E-DRUG: Data exclusivity and trials data disclosure - collision?(5)
------------------------------------------------------------------
dear E-druggers
There is a difference between data **protection** and data **exclusivity**.
Data **protection** is a general obligation for WTO member states to provide protection against unfair commercial use for undisclosed information only. The TRIPS agreement does not specify a timeframe for data protection.
TRIPS article 39.3 provides data protection to all producers of new chemical entities (pharmaceutical or agricultural chemicals; not only patent-holders or other inventors) against unfair commercial use of undisclosed data (for example, confidential information that they have provided to drug regulatory authorities in a drug registration dossier).
A drug regulator, who refers to a registration dossier of an originator product while assessing a generic drug application, does so in the interest of public health; most experts do not see this as being unfair commercial use or a violation of data protection.
Drug comapnies themselves have recently announced that they want all clinical data to be public (see IFPMA statement at
So there should be no conflict between data **protection** and clinical trials.
Data **exclusivity** is a TRIPS+ condition, often found in developed countries or in Free Trade Agreements, which goes far beyond data protection. Data exclusivity actively disallows regulatory authorities to consider generic drug applications for a number of years after the marketing approval of the originator drug.
Data exclusivity also blocks market access to generics if:
o The original product is not patented,
o The country does not have to grant patents yet (e.g., LDCs until 2016), or
o The country has issued a compulsory license.
Data exclusivity might even block a generic if the originator is not even marketed, depriving patients of access to an effective drug.
USA, EU and several Free Trade Agreements include data exclusivity periods of 6-10 year. This is a TRIPS+ condition, and should be avoided by developing countries.
Generic companies in Europe accepted a data exclusivity clause, in exchange for a Bolar clause. There is no obligation for developing countries under TRIPS to do so.
I hope this clarifies the confusion?
Wilbert Bannenberg
(a non-lawyer, so please correct me if I am wrongly interpreting TRIPS!)
---------
Dr Wilbert Bannenberg, Public Health Consultant
Mobile +31-6-20873123
Tel work +31-497-550713
Fax +31-497-550712
Email: wjb@wxs.nl
**please note: wilbertbannenberg@compuserve.com no longer valid**
Postal address:
Prins Bernhardstraat 1, 5571 GC Bergeyk, The Netherlands