Pharmaceuticals, Medical Devices and Food: Sectors Face Obstacles in Cargo Clearance – Judicial Proceedings Have Been the Solution

The increasing importance of business agility to the national and global economy requires recognition that delays in the production and supply chain of finished products or inputs may cause significant losses to market players, particularly companies in the pharmaceutical, medical device, and food sectors.

In recent months, companies in these and other sectors have faced significant delays in the clearance of imported cargo at Brazil’s main airports and ports due to strikes and standard operating procedures adopted by tax auditors of the Brazilian Federal Revenue Service. These delays have compromised entire production chains and caused economic, contractual, and even health-related losses.

At the core of the problem is the delay in customs clearance: the failure of the customs authority to proceed with the relevant procedure within the statutory eight-day period, as established by Article 4 of Decree No. 70,235/1972. Although customs legislation does not establish a specific deadline for completion of customs clearance, the case law of the Federal Regional Courts has applied this provision by analogy in order to safeguard the constitutional principle of administrative efficiency (Article 37 of the Federal Constitution).

In practice, the prolonged detention of cargo containing products and inputs for the pharmaceutical, medical device, and food sectors, when such cargo is assigned to the yellow or red customs inspection channels without additional requirements or plausible justification, may be challenged through a writ of mandamus seeking the immediate review and release of the goods. These legal actions are based on the existence of a clear and enforceable legal right impaired by an omission on the part of the Administration, as provided for in Article 5, item LXIX, of the Federal Constitution and Law No. 12,016/2009.

One of the grounds for granting an injunction, without hearing the opposing party in advance, is that strikes or standard operating procedures, even when constitutionally guaranteed to public servants (Article 37, item VII, of the Federal Constitution), may not compromise essential services, as recognized by the Brazilian Supreme Court.

The Supreme Court has held that, even in the absence of specific legislation governing strikes in the public service, the provisions of Law No. 7,783/1989 apply subsidiarily. This law requires the maintenance of a minimum number of workers in services that are essential to the community and cannot be interrupted.

This recognition is particularly relevant to foreign trade. In addition to being a typical function of the State, customs control is considered an essential public service, the interruption of which may cause irreparable harm to the national economy.

Furthermore, delays in customs clearance not only violate ordinary legislation but also constitutional principles, such as free enterprise (Article 1, item IV, of the Federal Constitution), the right to a reasonable duration of proceedings (Article 5, item LXXVIII), and national development (Article 3, item II). Requiring a company to wait indefinitely for an administrative decision without legal grounds compromises the exercise of its economic activity, affecting its business autonomy and legal certainty.

Court decisions have been based on this understanding. The Federal Regional Court of the 3rd Region (“TRF-3”) has already recognized that the State may not rely on strikes to justify delays in customs clearance, particularly when essential services to the population or the continuity of productive activities are at stake. The case law is clear: in the absence of formal requirements or irregularities, the Administration must ensure that customs clearance proceeds immediately within the statutory deadline.

Similarly, the Federal Regional Court of the 4th Region (“TRF-4”) has held that, even when an Import Declaration is submitted to documentary or physical inspection, the absence of movement within eight days constitutes an administrative omission that may be remedied through judicial proceedings. The underlying principle is the same: the right to the continuous, effective, and timely provision of public services.

In sectors that are essential to the population, such as healthcare and food, imported products and/or inputs often constitute indispensable assets for the operation of production lines and the supply of the market in general, including hospitals, supermarkets, pharmacies, and related commercial establishments.

Delays in the release of these shipments affect companies’ logistics planning, may result in contractual breaches, and, above all, create a risk of shortages in the market, threatening public health and food security.

Although undesirable as a systematic solution, judicial proceedings have become essential for the sector to remedy the illegality arising from delays in customs clearance and cargo release. The Judiciary has been addressing delays in import procedures, promoting a balance between public servants’ right to strike and the fundamental rights of individuals and companies to the continuity of economic activity and the regular supply of the population.