Pharmaceutical hurdles to harm reduction

Photo by bobbyramakantThe absence of coherent national and regional policies to support HIV harm reduction programs in Asian countries hit hard by injecting drug use is acute and limits the likelihood of these countries achieving ‘Universal Access’ targets by 2010.

Under these circumstances, it can be incredibly difficult for pharmaceutical companies to procure the raw materials needed for drugs that are classified as narcotics in many countries and manufacture and supplying these drugs to countries with non-supportive policies.

“There are successes and obstacles faced by pharmaceutical companies in introducing, maintaining, servicing or scaling up,”said Dr Naveen Saxena, Chairman of Rusan Pharmaceutical Limited in India, which manufactures drugs for opioid substitution therapies, hepatitis C (HCV) and multi-drug resistant tuberculosis (MDRTB).

“The biggest impediment once the opioid substitution therapy (OST) or needle syringe exchange program concept has been accepted by the medical and NGO fraternity is the police and home office and the International Narcotics Control Board (INCB),” Dr Saxeena said.

“Since both the essential drugs—methadone and buprenorphine—fall under the narcotic category, the internal ministry exercises such controls and delays in granting the clearances and quotas, which in turn delays the treatment provision by years.”

OST and needle syringe exchange programs are both accepted and promoted by WHO and methadone and buprenorphine are included on the organisation’s list of essential medicines since 2005. Yet in the majority of Asian coutrnies, these medicines remain illegal.

“The internal ministry has the task to cut down the supply of drugs of abuse, catch the drug peddlers,” said Dr Saxena, adding that the ministry should not interfere in well-established treatment protocols for injecting drug users (IDUs).

“The internal ministry should facilitate treatment because it helps in reducing street crimes and costs related to judicial procedures,” said Dr Saxena.

Another grave issue is the intermittent supply of substitution drugs. In Nepal, a methadone program was started but due to supply problems many NGOs and IDUs became reluctant to continue with the process.

In Myanmar, a single supply of methadone was provided by WHO’s India office, which lasted for just three to four months. In India, EU funding for OST programs in five cities dried out and the projects only survived after the government stepped in.

The capacity of civil society groups, particularly community-based organisations comprised of IDUs, needs to be built up to help facilitate the rapid scale-up of harm reduction programs. Drug user involvement in planning and designing such interventions as well as their deployment and evaluation is essential to ensure that such interventions meet the needs to targeted clients.

There are lessons to be learnt from TB drug-supply protocols. Different stakeholders need to sit down with pharmaceutical companies and come up with long-term bulk order systems to supply drugs to a certain region for a pre-agreed price.

Like the European Union, other regions such as South Asia, Southeast Asia, the South Asian Association for Regional Cooperation (SAARC) and or Central Asia, should come up with a regional registration procedure which should be respected by all countries. This would expedite the scale-up of OST programs, according to Dr Saxena.

Fortunately, the UN Regional Task Force on Injecting Drug Use and HIV/AIDS in Asia and the Pacifric has recently published a guide for miproving procurement procedures of such essential medicines in the region (see http://www.unodc.un.or.th/drugsandhiv/publications/2007/Step-by-Step.pdf).

As we inch towards the 2010 ‘Universal Access’ targets, it may be helpful not only to be mindful of the concerns of drug-manufacturers but also to learn from other interventions, such as Directly Observed Treatment Short-course (DOTS), which has successfully supplied TB drugs to more than 10 million people.

Bobby Ramakant-CNS

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