of
the study in order to convert the values in local money to an index that will
be used (usually US dollars), the ARV acquisition process, trade agreements
signed by each country, among others.
26
APLICATION THE METODOLY
Request authorization to undertake the study
Official communication should be drawn up and studied, requesting
the cooperation of diverse institutions where the interviews will take place
and data collected.
This communication should include an executive summary of the study,
pointing out the objectives of the study, its importance and what should be
expected of the institution. This will give the study the requisite formality
and seriousness, thus facilitating the cooperation of participating institutions
and people.
Carrying out logistical arrangements
The objective aspects must be present for the adequate development
of the study, such as communications, preparation of the printed material
and of the manual for the interviewers, availability of a computer for data
entry, a place to maintain an archive of the documents that are produced,
presentation letters, identification tags for the researchers, expense controls,
office material (pencils, drawing boards, etc.) among others.
An important stage is planning visits and interviews, if travel tickets,
hotel reservations, among others need to be purchased.
Collecting data for the study
Collecting the information that requires more effort will be considered
in Forms 1 and 2, which will depend on the level of computerization of the
data on prices, medicines and suppliers’ registration, and the level of
fragmentation of the health sector.
27
Conducting interviews with key informants
Carrying out interviews should be conducted in accordance with the
timeline established and follow the recommendations highlighted in the
paragraph Interviews of this manual. The interviews could be recorded with
the consent of the interviewee and later transcribed.
Building the data base
For the registration of the data obtained during the study, it is
recommended that the research team relies on a data base that allows for
the systemization of the data collected, carries out the calculations of the
indicators and allows for the production of the required reports for writing
up the final report. Towards this end, it is necessary to construct a data
base with people specialized in information technology.
This manual presents a model data base, a simple and easy-to-use
tool, developed with Excel (Microsoft) software, that allows for the registration
of data collected during the Field research, calculation of the proposed
quantitative indicators, and production of consultations and reports.
Structure of the data base
It is recommended that the data base be developed along the following
three modules:
� Module of the registration of the acquisition of medicines and
reagents.– permits the entry of acquisition prices of anti-retroviral
medicines and reagents obtained in the country by different
institutions.
� Module for consultations and reports. – allows for making
consultations about the data base concerning available data, which
will serve as a tool for decision makers in the countries.
� Module for the registration of the negotiation process.– additionally,
this data base allows for entering of acquisition prices of anti-retroviral
28
medicines resulting from the regional and collective negotiation
processes among the countries, which will serve: 1) to contain
information on medicines and negotiated prices, participating
companies in the negotiation processes, as well as the duration of
the reference prices, and 2) for later evaluations of the implementation
processes of the negotiations of the countries.
Quality control of the field research and data entry in the data base
The entire work process, from the planning, the execution and analysis
should be carried out with the perspective of quality control carried out by
the directing team and coordinator of the study. For example, the training of
interviewers, the planning of the field research, materials preparation, etc.
In the final stages of the study, increased methodological rigor should
be applied to give consistency to the results. Careful attention needs to be
given to data collection, filling in the forms and questionnaires, data entry
in the data base, etc.
Once the interviews have been conducted and data collection
completed, a supervisor should proceed to revise the instruments to verify
that they are complete, clearly and correctly filled out. Next, the data entry
in the data base should begin.
Data entry should be carried out by double typing (two people doing
data entry) to guarantee the soundness of the process, and it should be
revised by the supervisor. In the case of inconsistencies, the source
documents should be consulted.
The forms and questionnaires should be stored until the study has
been finalized, in accordance with the legal dispositions of each country.
29
ANALYSIS OF THE INFORMATION, WRITING THE FINALREPORT AND PRESENTION OF THE RESULTS
Data Analysis
The analysis should be carried out in light of the sanitary, legal,
economic and pharmaceutical context of the country. Within this analysis,
the information on prices is the most sensitive and objective part of the
evaluation. The price data effectively allows researchers to establish the
impact of the acquisition prices obtained in the negotiation process and the
degree to which the negotiated prices are realized in practice, as well as
the rest of the explanatory elements of the phenomenon.
Concerning the prices
For the price analysis, available information in the counties will be
taken into account, which will depend on the modality of the purchase that
can be classified in:
� Final Unit Price (which includes taxes and tariffs).
� Unit Prices (FOB or CIF or DDU2) about which the purchasing Unit
should make additional payment on tariffs, duties, etc.
The prices of the medicines expressed in local money should be
indexed (usually to the US dollar).
When there is more than one acquisition price for a certain ARV, one
can take on one of the following criteria:
a) The average of the pricesvi.
b) Total weighted average. – in the case of accounting with the
information of quantities acquired in each buying process of each
year.
2Annex 7 presents the operational definitions of the distinct types of prices.
30
c) Use as price for analysis that which was obtained in the purchase
or purchases representing 80% of the total financial value in a year
per ARV.
d) Annual cost/patient for the ARV medicinevii, which is determined
on the basis of how many patients are treated with an ARV medicine
during a given year and the total annual cost of this medicine. This
criterion is justified when the number of purchases per year, or
when there is less than one purchase year, is not of importance. To
carry out the price comparison in different time periods or between
countries, it is necessary to establish a standardized measure, which
in this case it is recommended that the weighted average of the
acquisition prices be used.
Writing the final report
The final report should contain the results with a brief discussion about
them given the context of the country. It is recommended that the discussion
be based on the conceptual framework of the study.
Presentation of the results
It is recommended that the results be presented to different institutions
that form part of the study. It is also advised that an executive summary of
the main results and recommendations be presented.
31
ANNEXES
32
33
Anne
x 1.
For
m 0
1 –
Info
rmat
ion
on A
RV
s
34
Annex 2. Instructions for filling out the “Form for collecting information about registered anti-retrovirals and their characteristics”
Collecting data
The data for filling out the form is obtained from the national medicines
regulatory agency, the national intellectual property agency, and from the
National HIV/AIDS Program. One should see if the required information is
available on official web sites. This facilitates data collection.
Instructions for filling out the form
� Date.– indicate the date in which the data was collected.
� International Common Denomination (DCI).– put the name of the
registered ARV according to its denomination or generic name.
� Concentration.– put the concentration of the registered ARV.
� Dosage form.– indicate the minimum unit of the dosage form of
the registered ARV. Ex, pill, vial (indicating volume) or blister.
� Brand name.– if it has one.
� Name of the producer.– put the name of the laboratory that makes
the ARV.– it is necessary if the ARV is produced nationally or is
imported (produced abroad).
� Owner of the registration.– is the company that registered the
ARV in the country, and note whether it has legal responsibility
for marketing the product.
� Medicine included in the EML.– note Yes or No, depending on
whether the ARV (active principal ingredient, concentration and
pharmaceutical form) is found in the current EML. This column
will be filled when reviewing the EML, which should have been
requested beforehand.
35
� Medicine included in the Treatment Protocol (TP).– note Yes or
No, depending on whether the ARV (active principal ingredient,
concentration and pharmaceutical form) is found in the current
TP for managing HIV/AIDS. If the protocol only considers the
active principal of the ARV, considered this parameter and write
Yes or No. This column will be filled when reviewing the PT, which
should have been requested beforehand.
� Laboratory that participates in the negotiation of prices.– Put Yes
or No depending on whether the laboratory that produces the
ARV participates in some negotiation process with the country.
To fill out this column, information about diverse, national or
international, processes of the negotiation should be taken into
consideration in which the country or institution has participated.
A Yes should be provided, although the ARV is marketed by a
different laboratory that negotiates the prices.
� Anti-retroviral negotiated.– put Yes or No, depending on whether
the ARV (active principal ingredient, concentration or
pharmaceutical form) was negotiated and if it has a reference
price at the national or international level in which the country
has participated. If the country has not carried out negotiations, it
could use the reference negotiation prices, respecting the duration
of such prices. In the case of the prices negotiated in the countries
of Latin America, these prices were in effect for two years.
� Medicine protected by patent.– put Yes or No, depending on
whether the active principle ingredient is under patent on the date
when the research was made. This information could be provided
by the National HIV/AIDS Program, the Medicines Regulatory
Agency, or the Intellectual Property agency. Experience from
testing the methodology revealed difficulties in obtaining access
to this information.
� Date of patent expiration.– indicate the month and year when the
ARV will no longer be protected by a patent.
36
� Medicine under test data protection.– put Yes or No, depending
on whether the medicine is still under the protection of test data.
It should be possible to research beforehand if the country has
legislation that protects test data. This information will be provided
by the Medicines Regulatory Agency, which should be solicited
prior to filling out the form.
� The date of the validity of test data protection.– register the
month and year until when the ARV has test data protection.
Note: No boxes on the form should be left blank. In case you do not obtain the
information, fill in N/A.
37
Anne
x 3.
For
m 0
2 –
Info
rmat
ion
on p
rices
and
sup
plie
rs
38
Annex 4. Instruction for filling out the Form for collecting information about
the acquisition of antiretrovirals
Data collection
The data for filling out the form is obtained from the areas of the
institutions responsible for the acquisition of ARVs that are part of the study.
All the prices of all the acquisitions of ARVs made during the time period of
the study should be collected. It is recommended that all the data be filled
in, starting with the earliest year.
It should be verified if the country has available information on State
purchases of products and quantities acquired, as well as the prices
adjudicated for ARVs on official Web pages. This makes collecting
information easier. One form for each institution should be used.
Instructions for filling out the form
� Date.– indicate the date in which the data was collected.
� Purchasing entity.– write the name of the purchasing institution. Use
one form per institution.
� International Common Denomination (DCI).– or INN (International
Non-proprietary Name) put the name of the registered ARV according
to its denomination or generic name.
� Concentration.– put the concentration of the registered ARV.
� Dosage form.– indicate the minimum unit of the dosage form of the
registered ARV. Ex, pill, vial (indicating volume) or blister.
� Brand name.– if it has one.
� Unit price.– register the acquisition price using up to three decimal
places. The price should correspond to the minimum unit of the
dosage form (pill, vial, blister). The price should be put in local money.
In case the price is expressed in US$ dollar, a note should be made.
39
� Type of price.– Indicate the type of price employed: FOB, CIF, DDU,
DDP (see The Operational Definitions Annex).
� Quantity.– register the minimum quantity of units of the dosage form
of the ARV acquired. (number of pills, number of vials, number of
blisters).
� Supplier.– register the name of the company that supplies the ARV.
It is not necessarily the manufacturer.
� Laboratory.– put the name of the laboratory that manufacturers the
ARV. In some cases, this information is easily found available on
the purchasing documents with just the name of the company that
offers the ARV.
� Date of purchase.– register the month and year of the ARV’s
acquisition.
� Mode of purchase.– indicate the type of process: national tender,
international tender, direct purchase, etc. These categories should
be adapted to the existing modalities in the country.
� Type of interbank dollar rate.– register the exchange rate
corresponding to the month/year in which the acquisition was made.
This information could be easily found on at the Central Bank of the
country.
Note: No boxes on the form should be left blank. In case you do not obtain the
information, fill in N/A.
40
Anne
x 5
. In
dica
tor
fram
ewor
k
41
42
43
44
Annex 6. Principal operational definitions
National system of epidemiological information.– System that registers,
revises and publishes biannual information regarding morbidity and mortality
for all the age groups, as well as the number of cases notified and people
that require or receive ARV treatment.
Treatment protocol.– Technical document that contains information that
serves to guide treatment in specific situations. Generally, they are officially
approved by the Ministry of Health.
Essential Medicines List.– The list enumerates the necessary minimum
medicines for primary health care system, and it includes the most effective,
safe and efficient medicines for illnesses given priority. These illnesses are
selected in function of their actual or future importance from the stand point
of public health and the possibilities to administer safe and efficient
treatment.
FB Price*.– (Free on Board ) convened cargo port. “Free on Board”
means that the seller makes delivery when the merchandise passes over
the board of the ship on to the port. This means that the purchaser should
be able to support all the cost and risk of lost and damage to the merchandise
from that point. The term FOB requires that the seller carries out the customs
processing for export. This term is used when dealing with maritime or
fluvial transport; for the rest of the cases, the term FCA (Free Carrier) is
used III.
CIF Price*.– (Cost, Insurance and Freight ) in the convened port of
destination. “Cost, insurance and freight” means that the seller carries out
the delivery when the merchandise passes over the board of the ship at the
convened port of destination. The seller should pay all the necessary costs
and freight for transporting the merchandise to the convened port of
destination, but the risk of lost and damage to the merchandise, as well as
whatever additional cost owing to any incidents after the moment of delivery,
are transmitted from the seller to the buyer. However, in conditions of CIF,
the seller should also seek to obtain maritime insurance for risks to the
buyer for the lost or damage to the merchandise during transport. The term
CIF requires that the seller undertake all the customs processes for export.
45
This term is used when dealing with maritime or fluvial transport; for the
rest of the cases, the term CIP (Carriage and Insurance Paid to) III is used.
PDDU Price.– (Delivered Duty Unpaid ) convened destination place.
“Delivered duty unpaid” means that the seller carries out the delivery of the
merchandise to the buyer, and the buyer is responsible for the costumes
processes at the port and the removal of the merchandise from the means
of transport at its arrival to the convened destination place. The seller should
assume all the contracted costs and risks to take the merchandise to that
place III.
DDP Price*.– (Delivered Duty Paid) convened destination place.
“Delivery duty paid” means that the seller carries out the delivery of the
merchandise to the buyer, carried out the customs processes but not the
unloading from the means of transportation, at its arrival to the convened
destination place. The seller has the same obligations as under DDU, but
also pays the import duties on the merchandise. This assumes the largest
obligation and risks for the seller within the IncotermsIII.
Patent.– The patent of a medicine provides the right to the research
laboratory to exclusively market an original drug during a specific period.
This patent period is justified by the necessity to amortize and compensate
the expenditures on research and development of a new product. During
the period of time during the patent, the manufacturing laboratory could
provide marketing licenses to other laboratories. When the patent expires,
the medicine can be registered by any pharmaceutical laboratory that is
capable of making it in accordance to the norms in place and with all the
safety guarantees.
Protection of test data.– The test data is the information developed to
guarantee the security and efficacy of a medicine based on clinical tests
undertaken on patients. Depending on the country, this data is or is not
protected from unauthorized third parties taking advantage of it. This
protection thus provides the innovating laboratory that developed the drug
a period of exclusive marketing of the active principal ingredient during
which copies would not be authorized.
46
Annex 7. Proposal for training the team responsible for field research
47
REFERENCES
I. Hamilton, G., Falistocco, C. América Latina y el Caribe : estrategias para
promover el Acceso universal a los medicamentos antirretrovirales para
HIV-SIDA
II. Marin N., Garcia C. Información sobre negociación de precios ARV:
Argentina, Paraguay, Uruguay. OPS/Brasil, NAF/ENSP, Fiocruz – Brasil.
Mayo de 2005.
III. Seoane E., Rodríguez R. Análisis del Impacto de la Negociación de Precios
de Medicamentos y Reactivos para el VIH/SIDA en los Países Andinos.
Organización Pan Americana de la Salud/Organización Mundial de la Salud.
Marzo 2005.
IV. OPS. Informe II Negociación Conjunta de precios de medicamentos
antirretrovirales en países de Sudamérica. Procesos y Resultados (octubre
2006). Disponible en http://www.paho.org/Spanish/AD/FCH/AI/
II_Ronda_de_Negociacion_Procesos_Resultados.pdf acceso en 15 Enero
2007
V. OPS. Informe: “Primera reunión del grupo de acompañamiento de las
negociaciones de antirretrovirales (GAN/ARV)”. 2-3 marzo de 2006.
Washington D.C. Disponible en http://www.gcth-sida.org/
index.php?option=com docman&task=doc view&gid =155& Itemid=31
acceso en 15 Enero 2007 Porras L. y Stern R. Comparación de precios de
ARV en 9 países de Centro y Sur América. Asociación Agua Buena. Octubre
2006.