The Latin
American Network of People Living with HIV/AIDS (REDLA+*)
issues the following statement on purchasing and distributing
non-brand name antiretroviral drugs**
or pharmaceutical products (ARVs) for
treatment of HIV/AIDS (brand name drugs are also known as innovator
or original drugs):
Considering
that:
1. Life, health, access to
scientific and technological advances, and egalitarian treatment are
human rights that states and governments must guarantee for persons
living with HIV/AIDS (PLWHA), as expressed in: national
constitutions; the Universal Declaration of Human Rights, the
American Declaration of the Rights and Duties of Man; the
International Convenant on Economic, Social and Cultural Rights; the
American Convention on Human Rights; and norms on the defense of
human rights such as the Declaration on Human Rights of PLWHA,
signed in England in 1990.
2. According to legal
national and international norms states and governments have the
duty to protect the
health care of citizens living with HIV/AIDS; national government
agencies are compelled to establish
mechanisms for strengthening their budgets for the implementation of
national HIV/AIDS policies in order to guarantee the rights to life,
health, access to scientific and technological advances, and the
non-discrimination of PLWHA.
3. States and governments
(in the context of their role as decision makers) lack information
on the manufacture and quality control of innovator, generic and
copied drugs in Latin America and the Caribbean.
4. Quality controls (bioequivalence
and bioavailability) must be done on every pharmaceutical product or
medication; these controls guarantee that pharmaceutical products or
medications are effective, safe and capable of producing therapeutic
effects (preventive and/or curative) against human ailment(s),
symptom(s), illness or disease.
5. Bioavailability
is the exact quantity of active ingredient in an orally-administered
medication that will reach the bloodstream and the time it takes to
do so from the moment of ingestion. Bioequivalence
is the degree of similarity or comparison between two drugs (between
an innovator drug and a generic or copied drug) containing the same
active ingredient in the same quantity, have the same form, and are
administered by the same means and in the same dosage, such that
they present a bioavailability so similar that it would be possible
to predict that the therapeutic effects of both drugs would be
essentially identical.
6. Manufacturers of
innovator, generic, and copied drugs have commercial interests.
7. The inappropriate use of
the term “generic medication” to refer to copies or similar
versions of medications, as well as the problems being created by
some medications lacking demonstrated therapeutic equivalence.
8. The possibility of
creating differences between persons living with HIV/AIDS due to
their having ingested different types of medications: innovator,
generic or copied drugs.
9. The lack of scientific
recommendations and technical publications on alternative treatment in regards to failure of
generic medications plans .
10. Following various
consultations with experts and as a result of our experience,
ethics, and disinterested commitment to the wellbeing of the
community of PLWHA in Latin America and the Caribbean, we wish to
share the following document describing the institutional and
consensual position of REDLA+ on procurement.
This document seeks to
establish and clarify the following points:
A. A drug is only a generic drug, and can only be called as such, if it is
“interchangeable”. For
this to be the case, the drug must have successfully passed tests to
show its therapeutic equivalence. With regard to antiretroviral
drugs, each medication must have successfully passed clinical tests
(in vivo) for, and must bear certification of its bioequivalence in
accordance with international guidelines (where this certification
is based on the results of the aforementioned clinical tests).
B. If a drug, once
manufactured (also called the completed pharmaceutical product) has
not passed or gone through the clinical laboratory tests (in vivo
phase) to certify its bioequivalence and bioavailability, it can
only be considered a similar or copied medication.
Its quality and the possible adverse effects it can produce in
people remain unknown, as do its actual therapeutic effects and
effectiveness in treating HIV/AIDS.
C. Completed drugs or
pharmaceutical products that have been shown to be pharmaceutically
equivalent through the appropriate testing methods but have not been
shown to be therapeutic equivalent, cannot be considered to be
generic drugs, and must be considered similar or copied drugs.
D. We consider that any
PLWHA who is administered similar or copied drugs is participating
in a test or clinical trial. A clinical trial is a scientific method
for studying in various phases (studies done with cellular cultures,
animal studies, and small consenting groups of human beings) the
effectiveness, quality, possible adverse effects and interactions of
a medication. Before administering the drug, national health
authorities must explain and notify PLWHA, clearly and equitably,
about the characteristics of the drug in question and of any
subsequent alterations done to it. If the PLWHA involved agree to
participate in the clinical trial, they must give their signed
informed consent to be part of the test or clinical trial in
accordance with the Declaration of Helsinki on Human
Experimentation. These clinical trials must be done under conditions
respectful of the fundamental rights of persons and of the ethical
criteria that guide biomedical research involving human beings.
E. Prescribing medications
or pharmaceutical products that have not passed the quality tests (bioequivalence
and bioavailability) cannot be considered part of a treatment plan,
but must instead be considered part of a test or clinical trial.
F. Certification of quality,
proof of quality, and good manufacturing practices, must follow the
completion of a pharmaceutical product, and each of the forms it
takes in the country where it will be consumed. Manufacturing
certificates for the active ingredient in a medication (chemical
compound that brings about a therapeutic effect and thus reduces or
eliminates symptoms, illness or disease) do not free producers
and/or buyers of their responsibilities, such as their duty to do
quality tests on completed pharmaceutical products aimed at human
consumption.
G. The national public
health authority or the public health authority of
each country has the responsibility to act on the
implementation, follow-up, and control of quality tests. It cannot
delegate this responsibility for any reason to a private entity or
to an international agency. The national authority is responsible
for information on whether a product is an innovator/original drug,
generic/interchangeable drug, or similar/copied drug and for
information on the nature of the drug’s therapeutic and adverse
effects.
H. The Declaration of
Commitment on HIV/AIDS, signed by the States and Governments of
Latin America and the Caribbean during the United Nations General
Assembly Special Session (UNGASS) states:
“By 2003, ensure that national
strategies, supported by regional and international strategies, are
developed in close collaboration with the international community,
including Governments and relevant intergovernmental organizations,
as well as with civil society and the business sector, to strengthen
health-care systems and address factors affecting the provision of
HIV- related drugs, including anti-retroviral drugs, inter alia,
affordability and pricing, including differential pricing, and
technical and health-care system capacity. Also, in an urgent manner
make every effort to provide progressively and in a sustainable
manner, the highest attainable standard of treatment for HIV/AIDS,
including the prevention and treatment of opportunistic infections,
and effective use of quality-controlled anti-retroviral therapy in a
careful and monitored manner to improve adherence and effectiveness
and reduce the risk of developing resistance; and to cooperate
constructively in strengthening pharmaceutical policies and
practices, including those applicable to generic drugs…”
Thus,
the Latin American Network of People Living with HIV/AIDS (REDLA+)
agrees that:
a. REDLA+
will support, only and exclusively, the distribution of
antiretroviral medications shown to be therapeutically equivalent
and to bear scientific certification to that effect. This
requirement applies to innovator products and generics that have
successfully passed tests of bioequivalence and bioavailability.
b. REDLA+
will support, only and exclusively, the distribution of generic
antiretroviral medications if the abovementioned tests have been
done and if their outcomes are periodically and randomly made
available at purchase and/or procurement points.
c. REDLA+
will keep a critical eye on the distribution of brand name and
generic antiretroviral medications.
d. REDLA+
will support, only and exclusively, universal access to treatment
for PLWHA according to criteria of equity and the same treatment for
everyone of the highest quality (known and proven). There are no
moral or ethical arguments for justifying substandard treatment for
PLWHA.
e. REDLA+
exhorts governments to formulate or adapt their drug regulation
legislation, including guaranteeing follow-up on quality control
processes throughout the manufacturing, distribution, storage, and
dispensing stages of medications. The requirement of guaranteeing
follow-up on quality control processes does not only apply to
completed pharmaceutical products. It applies throughout the steps
Good Manufacturing Practices require, and it must be implemented in
accordance with the policies the World Health Organization (WHO)
recommends.
f. REDLA+
will denounce policies, government officials, organizations, and
businesses that engage in practices that are illegal, conflict with
ethics, or promote partial information on our own treatment.
g. REDLA+
promotes and demands that PLWHA be treated only and exclusively with
drugs and treatment plans that have been clinically shown to be the
most effective.
h. REDLA+
will promote tests and clinical trials on humans that meet all the
ethical criteria, including the process of informed consent. In
situations of extreme necessity, such as PLWHA experiencing
resistance to proven treatment plans or drug combinations, we will
support treatment plans that, for example, involve “compassionate
access”.
i. REDLA+
satisfies its mission of exclusively promoting the quality of life
of PLWHA.
j. REDLA+
declares it does not have conflicts of interest with the
pharmaceutical industry and with health care systems and their
clients. We declare
having no interest whatsoever in the results of conflicts,
negotiations, purchases, or national, regional or international
bids, except for those specified in our bylaws .
k. REDLA+
exhorts the pharmaceutical industry to develop policies with social
content that take into consideration the lives of people and that do
not alone prioritize commercial earnings made from the sale of the
pharmaceutical products people living with HIV/AIDS consume.
REDLA+
considers that universal access to treatment, which includes ARVs
(among other things, and care for all PLWHA who need them can and
must be achieved through commitment , ethics, science, rigor, and
adherence to existing legal norms in the countries of Latin America
and the Caribbean. We,
PLWHA, do not wish to be the ones in our countries, to have our
bodies again used, to test the effectiveness or ineffectiveness of
ARVs.
Havana, Cuba, April 2003
REDLA+,
the Latin American Network of People Living with HIV/AIDS, is
composed of networks, groups, and associations of people living with
HIV/AIDS. It
has representatives or “Focal Points” in Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba,
Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua,
Panama, Paraguay, Peru, Dominica Republic, Uruguay, and Venezuela.
The above statement from REDLA+,
the Latin American Network of People Living with HIV/AIDS, is
the result of a consensual agreement among all the Focal Points of REDLA+.
In addition, more than 7,900 members of ESVIHSIDA ratified the
statement at the May 2003 ESVIHSIDA Discussion Forum.
The
signatories***
to the above statement from REDLA+ are
as follows:
- Pastor
Padron Bucarano / Integrante de GPSIDA, Villa Clara, Cuba
- Perceval
Carvalho / Natal, STV Brasil - Sociedade Terra Viva, Brasil
- Sergio
/ RNP+ Brasil
- Georgina
Gutiérrez Alvarado / Coordinadora del Programa de Mujer y SIDA
en Salud Integral para la Mujer (SIPAM, A.C.); y Vanguardia
Mexicana de Personas Afectadas por el VIH/SIDA (VANMPAVIH), México
- Rosalinda
Hernandez M. / Jefa Programa Nacional VIH/SIDA, Secretaría de
Salud, Honduras
- Roberto
Viñuela / Presidente Asociación Redes Nueva Frontera,
Argentina
- Maria
Fernanda Macedo / Brasil
- Raymundo Sandoval / ProPositivo
del Centro de Derechos Humanos, México D.F., MÉXICO
- Fausto Paez / Director Executivo LATITUD 0° MOVIMIENTO LGBT ECUATORIANO,
New York, USA
- Javier
Leonardo Varón
- Martín
de Jesús García Lira / Candidato para Diputado Federal por el
Distrito 14 de Guadalajara, Jalisco, México
- Gustavo
Adolfo Campillo Orozco / Presidente de Fundación Positivos por
la Vida; Miembro de CONASIDA, Medellín, Colombia
- Gabriel
Borges Gutiérrez / Coordinador General – Presidente de la
Delegación de PVVs, Buenos Aires, Argentina
- Lázaro
Rodríguez Corrales / Coordinador GPSIDA, Coordinador de Líneas
de PVVS, Voluntario de ONUSIDA en Pinar del Río y Miembro del
Equipo Nacional de PVVS, Cuba
- David
Mauricio Quintero / Fundacion Manos Fraternas Y FUNPPREVESS
- Cristina
Calderón / Guatemala
- Julio
Palma G. / Centro de Apoyo CAPVIH, Chile
- Maria
Beatriz Dreyer Pacheco / RNP+/POA Rede Nacional de Pessoas
Vivendo com HIV/Aids - Núcleo Porto Alegre – Brasil; Membro
do MLCM+
- Patricia
Pérez / Secretariado Regional América Latina de la ICW+
- Arturo
Vazquez Razo / Cord. Grupo de Autopoyo, Chiapas, México
- Aroldo
Enrique Pinedo Lanao / Director Ejecutivo de Fundación Manos
Amigas , Santa Marta, Colombia
- Psic
Andres Costilla Castro / Consejo Directivo de FRENPAVIH AC
y Director General de APLCS AC, México
- Aldo
Araujo / Director del Movimiento Homosexual de Lima (MHOL), Perú
* REDLA+
is the acronym for the Spanish language name of the
network, “Red Latinoamericana de Personas Viviendo con VIH/SIDA”.
The acronym has not been translated for the sake of avoiding
confusion.
**
The terms “drug” and “medication” are used interchangeably.
***
All details related to the signatories have been left in the
original Spanish to facilitate contacting them directly.
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