Hon. (Dr.) Hansaka Wijemuni – Deputy Minister of Health and Mass Media

¶ 01 Hon. Presiding Member, today’s discussion is on the Fourth COPE Report of the 10th Parliament. While earlier some spoke of hallucinations and delusions figuratively, let me return to substance.

¶ 02 COPE is vital, not to mete out punishments directly, but to surface findings essential for the country’s future. There is a misconception that audits and COPE exist to punish officials; in fact, COPE reports help us correct shortcomings. We welcome this report and its recommendations.

¶ 03 On the National Medicines Regulatory Authority (NMRA), established in 2015—ten years on, necessary developments were stalled, as if kept perpetually infantile. Since coming to office, we have been advancing needed reforms. COPE’s observations will aid that.

¶ 04 On Waiver of Registration (WoR): this mechanism allows limited, controlled imports of medicines or devices—typically in small quantities, for donations, or in special circumstances—through two committees (for medicines and for devices). In recent years, citing delays, a so-called “special pathway” was created to bypass proper process. The outcome was disastrous: non-medicinal substances imported as medicines; substandard products; contaminated ophthalmic drops causing patient harm. The Health Ministry ultimately had to compensate, though no compensation can restore lost vision. No one, inside or outside State service, has the right to endanger lives by breaking established rules. We invite COPE to continue its scrutiny and guidance.

¶ 05 Claims were made that Colombo National Hospital lacks analgesics or other essential medicines. That is incorrect; analgesics and the cited medicines are available. Sometimes, rather than checking hospitals, people propagate false narratives here. It was also alleged that doctors avoid writing prescriptions due to strict rules. Not so. Hospitals are supplied, and where gaps arise, hospital administrations have funds to procure. In emergencies beyond these channels, additional measures are in place. We remain committed to ensuring availability while maintaining regulatory integrity.