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The pharmaceutical sector is heavily regulated, with significant costs associated with both developing a new medicinal product and generating the data required to get a product to market. Protecting that data is therefore important.  Data exclusivity is a form of product exclusivity right for medicinal products in Europe, and market exclusivity is a related form of additional protection.

These two rights are in addition to any granted patent exclusivity right covering a medicinal product.

Why is data exclusivity granted?

The rationale for granting data and market exclusivity is to compensate the innovator company for the investment it has put in to developing the new medicinal product and to generating the data required to obtain a marketing authorisation.

Regulatory approval for medicinal products requires applicants to provide information about the efficacy and safety of their product to regulatory authorities. The first applicant for approval of a new medicinal product must provide a substantial body of data relating to the product (including the results of pre-clinical tests and clinical trials).

The regulatory regime permits generic companies, who subsequently wish to gain their own approval for the same drug substance, to rely on information filed by the innovator company that made the first application.  In order to be able to benefit from the data provided by the innovator in their regulatory filings for that medicinal product - the "reference medicinal product" - a generic company must show that their product has the same qualitative and quantitative composition as that product and that it is bioequivalent.

So what is the impact of a product enjoying "data exclusivity"?

An innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company (typically a generic company) for the same drug substance. 

For marketing authorisation applications made from November 2005 onwards, the period of data exclusivity in Europe has been harmonised as 8 years from the date of first authorisation in Europe.  For marketing authorisation applications made before November 2005, the period of data exclusivity varies from EU member state to EU member state, and is either 6 years or 10 years.

For marketing authorisation applications made from November 2005 onwards, there is an additional period of 2 years of "market exclusivity".  This is the period of time during which a generic company may not market an equivalent generic version of the originator's pharmaceutical product (although their application for authorisation may be processed during this period, such that they are in a position to market their product on the expiry of this additional 2 year period).

An extra year of protection for new indications

As noted above, the rules determining exclusivity changed in 2005. Under the "old rules" data exclusivity lasted either 6 or 10 years. The "new rules" follow an "8 + 2 + 1" year approach:

• During the first 8 years from the grant of the innovator company's marketing authorisation, data exclusivity applies.
• After the 8 years have expired a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.
• After a period of 10 years from the grant of the innovator company's marketing authorisation, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity. 
• This additional 1 year may be obtained in a number of circumstances, such as where the innovator company is granted a marketing authorisation for a significant new indication for the relevant medicinal product. In such a situation the generic company can only market their product after 11 years from the grant of the innovator company's marketing authorisation.

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