Data Exclusivity

Manufacturers of new medicines may be granted a period of ‘data exclusivity’, granting them exclusive rights over safety and efficacy data from preclinical tests and clinical trials submitted for the registration of the medicine by regulatory agencies.

In the EU, this data exclusivity lasts for a period of 8 years, plus an additional 2 years of market exclusivity from the date of approval of the medicine. After this period, the manufacturer is obliged to release the information to companies wishing to develop generic versions of the medicine. Read more about this here.

As a result, new medicines protected by data exclusivity remain unaffordable and inaccessible to many patients, as pharmaceutical companies are able to increase prices as far as the market allows, and generic producers are delayed in their approval and marketing of cheaper generic products. Read more about this here.

There is no exception to the 8-year period of data exclusivity, meaning that EU countries cannot register a generic product during the data exclusivity period, even when the medicine is needed for compelling public health reasons or emergencies, or when a compulsory license has been issued on a medicine patent.

The data exclusivity legislation of the EU goes beyond what is required by international intellectual property law [see Patents and IP], which does not require states to confer exclusive rights over data related to marketing approval. It only obliges states to protect undisclosed test data submitted for the registration of new chemical entities against unfair commercial use as started in Article 39.3 TRIPS Agreement

Data exclusivity legislation prolongs the period of time during which affordable generic medicines are not available, thus limiting accessibility of certain medicines to patients in need.

Further reading:

Pascale Boulet, ‘How patents, data exclusivity and SPCs interact to extend market exclusivity of medicines: the example of Truvada’ (Medicines Law & Policy)

Ellen F. M. ‘t Hoen, Pascale Boulet and Brook K. Baker, ‘Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation’