So, we'll be traveling next week up the turnpike to see counterparts from another Big Pharma, negotiating safety data exchange agreements. Or rather, observing the negotiation. This is PB's first face-to-face with another company. Yes it's true - PB is an underachiever, so to speak. I came into this racket late, after wasting a few years with more menial jobs. Now I'm not a youngster anymore, and I'm feeling it.
Anyway, the big legal issue with licensing for us has to do with reporting timelines, and the EU. Volume 9A, the European Commission's guidance document on pharmacovigilance (PV) was published in late January, and the big hit in licensing has to do with individual case handling reports (ICHRs). Specifically, the guidance explicitly states in Part 1, section 4.2, that the reporting clock date is set at "0" whenever the Marketing Authorisation Holder company or any company with a contractual arrangement with the MAH gets information about a adverse event. Ouch. Up until now, our practice has been to consider Day "0" the day when our company gets the report from our licensing partner. The deadline is day 15 - these are calendar days, not working days. So now we have to factor in much shorter data exchange timelines with other companies, and re-negotiate existing agreements.
Unfortunately, we don't have any electronic data exchange with our licensing partners. Our ability to do this is hampered by a lack of shared/compatible data standards and systems, and strained IT budgets. We're faxing and e-mailing case reports back and forth. We're doing this after the case has been entered into our own system, with our own internal timelines. Those internal guideline are geared toward our own company getting the reports in by day 15, not worrying about another company needing to do the same thing. Really, it's substantially shorter than 15 days already, because we've got to make the reports available to our marketing companies around the world, so they can submit the reports (usually a CIOMS) to their regulators.
So now, we have to decide either 1. Rework our individual case handling procedures to shorten our internal timelines, and expect our licensing partners to do the same, or 2. Assign one or the other of the companies to handle all of the reporting duties of a co-marketed drug to all of the regulators around the world, or 3. Share all source materials about adverse events with our partners the day they are received, and trust each party to send reports to their respective parts of the world's regulators
In reverse order, Number 3 is a non-starter, because our two companies could have completely different opinions on a case, if it's regulatory serious, listed with our core data sheet, etc. Then we would have two versions of the same case submitted to agencies, which would be a legal nightmare. We'd also never be able to produce a PSUR with competing cases.
Number 2 above can work fine if we're dealing with another large Pharma with established international reporting. They can do the case handling, submit the IPARs and QLLs to the Europeans for us, etc. The company I'm visiting next week can most likely do all that. But it gets really ugly when you've done a licensing deal with a company that only covers one country, like the US. If your licensing partner in the US is only selling your drug here, they have no reason to submit anything to European regulators. They may not even have the means to do so. And they probably won't tighten their internal timelines to get ICHRs to us quickly, so that we can.
So, we're often stuck with option 1, which is chaos and scrambling, or making exceptions for this or that product received from this or that source. Forget harmonization of processes. Or, my personal favorite variation on option 1, streamline your processes to cut out review times of ICHRs. Just type the case in and send it. This would put our reviewing physicians in a snit, but too bad. My company has too many reviews on an ICHR anyway. We've done some recent benchmarking, finding that other companies are just sending the reports, and worrying about medical review later.
But we know that *others* (Dr Wolfe, big law firms, David Graham at FDA) are scrutinizing our ICHRs, and our goal is to get the MedWatch exactly accurate before they go out the door the first time, being very careful with our wording. Franky, if you read my last couple of posts, it doesn't seem to be making any difference. We're under siege as it is, regardless of what we submit.