. /.   WORLD TRADE  
ORGANIZATION  G/RO/W/131 
8 October 2009 
 (09-4867) 
Committee on Rules of Origin Original:   English 
  
SWITZERLAND’S COMMENTS ON DOCUMENT G/RO/W/111/REV. 4 
  
 The following communication, dated 6 October 2009, is being circulated at the request of the 
Delegation of Switzerland.   
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   Switzerland would like to highlight some issues related to the proposed rules of origin in the 
Chemical - Pharmaceutical sector (Chapters 28 to 39). 
 
1. Structural issues related to HS Heading 30.02 
 
 Switzerland would like to reiterate the co mments submitted in its former communication 
(document G/RO/W/117 dated 11 April 2008), and bring additional information to a question 
concerning the non-applicability of the origin rule re lated to galenic forms of medicaments (ampoules, 
vials, etc.).  In our view, item HS 30.02 is a special ca se since both active substances and proportioned 
medicine forms are classified here.  The galenic fo rm is the proportioned medicine form (put up in 
measured doses).  It allows a patient to  take a medicament in the correct dosage.   Thus, the current 
formulation of the origin rule for proportioned me dicine forms is not appropriate (details below).  
 2. Active substances 
 
 Active substances are classified according to  the WCO under HS-heading 30.02.  According 
to Primary Rule 7 (Biotechnological Processes)  of Chapter 30, active substances can be 
biotechnologically processed.  The rule of origin "cha nge to the goods of this heading by biological or 
biotechnological processes" can be used. 
 
3. Galenic form, proportioned medicine form (ampoules, vials, etc.) 
 
 Active substances are classified by the WCO under HS-heading 30.02 (including sub-headings).  The same goes for galenic forms wh ich are also classified under HS-heading 30.02 
(including sub-headings).  In HS 30.02 the rule  CTH is not applicable for active substances of 
HS 30.02 which are processed in proportioned medi cine forms "Medicaments  (excluding goods of 
heading no 30.02, 30.05 or 30.06) …".  Example: monoclonal anti-body:  HS 3002.10;  ampoule with active substance monoclonal anti-body:  HS 3002.10.  Thus CTH does not apply in this case.  The 
same goes for the rule CTSH. 
 
4. Biotechnological processes 
 
 The ampoules are not biotechnologically manufactured.  The active substance is mixed with other auxiliary materials (excipients) and then f illed together into the ampoules.  The empty glass 
ampoule is filled in a germ-poor environment with sp ecial racking plants.  Staff is normally equipped 
with special protective clothing for germ-poor work.  Filling is thus to be considered as a technical 
process.  Since the packing process is not origin conferring, the production of the ampoule is to be G/RO/W/131 
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  considered as the last substantial processing operatio n (last substantial transformation).  Thus it is not 
possible that a biotechnological process takes plac e.  The rule for biotechnological processes is 
therefore not applicable for proportioned medicine forms.  
5. Rule for goods of heading 30.02 – Swiss proposal 
 
 Establishing an uniform rule of origin in  Chapter 30 for proportioned medicine:  from a 
systematic point of view medicine in the proportio ned form (put up in measured doses or packed for 
retail sale) of heading 30.02 should not have another approach for establishing origin compared to 
medicine in proportioned form (put up in measured doses or packed for retail sale) in heading 30.04.  
In the entire Chapter 30 the production of a propor tioned medicine form (excluding mere pressing of 
tablets or by mere encapsulation) should be origin conferring.  Therefore, the rule of origin for 
heading 30.02 for the proportioned medicine shoul d read "production of the measured doses or in 
forms or packing for retail sale except by mere pressi ng of tablets or by mere encapsulation".  It is 
noted that no residual rule was proposed for 30.02. 
 
6. Chapter Residual Rule for goods of headings 30.03 and 30.04 
 
 The proposed residual rule for goods of headings 30.03 and 30.04 produced by mixing or otherwise combining materials of different origin s indicates that these goods originate in the country 
that produced the therapeutic or prophylactic mate rials (disregarding solvents and other non-active 
additives) that predominate by weight or volum e, as appropriate, over those of each other single 
country.  This would mean in practice that a medicament originating in Switzerland and filled there in a glass ampoule would have the origin of the glass  ampoule.  This only because glass is heavier than 
the medicament itself. Such Residual rule contra dicts in our mind with the concept of the last 
substantial processing step (substantial transformation).  Therefore, a rule of origin based exclusively 
on weight or volume should not be adopted. 
 
7. Chapter Residual rule - for goods of headings 30.03, 30.04, 30.02 – Swiss proposal 
 
 We propose to amend point 1 of Chapter 30 residual rule as follows: 
 
 “Goods of headings 30.03 and 30.04 produced by  mixing or otherwise combining materials of 
different origins originate in the country that produced the therapeutic or prophylactic materials 
(disregarding solvents and other non-active additives)  that predominate by weight or volume, or by 
total value of materials and related processing activ ity, as appropriate, over those of each other single 
country.” 
 
 We propose to add the same residual rule for goods of 30.02.  
8. Chapter Residual rules for goods of Chapters 28 to 39 – Swiss proposal 
 
 Taking into account the considerations mentione d in the two last sentences of paragraph 6, we 
would also indicate that we still support the introducti on of an alternative value criteria as appropriate 
in the Chapter Rules of the Chemical - Ph armaceutical sector (HS Chapters 28 - 39).  
  
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