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In the pharmaceutical industry, strict compliance with delivery deadlines is essential. In commercial contracts between pharmaceutical companies and their suppliers, clarity and precision in stipulating delivery deadlines, as well as defining the consequences for non-compliance with these deadlines, are crucial to avoid disputes and ensure continuous supply to the market. Delays in the delivery of essential inputs can cause serious impacts, such as interruptions in medicaments production, compromises of research projects and even risks to public health. In this context, logistics plays a critical role that is amplified by the need for transportation and storage products under specific temperature and humidity conditions, in addition to complying with the regulatory standards of each country. The contracts signed between the parties must reflect this importance, establishing clauses that address the specific challenges of this area.

Brazilian legislation (for example, Article 389 of the Civil Code, Law #10,406/2002) establishes that the debtor is liable for losses and damages in the event of non-fulfillment of an obligation. In addition, the Law of Introduction to the Civil Code (Decree-Law #4,657/1942) provides, in its Article 9, that contracts must comply with the law of the place where they were constituted, which is especially relevant in international contracts. In turn, regulations from the Brazilian Health Regulatory Agency (ANVISA), such as its guide for qualifying the transportation of biological products, impose strict requirements for the transportation and storage of pharmaceutical products that must be considered in contracts.

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Delivery Deadlines: Definition and Consequences

Delivery deadlines are commitments that rely on strict quality control and, if not met, can generate significant liabilities. For example, a delay in the delivery of raw materials could jeopardize the production of an essential medicine, leading to market shortages and potentially putting lives at risk. To mitigate these risks, contracts should specify clear and achievable deadlines, detailing each step of the logistics process.

Setting intermediate stages, such as dates for partial delivery of inputs or progress reports, can help monitor compliance with the schedule. In international contracts, where logistical challenges are even greater, it is common to include clauses that provide for the extension of deadlines in situations of force majeure, such as port strikes or natural disasters, as provided for in Article 393 of the Brazilian Civil Code.

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Penalties for delay: A Commitment Tool

To ensure compliance with deadlines, contracts often establish penalties for delays in delivery, which may take the form of daily fines or a reduction in the total amount to be paid to the supplier. This approach, in addition to serving as an incentive to comply with obligations, also provides compensation to the party harmed by the delay.

A practical example can be found in vaccine supply contracts during the COVID-19 pandemic, where delays in the delivery of inputs for production were punished with considerable fines, due to the urgency and sensitivity of the product. However, it is important that contracts also include situations in which delay is justifiable, as provided for in the United Nations Convention on Contracts for the International Sale of Goods (CISG), incorporated into the Brazilian legal system by legislative decree #538/12, which allows for the waiver of penalties in situations involving unforeseeable circumstances or force majeure, such as port strikes, natural disasters, or global logistics blockades, as provided for in Article 393 of the Brazilian Civil Code.

In addition, it is prudent to provide dispute resolution mechanisms, such as mediation or arbitration, which can be used quickly to resolve conflicts related to delays and interruptions in the supply chain.

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Flexibility and Adaptation: Demands of the Logistics Context and Risk Mitigation.

While strict compliance with deadlines is crucial, contractual flexibility is also necessary to deal with unforeseen events. The regulatory environment in the pharmaceutical industry is constantly evolving, and sudden changes can affect a supplier's ability to meet its obligations within the established deadline.

For example, a change in the regulation of the transportation of controlled medicaments by ANVISA may require the supplier to adapt its logistics processes, potentially delaying delivery. To prevent unnecessary disputes, contracts can include renegotiation or schedule adjustment clauses, allowing the parties to revise deadlines based on external changes. This flexibility, however, must be accompanied by clear procedures for notification and approval of the parties involved, ensuring transparency and predictability.

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Just-in-Time Logistics: Advantages and Risks

Just-in-Time (JIT) practices have become increasingly common in the pharmaceutical industry, seeking to minimize storage and reduce costs. However, this approach increases dependence on logistics efficiency and exposes companies to significant risks in the event of delays. An example of this can be seen in contracts for the supply of inputs to produce high-demand medications, where any failure in delivery can immediately stop production.

To mitigate these risks, contracts that adopt the JIT model must include clauses that require constant monitoring and effective communication between the parties. The use of real-time tracking technologies, such as GPS systems, can be a contractual requirement, ensuring that both parties are aware of any possible delays in advance to take corrective measures.

Challenges in International Contracts: Global Supply Chains

In a globalized scenario, the pharmaceutical industry often relies on international suppliers, which adds an extra layer of logistical complexity. Issues such as customs barriers, differing regulations between countries and geopolitical instability can cause significant delays in the delivery of inputs.

For example, the COVID-19 pandemic has exposed the vulnerability of global supply chains, where lockdowns and export restrictions in several countries have delayed the delivery of essential inputs. To address these challenges, international contracts should provide for the possibility of supplier diversification and the adoption of contingency plans. In addition, the choice of jurisdiction and applicable law is crucial to avoid conflicts and ensure the effective enforcement of contractual terms.

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Conclusion

The logistical challenges in the pharmaceutical industry require contracts to be carefully drafted, with special attention to delivery deadlines and the implications of potential delays. The inclusion of clauses that establish penalties, offer flexibility for necessary adjustments, and incorporate modern monitoring technologies is essential to ensure the efficiency and safety of the delivery of critical inputs.

In addition, in international contracts, consideration of factors such as the choice of jurisdiction and risk management associated with the global supply chain is vital to mitigate logistical challenges. In this way, companies can ensure that their operations are not interrupted by avoidable problems, maintaining the production of essential medicines in line with market needs and current regulations.

This legal approach is crucial to maintaining healthy commercial relationships and protecting the interests of the parties involved in an industry where time and efficiency can literally save lives.