Safety Data Exchange Agreements in Pharmacovigilance
Marketing Authorization holders (MAH) for drugs/devices/vaccines may enter into business relationships with other pharmaceutical companies, Clinical Research Organizations (CROs) or other service providers in the process of obtaining the required authorization and marketing their finished dosage forms. These business relations vary depending on the requirements/interests of both the business partners and are governed by Master Service Agreements/Commercial agreements.
Safety Data Exchange Agreements are legal written contracts ensuring that all safety data regarding a licensed product makes its way quickly and reliably back to the marketing authorization holder so that they may fulfil their legal obligations to aggregate safety data and to submit safety reports in a timely manner.
The QPPV/ Local Representative of pharmacovigilance needs to ensure that the pharmacovigilance obligations are clearly defined for both the parties. Where these are unavailable/not required as per regulations, this responsibility is assigned to a dedicated point of contact (POC) role for pharmacovigilance agreement/ safety data exchange agreement (PVA/SDEA), often called the LPVRP. For more details on the roles and responsibilities of LPVRP, please refer our previous articles.
The objective of a pharmacovigilance agreement is to define a mechanism for smooth flow of information to the competent authorities. Therefore, it is desirable that the LPVRP critically evaluates all PV agreements including business agreements in order to review if the pharmacovigilance obligations of business partners are defined clearly. If the original agreement does not define pharmacovigilance obligations clearly, the LPVRP may also initiate another pharmacovigilance agreement for which the end of effective period should be later than the shelf-life or half life (as medically determined) of last marketed batch. All the obligations thus defined may not be rescinded despite termination of business between the concerned parties.
The LPVRP to ensure that the basic elements like safety data type, format, timeline, direction of flow and the party in charge of holding data are defined in the agreement. They should also ensure that there is a periodic reconciliation mechanism in place for ensuring that all the required data is shared with the ‘receiving party’ by ‘sending party’ and a receipt acknowledgement mechanism for receipt along with defined timelines. In case of a service provider, this could be defined in the service agreement.
Also defined in the agreement are training, periodic audits, planned and unplanned deviations and corrective and preventive actions (CAPAs) for the same where required, responses to regulatory inquires. In defining each activity, it is necessary to define the turn around time (TAT) for each. An MSA will also include clauses for termination, arbitration, jurisdictions. A business continuity plan (BCP) may be a part of this agreement or maybe drafted as a separate agreement. In cases where the service provider or partner is being supervised in their activities by the MAH, the TATs along with quality timelines and submission responsibilities along with the quality guidelines need to be defined.
There are some agreements which are purely for marketing and hence, do not cover pharmacovigilance data sharing and reporting obligations called zero PV agreements. This may be clearly stated as a part of the MSA/service agreement or defined in the pharmacovigilance system master file (PVSMF) of the LPVRP. These need to be redefined in case of market sharing agreements due to regulatory obligations (eg: local business partners in the Chinese market) and mergers/acquisitions/product transfers between MAH/piggyback marketing or change of service partners. In this case, where required, a new pharmacovigilance agreement shall come into force where the roles and responsibilities of each partner are clearly defined.
It is the responsibility of the LPVRP to find the right balance during the negotiations to cover both the global and local applicable regulations so that they may consult and take approvals of right stakeholders and conduct negotiations. Therefore, it is advisable to involve the LPVRP in executing pharmacovigilance agreement in order to ensure the respective departments are aligned with the requirements.
Therefore, it is clearly understood here that safety data exchange agreements play a pivotal role in all areas of a given pharmacovigilance system. Also, the parties defined in the original agreement need to possess all the required safety data for the applicable product and help the business partners and MAH in fulfilling their pharmacovigilance obligations effectively with ease.