- Regulator argues it is only following due procedure
Despite a Cabinet decision taken in January to upgrade the country’s cancer treatment infrastructure with high-quality radiotherapy equipment, regulatory holdups have delayed the provision of optimum care to cancer patients even as cases grow.
As per an agreement in 2013 for the supply of 14 linear accelerator (linac) machines under two phases, to be utilised for cancer treatments, the first phase of the project has already been implemented, although the second phase is yet to be executed.
The Cabinet decision in this regard notes that since many important features that are standards of modern cancer treatments utilised at present are not available in the specifications of the initial agreement signed in 2013, a proposal has been submitted by oncologists to secure upgraded machines.
Accordingly, the Cabinet granted its approval to upgrade the linac machines provided to the National Hospital of Kandy, National Hospital of Karapitiya, Teaching Hospital of Jaffna, and the Teaching Hospital of Batticaloa under the first phase and to secure the modern radiotherapy equipment for the five hospitals of Ratnapura, Badulla, Hambantota, Anuradhapura, and Kurunegala under the second phase within the Medium Term Budgetary Framework 2024‑2026 on a priority basis.
Mired in administrative delays
However, speaking to The Sunday Morning, Medical and Civil Rights Professional Association of Doctors (MCPA) President Dr. Chamal Sanjeewa noted that the process was mired in administrative delays, leading to setbacks in the procurement of the equipment.
He pointed out that the delay involved two different cases. Firstly, he noted that the Government wished to update the existing radiotherapy machines and bring in new models, for which National Medicines Regulatory Authority (NMRA) approval was needed. He added that this was being funded by the Treasury.
“The other issue is that the Asian Development Bank (ADB) has given a loan to buy new machines for the Karapitiya Hospital and several others. For this, they have to first go through the ministry procurement process. The delay here is at the ministry level with the Technical Evaluation Committee, where biomedical engineers are not giving approval or meeting regularly to evaluate the tender documents,” he charged.
Against this backdrop, patients requiring treatment have to bear numerous hardships, such as long waiting lists, deteriorated quality of life, and increased out-of-pocket expenditure.
“Most of our radiotherapy machines are outdated. That is why our cancer patients, when they are exposed to radiotherapy, undergo hair loss and hyperpigmentation. Moreover, the quality of life is poor with the available radiotherapy machines in Sri Lanka,” Dr. Sanjeewa noted.
“With the increasing number of cancer cases in Sri Lanka, when there is a waiting list for radiotherapy, if they are unable to get the treatment on time, they have to get the treatment from the private sector. This is why the College of Oncologists has suggested upgrading the present machines and buying the latest models – the linear accelerator – which will improve quality of life.”
Accordingly, Dr. Sanjeewa also stressed that this increase in cancer patients required a corresponding increase in the number of oncologists and oncosurgeons, given the shortage of such personnel. Further improvements required include improved bed capacity, Intensive Care Unit (ICU) capacity, and radiotherapy treatments, along with addressing the shortage in cancer medicines.
NCI plans for upgrades
Nevertheless, the National Cancer Institute (NCI), Maharagama is currently expecting the arrival of two of these linear accelerator machines next year.
NCI Director Dr. Aruna Jayasekara told The Sunday Morning: “We will be purchasing two linear accelerator machines with ADB funds. The purchasing order for this has been planned for December, so the machines will arrive by about March next year. We will also be purchasing a CT simulator and an MRI machine for the hospital.”
Addressing the current situation at the hospital, he said that while there were no significant issues, the new machines would significantly upgrade treatment.
“This hospital never had an MRI machine; we performed MRIs at the National Hospital of Sri Lanka, Colombo. The hospital has a CT simulator, but we will be replacing it since it’s very old. I believe the Government will be purchasing nine more linear accelerators for other hospitals. Once we get two, we will be able to undertake treatments without delay.”
He noted that going forward, they needed to increase the quality of treatment at the hospital, for which the new machines would prove useful.
NMRA denies delays
Meanwhile, NMRA Director General/Chief Executive Officer (CEO) Dr. K.M.G.K. Bandara noted that a decision had been made regarding the procurement of the linac machines, with the official decision to be communicated to the ministry.
“As a regulatory body, the NMRA only intervenes to issue a licence to import the relevant equipment. Procurement happens through the ministry. We are therefore not aware of the procurement details,” he said.
He further noted: “Although there were reports saying that an NMRA delay was holding things up, this is not what is happening. There is no special delay on the part of the NMRA. When issuing a licence for a product, there is a procedure we usually follow. According to this, a committee makes the relevant decisions after review, once we receive details and information from the supplier.
“While there may have been deadlines on the part of the ministry, the NMRA cannot give approval or agree to issue a licence without fulfilling the relevant criteria. This is what has been highlighted. This is not a delay on our part, but a delay in submitting the relevant documents on the part of the manufacturers.”
He further noted that the NMRA would inform the Government of its decision, although he declined to reveal what it was.
“As of now, this situation has been resolved and the ministry has been informed accordingly. The necessary documents have been submitted to take the decision we need and the decision has been made accordingly. The decision will be conveyed to the Government officially, after which the Government will take a decision regarding procurement.”
Attempts by The Sunday Morning to contact the Secretary to the Ministry of Health regarding the linac machine procurement proved futile.
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Cancer on the rise
Even as the need for radiotherapy equipment is being highlighted, the rising incidence of breast cancer poses a concern. With the upcoming Breast Cancer Awareness Month in October, the National Cancer Registry has revealed that around 28% of cancer cases reported in women in Sri Lanka are those of breast cancer, making it the most prevalent form of the disease affecting Sri Lankan women.
According to health authorities, approximately 15 new breast cancer cases are reported daily in Sri Lanka, while about three women die each day due to the disease.
Speaking to The Sunday Morning, Colombo North Teaching Hospital Consultant Cancer Surgeon Minoli Joseph said that there was a rise in the incidence of breast cancer in Sri Lanka, noting that requirement for a formal national mammography-based screening programme.
Dr. Joseph emphasised that since prevention was challenging, early detection remained the most effective strategy. “In Sri Lanka, screening is currently limited to clinical breast examination. Women aged 35 to 45 may have a clinical breast exam at Well Woman Clinics across the country. Currently, we do not have a formal national mammography-based screening programme, which, if introduced, could significantly improve outcomes,” she noted.
“Breast cancer is the most common cancer in women, both in Sri Lanka and globally. Based on our data, we diagnose approximately 4,500 new cases each year. In Sri Lanka, that is roughly equivalent to a one in 20 lifetime risk for women,” she said, noting that the reasons were multifactorial.
Outlining several contributing risk factors, she noted that a family history of breast or ovarian cancer, especially in first- or second-degree relatives, increased risk. Other causes of breast cancer include reproductive factors such as being childless, delaying childbirth until later in life, and not breastfeeding; postmenopausal weight gain, early menarche, late menopause, and use of hormone replacement therapy; as well as lifestyle influences such as smoking and alcohol consumption.
“Emerging evidence suggests that removal of the entire breast (mastectomy) does not always offer additional benefit over removal of the tumour alone (breast-conserving surgery). Indeed, for small tumours, patients undergoing breast-conserving surgery have better survival compared to those treated with mastectomy,” she noted.
She further said that although challenges existed, the State health sector provided a high quality of care which was delivered free to breast cancer patients. Nearly every province has an oncosurgical unit, mammography machines, and radiotherapy facilities. Chemotherapy and other systemic therapies are available in oncology units in each district.