Since this agreement is binding on all partners, the legal department should review and approve the document. Typically, companies develop the SDEA model. One of the main reasons for non-compliance with pharmacovigilance is the inadequacy of the SDEA. Routine monitoring of data exchanged according to the SDEA is required. There should be a database for SDEAs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. It is a smart idea to develop one or more radiators that can be inserted into all contracts and agreements. They should be developed with the legal department and get the approval of the Business Development Group so that they are automatically added to all contracts. This is not unusual, as most contracts have several clauses that are “boiler plates” that cover other issues such as insurance, liability, etc. In these types of agreements, the types of ADES and the distribution of activities depend on the needs of each company. Depending on MAH requirements, the SDEA may be asked to assign responsibilities for PSUR letters, reports and responses to regulatory authorities, local screenings, signal recognition, etc. It should be noted, however, that while only certain pharmacovigilance activities, such as adverse reaction monitoring and individual safety reporting are delegated to another party, the ADES still needs to be comprehensive enough to indicate all pharmacovigilance obligations and which party is responsible for which activity. In general, counterparties` pharmacovigilance obligations are limited to a limited number of clauses in framework contracts because of the comprehensiveness of the terms.
It is the responsibility of the local representative of PHARMACOVIGILANCE (QPPV) to ensure that the pharmacovigilance obligations are clearly defined for both parties. In an organized setting, this responsibility is assigned to a dedicated POC role for the APV/SDEA. These MA holders may have to establish different business relationships with other pharmaceutical companies or cros or other service providers in order to obtain the necessary authorization and market their manufacturing forms. These commercial relationships vary according to the requirements/consents/commitments/interests of both counterparties. These relationships are governed by master service agreements/trade agreements. SDEAs are written contracts drawn up between two or more cooperations to define the responsibilities of each party by referring to each pharmacovigilance activity. A well-developed agreement ensures compliance with the legislation and prevents the doubling of pharmacovigilance activities by different partners. Problems are common in that these agreements are concluded between companies in research, distribution or business development groups whose main objective is to initiate studies or sell more drugs. Drug safety (adverse reaction report) is rarely at the top of its list of priorities. In fact, they often don`t even think about it, or they realize at the last minute that they need a safe zone.
I have often been at the difficult point of getting an email or an agreement with the indication that the CEO will sign tomorrow and “Is the safe zone OK” or “Please send us a security perimeter immediately”. Since the SDEA is a binding written agreement between the partners, the legal department should review and approve the document. Sometimes it is included in a master contract (service) or contract. It is sometimes treated as a separate document between anti-drug groups. Sometimes the master`s contract has a short boxing section (see below).