Thursday, July 06, 2006
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It was announced recently (NOUVELOBS.COM | 07.06.06 | 18:15) that the Ministry of Health in France has accepted the arguments proposed by Mildt and the National Academy of Pharmacy and accordingly will re-classify buprenorphine ‘as a narcotic’. This re-classification is likely to be operational by the end of this year.
The Minister claims that this decision will have no impact on drug users or their treatment but will only have the effect of enhancing law enforcement efforts to reduce illegal trafficking in buprenorphine. Patients receiving buprenorphine treatment will however, be required to carry a copy of their buprenorphine prescription at all times to facilitate police operations against buprenorphine traffickers.
The main argument for the proposed re-classification is that this will substantially decrease buprenorphine trafficking. It is accepted that less than 5% of patients in substitution treatment divert their buprenorphine to the black market. Many clinicians involved in providing substitution treatment in France are concerned that the re-classification will discourage physicians and pharmacists (and even some potential patients) from involvement in buprenorphine or methadone maintenance treatment. Even a small decrease in participation by doctors or pharmacists in this treatment will considerably reduce access to drug treatment for the remaining 95% of patients who fully comply with all the requirements of their drug treatment.
There is no scientific evidence in France or from any other country that restricting the conditions under which buprenorphine treatment is provided will reduce trafficking in buprenorphine.
Previous experiences of similar restrictions have reduced legal access for patients in need and inadvertently increased the availability of the medication on the black market.
When general practitioners in Scotland stopped prescribing buprenorphine because of concern over its non-medical use, there was a subsequent increase in both the use of heroin and the number of drug overdose deaths .
Although these measures are likely to only have a negligible effect on diversion of buprenorphine to the black market, there is increasing evidence that police enforcement against drug users can have an unintended effect of increasing HIV infections in this population .
Morever, buprenorphine is not a ‘narcotic’. As a partial agonist, buprenorphine does not meet the pharmacological criteria set out in international treaties and regulations for classifying a drug as a ‘narcotic’. It is disappointing that France is considering re-classifying buprenorphine as a narcotic in the very same year that the WHO Expert Committee on Drug Dependence, after carefully considering the arguments, dismissed a proposal originating from the International Narcotics Control Board for re-classification.
Buprenorphine was introduced in France in the 1990s, together with other harm reduction measures, to help control an alarming epidemic of HIV among injecting drug users. Since its introduction, not only did the proportion of new AIDS cases accounted for by IDUs fall by over half, but also heroin overdose deaths fell from a peak of over 500 in 1994 to less than 100 per year. These public health benefits were mainly due to the widespread availability of buprenorphine from General Practitioners, improving access of injecting drug users to primary health care and to HIV treatments.
The way buprenorphine has been used in France was unique and produced considerable public health benefits. This experience demonstrated the importance of not classifying buprenorphine as a narcotic and aroused considerable interest at the international level. The French approach to buprenorphine treatment is now regarded as a model of effective harm reduction policy that other countries can learn from, especially those countries facing serious HIV epidemics among drug users.
If France re- classifies buprenorphine as a ‘narcotic’ primarily to reduce diversion of the drug to the black market, there is a considerable risk that this will not reduce trafficking but will have severe negative consequences nationally and also constitute a terrible precedent for other countries.
Doctors and pharmacists involved in substitution treatment in France do want to reduce diversion of buprenorphine to the black market. But they want to achieve this objective without risking hard-won and important public health gains, such as reduced HIV infections and drug overdose deaths, and social gains, such as reduced crime.
The international community of researchers in public health and harm reduction associations implore the French government not to classify buprenorphine as a narcotic as this decision would exclude thousands of drug users from substitution treatment and access to care. The consequence would be the further spread of the HIV epidemic in many emerging and developing countries.
‘Primum non nocere’ – first do no harm – is the principle of all medicine. It should also be the major guiding principle when deciding how medications should be classified and controlled.
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