Feizal Samath
COLOMBO, Feb 1 2008 (IPS) – Sri Lankan doctors and patients rights groups have rarely seen eye-to-eye on the global debate over costly branded drugs against cheap generics, but they are coming together against a new rule that requires doctors to use only generic names on their prescriptions or face jail.
The Sri Lanka Medical Council (SLMC), in a strong reaction to threats from Health Minister Nimal Siripala de Silva to jail doctors who do not stick to generic names, to the exclusion of brands, said in a statement: There are many crimes that may need imprisonment but this does not warrant such punishment. It is very unlikely that a minister of health in a civilised country would castigate doctors in this manner. #39 #39
According to the SLMC governing body of thousands of registered allopathic practioners doctors were perfectly within their right to prescribe brands while indicating the generic names of medicines.
The Peoples Movement for the Rights of Patients (PMRP), that has been campaigning for cheaper drugs, in a country where some 30 percent of the population lives below the poverty line, said De Silva s piecemeal solutions were worse than the disease.
At the heart of the matter is the growing dispute between generics and branded drugs, on the one hand, and cheaper, good quality medicines on the other. Caught in the middle are patients, mostly from poor rural villages, who do not have a clue about generics or brands and take the doctor s or pharmacist s word when buying medicines.
Doctors says they prescribe branded drugs as they are sure of quality and efficacy. But patients rights movements accuse some doctors of being in the pay of big drug companies, who sponsor them for overseas study and leisure trips and, in some cases, even finance the education of their children abroad.
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Louis Benedict, a veteran journalist and powerful campaigner for the PMRP, says the government must bring in comprehensive legislation to enforce the National Medicinal Drugs Policy, drafted three years ago by all stakeholders doctors, representatives of patients and the Ministry of Health, drug companies, etc and approved by the cabinet.
We have some 8,000 drugs now registered, a world record. The policy calls for slashing this figure to less than 1,000, he said. A new authority under the new reforms will evaluate the list of registered drugs and consider quality, efficacy, safety, the cost and the need for the drug making quality drugs available to all the people at affordable prices through more effective quality control and post marketing surveillance. He said the country could save billions of dollars in foreign exchange annually by stopping the import of thousands of non-essential drugs imported under highly expensive brand names.
Why the legislation is being delayed is a mystery. Benedict says the whole controversy could be resolved if the Health Ministry introduces the policy. He says there is concern that powerful vested interests with influence in the Ministry are blocking the proposed legislation and the Ministry is trying to divert attention by issuing piecemeal directives which are worsening the sickness.
The dispute over generics has dragged on for years and is a growing problem here as in much of the developing world, but the latest controvery was triggered by a government rule, effective from Jan. 1, 2008, for all drugs to be prescribed by its generic name only.
Adding fuel to the fire was a statement by the controversial De Silva, who has faced a series of strikes and other problems with all levels of government medical staff over the years with what are seen as poor decision-making on different issues.
A senior consultant, Dr. H.H.R. Samarasinghe, said, I didn #39t become a doctor to be told what to do by a minister. The government allows hundreds of brands to be imported into the country. Then they ask doctors to prescribe only generic medicine, for reasons best known to them, he said.
Dr B.G.D. Bujawansa, a past president of the Independent Medical Practitioners #39 Association, said, As private practitioners we are not under the Health Ministry. They can #39t make us follow the rule unless they change the Cosmetics, Devices and Drugs Act of 1980.
Many private doctors, who declined to be named, were unsure whether they would be penalised if they prescribed branded drugs.
Adrian Basnayake, president of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) representing all local drug companies, said a ban on prescriptions that carried brand names will put the patients at risk. Asked if there will be an adverse effect on the industry, he said: Yes there will be, but that #39s not the point. The industry will be there, it might operate on lower profits, and there might be employment terminated, that is true. But the point is one of quality and people being misled, Basnayake said.
Basnayake agrees with doctors that there are no stringent quality assurance mechanisms to check drugs (mostly imported from India) before and after they enter the market.
Doctors at state hospitals prescribe (and use) generic medicine in their daily work or when treating outpatients. But the same consultants prescribe expensive branded drugs in private practice. With state hospitals overcrowded with patients, and often facing drugs shortages, private hospitals with state-of-the-art facilities have sprung up across the countryside. Queues of patients waiting to consult popular doctors, paying high consultation fees, are a common sight at Colombo s posh private sector hospitals.
The price of generics and branded versions can be wide. For, example, the generic version of the antibiotic amoxycillin sells for a tenth of the price of branded versions.
The SLMC said that when a doctor prescribes a drug, he must be certain in his own mind that the drug has the desired effect, without deleterious side effects. This responsibility cannot be delegated to pharmacists. Who ultimately will take the responsibility? Will it be the prescribing doctor, or the dispensing pharmacist or sales person? There is a serious shortage of pharmacists in the country and it would be still worse if the responsibility is given to an unqualified, unregistered person, the council said.
Basnayake from the drugs industry says, If you make it unlawful for the doctor to prescribe brands, you put the patient at the mercy of the person in the pharmacy, who in Sri Lanka is mostly not qualified and can #39t even read the prescriptions.
Patients rights movements agree with this argument but say that the onus is on the government to create an environment for affordable, good quality drugs.
