In recent times, the pharmaceutical industry has been witnessing quite a few Mergers and Acquisitions (M&A) as companies want to grow organically as well as inorganically. Indeed there is intense competition in this field and companies want to sustain competition, and want to remain ahead of their peers. Considering the growing regulatory expectations, companies need to ensure that the entire M&A activity is executed properly.

Generally, the Pharmacovigilance (PhV) department is totally unaware of something like this happening in the company until there is any media announcement. Exceptional scenarios do exist, where key PhV personnel may be involved by the business teams. This is generally when there are some pending litigation cases pertaining to side effects.

However, the trend is now changing and the PhV personnel are getting involved during the due diligence activities while evaluating M&A. One should not forget that regulatory authorities closely monitor the M&A activities, so as to the time the PhV inspections at the appropriate time. Those who have witnessed such integrations won’t deny that this activity can give you sleepless nights until the activity is completed.

Some types of M&A in the Pharmaceutical industry include:

• Complete Merger
• Product(s) acquisition – with/ without employees
• Product(s) divestment
• Acquisition of the entire company
• Acquisition of majority stake
• Acquisition of minority stake
• Acquisition of a particular subsidiary or therapeutic area

Different pharma companies handle each of the above situations differently. Companies that are extremely dynamic and are on the continuous prowl for acquiring companies or products may have a proper guidance document for handling the above situations. Some companies even develop M&A checklists for PhV.

Needless to say, the Quality department plays a very important role in this activity. At times, in spite of proper planning and protocols, the integration activity may go haywire. This is more common when there is a wide time-gap between the announcement of M&A and the actual effective date. Considering the various approvals required in the respective countries, this time-gap cannot be predicted.

In any case, the overall activity needs to be undertaken very seriously and with strict timelines, as there may be an impending regulatory inspection. Timelines are also very important because there may be a high amount of tension/uncertainties in the acquiring company as well as the target company, and one cannot rule out any kind of attrition in the interim period. If key PhV personnel quit during this period, the situation may become more difficult to handle.

There is no right or wrong way for handling PhV integration during M&A. But yes, the Quality department needs to be actively involved and everything needs to be governed by proper protocols and change controls.

Some key aspects of handling PhV integration during M&A:

• Project Management and timelines

• Protocol (including agreements)
• Change Controls (both ends)
• PhV Infrastructure
• Safety Database (infrastructure, licences, excel database or no database)
• Safety Data Migration (vendor proposals, infrastructure integration and migration plan)
• Geographies (?regulated markets, local team etc)
• Website (forms, contact info, safety data, RSI etc)Vendors (in-house or outsourced)Medical Information (Call-center, toll-free numbers and other infrastructure)

• PhV personnel (? lay-off or anticipate increased workload)
• PSMF (Data Merger)
• Aggregate reports (? large PSUR for the acquired product within short timelines, necessitating data migration)
• XEVMPD/ IDMP data including nullification
• SOPs (harmonization)
• QPPV / Local Responsible person (Lay off or retain as back-up)
• Literature Search activities (including vendor)
• Company Product Dictionary
• Risk Minimization measures
• Physical data archival
• Allied functions and Training

PhV integration activity may at times result in delayed or duplicate reports. However, proper planning, due diligence, execution and adequate documentation is the key to successful integration. The term ‘successful’ is quite subjective and can only be confirmed during a regulatory inspection. Some companies which don’t wish to wait for inspection prefer to get the system audited by an external consultant.

Darwin’s theory of ‘Survival of the fittest’ does not hold true every time during M&A in Pharma companies, as companies tend to take strategic decisions considering various aspects. At times even the PhV department of the acquiring company may be vulnerable and succumb to situations/ decisions. Thankfully, this field is continuously evolving and there is no dearth of jobs in the developing countries.