Drug regulators study global treaty to tackle counterfeit drugs
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《英国医生杂志》
Drug regulators from some 40 countries have decided that further discussions are needed before a global treaty is introduced to tackle the growing trade in counterfeit drugs, which is estimated to affect 5% to 7% of the pharmaceutical market worldwide and results in death, disability, and injury.
The regulators were responding to a "concept paper" on a proposed international framework convention to combat the illegal trade. The paper was presented by the World Health Organization抯 department of essential medicines and policy at a two day meeting preceding the International Conference of Drug Regulatory Authorities in Madrid last week.
Counterfeit drugs affect developed and developing countries, although the problem is far more pronounced in the developing world梖or example, counterfeit drugs account for 40% to 50% of the total in Nigeria and Pakistan.
In Nigeria most counterfeit drugs originate from India, while in Latin America the source is often local. In the United States the number of cases investigated by the Food and Drug Administration rose from six in 1997 to 22 in 2002.
Erik Madsen of Interpol told the meeting that emerging evidence shows that counterfeiting was linked to organised crime and terrorist organisations, including al Qa抏da.
The concept paper says a framework convention would focus political will on the problem, oblige countries to establish laws to strengthen regulation of drugs, and detail the nature of the crimes and sanctions. It states that the large amounts of counterfeit drugs in some countries indicate that national measures alone have not been adequate to tackle the trade, which is global in nature.
One of the aims of the convention is to promote international cooperation and the exchange of information between countries, drug regulators, law enforcement agencies, and the drugs industry. Some delegates felt that not enough data were available to paint a complete picture of the problem, and others disputed the figures attributed to their country.
Dr Lembit Rago, WHO抯 coordinator of quality assurance and safety of medicines, called for more transparency, saying the drugs industry had a great deal of data but was "very reluctant to make them available." Marcel Moester, a Dutch healthcare inspector, said it would be useful, for example, if companies informed agencies if they saw an unexplained drop in sales for a certain product, so it could be investigated.
But companies were sensitive about sharing data, because they thought that raising awareness of counterfeiting could unsettle patients and make them worry about whether the drugs they were taking were fake, explained Peter Lowe, assistant director of the Counterfeiting Intelligence Bureau, part of the International Chamber of Commerce. However, he admitted that the lack of information did not help in trying to solve the problem. "There has to be a balance in there somewhere," he said.
But it was not only companies that fail to share data. WHO said it had received no incidence reports of counterfeit drugs from member countries after 2002, and it had received only 84 reports between 1999 and 2002. A senior WHO delegate thinks that one reason for the small number of reports could be that drug regulators are embarrassed to submit their reports, as it could reflect their lack of success in this area. To aid member states in reporting incidences WHO updated its reporting system last October.
Justina Molzon, associate director of the international programme at the Food and Drug Administration, which has just launched a report on counterfeit drugs, told the meeting that the framework convention was "good" but that drug regulators needed to consider it further before it went to a "higher level" for negotiation. Drug regulators agreed that this should be done before the next meeting of the International Conference of Drug Regulatory Authorities in 2006.(Madrid Liza Gibson)
The regulators were responding to a "concept paper" on a proposed international framework convention to combat the illegal trade. The paper was presented by the World Health Organization抯 department of essential medicines and policy at a two day meeting preceding the International Conference of Drug Regulatory Authorities in Madrid last week.
Counterfeit drugs affect developed and developing countries, although the problem is far more pronounced in the developing world梖or example, counterfeit drugs account for 40% to 50% of the total in Nigeria and Pakistan.
In Nigeria most counterfeit drugs originate from India, while in Latin America the source is often local. In the United States the number of cases investigated by the Food and Drug Administration rose from six in 1997 to 22 in 2002.
Erik Madsen of Interpol told the meeting that emerging evidence shows that counterfeiting was linked to organised crime and terrorist organisations, including al Qa抏da.
The concept paper says a framework convention would focus political will on the problem, oblige countries to establish laws to strengthen regulation of drugs, and detail the nature of the crimes and sanctions. It states that the large amounts of counterfeit drugs in some countries indicate that national measures alone have not been adequate to tackle the trade, which is global in nature.
One of the aims of the convention is to promote international cooperation and the exchange of information between countries, drug regulators, law enforcement agencies, and the drugs industry. Some delegates felt that not enough data were available to paint a complete picture of the problem, and others disputed the figures attributed to their country.
Dr Lembit Rago, WHO抯 coordinator of quality assurance and safety of medicines, called for more transparency, saying the drugs industry had a great deal of data but was "very reluctant to make them available." Marcel Moester, a Dutch healthcare inspector, said it would be useful, for example, if companies informed agencies if they saw an unexplained drop in sales for a certain product, so it could be investigated.
But companies were sensitive about sharing data, because they thought that raising awareness of counterfeiting could unsettle patients and make them worry about whether the drugs they were taking were fake, explained Peter Lowe, assistant director of the Counterfeiting Intelligence Bureau, part of the International Chamber of Commerce. However, he admitted that the lack of information did not help in trying to solve the problem. "There has to be a balance in there somewhere," he said.
But it was not only companies that fail to share data. WHO said it had received no incidence reports of counterfeit drugs from member countries after 2002, and it had received only 84 reports between 1999 and 2002. A senior WHO delegate thinks that one reason for the small number of reports could be that drug regulators are embarrassed to submit their reports, as it could reflect their lack of success in this area. To aid member states in reporting incidences WHO updated its reporting system last October.
Justina Molzon, associate director of the international programme at the Food and Drug Administration, which has just launched a report on counterfeit drugs, told the meeting that the framework convention was "good" but that drug regulators needed to consider it further before it went to a "higher level" for negotiation. Drug regulators agreed that this should be done before the next meeting of the International Conference of Drug Regulatory Authorities in 2006.(Madrid Liza Gibson)