The TGA, Australia has implemented a Data Protection Scheme for assessed listed medicines and published guidance to facilitate the scheme.
What is the scope of the guidance?
The guidance provides:
- an overview of the Data Protection Scheme for Assessed Listed medicines, and the
- criteria that must be met for information to be considered protected under the Scheme.
The guidance also includes details on how to submit an L(A) medicine application and make a restricted information certification.
What are Assessed listed [L(A)] medicines?
Assessed listed [L(A)] medicines are those medicines that meet the following criteria:
- are listed in the ARTG under section 26AE of the Act
- must carry at least one intermediate-level indication*
- must be certified, under subsection 26AB(2) of the Act, to be eligible for listing and safe for the purposes for which they are to be used
- include ingredients that have been previously evaluated by the TGA and are listed in the Therapeutic Goods (Permissible Ingredients) Determination (Permissible Ingredients Determination).
* Defined below
About intermediate indications
Intermediate indications relate to a use of a medicine:
- in preventing, curing or alleviating a disease, ailment, defect or injury in persons, other than a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; or
- in connection with alleviating a disease, ailment, defect or injury in persons, being a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form
What is the purpose of the Data Protection Scheme?
- The purpose of the Scheme is to incentivise innovation by protecting the results of investment in the development of new works and technology.
- The Scheme is designed to prevent competitor(s) from seeking market authorisation of generic forms of an assessed listed [L(A)] medicine by relying on clinical trials generated and used by the sponsor of the originator medicine to obtain market authorisation.
- The Scheme intends to provide industry with the means to finance further research and development activities by preventing others from capitalising on their investment and innovation.
What data protection will the scheme provide to successful applicants?
The Data Protection Scheme for L(A) medicines will provide successful applicants (sponsors) with a 5-year protection period for the clinical trial efficacy information* supporting their L(A) medicine starting from the date the medicine was included in the Australian Register of Therapeutic Goods (ARTG).
*Defined below
What is the definition of the data eligible for protection?
The raw clinical trial efficacy data and full clinical trial study report (collectively referred to as the clinical trial efficacy information) generated from a clinical trial that is used to support a new intermediate indication for existing ingredient(s) in an L(A) medicine application are eligible for data protection.
About the data protection period
If successful, clinical trial efficacy information supporting a new intermediate indication that has been derived from a clinical trial will be restricted. This means that access to use this information for another L(A) application will be restricted for a 5-year protection period.
The 5-year protection period will begin from the date the approved medicine is included in the ARTG, and ends 5 calendar years later e.g. a protection period starting 1 July 2021 will end on 30 June 2026.
- Use of the information during the 5-year protection period will be restricted to the person (sponsor) in relation to whom the existing medicine is listed [section 26AF(g) refers].
- This sponsor must certify that they own the information and have the legal right to use the information submitted with their application.
- During the protection period this person can give the TGA permission in writing to use this restricted information to support evaluation of another L(A) medicine.
- Once the protection period has expired, other sponsors can use the information that was restricted to support evaluation of their applications.
Which application categories are eligible for data protection?
Data protection:
- will usually apply to medicines submitted through the L(A) application category.
- can also apply to medicines submitted through the L(A) (Comparable Overseas Bodies) application category or L(A)C2 (new indication) application category if clinical trial efficacy information is used to support a new intermediate indication and certain criteria, as set out in the guidance, are met.
What are the criteria for data protection i.e. forinformation to be considered protected under the Scheme?
Data protection is dependent on whether the delegate of the Secretary has relied on specific clinical trial efficacy information within the application, and will coincide with the decision to list the L(A) medicine.
Briefly, this clinical trial information must:
- not be available in the public domain ( his excludes information contained in clinical trial registry)
- contain a clinical trial registry number
- be for a new intermediate indication-active ingredient combination
- be owned by the sponsor.
Where can you find further information?
Further detailed information is provided in the guidance document.
Source: TGA website