By Shannon Jayawardena
Regulatory framework is a vital component in Sri Lanka’s healthcare sector, said Ministry of Health, Nutrition and Indigenous Medicine Secretary Janaka Sugathadasa at the second annual meeting of South-East Asia Regulatory Network (SEARN) held last week.
Sugathadasa said: “Our healthcare module is truly unique and our Government has constantly been involved in our healthcare sector. Even now our health ministry is one of the largest spenders in the public. Health along with education, are the two pillars of our social democracy. Similarly we have quite consistently been regulating our healthcare sector.”
“Originally the regulation had been a partial part of our ministry but later the Government decided that the regulatory governors should be handled independently and thus established the National Medicine Regulatory Authority,” he added.
The National Medicines Regulatory Authority (NMRA) is the institution in which the Ministry of Health has vested the authority to ensure that the pharmaceuticals and medical devices available to the public meet the required standards of quality and are within the existing legislative framework with respect to the production, marketing and dispensing of these items.
Sugathadasa noted: “A regulator cannot and should not operate in isolation. Regulators should deal with the industry, economy and also with the clients. Clients are very important as they are members of the industry. A regulator’s responsibility is to ensure the quality of the products, be it drugs, pharmaceutical items, cosmetic products and so forth and the confidence of the market; not only for the purchases but also for the manufacturers and importers.”
Most patients are not quite educated in the medical sciences especially in Sri Lanka. 90% of the patients patronise public sector hospitals. Although people seek treatment from the healthcare professionals in the private sector, the Government is the biggest healthcare provider in Sri Lanka, he stated.
Sugathadasa said: “When it comes to ensuring access to medicine by all, especially to the poor and vulnerable sector of our population, a regulator’s role is very important. If you can’t ensure quality drugs and equipment at affordable prices, that will be a big issue in the market. Pharmaceutical is one of the largest markets in the world and here in Sri Lanka as well.”
He further emphasised on the fact that national regulators thereby have a large role to play in terms of efficiency, safety and innovation and it is very important to identify convergence and support systems that would be helpful to all regulators and all users of the regulatory system.