The Malta Independent 21 March 2023, Tuesday
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Procurement of medicines system ‘bureaucratic’, ‘very laborious’ – Ombudsman

Marc Galdes Sunday, 19 March 2023, 09:30 Last update: about 2 days ago

The Office of the Ombudsman described the process to procure medicines as being “bureaucratic”, based on an investigation carried out in 2022 where it took around a year for a patient to receive the medicine prescribed to them.

“From this and previous investigations, it is clear that the procurement process is very laborious,” the report said.


It also pointed out how there is a dispute between the Central Procurement Supplies Unit (CPSU), the Superintendent of Public Health and the Medicines Authority, over the procedure which should be followed when procuring medicines. “This issue prolongs the process to the detriment of patients.”

The report also criticised the CPSU’s “one-size-fits-all” approach when choosing which medicines to procure. The CPSU provides generic medicines and resists providing branded medicines to patients, even if the patients may be resistant to the generic medicines. “These regulations are hindering its operations to the detriment of patients.”

The case in question was part of the Ombudsman’s 2022 case notes and it began from a complaint made by the father of a 22-year-old type 1 diabetic patient who said that the Department of Health was not providing the insulin prescribed by his child’s consultant diabetologist.

The Commissioner for Health discovered that the patient was prescribed a type of insulin by the Exceptional Medicinal Treatment Committee (EMTC) after the patient had “experienced adverse reactions from three other types prescribed by the consultant”.

The CPSU informed the Commissioner that it had tried everything but the insulin could not be sourced. The Office of the Permanent Secretary, within the Ministry for Health, said that no offers were being received and as an alternative, the CPSU was providing a generic alternative to all patients requiring this treatment.

“This was the crux of the problem because the generic was not the solution,” the report said.

Attempting to find a solution, the Commissioner got in touch with a well-known UK pharmaceutical company that was known by the CPSU. In response, the company confirmed that they can provide the particular insulin and even asked whether the patient needed “pens or vials”.

Although the CPSU said that it could not find a supplier, the investigation found that the UK supplier was never even contacted.

The report further criticised the CPSU because once the correspondence was forwarded to them, it issued a call for quotations even though it could not find another supplier, “wasting even more time”.

Another issue which arose was that the CPSU, the Medicines Authority and the Superintendent of Public Health did not agree on the procurement process and argued for one-and-a-half months. There were arguments that this medicine should be procured on a named-patient basis, but the CPSU preferred an Article 20 concession from the Medicines Authority, which is what was eventually accepted.

However, this meant that the Medicines Authority could only approve a three-month supply of this medicine. Therefore, the report pointed out that the patient would have to go through the bureaucratic process all over again.

The report then pointed out “another futile hurdle” which occurred once the medicines were delivered to a representative in Malta.

The local firm did not have a distribution licence, therefore, transport to carry the refrigerated medicine had to be hired. However, there was a dispute over who should pay for this and the CPSU even suggested that the medicines should be sent back to the UK and re-sent directly to CPSU.

“This is bureaucracy at its best.”

Eventually, the transport charges of €118 were paid by someone out of their own pockets and the insulin was then delivered to CPSU that day and the patient received the insulin the following day.

“The Commissioner for Health expressed his disappointment that, notwithstanding the assistance of his Office, it still took 54 days for the insulin to reach the patient from when the supplier was found.”

Overall a year passed from the time when the patient was given approval by the EMTC until the actual delivery of the medicine, all the while, the patient was at risk of adverse complications.

Following this investigation, the Commission for Health recommended that an urgent meeting is held between the Ministry for Health, the Ministry for Active Ageing, the Chief Medical Officer (CMO), the Superintendent of Public Health, the chairman of the Medicines Authority and the managing director of the CPSU, with the aim of the meeting being to find a way to simplify the procedure.

It is also recommended that the procurement process be shortened and that the CPSU adopts a more client-oriented approach.

In response to the investigation “the Office of the Permanent Secretary assured the Commissioner that the patient will continue to receive the treatment indefinitely without any further hassle. They also renewed their commitment to continue serving public health service users to the best of their abilities”.

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