The case for rational access

Every two years, the World Health Organization (WHO) releases a list of medicines that it considers fundamental for governments across the world to make available to their people. The latest revision of the Essential Medicines List (EML) on June 6 adds several new drugs, including two oral cancer treatments, a new drug for hepatitis C, and new paediatric formulations of medicines for tuberculosis.

With this EML as a guide, WHO encourages countries to make their national lists. The 2017 list has 30 new medicines for adults and 25 new medicines for children, bringing the EML total to 433 drugs. “Medicines are recommended based upon mortality and the disease burden, and evidence of how well the medicine works. The cost of a drug is a consideration but it is not the only one. In the case of TB drugs, it is absolutely necessary to roll out these new drugs to people living with DR (drug-resistant) TB in India,” says Dr. Sumanth Gandra, who was part of the expert committee that helped shape the revised list.

A new TB drug, delamanid is neither registered nor available in the Indian TB programme but now WHO’s newly revised EML recommends that national governments take steps to make it available to the people. With 2.8 million new cases reported annually, India has some of the highest prevalence of DR TB, including multidrug-resistant and extensively drug-resistant tuberculosis, in the world. In January 2017, a teenage girl who was suffering from DR TB had taken the government to court for her right to access delamanid. The patient community has been requesting the government to direct Otsuka Pharmaceuticals, the company that holds monopoly over the drug, to register it in India without delay.

Use of antibiotics

Another revision that will have significant implication for India is the WHO’s latest recommendations on the use of antibiotics. Earlier this year, the public health community was alarmed as a 70-year-old American woman died after being infected by a superbug during her visit to India.

The WHO says it carried out the “biggest revision of the antibiotics section in the EML’s 40-year history” in an effort to curb antimicrobial resistance, dividing antibiotic drugs into three categories — ‘access’, ‘watch’, and ‘reserve’ — and framing recommendations on when each category should be prescribed or used. Antibiotics in the ‘access’ group should be available for common infections; ‘watch’ includes antibiotics recommended as first- or second-choice treatments for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of urinary tract infection) and upper respiratory tract infections, should be dramatically reduced to avoid further development of resistance. The ‘reserve’ category has last-resort antibiotics that WHO says “should be used only in the most severe circumstances when all other alternatives have failed”, such as for life-threatening infections due to multidrug-resistant bacteria.

“This list is aimed to guide countries to use the drugs in the ‘access’ category first. We now know that the potential for resistance is higher if the drugs in the other two lists are irrationally used. There is no surveillance as of now but the Indian government’s national action plan intends to examine the growing antimicrobial resistance. It will now be easier to watch the reserve list,” adds Dr. Gandra.


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