5 Reasons to Keep the Legal Department Away from your Quality Agreements
As consultants for the pharmaceutical industry, one of our services is setting up and negotiating (technical) quality agreements between suppliers and customers. We usually work for the pharmaceutical customer, so we wrote this blog from that perspective. We do realize that quality agreements go by different names, such as technical agreements, TQAs, QTAs, QAAs, etc. In this blog, however, we consider them all to be the same documents.
During recent years, we have noticed that lawyers and/or legal departments have become more and more involved with both content and process of quality agreements. Here are our 5 reasons why you should avoid this involvement and why it is better to keep the legal departments and lawyers far away from our quality agreements.
1: The purpose is patient safety, not legal enforcement
Let’s go back to the fundamental reason for having quality agreements; it is to protect our patients! In the sometimes-extensive supply chain we have manufactured the medicinal products that end up in our patients and there are a lot of players involved. Each player has its own (small) part to play in ensuring that we deliver a safe and effective product to the patient. The main purpose of quality agreements is to ensure that each party involved takes its responsibility and performs its tasks. By documenting this in a quality agreement, we make sure that no issues are forgotten and each party knows exactly what to do.
As far as we know, there has never been a court case about a quality agreement dispute. If you know about such a case, however, please let us know: HERE
2: It’s between quality organizations, not legal departments
As said, the purpose of having quality agreements is to ensure the quality of the product. Therefore, it is (usually) an agreement between the quality (assurance) organizations of the companies involved. These are not legal departments that employ lawyers. Quality assurance departments are there to ensure patient safety within their own organizations and people are simply being employed for that reason. It is all about patient safety!
3: It takes up a lot of time
In some cases where legal departments were actually involved in quality agreements, it took lawyers forever to actually understand the language used. Our record for negotiating a quality agreement stands at 15 months, with a total of over 40 hours of teleconferencing. The lawyer in question wished to discuss everything in great detail and asked for an explanation of every single sentence . On the other hand, a discussion of a quality agreement with quality staff may be concluded successfully after a 30-minute phone call.
4: Lack of knowledge of pharmaceutical terminology creates huge stacks of paper
As indicated, an agreement is usually between quality organizations of the companies involved. In general, there is a common understanding of terminology. As far as our experience with legal departments is concerned, this is not necessarily the case. In one negotiation, we were asked to provide definitions for terminology such as: drug product, investigational medicinal product, quality assurance, active pharmaceutical ingredient, HPLC, etc. This added a significant number of pages to an otherwise simple agreement.
5: It’s just not fun 😉
For all of you non-lawyers who have ever had to negotiate with lawyers: we all know it is not a lot of fun to do that, exactly for the reasons we have just mentioned. And since having fun is the most important thing in our job, we do believe this is a valid reason 😉.
In conclusion, if you need any support on setting up or negotiating quality agreements with your suppliers or customers, we can and are happy to assist you! We cannot promise you that we can keep the lawyers out, but we have dealt with them often, so we know what to expect.
Oh, before anyone gets offended: We do not want to engage in lawyer bashing whatsoever. However, we do strongly believe that their presence during quality agreement negotiations has no added value. Their skills and talents are put to better use elsewhere.