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Cancer medication: Presidential Secretariat questions banned med

18 Sep 2022

Director General of Health Services (DGHS) Dr. Asela Gunawardena has sought clarifications from the Director of the Apeksha Hospital over allegations of prescribing a banned drug – trastuzumab biosimilar (HERtiCAD) – for cancer patients, The Sunday Morning learns. Dr. Gunawardena had sought the clarifications in response to a query posed by the Presidential Secretariat. In a letter to the DGHS, Senior Additional Secretary to the President T.N. Amon has requested the DGHS to submit a comprehensive report on the matter before 8 September. However, The Sunday Morning learns that the matter is still under investigation by the Department of Health Services.   When contacted, Department of Health Services Medical Technology Services Director Dr. Anver Hamdani acknowledged that a letter had been sent to the DGHS and confirmed that the drug had not been channelled through official donations. “They have sent a letter to the Director General of Health Services. This drug was not received through an officially-channelled donation. There may be different donations that come to hospitals. The DGHS has called upon the Apeksha Hospital Director. The matter is being processed,” Dr. Hamdani said. When asked whether the Department had responded or submitted a report, Dr. Hamdani confirmed that a report had not been submitted yet. A case was filed in the Court of Appeal in March 2016 by Swiss pharmaceutical giant Hoffmann-La Roche Limited and its local agent A. Baur & Co. Limited against the National Medicines Regulatory Authority (NMRA), challenging the decision taken by the medicines regulator to grant registration to the first trastuzumab biosimilar in Sri Lanka. Initially, the Court had granted interim relief to the petitioners preventing the sale and distribution of the trastuzumab biosimilar in response to the ex-parte application made by Roche. The Court had subsequently vacated the stay order, noting the petitioners had deliberately refrained from giving notice to the NMRA of their intention to apply for interim relief. The Court had also noted that such interim relief would enhance the sale of Herceptin marketed by Roche and, in the process, establish a monopoly for it, and concluded interim relief would never have been granted if the Court had the benefit of an inter-parte inquiry. This allowed NMRA to grant market authorisation to other trastuzumab biosimilars as well, breaking Roche’s monopoly for trastuzumab in Sri Lanka. The case was finally dismissed by the Court of Appeal in October 2018. Attempts by The Sunday Morning to contact the NMRA to see whether the trastuzumab biosimilar (HERtiCAD) brand was registered and permitted in Sri Lanka were futile. Attempts made to contact DGHS Dr. Gunawardena on the matter also proved futile. – By Maheesha Mudugamuwa


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