Company Confidential Information (CCI) and the need to understand what it is and what it is not, is a hotly-debated topic in the pharmaceutical industry, especially in 2023. This is based on the fact that transparency-related initiatives across global health authorities are at an all-time high.
To increase the understanding of CCI, we speak with Director of Product Solutions Zach Weingarden to answer some of the industry’s most anticipated questions.
Question: What is the definition of Company Confidential Information (CCI)? And what are the typical types of information that pharmaceutical companies consider to be CCI?
Answer: Company, or commercial, confidential information (CCI) is information representing a privately held competitive advantage. Or another way to look at it, it is information that could be financially detrimental to a company if a competitor were to know about it.
In the pharmaceutical industry, an example may present itself when a company is in the early stages of investigating using a particular drug to treat a new type of problem. Say this drug is being marketed for another indication, but clinical researchers have an idea based on data or how the drug works as to how it might also be effective for another group of people. The company could use an existing trial to explore this possibility, and if it works, they have a competitive advantage by being the first to do so.
Question: How do pharmaceutical companies determine what information is CCI and what is not?
Answer: This is a complicated question. Mainly, different people have very different ideas about what is, or what should be, confidential. It boils down to whether something is a competitive advantage or not, and that can be extremely hard to define.
One clear criterion for CCI is that it must not have been previously shared publicly in any way. I have seen it often where a pharmaceutical executive expects certain information to be considered as CCI, but if it has been shared in a peer-reviewed journal article already, it is considered public information from a legal standpoint.
Question: Regarding regulatory bodies or other government agencies, what safeguards are in place to protect CCI?
Answer: When clinical documents are going to be shared publicly, in Canada or Europe for instance, there is a transparency process where the pharma company is allowed to propose redactions to specific pieces of text that they consider to be CCI. However, the agency will review the underlying text and determine if the redaction is valid based on the company’s justifications. Often, the public benefit of sharing the information outweighs the CCI consideration.
Question: Are there any laws or regulations that govern the protection of CCI in the pharmaceutical industry?
Answer: There are two major legislations that spell out the policies for releasing clinical trial information to the public. In Canada, the Health Canada Public Release of Clinical Information (PRCI) and in Europe, the European Medicines Agency Clinical Trials Regulation (CTR). Both agencies have frameworks for dealing with CCI.
Question: How can pharmaceutical companies justify CCI to global health authorities?
Answer: The EMA spells out its general considerations for CCI pretty clearly. In general, broad information is difficult to justify as CCI. The example I shared earlier about investigating a new indication would likely be rejected.
However, specific information about company operations, manufacturing details, or unique data analysis methods which are considered trade secrets might qualify. It is important for companies to understand the agency’s position related to the specific type of information so they can align their justification, and expectations, accordingly.
Question: What happens if the CCI is rejected, and what are some common mistakes that companies make when it comes to protecting their CCI?
Answer: The mistake is usually assuming that CCI would be covered in the first place. Around 90 percent of proposed CCI redactions are rejected by the agency. If the proposed redaction is too broad, there might be more specific pieces of information that can be redacted instead, so understanding the agency’s policy in advance is helpful.
Another common mistake is that the information has already been inadvertently disclosed to the public somehow. Unfortunately, once this has already happened, the cat is out of the bag, and no CCI protections will apply.
Companies can take two measures to address this proactively. First, conduct a thorough search of public information before proposing CCI redactions, and second, ensure that all public-facing information releases are reviewed from a CCI perspective to avoid this issue in the first place.
Question: Can information that was once considered CCI become public knowledge over time?
Answer: Of course, the second that CCI is included in any public document it is no longer considered confidential. It could be in a journal article, marketing materials, or even simply discussed in a public forum or presentation – it doesn’t matter.
Question: How do companies ensure that employees understand what information is considered CCI and how to protect it?
Answer: There needs to be a unified understanding across all stakeholders that generate, process, and manage company information of what is CCI and what isn’t. This is broader than the transparency department alone. At TrialAssure, we call this a Design for Transparency approach.
Everyone in the organization should be educated on this and it shouldn’t be up to individuals or functions to make this determination on their own. The overall process of generating and managing information should include steps to track and protect CCI.
There must be a mechanism to track and maintain information that is confidential and therefore cannot be shared in any public-facing channel. It must be accessible to all the relevant stakeholders in the organization and of course, kept up to date as information changes or becomes public.
Question: How do pharmaceutical companies balance the need for transparency with the need to protect CCI?
Answer: It’s a relatively new challenge since a lot more information is going public than ever before. Many companies are taking the standpoint of assuming that any written document will eventually go public.
This is a good thing, but it also means that everyone who is involved in writing these documents should be educated on company specific CCI considerations (and patient privacy too!). This also means that there is a need for intelligent tools to help balance the need to share with the need for privacy and protection of CCI.
If you have more questions on CCI, email Zach at firstname.lastname@example.org