Why Translation is Essential for the AAP (Autorisation d'Accès Précoce/Early Access Program) in French Healthcare

Translations of documentation for early access programs for innovative pharmaceutical products are important in numerous languages and countries. As a French to English translator, I frequently translate applications and documents related to the French Autorisation d'Accès Précoce (AAP), a valuable program in French healthcare.

​To explain the value of translation throughout the AAP, I outline the program below and explain 3 ways in which translation is essential in supporting the process.

What is the AAP?

​The Autorisation d'Accès Précoce, or Early Access Program, in France is a regulatory framework that allows patients with serious or life-threatening conditions to access certain medicinal products that have not yet received full marketing authorization but have shown promise in clinical trials. This program aims to provide patients with access to innovative treatments that may offer therapeutic benefits when no other approved treatment options are available.
 
Below, I break down the AAP program into 3 parts: the application process, evaluation/approval process, and the monitoring/reporting process. This is a general overview to illustrate that many documents must be translated throughout the program.*

1. The application process: First, the drug needs to meet certain eligibility criteria to be considered for use in an AAP program. These criteria are determined by the French Medicines Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) based on the specific characteristics of the medicinal product and the patient population. If it satisfies them, or if the healthcare professional (HCP) in charge of the patient’s care thinks it does, the HCP then applies to the ANSM for access via an AAP program. The application includes detailed information about the patient's condition, the investigational medicinal product, and the expected benefits and risks.
 
2. The evaluation/approval process: Once the application is in the ANSM’s hands, it evaluates each application on a case-by-case basis, considering the medical necessity and potential benefits and risks associated with the drug. The ANSM works closely with the manufacturer to assess available clinical data thoroughly and come to a well-founded decision. If the application is approved, the ANSM grants a temporary authorization for the use of the drug. This allows the patient to receive the treatment even before it has received full marketing authorization.
 
3. The monitoring/reporting process: Patients receiving the investigational medicinal product under the early access program are closely monitored for safety and efficacy. The manufacturer is required to provide regular updates and reports on the treatment's use and any adverse events. This allows the HCP, manufacturer of the drug, and the health authority to track everything that occurs and decide to continue using the treatment or even implement a clinical trial in the indication.

* For a more detailed explanation, a great article by PharmaLex (or BlueReg) can be found here.

Translation is Essential

You can imagine all of the documents that are produced and assessed throughout the process, which takes place over a long period of time. As a translator of French into English, I find that my work is essential because it supports the below aspects:

1. Supports international collaboration: In many cases, pharmaceutical companies conducting clinical trials or providing access to investigational products used in France may be based in other English-speaking countries. Thus, translated documents facilitate international collaboration and compliance with local and international regulatory standards.

2. Supports thorough regulatory review and compliance: Regulatory agencies like the ANSM need to review documents related to the early access program thoroughly. These include safety data, adverse event reports, journal articles, and more. Translations must be precise to enable regulators to accurately assess various features of the drug. Any errors or ambiguities in translation could lead to delays in the review process and, further down the line, could endanger patient safety.

3. Supports comprehension by healthcare professionals: Healthcare professionals are responsible for administering the drug and need to understand the treatment protocols, dosages, monitoring procedures, and safety precautions. For example, to safely administer the drug to their patient, an American HCP would benefit from reading information about adverse events that occurred in France under the AAP program. Thus, accurate translation of these documents becomes necessary so that this HCP can make an informed decision with their patient’s safety in mind.

As you can see, translation in the AAP program is necessary for many reasons. Translation is often thought of as only necessary for literature (poetry, fiction, etc.), but it carries just as much weight in the pharmaceutical industry, especially when it supports early access to innovative drugs.