In a major move to restore a patient-friendly health service in both the public and the private sectors, legislation is to be introduced soon for the setting up of a wide-powered National Medicinal Drug Regulatory Authority. The main objective of the NMDRA would be to ensure financial independence, improve efficiency and effectiveness, improve quality assurance of drugs, provide transparency and accountability and achieve regulatory balance.
Last week the Daily Mirror Health Action page carried an insight by World Health expert Dr. K. Balasubramaniam giving a description of the structural organization of the NMDRA best suited to implement the regulatory and other aspects of medicines in the National Medicinal Drug Policy.
In terms of draft legislation to be submitted to the Health Ministry, the new NMDRA will be expert based and not interest based. That means interested parties, such as transnational drug companies and even the Department of Health which is an importer of medicinal drugs, will not be represented on the NMDRA. The need for the NMDRA was highlighted recently by Professor Gita Fernando a specialist in pharmacology and president of the Sri Lanka Medical Association. She pointed out that after Sri Lanka went wholesale for the globalised capitalist market economy in 1977, more than 7,000 varieties of drugs under a multiplicity of brand names had been registered. This is perhaps a world record but, jokes apart, it means Sri Lanka with its dwindling foreign exchange reserves is wasting billions of rupees annually on the import of unnecessary non essential and highly expensive drugs under various brand names. A striking if not sickening case in point was that of paracetemol. As many as 135 varieties of this drug have been registered under various brand names, while rich countries like Britain with an excellent health service allows the prescription or sale of only five varieties of paracetemols.
According to Dr. Balasubramaniam, effective drug regulation is required to ensure the safety, efficacy and quality of drugs available in the market, as well as the accuracy and appropriateness of drug information provided to health professionals and the public.
Drug regulation is, therefore, a public policy response to the perceived problems and perceived needs of society, and it restricts private sector activities in a bid to attain social goals set by the state. Drug laws need to be updated to keep pace with changes in the pharmaceutical sector. This was the reason that the Ministry of Health, in collaboration with the World Health Organization (WHO), convened a multi-stakeholder workshop in February 2005 to review and update the national drug policy. A new National Medicinal Drug Policy (NMDP) was adopted by consensus by all stakeholders who participated in the workshop. The multi-stakeholder participants recognized the emerging problems and needs and collectively recommended the inclusion of two additional criteria namely the need, cause and cost-effectiveness. The participants recommended that the legislation also provide a provision for generic substitution.
The NMDRA will be entrusted with ensuring that all drugs available in the market are safe, effective of good quality, meet the real health needs of the people and are cost-effective. It is expected to carry out its tasks by applying the best available scientific knowledge and skills without bias. Competent human resources, adequate financial resources and freedom from the influence of politics and the interests of individuals, groups and the public are therefore critical. A sound organizational structure, the power to acquire and use resources, to appoint and dismiss staff and determine the level of their remuneration are essential for ensuring independent and unbiased decision-making with regard to drug regulation Dr. Balasubramaniam states.
The People`s Movement for the Rights of Patients ? spearheading the campaign for Professor Senaka Bibile`s essential medicines concept ? went to Galle last Sunday for a public health education and empowerment programme organized by the Saviya Development Foundation. The main speaker was the eminent medical personality Professor Carlo Fonseka, former Dean of the Medical Faculty. He stressed again that 85% of the diseases we get cure themselves because of the strong curative process within our bodies. Only 15% need external intervention. So if we have 7,000 varieties of drugs just to play this small curative role then it is apparently a case of too many pills killing the patient and this deadly trend needs to be stopped immediately.