Essentials of a National Drug Policy for SriLanka

By S W R de A Samarasinghe

(September 01, Kandy, Sri Lanka Guardian) The People’s Movement for the Rights of Patients (PMRP) wants the Supreme Court to order the Minister of Health to submit legislation to parliament to establish a national drug policy. A national drug policy is essential. The current system has two major weaknesses. First, not all patients can afford to buy even the cheapest generic drugs let alone expensive brand names that are available in the market. Second, there is no assurance of quality control of what is sold in the market. However, effectively addressing these two issues is not as simple as it may first appear.

PMRP which is the only public interest body that has taken a sustained interest since 2004 to get a national drug policy enacted has proposed, among other things, reducing the number of drugs that Sri Lanka imports from the current 14,000 to about 1,000. It also wants to establish a "Sri Lanka Drug Authority" (SLDA) much like the Food and Drug Administration of USA to test drugs that are produced locally and/or imported.

The first problem with the 1,000 drug policy is its arbitrariness. There is no logical reasons why the number should be 1,000 rather than say, 800, 1,500, 2,000 or even higher. If a competent technical panel is appointed to run the SLDA they should be given the freedom to decide on the number of drugs to be imported. The real issue is not an arbitrary number but the utility of the drugs for the patients. The decision to import a drug can be based on the following criteria:

* Need for the drug. The popular generic drugs are not an issue. However, if only one or few patients need a particular brand name drug for a rare disease those patients should have the right to access the drug. It won’t be a drain of the national treasury but may bring benefits to the sick. If not the privileged minority will travel abroad for treatment, often at state expense through the Presidential Fund that has, in effect, become a slush fund of sorts for people with right connections.

* The number of brand names and generics that should be imported to ensure healthy competition and prevent price gouging

* The flexibility to import new drugs that by definition will be brand names with patents lasting a minimum of twenty years

The US policy on generics is simple and straight forward. "FDA requires generic drugs to have the same quality and performance as the brand name drugs. Today, 7 in 10 prescriptions filled in the United States are for generic drugs. When it comes to price, there is a big difference in the US between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85% lower than the brand name product." This is evidence that Sri Lanka can enormously benefit by having quality generics. But assuring quality generics is a major challenge even for USA.

In September 2008 the US-FDA prohibited the import of 30 drugs from the largest Indian generic drug manufacturer Ranbaxy. FDA found that some of the data that Ranbaxy supplied to establish the efficacy of its generic drugs was of questionable validity. Sri Lanka clearly benefits from cheap Indian generics. But if we really want to maintain US level international standards for generics we have to follow the same policy that FDA follows. It will take many years for Sri Lanka develop capacity for minimum levels of quality control. In the circumstances we can do two things. We can generally follow the FDA on approval and prohibition of drug imports, generic or brand name. Secondly, we can have a long term plan to develop the technical capacity of the SLDA.

A drug policy along the above lines will provide some relief to the poor but definitely not total relief. People’s income do not rise because of regulation of drug prices. I have two specific proposals. When a generic is available in the market the doctor must be required by law to prescribe the generic . He or she may also prescribe a brand name as a substitute. If no generic is available and if more than one brand name is available in the market, at least two brand names must be mentioned in the prescription to give the consumer a choice. Doctors who violate these regulations must be severely punished with first offenders paying hefty fines and repeat offenders facing jail.

Even the above will not meet the needs of the very poor. For them a crude means test can be used to give subsidized medicine from state hospitals. There is no reason to give free medicine to relatively better off patients who enter state hospitals. Only the poor should be entitled to the subsidy.

None of the above can totally eliminate price fixing by importers and local producers. We pay little or no attention to price collusion in industries such as the drug industry. The proposed SLDA legislation must have very strong anti price fixing provision.

This is an opportunity to strengthen legislation to regulate the pharmacy industry that is grossly underserved by qualified pharmacists. The few who have a diploma often sell it to others for a fee so that people without any qualification can open pharmacies. In a situation where money is short for the patient to buy the needed drugs the ultimate "doctor" is the unqualified salesperson who decides which medicines to give and how much of each. This won’t stop just because 1,000 essential drugs are established. Sri Lanka must expand the training of pharmacists and modernize the industry as a part of the national drug policy.

Finally, one prediction can be made. If the government and the public are not willing to take on the doctor lobby that has a massive vested interest in protecting the lucrative perks – trips abroad, sponsored parties and so called annual sessions of every conceivable "college" and so on – that the the drug companies give them, Sri Lanka will not have a rational national drug policy.

The author is an economics professor at Tulane University, USA and the Executive Chairman of the Kandy-based think tank Global Vision – Centre for Knowledge Advancement. He can be reached at stanley_samarasinghe@hotmail.com -Sri Lanka Guardian