| Literature DB >> 35110312 |
Marie Clinckemaillie1, Alexandre Scanff2, Florian Naudet3, Adriaan Barbaroux4.
Abstract
OBJECTIVE: To investigate the financial relationships between key opinion leader (KOL) or non-KOL physicians and pharmaceutical and device companies in France.Entities:
Keywords: ethics (see medical ethics); health economics; public health; quality in health care
Mesh:
Year: 2022 PMID: 35110312 PMCID: PMC8811544 DOI: 10.1136/bmjopen-2021-051042
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Presents the three categories of financial ties and the date from which they had to be declared in the transparency in healthcare database (Transparence-Santé)
| Type of ties | Definition | Mandatory information to declare |
| Gifts | Anything that is allocated or paid without consideration by a company to a health actor, with a value greater than or equal to €10 including taxes. Available categories on the website=gifts, contribution to the cost of promotional, scientific or professional events, accommodation, hospitality, catering, transport, transport and hospitality, in-kind donations, donations, donations of money, grants, training, expenditures for services and advice, fees, failed category association, empty, other. | Identity of the parties concerned, amount, nature and date of each gift. Mandatory since the law of 2013; actual website availability in 2014. |
| Contractual agreements | Contracts involving obligations on the part of the physician and the industry. For example, participation in a congress as a speaker by the physician with payment for the lecture by the company, or participation at the presentation of a new medical device by the physician with payment for transport and accommodation by the company. The agreements concern research activities, clinical trials, participation in a scientific congress or training activities. | Identity of the parties concerned, the organiser, the name, date and place of the event, date of the agreement, its precise purpose (mandatory since the law of 2013; actual availability on the website since 2014) and the amount (mandatory since the law of 2016, actual availability on the website since 2017). If the agreements give rise to payments in gifts or remuneration, the payments can be reported in the agreements category or the gifts or remunerations categories, with a numerical link to the agreement. |
| Remunerations | Payment for work or services with a value of more than €10 including taxes. | Identity of the parties, final beneficiary, date of payment, amount if it is greater than or equal to €10 (available since 2015 but mandatory since the law of 2016, actual website availability in the remuneration section in 2017). |
The transparency in healthcare database was laid down in the ‘strengthening the safety of medicines and health products’ law of December 2011, and launched in July 2014.
Figure 1Flow chart representing how KOLs were identified by cross-checking three databases. BML, Bibliothèque Médicale AF Lemanissier; Cismef, Catalogue et index des sites médicaux de langue française; KOLs, key opinion leader; OL, opinion leader.
Median (IQR) amount of gifts to KOL and non-KOL physicians in euros (€)
| Gift category | Physician category | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 |
| Accommodation | All physicians | 210 (165–314) | 215 (165–341) | 215 (170–314) | 215 (164–323) | 221 (170–349) | 218 (173–328) |
| KOL | 218 (172–305) | 220 (170–330) | 218 (179–296) | 226 (176–313) | 221 (175–323) | 229 (180–344) | |
| Hospitality | All physicians | 50 (27–118) | 45 (25–60) | 46 (24–60) | 55 (30–60) | 53 (28–60) | 52 (28–60) |
| KOL | 70 (30–448) | 58 (28.2–258) | 60 (30–258) | 80.5 (40–362) | 60 (29–319) | 60 (30–329) | |
| Catering | All physicians | 40 (24–55) | 40 (24–56) | 38 (23–55) | 38 (23–56) | 38 (23–56) | 38 (24–57) |
| KOL | 40 (23–59) | 40 (23–59) | 40 (23–58) | 40 (23–58) | 40 (24–59) | 40 (24–59) | |
|
| All physicians | 208 (91–420) | 200 (88–398) | 191 (85–380) | 189 (79–357) | 182 (81–344) | 177 (77–332) |
| KOL | 202 (70–471) | 206 (74.2–461) | 244 (96–477) | 207 (77–445) | 198 (79.8–414) | 187 (71–395) | |
| Contributions to the cost of promotional events | All physicians | 60 (50–400) | 60 (50–404) | 60 (44–400) | 200 (55–455) | 400 (250–590) | 440 (260–650) |
| KOL | 320 (60–591) | 350 (60–600) | 390 (87–650) | 450 (186–729) | 470 (290–740) | 538 (290–796) | |
| Donations-Grants-Training | All physicians | 21 (17–30) | 23 (17–50) | 36 (23–94) | 62 (30–171) | 55 (29–171) | 55 (25–144) |
|
| 83 (60–275) | 68 (27.5–1578) | 96 (63.5–138) | 76 (45–192) | 155 (42–225) | 80 (42–180) | |
| Service and consulting | All physicians | 26 (22–30) | 30 (22–45) | 30 (24–50) | 30 (25–40) | 50 (25–80) | 116 (40–362) |
| KOL | 30 (24–120) | 47 (29–325) | 65 (30–600) | 32 (25–83) | 130 (74–309) | 158 (69–506) | |
| Other | All physicians | 100 (30–350) | 140 (30–496) | 100 (19–375) | 22 (16–84) | 25 (16–104) | 49 (16–220) |
| KOL | 337 (34.8–1000) | 800 (195–1188) | 700 (100–1000) | 310 (23–915) | 40 (12–153) | 79.5 (12–500) | |
| Total | All physicians | 45 (25–60) | 45 (25–60) | 45 (25–60) | 46 (25–60) | 48 (25–60) | 49 (26–60) |
| KOL | 59 (29–198) | 60 (30–224) | 60 (30–217) | 60 (30–213) | 60 (31–214) | 60 (31–210) |
KOL, key opinion leader.
Number of contractual agreements with no amount, total value of agreements for which an amount could be found and number of agreements with a declared amount in the contractual agreement section, total and median (IQR) amount of remunerations to KOL and non-KOL physicians, year by year since they are consistently declared
| Payment category | Physicians category | Amount | 2017 | 2018 | 2019 | Total |
| Contractual agreements | All physicians | No of agreements for which the amount could not be found in the agreement section (percentage of the number of agreements) | 446 204 (79%) | 443 687 (79%) | 394 393 (72%) | 1 284 284 |
| Total value of agreements for which an amount could be found in the agreement section in € | 42 905 877 | 39 962 079 | 43 098 150 | 125 966 106 | ||
| No of agreements with a declared amount in the agreement section | 118 860 | 119 844 | 150 987 | 389 691 | ||
| KOL | No of agreements for which the amount could not be found in the agreement section (percentage of the number of agreements) | 3514 (80%) | 3319 (80%) | 2663 (76%) | 9496 | |
| Total value of agreements for which an amount could be found in the agreement section in € | 1 123 947 | 1 040 295 | 1 000 651 | 3 164 893 | ||
| No of agreements with a declared amount in the agreement section | 903 | 837 | 843 | 2583 | ||
| Remunerations | All physicians | Total amount in € | 49 152 264 | 53 142 546 | 54 254 342 | 156,549 152 |
| Median (IQR) | 300 (65–750) | 350 (65–800) | 130 (50–613) | 250 | ||
| Number of remunerations | 77 277 | 77 436 | 96 160 | 250 573 | ||
| KOL | Total amount in € | 2 355 894 | 2 346 293 | 2 172 827 | 6 875 014 | |
| Median (IQR) | 946 (527–1440) | 1000 (600–1497) | 998 (538–1375) | 1000 | ||
| No of remunerations | 1950 | 1901 | 1876 | 5718 |
KOL, key opinion leader.
Figure 2Evolution of the three kinds of financial ties for key opinion leaders (KOLs) and all physicians. The gifts declared for all physicians decreased in number and value over time; the number, the value and the proportion of gifts declared for KOLs decreased. The contractual agreements declared for all physicians increased; the number, the value and the proportion of contractual agreements declared for KOLs decreased. The remunerations declared for all physicians increased; the number, the value and the proportion of remunerations declared for KOLs decreased. OL, opinion leader.