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[e-med] POUR AMELIORER LACCES A DES MEDICAMENTS DE QUALITE CONTRE LE VIH

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E-MED: POUR AMELIORER L?ACCES A DES MEDICAMENTS DE QUALITE CONTRE LE VIH
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[posté par Carinne Bruneton, ReMeD

COMMUNIQUE DE PRESSE CONJOINTONUSIDA/UNICEF/OMS
PREMIERS RESULTATS DE L?INITIATIVE POUR AMELIORER
L?ACCES A DES MEDICAMENTS DE QUALITE CONTRE LE VIH
http://www.unaids.org/whatsnew/newadds/index.html


Genève, 20 mars 2002 - Une nouvelle action pour évaluer la qualité des
médicaments contre le VIH pourrait rendre les traitements plus accessibles
aux pays démunis. L'Organisation mondiale de la Santé (OMS) a évalué
plusieurs médicaments et publie aujourd?hui la première liste des produits
conformes aux normes qu?elle recommande. On trouve dans cette phase initiale
du projet 40 produits de huit fabricants de spécialités et de médicaments
génériques. Sous la direction de l?OMS, l?initiative fait appel à l?
expertise de l?UNICEF et du Secrétariat de l?ONUSIDA et reçoit l?appui du
Fonds des Nations Unies pour la population (FNUAP) et de la Banque mondiale.

Ainsi que l?a déclaré Gro Harlem Brundtland, Directeur général de l?OMS: «Ce
projet démontre les contributions essentielles que peuvent apporter les
laboratoires, qu?ils fassent de la recherche ou produisent des médicaments
génériques, dans les domaines de l?innovation, de la qualité et de l?accès
aux médicaments essentiels. Nous voulons voir se développer l?accès des
malades à des soins de qualité, notamment pour des maladies comme le
VIH/SIDA qui les maintiennent dans un état de pauvreté et freine le
développement économique de leur communauté.»

Le projet pour l?accès à des médicaments et à des diagnostics du VIH/SIDA de
qualité fait partie de la stratégie d?ensemble du système des Nations Unies
pour améliorer l?accès aux traitements. Cette stratégie est conçue pour
encourager une utilisation rationnelle des médicaments, les mettre, ainsi
que les diagnostics, à des prix abordables, assurer un financement durable
et établir des systèmes fiables de santé et d?approvisionnement.

«Ce dispositif aidera les pays, ainsi que l?UNICEF et d?autres institutions,
à acheter des produits de qualité pour le traitement du VIH», explique Carol
Bellamy, Directeur général de l?UNICEF.

«Cette initiative des Nations Unies représente une étape importante pour
accroître le nombre de fournisseurs agréés de médicaments anti-VIH et
améliorer les conditions d?achat pour les personnes vivant avec le VIH/SIDA
dans les pays en développement, » a déclaré Peter Piot, Directeur exécutif
de l?ONUSIDA. «Nous espérons que ce projet donnera aux séropositifs un
meilleur accès à des médicaments abordables et de bonne qualité.»

La liste publiée aujourd?hui comporte onze antirétroviraux, avec lesquels
plusieurs trithérapies sont possibles, et cinq produits pour les infections
opportunistes.

Le projet pilote évalue les produits pharmaceutiques en fonction des normes
de qualité recommandées par l'OMS et du respect des bonnes pratiques de
fabrication. C?est le commencement d?un processus continu qui permettra d?
ajouter des produits et des fournisseurs sur cette liste, après avoir établi
qu?ils respectent bien les normes. La liste se trouve désormais sur les
sites Internet de l?OMS et d?autres institutions. Jusqu?à présent, l?
évaluation a porté sur huit laboratoires, mais 13 autres fournisseurs et 100
produits sont en cours d?examen.

Comme l?explique Jonathan Quick, Directeur à l?OMS de Médicaments essentiels
et politiques pharmaceutiques : «Nous sommes dans un processus dynamique et
la liste devrait s?allonger constamment, avec le développement de l?intérêt
des laboratoires et des programmes de lutte contre le VIH/SIDA dans les
pays.»

Il est essentiel d?avoir des méthodes de diagnostic appropriées pour
surveiller la progression du SIDA, le succès thérapeutique des traitements
et l?étendue des pharmacorésistances. Par le biais de son département
Sécurité transfusionnelle et technologie clinique, l?OMS évalue également
les tests et les technologies pour contrôler les traitements médicamenteux.

En outre, des directives sont en cours d?élaboration sur les normes
minimales à appliquer au contrôle en laboratoire des chimiothérapies. L?OMS
met également au point des programmes de formation et d?évaluation de la
qualité destinés aux agents de soins pour garantir une utilisation correcte
des tests.

Le VIH/SIDA est devenu la principale cause de mortalité en Afrique; sur les
40 millions de personnes vivant avec cette maladie dans le monde, 28
millions se trouvent en Afrique. En Asie et dans le Pacifique, l?épidémie se
propage rapidement. On estime qu?elle touche désormais 7,1 millions de
personnes dans cette région.

La première liste de produits et de fournisseurs évalués dans le cadre du
projet pour l?accès à des médicaments et à des diagnostics du VIH/SIDA de
qualité peut être consultée sur le site Internet de l?OMS :
http://www.who.int/medicines/

______________________________________

Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality

Pilot Procurement Quality and Sourcing Project

SUPPLIERS WHOSE  HIV-RELATED MEDICINES HAVE BEEN FOUND ACCEPTABLE, IN
PRINCIPLE,  FOR PROCUREMENT BY UN AGENCIES.
http://www.who.int/medicines/organization/qsm/activities/pilotproc/pilotproc
.shtml

Date: 2002-03-20
(Note: This list is the First edition. The list is regularly updated. Kindly
ensure that the most current list is used).

Background:

A "Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS
drugs and diagnostics of acceptable  quality" was actively started by WHO in
collaboration with other United Nations Organizations (UNAIDS, UNICEF, and
UNFPA) in March 2001. The World Bank supports this initiative. The
background to the project is described in the project description.

The procedure for assessing the acceptability in principle  of HIV/AIDS
drugs comprises various components including
1) The evaluation of product data and information provided by manufacturers
and suppliers, and
2) Inspection of manufacturing sites.

Due to the particular properties of several substances used in some
pharmaceutical finished dosage forms in the treatment of HIV/AIDS (e.g.
chiral activity, isomerism, sensitivity to relative humidity etc.), and the
current status where there are no Pharmacopoeia monographs and standards
available for several substances and finished products, WHO appointed
experts have performed a comprehensive and rigorous evaluation of the
products included in the list, with a view to establishing their compliance
with  international standards (see below).

Objective

The objective of the project, is to assess the acceptability in principle of
HIV/AIDS drugs for procurement by UN Agencies. The  assessment procedure  is
aimed at identifying  products and suppliers meeting WHO standards (see
below). Thus, the project facilitates the procurement of HIV/AIDS related
drugs of acceptable quality.

Method followed for pre-qualification

In assessing HIV/AIDS related drugs, the WHO Guiding Principles for
Evaluation of  Manufacturers for the Procurement and Sourcing of
Pharmaceutical Products, has been followed.

The two main components of the assessment process are
1) Dossier evaluation, and
2) Manufacturing site inspections.

Interested suppliers were requested to submit Expressions Of Interest (EOI).
The invitations for submitting Expressions of Interest were published in
October 2000 and August 2001. Product dossiers, containing product data and
information for innovator and generic products were requested for a thorough
evaluation. The dossiers were evaluated in accordance with the requirements
for the evaluation of Multisource products. (See reference below).

Other criteria taken into account in the  assessment process include:

·       Valid regulatory approval to manufacture
·       Regulatory or other approval of the product  in accordance with national
requirements
·       Product manufactured in compliance with GMP as certified by the national
regulatory authority and/or certified GMP inspectors
·       Product certificate exists in accordance with the WHO certification 
scheme
on the quality of pharmaceutical products moving in international commerce
·       Product dossier of acceptable quality submitted and positive outcome of
the assessment against the WHO recommended standards referred to below.
·       Positive outcome of the inspection of the manufacturing site performed 
by
inspectors appointed by WHO

In this voluntary assessment  process, interested manufacturers were
requested to submit product dossiers for various dosage forms and strengths
of the products in the categories listed below.

Antiretroviral agents

·       Non-Nucleoside Reverse Transcriptase Inhibitors such as Nevirapine;
Efavirenz; Delavirdine
·       Nucleoside Reverse Transcriptase Inhibitors such as Zidovudine,
Didanosine; Zalcitabine; Stavudine; Lamivudine; Abacavir; Lamivudine +
Zidovudine.
·       Protease Inhibitors such as Saquinavir, Ritonavir, Indinavir; 
Nelfinavir;
Amprenavir; Lopinavir + Ritonavir;
·       Anti-infective drugs listed below:

Antibacterial and antimycobacterial agents, including
Azithromycin; Clarithromycin; Clindamycin; Ceftriaxone; Cefixime;
Ciprofloxacin; Rifabutin

Antiprotozoal agents, including
Trimethoprim/Sulphamethoxazole (IV); Pentamidine; Pyrimethamine;
Sulfadiazine; Folinic acid

Antiviral agents, including
Acyclovir; Cidofovir; Ganciclovir; Forscarnet

Antifungal agents, including
Amphotericin B; Fluconazole; Itraconazole; Ketoconazole;

Anti-cancer drugs
Vinblastine; Etoposide; Bleomycin; Vincristine

1. Dossier evaluation.

Dossiers were thoroughly evaluated for compliance with WHO recommendations
and guidelines regarding the assessment of Multisource products ("Marketing
Authorization of Pharmaceutical Products with special Reference to
Multisource (Generic) Products: a Manual for a Drug Regulatory Authority,
WHO/DMP/RGS/98.5) and bio-equivalence data (Annex 9, WHO Technical Report
Series No 863), and ICH guidelines where appropriate to complement the
aforesaid WHO recommendations and guidelines.

Each product dossier was evaluated by a team of evaluators (three for
quality aspects, two for bio-availability/bio-equivalence). Suppliers were
informed of the outcome of the evaluation and were given the opportunity to
submit additional data and information requested.

To date, 160 product dossiers for various products and dosage forms from 21
suppliers were received.

Some dossiers have now been fully evaluated and all the required data and
information have been submitted. Those products that were found to comply
with the standards referred to above, have been included in the list.

Several suppliers are currently still generating additional data and
information on their products as part of the assessment process.  In
addition, new products may be submitted to WHO for evaluation. If  and when
products will be found to meet the specified standards, they will be added
to the list.

2. Inspections

In regard of products included in the list, inspections have been performed
at the manufacturing sites (excluding those manufacturing sites that were
recently inspected by regulatory authorities such as members from the
Pharmaceutical Inspection Co-operation Scheme (PIC/S), or regulatory
authorities with equivalent quality systems.  Manufacturers are inspected to
assess compliance with Good Manufacturing Practices (GMP) as recommended by
the World Health Organization (Quality Assurance of Pharmaceuticals. A
compendium of guidelines and related materials. Volume 2. Good Manufacturing
Practices and Inspection).  Several inspections have been performed and
others are due during 2002.

The inspections are performed by teams of inspectors.  The teams consist of
a WHO appointed lead inspector (from countries that are members of the
Pharmaceutical Inspection Co-operation Scheme, (PIC/S)), a World Health
Organization (WHO) representative from the Department Essential Drugs and
Medicines Policy (EDM), Quality Assurance and Safety: Medicines (QSM) team
in WHO, and an  inspector(s) from the National Drug Regulatory Authority
Inspectorate of the country in which the manufacturing site is located.

The inspection of the manufacturing site includes an  in-depth evaluation to
assess compliance with GMP. Specific focus is also placed on the
manufacturing process of the products concerned (HIV/AIDS). Detailed
inspection reports, listing all the observations and non-compliances have
been drafted and were communicated to manufacturers after each inspection.
Where deemed necessary, manufacturers have been required to implement
corrective action to address deficiencies, before their product was included
in the list.


Outcome of the pre-qualification

Only products and manufacturing sites found by the evaluators and inspectors
to meet the recommendations as stipulated in the WHO guidelines referred to
above are and will be included in the list of suppliers whose evaluated
products are recommended by WHO as being acceptable in principle for
procurement by UN Agencies. (See Table 1)

Future of the Project

In view of the worldwide focus and importance of the treatment of HIV/AIDS,
and to facilitate  the access to  HIV/AIDS drugs of acceptable quality, the
project continues and additional product data and information will be
evaluated, and manufacturing sites will be inspected. As these meet the
specified standards, they will be added to the  list.

The list will be reviewed and updated at regular intervals. Products and
manufacturing sites included in the list will be re-assessed at regular
intervals. Products and manufacturing sites will be removed from the list,
if as a result of a re-assessment, it is found that they no longer comply
with the specified standards.


General Notes:

1.      This  list will be updated regularly. Other products are being and will
be evaluated and will be added to the list as the data become available, the
sites are inspected, and the product and manufacturing sites are  found to
meet the recommendations and standards as specified in the WHO documentation
mentioned above.
2.      This  list indicates the  products found to be acceptable in principle,
as manufactured at the specified manufacturing sites.
3.      The UN organization intending to use this list to procure products may
wish to  ensure that only  products from the manufacturing sites  mentioned
in  this list will be supplied by the supplier (same formula, manufacturing
methods, manufacturing site as in the dossier provided for this project).
4.      This  list does  not constitute any  guarantee for the procurement of 
the
products from the suppliers mentioned.
5.      The fact that certain products and suppliers are not included in the 
list
does not furthermore mean that if evaluated and tested, they could not be
found to comply with the above-mentioned standards.
6.      This  list may  not be used by manufacturers and suppliers for 
commercial
or promotional purposes.
7.      This  list is not an exhaustive list of pharmaceutical products used in
the treatment of HIV/AIDS. It reflects those products for which data have
been submitted and evaluated as a result of the Pilot Procurement, Quality
and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable
quality, by interested suppliers which voluntarily participated in the
assessment project. There is furthermore no guarantee that the  products
included in the list and found to comply with the above-mentioned standards
will continue to meet those standards.
8.      This list reflects those products (manufactured at the specified
manufacturing sites) with respect to which  the product data and information
submitted were found to meet  the norms and standards recommended  by  WHO.
The manufacturing sites listed are those which have subsequently, as part of
the procedure, been found to meet  the norms and standards recommended  by
WHO at the time of inspection to assess compliance with Good Manufacturing
Practice for the products listed. Inclusion in the list does not, however,
imply any approval by WHO of the products and manufacturing sites in
question (which is the sole prerogative of national authorities).
9.      It is recommended that prior to procurement, UN  organizations
familiarise themselves with aspects such as quantification and  patents of
the products in question as well as  other related matters.
10.     Assessment of additional products and manufacturing sites will be
carried out at regular intervals.

Disclaimer:

Inclusion in the list does not constitute an endorsement, or warranty of the
fitness, of any product for a particular purpose, including in regard of its
safety and/or efficacy in the treatment of HIV/AIDS. WHO does not
furthermore warrant or represent that: 1) the list is complete or error
free; and/or that 2) the products and manufacturing sites which have been
found to meet the standards recommended by WHO, will continue to do so;
and/or that 3)the products listed have obtained regulatory approval for use
in the treatment of HIV/AIDS (or any other disease) in every country of the
world, or that their use is otherwise in accordance with the national laws
and regulations of any country, including but not limited to patent laws .
In addition, WHO wishes to alert procuring UN Agencies that the improper
storage, handling and transportation of drugs may affect their quality,
efficacy and safety. WHO disclaims any and all liability and responsibility
for any injury, death, loss, damage or other prejudice of any kind
whatsoever that may arise as a result of, or in connection with the
procurement, distribution and use of any product included in the list.

Acknowledgement:

WHO, UNICEF, UNAIDS, UNFPA (with the support of  the World Bank)
acknowledge the contribution provided in evaluation and inspection by  staff
from National Drug Regulatory Authorities of Argentina, Canada, Denmark,
Estonia, Finland, France, Hungary, India, Mexico, Philippines, Sweden,
Switzerland and Zimbabwe.
remed@remed.org
www.remed.org

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