3-month paperwork delays worsen drugs shortages

MBABANE – The pharmacy counters at public hospitals are sometimes empty or with a few medications.

As frustrations reach boiling point, doctors and nurses have resorted to a protest aimed at calling upon government to prioritise the health sector through provision of sufficient medicals required by patients.

They have embarked on protests at Mbabane Government Hospital, Mankayane Government Hospital and Nhlangano Health Centre.

It must be said that drugs shortages, long a periodic concern, have escalated in recent months to become a national emergency.

Occasionally, as criticism rains down upon the country’s pharmaceutical suppliers, which have been accused in some quarters of negligence or profiteering, two leading industry players have broken their silence, describing a procurement and importation system paralysed by bureaucracy and counterproductive regulatory double-handling.

Speaking under strict anonymity, the suppliers—herein referred to as supplier one and supplier two —provided detailed and, at times, damning testimony that pins the blame for medicine supply delays firmly on cumbersome governmental procedures.

culpability

What emerges is a story in which supplier culpability, often assumed, is undercut by what they describe as an ‘ordeal by paperwork’, stifling efficiency and sapping the goodwill of the very organisations relied upon to supply life-saving drugs.

Supplier one begins their account on receipt of an order for drugs from the Ministry of Health.

What might appear, to the outsider, a straightforward process of dispatching goods becomes a quagmire of regulatory hurdles even at the first hurdle.

Each product—be it a blister of antibiotics or a vial of insulin—must be listed on the Medicines Regulatory Unit (MRU) database.

This requirement extends to ensuring all registration documents for those products are up-to-date.

If even a single certificate has lapsed since the last procurement, the supplier must begin the process of collecting and resubmitting documentation from the original manufacturer.

“If everything is current, we proceed to request a Proforma Invoice (PFI) from our overseas manufacturer,” explains supplier one.

authorisation

“We then submit this invoice to the MRU. Following that, the MRU must convene and issue an authorisation letter for import. Depending on when papers are received and how often the committee sits, this process can be a matter of days or stretch up to a week or more.”

This initial waiting game is compounded by the inflexibility of the scheduling.

“Import permit applications are only accepted once a week—on Mondays—because the relevant committee meets on Tuesdays,” he further explains.

“If you miss the Monday cut-off, perhaps because of a delayed authorisation letter or a lost document, you must wait another full week. After submission, the permit then typically takes another week to be approved.”

These pauses, which repeat at each step, have a compounding effect. He elucidates: “From receiving the order to actually securing the import permit; we consistently wait three to four weeks—longer if there’s a public holiday or a committee sitting is postponed at short notice. Only then can we pay the manufacturer.”

But none of these delays take place in a vacuum, it has been learnt. It is understood that international norms exacerbate the wait as manufacturers will not even start making the goods until the suppliers have paid up front and in full.
no stock

“They keep little or no stock on hand; everything is made-to-order,” the veteran supplier said.

The Times SUNDAY has also established that transferring funds overseas requires the approved permit as banks will not process payment otherwise.

“If a manufacturer happens to have immediate stock available, they expect immediate payment, and by the time our permit has come through, the stock is often gone,” he lamented.

He added: “Once payment is made, the drugs are placed into the manufacturer’s production queue.”

The supplier explains that production generally takes 45-60 days—plus about 20 days if shipping from India.

This is what he said: “So even after the paperwork bottleneck, you’re lucky to have your order in-country within three months. That is, if everything goes right.”

Delays mount on the buyer’s side, too as they are not paid until after delivery, and often not for months afterward.

Government’s official terms are 45 days post-invoice, but this is seldom achieved.

invoices go unpaid

“We pay up front, wait months and sometimes, our invoices go unpaid for so long that it begins to affect our own ability to source new stock,” the supplier says.

The second supplier’s testimony reinforces these frustrations, and further expands upon the intricacies of the approval process.

He also expands that the first stage is the import authorisation letter from the MRU. The second supplier goes on to explain that all medicines to be imported must be included on an approved list, which is created when the contract is awarded, but often needs to be updated during the contract because some registration documents expire.

“For example, if a manufacturer’s plant is being re-evaluated or is waiting for a renewed licence, you simply cannot import—no matter the urgency of demand—until those documents arrive,” he explains.

He says it appears the MRU, for its part, draws a hard line as they do not consider pending renewals or expired documents, even if those documents were valid at the time of tender.

He pointed out that the authorisation letter, already subject to delays depending on committee ‘sitting times’, must be issued before application to the Ministry of Finance for an import permit.

Here, it is said that another batch of paperwork is required, which includes a valid tax clearance, revenue stamp purchases for duties and full set of company registration documents.

deadline

“Again, permit applications are only accepted weekly on Mondays, with a further week’s processing. Missing a deadline sends a supplier back to the start of the cycle,” he states in his explanatory response to our questionnaire.

Khanya Mabuza, the Principal Secretary in the Ministry of Health, said new guidelines have been crafted to address the challenges. He said these guidelines will prioritise pricing, quality and delivery timelines.

Asked about reports of government contemplating direct sourcing from manufacturers, the PS acknowledged that direct procurement poses challenges, particularly as low stock levels may put government at a disadvantage.

Post your comment

Your name:

Your e-mail address:

Add your comments:

Please enter the code you see in the image:

Image:

Code: