Protecting commercially confidential information (CCI) and personal information in Australian Public Assessment Reports (AusPARs)
Guidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).
Purpose
This guidance applies to sponsors of prescription medicines in Australia and outlines how TGA identifies and treats commercially confidential information (CCI) and personal information in drafting an Australian Public Assessment Report (AusPAR).
This guidance and the approach of the TGA reflect compliance with the considerations that give rise to the commercial exemptions in the Freedom of Information Act 1982 and relevant privacy principles.
Legislation
CCI and personal information in an AusPAR
Content for an AusPAR is derived from various stages of the assessment and decision-making processes.
As the AusPAR is a publicly available document, it is essential that any CCI and personal information be identified and where appropriate removed prior to publication.
Commercially confidential information (CCI)
Information on what is commercially confidential information (CCI) and our approach to the release of CCI to the public is available at TGA Approach to disclosure of commercial in confidence information (CCI).
For the purposes of AusPARs, the TGA has adopted the European Medicines Agency (EMA) approach which broadly defines the following two categories of information considered CCI:
- confidential intellectual property, ‘know-how’ and trade secrets (for example formulas, programs, process or information contained or embodied in a product, unpublished aspects of trademarks, patents and similar)
- commercial confidences (for example details of commercial arrangements, development plans of a company).
Information that is already in the public domain, or comes into the public domain prior to the publication of an AusPAR, is not considered commercially confidential. This includes published references or compiled searches for information submitted in support of an application to register a prescription medicine.
If information has been in the public domain through a breach of the law, it could still be considered confidential. However, the onus is on an owner of the information to inform the TGA in writing of the breach.
Unless there is an overriding public interest in disclosure, the TGA will refrain from disclosing CCI or personal information.
Information on the quality and manufacturing of medicines
In general, detailed information in relation to the matters described below may be CCI.
More general information should be disclosed. However, in certain circumstances even a general description of a specific aspect could be regarded as CCI, if justified.
Composition and product development
Pharmaceutical development information for new products is generally considered CCI. This includes detailed data concerning active substances, formulation and manufacturing and test procedures and validation.
In general, the names of manufacturers or suppliers of the active substance or the excipients are CCI unless disclosure is necessary for public health reasons (as it is for some biological products, for example).
The final qualitative formulation (composition) of the authorised product is not CCI.
Active substances
The principles contained in the diagram below apply to pharmaceutical and biological products and to novel excipients.
Classification of commercially confidential information for active substances
The image shows a table comparing commercially confidential information with information that is not commercially confidential for active substances.
This table provides guidance on how to classify different types of information related to active substances in terms of commercial confidentiality.
The table is divided into three columns:
- left column (blue): "Commercially confidential"
- middle column (pink): Categories of information
- right column (orange): "Not commercially confidential"
The table lists 10 categories in the middle column, with corresponding details on what is considered confidential (left) and not confidential (right) for each category.
The categories are:
- structure
- synthesis
- polymorphism and particle size
- impurities and degradation products
- test methods, specifications, acceptance criteria
- fermentation and purification
- manufacturing
- characterisation
- biotechnology products
- cell banks.
For each category, the left column generally describes detailed, specific information as commercially confidential, while the right column indicates that general, high-level information or statements are not commercially confidential.
Finished product
The principles contained in the diagram below apply to pharmaceutical and biological products.
Any confidentiality issue regarding novel packaging or medical device aspects should be justified by the sponsor and will be assessed according to the below principles.
Classification of commercially confidential information for finished product
A flow chart divided into two columns: 'Commercially confidential' and 'Not commercially confidential'.
Under the 'Commercially confidential' column:
- 'Qualitative and quantitative information unless disclosure is necessary for public health reasons'
- 'Detailed information on the test methods included in the specification of the finished product and the quantitative acceptance criteria unless tests are of Pharmacopoeial standard'
- 'Details on validation of the manufacturing process. Detailed descriptions of manufacturing and control processes'.
Under the 'Not commercially confidential' column:
- 'Degradation products'
- 'Test methods, specifications, acceptance criteria' with a note: 'General statements that the types of methods and specifications used were appropriate'
- 'Manufacturing'
- 'Stability studies' with a note: 'Information on the outcome of stability studies (e.g. carried out in real time conditions or accelerated conditions)'.
The 'Commercially confidential' items are on a light blue background, while the 'Not commercially confidential' items are on a light orange background with pink boxes for each item.
Nonclinical and clinical information
Information encompassing nonclinical and clinical development and its subsequent assessment by TGA is generally not CCI.
Examples include:
- data generated by the sponsor using another sponsor’s product, for example comparative studies against the reference medicinal product are not CCI by virtue of this is fact only. However, the commercial confidentiality of such data shall be assessed in accordance with the principles set out in this document
- published references submitted in support of an application to register a prescription medicine
- information related to environmental risk assessments and risk management plans.
Examples of nonclinical and clinical information that is CCI include:
- specific details on a method used in a study, which, upon justification from the sponsor, could be regarded as trade secret
- development plan from the company, for example for a different indication, when it is neither requested by TGA nor related to the safety of the product would also be CCI.
However, when the results and timelines of such studies are part of the conditions for ARTG approval, they are not regarded as CCI.
Information on inspections
Information on the outcome of inspections is not CCI, however specific details regarding facilities and equipment is considered to be CCI.
Contractual agreements
Contractual agreements between individuals or organisations are generally considered CCI.
Where contracts exist between companies and contract research organisations that have contributed to or are responsible for important information included in the dossier, they are generally not CCI.
Scientific advice
All information about new developments and formulations are CCI.
Pharmacovigilance information
Generally, a quantitative description of the sponsor's proposed pharmacovigilance activities is not considered to be CCI.
However, detailed descriptions of the pharmacovigilance system can at times be considered confidential if they contain individual patient data or business strategies such as planned studies or commercial agreements involving other companies or organisations.
List of references and original manuscripts
The list of references of the publications included in the dossier, or subsequent assessment processes is not CCI. An exception is if the actual manuscripts are included and they are subject to copyright.
Personal information
Personal information is defined in Subsection 6(1) of the Privacy Act 1988.
As the TGA is bound by the Privacy Act 1988 in relation to the collection, use and disclosure of personal information, personal information is not normally included in an AusPAR.