- Email: [email protected]
EMEA and consumer representation
THE LANCET
encourage the standardisation of simplified assays for drugs in common use. Subhash C Arya Centre for Logistical Research and Innovation, M-122 (of part 2), Greater Kailash-II, New Delhi-110048, India 1 2 3
4 5
Editorial. Quality control and essential drugs. Lancet 1997; 350: 601. Masood E. Warnings raised over black market vaccines. Nature 1995; 374: 669. Sesay MM. Expiry dates on pharmaceuticals—some worrying realities in Sierra Leone. Int Pharm J 1994; 8: 202–06. Roy J. The menace of substandard drugs. World Health Forum 1994; 15: 406–07. Roy J, Saha P, Sultana S, Kenyon AS. Rapid screening of marketed paracetamol tablets: use of thin-layer chromatography and a semiquantitative spot test. Bull WHO 1997; 75: 19–22.
EMEA and consumer representation SIR—Writing on behalf of the Committee for Proprietary Medicinal Products within the European Medicines Evaluation Agency (EMEA), J M Alexandre and K Strandberg (July 26, p 290)1 say that “it would be valuable to know more about what risks patients are willing to take to attain certain benefits”, but add that “the regulatory process would probably benefit more from such knowledge than from direct involvement of ‘consumer boards’. We believe that it is intellectually inconsistent to assert that data on patients’ feelings about risk-benefit ratios will be useful, but that involving representatives of patients in decisionmaking will not. Patients’ involvement in decisions challenges professionals in the regulatory environment as much as it does clinicians; both need to face the same hard issues. Research consistently indicates that, given the same data, patients make different decisions to health professionals. The only purpose of medical treatment or pharmaceutical regulation is the protection of people’s health. So how can the exclusion of consumer input into licensing decisions be justified? Consumer representatives sit on all the major medicines committees in Australia, where a policy of quality use of medicines has been systematically followed for many years. It is disappointing to learn that the EMEA is so frightened of consumer input. What do they have to fear? *Joe Collier, David Dickinson, Sheila McKechnie *Clinical Pharmacology Unit, St George’s Hospital Medical School, London SW7 0RE, UK; 53 Hosack Road, London; and Consumers Association, London 1
Alexandre JM, Strandberg K. EMEA and third-generation oral contraceptives. Lancet 1997; 350: 290.
Vol 350 • October 11, 1997
Allocation of donor organs SIR—Philippe Romano and co-workers (Aug 2, p 372)1 describe the results of an update of the French registration system of candidates for solid organ transplantation. The difficulties they encounter are not unique to France. Steinbrook2 raises issues that also merit a public discussion. One specific point is that the Eurotransplant liver allocation system, in which we take part, puts patients in smaller centres at a disadvantage by including the number of transplantations carried out in the calculation of the rank order of the waiting list. We propose a simple set of rules for patient-driven allocation of adult donor livers, based on a central waiting list with assigned waiting times. First, a donor liver from the pool is offered to the patient who has waited on the central waiting list for the longest time. If a donor liver from the pool or a locally acquired organ is used for another patient, then the patient who has waited the longest is assigned the waiting time of the patient who actually undergoes transplantation. This rule would balance the mean waiting times in the different centres. Second, if a donor liver from the pool or a locally acquired organ is refused and is subsequently transplanted successfully by another centre, this results in placement of the patient to whom the organ was offered at the bottom of the central waiting list. In this way the distribution of donor organs at unfavourable moments is balanced between centres. Third, when the actual waiting time of a patient passes any multiple of 1 year, the patient is automatically removed from the central waiting list, but upon request will be entered again. This rule penalises placement of nontransplantable patients on the waiting list. If a patient is unfairly moved to the bottom of the central waiting list this can be corrected locally. Fourth, patients placed on the emergency waiting list have absolute priority. Donor livers offered to emergency patients can be refused without consequences. When a donor liver offered to a high priority patient in another centre is used for transplantation, the patient who has been waiting for the longest time in the centre offering the organ is awarded a special status. So mandatory exchange for emergency patients remains unchanged. Finally, the size of the local donor regions should reflect the number of patients on the local list to prevent an uneven distribution of donor livers from the pool. This should be supervised by
the central organisation and should be revised every year. Compared with the existing Eurotransplant system, these rules ensure a more even distribution of the waiting times for all participating centres, and allow for local autonomy in deciding which patient will undergo transplantation first. The rules also protect patients in smaller centres. Moreover, they guarantee an immediate reward for donor livers offered to emergency patients through mandatory exchange, without otherwise changing current practice. This approach would discourage the refusal of donor livers offered from the pool and placement of patients on the waiting list with the sole purpose of increasing the chances of an offer from the pool. The maximum allowable waiting time on the general list is open to discussion. Sjoerd de Rave Department of Gastroenterology and Hepatology (Internal Medicine II), University Hospital Rotterdam, 3015 GD Rotterdam, Netherlands 1
2
Romano P, Boutin B, Houssin D. Organ transplant waiting list in France. Lancet 1997; 350: 372. Steinbrook R. Allocating livers—devising a fair system. N Engl J Med 1997; 336: 436–38.
WHO rejection of Taiwan as observer SIR—Lee Chen-Yuan (Aug 9, p 449)1 reports WHO’s rejection of Taiwan as observer. I was in the public audience of the WHO Assembly and recount here how this decision was made. A 2 h long debate was charged by China against Taiwan. When the debate ended, China immediately manipulated the situation to have the role call vote. It was obvious that China intended to identify any nation that supported Taiwan and institute the necessary measures against them afterwards. China imposed an unspoken threat to all nations including the USA, when the name of the nation was called. The US delegation, led by Secretary Donna Chalala, voted to abstain, and signalled that China’s rejection was unjust. However, the USA did not make their position clear in advance so that none of the other countries knew about the abstention until the end of the roll call. However, abstention by the USA fell short of active support for Taiwan. Taiwan has valuable contributions to make: their eradication of malaria, polio, measles, and tuberculosis; their success of family planning and national health insurance; and their experience as a developing country that is emerging as a developed country. In addition, 40% of Taiwanese
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encourage the standardisation of simplified assays for drugs in common use. Subhash C Arya Centre for Logistical Research and Innovation, M-122 (of part 2), Greater Kailash-II, New Delhi-110048, India 1 2 3
4 5
Editorial. Quality control and essential drugs. Lancet 1997; 350: 601. Masood E. Warnings raised over black market vaccines. Nature 1995; 374: 669. Sesay MM. Expiry dates on pharmaceuticals—some worrying realities in Sierra Leone. Int Pharm J 1994; 8: 202–06. Roy J. The menace of substandard drugs. World Health Forum 1994; 15: 406–07. Roy J, Saha P, Sultana S, Kenyon AS. Rapid screening of marketed paracetamol tablets: use of thin-layer chromatography and a semiquantitative spot test. Bull WHO 1997; 75: 19–22.
EMEA and consumer representation SIR—Writing on behalf of the Committee for Proprietary Medicinal Products within the European Medicines Evaluation Agency (EMEA), J M Alexandre and K Strandberg (July 26, p 290)1 say that “it would be valuable to know more about what risks patients are willing to take to attain certain benefits”, but add that “the regulatory process would probably benefit more from such knowledge than from direct involvement of ‘consumer boards’. We believe that it is intellectually inconsistent to assert that data on patients’ feelings about risk-benefit ratios will be useful, but that involving representatives of patients in decisionmaking will not. Patients’ involvement in decisions challenges professionals in the regulatory environment as much as it does clinicians; both need to face the same hard issues. Research consistently indicates that, given the same data, patients make different decisions to health professionals. The only purpose of medical treatment or pharmaceutical regulation is the protection of people’s health. So how can the exclusion of consumer input into licensing decisions be justified? Consumer representatives sit on all the major medicines committees in Australia, where a policy of quality use of medicines has been systematically followed for many years. It is disappointing to learn that the EMEA is so frightened of consumer input. What do they have to fear? *Joe Collier, David Dickinson, Sheila McKechnie *Clinical Pharmacology Unit, St George’s Hospital Medical School, London SW7 0RE, UK; 53 Hosack Road, London; and Consumers Association, London 1
Alexandre JM, Strandberg K. EMEA and third-generation oral contraceptives. Lancet 1997; 350: 290.
Vol 350 • October 11, 1997
Allocation of donor organs SIR—Philippe Romano and co-workers (Aug 2, p 372)1 describe the results of an update of the French registration system of candidates for solid organ transplantation. The difficulties they encounter are not unique to France. Steinbrook2 raises issues that also merit a public discussion. One specific point is that the Eurotransplant liver allocation system, in which we take part, puts patients in smaller centres at a disadvantage by including the number of transplantations carried out in the calculation of the rank order of the waiting list. We propose a simple set of rules for patient-driven allocation of adult donor livers, based on a central waiting list with assigned waiting times. First, a donor liver from the pool is offered to the patient who has waited on the central waiting list for the longest time. If a donor liver from the pool or a locally acquired organ is used for another patient, then the patient who has waited the longest is assigned the waiting time of the patient who actually undergoes transplantation. This rule would balance the mean waiting times in the different centres. Second, if a donor liver from the pool or a locally acquired organ is refused and is subsequently transplanted successfully by another centre, this results in placement of the patient to whom the organ was offered at the bottom of the central waiting list. In this way the distribution of donor organs at unfavourable moments is balanced between centres. Third, when the actual waiting time of a patient passes any multiple of 1 year, the patient is automatically removed from the central waiting list, but upon request will be entered again. This rule penalises placement of nontransplantable patients on the waiting list. If a patient is unfairly moved to the bottom of the central waiting list this can be corrected locally. Fourth, patients placed on the emergency waiting list have absolute priority. Donor livers offered to emergency patients can be refused without consequences. When a donor liver offered to a high priority patient in another centre is used for transplantation, the patient who has been waiting for the longest time in the centre offering the organ is awarded a special status. So mandatory exchange for emergency patients remains unchanged. Finally, the size of the local donor regions should reflect the number of patients on the local list to prevent an uneven distribution of donor livers from the pool. This should be supervised by
the central organisation and should be revised every year. Compared with the existing Eurotransplant system, these rules ensure a more even distribution of the waiting times for all participating centres, and allow for local autonomy in deciding which patient will undergo transplantation first. The rules also protect patients in smaller centres. Moreover, they guarantee an immediate reward for donor livers offered to emergency patients through mandatory exchange, without otherwise changing current practice. This approach would discourage the refusal of donor livers offered from the pool and placement of patients on the waiting list with the sole purpose of increasing the chances of an offer from the pool. The maximum allowable waiting time on the general list is open to discussion. Sjoerd de Rave Department of Gastroenterology and Hepatology (Internal Medicine II), University Hospital Rotterdam, 3015 GD Rotterdam, Netherlands 1
2
Romano P, Boutin B, Houssin D. Organ transplant waiting list in France. Lancet 1997; 350: 372. Steinbrook R. Allocating livers—devising a fair system. N Engl J Med 1997; 336: 436–38.
WHO rejection of Taiwan as observer SIR—Lee Chen-Yuan (Aug 9, p 449)1 reports WHO’s rejection of Taiwan as observer. I was in the public audience of the WHO Assembly and recount here how this decision was made. A 2 h long debate was charged by China against Taiwan. When the debate ended, China immediately manipulated the situation to have the role call vote. It was obvious that China intended to identify any nation that supported Taiwan and institute the necessary measures against them afterwards. China imposed an unspoken threat to all nations including the USA, when the name of the nation was called. The US delegation, led by Secretary Donna Chalala, voted to abstain, and signalled that China’s rejection was unjust. However, the USA did not make their position clear in advance so that none of the other countries knew about the abstention until the end of the roll call. However, abstention by the USA fell short of active support for Taiwan. Taiwan has valuable contributions to make: their eradication of malaria, polio, measles, and tuberculosis; their success of family planning and national health insurance; and their experience as a developing country that is emerging as a developed country. In addition, 40% of Taiwanese
1107