./.WORLD TRADE
ORGANIZATIONG/TBT/N/CHE/3
7 June 2001
(01-2797)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   SWITZERLAND
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Federal Office of Public Health, CH-3003 Berne
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:   State Secretariat
for Economic Affairs
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Transplant products
5. Title, number of pages and language(s) of the notified document:   Federal Law on the
Transplantation of Organs, Tissues and Cells (Transplantation Law); relevant articles: 2, 3,
4, 7 and 45.  The Transplantation Law is available in French only.
6. Description of content:   Under this new draft all products containing vital cells of human
or animal origin which are standardised as such or the production of which is standardised
will be considered as transplant products (such as organs, tissues and cells; combined withmedical devices or not).  Unlike human organs, tissues and cells, which are not allowed for
commercialisation within Switzerland and abro ad (only the technology), it is foreseen that
transplant products will be allowed for commercialisation (articles 7 and 45 of the Draft
Federal Law on the Transplantation of Organs, Tissues and Cells).  However, the price of
transplant products may not include any kind of compensation for the human material itself.
The production of transplant products will be subject to a permission and the placing on the
market will require an authorisation.  Transplant products will also be covered by the newFederal Law on Pharmaceutical products and Medical Device which has already been
notified previously (G/TBT/Notif.97.129).          
7. Objective and rationale, including the na ture of urgent problems where applicable:
Since the development of transplant-products requests high investments and contains
considerable business-risks it is allowed to tr ade them:  this rule departs from the general
prohibition of the trade of organs, tissues and cells and establishes an exception for
transplant products.  However, in order to protect public health (article 4 of the DraftFederal Law on the Transplantation of Organs, Tissues and Cells) the production of
transplant products will be subject to a permission and the placing on the market will
require an authorisation.G/TBT/N/CHE/3
Page 2
8. Relevant documents:   Federal Law on Pharmaceutical Products and Medical Device (in
French): http:/www.admin.ch/ch/f/ff/2000/5689.pdf.
9. Proposed date of adoption:
Proposed date of entry into force:  2004          
10. Final date for comments:   31 July 2001.
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:           