Good medicine to revive patient-friendly health service - Editorial

In one of the healthiest moves for the New Year, Health Minister Maithripala Sirisena is this month expected to introduce in Parliament tough new legislation for the implementation of a National Medicinal Drugs Policy based on Professor Senaka Bibile’s Essential Medicines Concept which scores of countries have implemented successfully but his own home country has for various reasons delayed it for about four decades.

In terms of the legislation, which is likely to be passed unanimously in Parliament, all importers, manufacturers or pharmacies will be required to reregister with the new Authority and conform to strict procedures. The main aim of the new law is to ensure that all people have access to quality drugs at affordable prices as a first step towards restoring a health service where the wellbeing of the patient is given top priority.

The new law will ensure that poor quality, outdated or counterfeit drugs are not sold to unsuspecting patients because at present some 15,000 varieties of drugs are known to be registered and there is little or no quality control. As a result, some patients pay as much as Rs.100 for a counterfeit drug which contains wheat flour, health rights groups say.

According to our sister paper the Sunday Times, under the law a new body known as the Medicinal Drugs, Devices and Cosmetics Authority will issue licences to those in the trade and will function as the Central Regulator for all matters related to medicinal drugs. The authority will comprise three ex-officio members — the Director General of Health Services, the Deputy Director General of Health Services and the Secretary to the Treasury. The Minister of Health will appoint five specialists in general medicine, general surgery, paediatrics, gynaecology and obstetrics and anaesthesiology.

In addition, a professor of pharmacology from any faculty of medicine and four professionals in the fields of management, law, accountancy or health will also be members while the minister will name the chairperson. We hope the head of the Authority will be a person respected for his integrity and honesty, accountability and transparency and will not be influenced by the millions that some vested interest are known to be offering to those involved in this field which was once a sacred vocation then became a profession and now to a large extent is a big business.

Health rights groups are expressing the hope that though the authority will function under the ministry and the minister will appoint the chairperson, the Authority will be able to act independently and register drugs on the basis of five factors—quality, safety, efficacy, the cost of the drug and the need for it. Powerful transnational drug corporations are known to be opposed to the last two factors—the cost of the drug and the need for it. Health action groups say they hope the authority or the ministry will not give into these vested interests because at present Sri Lanka is importing thousands of varieties of non-essential or unnecessary drugs at high prices and under various brand names. Among the powers and functions of the Authority will be to authorise registration and licensing of medicinal drugs, devices, cosmetics or investigational medicinal products. It will issue licences for manufacture, import, storage, distribution, transport and sale of medicinal drugs, devices, cosmetics or investigational medicinal products and will also have the power to cancel such licences if there is evidence of any illegal or unethical practices. The new Authority will also authorise the registration and regulation of pharmacies and drug stores. At present thousands of pharmacies are known to be functioning illegally without the presence of a pharmacist and we hope this will be stopped under the new law.

Among other factors, the sale or advertising of medicinal drugs as prevention or cure for diseases, disorders or abnormal physical states will be prohibited without the approval of the Authority. The distribution of samples to physicians will also be prohibited and hopefully patients won’t have to see medical representatives hanging around the rooms of consultants to peddle their drugs.