Country |
Recognizes Clinical Trial Exemption |
Exemption Covers New Drugs as well as Generics/Biosimilars?1 |
Ability to Export Data for Authorization in Foreign Jurisdiction?2 |
Argentina |
No3 |
n/a |
n/a |
Australia |
Yes |
Yes |
Yes |
Austria |
Yes |
Arguable4 |
Arguable4 |
Belgium |
Yes |
No |
No |
Brazil |
Yes |
Yes |
Yes |
Bulgaria |
Yes |
Not clear |
Not clear |
Canada |
Yes |
Yes |
Yes |
Chile |
No |
n/a |
n/a |
China |
Yes6 |
Not clear |
Not clear |
Croatia |
Yes |
Yes |
Not clear |
Czech Republic |
Yes |
Yes |
Yes |
Denmark |
Not yet7 |
- |
- |
Egypt5 |
Yes |
Yes |
Unclear |
France |
Yes |
Arguable4 |
Arguable4 |
Germany |
Yes |
Yes |
Yes |
Hong Kong |
No |
n/a |
n/a |
Hungary |
Yes |
Arguable4 |
Not clear |
India |
Yes |
Yes |
Yes |
Iran5 |
Yes |
Yes |
Unclear |
Ireland |
Yes |
No |
No |
Israel |
Yes |
Yes |
Not clear |
Italy |
Yes |
Arguable4 |
Yes |
Jordan5 |
Yes |
Yes |
Unclear |
Korea |
Yes?8 |
Not clear |
Not clear |
Latvia |
Yes |
Yes |
Yes |
Lebanon5 |
Yes |
Yes |
Unclear |
Mexico |
Yes |
Yes |
Yes |
Morocco5 |
Yes |
Yes |
Unclear |
Netherlands |
Yes |
Arguable4 |
No |
New Zealand |
Yes |
Yes |
Not clear |
Philippines |
Yes |
Arguable4 |
Yes |
Poland |
Yes |
Yes |
Probably limited to EU-member states |
Portugal |
Yes |
No |
No |
Romania |
Yes |
Yes |
Yes |
Russia |
Yes |
Yes |
Not clear |
Saudi Arabia5 |
Yes |
Yes |
Unclear |
Singapore |
Yes |
Yes |
Not clear |
Slovakia |
Yes |
Yes |
Yes |
South Africa |
Yes |
Not clear |
Not clear |
Spain |
Yes |
Yes |
Yes |
Sweden |
Yes |
No |
No |
Switzerland |
Yes |
Yes |
Yes |
Taiwan3,11 |
No |
n/a |
n/a |
Turkey |
Yes |
Yes |
Yes |
UAE5 |
Yes |
Yes |
Unclear |
Ukraine |
No |
n/a |
n/a |
United Kingdom |
Yes |
Yes9 |
No |
United States |
Yes |
Yes |
Yes10 |
1 This column addresses whether the clinical trial exemption is limited to abbreviated generic/biosimilar trials which rely on an innovator's data, or whether trials conducted on new drugs are exempt as well.
2 This column addresses whether the exemption is available in a first jurisdiction if the clinical trial is conducted in the first jurisdiction and the data generated is exported to a foreign jurisdiction for authorization in the foreign jurisdiction.
3 Exemption only recognized for non-commercial experimentation
4 Is arguable but not specifically addressed by statute
5 MENA requirements
6 Based on judicially-created law. A statutorily created provision went into effect on October 1, 2009.
7 Pursuant to the EU directive, a new law on pharmaceuticals was introduced, however it did not contain the Bolar provision of Article 10(6). The provision was to be introduced into a revised Danish Patents Act.
8 Korean law is largely modeled on Japanese law which judicially recognizes a clinical trial exemption. However, as of December 19, 2008 there is no Korean case law on point.
9 Exemption in UK extended to brand pharmaceuticals
10 Provided the activity is objectively related to generating information for the US FDA
11 Taiwan is working on a proposed amendment to their Patent Act that would provide an exemption for clinical trials
*This document is based on information provided by local counsel in various countries. It does not constitute a legal opinion. Prior to commencing activities in any country, a legal opinion should be obtained from the relevant local associate based on the specific facts.