Patients and state stand to gain from the WHO-approved limited drugs list

By M. K. P. Chandralal, Joint Secretary, Peoples Movement for Rights of Patients (PMRP)

In his letter “Restrictive drugs list won’t help patients” (The Sunday Times, February 8), Adrian Basnayake, president of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI), makes several frivolous charges against the People’s Movement for the Rights of Patients (PMRP).

The concept of a limited list of essential drugs was introduced in the1970s by Dr. Seneka Bibile, who maintained that a limited list of about 250 drugs linked to a state buying agency would provide better and rational treatment to patients and save on foreign exchange.

Experts from the World Health Organisation (WHO) recommended the Sri Lanka reforms of 1972-1977 as a model for other developing countries. The government saved between 35 and 40 percent in foreign exchange by implementing these reforms.

The WHO took up the idea of a limited list of essential drugs, and in 1977 published the WHO List of Model Drugs, comprising about 250 drugs. The concept of a limited list of essential drugs was taken up by all WHO member countries. The list is revised every two years. The 15th edition, published in March 2007, contains 350 essential drugs. In 1988, WHO published its “Guidelines for Developing National Drug Policies”, advising member countries to develop and implement their own national drug policies.

The Sri Lanka National Medicinal Drug Policy (NMDP), formulated during two workshops in 2005 by all stakeholders, including representatives from the PMRP and the SLCPI, was accepted by Parliament.
The Minister of Health appointed a National Standing Council to oversee the implementation of the drug policy. A draft Act to set up a Drug Regulatory Authority has been presented to the Minister. These details are given to show that the Ministry of Health has gone far to implement the NMDP.

The Sri Lankan NMDP was posted on the WHO website for other developing countries to use as a model. This shows the enormous importance WHO attaches to our NMDP. However, according to Mr Basnayake, our NMDP is flawed!

The letter poses the following question: “If the markets are not open, the million-dollar or billion-rupee question is: Who will be put in charge of pruning this list, and what criteria will be used?”

This question suggests that the writer has not seen the “List of Essential Medicines, Ministry of Health, Sri Lanka, Third Revision, October 2006”, published by the Ministry of Health.The question posed by Mr. Basnayake was answered by Dr. Athula Kahandaliyanage, the then Director General of Health Services. In his message, he says the Essential Drugs List has been compiled with the following main objectives:

  • To ensure the availability and affordability of efficacious, safe and good quality medicines relevant to the healthcare needs of the people in a sustainable and equitable manner
  • To promote the rational use of medicines by healthcare professionals and consumers
  • To promote local manufacturers of Essential Medicines.

The third revision of the List of Essential Medicines contains 340 essential drugs. The ratio of generic to brand is approximately 1.3. Therefore, the total number formulations needed to include the 340 essential drugs will be about 1,000. This was the basis for the estimate given by the PMRP and quoted in the letter.

The PMRP argues that the human and financial resources available with the Sri Lankan Drugs Authority ensure that each of the 1,000 formulations marketed in the country is of adequate quality, safety and efficacy.

On the other hand, if, as Mr. Basnayake says, the total number of drugs registered in the country, including a number of brands for each generic molecule, stands around 14,000, it will be impossible to ensure the quality of these drugs. The priority action to provide good quality drugs is to reduce the number of drugs in the market as soon as possible.

Another question posed was: “The million-dollar question is how a restrictive list of drugs could go towards reducing the amount of foreign exchange by the country – unless the PMRP plans on compromising quality and deny patients their fundamental right of choice”. The Ministry of Health has published details of health expenditure for 2002, the latest available.

The Ministry has also given the rupee value of drugs supplied for ambulatory out-patients in the private and public sectors. The public and private sectors each provide about 50 percent of the total out-patient care. In both sectors, the care is provided by the same consultant specialists. The patterns of illnesses and diseases of patients in both sectors are the same.

However, the private sector patients paid out of their own pockets Rs. 16.9 billion to purchase their medicines, while the cost of medicines for out-patients in the public sector was only Rs. 516 million. The quality of healthcare and the results were the same in both sectors.

The government saved more than Rs. 16 billion by using the limited list. Patients seeking care in the private sector paid Rs. 16.9 billion for unrestricted, highly expensive branded drugs. Enormous savings were made without compromising quality and denying patients their fundamental right of choice.
Let us examine how the rich advanced countries are facing the problem of increasing healthcare expenses.

“The Economist” magazine of December 6-12, 2008 published an article, “Patently absurd: The European Commission thinks Europe’s drugs market needs Fixing”, which is relevant, and supports the PMRP’s campaign for the promotion of generics.

On November 28, the European Commission unveiled a report that concluded that drug firms used a variety of unfair tactics to delay the entry of cheaper generic drugs to protect their expensive blockbuster drugs.

The European Commission has advised governments to control increasing healthcare expenditure by fixing Europe’s drug market and promoting generics.

The PMRP’s advice to the President is very similar: one solution to the economic crisis is to implement the National Medicinal Drug Policy, based on the concept of a limited list of essential drugs and generic promotion.

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