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Supply chain strategies require a close look at the regulatory factors and the drug import hurdles and hopes in the region.
Latin America is a dynamic region that shares similarities in cultures and social development. However, there is a wide diversity in government policies; hence, there is no unified and consistent way of handling foreign trade operations.
Latin America has continued to stay attractive for clinical research because of the amplitude and diversity of the regional population. The conduct of clinical research in Latin America has matured over the last few decades, requiring government authorities to develop and/or clarify new regulations in the areas of trade compliance.
To develop a well-defined strategy for importation processes and ensure a continuous supply chain for clinical trials, it is imperative to be able to answer two questions: How does this regulatory evolution impact the import process, and what are the main import challenges and opportunities faced in Latin America?
Parties in the importation process
Moving products across borders may sound simple, but it is important to understand the roles of all parties involved to learn and understand the complexity throughout the process.
CROs. General practice in the pharmaceutical industry is to delegate the conduct of a clinical trial to a contract research organization (CRO). This article will concentrate on import activities related to clinical trials and products such as investigational medicinal products (IMPs), non-IMPs, medical devices, and ancillaries.
Importer of record (IoR). The IoR is the party responsible for compliance with trade regulations of the importing country whose legal entity and associated tax numbers are used for import activities. As the importer, the party has three main legal responsibilities: ensuring the imported goods comply with local laws and regulation (including the end use of the products), filing an accurate and complete customs duty entry and presenting associated documents, and paying the assessed import duties and other taxes on those goods.
Interface between CRO and IoR. The CRO’s responsibilities could include managing the import and export activities for the clinical trials. The study sponsor may or may not contract the IoR services to the CRO; therefore, the sponsor could also act as the IoR in the selected countries. Which party can act as the IoR is dependent on the regulatory and legal framework of the country. It is important to have a clear and thorough discussion of this topic during contracting and project setup.
Customs brokers. A customs broker is a person or a party who is licensed by the local customs authority to perform formalities for shipments on behalf of the importer or the exporter. They are responsible for preparing and submitting documents required for customs clearance, paying import duties and value-added tax (VAT) at customs, and/or submitting shipping documents to other government agencies.
Ministry of Health (MoH). The MoH is the governmental ministry or agency responsible for the regulations
and approvals of pharmaceutical products, sanitary standards, regulations of the food industry, and import and export licenses. The authorities of the various countries are listed in the map at left (click to enlarge).
Customs. Customs is a state public office, located at the borders, airports, and/or seaports, where the goods that are imported or exported are registered, and the duties are assessed according to the corresponding tariff. Customs, in basic terms, function as the first filter for international shipping, mitigating any risk for the countries. Customs authorities are in charge of ensuring that all the goods entering the country are compliant with regulations, secured, and properly classified for taxes.
Developing processes to meet customs requirements is the first challenge for imports related to the conduct of clinical trials.
Latin American countries
Latin American countries such as Argentina, Brazil, Chile, Colombia, Mexico, Peru, Costa Rica, Ecuador, Guatemala, and Panama vary politically and economically, leading to highly complex restrictions on goods for importation. In contrast, some of the countries have streamlined processes simplifying the import process for companies.
The import process of medicinal products often requires import licenses. The import requirements for other clinical trial materials are dependent on the Harmonized Tariff Code, the end use of the product, and the country’s government agency’s regulations for the product.
Countries with high complexity
Argentina. Argentina is considered one of the most complex countries for performing importations for clinical trial supplies. Many items such as printed documents, measuring devices (rulers, stadiometer, etc.) and electrical products (laptops) are governed by various agencies and require specific certifications. Hence, it is critical that all items that will be imported are identified in advance prior to submitting the protocol to ANMAT (the MoH in Argentina).
With all the items being identified, a complete review of the import requirements can take place with the CRO’s Global Trade Compliance team. Then collaboratively, it can be determined if the items should be imported or purchased locally. Purchasing locally can result in cost savings and avoidance of complex import requirements.
Brazil. In Brazil, the MoH (ANVISA) requirements and timelines for importation have improved; however, the need for obtaining numerous import approvals has remained.
Depending on the clinical supplies and the regulatory approval strategies, one of three types of MoH import regulations can be used:
Furthermore, the timelines for the MoH import license approval are high and change from time to time depending on the MoH workload. The MoH can take from seven to 45 days to approve and release an import license at Guarulhos Airport in the state of São Paulo. If a shipment requires an import license prior to shipment, the timelines can increase to 55 days.
Currently, due to their high workload, the MoH at Guarulhos Airport is receiving support from the MoH of other states of Brazil. Most CROs and pharmaceutical companies are based in São Paulo and the Guarulhos Airport is requested since they have experienced staff for processing shipments for clinical trials. Thus, the MoH headquarters are working to decrease the import licenses timelines to seven days by the end of 2017.
Peru. The import process in Peru is challenging when it comes to customs clearance. Customs in Peru are very stringent and demand that all the information in the shipping documentation match perfectly with the content of the import license, which may significantly delay the customs clearance process if there are any discrepancies.
Separate import licenses are required for drug and ancillary supplies, which are subjected to MoH availability to be approved, meaning that submitting both import licenses at the same time does not mean they will be approved on the same day. This is very important to keep in mind in studies in Peru.
Chile. Chile’s restrictions to import IMPs have increased in complexity in the last two years. Both customs and MoH (known as ISP in Chile) have started to closely collaborate to ensure compliance of all regulations related to the import of medicinal products. It is required to submit an import license per shipment to the MoH, and the MoH does not allow the distribution of the medicinal product if the information in the shipping documentation, import license, and study protocol do not match.
It is critical that lot numbers of medicinal products, expiry dates, and corresponding certificates are accurate and provided to the MoH; otherwise, the import license that will allow distribution of the medicinal products to sites will not be granted.
Fortunately, imports of the majority of medical equipment do not require any import license. There are some exceptions, such as importing hypodermic needles, which require a specific import license, and the process is complicated. Similar to Argentina, it is recommended to outline the entire list of supplies that are used in the clinical trial and collaboration to be set up with the CRO’s Global Trade Compliance team to outline any obstacles and opportunities.
Countries with medium complexity
Mexico. Mexico, being the only Latin American country located in the northern part of America, yet being connected to rest of Latin America, offers logistical advantages to the pharmaceutical industry for conducting clinical trials. The MoH is involved in importation approval; however, Mexico has developed a unified system for import and an export license submission, which is linked between the MoH and customs, allowing shortening of timelines from the submission to the approval.
Mexico also offers special benefits of reduced import tax for imports related to clinical research. Additionally, there are advantages of free trade agreements between Mexico and other countries, where only MoH approvals for studies are required and there are limited import license requirements.
Colombia. In order to import drugs for clinical investigation, the medication must be approved by INVIMA (the MoH in Columbia) as a general import license; afterwards, an import license per six months or per shipment must be applied for.
Colombia is an attractive country to conduct clinical trials; however, medical equipment must be verified in advance because depending on the product to be imported, different certifications from different government agencies might be applicable and formal clearance through a customs broker is mandatory.
Countries with low complexity
Costa Rica, Ecuador, Guatemala, and Panama are constantly working on putting their names on the map of conducting clinical trials. Hence, there are limited import requirements for ancillaries and medical devices, and they follow the general process of trade facilitation commonly used by many countries.
Latin America has different particularities to consider for clinical trials. Therefore, it’s necessary to review the following topics that are related to the import processes and their implications.
MoH approval timelines and requirements. As soon as a new protocol is approved by the MoH, the import process can start. It is important to consider the timelines for clinical trial application (CTA) or import licenses approvals by the MoH. The approval timelines range from two to six months depending on the country.
Import barriers and risks. Latin American local authorities still consider shipments for clinical trials as commercial shipments (for sale) and often apply commercial requirements to the shipments, requiring documents that are not available for clinical supplies. Furthermore, communication between customs and other government agencies is limited, leading to confusion about the purpose of the supplies and delayed shipment clearance.
Looking forward in the region
Latin America has started to harmonize some of the importation processes and started to leverage technology to facilitate trade.
Online procedures/licenses. Countries have started to move from manual processes to electronic systems in order to improve the communication between authorities and better control of shipment documentation.
Dynamic region, specialized staff, and adaptation skills
Since the pharmaceutical industry has identified Latin America as a viable option for clinical research, not only have the regulations evolved, but the number of technical and specialized experts has increased to meet the industry’s needs to provide adequate and trained professionals for clinical trials development.
In Brazil, the CROs Association (ABRACRO) plays a very important role to contribute to the development of clinical research, collaborate to improve regulatory processes, and promote scientific and educational actions related to the activity in the country. ABRACRO has collaborated to create the first graduate program in clinical research in São Paulo, aiming to reduce the gap in the training of professionals in the segment and also stimulate the improvement of those who already work in the specialty. This association also provides workshops and forums.
Additionally, there is an import and logistics committee at ABRACRO, which meets to align import processes and share experiences. A customs broker with high expertise in clearing all CROs’ cargos is present. The broker brings regular issues, queries, and new trends with MoH and customs to the table. As a result, the CROs’ customs clearances are having standard processes.
With specialized public education, Mexico’s largest universities (UNAM and IPN) offer bachelor degrees in foreign trade and international commerce at no cost.
In Argentina, there are five top universities from Buenos Aires that offer bachelor degrees in international trade. All of them are private and their programs last four years on average.
Furthermore, the most important university at a national level (UBA) offers a postgraduate degree on business management of foreign trade and integration.
Importation for clinical trials in Latin America can become highly complex and increase study timelines. Therefore, prior to initiating a new clinical trial, a detailed analysis of all the supplies that will be imported needs to take place. By collaborating with the CRO’s Global Trade Compliance team, an import and export strategy can be developed to reduce timelines, decrease cost, and leverage trade provisions to optimize the supply chain.
Juan Bamberger is Manager, Global Trade Compliance; Roopal Patel is Senior Director & Global Head, Global Trade Compliance; both with PAREXEL International