Drug information publication system AIPS

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The drug information publication system AIPS is the central Swiss drug directory for specialist and patient information ( package inserts ), which is operated on behalf of the licensing and control authority for therapeutic products in Switzerland, Swissmedic , in order to meet the publication requirements according to Art. 16a, Paragraph 3 of the Medicines Ordinance.

Since January 1, 2013, all Swiss pharmaceutical companies have had to publish their specialist and patient information as a prerequisite for drug approval in AIPS. The publication of the drug information there is free of charge for pharmaceutical companies. All of the information collected is in the public domain and can be viewed by the specialist public as well as the general public, as well as being downloaded daily as XML by data refiners . In the specialist advertising for pharmaceuticals, detailed information on pharmaceuticals may only be referenced to the platform's URL www.swissmedicinfo.ch.

history

The Swiss Medicines Compendium has been published by Documed AG in Basel since 1979 . Since Swissmedic stipulated the complete publication of all drug information in one work, the drug compendium was for a long time the only such publication in Switzerland. All marketing authorization holders were obliged to publish their data in the drug compendium , for which Documed was paid by the companies. In return, approximately 34,000 copies of the drug compendium were distributed free of charge to persons authorized to dispense drugs.

Litigation

The company ywesee (pronounced why we see ) tried to get a contract with Documed about the publication rights for the drug information. When this failed due to the high prices according to ywesee, ywesee filed a complaint against Documed with the Swiss Competition Commission (WEKO) on November 11, 2003 , as it was not possible to publish a product competing with the drug compendium . In addition, ywesee downloaded all drug information from Documed's database. In December 2003 ywesee (at that time still sole proprietorship ) was confronted with a super-provisional injunction from Documed regarding the transfer of data from the drug compendium to the website oddb.org. This order was revoked in January 2004 by the civil court of Basel-Stadt . At the end of 2004 Documed was taken over by the Galenica Group. On February 11, 2005, Documed filed the main lawsuit. Documed's lawsuit was dismissed by the Swiss Federal Supreme Court in a leading decision, among other things because the specialist and patient information is officially required information. Officially required collections cannot be protected by copyright in Switzerland. As a result of the decision, the publication of patient information via oddb.org was approved as an alternative publication method by Swissmedic, but this publication method also involved payments for the authorization holder, this time to ywesee.

The leading decision of the Swiss Federal Supreme Court of February 13, 2008 in the legal dispute between Documed and ywesee and the ruling of the Competition Commission of July 7, 2008 in this matter formed the basis for a judgment of the Federal Administrative Court (BVGER) of June 17, 2011 in a Laboratoire process homéopathique Jacques Reboh et fils because of a condition for the approval of a homeopathic medicinal product against Swissmedic, in which the publication practice for specialist and patient information via a private company (Documed, ywesee) was declared inadmissible.

Structure of AIPS

The Federal Administrative Court judgment of 17 June 2011 resulted in the fact that Swissmedic decided to develop its own IT solution for a full list of specialist and patient information, the A Medicinal Products i nformation p ublikations s ystem AIPS. Orders from Swiss federal authorities that exceed the amount of CHF 248,000 must be awarded via a WTO tender . The WTO - tender Swissmedic was due to the most economically advantageous tender from the HCI Solutions , a subsidiary of Galenica acquired group. The tender volume won for creating and operating the platform is CHF 475,000 over 5 years.

Significance of the judgments and the publication requirement in the AIPS

As a result of the legal dispute, all specialist (German and French) and patient information (German, French and Italian) for Switzerland are now in the public domain and are available to everyone free of charge as XML. So today anyone can build software with the AIPS data without having to ask other companies for permission. If the specialist and patient information were protected by copyright, this data could not be obtained free of charge.

Various articles in the Swiss Medical Journal reacted critically to the changed circumstances regarding the publication of specialist information.

Since January 1, 2014, the specialist information from Swiss pharmaceutical companies is no longer published in paper form. Patient information has never been published in a comprehensive book in Switzerland.

Web links

Individual evidence

  1. ^ AIPS - Medicinal Information Publication System. (No longer available online.) In: swissmedic.ch. Archived from the original on February 1, 2014 ; Retrieved January 26, 2014 .
  2. ^ AIPS information event at Swissmedic, January 22, 2013. (No longer available online.) In: swissmedic.ch. Archived from the original on February 1, 2014 ; Retrieved January 26, 2014 .
  3. ↑ XML download AIPS Swissmedic. In: swissmedic.ch. Retrieved January 26, 2014 .
  4. ↑ Changes to drug advertising from January 2013 in connection with the new publication platform for Swissmedic's drug information. (No longer available online.) In: swissmedic.ch. January 3, 2013, archived from the original on March 18, 2014 ; accessed on March 18, 2014 .
  5. ↑ a b c d Competition Commission WEKO: Order of the Competition Commission of July 7, 2008 in the matter of investigation 32-0178 in accordance with Article 27 of the Federal Act on Cartels and Other Restraints of Competition of October 6, 1995 (Cartel Act (KG); SR 251) relating to the publication of information on medicinal products due to improper conduct in accordance with Article 7 KG. (PDF) In: ywesee.com. July 16, 2008, accessed January 26, 2014 .
  6. ↑ application for precautionary decision of 17 December 2003. (PDF): ywesee.com. Retrieved January 26, 2014 .
  7. ↑ Judgment of the Civil Court Presidium of Basel-Stadt from January 20, 2004. (PDF) In: ywesee.com. Retrieved January 26, 2014 .
  8. ↑ Galenica.com - History. Retrieved April 24, 2019 .
  9. ↑ statement of claim Documed of 11 February 2005. (PDF): ywesee.com. Retrieved January 26, 2014 .
  10. ^ Swiss Federal Supreme Court: Judgment of February 13, 2008, I. Civil Law Department. 4A_404 / 2007, 134 III 166. In: bger.ch. February 13, 2008, accessed March 9, 2014 .
  11. ↑ David Vasella: 4A_404 / 2007: Documed c. ywesee away. Medicinal Compendium (URG, UWG) (official publ.). In: swissblawg.ch. March 30, 2008, accessed March 9, 2014 .
  12. ↑ Art. 13 Information for healthcare professionals. In: Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the approval of medicinal products (AMZV) .
  13. ↑ Art. 5 Unprotected works. In: Federal Law on Copyright and Related Rights (URG).
  14. ↑ Juana Vasella: C-6885/2008: Change in practice for information on medication. In: swissblawg.ch. July 12, 2011, accessed March 26, 2014 .
  15. ↑ Weko ends investigation against Documed AG. In: news.admin.ch. July 17, 2008, accessed January 30, 2014 .
  16. ↑ David Vasella: Documed AG: Weko investigation stopped. In: swissblawg.ch. July 17, 2008, accessed March 9, 2014 .
  17. ↑ Federal Administrative Court judgment of June 17, 2011. C-6885/2008. (PDF; 578 kB) In: bvger.ch. June 17, 2011, accessed March 9, 2014 (French).
  18. ↑ David Vasella: C-6885/2008: Publication of the drug information - VAM 16a has no legal basis. In: swissblawg.ch. July 25, 2011, accessed March 9, 2014 .
  19. ↑ CH / BVGER: Swissmedic has to change the way it is used to provide information on medicines. (No longer available online.) In: handelszeitung.ch. July 1, 2011, archived from the original on March 18, 2014 ; accessed on March 9, 2014 .
  20. ↑ AIPS drug information publication system. Service tenders. In: simap.ch. Swissmedic, IT procurement management, April 5, 2012, accessed on April 28, 2014 .
  21. ↑ Swissmedic tender documents for the AIPS platform. In: docs.google.com. Retrieved January 26, 2014 .
  22. ↑ Swissmedic Annual Report 2012. (No longer available online.) In: swissmedic.ch. Archived from the original on February 1, 2014 ; Retrieved January 26, 2014 . , see page 54
  23. ↑ AIPS drug information publication system. Service surcharges. In: simap.ch. Swissmedic, IT procurement management, June 9, 2012, accessed on April 28, 2014 .
  24. ↑ Andreas Möckli: Galenica subsidiary Documed also faced with allegations of dumping . In: Tagesanzeiger . December 14, 2012, p. 43 .
  25. ^ Claudia Zaugg, Brigitte Morand, Richard Egger: Search of drug information and use of the drug compendium . In: Swiss Medical Journal . tape 93 , no. 11 , 2012, p. 429–432 ( saez.ch [PDF; accessed on March 26, 2014]).
  26. ↑ Gert Printzen: 35 Years of Medicinal Compendium et quo vadis . In: Swiss Medical Journal . tape 94 , no. 7 , 2013, p. 235 ( saez.ch [accessed on March 26, 2014]).
  27. ↑ After the 2013 book edition, only current electronic publications. In: documed.ch. Retrieved January 26, 2014 .