108
of the
BGA, but also undermine the drug law by allowing uncontrolled personal experience as evidence of drug effectiveness and requiring proof of causality beyond doubt for adverse drug reactions. If mutual recognition of national drug regulatory decisions becomes the norm, the activities of the Berlin courts could have an impact on European drug regulations since court rulings override BGA decisions. Peter S. Schönhöfer Ulrich M. Moebius 1. Schönhöfer PS.
Germany: effective drug regulation hampered by courts.
Lancet 1991; 337: 904. 2.
Oberverwaltungsgericht Berlin,
Az. 55 124.89,
judgement
of
May 6,
1990.
Verwaltungsgericht Berlin, Az. 14 A 452.91, judgement of Mar 11, 1992. Bundesgesundheitsamt: Immunpathogene Wirkung durch Arumalon? Pharm Ztg 1992; 137: 1278. 5. Berg PA, Dürk H, Saal J, Hopf G. Bovine cartilage and bone marrow
register would be accessible to France-Transplant members around the clock. Minister of Health Bernard Kouchner has since agreed to set up a register listing not only those wanting opt-out, but also those stating their desire to be organ donors. All polls indicate that 70 to 75% of French citizens agree to donate their organs but doctors who approach families of potential donors for consent say that 50% of the to
families refuse to give permission for organ retrieval, in some cases against the wishes of the brain-dead patient. The existence of such a donor register should help gain the organs that would otherwise be lost because of family
objections. Jean-Michael Bader
3. 4.
extract. Lancet 1989; i: 1275. 6. Bundesgesundheitsamt: Ruhen der
Zulassung: Arumalon. Pharm Ztg
1991; 137: 1802.
France: Transnational
transplants
Since 1976 French law has decreed a brain-dead adult citizen a consenting organ donor unless he had previously opted out of being one. It is therefore not surprising that France does more transplantations per million inhabitants than any other European country (though several European countries have now also adopted the rule of presumed consent). Another factor contributing to the high transplantation rates is the existence of France-Transplant, a private national organ-sharing agency set up in 1969 by transplantation specialists. One side-effect is the growing number of non-residents coming to France to receive organs. Last year 903 of the 3538 patients on the national kidney waiting list were non-residents, as were 118 of the 326 on the liver list. 18% of transplant patients are non-residents-10% of the hearts, 14% of the kidneys, and 35 % of livers donated have gone to non-residents. To explore this trend, the Ministry of Health commissioned a national survey by its general inspectorate for social affairs (IGAS). The inspectors visited 27 hospitals, and talked to 90 transplantation teams that were responsible for 80% of all grafts. The IGAS survey found 1066 non-residents on waiting lists, along with 3172 residents: 921 (86%) of the nonresidents were Italians. 29% of all liver transplantations by the 22 medical teams visited by the IGAS inspectors were done on Italian patients; the proportion was 50% for one team, and over 86% for another. The IGAS fears that the demand for organs by nonresidents might mean that French residents are being denied transplants. Furthermore, non-residents do not pay the full costs of services received. One centre has calculated that a liver transplantation costs Fr 487 777 (including the cost of a year’s follow-up), but the Ministry of Health special tariff (for very costly procedures) is only Fr 372 492. IGAS has recommended that France-Transplant should become state-owned, that non-residents should be charged the full cost of the service received, and that the Ministry of Health should limit the number of foreign patients eligible for transplantation. France-Transplant president, Prof Christian Cabrol, has confirmed that the organisation would follow government guidelines on transplantation for nonresidents. Officials of France-Transplant had suggested in Le Monde on June 6 a national register of residents opting out of being an organ donor, as exists in Belgium. This
Medicine and the Law Refusal of treatment by 16-year-old In London, the Court of Appeal, in an interim ruling on July 2, 1992, ordered that a 16-year-old girl with anorexia nervosa should be treated against her own wishes. Some may argue that this decision strikes a blow against "children’s rights". There is, however, an equally persuasive argument that the most important right of such a child is not the adult right of autonomous choice, but the right to be protected until such time as she is mentally and emotionally capable of making adult decisions. The subject of the court’s ruling was a girl referred to as "J". J had lost her parents and, more recently, her grandfather. She was in local authority care and had for some time shown features of anorexia nervosa. At 1 -7 m tall, she weighed less than 40 kg.J was already a patient in a psychiatric facility, but doctors wished to transfer her to a special unit for eating disorders. J refused to go and stopped eating altogether. The case was initiated by the local authority in the High Court, where Mr Justice Thorpe ruled that J was to be treated as the doctors and the local authority deemed fit. In its preliminary ruling, the Court of Appeal upheld this decision, pending a full judgment on the legal arguments. On the facts of the case, the justification for imposing treatment may have been quite straightforward: it may be that J was simply not thought to be mentally competent to make important decisions about herself. It can certainly be argued that the effects of anorexia nervosa include such a distortion of self-perception as to render even a generally intelligent and sensible person incapable of rational choice in this area. If that is the basis of the court’s decision, then it would not have mattered that J was 16. Had she been 26 or 56, the decision might have been the same. If, as many would assert, anorexia nervosa falls within the statutory classification of mental illness, then it should have been
possible to resolve the matter by the compulsory detention of J under a section of the Mental Health Act 1983. However, there seems to be a curious reluctance to "section" adolescents. Although there is a stigma attached to being sectioned and it is generally thought desirable for patients to agree to admission, the voluntary/involuntary distinction becomes meaningless if adolescents avoid being sectioned only to be detained against their will by court order. The advantage of proceeding under the Mental Health Act is that there are at least limited procedural safeguards and appeal mechanisms. There is, though, a wider issue in this case, apart from the factual question of whether J was capable of exercising
109
judgment. The crux of the matter lies in the interpretation of section 8 of the Family Law Reform Act mature
1969. That Act states that "The consent of a minor who has
attained the age of 16 years to any surgical, medical or dental shall be as effective as it would be if he were of was omitted, whether deliberately or by What age". was any express reference to the reverse situation, oversight, a child in which might wish to refuse consent to treatment. At first sight, it might seem logical that the right to consent should go hand in hand with the right to refuse consent. For an adult to give consent suggests that a decision has been made, on the basis of mature reflection on the alternatives, including refusal. However, in the 1991 case of Re R, Lord Donaldson, one of the judges in the present case, held that consent and refusal were distinct processes. The law had allowed children to give valid, independent consent, but had said nothing about refusal. In an example of exceedingly restrictive interpretation, Lord Donaldson concluded that a child who was mature enough to consent was not necessarily mature enough to refuse. To put it another way, the extension to the child of the right to consent had not taken from her parents (or the local authority, or the court exercising its wardship jurisdiction) their own power to consent on the child’s behalf. This interpretation enables teenage girls to consent to contraception, yet to be denied the chance to reject life-saving treatment. However, closer examination reveals flaws in the argument. To have the right to consent without the right to refuse turns a procedure intended to protect the patient’s right to bodily integrity into a meaningless rubber-stamping exercise. If adolescents of 16 or 17 need protection from their own ill-advised refusals of treatment, then surely the statute is misguided and we should also be protecting them against acceptance of equally ill-advised and unnecessary risks, such as cosmetic surgery. On the other hand, if J’s case approves the distinction between consent and refusal proposed in Re R, it would mean that a mature 17-year-old would have no right to veto her parent’s consent to elective surgery, or to participation in a research trial, or even to an abortion. Furthermore, as was argued by counsel before the High Court, the tone of the Children Act 1989 is certainly to allow children the right to refuse as well as to consent. Schedule 3, para 5(5), for example, explicitly permits mature children who are under supervision orders to refuse medical treatment. It is very questionable whether J was in an emotional state to make decisions. Holding her up as an example of the danger of allowing full decision-making power to adolescents who might be entrusted with important choices would simply not be appropriate. It would be unfortunate if the Court of Appeal were to use this case to impose unnecessary restrictions on the law relating to the consent of minors. Elizabeth Roberts treatment...
full
Obituary Fritz Deinhardt Prof Fritz Deinhardt, director of the Max Pettenkofer-Institut in Munich, died on April 30.
von
Graduating at a time when German medical science was at a low (1952), Fritz Deinhardt left Germany to be trained in the laboratory of W. and G. Henle in Philadelphia. He developed rapidly, working on mumps and various other virus/cell systems. By 1961 he had a department in Chicago, where he followed up the ebb
interests of the Henles in hepatitis. With his English wife Jean, a zoologist, he did the most conclusive work at the time to show that a hepatitis virus could be transmitted to common marmosets. He also became interested in retroviruses of primates, and what he learned from this seemingly peripheral experience proved very valuable when AIDS came along. In 1977 he returned to Germany to be head of the Max von Pettenkofer-Institut in Munich, where he continued to direct productive research, particularly on hepatitis.
Deinhardt
was an
international
man.
His views
were
much
sought after by WHO and other bodies, and he chaired the EC programme EVA (support for research on vaccines against AIDS). He could criticise the three countries with which he
was
linked-
goading the British for revealing, as they talked, that they thought of Europe as "them" and not "us". With Jean he complemented formal discussions and committee meetings with relaxed and generous hospitality. Many have cause to mourn his passing. David Tyrrell Robin Fox adds: When we were assembling The Lancet’s International Advisory Board two years ago, Fritz Deinhardt was an obvious candidate-a careful and thorough reviewer, a medical scientist of international standing, and a wise man. What we had not known about was his generous spirit and his affection for the journal. These emerged as we read a succession of messages from Munich, consistently warm, positive, and creative beyond the call of any duty. The Lancet has lost a good friend.
Noticeboard Monitoring doctors’ competence Concern about the ability of the medical profession to discipline itself and about whether state licensing boards had access to disciplinary actions taken against doctors in their own or other states led to the enactment of the Health Care Quality Improvement Act in 1986 in the USA and to the setting up of the National Practitioner Data Bank (NPDB), which collects comprehensive data on punitive actions taken against, and malpractice payments made on behalf of, health-care professionals. The law requires hospitals to check with the NPDB the records of a doctor or dentist at time of appointment and then every two years. Other organisations such as health maintenance organisations, nursing homes, and licensing bodies may also make inquiries. In the year since the NPDB started operating on Sept 1,1990, the bank received almost 800 000 inquiries, an average of more than 3000 per working day, mostly from hospitals.l 2500 health-care practitioners sought information about themselves. 2779 (15%) of the reports made to the NPDB were of punitive actions taken with respect to a practitioner’s licence, clinical privileges, or professional society membership. Of the 1968 licensure actions, 35 % were of the practitioner being put on probation, 17% were of suspensions of licences, and 13% were of revocations of licences. There are no strictly comparable data against which to set these findings, so their interpretation is difficult. Uncertainties about the data are raised by the fact that the number of malpractice payments reported to the bank was approximately half that estimated by the General Accounting Office for 1984. Similarly, the number of medical licensure actions was about half the number estimated by the Federation of State Medical Boards (though the Federation’s numbers include actions for reasons other than medical incompetence). And does the inverse relation between the rates of licensure actions and the size of a state’s physician population indicate that small medical communities are better able than large ones to exercise rigorous peer review, or that some feature of areas with large doctor populations have a beneficial influence on practice? Studies on how best the bank should operate, how it is being used, and its long-term effect on licensing and peer review are
underway or being planned. F, Politzer RM, Lewis CT, Bastacky S, Rodale J, Hermon RG. The Nanonal Practitioner Data Bank. Report from the first year. JAMA 1992, 268: 73-79.
1. Mullan
of the
BGA, but also undermine the drug law by allowing uncontrolled personal experience as evidence of drug effectiveness and requiring proof of causality beyond doubt for adverse drug reactions. If mutual recognition of national drug regulatory decisions becomes the norm, the activities of the Berlin courts could have an impact on European drug regulations since court rulings override BGA decisions. Peter S. Schönhöfer Ulrich M. Moebius 1. Schönhöfer PS.
Germany: effective drug regulation hampered by courts.
Lancet 1991; 337: 904. 2.
Oberverwaltungsgericht Berlin,
Az. 55 124.89,
judgement
of
May 6,
1990.
Verwaltungsgericht Berlin, Az. 14 A 452.91, judgement of Mar 11, 1992. Bundesgesundheitsamt: Immunpathogene Wirkung durch Arumalon? Pharm Ztg 1992; 137: 1278. 5. Berg PA, Dürk H, Saal J, Hopf G. Bovine cartilage and bone marrow
register would be accessible to France-Transplant members around the clock. Minister of Health Bernard Kouchner has since agreed to set up a register listing not only those wanting opt-out, but also those stating their desire to be organ donors. All polls indicate that 70 to 75% of French citizens agree to donate their organs but doctors who approach families of potential donors for consent say that 50% of the to
families refuse to give permission for organ retrieval, in some cases against the wishes of the brain-dead patient. The existence of such a donor register should help gain the organs that would otherwise be lost because of family
objections. Jean-Michael Bader
3. 4.
extract. Lancet 1989; i: 1275. 6. Bundesgesundheitsamt: Ruhen der
Zulassung: Arumalon. Pharm Ztg
1991; 137: 1802.
France: Transnational
transplants
Since 1976 French law has decreed a brain-dead adult citizen a consenting organ donor unless he had previously opted out of being one. It is therefore not surprising that France does more transplantations per million inhabitants than any other European country (though several European countries have now also adopted the rule of presumed consent). Another factor contributing to the high transplantation rates is the existence of France-Transplant, a private national organ-sharing agency set up in 1969 by transplantation specialists. One side-effect is the growing number of non-residents coming to France to receive organs. Last year 903 of the 3538 patients on the national kidney waiting list were non-residents, as were 118 of the 326 on the liver list. 18% of transplant patients are non-residents-10% of the hearts, 14% of the kidneys, and 35 % of livers donated have gone to non-residents. To explore this trend, the Ministry of Health commissioned a national survey by its general inspectorate for social affairs (IGAS). The inspectors visited 27 hospitals, and talked to 90 transplantation teams that were responsible for 80% of all grafts. The IGAS survey found 1066 non-residents on waiting lists, along with 3172 residents: 921 (86%) of the nonresidents were Italians. 29% of all liver transplantations by the 22 medical teams visited by the IGAS inspectors were done on Italian patients; the proportion was 50% for one team, and over 86% for another. The IGAS fears that the demand for organs by nonresidents might mean that French residents are being denied transplants. Furthermore, non-residents do not pay the full costs of services received. One centre has calculated that a liver transplantation costs Fr 487 777 (including the cost of a year’s follow-up), but the Ministry of Health special tariff (for very costly procedures) is only Fr 372 492. IGAS has recommended that France-Transplant should become state-owned, that non-residents should be charged the full cost of the service received, and that the Ministry of Health should limit the number of foreign patients eligible for transplantation. France-Transplant president, Prof Christian Cabrol, has confirmed that the organisation would follow government guidelines on transplantation for nonresidents. Officials of France-Transplant had suggested in Le Monde on June 6 a national register of residents opting out of being an organ donor, as exists in Belgium. This
Medicine and the Law Refusal of treatment by 16-year-old In London, the Court of Appeal, in an interim ruling on July 2, 1992, ordered that a 16-year-old girl with anorexia nervosa should be treated against her own wishes. Some may argue that this decision strikes a blow against "children’s rights". There is, however, an equally persuasive argument that the most important right of such a child is not the adult right of autonomous choice, but the right to be protected until such time as she is mentally and emotionally capable of making adult decisions. The subject of the court’s ruling was a girl referred to as "J". J had lost her parents and, more recently, her grandfather. She was in local authority care and had for some time shown features of anorexia nervosa. At 1 -7 m tall, she weighed less than 40 kg.J was already a patient in a psychiatric facility, but doctors wished to transfer her to a special unit for eating disorders. J refused to go and stopped eating altogether. The case was initiated by the local authority in the High Court, where Mr Justice Thorpe ruled that J was to be treated as the doctors and the local authority deemed fit. In its preliminary ruling, the Court of Appeal upheld this decision, pending a full judgment on the legal arguments. On the facts of the case, the justification for imposing treatment may have been quite straightforward: it may be that J was simply not thought to be mentally competent to make important decisions about herself. It can certainly be argued that the effects of anorexia nervosa include such a distortion of self-perception as to render even a generally intelligent and sensible person incapable of rational choice in this area. If that is the basis of the court’s decision, then it would not have mattered that J was 16. Had she been 26 or 56, the decision might have been the same. If, as many would assert, anorexia nervosa falls within the statutory classification of mental illness, then it should have been
possible to resolve the matter by the compulsory detention of J under a section of the Mental Health Act 1983. However, there seems to be a curious reluctance to "section" adolescents. Although there is a stigma attached to being sectioned and it is generally thought desirable for patients to agree to admission, the voluntary/involuntary distinction becomes meaningless if adolescents avoid being sectioned only to be detained against their will by court order. The advantage of proceeding under the Mental Health Act is that there are at least limited procedural safeguards and appeal mechanisms. There is, though, a wider issue in this case, apart from the factual question of whether J was capable of exercising
109
judgment. The crux of the matter lies in the interpretation of section 8 of the Family Law Reform Act mature
1969. That Act states that "The consent of a minor who has
attained the age of 16 years to any surgical, medical or dental shall be as effective as it would be if he were of was omitted, whether deliberately or by What age". was any express reference to the reverse situation, oversight, a child in which might wish to refuse consent to treatment. At first sight, it might seem logical that the right to consent should go hand in hand with the right to refuse consent. For an adult to give consent suggests that a decision has been made, on the basis of mature reflection on the alternatives, including refusal. However, in the 1991 case of Re R, Lord Donaldson, one of the judges in the present case, held that consent and refusal were distinct processes. The law had allowed children to give valid, independent consent, but had said nothing about refusal. In an example of exceedingly restrictive interpretation, Lord Donaldson concluded that a child who was mature enough to consent was not necessarily mature enough to refuse. To put it another way, the extension to the child of the right to consent had not taken from her parents (or the local authority, or the court exercising its wardship jurisdiction) their own power to consent on the child’s behalf. This interpretation enables teenage girls to consent to contraception, yet to be denied the chance to reject life-saving treatment. However, closer examination reveals flaws in the argument. To have the right to consent without the right to refuse turns a procedure intended to protect the patient’s right to bodily integrity into a meaningless rubber-stamping exercise. If adolescents of 16 or 17 need protection from their own ill-advised refusals of treatment, then surely the statute is misguided and we should also be protecting them against acceptance of equally ill-advised and unnecessary risks, such as cosmetic surgery. On the other hand, if J’s case approves the distinction between consent and refusal proposed in Re R, it would mean that a mature 17-year-old would have no right to veto her parent’s consent to elective surgery, or to participation in a research trial, or even to an abortion. Furthermore, as was argued by counsel before the High Court, the tone of the Children Act 1989 is certainly to allow children the right to refuse as well as to consent. Schedule 3, para 5(5), for example, explicitly permits mature children who are under supervision orders to refuse medical treatment. It is very questionable whether J was in an emotional state to make decisions. Holding her up as an example of the danger of allowing full decision-making power to adolescents who might be entrusted with important choices would simply not be appropriate. It would be unfortunate if the Court of Appeal were to use this case to impose unnecessary restrictions on the law relating to the consent of minors. Elizabeth Roberts treatment...
full
Obituary Fritz Deinhardt Prof Fritz Deinhardt, director of the Max Pettenkofer-Institut in Munich, died on April 30.
von
Graduating at a time when German medical science was at a low (1952), Fritz Deinhardt left Germany to be trained in the laboratory of W. and G. Henle in Philadelphia. He developed rapidly, working on mumps and various other virus/cell systems. By 1961 he had a department in Chicago, where he followed up the ebb
interests of the Henles in hepatitis. With his English wife Jean, a zoologist, he did the most conclusive work at the time to show that a hepatitis virus could be transmitted to common marmosets. He also became interested in retroviruses of primates, and what he learned from this seemingly peripheral experience proved very valuable when AIDS came along. In 1977 he returned to Germany to be head of the Max von Pettenkofer-Institut in Munich, where he continued to direct productive research, particularly on hepatitis.
Deinhardt
was an
international
man.
His views
were
much
sought after by WHO and other bodies, and he chaired the EC programme EVA (support for research on vaccines against AIDS). He could criticise the three countries with which he
was
linked-
goading the British for revealing, as they talked, that they thought of Europe as "them" and not "us". With Jean he complemented formal discussions and committee meetings with relaxed and generous hospitality. Many have cause to mourn his passing. David Tyrrell Robin Fox adds: When we were assembling The Lancet’s International Advisory Board two years ago, Fritz Deinhardt was an obvious candidate-a careful and thorough reviewer, a medical scientist of international standing, and a wise man. What we had not known about was his generous spirit and his affection for the journal. These emerged as we read a succession of messages from Munich, consistently warm, positive, and creative beyond the call of any duty. The Lancet has lost a good friend.
Noticeboard Monitoring doctors’ competence Concern about the ability of the medical profession to discipline itself and about whether state licensing boards had access to disciplinary actions taken against doctors in their own or other states led to the enactment of the Health Care Quality Improvement Act in 1986 in the USA and to the setting up of the National Practitioner Data Bank (NPDB), which collects comprehensive data on punitive actions taken against, and malpractice payments made on behalf of, health-care professionals. The law requires hospitals to check with the NPDB the records of a doctor or dentist at time of appointment and then every two years. Other organisations such as health maintenance organisations, nursing homes, and licensing bodies may also make inquiries. In the year since the NPDB started operating on Sept 1,1990, the bank received almost 800 000 inquiries, an average of more than 3000 per working day, mostly from hospitals.l 2500 health-care practitioners sought information about themselves. 2779 (15%) of the reports made to the NPDB were of punitive actions taken with respect to a practitioner’s licence, clinical privileges, or professional society membership. Of the 1968 licensure actions, 35 % were of the practitioner being put on probation, 17% were of suspensions of licences, and 13% were of revocations of licences. There are no strictly comparable data against which to set these findings, so their interpretation is difficult. Uncertainties about the data are raised by the fact that the number of malpractice payments reported to the bank was approximately half that estimated by the General Accounting Office for 1984. Similarly, the number of medical licensure actions was about half the number estimated by the Federation of State Medical Boards (though the Federation’s numbers include actions for reasons other than medical incompetence). And does the inverse relation between the rates of licensure actions and the size of a state’s physician population indicate that small medical communities are better able than large ones to exercise rigorous peer review, or that some feature of areas with large doctor populations have a beneficial influence on practice? Studies on how best the bank should operate, how it is being used, and its long-term effect on licensing and peer review are
underway or being planned. F, Politzer RM, Lewis CT, Bastacky S, Rodale J, Hermon RG. The Nanonal Practitioner Data Bank. Report from the first year. JAMA 1992, 268: 73-79.
1. Mullan
