The start of antiretroviral production at the Mozambican Medication Society (SMM – Sociedade Moçambicana de Medicamentos) – a project supported by Fiotec - is forecasted for July. The information has been forwarded by the coordinator of the project, Licia de Oliveira, in an interview with the Social Communication Coordination Office (CCS/Fiocruz). The first medication manufactured will be Nevirapine, whose three pilot lots may be distributed to the people of Mozambique after a period of six months of trials to ensure quality.
The objective of SMM – the first company from the segment with 100% public capital installed in Africa – is to facilitate the Mozambican population’s access to AIDS treatment. Mozambique is one of the ten countries most affected by the HIV virus in the world, with 1.7 million infected patients in a population of 21.4 million people. In addition to antiretrovirals, medications to fight high blood pressure, type 2 diabetes, and anti-inflammatory drugs will be produced, and others are still in an agreement phase.
According to the report from CCS, the initiative, which has had significant participation of the Drugs Technology Institute (Farmanguinhos/Fiocruz), is part of the health cooperation with the countries of the Community of Portuguese Language Countries (CPLP), determined in the Health Cooperation Strategic Plan (Pecs), signed by the Ministers of Health of CPLP in 2009, in Lisbon.
See the entire interview of CCS/Fiocruz with Licia de Oliveira, who also speaks for the Chief of Staff of Farmanguinhos and is associate director of the Fiocruz Office in Africa.
How was the trajectory of the project carried out from creation up to implantation in Mozambique?
Licia: The international cooperation between Brazil and Mozambique started in 2003, by means of an initiative from the then President Lula and the President of Mozambique at the time, Joaquim Chissano. Both considered the relevance and pertinence of a public medications industry in Mozambique aligned with the policy of pharmaceutical production within the scope of the Ministry of Health and the Brazilian states. President Dilma Roussef has included the project of the factory on the strategic agenda of international cooperation of her government, ensuring the good results achieved until now, and the current President of Mozambique, Armando Guebuza, has also enthusiastically continued the actions that proceed until now.
Between 2004 and 2007, several studies have been prepared such as the technical and economic viability one, which was conclusive on the possibility of instituting the factory in Maputo. In 2008, Fiocruz was designated by the Ministry of Health as the institution in charge of executing the challenging project, and Farmanguinhos, as a medications productive unit, was indicated for coordination and execution. The actions of this project respond to the political guidelines of Brazilian diplomacy, strengthening the relations among the countries in the southern hemisphere, also known as South-South cooperation. This international cooperation, in the modality of structuring action, aims at sharing the successful actions of the Brazilian Unified Health System, such as public medications production, with Mozambique. The conclusion of the initiative is predicted for 2014 and might be extended if the next governments wish so.
How many antiretroviral units and other types of medications will be manufactured per year?
Licia: The installed capacity in the new line of solid dosages for a workday of 8h/day is of 226 million pharmaceutical units of antiretrovirals and 145 million pharmaceutical units of multi-products per year.
A part of these medications will be antiretrovirals, to treat AIDS. The other types of medications manufactured will be intended to treat which diseases?
Licia: In addition to antiretroviral medications, we will have medications to fight high blood pressure, type 2 diabetes, anti-inflammatory drugs and others still in an agreement phase. Furthermore, the factory will continue to produce sodium chloride, glucose and is already launching Ringer's Lactate, a new product in the line of serums.
When will the production of medications be initiated?
Licia: The production of three pilot lots of the first medication (Nevirapine) should be initiated in July. These lots become stable for the period of six months, at the end of which, their quality being ensured, they may be distributed to the people of Mozambique. New medications will be produced starting month to month. Furthermore, the line of packaging at the Mozambican Medications Society (SMM) will also be initiated for medications produced in Farmanguinhos, also to be donated for a more immediate distribution in Mozambique. This represents the partnership between SMM and Farmanguinhos, the latter acting as a production location in this initial phase when the pilot lots of medications will still be stable.
The factory also has strong investment in quality assurance, so as to respond to the requirements of good manufacturing practices, and is already preparing all the documentation to request an inspection for international certification. This is an innovative framework for the public medications industry on the African continent.
What is the value of the investment on the project?
Licia: Brazil, in addition to donating around R$ 13 million in equipment, shall fulfill a total investment of around R$ 40 million executed between 2008 and 2014, the date predicted for concluding the transfer of medications technology. The project was conceived with financing shared by the governments of Brazil and Mozambique. Brazil was in charge of donating industrial equipment, quality control and the environmental treatment station. Also under Brazilian responsibility are the costs of transferring the technologies of 21 medications, preparing documentation of quality assurance and requesting international certification, training for Mozambicans through the course of four years, inputs to produce the first three lots of medications at the factory, technical studies, an executive project for the work, technical missions and management of the project. Mozambique, on its turn, was responsible for acquiring the location for the factory to be installed, purchasing the only pharmaceutical industry that used to operate in the country producing parenteral solutions in large volumes (physiological and glucose serum), carrying out adequacy works, which was done in a partnership with Vale, hiring all personnel and, as from 2009, factory operation.
Currently, only half of HIV positive applicants for treatment in Mozambique have access to medications. Furthermore, the country is largely dependent on imports of these medications. What will be the benefits for Mozambique with the installation of the factory?
Licia: Public production of medications in Mozambique is going to contribute to the self-sufficiency of the country for medications under production at the new factory and, with local production, the country will ensure its capacity to offer the items under production in a way to strengthen Mozambicans' access to the medications available. The medications factory will have an international quality standard of good manufacturing practices and production of medications that integrate the List of Essential Medications.There will be a transfer of technology of 21 medications, among which, Lamivudine+Zidovudine, Nevirapine, Hydrochlorothiazide. The factory is going to operate with two lines producing solid dosages (pills, capsules): antiretrovirals and multi-products, the latter to produce several other medications.
The Quality Control Laboratory of the factory, in addition to carrying out analyses on raw materials, packaging, medications in progress and finished, can operate as support to the pharmaceutical assistance policy of Mozambique, carrying out analyses on other medications used in the country so as to identify their quality. Mozambique, like so many other countries in the world, suffers especially from counterfeit and pirated medications and has a low capacity to check the quality of what is sold or distributed within the country. More than 100 Mozambican professionals will be trained with new technical and managerial skills to operate in the pharmaceutical industrial segment. Skills include the development of new generic medications, quality control of finished products and pharmaceutical inputs and management of the whole logistics chain.
Will Mozambique be able to become an exporting center for all of Africa?
Licia: The factory is installed for a productive capacity in such a way to produce medications in one working shift (eight hours) or in up to three working shifts (24 hours). Therefore, there is a possible variation in increase of up to 200% of production in accordance with the demand. Initially, with the production within eight hours of work, sales are predicted with the public and private areas in Mozambique, including hospitals, distributers and pharmacies. Subsequently, the factory may export to neighboring countries, with focus on the region of Sub-Saharan Africa.
The initiative has also had participation of the Fiocruz office in Maputo, recently installed. What was its contribution to the project?
Licia: With focus on the factory’s initiative, the representation of the office participates in the technical group for monitoring international cooperation projects in Mozambique, integrated by financers, governmental and non-governmental agencies, in the search for a more synergetic result for the country. In this regard, the partnership with the office in Africa has been of fundamental importance in order to overcome the difficulties that a project of such complexity, in execution in a geographically and culturally distant country, presents as constant challenges and in different hierarchical spheres of both countries. The Office of Fiocruz in Africa has the mission of monitoring the set of actions in international cooperation, being an institution operating in the political (as facilitator of mediations between Brazil and the partner country), managerial (by means of monitoring projects) and operational (with administrative support) levels.
Why was Mozambique the country chosen to install the factory?
Licia: Political stability, the path that it pursues for social and economic development and for consolidating democracy, the number of cases and incidence of HIV in the country, the commitments assumed in return, the cultural and language proximity and the historic, diplomatic relation between our countries have certainly contributed to the decision of Brazilian foreign policy in establishing this innovative South-South partnership. Brazilian international cooperation in a general way and the factory's project in particular have been awakening the interest of academicians in all continents, who seek us to learn about this shared form in responsibilities and autonomous in decisions of this partnership still in progress of implementation. And the commitment and involvement of the set of actors involved give the initiative a singular face of responsibility of the countries, permanent political and managerial challenges and a large wish to succeed.
Is there a forecast for implanting the initiative in other African countries as well?
Licia: There was a request, on the part of the Head of State of Benin, to President Dilma, this year. The Minister of Health should be in Brazil this month with a planned visit to Fiocruz and Farmanguinhos. Brazilian cooperation has strengthened a lot in the last ten years and Brazil has improved its mechanisms of decision on the demands that must be met, as well as increased its quality of responses to partners. Our country has been frequently requested in this phase of insertion as a new actor within the scenario of international cooperation. To install a medications factory in an African country represents, in addition to entering the pharmaceutical sector, an exceptional leap in technological knowledge and development of skills. However, it is a highly valuable financial investment in installation and which continues in the first years of operation.
Therefore, it depends on a lot of political determination, availability of people exclusively dedicated to the initiative and trainings, retaining trained personnel, financial availability to confront the investments necessary to operate the production and to monitor the international requirements for quality assurance of medications. In addition to this, it depends on strengthening the medication regulation area, a necessary situation for the country to show the world the quality of its pharmaceutical production. For all these implications, this is an action that depends on previous conditions in order to be carried out and successful.
Source: CCS/Fiocruz
