Pharmaceutical firms' generosity and physicians: Legal aspects in Belgium.

Medicine and Law

Volumn 22, Issue 3, 2003, Pages 473-487

  Desmet, Christophe ^a,b,c  

^a UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^b RESEARCH FOUNDATION FLANDERS FWO   (Belgium)

^c Directorate Gen Pub Hlth Protect   (Belgium)

Author keywords

Conflict of interest; Drug promotion; Financial relationships; Gift giving pratices; Pharmaceutical industry; Prescribe behaviour; Seeding trial; Undue influence

Indexed keywords

GENERIC DRUG; NITRATE;

ANGINA PECTORIS; BELGIUM; CLASSIFICATION; CLINICAL TRIAL; COST; DRUG COST; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; FEE; HUMAN; JURISPRUDENCE; LAW; LAW ENFORCEMENT; MEDICAL DOCUMENTATION; MEDICAL ETHICS; MEDICAL INSTRUMENTATION; MEDICOLEGAL ASPECT; MONEY; PATIENT CARE; PERCEPTION; PHYSICIAN ATTITUDE; REVIEW; WELFARE;

EID: 0242302632     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (49)

1. The Council on Ethical and Judicial Affairs of the American Medical Association, "Gifts to physicians from industry.", JAMA. 1991, Volume 265:501.
2. For an update see:-, "Guidelines on Gifts to Physicians From Industry: An Update", Food and Drug Law Journal 2001, 56:27-40; J. Jureidini and P. Mansfield,
3. J. Jureidini and P. Mansfield, "Does drug promotion adversely influence doctors' abilities to make the best decisions for patients?", Australian Psychiatry 2001, 9:95-100.
4. World Health Organization - Department of Essential Drugs and Medicines Policy (EDM), "Promoting rational use of medicines: Core components", Newsletter no 5, september 2002. (Internet: http://www.who.int/medicines/library/edm general/6pagers/ppm05en.pdf)
5. W.H.O., Ethical Criteria for Medicinal Drug Promotion, Geneva, W.H.O., 1988.
6. See also: S.L. Coyle, "Physician-Industry Relations. Part 1: Individual Physicians", Ann. Intern. Med. 2002, 136:396-402
7. P.A. Komesaroff and I.A. Kerridge, "Ethical issues concerning the relationship between medical practitioners and the pharmaceutical industry", M.J.A. 2002, 176:118-121.
8. T. Vansweevelt, "De cadeaucultuur in de medische sector: There's no such thing as a free lunch?", T. Gez. 1998-99, 12-22. For the sake of completeness reference can be made to the ethical code issued by the (Belgian) Association of the Pharmaceutical Industry, which also contains stipulations on this problem. The Code of Professional Ethics of Physicians however only deals in an indirect manner with the problem of gift-giving: the prohibition to conceive medicine as a business affair (art. 10) and the prohibition of dichotomy and unlawful enrichment (art. 80-81). The National Order of Physicians did however issue advices on "The commercialisation of medicine" (1978), on "Experiments with medicinal products" (22 August 1992), on "Advantages provided to physicians by the pharmaceutical industry" (22 August 1998), and on "The relation of physicians with the pharmaceutical industry" (16 November 2002). Recently the Order formally joined the opinion of the "Académie Royale de Médecine de Belgique" on the relatron detween physicians and pharmaceutical companies (28 September 2002).
9. A circular of the Belgian Pharmaceutical Inspectorate of 7 May 1996 recalls that, in respect of art. 5, 6° of the Crown Order of 7 April 1995, advertising by means of any object whatsoever, other than the usual means of communication, is illegal. According to the circular, the above enumerated objects can not be considered as 'usual means of communication'. http://www.afigp.fgov.be/NL%20home/archief/omzendbrieven/oz%20reclame%20070 596.PDF
10. J. Peppin, "Pharmaceutical sales representatives and physicians: Ethical considerations of a relationship", J. Med. Phil. 1996, 21:83-99.
11. T. Vansweevelt, "De cadeaucultuur in de medische sector: There's no such thing as a free lunch?", T. Gez. 1998-99, 15.
12. J.P. Kassirer, "Financial Indigestion", J.A.M.A. 2000, 284:2156-2157: Without free meals, many potential attendees would remain ignorant of new advances, as they would never sacrifice their free time to attend some meeting.
13. National Order of Physicians, "Advice on the Commercialisation of medicine", T. Orde Van Geneesheren 1978, nr. 27, p. 5.
14. Especially in the case of clinical studies a physician may be confronted with a conflict of (financial) self-interest and patient's interests. See: E.G. Campbell, K. Seashore Louis and D. Blumenthal, "Looking a Gift Horse in the Mouth - Corporate Gifts Supporting Life Sciences Research", J.A.M.A. 1998, 279:995-999
15. R.V. Gibbons, F.J. Landry, D.L. Blouch, D.L. Jones, F.K. Williams, C.R. Lucey et al., "A comparison of physicians' and patients' attitudes toward pharmaceutical industry gifts.", J. Gen. Intern. Med. 1998, 13:151-154
16. A. Wazana, "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?", J.A.M.A. 2000, 283:373-380.
17. M.D. Rawlins, "Doctors and the drug makers", Lancet 1984, 2:276-278.
18. See also: M.M. Chren, C.S. Landefeld and T.H. Murray, "Doctors, drug companies, and gifts", J.A.M.A. 1989, 262:3448-3451.
19. See: M.D. Rawlins, "Doctors and the drug makers", Lancet 1984, 2:277. See also: http://www.hbvl.be/nieuwsextra/dossiers/-g/generics/dossier.asp
20. See: S.E. Goldfinger, "A matter of influence", N. Engl. J. Med. 1987, 316:1408-1409.
21. J.M. Drazen and G.D. Curfman, "Financial Associations of Authors", N. Eng. J. Med. 2002, 346:1901-1902.
22. See also: S.J. Pocock, Clinical Trials: A Practical Approach, Wiley, Chichester, 1991, 266p. See also the above mentioned advice of the "Académie Royale de Médecine de Belgique" on the relation between physicians and pharmaceutical companies (28 September 2002).
23. Law of 25 March 1964, Moniteur Belge 17 April 1964, as amended by Law of 21 June 1983.
24. See also article 127, § 4 of the Law on the compulsory health and disability insurance of 14 July 1994.
25. T. Vansweevelt, "De cadeaucultuur in de medische sector: There's no such thing as free lunch?", T. Gez. 1998-99, 17.
26. Parliamentary Report Diegenant with the bill tending to amend the Law on Medicinal Products of 25 March 1964, Parliamentary Documents Chamber 1981-1982, nr. 204/9, p. 20, where a calendar on plastic was quoted explicitly as an example of such non-valuable object.
27. Council Directive 92/28//EEC of 31 March 1992 on the advertising of medicinal products for human use, Official Journal L. 30 April 1992, vol. 113, p. 13. Replaced by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Official Journal L. 28 november 2001, vol. 311, p. 67-128.
28. Art. 2, §1, 3° of the Crown Order of 7 April 1995, Moniteur Belge 12 May 1995.
29. For instance, textbooks or diagnostic equipment, as long as they're not too expensive.
30. Kh. Brussel 26 December 1994, T. Gez. 1998-99, 30.
31. The Crown Order of 7 April 1995 was not yet in force at that time.
32. Brussel 2 June 1995, J.T. 1995, 649;
33. T. Gez. 1998-99, 26.
34. Cour de Cassation 9 January 1997, J.L.M.B. 1997, 623;
35. Cour de Cassation, T. Gez. 1998-99, 28;
36. Cour de Cassation, Arr. Cass. 1997, 49.
37. T. Vansweevelt, "De cadeaucultuur in de medische sector: There's no such thing as a free lunch?", T. Gez. 1998-99, 20.
38. See also: M. Moens, "De ethische positie van de artsen tegenover de geneesmiddelenindustrie", De Geneesheer-Specialist 2000, nr. 7, p. 22-29.
39. Law of 2 August 2002, Moniteur Belge 29 August 2002.
40. Otherwise the wording "rewarded" should have been used, see article 6, section 3, litteraj Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal L. 1 May 2000, vol. 121, p.34-44.
41. "Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy".
42. To be multiplied by five. See Art. 16 §3, 1° Law on Medicinal Products.
43. T. Vansweevelt, "De cadeaucultuur in de medische sector: There's no such thing as a free lunch?", T. Gez. 1998-99, 22.
44. See also: J.P. Kassirer, "Financial indigestion" J.A.M.A. 2000, 284:2157.
45. See: C. Orellana, "German doctors' links with drug firm investigated", Lancet 2002, 359:1039;
46. "Ärzte-Bestechungsskandal weitet sich aus", Frankfurter Allgemeine Zeitung 11 March 2002;
47. "Korrumpierte ÄrztInnen", BUKO Pharma-Kampagne, Pharma-Brief, März-April 2002, 1-2.
48. See also: M. Kind, "Ärzte - Opfer oder Förderer der Korruption?", Wiener Medizinische Wochenschrift (W.M.W.) 2002, 152:249-252. The recent investigations in Germany towards the possible involement of more than 1000 physicians in gift-giving practices were started up from an earlier investigation towards tax dodging by the pharmaceutical firm GlaxoSmithKline. Closer inspection of several tax forms of the company made these gift-giving practices come to the surface. For a good summary of legal cases concerning gift-giving practices in The Netherlands, we refer to http://www.trouw.nl/zorgengezondheid/farmaceutischeindustrie/index.html and to http://www.recht.nl/gezondheidsrecht/dossiers/geneesmiddelen/.
49. S.L. Coyle, "Physician-Industry Relations. Part 1: Individual Physicians", Ann. Intern. Med. 2002, 136:397.