# News 2007 #

January - February - March - April - May - June - July - August

News 2006

News 2005

News 2004

 

September 2007

-        Swiss Federal Council's proposed message for a new constitutional article on research on humain beings

http://www.bag.admin.ch/themen/medizin/00701/00702/03990/03994/index.html?lang=fr 

 

August 2007

 

July 2007

-        Swissmedic's new documents regarding insurance for clinical trials

http://www.newsmaker.ch/upload/customers/swissmedic/Commentaire(4).pdf  http://www.swissmedic.ch/files/pdf/Schaeden_Rahmenbedingungen-F.pdf

 

June 2007

-        Swissmedic's annual report 2006

http://www.swissmedic.ch/files/pdf/Swissmedic_Geschaeftsbericht_2006.pdf

 

May 2007

-        Federal Tribunal's decision in Schering v. Swissmedic (advertising regulations) (2A.20/2007)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=09.05.2007_2A.20/2007

-        Federal Tribunal's decision (withdrawal of authorization) (2A.626/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=01.05.2007_2A.626/2006

-        Federal Tribunal's decision (illegal dispensing by pharmacist) (6P.11/2007 6S.26/2007)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=04.05.2007_6P.11/2007

 

April 2007

-        Federal Tribunal's decision (inclusion in the reimbursement list) (K 148/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=03.04.2007_K_148/06

-        Federal Tribunal's decision (authorization)

http://relevancy.bger.ch/AZA_BVGer/pdf/aza/2007/c_02095_2006_2007_04_09_t.pdf

 

March 2007

-        Federal Tribunal's decision (authorization) (2A.526/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=06.03.2007_2A.526/2006

-        Federal Tribunal's decision (medical device)

http://relevancy.bger.ch/AZA_BVGer/pdf/aza/2007/c_02096_2006_2007_03_05_t.pdf

-        EMEA, draft Guideline on first-in-man clinical trials

http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf

-        EMEA annual report 2006

 http://www.emea.europa.eu/pdfs/general/direct/emeaar/EMEA_Annual_Report_2006_full.pdf

 

February 2007

-        Federal Council's projet to modify the LPTh

http://www.bag.admin.ch/themen/medizin/00707/index.html?lang=fr  http://www.bag.admin.ch/themen/medizin/00707/index.html?lang=fr&download=M3wBPgDB/8ull6Du36WenojQ1NTTjaXZnqWfVp7Yhmfhnapmmc7Zi6rZnqCkkIZ2f397bKbXrZ6lhuDZz8mMps2gpKfo

 

January 2007

-        U.S. Supreme Court, MedImmune v. Genentech

http://www.supremecourtus.gov/opinions/06pdf/05-608.pdf 

-        Federal Tribunal's decision (inclusion in the reimbursement list) (ATF 133 V 239) (K 45/2005)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=24.01.2007_K_45/05

 

# News 2006 #

January, February, March, April, May, June, July, August, September, October, November

News 2005

News 2004

 

December 2006

-        Swissmedic's classification of substances as food or medicines

http://www.swissmedic.ch/files/pdf/Einleitung_Publikation_Abgrenzung_LM-AM_F.pdf

-        Federal Tribunal's decision (2A.287/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=22.12.2006_2A.287/2006 

-        Federal Tribunal's decision (withdrawal of authorization) (2A.243/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=22.12.2006_2A.243/2006

-        U.S. FDA, Proposed rule on expanded access to investigational drugs for treatment use and Proposed rule on charging for investigational drugs

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-9684.pdf & http://www.fda.gov/OHRMS/DOCKETS/98fr/06-9685.pdf 

-        EU  Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_404/l_40420061230en00090025.pdf

 

 

November 2006

-        Federal Tribunal's decision (2A.343/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=01.11.2006_2A.343/2006

-        Federal Tribunal's decision (prescription) (2A.48/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=03.11.2006_2A.48/2006 

-        Federal Tribunal's decision (2A.56/2006 + 2P.32/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=16.11.2006_2P.32/2006

 

October 2006

-        Swiss revised ordinances on therapeutic products, entry into force

http://www.swissmedic.ch/fr/fach/overall.asp?theme=0.00084.00002&theme_id=499&news_id=4874&page=1

-        EMEA, Publication of withdrawals 

http://www.emea.eu.int/pdfs/human/euleg/23935005en.pdf

-        EMEA, Publication of negative opinions and withdrawals

http://www.emea.eu.int/pdfs/human/euleg/31135505en.pdf

-        EU Commission, Ethical considerations regarding clinical trials on children 

http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/docs/paeds_ethics_consultation20060929.pdf

 

September 2006

-        E.U. Court of First Instance, T-168/01, GSK v. Commission (antitrust)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=T-168/01&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

-        E.U. Court of Justice, C-526/04, Laboratoires Boiron (tax)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Submit&docj=docj&numaff=&datefs=&datefe=&nomusuel=&domaine=&mots=medicinal&resmax=100

-        EMEA, Template for EU Risk Management Plan

http://www.emea.eu.int/pdfs/human/euleg/19263206en.pdf

-        Swissmedic's comments on the simplified authorization for orphan and rare drugs

http://www.swissmedic.ch/files/pdf/Commentaires_sur_l%E2%80%99autorisation_simplifi%C3%A9e.pdf http://www.swissmedic.ch/files/pdf/Commentaires_sur_les_m%E9dicaments_orphelins.pdf

 

August 2006

-        Swissmedic's requirements for Internet advertising

http://www.newsmaker.ch/upload/customers/swissmedic/Arzneimittelwerbung_im_Internet_D-F(2).pdf

-        Federal Tribunal's decision on imports of unauthorized medicinal products (2A.342)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2006/Entscheide_2A_2006/2A.342__2006.html

-        Federal Tribunal's decision Pfizer v. Swissmedic (2A.63/2006)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=10.08.2006_2A.63/2006

-      U.S. Court of Appeals for the Tenth Circuit, Nutraceuticals v. FDA (05-4151) (ephedra ban)  

 

July 2006

-        Federal Tribunal's decision on withdrawal of authorization (2A.132)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2006/Entscheide_2A_2006/2A.132__2006.html

-        Federal Tribunal's decision on withdrawal of authorization (2A.131)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=20.07.2006_2A.131/2006

-        Federal Tribunal's decision (2A.723/2005)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=04.07.2006_2A.723/2005

-        EU Commission, Draft guidance on non-commercial clinical trials 

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/07_2006/guide_noncommercial_2006_07_27.pdf

-        EU Commission, Definition of investigational medicinal products 

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/07_2006/def_imp_2006_07_27.pdf

-      U.S. Court of Appeals for the Fourth Circuit, Mylan v. FDA (05-2160) (approval of authorized generics)  

 

 

June 2006

-      U.S. Appeal Court for the District of Columbia, Apotex v. FDA (06-5105) (ANDA 180-day exclusivity) 

-      Federal Tribunal's decision on advertising (2A.607/2005)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2005/Entscheide_2A_2005/2A.607__2005.html

 

 

May 2006

-        E.U. Court of Justice, Decision C-431/04 (supplementary protection certificate)

http://curia.eu.int/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=C-431/04&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

-        Federal Tribunal's decision on unauthorized products (ATF 132 II 298) (2A.669 + 677/2005)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2005/Entscheide_2A_2005/2A.669__2005.html

-        Swissmedic's 2005 Annual Report 

http://www.swissmedic.ch/files/pdf/swissmedic_GB_05.pdf 

-        CORE PT, decision (HM 05.139)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.139Entscheid.pdf

-        CORE PT, decision (HM 05.148)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.148Entscheid.pdf

-      U.S. Court of Appeals for the District of Columbia, Abigail Alliance v. FDA (05-5350) (access to investigational drugs)

 

April 2006

-        E.U. Court of First Instance, T-202/04, Madaus v. OHIM (Communitry trade mark)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=T-202/04&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

 

March 2006

-        Swiss Federal Tribunal, decision 2A.92/2006 (authorization)

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=09.03.2006_2A.92/2006

-        Swiss Federal Tribunal, decision 4P.285/2005 (unfair competition among pharmacies)

http://www.polyreg.ch/d/informationen/bgeunpubliziert/Jahr_2005/Entscheide_4P_2005/4P.285__2005.html

-        Swissmedic's pharmacovigilance report 

http://www.newsmaker.ch/upload/customers/swissmedic/Medienrohstoff%20Meldesysteme%202006%20F.pdf 

-        Swissmedic's report on the results of the consultation procedure regarding the new ordinances

http://www.bag.admin.ch/themen/medizin/00707/01705/index.html?lang=fr&download=M3wBUQCu/8ulmKDu36WenojQ1NTTjaXZnqWfVp7Yhmfhnapmmc7Zi6rZnqCkkIV3fHyDbKbXrZ2lhtTN34al3p6YrY7P1oah162apo3X1cjYh2+hoJVn6w==

-        CORE PT, decision (advertising) (HM 05.143)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.143Entscheidanonym.pdf 

-        CORE PT, decision (HM 05.142)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.142Entscheidanonym.pdf 

-        CORE PT, decision (advertising) (HM 05.124)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.124Entscheidanonym.pdf 

-        E.U. Court of Justice, C-495/04, A.C. Smits-Koolhoven (tax)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=C-495/04&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

-        E.U. Court of First Instance, T-26/02, Daiichi v. Commission (competition)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=T-26/02%20&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

-        E.U. Court of First Instance, Decision T-15/02 (BASF fines in the vitamin cartel)

http://curia.eu.int/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=T-15/02%20&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100 

-    EMEA's 2005 Annual Report 

http://www.emea.eu.int/pdfs/general/direct/emeaar/AnnualReport2005.pdf 

-      U.S. Court of Appeals for the District of Columbia, Teva v. FDA (05-5401) (180-day exclusivity)  

 

February 2006

-        Federal Penal Tribunal's decision BV.2005.35 (Swissmedic cooperation)

http://www.bstger.ch/pdf/BV_2005_35.pdf 

-        Federal Tribunal's decision 2A.104/2006 (procedural issues)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2006/Entscheide_2A_2006/2A.104__2006.html 

-        Federal Tribunal's decision (ATF 123 II 200) (2A.523/2005) (exemption from authorization requirement)

http://www.polyreg.ch/bgeleitentscheide/Band_132_2006/BGE_132_II_200.html

-        Federal Tribunal's decision 2A.523/2005

http://jumpcgi.bger.ch/pdf/aza/2006/2a_0523_2005_2006_02_21_t.pdf

-        Office for Public Health's  project of a new law on research (loi relative à la recherche sur l'être humain)

http://www.bag.admin.ch/humanforsch/aktuell/f/F_Verfassungsartikel.pdf http://www.bag.admin.ch/humanforsch/aktuell/f/F_Humanforschungsgesetz.pdf http://www.bag.admin.ch/humanforsch/aktuell/f/F_Verf_Erlaeuterungen.pdf http://www.bag.admin.ch/humanforsch/aktuell/f/F_HFG_Erlaeuterungen1.pdf

-        CORE PT, decision (importation) (HM 06.155)

http://www.vpb.admin.ch/rohtexte/R/2006/HM06.155Entscheidanonym.pdf 

-        CORE PT, decision (payment for information) (HM 06.153)

http://www.vpb.admin.ch/rohtexte/R/2006/HM06.153Entscheidanonym.pdf 

 

January 2006

-        Federal Tribunal's decision 132 V 18 (K 145/05) (reimbursement by insurance of pharmacy's drug payment)

http://www.polyreg.ch/bgeleitentscheide/Band_132_2006/BGE_132_V_18.html

-        Swissmedic report on article 33 LPTh (Journal 1/2006)

http://www.swissmedic.ch/files/pdf/Auszug_Art_33.pdf

-        Swissmedic fights illegal advertising 

http://www.swissmedic.ch/fr/fach/overall.asp?theme=0.00081.00002&theme_id=477&news_id=4749&page=1
http://www.newsmaker.ch/upload/customers/swissmedic/Information_aux_médias(2).pdf, http://www.newsmaker.ch/upload/customers/swissmedic/Information_aux_médias2.pdf 

-        Swissmedic's rules on complementary medicines 

http://www.swissmedic.ch/fr/fach/overall.asp?theme=0.00081.00002&theme_id=477&news_id=4741&page=1 

-        Swissmedic's rules on well-known medicines 

http://www.swissmedic.ch/fr/fach/overall.asp?theme=0.00081.00002&theme_id=477&news_id=4740&page=1 

-        OFSP's report on proposed OAMal revision 

http://www.bag.admin.ch/kv/gesetze/f/Modifications06_F.PDF http://www.bag.admin.ch/kv/gesetze/f/Commentaire06_F.PDF 

-        CORE PT, decision (importation) (HM 05.117)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.117Entscheidanonym.pdf 

-        CORE PT, decision (HM 05.119)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.119Entscheidanonym.pdf 

-        CORE PT, decision (advertising) (HM 05.132)

http://www.vpb.admin.ch/rohtexte/R/2006/HM05.132Entscheidanonym.pdf 

-        CORE PT, decision (HM 04.061)

http://www.vpb.admin.ch/rohtexte/R/2006/HM04.061Entscheidanonym.pdf 

-        U.S. Supreme Court decision, Gonzales v. Oregan (suicide and practice of medicine) 

http://supct.law.cornell.edu/supct/pdf/04-623P.ZO ; http://supct.law.cornell.edu/supct/pdf/04-623P.ZD ; http://supct.law.cornell.edu/supct/pdf/04-623P.ZD1 

-      U.S. Court of Appeals for the District of Columbia, Novartis v. FDA (04-5414) (changes to facilitate generic approval ) 

-      E.U. Court of First Instance, Decision T-251/03 (competence of the Commission in national authorization procedures)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=T-251/03&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

-        E.U. Court of First Instance, C-273/03, Merck (Marketing authorisation and SPC)

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en&Submit=Rechercher&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=T-273/03&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

 

 

# News 2005 #

January, February, March, April, May, June, August, September, October, November

News 2006

News 2004

 

December 2005

-        OFSP's draft ordinances accompanying the law on transplantation

http://www.bag.admin.ch/transpla/aktuell/f/TransplantationsVo.pdf  http://www.bag.admin.ch/transpla/aktuell/f/Erl_TransplantationsVo.pdf http://www.bag.admin.ch/transpla/aktuell/f/Organzuteilungsverordnung.pdf  http://www.bag.admin.ch/transpla/aktuell/f/Erl_OrganzuteilungsVo.pdf   http://www.bag.admin.ch/transpla/aktuell/f/XenotransplantationsVo.pdf   http://www.bag.admin.ch/transpla/aktuell/f/Erl_XenotransplantationsVo.pdf  http://www.bag.admin.ch/transpla/aktuell/f/TransplantationgsgebVo.pdf   http://www.bag.admin.ch/transpla/aktuell/f/Erl_TxGebVo.pdf http://www.bag.admin.ch/transpla/aktuell/f/Begleitschreiben_IK.pdf

-      U.S. District Court decision, McNellis v. Pfizer (Zoloft, suicide, preemption) 

-      EU Commission's draft guideline on elements required to support the 1-year extension of the data protection period. 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/12-05/Guideline%20on%2014_11_%20for%20public%20consultation.pdf 
http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/12-05/10%20_5_%20guideline%20for%20public%20consultation%2016%20December%202005.pdf 

-      EU Commission's proposed volume 9A on pharmacovigilance 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/12-05/draft%20of%20Volume%209a_12_2005.pdf 

-      EU Commission's draft guideline on the scope of the optional centralized procedure 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/12-05/Optional%20scope%20publ%2021%2012%2005.pdf 

 

November 2005

-    Federal Counsil's  revision of the OAMal

http://www.bag.admin.ch/kv/gesetze/f/oamal_091105_projet_f.pdf

-    Federal Tribunal's  decision 2A.278/2005  (marketing authorization, change to the information notice)

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=29.11.2005_2A.278/2005 

-    U.S. District Court decision, Adamu v. Pfizer (Trovan, clinical trials in Nigeria, lack of subject matter jurisdiction) 

-    E.U. Court of First Instance, T-154/03, Biofarma v. OHIM (Community trade mark)

 

October 2005

-    Swissmedic's  enforcement control communication

http://www.newsmaker.ch/upload/customers/swissmedic/Information_aux_médias.pdf 

-        E.U. Commission, Detailed guidance for the request for authorisation of a clinical trial (revised)

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/10_05/CA_14-2005.pdf 

 

September 2005

-    Swiss Federal Tribunal's Decision 131 V 349 (K 100/04) (off-label reimbursement)

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=21.09.2005_K_100/04 

-    Swiss Federal Tribunal's Decision K 144/04 on reimbursement of liver transplantation costs from a live donor

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=21.09.2005_K_144/04

-    CORE PT, decision (HM 05.107) on product classification

http://www.vpb.admin.ch/rohtexte/R/2005/HM05.107Entscheidanonym.pdf

 

August 2005

-        PhRMA Guiding Principles on DTC Advertising of Rx drugs  

from http://www.phrma.org/mediaroom/press/releases/02.08.2005.1195.cfm 

-    Swiss Federal Tribunal's Decision 2A.522/2004 on clinical trials

http://jumpcgi.bger.ch/cgi-bin/JumpCGI?id=18.08.2005_2A.522/2004

-    Swiss Federal Tribunal's Decision 2A.139/2005 on marketing authorizations 

http://www.polyreg.ch/bgeunpubliziert/Jahr_2005/Entscheide_2A_2005/2A.139__2005.html 

-    Swiss Federal Tribunal's Decision 2A.16/2005 on marketing authorizations 

http://www.polyreg.ch/bgeunpubliziert/Jahr_2005/Entscheide_2A_2005/2A.16__2005.html 

 

July 2005

-    Swiss Federal Tribunal's Decision xxx

 

June 2005

-        Swissmedic's new set of draft ordinances regarding drugs

http://www.swissmedic.ch/files/pdf/AMZV_fr_Erlass_Juni05.pdf (OEMéd)
http://www.swissmedic.ch/files/pdf/AMZV_fr_Erlaeuterung_Juni05.pdf (OEMéd report)
http://www.swissmedic.ch/files/pdf/VAZV_fr_Erlass_Juni05.pdf (OASMéd)
http://www.swissmedic.ch/files/pdf/VAZV_fr_Erlass_Juni05.pdf (OASMéd report)
http://www.swissmedic.ch/files/pdf/HGebV_fr_Erlass_Juni05.pdf (OEPT)
http://www.swissmedic.ch/files/pdf/HGebV_fr_Erlaeuterung_Juni05.pdf (OEPT report)
http://www.swissmedic.ch/files/pdf/KPAV_fr_Erlass_Juni05.pdf (OAMédcophy)
http://www.swissmedic.ch/files/pdf/KPAV_fr_Erlaeuterung_Juni05.pdf (OAMédcophy report)

-    Swiss Appeal Commission CORE-PT  Decision JAAC 70.19 (quality issues)

http://www.vpb.admin.ch/franz/doc/70/70.19.html 

-    Swiss Appeal Commission CORE-PT  Decision JAAC 70.20 (importation)

http://www.vpb.admin.ch/franz/doc/70/70.20.html 

-    Swiss Appeal Commission CORE-PT  Decision JAAC 70.21 (procedure)

http://www.vpb.admin.ch/franz/doc/70/70.21.html 

-        U.S. Supreme Court Decision, Merck KGAA v. Integra (Patent, Bolar) 

http://a257.g.akamaitech.net/7/257/2422/13jun20051230/www.supremecourtus.gov/opinions/04pdf/03-1237.pdf 

-        U.S. Supreme Court Decision, Gonzales v. Raich (Medical marijuana) 

http://a257.g.akamaitech.net/7/257/2422/06jun20051130/www.supremecourtus.gov/opinions/04pdf/03-1454.pdf 

-        U.S. Supreme Court Decision, Kelo v. City of New London (Taking clause) 

http://straylight.law.cornell.edu/supct/pdf/04-108P.ZO  http://straylight.law.cornell.edu/supct/pdf/04-108P.ZC  http://straylight.law.cornell.edu/supct/pdf/04-108P.ZD   http://straylight.law.cornell.edu/supct/pdf/04-108P.ZD1 

-        U.S. District Court New York Decision Suthers v. Amgen (access to investigational treatment following a trial) 

http://courthousenews.com/amgen.pdf  

-    Swiss Federal Tribunal's Decision 2A.660/2004

http://www.polyreg.ch/bgeunpubliziert/Jahr_2004/Entscheide_2A_2004/2A.660__2004.html 

-    Swiss Federal Council's Decision on the social reimbursement of alternative medicine 

http://www.bag.admin.ch/dienste/medien/2005/f/anhaenge/KV%20PEK%20Erl_030605.pdf  http://www.bag.admin.ch/dienste/medien/2005/f/05060321.htm 

-    Swissmedic, Information on the recognition of Swiss marketing authorization by Liechtenstein 

http://www.swissmedic.ch/cgi/news/index.asp?sitetype=laien&news_id=4551
http://www.seco.admin.ch/imperia/md/content/news/medienmitteilungen/h_botschaft_fuerstentum_1_d.pdf?PHPSESSID=c025e39dd0d2788530b02f11c240e27d 

-        E.U. Court of Justice, Decision C-211/03, C-299/03, C-316/03 (distinction between food and medicinal products)

http://curia.eu.int/jurisp/cgi-bin/form.pl?lang=en&Submit=Submit&alldocs=alldocs&docj=docj&docop=docop&docor=docor&docjo=docjo&numaff=&datefs=2005-01-01&datefe=2005-08-11&nomusuel=&domaine=&mots=medicinal&resmax=100 

-        E.U. Court of Justice, Decision C-456/03 (patent for biotechnological inventions)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0456 

-        E.U. Commission, AstraZeneca Decision (abuse of dominant position)

http://ec.europa.eu/comm/competition/antitrust/cases/decisions/37507/prov_version.pdf 

 

May 2005

-    Swiss Federal Tribunal's Decision xxx

-    Swissmedic, May 2005 Journal , position on Liechtenstein differed recognition of Swiss authorizations 

http://www.swissmedic.ch/files/pdf/05_2005.pdf  (p.345)

-        E.U. Court of Justice, Decision C-53/03, Syfait  (abuse of dominant position? restriction of parallel imports)

http://curia.eu.int/jurisp/cgi-bin/gettext.pl?lang=en&num=79949468C19030053&doc=T&ouvert=T&seance=ARRET&where=() 

-        E.U. Court of Justice, Decision C-212/03 (personal imports)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0212 

-        E.U. Court of Justice, Decision C-444/03 (authorization of homeopathic products)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0444 

-        E.U. Commission. Consultation paper and draft regulation on advanced therapies (human tissue engineered products and other cell/tissue based products) 

http://pharmacos.eudra.org/F2/advtherapies/docs/ConsultationPaper-AdvancedTherapies-2005-May-04.pdf http://pharmacos.eudra.org/F2/advtherapies/docs/DraftRegulation-Advanced%20Therapies-2005-May-04.pdf 

-    Swiss Federal Tribunal's Decision K 83/04 (social reimbursement of pharmaceuticals)

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=02.05.2005_K_83/04  

-    Swiss Appeal Commission CORE-PT  Decision JAAC 69.98 (sale of pharmaceutical specialiies)

http://www.vpb.admin.ch/franz/doc/69/69.98.html 

-    Swissmedic's 2004 Annual Business Report 

http://www.swissmedic.ch/files/pdf/swissmedic_GB_2004.pdf 

 

April 2005

-    Swiss Appeal Commission CORE-PT  Decision JAAC 70.22 (manufacturing)

http://www.vpb.admin.ch/franz/doc/70/70.22.html 

-    Swiss Appeal Commission CORE-PT  Decision JAAC 69.99 (drug advertising) 

http://www.vpb.admin.ch/franz/doc/69/69.99.html 

-    Swiss Office for Public Health's Report on alternative medicines 

http://www.bag.admin.ch/kv/forschung/f/2005/Schlussbericht_PEK.pdf 

http://www.bag.admin.ch/kv/forschung/f/2005/Gesundheitsbefragung-KM.pdf 

-        U.S. Supreme Court Decision, Dura Pharmaceuticals v. Broudo (Securities Litigation)

http://supct.law.cornell.edu/supct/pdf/03-932P.ZO 

-        U.S. District Court of Utah, Decision, Nutraceutical v. FDA (Ephedra)

http://www.utd.uscourts.gov/reports/204cv409-28.pdf 

-        E.U. Court of Justice. Decision C-207/03 + C-252/03, Millenium, Novartis, (Supplementary protection certificate)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0207 

-        E.U. Commission. Directive 2005/28/EC  laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2005_28/DIR_2005_28_EN.pdf 

 

March 2005

-    Swiss Federal Tribunal's Decision 131 I 198 (2P.324/2003) (procedural)

http://www.polyreg.ch/bgeleitentscheide/Band_131_2005/BGE_131_I_198.html 

-        U.S. FDA, Premarketing Risk Assessment, Guidance for Industry.

http://www.fda.gov/cder/guidance/6357fnl.pdf 

-        U.S. FDA, Development and Use of Risk Minimization Action Plans, Guidance for Industry.

http://www.fda.gov/cder/guidance/6358fnl.pdf 

-        U.S. FDA, Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, Guidance for Industry.

http://www.fda.gov/cder/guidance/6359OCC.pdf 

-        U.S. FDA, Pharmacogenomic Data Submissions, Guidance for Industry.

http://www.fda.gov/cder/guidance/6400fnl.pdf 

http://www.fda.gov/cder/guidance/6400fnlAttch.pdf 

-        U.S. FDA, Using a Centralized IRB Review Process in Multicenter Clinical Trials, Draft Guidance. 

http://www.fda.gov/cder/guidance/OC273dft.pdf 

-        EMEA. Revised Code of Conduct 

 http://www.emea.eu.int/pdfs/general/admin/Conduct/647003en.pdf 

-        EMEA. Inspection Guidance (EMEA/INS/GMP/50288/2005) 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/03_05/ASM%20Inspections%20Guidance%20_final_20050303.pdf 

-        European Commission. Proposal for a Council Regulation amending Regulation 297/95 on fees payable to the EMEA (COM (2005) 106 final)

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/04_05/com2005_0106en01.pdf 

-        EMEA. Tenth Annual Report 2004 (EMEA/61492/2005/EN/Final)

http://www.emea.eu.int/pdfs/general/direct/emeaar/ar6149205en.pdf 

-        U.N. General Assembly's Declaration on Human Cloning,  

http://www.un.org/News/Press/docs/2005/ga10333.doc.htm 

 

February 2005

-        E.U. Commission's Proposal for a Regulation on penalties under Regulation 726/2004 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/02_05/Penalties%20-%20Public%20consultation%2002%202005.pdf 

-        E.U. Commission's User Guide for the Application Form

http://pharmacos.eudra.org/F2/eudralex/vol-2/B/UserGuide2_20050303.pdf 

http://pharmacos.eudra.org/F2/eudralex/vol-2/B/part1a_03-2005.pdf 

-        E.U. Commission's Various Notices to Applicants 

http://pharmacos.eudra.org/F2/eudralex/vol-2/C/mr-renewal-form_2005_03.pdf  

http://pharmacos.eudra.org/F2/eudralex/vol-2/C/bluebox_03_2005.pdf 

http://pharmacos.eudra.org/F2/eudralex/vol-2/A/ctd-chap7_2005-03.pdf 

-        E.U. Commission's EUDRACT (draft) Guideline (data fields to be included) 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/03_05/Draft_guid_EudraCT_data_20050303.pdf 

-    Swissmedic's general conditions on insurance for clinical trials

http://www.swissmedic.ch/files/pdf/Schaeden_Rahmenbedingungen-F.pdf 

-    Swissmedic's Statistics on Pharmacovigilance (Annonce d’incidents liés à l’utilisation de produits thérapeutiques)

http://www.newsmaker.ch/upload/customers/swissmedic/Information_aux_médias(2).pdf 

-    Swiss Federal Insurance Tribunal's decision, K 45/03 (possibility for the insured individual to appeal social sickness insurance premiums) 

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=01.02.2005_K_45/03 

-        Draft OECD Guidelines for the Licensing of Genetic Inventions

http://www.oecd.org/dataoecd/44/44/34343903.pdf 

-        U.S. Class Action Fairness Act of 2005

http://www.theorator.com/bills109/s5.html 

-        U.S. National Institutes of Health (NIH), Public Access Initiatives

http://www.nih.gov/about/publicaccess/publicaccess_imp.pdf  http://www.nih.gov/about/publicaccess/index.htm 

 -        U.S. Commonwealth Court v. various pharmaceutical companies, 868 A.2d 624 (2005)  (jurisdiction over foreign defendants)

http://www.courts.state.pa.us/OpPosting/CWealth/out/212MD04_2-1-05.pdf 

 

 

January 2005

-        Swiss Federal Tribunal's Decision 6P.151/2004 (illegal prescription of unauthorized drugs)

http://www.polyreg.ch/bge/bgeunpubliziert/Jahr_2004/Entscheide_6P_2004/6P.151__2004.html 

-        E.U. Court of Justice,  C-245/03, Merck v. Belgium, 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/02_05/C-245-03%20judgment%2020%2001%202005.pdf 

-        E.U. Court of Justice,  C-296/03, GSK v. Belgium

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/02_05/C-296-03%20judgment%2020%2001%202005.pdf 

-        E.U. Court of Justice,  C-74/03, SKB v. Denmark

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/02_05/C-74-03%20judgment%2020%2001%202005.pdf 

-        OECD Competition Committee, Intellectual Property Rights Report  

http://www.oecd.org/dataoecd/61/48/34306055.pdf 

-        IFPMA Joint Position on the disclosure of clinical trial information

http://www.ifpma.org/documents/NR2204/joint%20position_clinical%20trials.PDF 

-        U.S. Court of Appeals for the Federal Circuit in Teva v. Pfizer 

http://caselaw.lp.findlaw.com/data2/circs/fed/041186p.pdf 

-        E.U. Commission,  Questions & Answers - Clinical Trial Documents 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/01_05/ClinicalTrialQ&A%20_24-01-05.pdf 

-    Swissmedic's Guidelines on TV advertising (Image finale des publicités pour les médicaments diffusées au cinéma et à la télévision)

http://www.swissmedic.ch/files/pdf/01_2005.pdf (p.12-13)

-    Commission de la concurrence, Préavis sur le projet de modification de la loi sur les brevets, règles en matière d'épuisement , p.1177

http://www.weko.admin.ch/publikationen/00212/RPW-2004-4.pdf?lang=de 

 

 

 

# News 2004 #

News 2005

Novembre, October, September, August, July, June, May, April, March, February, January

 

December 2004

-    U.S. HHS Task Force on Drug Importation,  Report on Prescription Drug Importation 

http://www.hhs.gov/importtaskforce/Report1220.pdf 

-    Swiss Federal Council's opinion on the Report of the "Commission de gestion du Grand Conseil" on Swissmedic 

http://www.admin.ch/ch/f/ff/2005/333.pdf 

-    Swiss Report on patent rights exhaustion through parallel imports

http://www.ejpd.admin.ch/doks/mm/files/041203_patent_roh-f.pdf 

http://www.evd.admin.ch/imperia/md/content/dossiers/importations_paralleles/f/rapport_final_envoi-wak_f_04-12-15.pdf?PHPSESSID=e26ecfb2ba096407a0ea92ede049c508 

-    French Competition Council decision n° 04-D-77 in Productiv v. GSK 

http://www.conseil-concurrence.fr/pdf/avis/04d77.pdf 

-    E.U. Decision of 27 December 2004 amending Decision 2001/497/EC as regards the introduction of an alternative set of standard contractual clauses for the transfer of personal data to third countries (2004/915/EC) (C(2004) 5271)

http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2004/l_385/l_38520041229en00740084.pdf 

http://europa.eu.int/rapid/pressReleasesAction.do?reference=MEMO/05/3&format=HTML&aged=0&language=EN 

-    E.U. Decision 2004/858/CE  of 15  December 2004 setting up an executive agency, the ‘Executive Agency for the Public Health Programme’, for the management of Community action in the field of public health

http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2004/l_369/l_36920041216en00730075.pdf 

-    E.U. Court of Justice, Decision C-36/03 , Approved Prescription Services (essentially similar products)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0036 

-    E.U. Court of Justice, Decision C-41/02  (enriched foodstuff)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62002J0041 

 

November 2004

-        Switzerland approves the law on stem cell research

http://www.admin.ch/ch/f/pore/va/20041128/det516.html 

-    E.U. Commission study on Innovation in Pharmaceuticals

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/EU%20Pharma%20Innovation_25-11-04.pdf 

-    E.U. study on price of orphan drugs 

http://pharmacos.eudra.org/F2/orphanmp/doc/pricestudy/Rapport%20final%20final%20partie%201%20web.pdf 

http://pharmacos.eudra.org/F2/orphanmp/doc/pricestudy/Rapport%20final%20final%20Partie%202%20web.pdf 

-    Draft E.U. Comission Regulation on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/draft-regulation_13-10-2005.pdf 

-    E.U. Court of Justice decision in Peak Holding (exhaustion of trademark rights) 

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0016

-    E.U. Court of Justice decision in British Horseracing  (C-203/02) (database protection) 

http://curia.eu.int/jurisp/cgi-bin/gettext.pl?lang=en&num=79958890C19020203&doc=T&ouvert=T&seance=ARRET&where=() 

http://curia.eu.int/jurisp/cgi-bin/gettext.pl?lang=en&num=79958890C19020338&doc=T&ouvert=T&seance=ARRET&where=() 

 

October 2004

-        Clarification of the Helsinki Declaration by the World Medical Association (WMA)

http://www.wma.net/e/press/2004_24.htm  http://www.wma.net/e/ethicsunit/helsinki.htm 

-        WMA's Guidelines on the Relationship between Physicians and Commercial Enterprises 

http://www.wma.net/e/press/2004_20.htm 

-        Swiss parliamentary debate on the draft Law on Transplantation (loi fédérale sur la transplantation)

http://www.parlament.ch/ab/frameset/d/s/4705/111349/d_s_4705_111349_111448.htm?DisplayTextOid=111449 (Conseil des Etats, 4 octobre 2004)

http://www.parlament.ch/ab/frameset/d/s/4705/112877/d_s_4705_112877_112881.htm?DisplayTextOid=112882 (vote final, 8 octobre 2004)

http://www.admin.ch/ch/f/ff/2004/5115.pdf (loi telle que publiée dans la Feuille fédérale du 19 octobre 2004)

-        Swiss parliamentary debate on the draft Law on genetic analysis (loi fédérale sur l'analyse génétique humaine)

http://www.parlament.ch/ab/frameset/d/s/4705/111349/d_s_4705_111349_111471.htm?DisplayTextOid=111472 (4 octobre 2004)

http://www.parlament.ch/ab/frameset/f/n/4705/111547/f_n_4705_111547_111752.htm (Conseil national, 5 octobre 2004)

http://www.parlament.ch/ab/frameset/d/n/4705/112869/d_n_4705_112869_112959.htm?DisplayTextOid=112960 (vote final - 8 octobre 2004)

http://www.admin.ch/ch/f/ff/2004/5145.pdf (loi telle que publiée dans la Feuille fédérale du 19 octobre 2004)

-        Swiss  Interpharma: La Santé publique en Suisse (2004)

http://www.interpharma.ch/fr/pdf/gws04f.pdf 

-        Swiss  Federal Tribunal, Decision 131 II 44 (2A.408/2004) (foreign drug delivery)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2004/Entscheide_2A_2004/2A.408__2004.html 

-        E.U. Consultation Paper  on Provisions for Small and Medium-sized Enterprises (SMEs) 

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/SMEs%20provisions-Consultation%20paper-10142004.pdf 

-        E.U. Implementation Plan for regulatory cooperation agreed by EC, EMEA and FDA

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/oct/ec_emea_fda_conf_impl.pdf  

-        E.U. Advocate General's Opinion in case C-53/03 (Synetairismos Farmakopoion Aitolias v. Glaxosmithkline AEVE)

http://curia.eu.int/jurisp/cgi-bin/gettext.pl?lang=en&num=79958971C19030053&doc=T&ouvert=T&seance=CONCL&where=() 

-        E.U. Commission's Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

http://trade-info.cec.eu.int/doclib/docs/2004/october/tradoc_119802.pdf 

-        Decision of the E.U. Court of Justice in C-31/03 (Pharmacia Italia ) (Supplementary protection certificate)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62003J0031 

-        U.S. FDA's Draft Guidance Pharmacokinetics in Pregnancy, Study Design, Data Analysis, and Impact on Dosing and Labeling

http://www.fda.gov/cder/guidance/5917dft.pdf (17 pages)

 

 

September 2004

-        U.S. 9th Circuit Court of Appeals' decision on Oregon's assisted suicide law (State of Oregon v. Ashcroft).  

http://www.ca9.uscourts.gov/ca9/newopinions.nsf/f63c3857ebe8263588256e9f007cac71/$file/0235587.pdf?openelement 

-        U.S. Accreditation Council for Continuing Medical Education's (ACCME) updated Standards for Commercial Support 

http://www.accme.org/incoming/182_SCS_1_April_2004_SCS%20_approved.pdf 

http://www.accme.org/whatsnew/sec_new_nw1_255.asp 

http://preprod.cms.accme.duodesign.com/index.cfm/fa/faq.home/Faq.cfm 

-        FDA Final Report on Pharmaceutical CGMPs for the 21st century & Guidance documents

http://www.fda.gov/cder/gmp/gmp2004/CGMP%20report%20final04.pdf 

http://www.fda.gov/cder/guidance/6452dft.pdf Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 

http://www.fda.gov/cder/guidance/6419fnl.pdf A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance 

http://www.fda.gov/cder/guidance/OCLove1dft.pdf Current Good Manufacturing Practice for Combination Products 

http://www.fda.gov/cder/guidance/5882fnl.pdf Sterile Drug Products Produced by Aseptic Processing 

http://www.fda.gov/cder/guidance/6032dft.pdf Computerized Systems Used in Clinical Trials 

-        FDA supports advisory committee's position on the risks of antidepressants use in children and adolescents.

http://www.fda.gov/cder/drug/antidepressants/default.htm http://www.fda.gov/bbs/topics/news/2004/NEW01116.html  http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm http://www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm 

-        U.S. District Court for the Southern District of New York, In re Bayer AG Securities Litigation, (2004). 

 

-        E.U. Commission's Proposal for a regulation on medicinal products for paediatric use 

http://pharmacos.eudra.org/F2/Paediatrics/docs/Paeds%20reg%20adopted%2029%20September%202004%20English.pdf 

http://pharmacos.eudra.org/F2/Paediatrics/docs/overview%20and%20explanation%20of%20the%20proposal%201.pdf 

http://pharmacos.eudra.org/F2/Paediatrics/docs/Paeds%20memo%2029%20Sept.pdf 

http://pharmacos.eudra.org/F2/Paediatrics/docs/Paeds%20Q&A%20September%2029.pdf 

-        Decision of the Swiss REKO Commission, JAAC 69.23 (suspension of marketing authorization)

http://www.vpb.admin.ch/franz/doc/69/69.23.html 

-        Decision of the Swiss Federal Insurance Tribunal 130 V 532 (K 103/03) (reimbursement of drug not on Specialty List)

http://www.polyreg.ch/bgeleitentscheide/Band_130_2004/BGE_130_V_532.html 

-        Decision of the Swiss Federal Tribunal in 2P.134/2003 (médecins LAMal)

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=06.09.2004_2P.134/2003  

-        Decision of the Swiss Federal Tribunal in 1S.5/2004 

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=07.09.2004_1S.5/2004

-        Decision of the Swiss Federal Tribunal in 2A.469/2003 (Article 9.4 LPTh)

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=06.09.2004_2A.469/2003 

-        Decision of the Swiss Federal Tribunal in 2A.469/2004

http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=01.09.2004_2A.469/2004 

-        Parliament's debates on Swiss Law on Transplantation (loi fédérale sur la transplantation)

http://www.parlament.ch/ab/frameset/d/n/4705/109471/d_n_4705_109471_109472.htm?DisplayTextOid=109473 (September 22, 2004; Conseil national)

http://www.parlament.ch/ab/frameset/f/n/4705/110958/f_n_4705_110958_111044.htm (September 30, Conseil national)

http://www.parlament.ch/ab/frameset/d/s/4705/110481/d_s_4705_110481_110482.htm?DisplayTextOid=110483 (September 29, 2004; Conseil des Etats)

-        Parliament's debates on Swiss Law on Sickness insurance

http://www.parlament.ch/ab/frameset/d/s/4705/108898/d_s_4705_108898_108949.htm?DisplayTextOid=108950 (September 21, 2004; Conseil des Etats)

http://www.parlament.ch/ab/frameset/d/n/4705/110766/d_n_4705_110766_110839.htm?DisplayTextOid=110840 (September 29, 2004; Conseil national)

http://www.parlament.ch/ab/frameset/f/n/4705/110958/f_n_4705_110958_110959.htm (September 30, 2004; Conseil national)

-        Parliament's debates on Swiss Law on Human Genetic Analysis 

http://www.parlament.ch/ab/frameset/f/n/4705/108702/f_n_4705_108702_108707.htm (Conseil national, September 20, 2004)

-        Message of the Swiss Federal Council on the proposed revision of Federal Law on Sickness insurance (révision partielle de la LAMal) 

http://www.bag.admin.ch/kv/projekte/f/botschaft_2b.pdf   (especially p.11-12)

-        Entry into force of the revision of various ordinances accompanying the Swiss Law on Therapeutic Products 

http://www.admin.ch/ch/f/as/2004/4037.pdf

http://www.bag.admin.ch/dienste/medien/2004/f/04081858.htm (press release)

 

August 2004

-        Report on Swissmedic: Commission de gestion du Conseil d'Etat, Problèmes lors de la mise en fonction de Swissmedic et évaluation de la situation actuelle, 

http://www.parlament.ch/f/ed-pa-gpk-swissmedic.pdf.

-        U.S. District Court for the Northern District of California, In re CV Therapeutics, Inc. Securities Litigation, (2004). 

-        Decision of the Swiss REKO Commission, JAAC 69.22 (importation)

http://www.vpb.admin.ch/franz/doc/69/69.22.html 

 

July  2004

-        Swissmedic's Guide on the purchase of drugs over the Internet

http://www.swissmedic.ch/files/pdf/Internetleitfaden-F.pdf 

-        Proposal to revise Swiss Patent Law (June 7, 2004) /
         Rapport explicatif relatif à des modifications dans le droit des brevets           

Draft revised law: http://www.ige.ch/F/jurinfo/documents/j10013f.pdf

Explicative report: http://www.ige.ch/F/jurinfo/documents/j10014f.pdf 

-    Report of the Swiss Federal Data Protection Commissioner for 2003/2004

http://www.edsb.ch/f/doku/jahresberichte/tb11/tb11f.pdf 

-    TARMED Report of the Swiss Federal Data Protection Commissioner 

http://www.edsb.ch/f/themen/gesundheit/tarmed-bericht_f.pdf 

-        Decision of the Swiss REKO Commission, JAAC 69.24 (inspection)

http://www.vpb.admin.ch/franz/doc/69/69.24.html 

 

-        Draft Commission Directive  of the E.U. Commission on good clinical practice 

http://pharmacos.eudra.org/F2/pharmacos/news/DirectiveGCP20040614.pdf

-    U.S. Center for Science in the Public Interest, Integrity in Science, Non-Disclosure of Conflicts of Interest in Four Leading Medical and Scientific Journals, 

http://cspinet.org/new/pdf/unrevealed_final.pdf 

-        CDER, FDA, Guidance for Industry, Fast Track Drug Development Programs  Designation, Development, and Application.

http://www.fda.gov/cder/guidance/5645fnl.pdf 

-        CDER, FDA, Guidance for Industry, Available Therapy. 

http://www.fda.gov/cder/guidance/5244fnl.pdf 

 

June 2004

-    Communication from the Commission, Science and technology, the key to Europe's future - Guidelines for future European Union policy to support research (COM (2004) 353 (01))

http://europa.eu.int/eur-lex/en/com/cnc/2004/com2004_0353en01.pdf 

-        Decision of the Swiss REKO Commission, JAAC 69.21 (marketing authorization)

http://www.vpb.admin.ch/franz/doc/69/69.21.html 

-    Decision of the  Swiss Appeal Commission for Therapeutic Products, JAAC 68.189 (right of the applicant to access documents relied upon by Swissmedic in its authorization procedure). 

http://www.vpb.admin.ch/franz/doc/68/68.169.html 

-        Home Affairs Department, Report on the results of the Swiss Consultation Procedure for the second set of ordinances accompanying the Federal Law on Therapeutic Products 

http://www.bag.admin.ch/heilmitt/aktuell/f/VL-Bericht%20HMVII_f.pdf 

Explicative report on these proposed ordinances (June 2003): http://www.bag.admin.ch/heilmitt/gesetz/f/erl_hmvp.pdf

Proposed revised ordinances (June 2003): http://www.bag.admin.ch/heilmitt/gesetz/f/erl_hmvp.pdf 

-        Home Affairs Department, Report on the results of the Swiss Consultation Procedure for the draft ordinance on stem cell research 

http://www.bag.admin.ch/embryonen/verordnung/f/vl_bericht.pdf 

Explicative report on the proposed ordinance: http://www.bag.admin.ch/embryonen/verordnung/f/erl_bericht.pdf  

Proposed ordinance http://www.bag.admin.ch/embryonen/verordnung/f/vo_entwurf.pdf 

-        U.S. Supreme Court decision in Roche (vitamins), 124 S. Ct. 2359 (antitrust abroad)

http://a257.g.akamaitech.net/7/257/2422/14june20041300/www.supremecourtus.gov/opinions/03pdf/03-724.pdf 

 

May  2004

-        Explicative Report regarding amendment of Swiss patent law relating to biotech inventions 

http://www.ejpd.admin.ch/doks/mm/files/040607b_ber-f.pdf 

http://www.ejpd.admin.ch/doks/mm/files/040607a_entw-f.pdf 

-        Proposed revision of Ordinance on Sickness Insurance (OAMal) 

http://www.bag.admin.ch/dienste/medien/2004/f/anhaenge/04052639-kvv.pdf

http://www.bag.admin.ch/dienste/medien/2004/f/anhaenge/04052639.pdf 

http://www.edi.admin.ch/themen/00056/00153/040526_revision_lamal.pdf?lang=fr 

-        Entry into force of the revised Ordinance on Foodstuff

http://www.admin.ch/ch/f/as/2004/457.pdf http://www.admin.ch/ch/f/rs/8/817.02.fr.pdf

-        Decision of the Swiss Federal Insurance Tribunal 130 V 377 (K 150/03) (art. 56 LAMal)

http://www.consano.ch/EVGEntscheid18052004.pdf 

http://www.bag.admin.ch/kv/rkuv/d/2004/rkuv_4_2004.pdf 

-        Decision of the Swiss Federal Tribunal in 2a.374/2003 (health claims for food)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2003/Entscheide_2A_2003/2A.374__2003.html 

-        Opinion of E.U. Advocate General in C-438/02 (Monopoly on the retail sale of medicinal products)

http://curia.eu.int/jurisp/cgi-bin/form.pl?lang=en&Submit=Submit&docrequire=alldocs&numaff=&datefs=2000-01-01&datefe=2004-07-01&nomusuel=&domaine=&mots=pharmaceutical&resmax=100 

-        CDER, FDA, Report to the Nation 2003. 

http://www.fda.gov/cder/reports/rtn/2003/rtn2003.pdf 

-        U.S. District Court for the District of Massachusetts, In re Transkaryotic Therapies Securities Litigation, 319 F. Supp.2d 152 (2004). 

http://pacer.mad.uscourts.gov/dc/opinions/zobel/pdf/transkaryotic.pdf 

 

 

April 2004

-        Entry into force of the revised Swiss Law on Competition (LCart) (RS 251)

http://www.admin.ch/ch/f/rs/2/251.fr.pdf 

Conference by Prof. Stoffel: http://www.weko.admin.ch/news/00004/Vortrag_Stoffel.pdf?lang=fr 

-        Decision of the Swiss Federal Tribunal in 5C.26/2004 (art. 56 LAMal)

http://www.polyreg.ch/bgeunpubliziert/Jahr_2004/Entscheide_5C_2004/5C.26__2004.html 

-        Decision of the E.U. Court of Justice in C-106/01 (Novartis v. SangStat) (marketing authorization, generic)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62001J0106 

-        Opinion of E.U. Advocate General in C-31/03 (grant of a supplementary protection certificate)

-        Decision of the E.U. Court of Justice in C-387/99 (Food preparations containing three times more vitamins)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=61999J0387 

-        Decision of the E.U. Court of Justice in C-418/01 (IMS Health) (Abuse of a Dominant Position)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62001J0418 

-        Decision of the E.U. Court of Justice in C-112/02 (Kohlpharma) (Application for marketing authorisation under a simplified procedure)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62002J0112 

-        Decision of the E.U. Court of Justice in C-150/00 (European Commission v. Austria) (foodstuff and medicinal products) xxx

 

March 2004

-        Decision of the Swiss Federal Tribunal (2A.156/2004) (Swissmedic's authorization)

http://wwwsrv.bger.ch/cgi-bin/AZA/MapProcessorCGI_AZA?mapfile=pull/ConvertDocFrameCGI.map&ri=fr&lang=fr&ds=AZA_pull&d=07.06.2004_2A.318%2f2004&pa=4%7eheilmittel%4010%7eheil_mittel%401%7eheil%401%7emittel%401%7e&

-    Decision of the  Swiss Appeal Commission for Therapeutic Products, JAAC 68.134. 

http://www.vpb.admin.ch/franz/doc/68/68.134.html 

-        Decision of the E.U. Court of Justice in C-264/01, C-306/01 (Competition law and sickness insurance)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62001J0264 

-        Decision of the E.U. Court of Justice in C-24/00 (foodstuff and vitamins) xxx

-        E.U. Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article 81(3) of the Treaty to categories of technology transfer agreements

http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_123/l_12320040427en00110017.pdf ;                       

-        E.U. Commission Notice, Guidelines on the application of Article 81 of the EC Treaty to technology transfer agreements, (2004/C 101/02)

http://europa.eu.int/cgi-bin/eur-lex/udl.pl?REQUEST=Seek-Deliver&COLLECTION=oj&SERVICE=eurlex&LANGUAGE=en&DOCID=2004c101p00020042&ext=.pdf

 

 

February 2004

-        Monsieur Prix (Price Surveillance), 2003 Annual Report Products (Section 5, pages 1066-1070 on drug prices)   

http://www.monsieur-prix.admin.ch/upl_rapp/rapport_annuel_2003.pdf

-        Monsieur Prix (Price Surveillance) study on drug prices and Swiss sickness insurance 

http://www.monsieur-prix.admin.ch/upl_etud/Studie_Arzneimittelpreiskontrolle.pdf 

 

 

January 2004

-    Entry into force of the revised Ordinance on Sickness Insurance (OAMal)

http://www.bsv.admin.ch/aktuell/presse/2003/f/03041602.pdf 

http://www.bsv.admin.ch/aktuell/presse/2003/f/0306060101.pdf 

-    Decision of the  Swiss Appeal Commission for Therapeutic Products, JAAC 68.133. 

http://www.vpb.admin.ch/franz/doc/68/68.133.html 

-    Decision of the  Swiss Federal Insurance Tribunal K 18/00. 

http://www.polyreg.ch/bgeunpubliziert/Jahr_2000/Entscheide_K_2000/K_18__2000.html 

-    Decision of the Swiss Federal Tribunal 130 I 16 (1P.689/2003) (forced medication). 

http://www.polyreg.ch/bgeleitentscheide/Band_130_2004/BGE_130_I_16.html

-        Decision of the E.U. Court of Justice in C-101/01 (Data Protection, publication of personal data)

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62001J0101 

-        Decision of the E.U. Court of Justice in C-2/01 P (Bayer) (Competition law, Meaning of agreement between undertakings) 

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=62001J0002

-        FDA, Draft Guidance for Industry, "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms.

www.fda.gov/cder/guidance/6019dft.pdf

 

 

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Last updated July 8, 2007