Print version ISSN 0042-9686
Bull World Health Organ vol.87 n.10 Genebra Oct. 2009
LESSONS FROM THE FIELD
Initiative Accélérer l'Accès : expérience acquise avec un programme de délivrance des ARV au poste de travail, mené par une multinationale en Afrique
Iniciativa para Acelerar el Acceso: experiencia de un programa en los centros de trabajo de una multinacional en África
S Van der BorghtI, *; V JanssensII; MF Schim van der LoeffIII; A KajembaIII; H RijckborstI; JMA LangeII; TF Rinke de WitII
IHeineken International Health Affairs, Tweede Weteringplantsoen 21, 1017 ZD Amsterdam, Netherlands
IIPharmAccess Foundation, Amsterdam, Netherlands
IIIGGD (Public health service), Amsterdam, Netherlands
IVBralima SARL, Kinshasa, Democratic Republic of the Congo
PROBLEM: A multinational company with operations in several African countries was committed to offer antiretroviral treatment to its employees and their dependants.
APPROACH: The Accelerating Access Initiative (AAI), an initiative of six pharmaceutical companies and five United Nations' agencies, offered the possibility of obtaining brand antiretroviral drugs (ARVs) at 10% of the commercial price. PharmAccess, a foundation aimed at removing barriers to AIDS treatment in Africa, helped to establish an HIV policy and treatment guidelines, and a workplace programme was rolled out from September 2001.
LOCAL SETTING: Private sector employers in Africa are keen to take more responsibility in HIV prevention and AIDS care. An important hurdle for African employers remains the price and availability of ARVs.
RELEVANT CHANGES: The programme encountered various hurdles, among them the need for multiple contracts with multiple companies, complex importation procedures, taxes levied on ARVs, lack of support from pharmaceutical companies in importation and transportation, slow delivery of the drugs, lack of institutional memory in pharmaceutical companies and government policies excluding the company from access to ARVs under the AAI.
LESSONS LEARNED: The launch of the AAI enabled this multinational company to offer access to ARVs to its employees and dependants. The private sector should have access to these discounted drugs under the AAI. A network of local AAI offices should be created to assist in logistics of drugs ordering, purchase and clearance. No taxes should be levied on ARVs.
PROBLÉMATIQUE: Une entreprise multinationale opérant dans plusieurs pays africains s'est engagée à proposer un traitement antirétroviral à ses employés et à leurs dépendants.
DÉMARCHE: L'Initiative Accélérer l'Accès (IAA), impliquant six entreprises pharmaceutiques et cinq agences des Nations Unies, offre la possibilité d'acquérir des antirétroviraux (ARV) de marque à un dixième de leur prix dans le commerce. PharmAcces, une fondation visant à éliminer les obstacles au traitement du sida en Afrique, a aidé à mettre en place une politique contre le VIH, ainsi que des recommandations thérapeutiques, et un programme de lutte contre cette maladie au poste de travail a été mis en route en septembre 2001.
CONTEXTE: local En Afrique, les employeurs du secteur privé souhaiteraient prendre plus de responsabilités dans la prévention du VIH et la prestation de soins concernant le sida. Le prix et le manque de disponibilité des ARV restent un obstacle important dans cette voie.
MODIFICATIONS: pertinentes Le programme s'est heurté à diverses difficultés, dont la nécessité de passer de multiples contrats avec un grand nombre d'entreprises, la complexité des procédures d'importation, les taxes prélevées sur les ARV, le manque de soutien des entreprises pharmaceutiques pour l'importation et le transport de ces médicaments, la lenteur de leur livraison, le manque de mémoire institutionnelle de l'industrie pharmaceutique et les politiques gouvernementales interdisant aux entreprises d'accéder aux ARV par le biais de l'IAA.
ENSEIGNEMENTS: tirés Le lancement de l'IAA a permis à cette entreprise multinationale de proposer un accès aux ARV à ses employés et à leurs dépendants. Le secteur privé devrait avoir accès à des ARV à prix réduit dans le cadre de l'IAA. Il faudrait aussi créer un réseau de bureaux locaux de l'IAA pour apporter une assistance logistique dans la commande, l'acquisition et l'autorisation de ces médicaments. Aucune taxe ne devrait être prélevée sur les ARV.
PROBLEMA: Una multinacional que operaba en varios países africanos se comprometió a ofrecer tratamiento antirretroviral a sus empleados y a sus familiares a cargo.
ENFOQUE: La Iniciativa para Acelerar el Acceso (IAA), en la que participan seis empresas farmacéuticas y cinco organismos de las Naciones Unidas, ofreció la posibilidad de obtener antirretrovirales (ARV) comerciales a un 10% del precio habitual. PharmAccess, una fundación cuyo objetivo es eliminar las barreras al tratamiento del sida en África, ayudó a establecer una política y directrices terapéuticas para la infección por VIH, y a partir de septiembre de 2001 se puso en marcha un programa para los centros de trabajo.
CONTEXTO: local Los empleadores del sector privado de África tienen gran interés en asumir más responsabilidad en la prevención de la infección por VIH y la atención a los enfermos de sida, pero el precio y la disponibilidad de ARV siguen siendo obstáculos importantes para ellos.
CAMBIOS DESTACABLES: El programa tropezó con diversos obstáculos, entre ellos la necesidad de múltiples contratos con diversas empresas, unos procedimientos de importación complejos, los impuestos que gravaban los antirretrovirales, la falta de apoyo de las empresas farmacéuticas para la importación y el transporte, la lentitud del suministro de los medicamentos, la falta de memoria institucional en las compañías farmacéuticas, y las políticas gubernamentales que impedían a la empresa acceder a los antirretrovirales en el marco de la IAA.
ENSEÑANZAS EXTRAÍDAS: El lanzamiento de la IAA permitió a esta multinacional ofrecer acceso a los ARV a sus empleados y sus familiares a cargo. El sector privado debería tener acceso a esos medicamentos con descuento en el marco de la IAA. Se debería crear una red de oficinas locales de IAA que facilitaran la logística de los pedidos, la autorización y la compra de los medicamentos. Por último, los ARV no deberían estar sujetos a impuestos.
HIV is the largest threat to adult survival in sub-Saharan Africa. According to UNAIDS, 33 million people were living with HIV by December 2007, of whom 22 million were in sub-Saharan Africa. In 2007 an estimated 1.5 million sub-Saharan Africans died of AIDS and an estimated 1.9 million became infected with HIV.1 Several international initiatives were launched to increase funding for antiretroviral therapy. This has led to a spectacular increase in access to antiretroviral drugs (ARVs) in Africa: by April 2007 an estimated 28% of eligible HIV patients in sub-Saharan Africa were on ARVs.2 One initiative that aimed to increase access was the Accelerating Access Initiative (AAI). This paper reports practical experiences of a multinational company with the AAI.
In May 2000 five United Nations organizations United Nations Population Fund (UNFPA), United Nations Children's Fund (UNICEF), WHO, The World Bank and the Joint United Nations Programme on HIV/AIDS (UNAIDS) announced a partnership with five pharmaceutical companies to address the lack of affordable HIV medicines in resource-poor settings.3 This partnership, the AAI,4 was committed to offer ARVs at about 10% of the commercial price to the public sector and nongovernmental organizations that complied with three conditions (correct use, no mark-up, no backflow of drugs to markets in developed countries). By September 2006, an estimated 424 000 Africans were treated with ARVs provided through AAI arrangements,5 most of them in public sector treatment programmes.
In July 2001, multinational brewing company Heineken International, with headquarters in the Netherlands and operating companies (OPCOs) in several African countries, decided to include ART among the medical benefits for employees and their dependants, including children. The company, itself selling a brand beer, preferred to purchase brand ARVs, and accepted that this would make the programme more expensive. The AAI price reductions made the provision of ARVs to employees and dependants affordable for the company. A partnership was established with PharmAccess, a foundation specialized in removing barriers to AIDS treatment in Africa.
PharmAccess conducted assessments, provided training, helped define treatment protocols, provided laboratory support, established a web-based database for patient follow-up6 and conducted monitoring, evaluation and quality control. PharmAccess interacted with AAI to guarantee a continuous availability of ARVs at the OPCOs. The programme was gradually rolled out at 14 OPCOs in 6 countries: Burundi, the Congo, the Democratic Republic of the Congo, Nigeria, Rwanda and Sierra Leone. The average size of the workforce per OPCO varied between 200 and 500 employees; including spouses and children, the total target population was ± 30 000 of which 10 332 were adults (Table 1). Through the company's voluntary counselling and testing programme, 531 infections were diagnosed among employees and dependants, and 273 HIV patients had started highly active ARV therapy (HAART) by mid-2008.
PharmAccess arranged purchase and shipment of ARVs and the OPCOs organized customs clearance and storage. The chosen first and second line regimens implied procurement of eight drugs from six different pharmaceutical companies. PharmAccess signed agreements with these six companies. Because neither the pharmaceutical companies nor PharmAccess had local offices in most of the six countries, the local OPCO had to clear the goods at customs. If the products were not yet registered in the country, the OPCO had to arrange temporary import permits. In the rare cases that a pharmaceutical company had a local office, this did not assist in ordering and receiving drugs for the company. It was difficult to import newer ARVs as they were usually not registered.
After some time it became possible in some countries to purchase ARVs (both generic and brand) locally. If the drugs were prequalified by WHO, the OPCOs obtained ARVs locally through government agencies. The Ministry of Health in one country felt that drugs purchased with a grant from the Global Fund to fight AIDS, Tuberculosis and Malaria should not be re-sold, so it stopped the provision of drugs to the OPCO. The same government declined to provide free ARVs to the OPCO, arguing that a for-profit private company should not have access to free drugs. Given these challenges, the company sometimes purchased generic ARVs. Generic drug companies were generally more helpful than brand pharmaceutical companies in the importation of products through their local representatives. For newer drugs, the AAI was the only source of supply.
Procuring ARVs was complex. Several pharmaceutical companies had not yet developed AAI-agreement documents and practicalities differed from one to another. Sometimes a pharmaceutical company insisted that PharmAccess should sign one agreement per country rather than one general agreement covering all sub-Saharan countries. The high turnover of staff in the pharmaceutical companies affected institutional memory; at times PharmAccess had to explain AAI procedures to new staff at pharmaceutical companies.
The price discount that was obtained was different per product and per company and varied between 77% and 93%. The door-to-door delivery time of small ARV orders varied between 1 and 5 months. Despite the explicit assurance that pharmaceutical companies would carry transport costs of ARVs, this was not always the case in practice. Surprisingly none of the pharmaceutical companies ever requested PharmAccess to provide evidence of drug flows or absence of mark-up.
The AAI was set up as a public sector, country-led process.7 This implied that the private sector in most African countries could not benefit from the AAI. We argue that allowing the African private sector employers, private clinics and private health insurance companies to obtain ARVs through AAI will contribute to more sustainable access for all patients in sub-Saharan Africa.8
Private sector employers in Africa are keen to take more responsibility in HIV prevention and AIDS care.9 An important hurdle for African employers remains the price of ARVs; allowing them access to ARVs under the AAI would make a big difference. The overstretched African public health care sector would indirectly benefit from this, allowing increased access for the poor.
The second sector that would benefit from AAI support is the private health care sector. Private clinics in Africa provide care to a substantial and increasing part of the population.10 National governments should allow these clinics to use ARVs obtained through AAI. The quality of the performance of these clinics should be assessed and monitoring is needed regarding mark-ups on drugs; all private clinics providing ARVs should comply with national treatment standards.11
The third entity requiring access to AAI is the private health insurance sector in Africa. Private health insurance is uncommon in most of sub-Saharan Africa but this situation is changing in several countries.12 Health insurance and managed care may be instrumental in making African health care more self-supporting and less dependent on external donors. Therefore, African health maintenance organizations and health insurance companies should be given access to AAI-discounted ARVs.
The launch of the AAI in the year 2000 enabled this multinational to provide ARV therapy to its employees, their spouses and children in Africa. The company's experience with the AAI indicates the need for local AAI offices in African countries. Such offices could facilitate ordering, clearance and channel bulk-procurement of ARVs for the three private sector actors named previously.
Registration of drugs is often problematic, importation is highly complex and taxes are being levied on ARVs. These issues should be addressed by African governments. The lessons learned are summarized in Box 1.
The AAI has led to substantial price reductions of brand drugs and increased access to ARVs. Administrative, logistical and regulatory hurdles have meant that the full potential of the AAI has not been fulfilled. The following four recommendations are made to strengthen the AAI and increase access to affordable good quality drugs in sub-Saharan Africa. (i) AAI eligibility should be extended beyond the public sector. Local private clinics, health insurers and health maintenance organizations should get access to AAI ARVs, under specific conditions. (ii) Governments should waive taxes on ARVs, simplify and harmonize the drug registration process and certify private clinicians. (iii) Private companies and non-profit organizations that wish to provide ART to their employees and dependants should be encouraged to do so and should benefit from AAI. (iv) The pharmaceutical companies within AAI should support the creation of a network of local AAI distributors of ARVs. International donor funds should invest in this network.
JMA Lange & TF Rinke de Wit are also affiliated with the Center for Poverty-related Communicable Diseases (CPCD), Academic Medical Center (AMC), University of Amsterdam, Meibergdreef 9, 1100 DE Amsterdam, the Netherlands. The pharmaceutical companies in the AAI were, initially, Boehringer-Ingelheim, Bristol Myers Squibb, GlaxoSmithKine, Merck&Co and F Hoffman-LaRoche. Abbott Laboratories joined in 2001 and Gilead Sciences in 2004.
Funding: The Workplace programme is funded by Heineken International.
Competing interests: None declared.
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(Submitted: 16 April 2008 Revised version received: 9 January 2009 Accepted: 28 January 2009 Published online: 20 August 2009)