Completion on health professionals linked to medicinal products-and pharmaceutical companies and specialised businesses with medical devices

Purses to section 202 (a) (1). 5 and 6, and section 202 c (3). 2, in the health care law, cf. Law Order no. 913 of 13. July 2010, as amended by law no. 518 of 26. May 2014, section 43 (b) (b). Paragraph 2, section 43 (c), 3, and section 104 (3). 3, in the case of medicinal products, cf. Law Order no. 506 of 20. April 2013, as amended by law no. 518 of 26. May 2014, and section 2 b (b). 3 and 4, section 2 (c), 4, and section 6 (4). Two, in Law No 1046 of 17. In December 2002 on medical equipment, as amended by law no. 359 of 9. April 2013 and Law No 518 of 26. May 2014 :

Conventing of the Bekendom Decision

§ 1. The provisions relating to the association of pharmaceutical companies shall apply to doctors and dentists who are working or assisted by patient processing and pharmacists in Denmark.

§ 2. The provisions relating to the association of media companies shall apply to doctors, dentists and nurses working or assisted by patient care and pharmacists in Denmark.

§ 3. The provisions relating to the association of specialised shops with medical equipment shall apply to doctors working or assisted by patient treatment in Denmark.

§ 4. Pharmaceuticals shall be taken to mean establishments which have a permit in accordance with Article 7 (7) of the medicinal product. Paragraph 1, or Section 39 (2). 1, with the exception of public hospitals.

§ 5. In the case of media companies, undertakings established in Denmark manufacturing, importing or distributing medical devices at risk-load II (a, II (II) or III, medical devices for in vitro diagnostics or active implantable medical devices ; and representatives of such undertakings, with the exception of public hospitals.

§ 6. In the case of special business with medical devices, business is established in Denmark, which specialised distributors of medical equipment at risk-load II (a, II (II) or III, medical devices for in vitro diagnostics or active implantable medical equipment and representatives of such business. A business is a specialized dealer when the medical equipment accounts for more than 50% of the business product's product order and business.

Association for medicinal products and medico enterprises and special business with medical devices

§ 7. The health professionals referred to in section 1 3 shall not be either running or associated with a medicinal product, or a special business with medical equipment, with less health professionals having reported to the Health Services, cf. sections 8 or 9, or after application has received the permission of the Health Board for the association, cf. § 11.

Paragraph 2. The provision in paragraph 1 shall be However, in sections 5 and 6, they also have products at risk-class I, and the specific affiliation of health workers in the company or business alone is related to the risk-lasse. The provision also does not apply to nurses ' association to a company subject to sections 4 and 5, if the nurse's specific link to the company alone relates to medicinal products.

Paragraph 3. In the case of possession of securities, provision shall apply to paragraph 1. 1 not if ownership includes shares in investment associations, pension associations and pool schemes with a deposition rights delegated to third parties.

Paragraph 4. For the purposes of notifications and applications in accordance with paragraph 1. 1, the Board of Health shall draw up and publish lists with a unique identification of pharmaceutical companies, media companies and specialist shops with medical equipment covered by section 4 to 6.

Notification of association

§ 8. Healthcare professionals may be associated with a medicinal product or media services following prior notification to the Board of Health, if the association alone consists in the following :

1) Education tasks, including lectures.

2) Research tasks, including clinical trials and testing of medical devices.

3) Ownership, including possession of securities, to a value of not more than $200,000. at the time of acquisition.

Paragraph 2. If a health expert owns securities in several companies, the 200 000 DKK limit applies. for ownership in each company.

§ 9. Doctors can drive or be attached to a special store with medical equipment after prior notification to the Board of Health. This applies to all species of association to the business.

§ 10. Notification must be carried out digitally using a schema that is on the Home Page of the Health Management website.

Paragraph 2. The notification must include the following information, cf. however, paragraph 1 3 :

1) Identification of the health care staff.

2) Identification of the company or business.

3) Information about the mapping, including the nature, timelage and payment of the association.

Paragraph 3. For ownership, the information provided for in paragraph 1 2 shall be supplemented by the following information :

1) Type of ownership (ownership, number of shares, parties, etc.).

2) Acquire Time.

3) The value at the time of acquisition.

Application for Mapping

§ 11. Healthcare personnel must have the health of the Board of Health to operate or be linked to a medicinal product or media company, unless the association is covered by the notification system in section 8.

§ 12. The application must be digitally applied using a schema that is on the Home Page of the Health Management Web page.

Paragraph 2. The application must include the following information, cf. however, paragraph 1 3 :

1) Identification of the health care staff.

2) Identification of the company.

3) Information about the mapping, including the nature, timelage and payment of the association.

4) Information on the coordination, extradition or use of or influence on the choice of products from the establishment by the people of the company.

Paragraph 3. In the case of an application for ownership, including possession of securities, the information provided for in paragraph 1 shall apply. 2 shall be supplemented by the following information :

1) Type of ownership (ownership, number of shares, parties, etc.).

2) Acquire Time.

3) The value at the time of acquisition.

4) Acquisitions to inheritance.

§ 13. For the purpose of assessing an application from a health expert to be linked to a medicinal product or media company, the Board of Health must place the emphasis on the following conditions, cf. however, section 14 :

1) The association must be compatible with the work of health workers with patient care or as an apothecary in relation to the nature and work field of the company.

2) The association must not present a nearby risk that the health care staff will be encouraged to promote consumption, ordination, supply or sale of a particular product.

3) The payment, health care professionals, must be reasonable and reflect the scope and nature of the work carried out by the health care staff.

4) The association must not imply a nearby risk of any doubt about the fundamental imbodiment of health workers.

§ 14. For the purpose of assessing an application from a health expert to have ownership in a whole or in part to have ownership in a medicinal product or media company, the Board of Health must place the emphasis on the following conditions :

1) The ownership must be compatible with the work of health workers with patient care or as an apothecary in relation to the nature and work field of the company, as well as the economic value of the person ' s own share.

2) Healthcare must not, in its work on patient care or as an apothecary, could significantly influence the choice and use of products from the company.

3) The association must not imply a nearby risk of any doubt about the fundamental imbodiment of health workers.

Paragraph 2. The application for ownership in a company that develops medicinal products or medical equipment must, as a starting point, be accommodated if the company's products are not placed on the market. Bringing the establishment later on medicinal products or medical equipment on the market will have to submit a new application to the Board of Health at the market of health workers. If the Board of Health deforms this new application, the original authorisation shall be refused to be attached to the establishment, and the Board shall set a time limit for when the health care staff are to have settled their ownership.

Paragraph 3. If a health-care person inherits value securities to a value of over 200 kroner. and shall be refused on an application after paragraph 12 to possess the securities, shall be reduced to a value of not more than DKK 200. no later than two years after the decision of the Health Board.

Publication

§ 15. The Board of Health shall publish the following information on health professionals who have notified or been given permission to have an association following sections 8 14 :

1) Identification of health care staff, e.g. name and authorization ID.

2) Identification of the company or business.

3) Nature and time-scale of the association.

4) Total of the health workers per year. calendar year from the company.

5) For transferable securities : the number and value of the acquisition date.

Paragraph 2. Publication shall be carried out on the Health Board ' s website when the health care staff has carried out a review or-whose permission is required-when the Board of Health has approved the association.

Paragraph 3. Information about a relationship relationship will be deleted from the Health Management Web page 2 years after the association is terminated. Health care staff must be aware of the time when the association is terminated or ceaseesinfully.

Entities reporting and obligation of information

§ 16. Pharmacy establishments must report information to the Health Services Board of doctors, dentists and pharmacists associated with the company, cf. Article 43 (b) of the medicinal product. 1.

Paragraph 2. Media companies must report information to the Health Board on doctors, dentists, nurses and pharmacists who are associated with the company, see. Law on medical equipment, section 2 b (s). 1.

Paragraph 3. Special business with medical equipment must report information to the Health Services Board of doctors associated with the business, cf. Law on medical equipment, section 2 b (s). 2.

Paragraph 4. The provisions of paragraph 1. 1-3 shall not apply to the possession of transferable securities.

§ 17. The reports referred to in section 16 shall be carried out digitally once a year at the latest by 31. This January will be used by a schedule which is on the Health Board's website. The report shall include health-care professionals who have been associated with the company during the previous calendar year.

Paragraph 2. The report shall include the following information :

1) The company or business name and CVR number.

2) The full name, workplace, home address, and social security number of health professionals.

3) The time period for the mapping.

Paragraph 3. At the same time, with the reporting to the Health Services, the company must inform the individual health experts of the content of the alert.

Paragraph 4. The Board of Health may require additional information from the company on the individual association conditions, including the nature and scale of the association, and the amount of payment received by the health care staff.

§ 18. Medicinal and medium-sized mediators shall, when they agree on an agreement assigns a doctor, dentist, nurse (only media coincompanies) or pharmacies to the company, inform the person of the rules on health professionals linked to medicinal products-and media companies, including the person ' s obligation to notify the Board of Health or the application for the Administrative Board's permission to be associated with the company and the publication of the information on the association.

Paragraph 2. Special business with medical equipment must, when upon agreement associate a doctor to the business, inform the doctor of the rules of doctors ' obligation to notify the Board of Health and the publication of information on the management of the management of information relating to the management of the Board ; the association.

Penalty clause

§ 19. With fine punishment, the one who

1) is breaching section 7 (3). Paragraph 1, section 16, paragraph 1. 1-3, section 17, paragraph 17. 1-3, and § 18, or

2) not provide information after paragraph 17 (3). 4.

Paragraph 2. Companies can be imposed on companies. (legal persons) punishable by the rules of the penal code 5. Chapter.

Entry into force and transitional provisions

20. The announcement shall enter into force on 1. November 2014.

Paragraph 2. Publication no. 794 of 15. July 2008 on the notification of information about doctors, dentists and pharmacists associated with pharmacocompanies, etc. are repealed.

§ 21. Alms relating to the association of pharmaceutical companies issued by the Health Service for doctors, dentists and pharmacists in accordance with Article 3 (3) of the apothecary. 2 and 3, before 1. November 2014, shall retain their validity after this date, provided that the health care staff at the latest is 1. April 2015 has notified the Board of Health via the Schema on the Board of Direction.

Paragraph 2. The doctors, dentists, nurses, or apothecaries, there's that one. In November 2014, an association with a media business or special business with medical equipment covered by the provisions of this notice may, by notification, be notified to the Board of Health at the latest by 1. April 2015 continue to be such a link. Notification must be made through the form of the board of the Board of Govern.

§ 22. Pharocious establishments shall first report to them in section 16 (3). 1, mentioned information to the Health Management Board of the calendar year 2014, not later than 31. January 2015.

Paragraph 2. Medicoenterprises and special business with medical equipment must first be reported to them in section 16 (3). 2 and 3, mentioned information to the NHA for the period 1. November 2014 to 31. December 2015, not later than 31. January 2016.