After spending more than a billion dollars to develop a drug, it needs to be commercialised in as many global markets as possible before the patent expires to obtain the biggest return on that considerable investment. It is a sound strategy but is fraught with risk. While most companies recognise the challenges around understanding a new set of regulations, marketing demands and sales cycles, they may not be aware of the potential risk to their intellectual property when making regulatory submissions.
In emerging markets, we have heard of several horror stories in which proprietary Chemistry, Manufacturing and Controls (CMC) information from submissions ends up in the hands of local manufacturers, and reports from clinical studies appear in public domain. In one instance, a company obtained approval for their new cardiovascular drug only to find that a local generic company had it on the market before they could arrange supplies themselves. In another, an innovative company’s Clinical Study Reports (CSRs), which include full reports of clinical studies conducted by the company, turned up in generic applications. The manufacturing company only discovered the data breach when the regulator asked them to confirm the details of the trial, as their name was on every page of the CSR.
Fortunately, there are ways to mitigate this risk. The most effective strategy is to limit the amount of information shared in these submissions to that which is necessary for approval. Of course applicants should not hide bad news or withhold information pertinent to the judgement of the risk/benefit ratio for their products. Rather, they should accurately and concisely summarise information to allow the regulator to come to a swift assessment. Most ‘export’ markets require a lower level of detail in their submissions when the product has already been approved in the US, EU and/or Japan. Limiting the amount of information provided serves to both protect proprietary data, while also speeding the registration process as regulators will have less information to evaluate and (hopefully) fewer questions.
It is important to provide summaries of data, especially synthetic routes and other CMC information, rather than unabridged details. Ranges rather than specific numbers are usually sufficient. For example:
- When providing information about the type of equipment used for manufacturing, don’t include specific brand names
- Rather than including specific times and temperatures used in the manufacturing process, provide broad ranges to avoid others being able to easily replicate your processes
- Be general when including the synthetic route and only supply it when required
- Also do not include CSRs in your submissions. These are not required in most export markets. It is usually sufficient to include standard summaries in tabular format along with full copies of all published reports, including nonclinical studies. CSRs can be provided on request if needed.
A good rule of thumb is that it is never wise to provide more information than strictly necessary for any regulatory submission. Providing too much information slows down the assessment and approval process as the regulator will be duty-bound to assess all information. It also increases the risk of proprietary information becoming compromised. This approach can help companies successfully and safely bring products to markets that have already undergone a thorough assessment and approval in the US, EU and/or Japan.