Experiência de importação de equipamentos para pesquisa no ELSA-Brasil Experience of importation of equipment for research in the ELSA-Brasil

OBJETIVO: Políticas de fomento à pesquisa em saúde foram estabelecidas na última década, avançando a produção científi ca nacional. Tal movimento não foi acompanhado do aperfeiçoamento do arcabouço legal-institucional, difi cultando o desenvolvimento dos projetos de pesquisa. Isso inclusive no que tange às atividades de importação de equipamentos. O objetivo deste artigo foi analisar o processo de importação de equipamentos para o Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil).


INTRODUCTION
a Ministério da Saúde, Departamento de Ciência e Tecnologia, Secretaria de Ciência, Tecnologia e Insumos Estratégicos.Programa de fomento à pesquisa para os sistemas e serviços locais de saúde: gestão compartilhada em saúde.Rev Saude Publica.2006;40( 6 The Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) is a multicenter study aimed at following the health of 15,000 adult women and men to investigate the incidence of chronic diseases, especially cardiovascular diseases and diabetes. 1This study includes six centers from three Brazilian regions and, as any multicenter study, 2,4,5 its development poses the challenge of standardizing procedures such as specialized tests and respective equipment.In this way, the purchasing activity is particularly challenging and essential to achieve the proposed objectives.
The present study aimed to analyze the acquisition process of medical equipment importation for the ELSA-Brasil.

METHODS
A case study was conducted on the importation of medical equipment for the following three procedures performed in the ELSA-Brasil: pulse wave velocity (PWV), ultrasonography and retinography (Table 1).
Aiming to meet the need for uniformity of clinical tests and technical standardization of equipment, importation was performed jointly by six Investigation Centers (IC) of the ELSA-Brasil.This joint process required the defi nition of activities to be shared among the ICs and those that could be performed independently (Table 2).Documentary research was conducted between 2007 and 2009 -the period of equipment importation.Internal reports on management, budgets, tax receipts and equipment importation documents fi led in the fi ve ICs (Federal Universities of Bahia, Minas Gerais and Rio Grande do Sul, Oswaldo Cruz Foundation in Rio de Janeiro and University of São Paulo -USP) were consulted.The IC located in the Federal University of Espírito Santo (UFES) was excluded from the analysis as it did not have suffi cient data to identify the importation stages and processes.A more in-depth analysis of administrative processes was performed in the state of Bahia, where non-structured interviews were conducted with researchers and key informers (customs offi cer, importation sector technicians and other institution professionals).
Data were treated and organized into three stages representative of the importation process: administrative-operational, exchange rate-oriented and fi scal.The fi rst stage included specifi cation, approval and negotiation activities, in addition to the documents required for importation.The exchange rate-oriented stage included exchange closing and payment.The fi scal stage included shipping, unloading and customs release and delivery of goods (Table 2).The durations of these stages were calculated comparatively between investigation centers and pieces of equipment.The following categories of analysis were considered for the identifi cation of facilitating factors and obstacles: administrative processes of importation, legal-normative basis, institution's role in the processes and conditions for the acquisition/importation of equipment.

Administrative-operational stage
After the selection of tests by the Assistant Committee of Clinical Tests and remaining technical-scientifi c levels and their approval by the Directive Committee, the responsible Reading Center (RC) had the task of defi ning the technical specifi cation of the respective equipment (Table 1).
The Directive Committee defi ned an IC to consolidate and unify contacts and information, facilitating the joint negotiation of price and warranty conditions and thus enabling signifi cant discounts and an expanded warranty, according to the information available on the "Proforma Invoices", as international invoices are known (data not shown).
A manager responsible for requesting the Proforma Invoice, handling impasses and diffi culties, sharing experiences, socializing solutions and, on certain occasions, conciliating the parties involved was designated for each IC.The manager was in charge of informing everyone about the importation in each IC to unify processes and meet the study's general agenda.
Aiming to comply with the criterion of unenforceability (article 25, sections 1, 2 and 3, Law 8,666/93), d the respective suppliers were asked to submit a "letter of exclusivity", i.e. a document stating that only a certain manufacturer/supplier had the equipment with exclusivity.The legal departments of the foundations understand the need for an offi cial opinion that confi rms compliance with the legislation in different ways.Among the fi ve cities studied, three of them (Research and Extension Support Foundation, Foundation for Scientific and Technological Development in Health, and State of Rio Grande do Sul Medical Foundation) included this activity in the process.The administrative-operational stage of certain ICs had the highest number of consecutive days, due to the legal analysis to grant exemption from public tender.Despite the initial diffi culty in having a global negotiation and subsequently dividing it among the ICs, the administrative-operational stage was the fastest of the three and lasted a minimum of eight days for the PWV equipment (RJ IC) and a maximum of 101 days for PWV equipment as well (BA IC), with a mean of 55 days.Its length of time of execution was acceptable, although this time could be reduced.

Exchange rate stage
After the administrative-operational stage was concluded, exchange rate closing began, i.e. the procedures performed to pay for the equipment.Law 8,010/90, e which regulates the importation of goods that are not produced in Brazil and aimed at scientifi c and technological research in this country, provides for tax exemption as long as the executing higher education institution and its respective foundation have paid the federal taxes and complied with the requirements.It is the responsibility of the Conselho Nacional de Desenvolvimento Científi co e Tecnológico (CNPq -National Council for Scientifi c and Technological Development) to send the list of importing organizations, authorized merchandise, values and amounts to the Federal Revenue Service and the Banco do Brasil (BB), particularly to the Foreign Trade Department.The CNPq is the organization that distributes and controls the global quota of importations for research, defi ned by the Ministry of Economy in agreement with the Ministry of Science and Technology.This information is made available in the beginning of the year and it is known as "importation window" in the jargon of the foundations.Once the authorization is confi rmed, the operational activities begin in each foundation (Table 2).
The foundations made a fi nancial commitment, allocating the required amount from the project's account to guarantee the payment of the equipment, after adjusting the exchange rate according to the foreign currency shown in the proforma invoice.The Importation Permit is the electronic document of authorization processed in the Federal Revenue Service's Integrated Foreign Trade System, prior to dispatching merchandise abroad and valid for 60 days.After being issued, the BB sent a letter of credit to the exporter -a document proving the fi nancial commitment and international purchase order.The shipping instructions were sent to the exporter, the document with information about shipping with insurance, including the recommended customs offi cer who was authorized to perform the customs dispatch.The exchange rate stage is centered on foundation activities and it was divided into fi ve activities (Table 2).The exchange rate stage lasted a minimum of 11 days for the PWV equipment (Bahia [BA] IC) and a maximum of 381 days for the retinography equipment (São Paulo [SP] IC), with a mean of 196 days to be concluded.

Fiscal stage
This stage begins with the shipping of the equipment by the supplier and ends when it is delivered to its destination.This is when the equipment is dispatched by the Federal Revenue Service, with the payment of taxes to the Infraero (Brazilian Airport Infrastructure Company) and release by the Agência Nacional de Vigilância Sanitária (ANVISA -National Health Surveillance Agency).The customs offi cer is a dispatcher specialized in importation, regulated and specifi ed by the Foundation, who performs in the majority of the seven activities of this stage (Table 2).After being released by customs, the equipment is transported to the project, where the delivery conditions are confi rmed to be adequate by the IC coordinator to make the payment as stated in the letter of credit, thus ending the importation process.In the ELSA-Brasil, this stage was the longest one, lasting a minimum of 43 days for retinography equipment (SP IC) and a maximum of 388 days for retinograhy equipment as well (Rio Grande do Sul [RS] IC), with a mean of 215.5 days.This long duration had a direct impact on the study timetable.

RESULTS
The PWV equipment was the fi rst to be standardized and the fi rst to be negotiated jointly as a pilot to adjust procedures and contacts between the ICs and their foundations.The Cardiovascular Physiology RC, responsible for reading 15,000 PWV tests, defi ned the equipment and its technical specifi cations.The BA IC was selected to lead the fi rst purchase.
The total time spent between the fi rst attempt to start the importation and the delivery of the equipment in the last IC was approximately ten months, varying from 174 days in the BA IC to 309 days in the Rio de Janeiro [RJ] IC, with an average of 246 days (Figure 1).
Due to the lack of a national registration, the ANVISA required 96 days to release the importation of the PWV equipment, which represented the majority of the 101 days of the administrative-operational stage (Figure 2a).
The importation of the bioimaging device, led by the SP IC, was the one with the highest technical complexity, as it had to comply with the ultrasonography and echocardiography specifi cations, in addition to enabling the transmission of images produced in the IC to all RCs and Data Center (DC).The equipment selected had not been previously registered with ANVISA and it was necessary to wait for its registration to start the importation.Despite the complexity, the total time spent from the beginning of the importation process to the delivery of the equipment to the last center was approximately eight months, varying between 144 days in the SP IC and 237 days in the RJ IC, with a mean of 184 days (Figures 1 and 2b).
The retinography equipment was quickly defi ned by the Retina RC and the RS IC was the importation manager.
The model selected was registered with the ANVISA, as it had been previously used in the country on a commercial scale.This aspect, which facilitated the process, had not occurred in previous acquisitions, although the importation of this equipment became one of the greatest politicalbureaucratic impasses faced by the ELSA-Brasil.As required by the representative of the American company in Brazil, foundations made the payment in advance and the exchange rate stage was quickly concluded, with the exception of the University of São Paulo Medical School, which did not pay in advance and consequently causing this stage to be extended.When the delivery deadline of 60 days expired, the equipment had not been delivered.As it turned out, the American manufacturer had disagreements with the representative in Brazil and claimed that the payment of the six pieces of equipment had not been made.A possible international legal action was discussed.Several contacts were made until the questions regarding this issue were fi nally clarifi ed, when researchers found out that the model selected for this study was not being manufactured any longer.Consequently, the manufacturer decided to deliver the new model corresponding to the one previously selected, which required new importation documentation and request to the ANVISA, as the new model had not been registered in the country yet.There was a long request process with this health institution until Resolution RDC 1 of January 22 nd 2008 from the ANVISA'S Collegiate Board of Directors was published in the Federal Offi cial Gazette on January 23 rd 2008.In this resolution, the ANVISA provides for the importation and exportation for scientifi c research performed by non-profi t institutions and/or researchers, enabling the release of equipment for this study.According to the RDC 1, in its article 6, "The inspection and release of imported materials for scientifi c and technological research purposes will be prioritized.After the protocol and legal requirements are met, a permit will be issued within 24 hours."[bolded emphasis added].
The time spent between the beginning of the importation process by the RS IC and the delivery of the last piece of equipment was the longest of the three, totaling 15 months, without great variations among the ICs and with a mean of 447 days (Figure 1).This caused the retinography equipment fi scal stage to be the longest of all ELSA-Brasil importations (Figure 2c).
When analyzing the contribution of each stage to the duration of the importation process of different pieces of equipment in each IC (Figures 2a, 2b and 2c), the administrative-operational stage -which primarily depends on the fl ows of activities in the foundation and on the relationship between this foundation and the coordination of each IC -is found to be highly varied, tending to be longer when this stage included the issue of legal opinions (overall mean of 55 days).At times, the situation was worse if these opinions differed from each other signifi cantly, when the Research Funding Agency (FINEP) had to be included to resolve confl icts of interpretation of the legislation and, in this way, continue the importation activities.
Delays in the exchange rate stage resulted from problems related to the CNPq's institutional quotas and to the "importation window", as it was necessary to wait for the release of annual institutional quotas for importation.This stage lasted 196 days on average from beginning to end (Figures 2a, 2b and 2c).
The fi scal stage was the longest, due to the lack of previous registration in the country, especially for the re-issuing of the retinography equipment importation documents resulting from expired validation deadlines and changes in the model (Figures 2a, 2b and 2c).

DISCUSSION
There were no systematic records on the information required to assess the management of equipment acquisition processes, thus posing a great challenge to the performance of the present study.This resulted, among other things, in the exclusion of one IC that did not have suffi cient data on the stages under analysis.
Foundations that support institutions have wide experience in research support with well-defi ned lifecycles.However, their managerial structure must be adjusted to support longitudinal studies such as the ELSA-Brasil, which require permanent management.
The specifi cities of a multicenter study, including six implementing institutions and their respective foundations, posed new challenges as they required the standardization of procedures and equipment.This frequently challenged the interpretation of the legal implications by the parties involved, thus increasing the duration of the administrative-operational stage.
The foundations' inexperience in networking was a hindering factor, often resulting in the omission of information and decisions.However, the integration required by this multicenter study led to a broad exchange of experiences, equally productive for centers and foundations.This exchange generated new knowledge and enabled the adoption of corrective measures in the internal routines of foundations and ICs.
The unified negotiation allowed better purchasing conditions with lower prices and an extended warranty of up to 36 months.However, communication between the manager of each IC and the respective foundation was not usually suffi cient, requiring processes to be performed again.The technical body of these institutions was not always aware of the decisions of the Directive Committee, which at times prevented the fl ow of documents required for importation.
What stands out is the importance of previously checking whether the equipment is registered with the ANVISA and whether a special authorization of importation for research is required, including the reason and documentation and calculating the corresponding deadlines in the study planning.
The Brazilian legislation needs to be improved to meet the new requirements of health research activities.Based on the description of the stages required for the acquisition of imported medical equipment and the description of the diffi culties, researchers of this study hope to have contributed to the improvement in the management of subsequent ELSA-Brasil stages and other Brazilian research projects funded by public resources and with similar needs.
A manual describing the stages required, legislation involved and information about the types of payment implemented can be useful for research project management, researchers, managers and foundations.It can answer questions, enable administrative processes to be more effi cient, and support the qualifi cation and capacitybuilding of new managers in science and technology, recording the organizational knowledge acquired in the exercise of activities.
The acquisition of materials and goods aimed at scientifi c research is a concern for all participants involved in this process.It includes the cost and quality of the products acquired, but especially the capacity of public organizations to supply their stocks as fast as it is required, within the deadline of the projects. 3e adequate planning of activities associated with the importation of equipment enables, among other aspects, the reduction in the durations of the three stages previously described.In research, this is refl ected in the greater productivity in the execution and compliance with the goals and in the rational use of public resources.
The scarce literature on the theme studied emphasizes the need to invest in project management to guarantee the reduction in its costs and lifecycle.f With the increase in the fi nancial investment in health research in Brazil, 9 adequate planning and professionalization of management are key factors to guarantee fast and effective control of processes, especially because this does not turn researchers away from research activities.As a result, high-quality scientifi c knowledge is produced, which can be the basis for public policies on health.
However, more managers need to be qualifi ed, who, in addition to managing projects, enable the interaction between the academia and public policy institutions, strengthening the purpose of the Ministry of Health and Ministry of Science and Technology.a f Telles M, Costa S. Gestão de projetos de pesquisa fi nanciados por órgãos de fomento: o caso da Diretoria de Metrologia Científi ca e Industrial do Inmetro.In: 3. Simpósio de Excelência em Gestão e Tecnologia; 2006 out 16-18; Resende, RJ.Rio de Janeiro: ANGRAD; 2006.p.12.
Research projects are complex processes, including interdependent activities and a high level of uncertainty of results, thus challenging the prediction of risks and hindering management. 12The ELSA-Brasil, due to its multicenter, multi-disciplinary and longitudinal design, brings new challenges and solutions which foundations, researchers and funding agencies had not experienced before.This study showed results that enable one to rethink the concepts and modus operandi, aiming to help overcome infl exible models of research project management in Brazil.Thus, researchers hope to contribute to the construction of a new context of science, technology and innovation in health and to support promotion policies so they can achieve their expected results, increasing this country's rank in scientifi c knowledge production.

Figure 2 .
Figure 2. Duration of the importation process by stage and Investigation Center by type of equipment.ELSA-Brasil

Table 1 .
Characteristics of the equipment imported by the ELSA-Brasil.

Table 2 .
Stages and activities for the importation of equipment for the ELSA-Brasil.