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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 naf@ensp.fiocruz.br).

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

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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.

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rices

and

sup

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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

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fram

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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.