Voluntary self-regulation for the pharmaceutical industry

from Wikipedia, the free encyclopedia

The voluntary self-regulation for the pharmaceutical industry eV (short FS Arzneimittelindustrie eV, FSA) is a registered association of pharmaceutical companies based in Berlin . It was founded in 2004. The association is not an interest group, but has the task of establishing binding rules for ethical pharmaceutical marketing, making these rules known and enforcing them among association members.

Goals and principles

The aim of the FSA is to promote ethical behavior between the pharmaceutical industry and members of the medical professional groups as well as the organizations of patient self-help and to ensure fair competition among companies. The central instrument of the FSA are two codes, the association's "codes of law", which lay down binding rules for cooperation between pharmaceutical companies and medical specialist groups and patient organizations.

By recognizing the FSA Code of Practice, the member companies undertake not to unduly influence the physician's freedom of procurement, decision-making and therapy. These include transparency requirements, the prohibition of surreptitious advertising , rules for distributing product samples, invitations to scientific training events and congresses, hospitality for doctors and gifts.

With the FSA Code of Conduct patient organizations , the member companies undertake to disclose which self-help groups they support and in what way. The goal of the FSA Code of Conduct patient organizations is to prevent covert, unfair influence on self-help groups. Companies have to publish once a year which patient organizations they support and with what amounts.

In 2010, voluntary self-regulation was expanded and recommendations were drawn up for cooperation between pharmaceutical companies and healthcare facilities and their employees. This includes, for example, health insurance companies , associations of statutory health insurance physicians and authorities.

In 2013 the FSA adopted a third code, the Transparency Code . With this, the FSA members undertake to disclose pecuniary benefits to doctors and other members of the specialist community as well as medical institutions. From 2016, everyone will be able to see which doctors and other members of the medical health professions the companies work with and in what way.

Sanction options

As one of the few organizations for self-regulation, the FSA has direct sanctions against its member companies. The FSA can impose declarations of cease and desist and prohibition orders with penalties. In addition, a two-tier procedure was introduced that provides for a range of penalties ranging from 5,000 (minimum penalty) to 400,000 euros.

Both the board and the management of the association can initiate proceedings. Anyone can submit complaints to the FSA, regardless of whether they are doctors, patients, health insurances or authorities. Of 378 complaints since it was founded in 2004, 158 cases were justified, which resulted in a warning or the payment of fines and fines. In addition, the association names the company in the event of violations and issues public reprimands. The highest fine imposed so far was 50,000 euros.

organs

The structure of the FSA is laid down in the association's statutes and is comparable to the structure of state bodies.

  • The general assembly consists of one representative from each member company and adopts changes to the codes (“the laws”).
  • The Arbitration Bodies of the 1st and 2nd instance decide on the legality of the conduct of pharmaceutical companies on the basis of the codes and impose penalties if necessary. The panel of first instance can consist of the managing director or a third party and is entrusted by the board. Half of the Arbitration Panel of the 2nd Instance consists of company members of the association members, a quarter are representatives of the medical profession and a further quarter are representatives of the patients, who can be proposed by their associations. The independent chairman of the Arbitration Panel of the Second Instance must be qualified to hold the office of judge and may not work for a member of the association or another company in the pharmaceutical industry.
  • The board is elected by the general assembly for three years. The board members represent the association externally and develop the association further, for example by proposing changes or additions to the codes to the general assembly.
  • The managing director is appointed by the board of directors and conducts the business that involves the day-to-day administration of the association and that have been entrusted to him by the board of directors and the general assembly. This includes, among other things, educating professionals and the public about the association and the codes, as well as advising members on all code issues.

development

The FSA was founded in 2004 by 39 companies from the Association of Research into Pharmaceutical Manufacturers (VFA). In 2006 the manufacturers of prescription drugs of the Federal Association of the Pharmaceutical Industry (BPI) joined the association. In 2008, however, the BPI companies founded their own association for self-regulation (“ Medicines and Cooperation in Healthcare eV ”, AKG) and for the most part withdrew from the FSA. Like the FSA, the AKG focuses on preventive measures. The AKG has not yet imposed any sanctions.

According to the FSA, it currently has 59 member companies and 25 companies have submitted. These companies cover over 70 percent of the German pharmaceutical market for prescription drugs. The association fee is between 1,000 and 24,000 euros per year, depending on sales.

Individual evidence

  1. ↑ §2 of the FSA's articles of association (PDF; 96 kB), dated December 1, 2011
  2. ↑ FSA Code of Medical Specialists (PDF; 2.1 MB), December 1, 2011
  3. ↑ Announcement No. 3/2015 on the application for recognition as competition rules of the association "Voluntary self-regulation for the pharmaceutical industry eV" (FSA-Codex professional groups) ( BAnz AT 20.03.2015 B9 )
  4. ↑ §12 of the FSA code of conduct for patient organizations (PDF; 2.0 MB), December 1, 2011
  5. ↑ FSA website (PDF; 2.0 MB)
  6. ↑ FSA press release from November 27, 2013
  7. ↑ §24 of the FSA's rules of procedure (PDF; 172 kB), December 1, 2011
  8. ↑ page 21 in the annual report 2011 of the FSA (PDF; 1.2 MB)
  9. ^ Association statutes of the FSA (PDF; 96 kB), July 31, 2012
  10. ^ Pharmaceutical newspaper , 03/2008 edition
  11. ↑ Annual report of the FSA (PDF; 1.2 MB), 2011, page 6
  12. ↑ FSA contribution regulations , last accessed on April 18, 2012.

Web links